Celltrion Presents Positive Real-World Data on Switching from intravenous (IV) to subcutaneous (SC) infliximab at UEG Week 2025 Meet the Expert sessions




Celltrion Presents Positive Real-World Data on Switching from intravenous (IV) to subcutaneous (SC) infliximab at UEG Week 2025 Meet the Expert sessions

• Switching from intravenous (IV) to subcutaneous (SC) infliximab was shown to be well tolerated, with a low relapse risk for most IBD patients and high treatment persistence^{1, 2}

INCHEON, South Korea–(BUSINESS WIRE)–Celltrion, Inc. today showcased real-world evidence supporting the use of subcutaneous (SC) infliximab, confirming the efficacy and safety of switching to SC infliximab 120mg every two weeks in patients with inflammatory bowel disease (IBD).

The real-world evidence was presented at the Meet the Expert (MTE) Sessions at UEG 2025, and included presentations from Professor Nicolas Mathieu, Medical Director of MICI Institut Privé, Cliniques des Cèdres and Associate Professor of Gastroenterology, and Prof Anthony Buisson, Head of IBD Unit at University Hospital Estaing, Clermont Ferrand, France.

Professor Nicolas Mathieu presented a real-life study which demonstrated that the switch from IV infliximab to SC infliximab is well tolerated amongst patients. The presentation particularly highlighted the results from the multicentric, prospective PEREM real-life cohort study, which found high treatment persistence, with more than 95% of patients in remission remaining on therapy after one year in real-world practice.¹ In addition, there was no significant difference of SC infliximab persistence at Week 48 between patients who were on combination therapy with immunomodulator at both inclusion and 3 months and those on SC infliximab monotherapy.²

In Professor Anthony Buisson’s session, it was shared that patients switching from IV to SC infliximab is feasible and safe, even in challenging cases such as obesity, prior perianal disease, or patients with complicated phenotypes (structuring or fistulizing CD). Long term persistence of SC infliximab was also confirmed in multiple studies across the UK and France, and was generally considered effective, safe, and well accepted, with low relapse risk in most IBD patients. SC infliximab also showed promising efficacy after IV induction in patients with active perianal lesions.¹

“The Meet the Expert sessions provide an important opportunity to share real-world evidence on the role of subcutaneous infliximab,” said Nam Lee, Vice President of Global Medical Affairs at Celltrion. “The evidence confirms that switching from intravenous to subcutaneous therapy is effective and safe and supports more sustainable healthcare delivery.”

Notes to Editors:

About the subcutaneous (SC) formulation of CT-P13

CT-P13 SC is the world’s first subcutaneous formulation of infliximab. A 120mg fixed dose of CT-P13 SC has been approved for use in 60 countries including the US, UK, EU, Canada, Brazil, Australia and Taiwan, in adults regardless of body weight. The SC formulation of infliximab has the potential to enhance treatment options by providing high consistency in drug exposure and a convenient method of administration.^3,4 In July 2024, CT-P13 SC received final approval from the European Commission for an additional dosing regimen and dose escalation, which allows 3-IV induction dosing regimen and dose escalation of subcutaneous maintenance dose from CT-P13 SC 120 mg Q2W to 240 mg Q2W for patients with loss of response.⁵ Long term data from two-year extension of the LIBERTY studies (LIBERTY-CD and LIBERTY-UC) have demonstrated sustained efficacy and safety of CT-P13 SC, with clinical remission, response, and corticosteroid-free remission generally maintained through Week 102.⁶

About Celltrion

Celltrion is a leading biopharmaceutical company that specializes in researching, developing, manufacturing, marketing and sales of innovative therapeutics that improve people’s lives worldwide. Celltrion is a pioneer in the biosimilar space, having launched the world’s first monoclonal antibody biosimilar. Our global pharmaceutical portfolio addresses a range of therapeutic areas including immunology, oncology, haematology, ophthalmology and endocrinology. Beyond biosimilar products, we are committed to advancing our pipeline with novel drugs to push the boundaries of scientific innovation and deliver quality medicines.

For more information, please visit our website www.celltrion.com/en-us and stay updated with our latest news and events on our social media – LinkedIn, Instagram, X, and Facebook.

FORWARD-LOOKING STATEMENT

Certain information set forth in this press release contains statements related to our future business and financial performance and future events or developments involving Celltrion Inc. and its subsidiaries that may constitute forward-looking statements, under pertinent securities laws. This press release contains forward looking statements. These statements may be also identified by words such as “prepares”, “hopes to”, “upcoming”, “plans to”, “aims to”, “to be launched”, “is preparing”, “once gained”, “could”, “with the aim of”, “may”, “once identified”, “will”, “working towards”, “is due”, “become available”, “has potential to”, “anticipates”, the negative of these words or such other variations thereon or comparable terminology.

In addition, our representatives may make oral forward-looking statements. Such statements are based on the current expectations and certain assumptions of Celltrion Inc. and its subsidiaries’ management, of which many are beyond its control.

Forward-looking statements are provided to allow potential investors the opportunity to understand management’s beliefs and opinions in respect of the future so that they may use such beliefs and opinions as one factor in evaluating an investment. These statements are not guarantees of future performance and undue reliance should not be placed on them.

Such forward-looking statements necessarily involve known and unknown risks and uncertainties, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or results expressed or implied by such forward-looking statements.

Celltrion Inc. and its subsidiaries undertake no obligation to update forward-looking statements if circumstances or management’s estimates or opinions should change except as required by applicable securities laws.

References

¹ Buisson A et al. Clinical Gastroenterology and Hepatology 2023; Buisson A et al. Alimentary Pharmacology and Therapeutics 2023

² Mathieu N et al., Persistence and Safety of Subcutaneous Infliximab 1 Year After Switch From Intravenous Route in IBD Patients in REMission. Clinical Gastroenterology and Hepatology. 2025

³ Schreiber S et al., Gastroenterology. 2021;160(7):2340-2353

⁴ Westhovens R et al., Rheumatology. 2021;60(5):2277-2287

⁵ European Medicines Agency Summary of Product Characteristics (SmPC), Remsima®. Available at link to SmPC [Last accessed October 2025].

⁶ Colombel JF et al., Subcutaneous Infliximab (CT-P13 SC) as Maintenance Therapy for Crohn’s Disease and Ulcerative Colitis: 2-Year Results from Open Label Extensions of Two Randomized Controlled Trials (LIBERTY). Journal of Crohn’s and Colitis. 2025;19(6):jjaf060

Contacts

For further information please contact:
Donna Gandhi

dgandhi@hanovercomms.com
+44 (0) 7827 053 502

DATROWAY® Demonstrated Statistically Significant and Clinically Meaningful Improvement in Overall Survival as First-Line Therapy for Patients with Metastatic Triple Negative Breast Cancer for Whom Immunotherapy Was Not an Option in TROPION-Breast02




DATROWAY® Demonstrated Statistically Significant and Clinically Meaningful Improvement in Overall Survival as First-Line Therapy for Patients with Metastatic Triple Negative Breast Cancer for Whom Immunotherapy Was Not an Option in TROPION-Breast02

• Daiichi Sankyo and AstraZeneca’s DATROWAY is the first and only therapy to significantly improve overall survival versus chemotherapy in this patient population
• DATROWAY also demonstrated a highly statistically significant and clinically meaningful improvement in the dual primary endpoint of progression-free survival
• Plans for global regulatory submissions are underway

TOKYO & BASKING RIDGE, N.J.–(BUSINESS WIRE)–Positive topline results from the TROPION-Breast02 phase 3 trial showed DATROWAY^® (datopotamab deruxtecan) demonstrated a statistically significant and clinically meaningful improvement for the dual primary endpoints of overall survival (OS) and progression-free survival (PFS) compared to investigator’s choice of chemotherapy as first-line treatment for patients with locally recurrent inoperable or metastatic triple negative breast cancer (TNBC) for whom immunotherapy was not an option.

