Naobios and SGS Partner to Manufacture Respiratory Syncytial Virus (RSV) Challenge Agent




Naobios and SGS Partner to Manufacture Respiratory Syncytial Virus (RSV) Challenge Agent

Collaboration supports Controlled Human Infection Model (CHIM) studies that help accelerate development of effective and affordable RSV vaccines

NANTES, France & GENEVA–(BUSINESS WIRE)–Naobios, a Contract Development and Manufacturing Organization (CDMO) providing bioprocess development and GMP production of clinical batches of virus-based products, and SGS, the world’s leading testing, inspection and certification company, today announce their partnership in the manufacturing of a Respiratory Syncytial Virus (RSV) challenge agent for use in Controlled Human Infection Model (CHIM) studies conducted by SGS.

Produced under cGMP conditions, the Human Viral Challenge Agent (HVCA) is derived from a 2015 A-strain isolate that closely mirrors currently circulating RSV strains, with its realistic infection profile allowing researchers to generate robust, decision-enabling data on vaccine efficacy and immune response dynamics.

Naobios has already successfully completed the development, manufacturing and filling of several HVCAs for study use on the global market. HVCAs are used in strictly controlled clinical trials (or CHIM studies) in which healthy volunteers are intentionally given a carefully considered dose of a pathogen inoculated under rigorous ethical, regulatory and biosafety oversight to evaluate prophylactic vaccines or curative treatments.

These studies enable early and cost-efficient evaluation of RSV vaccines to prevent infection.

To generate first‑in‑human proof-of-concept data, in October 2025 12 healthy participants were inoculated at the SGS Clinical Pharmacology Unit in Antwerp, Belgium, with the RSV A-strain challenge agent. The participants showed a 100% attack rate with mild, self-resolving pathology.

“In response to the growing use of CHIM studies, we have invested to extend our range of services, enabling us to meet the critical needs of clients worldwide,” said Eric Le Forestier, general manager of Naobios. “This partnership with SGS demonstrates that Naobios continues to be a key global player and first-choice partner for viral challenge agent manufacturing in accordance with cGMP.”

About Naobios

Naobios is a Contract Development and Manufacturing Organization (CDMO) providing bioprocess development and offering GMP production of clinical batches of BSL2/BSL3 viral vaccines, oncolytic viruses, viral vectors and human viral challenge agents. Naobios joined the Clean Biologics group in 2019.

Having built up 20 years’ experience in bioprocess development, Naobios helps its clients to bring their drug candidates to the clinical stage as rapidly as possible – at the highest level of quality – whilst building on its technical know-how in scalable and industrial processes.

www.naobios.com

Contacts

Lorraine Walters

lorraine@ala.associates

Céline Gonzalez

celine@ala.associates

GenSight Biologics Provides Updates about GS010/LUMEVOQ® Early Access Programs and the Ongoing REVISE Study




GenSight Biologics Provides Updates about GS010/LUMEVOQ® Early Access Programs and the Ongoing REVISE Study

PARIS–(BUSINESS WIRE)–Regulatory News:

GenSight Biologics (Euronext: SIGHT, ISIN: FR0013183985, PEA-PME eligible), a biopharma company focused on developing and commercializing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders, today provided updates on the GS010/LUMEVOQ^® early access programs currently underway and the ongoing dose-ranging study REVISE. GS010/LUMEVOQ^® is the Company’s candidate gene therapy in clinical development as a treatment for Leber Hereditary Optic Neuropathy (LHON) caused by a mutated ND4 mitochondrial gene.¹

France: Approval of Applications in Named Patient Early Access (AAC) Program; Continuing Enrollment in the REVISE Study

Following the authorization of the AAC program by the national medicines safety agency ANSM in December 2025, individual applications that were submitted in February were approved today. The Company is completing the administrative steps to finalize delivery of the product to the 15-20 National Hospital, where the treatments have been scheduled for mid- and late March.

The dose-ranging study REVISE is progressing on schedule, with the first patient treated in February and the second patient expected to be enrolled over the next few weeks.

Israel: Second Patient for Paid Named Patient Program

A second patient in Israel was approved for treatment under the Paid Named Patient Program by the Israeli Ministry of Health (IMOH). The Company is supporting the logistical activities to ship and administer the treatment by next quarter.

USA: Second Individual IND Cleared for Expanded Access Program

A second US patient will be treated as part of the GS010/LUMEVOQ^® expanded access program after the FDA cleared the single patient IND for the patient in January 2026. The agency’s decision follows the treatment last year of the patient whose individual patient IND was cleared in October 2025.

First payments for the treatments in France are expected to be received before the end of March. Although the Company is unable to predict the precise timing of the treatments and payments in the various early access programs in the coming year, the expected revenues in the aggregate, are expected to be sufficient to, at a minimum, ensure the Company’s operational continuity beyond the February 2026 cash horizon indicated in the January 8th press release and, in the ordinary course of business, through 2026. Beyond this baseline, the Company will continue its funding operations, on a dilutive and non-dilutive basis, to further extend the cash runway and in particular to finance the RECOVER Phase III trial.

About GenSight Biologics

GenSight Biologics S.A. is a clinical-stage biopharma company focused on developing and commercializing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders. GenSight Biologics’ pipeline leverages two core technology platforms, the Mitochondrial Targeting Sequence (MTS) and optogenetics, to help preserve or restore vision in patients suffering from blinding retinal diseases. GenSight Biologics’ lead product candidate, GS010 (lenadogene nolparvovec) is in Phase III in Leber Hereditary Optic Neuropathy (LHON), a rare mitochondrial disease that leads to irreversible blindness in teens and young adults. GS010 is currently in clinical development, has not to date been granted marketing authorization in France or any other jurisdiction, and is therefore not available commercially. Using its gene therapy-based approach, GenSight Biologics’ product candidates are designed to be administered in a single treatment to each eye by intravitreal injection to offer patients a sustainable functional visual recovery.

Contacts

GenSight Biologics
Chief Financial Officer

Jan Eryk Umiastowski

jeumiastowski@gensight-biologics.com

ENHERTU® Granted Priority Review in the U.S. as Post-Neoadjuvant Treatment for Patients with HER2 Positive Early Breast Cancer




ENHERTU® Granted Priority Review in the U.S. as Post-Neoadjuvant Treatment for Patients with HER2 Positive Early Breast Cancer

• Based on DESTINY-Breast05 phase 3 trial results, which showed ENHERTU reduced the risk of invasive disease recurrence or death by 53% compared to T-DM1
• If approved, Daiichi Sankyo and AstraZeneca’s ENHERTU has the potential to become a new standard of care in this early breast cancer setting

TOKYO & BASKING RIDGE, N.J.–(BUSINESS WIRE)–Daiichi Sankyo (TSE: 4568) and AstraZeneca’s (LSE/STO/NYSE: AZN) supplemental Biologics License Application (sBLA) for ENHERTU^® (fam-trastuzumab deruxtecan-nxki) has been accepted and granted Priority Review in the U.S. for the treatment of adult patients with HER2 positive (immunohistochemistry [IHC] 3+ or in-situ hybridization (ISH)+) breast cancer who have residual invasive disease after neoadjuvant HER2 targeted treatment.

ENHERTU is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca.

The U.S. Food and Drug Administration (FDA) grants Priority Review to applications for medicines that, if approved, would offer significant benefit over available treatment options by demonstrating safety or efficacy improvements, preventing serious conditions or enhancing patient compliance. The Priority Review follows receipt of Breakthrough Therapy Designation granted by the FDA in December 2025 for ENHERTU based on data from the DESTINY-Breast05 phase 3 trial presented at the 2025 European Society of Medical Oncology (#ESMO25) Congress and subsequently published in The New England Journal of Medicine. The Prescription Drug User Fee Act (PDUFA) date, the FDA target action date for their regulatory decision, is July 7, 2026.

Results from DESTINY-Breast05 showed ENHERTU significantly reduced the risk of invasive disease recurrence or death (invasive disease-free survival [IDFS]) by 53% (hazard ratio [HR]=0.47; 95% confidence interval [CI]: 0.34-0.66; p<0.0001) compared to trastuzumab emtansine (T-DM1) as a post-neoadjuvant treatment for patients with HER2 positive breast cancer with residual invasive disease following neoadjuvant therapy. Trial results demonstrated a three-year IDFS rate of 92.4% (95% CI: 89.7-94.4) in the ENHERTU arm compared to 83.7% with T-DM1 (95% CI: 80.2-86.7). IDFS findings were consistent across all prespecified subgroups.

Data also showed that ENHERTU significantly reduced the risk of disease recurrence or death by 53% (HR=0.47; 95% CI: 0.34-0.66; p<0.0001) compared to T-DM1. Treatment with ENHERTU in DESTINY-Breast05 also reduced the risk of distant disease recurrence (distant recurrence-free interval [DRFI]) by 51% (HR=0.49; 95% CI: 0.34-0.71) and the risk of brain metastases (brain metastasis-free interval [BMFI]) by 36% (HR=0.64; 95% CI: 0.35-1.17) versus T-DM1.

The sBLA is being reviewed under Project Orbis, which provides a framework for the concurrent submission and review of oncology medicines among participating international partners. This initiative is designed to bring effective cancer treatments to patients as early as possible.

“For patients with residual invasive disease after neoadjuvant therapy, identifying additional treatments following surgery is critical to help further reduce the risk of recurrence and help prevent progression to metastatic disease,” said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo. “This Priority Review reinforces the potential of ENHERTU to become a new standard of care for HER2 positive early breast cancer based on the results of DESTINY-Breast05.”