DATROWAY is a specifically engineered TROP2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (LSE/STO/Nasdaq: AZN).

Approximately 70% of patients with metastatic TNBC are not candidates for immunotherapy, including all patients whose tumors do not express PD-L1 as well as patients with PD-L1 expressing tumors who cannot receive immunotherapy due to other factors.¹ Chemotherapy remains the first-line standard of care for these patients.²

“DATROWAY is the first antibody drug conjugate and the only therapy to significantly improve overall survival compared to chemotherapy in patients with metastatic triple negative breast cancer for whom immunotherapy is not an option,” said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo. “These landmark results from TROPION-Breast02 strengthen our confidence in our ongoing clinical development program for DATROWAY in triple negative breast cancer and other tumor types. We look forward to discussing these data with global regulatory authorities and to bringing DATROWAY to patients with triple negative breast cancer as soon as possible.”

“TROPION-Breast02 is the only trial ever to show an overall survival benefit in the first-line treatment of patients with metastatic triple negative breast cancer for whom immunotherapy is not an option,” said Susan Galbraith, MBBChir, PhD, Executive Vice President, Oncology Hematology R&D, AstraZeneca. “We expect today’s results will mark an inflection point in the treatment of these patients who have the poorest prognosis of any type of breast cancer and urgently need better options.”

The safety profile of DATROWAY was consistent with previous clinical trials of DATROWAY in breast cancer. These data from TROPION-Breast02 will be presented at an upcoming medical meeting and shared with regulatory authorities.

Daiichi Sankyo and AstraZeneca are evaluating DATROWAY across stages and treatment settings of TNBC in three additional phase 3 trials. TROPION-Breast03 is evaluating DATROWAY as adjuvant therapy with or without AstraZeneca’s anti-PD-L1 therapy durvalumab versus investigator’s choice of therapy in patients with stage I-III TNBC with residual invasive disease after neoadjuvant systemic therapy. TROPION-Breast04 is evaluating neoadjuvant DATROWAY plus durvalumab versus neoadjuvant pembrolizumab plus chemotherapy in patients with stage II-III triple negative or hormone receptor (HR) low, HER2 low or negative breast cancer. TROPION-Breast05 is evaluating first-line DATROWAY with or without durvalumab versus investigator’s choice of therapy in patients with metastatic TNBC whose tumors express PD-L1.

About TROPION-Breast02

TROPION-Breast02 is a global, multicenter, randomized, open-label phase 3 trial evaluating the efficacy and safety of DATROWAY versus investigator’s choice of chemotherapy (paclitaxel, nab-paclitaxel, capecitabine, carboplatin or eribulin) in patients with previously untreated locally recurrent inoperable or metastatic TNBC for whom immunotherapy was not an option. This included patients whose tumors did not express PD-L1 as well as patients with PD-L1 expressing tumors who could not receive immunotherapy due to prior exposure in early-stage disease, comorbidities or immunotherapy not being accessible in their geography. Enrollment included patients with de novo or recurrent disease, regardless of disease-free interval, and those with poor prognostic factors such as brain metastases.

The dual primary endpoints of TROPION-Breast02 are PFS assessed by blinded independent central review and OS. Key secondary endpoints include PFS as assessed by investigator, objective response rate, duration of response, disease control rate, pharmacokinetics and safety.

TROPION-Breast02 enrolled 644 patients at sites in Africa, Asia, Europe, North America and South America. For more information visit ClinicalTrials.gov.

About Triple Negative Breast Cancer

TNBC accounts for approximately 15% of all breast cancer cases, with an estimated 345,000 diagnoses globally each year.^3,4 TNBC is diagnosed more frequently in younger and premenopausal women, and is more prevalent in Black and Hispanic women.^5,6,7 Metastatic TNBC is the most aggressive type of breast cancer and has the worst prognosis, with median overall survival of just 12 to 18 months and only about 14% of patients living five years following diagnosis.^5,8,9

While some breast cancers may test positive for estrogen receptors, progesterone receptors or overexpression of HER2, TNBC tests negative for all three.⁵ Due to its aggressive nature and absence of common breast cancer receptors, TNBC is characteristically difficult to treat.⁵ For patients with metastatic disease with PD-L1 expressing tumors, the addition of immunotherapy to chemotherapy has improved outcomes in the first-line setting.^10,11 However, for approximately 70% of patients with metastatic TNBC who are not candidates for immunotherapy, chemotherapy remains the first-line standard of care.^1,2

TROP2 is a protein broadly expressed in several solid tumors, including TNBC.¹² TROP2 is associated with increased tumor progression and poor survival in patients with breast cancer.^13,14

About DATROWAY

DATROWAY (datopotamab deruxtecan; datopotamab deruxtecan-dlnk in the U.S. only) is a TROP2 directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, DATROWAY is one of six DXd ADCs in the oncology pipeline of Daiichi Sankyo, and one of the most advanced programs in AstraZeneca’s ADC scientific platform. DATROWAY is comprised of a humanized anti-TROP2 IgG1 monoclonal antibody, developed in collaboration with Sapporo Medical University, attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.

DATROWAY (6 mg/kg) is approved in more than 35 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HR positive, HER2 negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease based on the results from the TROPION-Breast01 trial.

DATROWAY (6 mg/kg) is approved in Russia and the U.S. for the treatment of adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy, based on the results from TROPION-Lung05 and TROPION-Lung01 trials. Continued approval for this indication in the U.S. may be contingent upon verification and description of clinical benefit in a confirmatory trial.

About the DATROWAY Clinical Development Program

A comprehensive global clinical development program is underway with more than 20 trials evaluating the efficacy and safety of DATROWAY across multiple cancers, including NSCLC, TNBC and urothelial cancer. The program includes eight phase 3 trials in lung cancer and five phase 3 trials in breast cancer evaluating DATROWAY as a monotherapy and in combination with other cancer treatments in various settings.

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 seven ADCs in clinical development crafted from two distinct ADC technology platforms discovered in-house by Daiichi Sankyo.

The ADC platform furthest in clinical development is Daiichi Sankyo’s DXd ADC Technology where each ADC consists of a monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. The DXd ADC portfolio currently consists of ENHERTU, a HER2 directed ADC, and DATROWAY, a TROP2 directed ADC, which are being jointly developed and commercialized globally with AstraZeneca. Patritumab deruxtecan (HER3-DXd), a HER3 directed ADC, ifinatamab deruxtecan (I-DXd), a B7-H3 directed ADC, and raludotatug deruxtecan (R-DXd), a CDH6 directed ADC, are being jointly developed and commercialized globally with Merck & Co., Inc, Rahway, NJ, USA. DS-3939, a TA-MUC1 directed ADC, is being developed by Daiichi Sankyo.

The second Daiichi Sankyo ADC platform consists of a monoclonal antibody attached to a modified pyrrolobenzodiazepine (PBD) payload. DS-9606, a CLDN6 directed PBD ADC, is the first of several planned ADCs in clinical development utilizing this platform.

Ifinatamab deruxtecan, patritumab deruxtecan, raludotatug deruxtecan, DS-3939 and DS-9606 are investigational medicines that have not been approved for any indication in any country. Safety and efficacy have not been established.

DATROWAY U.S. Important Safety Information

Indications

DATROWAY^® is a Trop-2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of:

• adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy.

  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 the confirmatory trial.

• adult patients with unresectable or metastatic, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease.

Contraindications

None.

Warnings and Precautions

Interstitial Lung Disease/Pneumonitis

DATROWAY can cause severe, life-threatening, or fatal interstitial lung disease (ILD) or pneumonitis.

Locally Advanced or Metastatic NSCLC

In the pooled safety population of 484 patients with NSCLC from TROPION-Lung01, TROPION-Lung05, and TROPION-PanTumor01, ILD/pneumonitis occurred in 7% of patients treated with DATROWAY, including 0.6% of patients with Grade 3 and 0.4% with Grade 4. There were 8 (1.7%) fatal cases. The median time to onset for ILD was 1.4 months (range: 0.2 months to 9 months). Eleven patients (2.3%) had DATROWAY withheld and 20 patients (4.1%) permanently discontinued DATROWAY due to ILD/pneumonitis. Systemic corticosteroids were required in 79% (26/33) of patients with ILD/pneumonitis. ILD/pneumonitis resolved in 45% of patients.

Unresectable or Metastatic Breast Cancer

In the pooled safety population of 443 patients with breast cancer from TROPION-Breast01 and TROPION-PanTumor01, ILD/pneumonitis occurred in 3.6% of patients treated with DATROWAY, including 0.7% of patients with Grade 3. There was one fatal case (0.2%). The median time to onset for ILD was 2.8 months (range: 1.1 months to 10.8 months). Four patients (0.9%) had DATROWAY withheld and 7 patients (1.6%) permanently discontinued DATROWAY due to ILD/pneumonitis. Systemic corticosteroids were required in 60% (9/15) of patients with ILD/pneumonitis. ILD/pneumonitis resolved in 40% of patients.

Patients were excluded from clinical studies for a history of ILD/pneumonitis requiring treatment with steroids or for ongoing ILD/pneumonitis.

Monitor patients for new or worsening respiratory symptoms indicative of ILD/pneumonitis (e.g., dyspnea, cough, fever) during treatment with DATROWAY. For asymptomatic (Grade 1) ILD/pneumonitis, consider corticosteroid treatment (e.g., ≥0.5 mg/kg/day prednisolone or equivalent). For symptomatic ILD/pneumonitis (Grade 2 or greater), promptly initiate systemic corticosteroid treatment (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.

Withhold DATROWAY in patients with suspected ILD/pneumonitis and permanently discontinue DATROWAY if ≥Grade 2 ILD/pneumonitis is confirmed.

Ocular Adverse Reactions

DATROWAY can cause ocular adverse reactions including dry eye, keratitis, blepharitis, meibomian gland dysfunction, increased lacrimation, conjunctivitis, and blurred vision.

In the pooled safety population, ocular adverse reactions occurred in 36% of patients treated with DATROWAY. Twenty patients (2.2%) experienced Grade 3 ocular adverse reactions, which included keratitis, dry eye, and blurred vision, and one patient experienced a Grade 4 ocular adverse reaction of conjunctival hemorrhage. The most common (≥5%) ocular adverse reactions were dry eye (17%), keratitis (14%), and increased lacrimation (7%). The median time to onset for ocular adverse reactions was 2.3 months (range: 0.03 months to 23.2 months). Of the patients who experienced ocular adverse reactions, 39% had complete resolution, and 10% had partial improvement (defined as a decrease in severity by one or more grades from the worst grade at last follow up). Ocular adverse reactions led to dosage interruption in 3.6% of patients, dosage reductions in 2.5% of patients, and permanent discontinuation of DATROWAY in 1% of patients.

Patients with clinically significant corneal disease were excluded from clinical studies.

Advise patients to use preservative-free lubricant eye drops several times daily for prophylaxis. Advise patients to avoid use of contact lenses unless directed by an eye care professional.

Refer patients to an eye care professional for an ophthalmic exam including visual acuity testing, slit lamp examination (with fluorescein staining), intraocular pressure, and fundoscopy at treatment initiation, annually while on treatment, at end of treatment, and as clinically indicated.

Promptly refer patients to an eye care professional for any new or worsening ocular adverse reactions. Monitor patients for ocular adverse reactions during treatment with DATROWAY, and if diagnosis is confirmed, withhold, reduce the dose, or permanently discontinue DATROWAY based on severity.

Stomatitis

DATROWAY can cause stomatitis, including mouth ulcers and oral mucositis.

In the pooled safety population, stomatitis occurred in 63% of patients treated with DATROWAY, including 8% of patients with Grade 3 events and one patient with a Grade 4 reaction. The median time to first onset of stomatitis was 0.5 months (range: 0.03 months to 18.6 months). Stomatitis led to dosage interruption in 6% of patients, dosage reductions in 11% of patients, and permanent discontinuation of DATROWAY in 0.5% of patients.

In patients who received DATROWAY in TROPION-Breast01, 39% used a mouthwash containing corticosteroid for management or prophylaxis of stomatitis/oral mucositis at any time during the treatment.

Advise patients to use a steroid-containing mouthwash for prophylaxis and treatment of stomatitis. Instruct the patient to hold ice chips or ice water in the mouth throughout the infusion of DATROWAY.

Monitor patients for signs and symptoms of stomatitis. If stomatitis occurs, increase the frequency of mouthwash and administer other topical treatments as clinically indicated. Based on the severity of the adverse reaction, withhold, reduce the dose, or permanently discontinue DATROWAY.

Embryo-Fetal Toxicity

Based on its mechanism of action, DATROWAY can cause embryo-fetal harm when administered to a pregnant woman because the topoisomerase inhibitor component of DATROWAY, DXd, is genotoxic and affects actively dividing cells.

Advise patients of the potential risk to a fetus. Advise female patients of reproductive potential to use effective contraception during treatment with DATROWAY and for 7 months after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with DATROWAY and for 4 months after the last dose.