“While there has been significant progress in treating HER2 positive early breast cancer, managing patients at a higher risk of recurrence remains challenging,” said Susan Galbraith, MBBChir, PhD, Executive Vice President, Oncology Hematology R&D, AstraZeneca. “With this Priority Review, we move closer to bringing ENHERTU to the post-neoadjuvant setting, offering more patients the opportunity for sustained long-term outcomes and a potential path to cure.”

The safety profile of ENHERTU observed in DESTINY-Breast05 was consistent with its known profile with no new safety concerns identified. Grade 3 or higher treatment emergent adverse event (TEAE) rates were comparable between ENHERTU (50.6%) and T-DM1 (51.9%). The most common grade 3 or higher TEAEs occurring in 5% or more of patients treated with ENHERTU were decreased neutrophil count (15.5%), decreased white blood cell count (10.1%), decreased platelet count (6.7%) and neutropenia (8.1%). Rates of interstitial lung disease (ILD) or pneumonitis were low in both arms with ILD events occurring in 9.6% of the ENHERTU arm and 1.6% of the T-DM1 arm. The majority of ILD or pneumonitis events were low grade (grade 1 [ENHERTU=16; 2.0%; T-DM1=8; 1.0%] or grade 2 [ENHERTU=52; 6.5%; T-DM1=5; 0.6%]). There were no grade 3 or higher ILD or pneumonitis events for T-DM1. In the ENHERTU arm, there were seven grade 3 events (0.9%) and two grade 5 events (0.2%) as determined by an independent adjudication committee.

Regulatory submissions for ENHERTU based on DESTINY-Breast05 are under review in the EU and Japan. In addition, an sBLA for ENHERTU followed by paclitaxel, trastuzumab and pertuzumab (THP) currently is under review in the U.S. for the neoadjuvant treatment of adult patients with HER2 positive (IHC 3+ or ISH+) stage 2 or stage 3 breast cancer based on results from the DESTINY-Breast11 trial with a PDUFA date of May 18, 2026.

About DESTINY-Breast05

DESTINY-Breast05 is a global, multicenter, randomized, open-label, phase 3 trial evaluating the efficacy and safety of ENHERTU (5.4 mg/kg) versus T-DM1 in patients with HER2 positive early breast cancer with residual invasive disease in breast or axillary lymph nodes following neoadjuvant therapy and a high risk of recurrence. High risk of recurrence was defined as presentation with inoperable cancer (prior to neoadjuvant therapy) or pathologically positive axillary lymph nodes following neoadjuvant therapy.

The primary endpoint of DESTINY-Breast05 is investigator-assessed IDFS, which is defined as the time from randomization until first invasive local, axillary or distant recurrence or death from any cause. The key secondary endpoint is investigator-assessed DFS. Other secondary endpoints include overall survival, DRFI, BMFI, interval and safety.

DESTINY-Breast05 enrolled 1,635 patients in Asia, Europe, North America, Oceania and South America. For more information about the trial, visit ClinicalTrials.gov.

About Post-Neoadjuvant Treatment for HER2 Positive Early Breast Cancer

Breast cancer is the second most common cancer and one of the leading causes of cancer-related deaths worldwide.¹ More than two million breast cancer cases were diagnosed in 2022, with more than 665,000 deaths globally.¹ In the U.S., more than 320,000 cases of breast cancer are diagnosed annually with more than 42,000 deaths.²

HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumors including breast cancer.³ HER2 protein overexpression may occur as a result of HER2 gene amplification and is often associated with aggressive disease and poor prognosis in breast cancer.³ Approximately one in five cases of breast cancer is considered HER2 positive.⁴

For patients with HER2 positive early breast cancer, achieving pathologic complete response (pCR) with neoadjuvant treatment is the earliest indicator of improved long-term survival.⁵ However, approximately half of patients who receive neoadjuvant treatment do not experience pCR, putting them at increased risk of disease recurrence.^6,7,8,9,10

Despite receiving additional treatment for residual disease in the post-neoadjuvant setting, some patients still experience invasive disease or death and current treatment options have shown limited impact on central nervous system recurrence.¹¹ Once patients are diagnosed with metastatic disease, the five-year survival rate drops from nearly 90% to approximately 30%.¹²

Post-neoadjuvant therapy represents a key opportunity to minimize the risk of recurrence and prevent progression to metastatic disease for patients with residual disease. New treatment options are needed in the early breast cancer setting to help reduce the likelihood of disease progression and improve long-term outcomes for more patients.^13,14

About ENHERTU

ENHERTU (trastuzumab deruxtecan; fam-trastuzumab deruxtecan-nxki in the U.S. only) is a HER2 directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, ENHERTU is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced program in AstraZeneca’s ADC scientific platform. ENHERTU consists of a HER2 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.

ENHERTU (5.4 mg/kg) in combination with pertuzumab is approved in the U.S. as a first-line treatment for adult patients with unresectable or metastatic HER2 positive (IHC 3+ or ISH+) breast cancer, as determined by an FDA-approved test, based on the results from the DESTINY-Breast09 trial.

ENHERTU (5.4 mg/kg) is approved in more than 90 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2 positive (IHC 3+ or ISH+) breast cancer who have received a prior anti-HER2-based regimen, either in the metastatic setting or in the neoadjuvant or adjuvant setting, and have developed disease recurrence during or within six months of completing therapy based on the results from the DESTINY-Breast03 trial.

ENHERTU (5.4 mg/kg) is approved in more than 90 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2 low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy based on the results from the DESTINY-Breast04 trial.

ENHERTU (5.4 mg/kg) is approved in more than 60 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic hormone receptor (HR) positive, HER2 low (IHC 1+ or IHC 2+/ ISH-) or HER2 ultralow (IHC 0 with membrane staining) breast cancer, as determined by a locally or regionally approved test, that have progressed on one or more endocrine therapies in the metastatic setting based on the results from the DESTINY-Breast06 trial.

ENHERTU (5.4 mg/kg) is approved in more than 70 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic NSCLC whose tumors have activating HER2 (ERBB2) mutations, as detected by a locally or regionally approved test, and who have received a prior systemic therapy based on the results from the DESTINY-Lung02 and/or DESTINY-Lung05 trials. Continued approval in China and the U.S. for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

ENHERTU (6.4 mg/kg) is approved in more than 80 countries/regions worldwide for the treatment of adult patients with locally advanced or metastatic HER2 positive (IHC 3+ or IHC 2+/ISH+) gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen based on the results from the DESTINY-Gastric01, DESTINY-Gastric02 and/or DESTINY-Gastric04 trials.

ENHERTU (5.4 mg/kg) is approved in more than 10 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2 positive (IHC 3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options based on efficacy results from the DESTINY-PanTumor02, DESTINY-Lung01 and DESTINY-CRC02 trials. Continued approval in the U.S. for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

About the ENHERTU Clinical Development Program

A comprehensive global clinical development program is underway evaluating the efficacy and safety of ENHERTU as a monotherapy or in combination or sequentially with other cancer medicines across multiple HER2 targetable cancers.

About the Daiichi Sankyo and AstraZeneca Collaboration

Daiichi Sankyo and AstraZeneca entered into a global collaboration to jointly develop and commercialize ENHERTU in March 2019 and DATROWAY^® in July 2020, except in Japan where Daiichi Sankyo maintains exclusive rights for each ADC. Daiichi Sankyo is responsible for the manufacturing and supply of ENHERTU and DATROWAY.

About the ADC Portfolio of Daiichi Sankyo

The Daiichi Sankyo ADC portfolio consists of eight ADCs in clinical development crafted from ADC technology discovered in-house by Daiichi Sankyo.

The DXd ADC Technology platform of Daiichi Sankyo consists of seven ADCs in clinical development where each ADC is comprised of a monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. The DXd ADCs include ENHERTU and DATROWAY, which are being jointly developed and commercialized globally with AstraZeneca, and ifinatamab deruxtecan (I-DXd), raludotatug deruxtecan (R-DXd) and patritumab deruxtecan (HER3-DXd), which are being jointly developed and commercialized globally with Merck & Co., Inc, Rahway, NJ, USA. DS-3939 and DS3790 are being developed by Daiichi Sankyo.

An additional ADC being developed by Daiichi Sankyo is DS3610, which consists of an antibody attached to a novel payload that acts as an agonist of STING.

Ifinatamab deruxtecan, raludotatug deruxtecan, patritumab deruxtecan, DS-3939, DS3610 and DS3790 are investigational medicines that have not been approved for any indication in any country. Safety and efficacy have not been established.

ENHERTU U.S. Important Safety Information

Indications

ENHERTU is a HER2-directed antibody and topoisomerase inhibitor conjugate indicated:

• HER2-Positive Metastatic Breast Cancer
  • In combination with pertuzumab as first-line treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+ or ISH+) breast cancer, as determined by an FDA-approved test
  • As monotherapy for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+ or ISH+) breast cancer who have received a prior anti-HER2-based regimen either in the metastatic setting, or, in the neoadjuvant or adjuvant setting and have developed disease recurrence during or within six months of completing therapy

• HER2-Low and HER2-Ultralow Metastatic Breast Cancer
  • As monotherapy for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-low (IHC 1+ or IHC 2+/ISH-) or HER2-ultralow (IHC 0 with membrane staining) breast cancer, as determined by an FDA-approved test, that has progressed on one or more endocrine therapies in the metastatic setting
  • As monotherapy for the treatment of adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer, as determined by an FDA-approved test, who have received a prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy

• HER2-Mutant Unresectable or Metastatic Non-Small Cell Lung Cancer (NSCLC)
  • As monotherapy for the treatment of adult patients with unresectable or metastatic NSCLC whose tumors have activating HER2 (ERBB2) mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy

    This indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

• HER2-Positive Locally Advanced or Metastatic Gastric Cancer
  • As monotherapy for the treatment of adult patients with locally advanced or metastatic HER2-positive (IHC 3+ or IHC 2+/ISH positive) gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen

• HER2-Positive (IHC 3+) Unresectable or Metastatic Solid Tumors
  • As monotherapy for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options

    This indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

ENHERTU U.S. Important Safety Information

Contraindications

None.