Adverse Reactions

The pooled safety population described in WARNINGS AND PRECAUTIONS reflects exposure to DATROWAY in 927 patients as a single agent at 6 mg/kg administered as an intravenous infusion once every 3 weeks (21-day cycle) until disease progression or unacceptable toxicity. This included 137 patients with NSCLC in TROPION-Lung05, 297 patients with NSCLC in TROPION-Lung01, 360 patients with HR-positive, HER2-negative breast cancer in TROPION-Breast01, and 50 patients with NSCLC and 83 patients with breast cancer in TROPION-PanTumor01 (NCT03401385). Among 927 patients who received DATROWAY, 45% were exposed for 6 months or longer and 19% were exposed for greater than one year. In this pooled safety population, the most common (≥20%) adverse reactions were stomatitis (63%), nausea (52%), fatigue (45%), alopecia (38%), constipation (28%), decreased appetite (23%), rash (23%), vomiting (22%), and musculoskeletal pain (20%). In this pooled safety population, the most common (≥2%) Grade 3 or 4 laboratory abnormalities were decreased lymphocytes (9%) and decreased hemoglobin (3.5%).

Locally Advanced or Metastatic EGFR-Mutated Non-Small Cell Lung Cancer

TROPION-Lung05, TROPION-Lung01, TROPION-PanTumor01

The safety of DATROWAY was evaluated in 125 patients with EGFR-mutated NSCLC who received DATROWAY 6 mg/kg administered as an intravenous infusion once every 3 weeks (21-day cycle) until disease progression or unacceptable toxicity in TROPION-Lung05 and TROPION-Lung01 as well as TROPION-PanTumor01 (NCT03401385). Among these patients, the median duration of treatment was 6.1 months (range 0.7 months to 41.7 months).

The median age was 63 years (range: 36 to 81), 56% of patients were <65 years, 62% of patients were female; 66% were Asian, 26% were White, 0.8% were Black, 6% were other races; and 2.4% were of Hispanic ethnicity.

Serious adverse reactions occurred in 26% of patients who received DATROWAY. Serious adverse reactions in >1% of patients who received DATROWAY were COVID-19 (4%), stomatitis (2.4%), and pneumonia (1.6%). Fatal adverse reactions occurred in 1.6% of patients who received DATROWAY, due to death not otherwise specified.

Permanent discontinuation of DATROWAY due to an adverse reaction occurred in 8% of patients. Adverse reactions which resulted in permanent discontinuation of DATROWAY in >1% of patients included ILD/pneumonitis (2.4%) and abnormal hepatic function (1.6%).

Dosage interruptions of DATROWAY due to an adverse reaction occurred in 43% of patients. Adverse reactions which required dosage interruption in >1% of patients included COVID-19 (13%), stomatitis (7%), fatigue (6%), pneumonia (4%), anemia (2.4%), amylase increased (2.4%), keratitis (2.4%), ILD/pneumonitis (1.6%), decreased appetite (1.6%), dyspnea (1.6%), rash (1.6%), and infusion-related reaction (1.6%).

Dose reductions of DATROWAY due to an adverse reaction occurred in 26% of patients. Adverse reactions which required dose reduction in >1% of patients included stomatitis (14%), keratitis (1.6%), fatigue (1.6%), decreased weight (1.6%) and COVID-19 (1.6%).

The most common (≥20%) adverse reactions, including laboratory abnormalities, were stomatitis (71%), nausea (50%), alopecia (49%), fatigue (42%), decreased hemoglobin (34%), decreased lymphocytes (32%), constipation (31%), increased calcium (31%), increased AST (28%), decreased white blood cell count (27%), increased lactate dehydrogenase (23%), musculoskeletal pain (22%), decreased appetite (20%), increased ALT (20%), and rash (20%).

Clinically relevant adverse reactions occurring in <10% of patients who received DATROWAY included dry skin, blurred vision, abdominal pain, conjunctivitis, dry mouth, ILD/pneumonitis, skin hyperpigmentation, increased lacrimation, and visual impairment.

Unresectable or Metastatic, HR-Positive, HER2-Negative Breast Cancer

TROPION-Breast01

The safety of DATROWAY was evaluated in 360 patients with unresectable or metastatic HR-positive, HER2-negative (IHC 0, IHC1+ or IHC2+/ISH-) breast cancer who received at least one dose of DATROWAY 6 mg/kg in TROPION-Breast01. DATROWAY was administered by intravenous infusion once every three weeks. The median duration of treatment was 6.7 months (range: 0.7 months to 16.1 months) for patients who received DATROWAY.

Serious adverse reactions occurred in 15% of patients who received DATROWAY. Serious adverse reactions in >0.5% of patients who received DATROWAY were urinary tract infection (1.9%), COVID-19 infection (1.7%), ILD/pneumonitis (1.1%), acute kidney injury, pulmonary embolism, vomiting, diarrhea, hemiparesis, and anemia (0.6% each). Fatal adverse reactions occurred in 0.3% of patients who received DATROWAY and were due to ILD/pneumonitis.

Permanent discontinuation of DATROWAY due to an adverse reaction occurred in 3.1% of patients. Adverse reactions which resulted in permanent discontinuation of DATROWAY in >0.5% of patients included ILD/pneumonitis (1.7%) and fatigue (0.6%).

Dosage interruptions of DATROWAY due to an adverse reaction occurred in 22% of patients. Adverse reactions which required dosage interruption in >1% of patients included COVID-19 (3.3%), infusion-related reaction (1.4%), ILD/pneumonitis (1.9%), stomatitis (1.9%), fatigue (1.7%), keratitis (1.4%), acute kidney injury (1.1%), and pneumonia (1.1%).

Dose reductions of DATROWAY due to an adverse reaction occurred in 23% of patients. Adverse reactions which required dose reduction in >1% of patients included stomatitis (13%), fatigue (3.1%), nausea (2.5%), and weight decrease (1.9%).

The most common (≥20%) adverse reactions, including laboratory abnormalities, were stomatitis (59%), nausea (56%), fatigue (44%), decreased leukocytes (41%), decreased calcium (39%), alopecia (38%), decreased lymphocytes (36%), decreased hemoglobin (35%), constipation (34%), decreased neutrophils (30%), dry eye (27%), vomiting (24%), increased ALT (24%), keratitis (24%), increased AST (23%), and increased alkaline phosphatase (23%).

Clinically relevant adverse reactions occurring in <10% of patients who received DATROWAY included infusion-related reactions (including bronchospasm), ILD/pneumonitis, headache, pruritus, dry skin, dry mouth, conjunctivitis, blepharitis, meibomian gland dysfunction, blurred vision, increased lacrimation, photophobia, visual impairment, skin hyperpigmentation, and madarosis.

Contacts

Global/US:
Jennifer Brennan

Daiichi Sankyo, Inc.