Warnings and Precautions

Interstitial Lung Disease / Pneumonitis

Severe, life-threatening, or fatal interstitial lung disease (ILD), including pneumonitis, can occur in patients treated with ENHERTU monotherapy or ENHERTU in combination with pertuzumab. A higher incidence of Grade 1 and 2 ILD/pneumonitis has been observed in patients with moderate renal impairment. Advise patients to immediately report cough, dyspnea, fever, and/or any new or worsening respiratory symptoms. Monitor patients for signs and symptoms of ILD. Promptly investigate evidence of ILD. Evaluate patients with suspected ILD by radiographic imaging. Consider consultation with a pulmonologist. For asymptomatic ILD/pneumonitis (Grade 1), interrupt ENHERTU until resolved to Grade 0, then if resolved in ≤28 days from date of onset, maintain dose. If resolved in >28 days from date of onset, reduce dose 1 level. Consider corticosteroid treatment as soon as ILD/pneumonitis is suspected (e.g., ≥0.5 mg/kg/day prednisolone or equivalent). For symptomatic ILD/pneumonitis (Grade 2 or greater), permanently discontinue ENHERTU. Promptly initiate systemic corticosteroid treatment as soon as ILD/pneumonitis is suspected (e.g., ≥1 mg/kg/day prednisolone or equivalent) and continue for at least 14 days followed by gradual taper for at least 4 weeks.

HER2-Positive, HER2-Low, and HER2-Ultralow Metastatic Breast Cancer, HER2-Mutant NSCLC, and Solid Tumors (Including IHC 3+) (5.4 mg/kg)

ENHERTU as Monotherapy

In patients treated with ENHERTU 5.4 mg/kg, ILD occurred in 12% of patients. Median time to first onset was 5.5 months (range: 0.9 to 31.5). Fatal outcomes due to ILD and/or pneumonitis occurred in 0.9% of patients treated with ENHERTU.

ENHERTU in Combination with Pertuzumab

In patients treated with ENHERTU 5.4 mg/kg in combination with pertuzumab (N=431), ILD occurred in 12% of patients. Median time to first onset was 8.0 months (range: 0.6 to 33.8). Fatal outcomes due to ILD and/or pneumonitis occurred in 0.5% of patients treated with ENHERTU in combination with pertuzumab.

HER2-Positive Locally Advanced or Metastatic Gastric Cancer (6.4 mg/kg)

In patients with locally advanced or metastatic HER2-positive gastric or GEJ adenocarcinoma treated with ENHERTU 6.4 mg/kg, ILD occurred in 10% of patients. Median time to first onset was 2.8 months (range: 1.2 to 21).

Neutropenia

Severe neutropenia, including febrile neutropenia, can occur in patients treated with ENHERTU monotherapy or ENHERTU in combination with pertuzumab. Monitor complete blood counts prior to initiation of ENHERTU and prior to each dose, and as clinically indicated. For Grade 3 neutropenia (Absolute Neutrophil Count [ANC] <1.0 to 0.5 x 10⁹/L), interrupt ENHERTU until resolved to Grade 2 or less, then maintain dose. For Grade 4 neutropenia (ANC <0.5 x 10⁹/L), interrupt ENHERTU until resolved to Grade 2 or less, then reduce dose by 1 level. For febrile neutropenia (ANC <1.0 x 10⁹/L and temperature >38.3º C or a sustained temperature of ≥38º C for more than 1 hour), interrupt ENHERTU until resolved, then reduce dose by 1 level.

HER2-Positive, HER2-Low, and HER2-Ultralow Metastatic Breast Cancer, HER2-Mutant NSCLC, and Solid Tumors (Including IHC 3+) (5.4 mg/kg)

ENHERTU as Monotherapy

In patients treated with ENHERTU 5.4 mg/kg, a decrease in neutrophil count was reported in 65% of patients. Nineteen percent had Grade 3 or 4 decreased neutrophil count. Median time to first onset of decreased neutrophil count was 22 days (range: 2 to 939). Febrile neutropenia was reported in 1.2% of patients.

ENHERTU in Combination with Pertuzumab

In patients treated with ENHERTU 5.4 mg/kg in combination with pertuzumab (N=431), decreased neutrophil count occurred in 79% of patients. Median time to first onset was 22 days (range: 5 to 994). Twenty-nine percent had Grade 3 or 4 decreased neutrophil count. Febrile neutropenia was reported in 2.6% of patients.

HER2-Positive Locally Advanced or Metastatic Gastric Cancer (6.4 mg/kg)

In patients with locally advanced or metastatic HER2-positive gastric or GEJ adenocarcinoma treated with ENHERTU 6.4 mg/kg, a decrease in neutrophil count was reported in 72% of patients. Fifty-one percent had Grade 3 or 4 decreased neutrophil count. Median time to first onset of decreased neutrophil count was 16 days (range: 4 to 187). Febrile neutropenia was reported in 4.8% of patients.

Left Ventricular Dysfunction

Patients treated with ENHERTU may be at increased risk of developing left ventricular dysfunction. Left ventricular ejection fraction (LVEF) decrease has been observed with anti-HER2 therapies, including ENHERTU. Assess LVEF prior to initiation of ENHERTU and at regular intervals during treatment as clinically indicated. Manage LVEF decrease through treatment interruption. When LVEF is >45% and absolute decrease from baseline is 10-20%, continue treatment with ENHERTU. When LVEF is 40-45% and absolute decrease from baseline is <10%, continue treatment with ENHERTU and repeat LVEF assessment within 3 weeks. When LVEF is 40-45% and absolute decrease from baseline is 10-20%, interrupt ENHERTU and repeat LVEF assessment within 3 weeks. If LVEF has not recovered to within 10% from baseline, permanently discontinue ENHERTU. If LVEF recovers to within 10% from baseline, resume treatment with ENHERTU at the same dose. When LVEF is <40% or absolute decrease from baseline is >20%, interrupt ENHERTU and repeat LVEF assessment within 3 weeks. If LVEF of <40% or absolute decrease from baseline of >20% is confirmed, permanently discontinue ENHERTU. Permanently discontinue ENHERTU in patients with symptomatic congestive heart failure. Treatment with ENHERTU has not been studied in patients with a history of clinically significant cardiac disease or LVEF <50% prior to initiation of treatment.

HER2-Positive, HER2-Low, and HER2-Ultralow Metastatic Breast Cancer, HER2-Mutant NSCLC, and Solid Tumors (Including IHC 3+) (5.4 mg/kg)

ENHERTU as Monotherapy

In patients treated with ENHERTU 5.4 mg/kg, LVEF decrease was reported in 4.6% of patients, of which 0.6% were Grade 3 or 4.

ENHERTU in Combination with Pertuz

Contacts

Media Contacts:

Global/US:
Jennifer Brennan

Daiichi Sankyo

jennifer.brennan@daiichisankyo.com
+1 908 900 3183 (mobile)

Japan:
Daiichi Sankyo Co., Ltd.

DS-PR_jp@daiichisankyo.com

Investor Relations Contact:
DaiichiSankyoIR_jp@daiichisankyo.com

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Genentech Provides Update on Phase III persevERA Study in ER-positive Advanced Breast Cancer




Genentech Provides Update on Phase III persevERA Study in ER-positive Advanced Breast Cancer

• persevERA Breast Cancer study did not meet the primary objective of a statistically significant improvement in progression-free survival, but a numerical improvement was observed

• Giredestrant plus palbociclib was well tolerated and adverse events were consistent with the known safety profiles of each individual treatment

• Genentech is committed to transforming ER-positive breast cancer care, anchored by the landmark success of lidERA in early-stage disease and evERA in the advanced setting

• The FDA recently accepted the New Drug Application based on evERA data; Phase III lidERA data will be submitted to the FDA in the coming weeks

• persevERA is the first of two distinct Phase III studies in the first-line setting; pionERA study of giredestrant in combination with physician’s choice of CDK4/6 inhibitor in endocrine-resistant ER-positive breast cancer is expected to readout in 2027

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today results from the Phase III persevERA Breast Cancer study evaluating investigational giredestrant in combination with palbociclib for people with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer. The study did not meet its primary objective of a statistically significant improvement in progression-free survival in the intent-to-treat population versus letrozole plus palbociclib, but a numerical improvement was observed. The adverse events for the giredestrant combination were manageable and consistent with the known safety profiles of each individual treatment.

“While persevERA didn’t meet its primary objective, we are confident in the potential of giredestrant to become a new standard-of-care endocrine therapy in early and advanced ER-positive breast cancer,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “We believe there is a path forward for combining giredestrant with a CDK4/6 inhibitor in the adjuvant setting and we are conducting further studies. The efficacy demonstrated in evERA and lidERA provides clear validation of the clinical activity of giredestrant and reinforces the strength of our expanding clinical development program.”