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

Read full story here

NanoPhoria Bioscience secures €83.5 Million Series A to Advance Breakthrough Heart Failure Therapy and Expand Portfolio for Novel Nano-in-Micro Delivery Platform




NanoPhoria Bioscience secures €83.5 Million Series A to Advance Breakthrough Heart Failure Therapy and Expand Portfolio for Novel Nano-in-Micro Delivery Platform

• Series A financing will advance the company’s lead candidate for heart failure with reduced ejection fraction (HFrEF) through completion of early clinical development and GMP manufacturing scale-up and regulatory programs
• Funds raised will also enable NanoPhoria to pursue indications beyond HFrEF
• The raise is the largest ever Italian biotech, Series A round

MILAN–(BUSINESS WIRE)–NanoPhoria Bioscience, a Milan-based biotech company, today announced the successful first close of its €83.5 million Series A financing round. The round was led by XGEN Venture, Sofinnova Partners, and CDP Venture Capital, with Panakès Partners also investing and one other undisclosed investor joining the round.

The funding will propel NanoPhoria’s lead candidate, NP-MP1, through IND-enabling studies and early clinical development. NP-MP1 is a first-in-class peptide that targets cardiac L-type calcium channels to improve ejection fraction for the treatment of heart failure with reduced ejection fraction (HFrEF).

Delivered via NanoPhoria’s proprietary lung-to-heart nano-in-micro technology, NP-MP1 has demonstrated excellent efficacy in preclinical models of heart failure and aims to address a root cause of HFrEF by improving cardiac contractility. HFrEF is a condition affecting millions globally with a five-year mortality rate of approximately 40%.

“This financing is a transformational milestone for NanoPhoria,” said Claudio De Luca, CEO and co-founder. “It enables us to accelerate clinical development of NP-MP1 and expand our pipeline. Our innovative delivery platform allows us to target previously inaccessible cellular targets in the cardiomyocyte, thereby bringing us closer to delivering life-changing treatments for patients living with serious cardiac and other chronic conditions who are underserved by existing treatments. We are profoundly grateful to our scientific founders, our investors, our Board, and our Chair, Suman Shirodkar, whose vision and efforts have shaped NanoPhoria’s progress and ambition.”

This investment perfectly aligns with XGEN’s strategy to lead early financing rounds in the most innovative Italian startups that address true medical needs,” said Paolo Fundarò, Managing Partner at XGEN Venture. “NanoPhoria’s science provides a novel, and viable, way of delivering highly potent therapeutics directly to the heart and we look forward to working alongside such a fantastic syndicate of investors.”

“NanoPhoria’s platform has the potential to redefine treatment paradigms in cardiovascular and other chronic diseases which is why we are excited to invest in this company,” added Henrijette Richter, Managing Partner at Sofinnova Partners. “This financing builds on the early support of my colleague Lucia Faccio, Partner in the Sofinnova Telethon Strategy, whose role was instrumental in supporting the company in its early days to take shape. The investment reflects Sofinnova’s broader commitment to backing world-class science across Europe, from early-stage company creation to late-stage growth.”

About NanoPhoria

Founded in 2022 by Daniele Catalucci, Michele Iafisco, Alessio Alogna and Claudio De Luca NanoPhoria is a spin-off from Italy’s National Research Council (CNR). The company is developing a versatile, nano-in-micro & lung-to-heart delivery platform based on inorganic calcium phosphate nanoparticles. The company’s first product is a pre-clinical stage treatment for heart failure with reduced ejection fraction (HFrEF), a chronic syndrome affecting the lives of millions worldwide. NanoPhoria is supported by Sofinnova Partners, XGEN Venture, CDP Venture Capital and other investors. Learn more at NanoPhoria.com

About Sofinnova Partners

Sofinnova Partners is a leading European venture capital firm in life sciences, specializing in healthcare and sustainability. Based in Paris, London and Milan, the firm brings together a team of professionals from all over the world with strong scientific, medical and business expertise. Sofinnova Partners is a hands-on company builder across the entire value chain of life sciences investments, from seed to later-stage.

Founded in 1972, Sofinnova Partners is a deeply established venture capital firm in Europe, with 50 years of experience backing over 500 companies and creating market leaders around the globe. Today, Sofinnova Partners manages over €4 billion in assets. For more information, please visit: sofinnovapartners.com.

About XGEN Venture

XGEN Venture is a premier venture capital firm dedicated to advancing innovations in the life sciences sector. With nearly two decades of experience, the founding team has a proven track record of building breakthrough life sciences startups in Italy and internationally. XGEN is currently investing out of its first fund, XGEN Venture Life Science Fund, launched in 2022, and focusing on early-stage investments across biotechnology, medical devices, and diagnostics. For more information: www.xgenventure.com

About CDP Venture Capital

CDP Venture Capital is an Asset Management Company with €4.7 billion in assets under management. It operates with a series of funds that aim to support startups throughout all their life stages, making both direct and indirect investments. The CDP Venture Capital contribution to Nanophoria’s Series A round was performed through its Large Ventures Fund.

About Panakès Partners

Panakès Partners is a Venture Capital firm, based in Milan, that invests in the most ambitious companies and teams developing revolutionary technologies and products in the field of life sciences with the aim of improving the lives of people around the world. Panakès, founded in 2016 by Fabrizio Landi, Alessio Beverina and Diana Saraceni, has €250 million under management. www.panakes.it

Contacts

Barnaby Pickering, Director, 59 North Communications

Barnaby.Pickering@59North.bio
+447300796779

Claudio De Luca, CEO and Founder, NanoPhoria

claudio.deluca@nanophoria.com

Ignota Labs Acquires Kronos’s Clinical Pipeline




Ignota Labs Acquires Kronos’s Clinical Pipeline

Kronos, once valued at $3.5B, Had Two Phase 2 Stage Assets

CAMBRIDGE, England–(BUSINESS WIRE)–Ignota Labs, the AI drug turnaround company, has announced its acquisition of Kronos’s clinical assets, istisociclib, a CDK9 inhibitor, and entospletinib and lanraplenib, SYK inhibitors. Kronos’ valuation peaked at $3.5 billion after its IPO; however, it failed to progress its assets past Phase 2 trials and subsequently ceased operations. Given the challenges relating to safety and clinical positioning, Ignota Labs saw promise in the clinical portfolio and has acquired Kronos’s clinical IP in full.

Ignota Labs combines cheminformatics and bioinformatics in its AI platform, SAFEPATH, to identify the root causes of safety issues and improve safety while maintaining therapeutic effectiveness. Ignota’s proprietary process will now assess the Kronos assets to identify the issue, solve the causes of toxicity, and develop the drug clinically and commercially to get it to patients.

Sam Windsor, Co-Founder and CEO at Ignota Labs, said: “We are acquiring assets that have demonstrated therapeutic effect, but failed in their development and were shelved despite tens of millions of dollars already invested in them. This is where Ignota Labs come in: unlocking value by turning around failing drugs so that they can quickly get back into clinical trials and bring fresh hope to the patients waiting for these drugs.”

Blood cancers and autoimmune disorders remain large, underserved markets. Chronic lymphocytic leukaemia (CLL) is an $8 billion market globally, and immune thrombocytopenia purpura (ITP) represents a $1.5 billion opportunity. By reviving these clinical assets, Ignota Labs is uniquely positioned to address these substantial patient and market needs.

Dr. Jordan Lane, Co-Founder and Chief Scientific Officer, said: “These drugs are desperately needed. Both CKD9 inhibitors and SYK inhibitors have shown clinical benefit to patients. By in-licensing these drugs, we are uniquely placed to bring these best-in-class drugs to patients with diseases that desperately need them.”