The giredestrant clinical development program is made up of distinct studies designed to reflect the specific disease biology of each stage of breast cancer. Genentech will continue to advance the clinical development program to identify the people with ER-positive breast cancer who can derive the greatest benefit from giredestrant.

Giredestrant Phase III clinical development program

evERA was the first positive Phase III readout for giredestrant, followed by lidERA in the early-stage setting. The scientific rationale for lidERA was supported by prior results in the neoadjuvant setting, including the Phase II coopERA trial showing that giredestrant was superior to an aromatase inhibitor in reducing malignant cell division (Ki67 levels). This growing body of evidence underscores the potential of giredestrant to become a new standard-of-care endocrine therapy across ER-positive early-stage and advanced breast cancer.

persevERA is the first of two distinct Phase III studies in the first-line setting; the pionERA study of giredestrant in combination with physician’s choice of cyclin-dependent kinase (CDK)4/6 inhibitor in endocrine-resistant ER-positive, HER2-negative breast cancer is expected to readout in 2027.

The United States Food and Drug Administration (FDA) recently accepted the New Drug Application based on the evERA data. In the coming weeks, Genentech will submit the giredestrant Phase III lidERA data in early-stage breast cancer to the FDA.

The full results from persevERA will be presented at an upcoming medical meeting.

About the persevERA Breast Cancer study

persevERA Breast Cancer [NCT04546009] is a Phase III, randomized, double-blind, placebo-controlled, multicenter study evaluating the efficacy and safety of giredestrant plus palbociclib versus letrozole plus palbociclib as first-line treatment for people with estrogen receptor-positive, human epidermal growth factor receptor 2-negative, locally advanced or metastatic breast cancer. The study enrolled 992 patients globally.

The primary endpoint is investigator-assessed progression-free survival. Key secondary endpoints include overall survival, objective response rate, duration of response and safety.

About giredestrant

Giredestrant is an investigational, oral, potent next-generation selective estrogen receptor degrader and full antagonist.

Giredestrant is designed to block estrogen from binding to the estrogen receptor (ER), triggering its breakdown (known as degradation) and stopping or slowing down the growth of cancer cells.

Giredestrant has an extensive clinical development program and is being investigated in five company-sponsored Phase III clinical trials that span multiple treatment settings and lines of therapy to benefit as many people as possible:

• Giredestrant versus standard-of-care endocrine therapy (SoC ET) as adjuvant treatment in ER-positive, human epidermal growth factor receptor 2 (HER2)-negative early-stage breast cancer (lidERA Breast Cancer; NCT04961996)
• Giredestrant plus everolimus versus SoC ET plus everolimus in ER-positive, HER2-negative, locally advanced or metastatic breast cancer (evERA Breast Cancer; NCT05306340)
• Giredestrant plus palbociclib versus letrozole plus palbociclib in ER-positive, HER2-negative, endocrine-sensitive, recurrent locally advanced or metastatic breast cancer (persevERA Breast Cancer; NCT04546009)
• Giredestrant plus investigator’s choice of a cyclin-dependent kinase (CDK)4/6 inhibitor versus fulvestrant plus a CDK4/6 inhibitor in ER-positive, HER2-negative advanced breast cancer resistant to adjuvant endocrine therapy (pionERA Breast Cancer; NCT06065748)
• Giredestrant plus dual HER2 blockade versus dual HER2 blockade in ER-positive, HER2-positive locally advanced or metastatic breast cancer (heredERA Breast Cancer; NCT05296798)

About estrogen receptor (ER)-positive breast cancer

Globally, the burden of breast cancer continues to grow, with 2.3 million women diagnosed and 670,000 dying from the disease every year. Breast cancer remains the number one cause of cancer-related deaths amongst women, and the second most common cancer type.

ER-positive breast cancer accounts for approximately 70% of breast cancer cases. In the U.S. and EU5, an estimated 273,000 people are diagnosed in the early-stage setting, 88,000 people are diagnosed in first-line and 106,000 in the second and third-line setting combined.

A defining feature of ER-positive breast cancer is that its tumor cells have receptors that attach to estrogen, which can contribute to tumor growth.

Despite treatment advances, ER-positive breast cancer remains particularly challenging to treat due to its biological complexity. In the early-stage setting, up to a third of people eventually experience disease recurrence on or after adjuvant endocrine therapy treatment. Additionally, many have to interrupt or stop treatment early due to safety or tolerability issues, thereby increasing the risk of death. In advanced settings, resistance to endocrine therapy – particularly following treatment with cyclin-dependent kinase inhibitors – increases the risk of disease progression and is associated with poor outcomes.

There is an urgent need for more effective treatments that can delay clinical progression and reduce the burden of treatment on people’s lives.

About Genentech in Breast Cancer

Genentech has been advancing breast cancer research for more than 30 years with the goal of helping as many people with the disease as possible. Our medicines, along with companion diagnostic tests, have contributed to bringing breakthrough outcomes in multiple types of breast cancers. As our understanding of breast cancer biology rapidly improves, we are working to identify new biomarkers and approaches to treatment for other subtypes of the disease, including estrogen receptor-positive breast cancer, which is a form of hormone receptor-positive breast cancer, the most prevalent type of all breast cancers.

About Genentech

Founded 50 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.

Contacts

Media Contact: Jared Preston (650) 467-6800

Advocacy Contact: Julie Burns (860) 881-6594

Investor Contacts: Loren Kalm (650) 225-3217

Bruno Eschli +41 61 68-75284

Zura Bio to Present Phase 2 TibuSURE Study Design Poster Evaluating Dual IL-17A and BAFF Inhibition in Systemic Sclerosis at 9th Systemic Sclerosis World Congress




Zura Bio to Present Phase 2 TibuSURE Study Design Poster Evaluating Dual IL-17A and BAFF Inhibition in Systemic Sclerosis at 9th Systemic Sclerosis World Congress

HENDERSON, Nev.–(BUSINESS WIRE)–$ZURA #TeamZura—Zura Bio Limited (Nasdaq: ZURA) (“Zura”), a clinical-stage biotechnology company developing novel and differentiated medicines to meaningfully improve the lives of patients with serious and debilitating autoimmune and inflammatory diseases, today announced that the design of its ongoing Phase 2 TibuSURE clinical trial evaluating tibulizumab (ZB-106) in systemic sclerosis (SSc) has been accepted for poster presentation at the Systemic Sclerosis World Congress, taking place March 5–7, 2026 in Athens, Greece.

The poster, titled “TibuSURE: A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study with Open-Label Extension to Evaluate the Efficacy, Safety, and Tolerability of Tibulizumab in Adults with Systemic Sclerosis” (Abstract ID 184; Poster P.267), outlines the rationale and design of the global Phase 2 study. No clinical efficacy or safety data will be presented.

Diffuse cutaneous systemic sclerosis (“dcSSc”) is a rare, progressive autoimmune disease characterized by immune activation, vasculopathy and fibrosis affecting the skin and internal organs, including the lungs. Treatment options remain limited, highlighting the need for therapeutic approaches that address multiple drivers of disease biology.

TibuSURE is the first clinical trial designed to evaluate the dual inhibition of interleukin-17A (“IL-17A”) and B-cell activating factor (“BAFF”) in dcSSc. Tibulizumab is an investigational bispecific antibody engineered to simultaneously neutralize IL-17A and BAFF, two cytokines implicated in inflammation, autoimmunity and fibrotic progression in SSc. By targeting complementary immune pathways, tibulizumab represents a differentiated investigational strategy intended to modulate both inflammatory and fibrotic disease processes.

The ongoing global Phase 2 study is expected to enroll approximately 80 adults who will be randomized 1:1 to receive tibulizumab or placebo every four weeks for 24 weeks, followed by a 28-week open-label extension. The primary endpoint is change from baseline in modified Rodnan Skin Score at Week 24. Topline results are currently anticipated in the first half of 2027.

Poster Presentation Details

• Poster Number: P.267
• Presenting Author: Christopher Denton, M.D., Ph.D., FRCP, Professor of Experimental Rheumatology at University College London
• Session Times (Local Athens Time, EET / UTC+2):
  • Friday, March 6, 2026: 13:20–14:25
  • Saturday, March 7, 2026: 12:35–13:50

ABOUT TIBULIZUMAB (ZB-106)

Tibulizumab is an investigational, humanized, tetravalent dual-antagonist antibody engineered by fusing Taltz^® (ixekizumab) and tabalumab to bind to and neutralize both IL-17A and BAFF. It is currently being evaluated in two Phase 2 clinical studies in adults with hidradenitis suppurativa and systemic sclerosis. Prior to in-licensing by Zura, Phase 1/1b studies were conducted in patients with Sjögren’s syndrome and rheumatoid arthritis.

Tibulizumab is an investigational compound and has not been approved for marketing by the U.S. Food and Drug Administration or any other regulatory authority.

ABOUT ZURA

Zura is a clinical-stage, multi-asset immunology company developing novel dual-pathway antibodies for autoimmune and inflammatory diseases with unmet need. Zura’s pipeline includes product candidates designed to target key mechanisms of immune system imbalance, with the goal of improving efficacy, safety, and dosing convenience for patients.

Zura’s lead product candidate, tibulizumab (ZB-106), is being evaluated in two Phase 2 clinical studies in adults: TibuSHIELD, a study in hidradenitis suppurativa (HS), and TibuSURE, a study in systemic sclerosis (SSc). Additional product candidates crebankitug (ZB-168) and torudokimab (ZB-880) have completed Phase 1/1b studies and are being evaluated for their potential across a range of autoimmune and inflammatory conditions.

For more information, please visit www.zurabio.com.

FORWARD-LOOKING STATEMENTS

Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words and phrases such as “believe,” “designed to,” “expect,” “may,” “plan,” “potential,” “will” and similar expressions, and are based on Zura’s current beliefs and expectations. These forward-looking statements include expectations regarding the development and potential therapeutic benefits of Zura’s product candidates; the timing of enrollment, initiation, progress, and results of Zura’s current and future clinical trials, including TibuSURE, including reporting of data therefrom; and Zura’s plans to present the design of its Phase 2 TibuSURE clinical trial at the Systemic Sclerosis World Congress. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the development of therapeutic product candidates, such as the risk that any one or more of Zura’s current or future product candidates will not be successfully developed or commercialized; the risk of delay or cessation of any planned clinical trials of Zura’s current or future product candidates; the risk that prior results, such as signals of safety, activity or durability of effect, observed from preclinical trials, will not be replicated or will not continue in ongoing or future studies or clinical trials involving Zura’s current or future product candidates; the risk that modeling data indicating therapeutic potential, or clinical evidence from other drug candidates, will not be replicated in ongoing or future studies or clinical trials involving Zura’s current or future product candidates; the risk that Zura’s current or future product candidates or procedures in connection with the administration thereof will not have the safety or efficacy profile that Zura anticipates; risks regarding the accuracy of Zura’s estimates of expenses, capital requirements and needs for additional financing; changes in expected or existing competition; changes in the regulatory environment; the uncertainties and timing of the regulatory approval process; unexpected litigation or other disputes; the impacts of macroeconomic conditions on Zura’s business, clinical trials and financial position; and other risks and uncertainties that are described in Zura’s Annual Report on Form 10-K for the year ended December 31, 2024, as supplemented by its Quarterly Reports on Form 10-Q for the quarterly periods ended March 31, 2025, June 30, 2025 and September 30, 2025, and other filings with the Securities and Exchange Commission. Any forward-looking statements speak only as of the date of this press release and are based on information available to Zura as of the date hereof, and Zura assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

Contacts

Megan K. Weinshank

Head of Corporate Affairs

ir@zurabio.com

Organigram Global Expands FAST™ Innovation Platform with SHRED Shotz, Leveraging SHRED Brand Equity




Organigram Global Expands FAST™ Innovation Platform with SHRED Shotz, Leveraging SHRED Brand Equity

FAST™-powered SHRED Shotz extends the SHRED brand into shot-sized beverages

TORONTO–(BUSINESS WIRE)–Organigram Global Inc. (NASDAQ: OGI) (TSX: OGI), (the “Company” or “Organigram”), Canada’s #1 cannabis company by market share¹ is pleased to announce the launch of SHRED Shotz, a compact, single-serve 65ml cannabis beverage powered by FAST™, Organigram’s fast-acting nanoemulsion technology platform designed to deliver a 15-minute onset².

This launch reflects Organigram’s focus on differentiated innovation while leveraging the scale of SHRED, one of the Company’s best-known brands. SHRED surpassed $200 million in retail sales in 2025³, underscoring the brand’s momentum and track record of expansion into new formats. With SHRED Shotz, Organigram is introducing a compact format designed to help broaden the beverage category and bring new consumers into the segment.

“SHRED Shotz is another clear example of how we successfully translate consumer insights into meaningful product innovation,” said Eric Williams, Organigram Global’s Vice President of Marketing. “With FAST™ powering the formulation, we are bringing that technology into a compact, single-serve beverage under the SHRED brand, allowing us to expand into new occasions with a format built for taste, convenience and predictability.”

About FAST™ nanoemulsion technology

FAST™ is a patent-pending nanoemulsion technology platform designed to support a faster-onset ingestible experience and consistent performance across product formats. Organigram has previously reported clinical pharmacokinetic (PK) research completed through the Product Development Collaboration, a joint research and development initiative with BAT, showing that, depending on the ingestible format, FAST™ delivered up to approximately 50% faster onset, improved bioavailability (the amount absorbed into the bloodstream), and up to double cannabinoid delivery at peak compared with traditional ingestible products⁴.

SHRED Shotz are expected to be available for sale at Canadian cannabis retailers sometime in March in Ontario and Atlantic Canada, with availability in other provinces expected to follow soon after. Each compact 65 mL bottle contains 10 mg THC and will be available in Blue Razzberry and OG Lemonade flavours.

About Organigram Global Inc.

Organigram Global Inc. is a NASDAQ Global Select Market and TSX listed company whose wholly owned subsidiary, Organigram Inc., is a licensed cultivator of cannabis and manufacturer of cannabis-derived goods in Canada. Through its acquisition of Collective Project, Organigram Global participates in the U.S. and Canadian cannabinoid beverage markets. Organigram is focused on producing high-quality cannabis for adult consumers, as well as developing international business relationships to extend the Company’s global footprint. Organigram has developed and acquired a portfolio of cannabis brands, including Edison, Big Bag O’ Buds, SHRED, SHRED’ems, Monjour, Tremblant Cannabis, Collective Project, Trailblazer, BOXHOT and DEBUNK. Organigram operates cultivation and processing facilities in Moncton, New Brunswick and Lac Supérieur, Quebec, with a dedicated edibles manufacturing facility in Winnipeg, Manitoba. The Company operates two additional cannabis processing facilities in Southwestern Ontario; one in Aylmer and the other in London. The facility in Aylmer houses best-in-class CO2 and Hydrocarbon extraction capabilities, and is optimized for formulation refinement, post-processing of minor cannabinoids, and pre-roll production. The facility in London is optimized for labelling, packaging, and national fulfillment. The Company is regulated by Health Canada under the Cannabis Act and the Cannabis Regulations (Canada).

Forward-Looking Information
This news release contains forward-looking information. Often, but not always, forward-looking information can be identified by the use of words such as “plans”, “expects”, “estimates”, “intends”, “anticipates”, “believes” or variations of such words and phrases or statements that certain actions, events, or results “may”, “could”, “would”, “might” or “will” be taken, occur or be achieved. Forward-looking information including expectations regarding market performance involves known and unknown risks, uncertainties and other factors that may cause actual results, events, performance or achievements of Organigram Global to differ materially from current expectations or future results, performance or achievements expressed or implied by the forward-looking information contained in this news release. Risks, uncertainties and other factors involved with forward-looking information could cause actual events, results, performance, prospects and opportunities to differ materially from those expressed or implied by such forward-looking information include timing for launch of products, changes in the regulatory landscape, acceptance of products and different product forms in the local market and factors and risks disclosed in the Company’s most recent annual information form, management’s discussion and analysis, and other Company documents filed from time to time on SEDAR+ (see www.sedarplus.ca) and filed or furnished to the Securities and Exchange Commission on EDGAR (see www.sec.gov). Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Although the Company believes that the assumptions and factors used in preparing the forward-looking information in this news release are reasonable, undue reliance should not be placed on such information and no assurance can be given that such events will occur in the disclosed timeframes or at all. The forward-looking information included in this news release is made as of the date of this news release and the Company disclaims any intention or obligation, except to the extent required by law, to update or revise any forward-looking information, whether as a result of new information, future events or otherwise.

Contacts

Media Contact
Max Schwartz, Director of Investor Relations investors@organigram.ca
Mark McKay, Director of Communications mark.mckay@organigram.ca

Intelligent Manufacturing in China Sets a New Benchmark for Design: GUTX Probiotic Dual-Compartment Fresh Probiotics Wins the 2025 French Design Awards




Intelligent Manufacturing in China Sets a New Benchmark for Design: GUTX Probiotic Dual-Compartment Fresh Probiotics Wins the 2025 French Design Awards

HANGZHOU, China–(BUSINESS WIRE)–Recently, the winners of the prestigious French Design Awards, often referred to as the “pinnacle” of the design world, have been announced.

In this award selection, GUTX, a professional probiotic brand produced by Siliankang® under Hangzhou Grand Biologic Pharmaceutical INC won the 2025 French Design Awards for its world-first “Dual-Compartment Fresh Probiotic” packaging design. This not only signifies that GUTX’s packaging innovation has gained authoritative recognition from the global design community, but also makes it the first brand in China to win this award in the field of probiotic packaging, leaving a significant mark on the industrial design of China’s health industry.

Dual-compartment packaging breaks through industry pain points, achieving a dual pursuit of aesthetics and functionality

GUTX’s award-winning “Dual-Compartment Fresh Probiotic” product packaging is designed to address the pain point of unclear probiotic activity in traditional products. Its innovative “powder-liquid separation dual-compartment structure” completely revolutionizes the traditional single-form packaging of probiotic powders. It places the highly active probiotic powder and the exclusive activation liquid in separate sealed compartments and no need to brew when using it. Simply press the button to instantly mix the powder and liquid, and the probiotics will be quickly activated, truly achieving “ready to drink and enjoy freshness immediately”.

Looking to the future: From Chinese design to the global stage

GUTX Dual-Compartment Fresh Probiotic won an award for its outstanding packaging design, which is not only an honor for the brand but also a milestone for the industry. This signifies a shift in China’s health industry from simply “product output” to “output of design standards and technological standards.”

The brand plans to showcase the award-winning design at Milan Design Week this April. Participating in this grand event will allow GUTX to showcase the functional value and aesthetic appeal of its dual-compartment packaging on the world stage, and will undoubtedly be a significant opportunity for GUTX and even Chinese probiotics to expand overseas. This will help brands break through geographical boundaries, promote innovative probiotic products intelligent manufacturing in China to overseas markets, and allow global consumers to witness the dual strength of Chinese design and technology.