About Ignota Labs

Ignota Labs turns around promising but failing drugs, bringing new life to abandoned projects and new hope to patients. In preclinical and clinical studies, safety assessments typically reveal what went wrong—such as liver damage or heart issues—but fail to explain why these issues occurred, or how they might be mitigated. SAFEPATH is a first-of-its-kind AI platform that combines advanced machine learning models with a multimodal data approach to enable a deep understanding of toxicity mechanisms, and offers actionable insights to facilitate drug turnaround. The clinical stage company was founded by Cambridge researchers and pharmaceutical consultants, and investors include AIX Ventures, Montage Ventures, and Modi Ventures.

For more information, visit www.ignotalabs.ai.

Contacts

Media contact: hailey@commplicated.com / +44 07480 559199

Alto Neuroscience Receives FDA Fast Track Designation for ALTO-101 for the Treatment of Cognitive Impairment Associated with Schizophrenia




Alto Neuroscience Receives FDA Fast Track Designation for ALTO-101 for the Treatment of Cognitive Impairment Associated with Schizophrenia

– ALTO-101, a novel PDE4 inhibitor, has demonstrated pro-cognitive effects in healthy volunteers –

– Designation highlights the significant unmet need for new treatments for cognitive impairment associated with schizophrenia (CIAS) –

– Enrollment remains ongoing in a Phase 2 proof-of-concept study of ALTO-101 in patients with CIAS –

MOUNTAIN VIEW, Calif.–(BUSINESS WIRE)–$ANRO #FastTrack–Alto Neuroscience, Inc. (“Alto”) (NYSE: ANRO) a clinical-stage biopharmaceutical company focused on the development of novel precision medicines for neuropsychiatric disorders, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ALTO-101 for the treatment of cognitive impairment associated with schizophrenia (CIAS). There are currently no approved treatments for CIAS, a core feature of schizophrenia that severely impacts daily functioning and quality of life for millions of patients.

Fast Track designation is an FDA process designed to facilitate the development and expedite the review of drugs intended to treat serious conditions and fill an unmet medical need. A drug that receives Fast Track designation may be eligible for more frequent meetings with the FDA to discuss the drug’s development plan, as well as eligibility for accelerated approval and priority review, if relevant criteria are met.

“Receiving Fast Track designation from the FDA underscores the critical need for new, effective treatments for patients suffering from cognitive impairment associated with schizophrenia,” said Amit Etkin, M.D., Ph.D., founder and chief executive officer of Alto Neuroscience. “This designation is a significant milestone for the ALTO-101 program and we believe it is a testament to its potential as a novel treatment approach. Our Phase 1 data, which demonstrated significant and clinically relevant effects of ALTO-101 on both EEG measures and cognitive performance in healthy subjects, provides strong validation for its mechanism. We are committed to advancing this program expeditiously for the millions of patients who currently have no approved treatment options to address these debilitating cognitive deficits.”

ALTO-101 is a novel small molecule phosphodiesterase-4 (PDE4) inhibitor. The PDE4 enzyme plays a key role in the brain by breaking down cyclic adenosine monophosphate (cAMP), a molecule crucial for neuronal signaling and synaptic plasticity, which are fundamental to learning and memory. By inhibiting PDE4, ALTO-101 increases cAMP levels, which is believed to enhance neural circuits and improve cognitive function. The cognitive deficits in schizophrenia, which include impaired attention, memory, and executive function, represent a substantial and underserved aspect of the illness.

About Cognitive Impairment Associated with Schizophrenia (CIAS)

Cognitive impairment is a core and disabling feature of schizophrenia, affecting areas such as memory, attention, processing speed, and executive function. These deficits are a primary determinant of poor functional outcomes for patients, impacting their ability to work, maintain social relationships, and live independently. Currently, there are no approved treatments for CIAS, representing a significant unmet medical need for the millions of people living with schizophrenia worldwide.

About Alto Neuroscience

Alto Neuroscience is a clinical-stage biopharmaceutical company with a mission to redefine psychiatry by leveraging neurobiology to develop personalized and highly effective treatment options. Alto’s Precision Psychiatry Platform™ measures brain biomarkers by analyzing EEG activity, neurocognitive assessments, wearable data, and other factors to better identify which patients are more likely to respond to Alto product candidates. Alto’s clinical-stage pipeline includes novel drug candidates in bipolar depression, major depressive disorder, treatment resistant depression (TRD), and schizophrenia, and other mental health conditions. For more information, visit www.altoneuroscience.com or follow Alto on X.

Forward-Looking Statements

This press release may contain forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “expects,” “plans,” “will” and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, but are not limited to, statements regarding Alto’s expectations about the potential benefits, activity, effectiveness and safety of its product candidates and Precision Psychiatry Platform (“Platform”); statements regarding Alto’s expectations for the design, progress and results of its ongoing Phase 2 POC trial of ALTO-101 in CIAS; Alto’s ability to recognize the benefits of receiving Fast Track designation, Alto’s expectations with regard to the design and results of its clinical trials. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various factors, including uncertainties inherent in the initiation, progress and completion of clinical trials, including the Phase 2 POC trial of ALTO-101, and other important factors, any of which could cause Alto’s actual results to differ from those contained in the forward-looking statements, which are described in greater detail in the section titled “Risk Factors” in each of Alto’s Annual Report on Form 10-K for the fiscal year ended December 31, 2024 and Alto’s Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2025 filed with the Securities and Exchange Commission (“SEC”) as well as in other filings Alto may make with the SEC in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and Alto expressly disclaims any obligation to update any forward-looking statements contained herein, whether because of any new information, future events, changed circumstances or otherwise, except as required by law.

Availability of Information on Alto’s Website

Alto routinely uses its investor relations website to post presentations to investors and other important information, including information that may be material. Accordingly, Alto encourages investors and others interested in Alto to review the information it makes public on its investor relations website.

Contacts

Investor and Media Contact:
Nick Smith

investors@altoneuroscience.com
media@altoneuroscience.com

KalVista Pharmaceuticals Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)




KalVista Pharmaceuticals Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

FRAMINGHAM, Mass. & SALISBURY, England–(BUSINESS WIRE)–KalVista Pharmaceuticals, Inc. (Nasdaq: KALV), today announced that the compensation committee of KalVista’s board of directors granted two newly-hired employees inducement options to purchase an aggregate of 30,000 shares of KalVista common stock on October 1, 2025 as inducements material to each employee entering into employment with KalVista. The options have an exercise price that is equal to the closing price of KalVista common stock on the first day a closing price is reported following the grant date.

One-fourth of the options vest on the one-year anniversary of the vesting commencement date and the remainder vest in equal monthly installments over the next three years, in each case subject to the new employee’s continued service with the company. Each stock option has a 10-year term and is subject to the terms and conditions of KalVista’s Inducement Equity Incentive Plan and a stock option agreement covering the grant.

The options were granted in accordance with Nasdaq Listing Rule 5635(c)(4).

About KalVista Pharmaceuticals, Inc.

KalVista is a global pharmaceutical company dedicated to delivering life-changing oral therapies for individuals affected by rare diseases with significant unmet needs. The KalVista team discovered and developed EKTERLY^®—the first and only oral on-demand treatment for hereditary angioedema (HAE)—and continues to work closely with the global HAE community to improve treatment and care for this disease around the world. For more information about KalVista, please visit www.kalvista.com and follow us on LinkedIn, X, Facebook and Instagram.

Contacts

Ryan Baker

Head, Investor Relations

(617) 771-5001

ryan.baker@kalvista.com

Molly Cameron

Director, Corporate Communications

(857) 356-0164

molly.cameron@kalvista.com

Bruker Announces Orders for NIH- and NSF-Funded NMR Systems from New York Structural Biology Center, University of Delaware and Northwestern University




Bruker Announces Orders for NIH- and NSF-Funded NMR Systems from New York Structural Biology Center, University of Delaware and Northwestern University

BILLERICA, Mass.–(BUSINESS WIRE)–$BRKR #BRKR—Bruker Corporation (Nasdaq: BRKR) today announced new orders for advanced Nuclear Magnetic Resonance (NMR) instrumentation from the New York Structural Biology Center (NYSBC), the University of Delaware and Northwestern University. Supported by the National Institutes of Health (NIH) and the National Science Foundation (NSF), these high-performance systems will enable leading research teams to pursue breakthroughs across a wide range of scientific research, drug discovery and disease biology disciplines.

The New York Structural Biology Center (NYSBC) ordered an NIH-funded Multifield NMR Relaxometry System. This advanced relaxometry system will be the first in North America and serves a consortium of nine research institutions in New York State as well as the national community through the NIH-funded Center on Macromolecular Dynamics by NMR spectroscopy. The system consists of a fast NMR sample shuttle system, a magnetic tunnel, and an electromagnetic field cycling coil (FCC), all mounted on a 700 MHz superconducting NMR magnet.

“This novel NMR Relaxometry system is a technological breakthrough that enables for the very first time measurements of spin-lattice relaxation rate constants for ¹H, ¹⁵N, ¹³C and other spins in biological macromolecules, including proteins and nucleic acids, over the range of magnetic fields from 100 µT to 16.4 T,” said Arthur G. Palmer, Professor of Biochemistry and Molecular Biophysics at Columbia University and Director of NMR Spectroscopy at NYSBC. “Critically, this instrumentation opens new time regimes for elucidating dynamics of these molecules and enables research ranging from understanding fundamental biological processes in normal and pathological states to discovery of potential new drugs for treatment of cancer and other diseases”.

At the University of Delaware, the Department of Chemistry and Biochemistry has ordered a 600 MHz Dynamic Nuclear Polarization (DNP) NMR spectrometer, funded by the NSF Major Research Instrumentation (MRI) program. This instrument will serve over 25 research groups at the University of Delaware and 12 collaborating institutions, supporting projects that range from understanding the molecular basis of disease to developing new materials and sustainable technologies. The new spectrometer’s enhanced sensitivity will enable investigations of complex biological and engineered systems, including intact cells, protein assemblies, polymers, pharmaceutical formulations, and catalysts.

“This new DNP NMR system will open up avenues of discovery for us not possible with our existing instrumentation,” said Professor Tatyana Polenova, Department of Chemistry and Biochemistry, University of Delaware. “It will impact multiple fields, from structural biology to materials science, and provide training opportunities for students and collaborators. We are grateful for the support of the NSF MRI program, which makes this leap in research capability possible.”

At Northwestern University, the Integrated Molecular Structure Education and Research Center (IMSERC) recently ordered an 800 MHz NMR spectrometer. The instrument will benefit over 15 NIH-funded research groups and the broader Chicago research community, including the Chicago Biomedical Consortium. Key research applications include high-resolution biomolecular NMR for drug discovery, protein-ligand interactions, neurodegenerative disease research, regenerative medicine, and advanced materials development.

“I expect our new 800 MHz NMR spectrometer to transform our ability to conduct high-resolution biomolecular studies and accelerate discoveries in drug development, neurodegenerative disease, and regenerative medicine,” said Dr. Joshua Ziarek, Associate Professor, Department of Pharmacology at the Northwestern University Feinberg School of Medicine. “By making state-of-the-art NMR accessible locally, we are positioning Northwestern as a regional hub for high-field NMR and supporting the next generation of scientific leaders.”

The aggregate value of these three federally funded NMR orders is approximately $10 million, and they are expected to be delivered and installed next year in 2026.

About Bruker Corporation – Leader of the Post-Genomic Era (Nasdaq: BRKR)

Bruker is enabling scientists and engineers to make breakthrough post-genomic discoveries and develop new applications that improve the quality of human life. Bruker’s high-performance scientific instruments and high value analytical and diagnostic solutions enable scientists to explore life and materials at molecular, cellular, and microscopic levels. In close cooperation with our customers, Bruker is enabling innovation, improved productivity, and customer success in post-genomic life science molecular and cell biology research, in applied and biopharma applications, in microscopy and nanoanalysis, as well as in industrial and cleantech research, and next-gen semiconductor metrology in support of AI. Bruker offers differentiated, high-value life science and diagnostics systems and solutions in preclinical imaging, clinical phenomics research, proteomics and multiomics, spatial and single-cell biology, functional structural and condensate biology, as well as in clinical microbiology and molecular diagnostics. For more information, please visit www.bruker.com.

Contacts

Investor Contact:
Joe Kostka

Director – Investor Relations

Bruker Corporation

T: +1 978 313-5800

E: Investor.Relations@bruker.com

Media Contact:
Markus Ziegler

Sr. Director and Head of Group Marketing

Bruker BioSpin

T: +49 172 3733531

E: pr@bruker.com

FDA Approves Genentech’s Tecentriq Plus Lurbinectedin as First-Line Maintenance Therapy for Extensive-Stage Small Cell Lung Cancer




FDA Approves Genentech’s Tecentriq Plus Lurbinectedin as First-Line Maintenance Therapy for Extensive-Stage Small Cell Lung Cancer

– Combination reduced the risk of disease progression or death by 46% and risk of death by 27% in pivotal Phase III IMforte study –

– First and only combination therapy for the first-line maintenance treatment of ES-SCLC, which is critical to help address the high rate of relapse in ES-SCLC –

– Regimen recommended in National Comprehensive Cancer Network^® Guidelines for SCLC^* –

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved Tecentriq^® (atezolizumab) and Tecentriq Hybreza^® (atezolizumab and hyaluronidase-tqjs) in combination with lurbinectedin (Zepzelca^®) for the maintenance treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) whose disease has not progressed after first-line induction therapy with Tecentriq or Tecentriq Hybreza, carboplatin and etoposide (CE). This approval marks the first and only combination therapy for the first-line maintenance treatment of ES-SCLC, a highly aggressive disease for which treatment options have been limited. The U.S. National Comprehensive Cancer Network^® Clinical Practice Guidelines in Oncology (NCCN Guidelines^®)* have been updated to include the regimen as a category 2A and preferred option for maintenance treatment of people with ES-SCLC, following induction therapy with Tecentriq and CE.