Contacts

Hangzhou Grand Biologic Pharmaceutical INC

Contact Person: Fan Jiaxu

fanjiaxu@hzydsw.cn
https://www.hzydsw.cn/

GAIA and Daiichi Sankyo Europe Enter Exclusive Partnership to Launch Next-Generation Digital Therapeutic for Cardiovascular Care in Europe.




GAIA and Daiichi Sankyo Europe Enter Exclusive Partnership to Launch Next-Generation Digital Therapeutic for Cardiovascular Care in Europe.

HAMBURG, Germany & MUNICH–(BUSINESS WIRE)–GAIA, the pioneer in evidence-based digital therapeutics and Daiichi Sankyo Europe, today announced an exclusive strategic partnership to commercialize lipodia upon regulatory approval¹.

This digital therapeutic is designed to support adults living with hypercholesterolemia. The comprehensive collaboration brings together GAIA’s long-standing expertise in developing clinically validated non-pharmacological interventions with Daiichi Sankyo’s highly scientific experience in cardiovascular risk management and health. Together, the partners – both members of the German Association of Research-Based Pharmaceutical Companies (vfa) – aim to address a persistent gap in chronic care: leveraging digital technologies to make a difference in patients’ lives by supporting sustainable, long-term behaviour change.

Expanding Cardiovascular Care Beyond Medicines

Under the agreement, Daiichi Sankyo Europe secures exclusive rights for lipodia, marking a strategic expansion of its cardiovascular portfolio into digital therapeutics. The partnership initially covers Germany as the largest European healthcare market and incorporates expansion mechanisms for all major markets on the continent. It reflects a growing recognition that holistic heart health requires integrated solutions that combine pharmacological treatment with evidence-based behavioural support. Cardiovascular diseases (CVD) remain Europe’s leading cause of death and are responsible for more than 10,000 deaths every day. Yet, 80% of heart disease and stroke are preventable. The major risk factors for CVD include high blood pressure, high cholesterol, diabetes, smoking, obesity and physical inactivity, with poor diet, excessive alcohol consumption, and stress further contributing to its prevalence.² Grounded in the latest, evidence-based behavioural health science and combining it with top-of-class psychological and psychotherapeutic methods, lipodia adapts dynamically to individual patient needs through interactive dialogues. Comprehensive additional functionalities further support the integration of healthy routines into everyday life, helping patients translate intention into sustained action. Lipodia is a next-generation, fully-automated digital therapeutic, accessible on almost any connected device, enabling flexible, location-independent use.

Dr. Mario Weiss, CEO GAIA: “Digital therapeutics unlock a new dimension of cardiovascular care by addressing the behavioural and psychological factors that medication alone cannot solve. With lipodia, we are translating more than two decades of scientific, technological, and therapeutic expertise into a scalable solution for one of the most widespread chronic conditions. Through our partnership with Daiichi Sankyo Europe, we are in the best position to integrate this evidence-based digital therapy into routine care in the near future, achieving the reach, scientific credibility, and impact that patients and physicians expect.”

Oliver Appelhans, Head of EU Specialty Business Unit, Daiichi Sankyo Europe:

“At Daiichi Sankyo, we care for every heartbeat. Our goal is to protect people from cardiovascular disease and help those who suffer from it, so they can enjoy every precious moment that life has to offer. Digital therapeutics represent an important next step in delivering holistic heart health. By partnering with GAIA, we are combining pharmaceutical excellence with evidence-based digital therapeutic innovation to support patients beyond our medicines. This collaboration reflects our patient-centric approach to develop new solutions that improve long-term outcomes.”

Pathway to Reimbursed Access

To ensure broad patient access, GAIA plans to submit lipodia for reimbursement as soon as the data from the pivotal phase 3 RCT are available. Upon approval, the digital therapeutic would be reimbursed by statutory health insurance through the DiGA pathway³ and prescribed by physicians as part of routine cardiovascular care in the third largest healthcare market in the world — significantly lowering access barriers for patients.

With cardiovascular disease remaining one of the leading causes of morbidity in Germany and beyond, the partnership positions lipodia as a scalable, evidence-based complement to established treatment pathways and reinforces Germany’s role as a leading market for regulated digital therapeutics.

About GAIA

GAIA is the global leader in the development of evidence-based, fully-automated digital therapeutics that have benefited patients, physicians, and insurers for over two decades. Its product portfolio includes not only digital health applications (DiGA) but also numerous innovative therapeutics for mental health conditions, as well as other therapeutic areas such as immunology, rheumatology, MS, and back pain.

For over 25 years, GAIA has combined scientific, technological, and therapeutic expertise under one roof. Its goal is to support as many people as possible in restoring and maintaining their mental and physical health, thus improving their quality of life and well-being. The expert team at GAIA has confirmed the efficacy of its products in over 30 RCTs and meta-analyses. GAIA is the 48th member of the Association of Research-Based Pharmaceutical Companies (vfa). For more information, please visit www.gaia-group.com/en.

About Daiichi Sankyo

Daiichi Sankyo is an innovative global healthcare company contributing to the sustainable development of society that discovers, develops, and delivers new standards of care to enrich the quality of life around the world. With more than 120 years of experience, Daiichi Sankyo leverages its world-class science and technology to create new modalities and innovative medicines for people with cancer, cardiovascular, and other diseases with high unmet medical need. For more information, please visit www.daiichi-sankyo.eu.

¹Patients are in phase-3 of the RCT

²World Heart Federation. Prevention. Available at: https://world-heart-federation.org/what-we-do/prevention/. Last accessed October 2025

³DiGA (Digitale Gesundheitsanwendungen) can be prescribed to persons covered by the German statutory health insurance and are reimbursed by the health insurance, if the DiGA has successfully completed the assessment of the German Federal Institute for Drugs and Medicinal Devices (BfArM) leading to a listing in a directory of reimbursable digital health applications. See https://www.bfarm.de/EN/Medical-devices/Tasks/DiGA-and-DiPA/Digital-Health-Applications/Interesting-facts/_node.html, last accessed on 19Feb2026

Contacts

Press contact GAIA
Ulrike Voß

GAIA AG

Hans-Henny-Jahnn-Weg 53

22085 Hamburg

E-Mail: presse@gaia-group.com
Telefon: +49 40 3510520

www.gaia-group.com

Press contact Daiichi Sankyo:
Erika Verni

Daiichi Sankyo Europe GmbH

Zielstattstraße 48, 81379 München

E-mail: erika.verni@daiichisankyo.com
Telefon: +49 15154478431

Galderma Delivers Record 2025 Results With Net Sales of 5.207 Billion USD, up 17.7% at Constant Currency1, and Core EBITDA2 of 1.211 billion USD, Growing 18.9% at Constant Currency




Galderma Delivers Record 2025 Results With Net Sales of 5.207 Billion USD, up 17.7% at Constant Currency1, and Core EBITDA2 of 1.211 billion USD, Growing 18.9% at Constant Currency

Ad hoc announcement pursuant to Art. 53 LR

ZUG, Switzerland–(BUSINESS WIRE)–Galderma Group AG (SIX:GALD), the pure-play dermatology category leader, today announced its financial results for the full year 2025.

• Record net sales of 5,207 million USD, surpassing 5 billion USD in a year for the first time and representing 17.7% year-on-year growth on a constant currency¹ basis, primarily driven by volume.
• Broad-based net sales growth, growing double-digits in both International markets and the U.S.
• Outperforming the market in each product category, with strong net sales growth in Injectable Aesthetics (11.5%), Dermatological Skincare (9.3%) and Therapeutic Dermatology (50.2%), all year-on-year at constant currency.
• Strong launch momentum across future growth drivers, including Nemluvio^® (nemolizumab) delivering 452 million USD in net sales; Relfydess™ (RelabotulinumtoxinA) outperforming expectations in 17 International markets; Sculptra^® gaining significant market share in its first year in China; and continued new product launches across Galderma’s full portfolio of flagship brands.
• Significant progress and strategic investments across a robust innovation pipeline, highlighted by key submissions and approvals from the broadest pipeline in the industry in Injectable Aesthetics, the introduction of scientifically-differentiated products in Dermatological Skincare, and the initiation of clinical trials for new nemolizumab indications in Therapeutic Dermatology.
• Extended scientific leadership in dermatology, with a strong presence at key congresses and industry events as well as market leadership in education.
• Core EBITDA grew to 1,211 million USD, up 18.9% year-on-year at constant currency, ahead of net sales growth. Reported Core EBITDA margin was 23.3%, representing a year-on-year margin expansion of 24 basis points at constant currency, which exceeded initial expectations in a year of major launches and reinvestments in growth.
• Core EPS³ grew to 3.69 USD, up 76.7% year-on-year, driven by strong Core EBITDA growth, reduced financing and tax expenses, as well as share repurchases.
• Strengthened balance sheet and cash flow generation, with net leverage⁴ reduced to 1.5x at the end of December 2025, alongside lowered interest payments and improvements in net working capital.
• 2026 full-year guidance with attractive top- and bottom-line growth, expecting net sales growth of 17-20% at constant currency and a Core EBITDA margin of approximately 26% at constant currency.
• Sustained confidence in the mid-term outlook, specifying 2023-2027 guidance within or above the previously communicated ranges and raising the peak sales guidance for Nemluvio from above 2 billion USD to above 4 billion USD for prurigo nodularis and atopic dermatitis globally.

“2025 was an outstanding year for Galderma and a defining step in our journey towards becoming the undisputed dermatology powerhouse. We delivered record financial results with broad-based net sales growth across all product categories and geographies, driven by clear strategic focus, disciplined execution, science-driven innovation and the successful scaling of our proven Integrated Dermatology Strategy. With a strengthened financial profile, global scale and the world’s broadest dermatology portfolio, we enter our next phase of growth with clarity, confidence and ambition.”

FLEMMING ØRNSKOV, M.D., MPH

CHIEF EXECUTIVE OFFICER

GALDERMA

Commercial performance

For the full year 2025, Galderma delivered record net sales of 5,207 million USD, exceeding 5 billion USD for the first year. Year-on-year net sales growth for the year was 17.7% at constant currency. Growth overall was predominantly volume-driven, with a favorable product mix more than offsetting pricing effects from the competitive environment. In the fourth quarter, net sales grew 25.2% year-on-year at constant currency, reflecting an acceleration in each product category.

Net sales growth for the year was widespread across geographies and product categories. Both geographies’ net sales grew double-digits while all product categories outpaced their respective markets.

International sustained its strong net sales growth momentum in highly attractive, largely underpenetrated markets. Injectable Aesthetics delivered double-digit net sales growth and outperformed the market in both Neuromodulators and Fillers & Biostimulators. Both Restylane and Sculptra delivered net sales growth with market share gains in most key countries despite continued softness in the Filler market. Dermatological Skincare also delivered double-digit net sales growth, with outstanding growth particularly in India and China. Therapeutic Dermatology net sales growth was driven by Nemluvio, with strong launch trajectories also in its first European markets.

The U.S. delivered net sales growth in each product category. Net sales growth was especially strong for Neuromodulators as well as for Therapeutic Dermatology, driven by Nemluvio. Injectable Aesthetics outgrew a soft market and gained share in both Neuromodulators and Fillers & Biostimulators. Neuromodulators and Biostimulators net sales grew double-digit while Fillers continued to be impacted by market softness. Dermatological Skincare net sales growth was mainly driven by Alastin, growing double-digits, while Cetaphil had a strong fourth quarter from the ramp-up of recent launches and year-end activations. Therapeutic Dermatology had outstanding net sales growth driven by Nemluvio’s strong trajectory in prurigo nodularis and atopic dermatitis, more than offsetting the anticipated decline in mature products.

Overall, Galderma capitalized on its five key opportunity areas for 2025, including 1) significant launches, including the strong uptake of Nemluvio and Relfydess in first markets and of Sculptra in China, 2) market share gains, 3) a strengthened financial profile, 4) a shift to long-term growth, and 5) dynamic commercial investments to continue to drive growth.

Injectable Aesthetics

Injectable Aesthetics net sales for the full year were 2,572 million USD, up 11.5% year-on-year at constant currency. Galderma remained on a strong growth trajectory, consistently outpacing the market, driven by focused execution, new product launches and further geographic penetration.

Neuromodulators net sales were 1,471 million USD, up 14.3% year-on-year at constant currency. Both geographies delivered double-digit growth and continued to gain market share. Dysport^® continued to outperform globally, with strong growth in top markets. Relfydess had a strong year of launches, gaining significant share as a next generation neuromodulator recognized for its superior profile, while setting a high comparable base for 2026. Demonstrating focused execution of its Neuromodulator portfolio strategy, with net sales increasing for both Relfydess and Dysport in markets where Relfydess was launched.

Fillers & Biostimulators net sales were 1,101 million USD, up 8.0% year-on-year at constant currency. Both geographies continued to gain market share, driven especially by Sculptra and the uptake of new launches, including Sculptra in China and Restylane^® SHAYPE™ in Brazil. Fillers globally continued to be impacted by market softness with important pricing pressures, as a result of lower consumer demand and aggressive promotional activity from competitors in the mid-face. Biostimulators maintained its double-digit net sales growth momentum in both geographies, as Sculptra continued to strengthen its position as the leading brand with proven regenerative capabilities. Sculptra growth was particularly high in key International markets and especially in China thanks to a strong launch trajectory.

Galderma also made progress in preparing the next frontier of growth in Injectable Aesthetics, maintaining its commercial and regulatory momentum.

In Neuromodulators, Relfydess is quickly ramping up and is now approved in 23 International markets. On February 2, 2026, Galderma announced that the U.S. Food & Drug Administration (FDA) accepted the resubmission of Relfydess’ Biologics License Application (BLA) for the temporary improvement of moderate‑to‑severe glabellar lines (frown lines) and lateral canthal lines (crow’s feet) in adults.

In Fillers, the U.S. FDA approved Restylane Lyft™ with Lidocaine in November 2025 for augmentation of the chin region to improve the chin profile in patients over the age of 21 with mild-to-moderate chin retrusion. In Biostimulators, Galderma continues to demonstrate leadership in regenerative aesthetics. Beyond the important launch of Sculptra in China, a new chapter opened for the brand in December 2025, with the European Union (EU) Medical Device Regulation (MDR) certification expanding its approved clinical applications beyond the face to include the gluteal area, posterior thighs, décolletage, and upper arms.

Galderma is also shaping the aesthetics journey for patients undergoing medication-driven weight loss, based on its proven Restylane and Sculptra portfolio. With its dedicated scientific agenda for market-leading education and training activities with healthcare professionals, Galderma also saw strong conversion of new patients to its portfolio in the U.S. from its SCULPT & LIFT™ direct-to-consumer campaign.

Dermatological Skincare

Dermatological Skincare net sales for the full year were 1,449 million USD, up 9.3% year-on-year at constant currency. Both Cetaphil and Alastin continued on their strong growth trajectories, outpacing their respective segments globally.

Growth was very strong in International markets, with Cetaphil gaining share and delivering exceptional performance in Asia. Notably, China and India continued to deliver outstanding net sales growth, with particularly strong performance from year-end activations. Alastin continued to ramp-up in International markets. In the U.S., growth was driven by Alastin, which continued to deliver double-digit growth and to be the fastest growing top physician-dispensed skincare brand. Cetaphil in the U.S., in a year of constrained consumer spending, had a strong fourth quarter from the ramp-up of recent launches and year-end activations.

Galderma’s digital-first strategy remained a powerful growth engine for Cetaphil, with e-commerce its fastest growing channel. Growth was particularly strong in the fourth quarter for Cetaphil in China, with strong year-end activations. This included another record performance during the Double 11 shopping festival, outperforming the skincare market online, a major Zootopia 2 campaign, and celebrity endorsements. Globally, Cetaphil also had over 100 million impressions from key global activations, including CetaSphere – one of the world’s largest skincare advocacy networks – and Derm on Tour – an immersive, science-driven pop-up experience offering free dermatology consultations in select cities. Alastin grew across channels, with a focus on physician-first engagement.

Galderma also launched differentiated innovation in Dermatological Skincare to drive further growth, starting in the U.S. with the opportunity to expand in International markets. Among key Cetaphil launches were the Skin Activator Hydrating & Firming line for aging, fragile skin and the Nourishing Oil to Foam Cleanser for sensitive skin, both creating entirely new categories based on strong science delivering breakthrough benefits. Alastin^® also further strengthened its portfolio with the launch of Restorative Skin Complex featuring Next Generation TriHex Technology (TriHex+^TM). This formula includes two groundbreaking additions, proven to help visibly restore facial radiance and plumping by supporting the skin’s own regenerative abilities. In International markets, Galderma continued to roll-out key innovation, such as Cetaphil’s Bright Healthy Radiance or Gentle Exfoliating lines.

Therapeutic Dermatology

Therapeutic Dermatology net sales were 1,185 million USD, up 50.2% year-on-year at constant currency. Net sales growth was very strong, driven by an outstanding launch trajectory of Nemluvio in prurigo nodularis and atopic dermatitis. This more than offset the anticipated decline in the mature Therapeutic Dermatology portfolio in the U.S., along with modest growth from the mature portfolio in International markets.

For the year, Nemluvio contributed 452 million USD in net sales. The vast majority of Nemluvio sales were recorded in the U.S., split roughly equally between prurigo nodularis and atopic dermatitis, with the share of the latter increasing quickly. The launch trajectory has been very strong in the U.S., and even stronger in Nemluvio’s first International launch markets despite representing a small share of sales.

Nemluvio’s significant market share gains in the U.S. are underpinned by a differentiated profile, salesforce expansion, market-leading education, and enhanced market access. In the U.S., Nemluvio paid new patient starts (NBRx), from the end of December 2025 to the end of January 2026, was trending at about 35% market share in prurigo nodularis and about 8% in atopic dermatitis. The majority of patients starting treatment continue to be new to biologics. Following broad first-line biologic access for Nemluvio across commercial plans in 2025, Galderma secured its first major Medicare access win beginning January 2026. An important gross-to-net impact is expected in the first quarter of the year, driven both by access expansion and typical seasonal copay resets in the period.

Beyond launching Nemluvio in five International markets in 2025, Galderma continued to make regulatory progress, with approvals now secured in Canada and South Korea, and additional submissions underway.

Scientific leadership and excellence in medical education

In 2025, Galderma reaffirmed its leadership in dermatology, supported by an innovative, science‑based portfolio, continued progress on its scientific agenda, and a strong presence at scientific congresses and key industry events.

Among the highlights, Galderma presented long‑term Nemluvio data in prurigo nodularis and atopic dermatitis, reinforcing its consistent safety profile and durable clinical efficacy across both indications up to two years, at the European Academy of Dermatology and Venereology (EADV) 2025, the Revolutionizing Atopic Dermatitis (RAD) Conference, and the XIV International Congress of Dermatology (ICD). In addition, Galderma announced the initiation of two new clinical trials evaluating nemolizumab in Systemic Sclerosis (SSc) and Chronic Pruritus of Unknown Origin (CPUO), with the first patient enrolled in the CPUO trial in December 2025.

As well as presenting new Relfydess data throughout the year, Galderma unveiled final nine-month data from a phase IV first-of-its-kind trial showing lasting efficacy and patient satisfaction with Restylane Lyft or Contour^® in combination with Sculptra when addressing facial aesthetic changes following medication-driven weight loss. This work supported the development of international consensus‑based guidelines.

Galderma also had a strong presence at additional major medical congresses, including the IMCAS World Congress 2025, the Aesthetic & Anti-Aging Medicine World Congress (AMWC) Monaco, AMWC Dubai, and the American Society for Dermatologic Surgery (ASDS) 2025 Annual Meeting.

During the year, over 290,000 healthcare professionals were reached through education, training and medical awareness activities,⁵ including the Galderma Aesthetic Injector Network (GAIN) – which celebrated its 10^th anniversary in 2025 – the Global Sensitive Skincare Faculty (GSSF), and the Skin Knowledge and Innovation Network (SKIN).

Financial scorecard

For the full year 2025, Galderma delivered 1,211 million USD in Core EBITDA, up 18.9% year-on-year at constant currency. The reported Core EBITDA margin was 23.3%, representing a margin expansion of 24 basis points at constant currency compared to 2024. Core EBITDA grew ahead of net sales, in a year of major launches with reinvestments into growth, thanks to ongoing operating leverage as well as a reduced adverse P&L impact from nemolizumab as a result of greater sales. Improvements in operating expenses also offset the impact of pricing effects and unfavorable product mix on gross margin.

Galderma delivered even greater growth in Core net income for the full year. Core net income was 871 million USD, up 75.4% year-on-year, driven by strong Core EBITDA growth as well as reduced financing and tax expenses. The latter include a one-time, non-cash benefit on the effective tax rate, from recognizing deferred tax assets on past tax losses in Switzerland.

Galderma demonstrated very strong cash generation for the year, due to significant Core EBITDA growth, favorable net working capital movements, and lower interest payments. Net working capital positions improved significantly behind effective net working capital management, structural improvements driven by shifts in market and product mix and phasing benefits.

Core CapEx benefitted from improved phasing of project spend as well as continued focus on spend efficiencies and site operating performance. Core CapEx as a percentage of sales continues to come down due to the high net sales growth. Investments significantly increased capacity at all of Galderma’s manufacturing sites, including the build-out of the biologics production site for Relfydess in Uppsala, Sweden. Beyond CapEx, Galderma also committed to spend more than 650 million USD on U.S. manufacturing through 2030, via contract manufacturing partners. Additional technology transfers to the U.S. focused on key growth drivers have also been initiated.

Core EPS was 3.69 USD per share, up 76.7% year-on-year, benefitting from the share repurchases executed in the year. Galderma repurchased shares for 363 million USD in the accelerated bookbuild offerings of Galderma shares by Sunshine SwissCo GmbH (“EQT”), Abu Dhabi Investment Authority (“ADIA”) and Auba Investment Pte. Ltd. (“Auba”) which took place throughout the year. Funded from existing liquidity on hand, they are to be held in treasury to support Galderma’s employee participation plans, business development activities and/or treasury management.

Continuing on a rapid deleveraging trajectory, net leverage came down to 1.5x at the end of December 2025. For the full year, Galderma’s ambitious deleveraging and refinancing was underpinned by further partial repayment of its Term Loan of 1.5 billion USD. This was based on an early debt repayment of 240 million USD and debt refinancing of 1,260 million USD, which included several CHF and EUR bond issuances.

Building on its strengthened financial profile headlined by investment grade ratings from S&P (BBB, positive) and Fitch (BBB, stable), Galderma swiftly replaced in February 2026 its Revolving Credit Facility originally implemented at the time of the IPO in 2024, with significantly improved terms and a size increase from 0.7 to 1 billion USD.

Galderma continued to demonstrate its commitment to superior shareholder returns, including through share repurchases and dividend payment. Following another record year, Galderma’s Board will propose, for approval at the upcoming Annual General Meeting, a dividend payment out of reserves from capital contributions of 0.35 CHF (gross) per share.⁶

Galderma continued to diversify and strengthen its long‑term shareholder base. This included an additional 10% equity investment from L’Oréal, bringing their total shareholding in Galderma to 20%, with the transaction closed in February 2026.

ESG remains an integral pillar of Galderma’s strategy. In 2025, Galderma focused on strengthening the three constitutive elements of its ESG Strategy. This included streamlining its ESG Framework through an inaugural double materiality assessment, strengthening its ESG Governance to support auditable non-financial reporting, and delivering against a clear ESG Ambition. Galderma’s ESG Strategy has gained external recognition through improvements in key ESG ratings. For instance, in 2025, Galderma received an AA rating (on a scale of AAA-CCC) in the MSCI ESG Ratings assessment, up from BBB in 2024.

Outlook

Galderma expects 2026 to be another year of opportunities, with very strong top-line growth and significant Core EBITDA margin expansion. Galderma expects net sales growth of 17-20% at constant currency and a Core EBITDA margin of approximately 26% at constant currency for the full year.

Galderma’s proven integrated dermatology strategy is underpinning net sales growth, expected to be ahead of the market in each product category. It also continues to drive operating leverage, while allocating appropriate level of investments into growth in a competitive environment. Confident in the ability to deliver, the guidance also reflects existing uncertainties. Galderma’s dynamic approach to commercial investments provides resilience and flexibility to capture opportunities, leveraging a broad portfolio and geographic reach.

In terms of foreign exchange impacts, while guidance is at constant currency, based on spot rates as of the end of February 2026, USD depreciation is expected to have a positive impact on reported net sales and a negative impact on reported Core EBITDA margin, which is due to headquarter costs denominated mainly in CHF. A table with Galderma’s exposure to key foreign exchange currency pairs is available in the Appendix. As for tariffs, exposure remains manageable, with the guidance assuming a 15% U.S. tariff on the import value of Restylane and Sculptra.

Following a stronger than originally anticipated first year on the market in the U.S. and in European markets in prurigo nodularis and atopic dermatitis, Galderma is raising its peak sales guidance for Nemluvio from above 2 billion USD to above 4 billion USD for both indications globally. This reflects its strong launch trajectory with higher demand than expected based on positive real-world experience in addition to an already differentiated clinical profile.

In light of its greater expectation for Nemluvio and confidence in its broad-based growth trajectory, Galderma is specifying its 2023-2027 mid-term guidance to be within or above the previously stated ranges as per the table available in the Appendix, along with additional modelling metrics for 2026. Guidance for the mid-term is based on the same tariff assumption as for 2026⁷, and subject to the same expected impact from foreign exchange.

Webcast details

Galderma will host its financial results call today at 14:00 CET to discuss the full year 2025 results and respond to questions from financial analysts. Investors and the public may access the webcast by registering on the Galderma Investor Relations website at https://investors.galderma.com/events-presentations.

2025 Annual Report

Galderma issued its 2025 Annual Report today, and it is available at https://investors.galderma.com/financial-reports.

About Galderma

Galderma (SIX: GALD) is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology.

Contacts

For further information:

Media

Christian Marcoux, M.Sc.

Chief Communications Officer

christian.marcoux@galderma.com
+41 76 315 26 50

Richard Harbinson

Corporate Communications Director

richard.harbinson@galderma.com
+41 76 210 60 62

Investors

Emil Ivanov

Head of Strategy, Investor Relations and ESG

emil.ivanov@galderma.com
+41 21 642 78 12

Jessica Cohen

Investor Relations and Strategy Director

jessica.cohen@galderma.com
+41 21 642 76 43

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Allosteric Bioscience, Inc. Targets Optimizing Aging and Longevity: Quantum Computing, Advanced AI, Genomics




Allosteric Bioscience, Inc. Targets Optimizing Aging and Longevity: Quantum Computing, Advanced AI, Genomics

NEW YORK–(BUSINESS WIRE)–Allosteric Bioscience, Inc. is utilizing Genetics, Genomics, Systems Biology, Quantum Computing, Advanced Proprietary AI and Proprietary Molecular Technologies for understanding and controlling the Molecular Mechanism of Aging and Longevity with the goal of optimizing the aging process and extending longevity.

Aging factors that are being targeted are Lamin A which is critical for proper cellular function, Tryptophan Metabolism involved in most aging related diseases, improved DNA repair, optimizing mitochondrial metabolism, prevention and treatment of sarcopenia (muscle wasting due to aging or weight loss drugs) and control of factors comprising a Master Aging Complex identified by Dr. Arthur P. Bollon, who is President and Co-Founder of Allosteric Bioscience, Inc.

Dr. Bollon indicates that “Creation of modulators for key controlling factors involved in the aging molecular mechanism could reduce aging related diseases and significantly extend longevity. We welcome inquires about our technologies and opportunities for collaboration and partnering”.

Contacts

Dr. Arthur P. Bollon, President and Co-Founder of Allosteric Bioscience, Inc., arthurb@flash.net, abollon@allostericbioscience.com, 469-585-7613.

Bruce Meyers, Executive Chairman and Co-Founder of Allosteric Bioscience, Inc., bmeyers@allostericbioscience.com, 469-391-7957.

www.allostericbioscience.com