“For people with extensive-stage small cell lung cancer and their families, the period after induction therapy is often filled with uncertainty, given the high risk of relapse,” said Roy Herbst, M.D., Ph.D., deputy director and chief of medical oncology and hematology at Yale Cancer Center and Smilow Cancer Hospital. “The Tecentriq and Zepzelca combination provides a new option and a proactive approach in this setting shown to improve progression-free and overall survival in patients who haven’t progressed after standard induction treatment with Tecentriq and chemotherapy. The approval may lead to a meaningful shift in how we manage this challenging disease and gives us a new tool to help to delay disease progression and extend survival.”

“The Tecentriq and lurbinectedin combination reduced the risk of disease progression or death by nearly half,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “We are proud to deliver this advancement for the small cell lung cancer community in partnership with Jazz Pharmaceuticals, as it reflects our abiding commitment to improving outcomes in the hardest-to-treat cancers.”

The FDA approval is based on results from the Phase III IMforte study, which showed that the Tecentriq and lurbinectedin combination reduced the risk of disease progression or death by 46% and the risk of death by 27%, compared to Tecentriq maintenance therapy alone. Following 3.2 months of induction therapy, the median overall survival for the Tecentriq plus lurbinectedin regimen was 13.2 months versus 10.6 months for Tecentriq alone (stratified hazard ratio [HR]=0.73; 95% CI: 0.57–0.95; p=0.0174). Median progression-free survival by independent assessment was 5.4 months versus 2.1 months, respectively (stratified HR=0.54; 95% CI: 0.43–0.67; p<0.0001). Safety was generally consistent with the known safety profiles of Tecentriq and lurbinectedin.

Today’s approval builds on Tecentriq’s established role in ES-SCLC. In 2019, the FDA approved Tecentriq in combination with chemotherapy for the first-line treatment of adults with ES-SCLC, based on the IMpower133 study, which at the time was the first new treatment option in two decades for this patient population.

*NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

About the IMforte study

IMforte [NCT05091567] is a Phase III, open-label, randomized trial evaluating the efficacy and safety of Tecentriq^® (atezolizumab) plus lurbinectedin (Zepzelca^®) versus Tecentriq alone as first-line maintenance therapy for adults (≥18 years) with extensive-stage small-cell lung cancer (ES-SCLC). Patients first received induction therapy with Tecentriq, carboplatin and etoposide for four 21-day cycles. Those without disease progression were then randomized 1:1 to receive maintenance therapy with either Tecentriq plus lurbinectedin or Tecentriq alone until disease progression or unacceptable toxicity. The study enrolled 660 patients in the induction phase and randomized 483 patients in the maintenance phase. The study’s primary endpoints were independent review facility-assessed progression-free survival and overall survival from randomization into the maintenance phase.

The trial is sponsored by Genentech and co-funded by Jazz Pharmaceuticals.

About Tecentriq^® (atezolizumab)

Tecentriq (atezolizumab) is a monoclonal antibody designed to bind with a protein called PD-L1, which is expressed on tumor cells and tumor-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the re-activation of T cells. Tecentriq may also affect normal cells.

Important Safety Information and Indications

What are Tecentriq and Tecentriq Hybreza?

Tecentriq (atezolizumab) and Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) are prescription medicines used to treat:

Adults with a type of lung cancer called “extensive stage small cell lung cancer (SCLC)”, which is SCLC that has spread or grown

• Tecentriq or Tecentriq Hybreza may be used with the chemotherapy medicines carboplatin and etoposide as your first treatment
• Tecentriq or Tecentriq Hybreza may be used with the medicine lurbinectedin as maintenance treatment when your lung cancer:
  • has not progressed after first treatment with Tecentriq or Tecentriq Hybreza and the chemotherapy medicines carboplatin and etoposide.

It is not known if Tecentriq Hybreza is safe and effective in children.

It is not known if Tecentriq is safe and effective when used in children for the treatment of SCLC.

What is the most important information about Tecentriq and Tecentriq Hybreza?

Tecentriq and Tecentriq Hybreza can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. You can have more than one of these problems at the same time. These problems may happen anytime during your treatment or even after your treatment has ended.

Call or see your healthcare provider right away if you develop any new or worse signs or symptoms, including:

Lung problems

• cough
• shortness of breath
• chest pain

Intestinal problems

• diarrhea (loose stools) or more frequent bowel movements than usual
• stools that are black, tarry, sticky, or have blood or mucus
• severe stomach-area (abdomen) pain or tenderness

Liver problems

• yellowing of the skin or the whites of the eyes
• severe nausea or vomiting
• pain on the right side of their stomach area (abdomen)
• dark urine (tea colored)
• bleeding or bruising more easily than normal

Hormone gland problems

• headaches that will not go away or unusual headaches
• eye sensitivity to light
• eye problems
• rapid heartbeat
• increased sweating
• extreme tiredness
• weight gain or weight loss
• feeling more hungry or thirsty than usual
• urinating more often than usual
• hair loss
• feeling cold
• constipation
• your voice gets deeper
• dizziness or fainting
• changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness

Kidney problems

• decrease in your amount of urine
• blood in your urine
• swelling of your ankles
• loss of appetite

Skin problems

• rash
• itching
• skin blistering or peeling
• painful sores or ulcers in mouth or nose, throat, or genital area
• fever or flu-like symptoms
• swollen lymph nodes

Problems can also happen in other organs.

These are not all of the signs and symptoms of immune system problems that can happen with Tecentriq or Tecentriq Hybreza. Call or see your healthcare provider right away for any new or worse signs or symptoms, including:

• Chest pain, irregular heartbeat, shortness of breath, or swelling of ankles
• Confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems, tingling or numbness of the arms or legs
• Double vision, blurry vision, sensitivity to light, eye pain, changes in eyesight
• Persistent or severe muscle pain or weakness, muscle cramps
• Low red blood cells, bruising

Infusion reactions that can sometimes be severe or life-threatening. Signs and symptoms of infusion reactions may include:

• chills or shaking
• itching or rash
• flushing
• shortness of breath or wheezing
• dizziness
• feeling like passing out
• fever
• back or neck pain

Complications, including graft-versus-host disease (GVHD), in people who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic). These complications can be serious and can lead to death. These complications may happen if you underwent transplantation either before or after being treated with Tecentriq or Tecentriq Hybreza. Your healthcare provider will monitor you for these complications.

Getting medical treatment right away may help keep these problems from becoming more serious. Your healthcare provider will check you for these problems during your treatment with Tecentriq or Tecentriq Hybreza. Your healthcare provider may treat you with corticosteroid or hormone replacement medicines. Your healthcare provider may also need to delay or completely stop treatment with Tecentriq or Tecentriq Hybreza if you have severe side effects.

Before you receive Tecentriq or Tecentriq Hybreza, tell your healthcare provider about all of your medical conditions, including if you:

• have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus
• have received an organ transplant
• have received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic)
• have received radiation treatment to your chest area
• have a condition that affects your nervous system, such as myasthenia gravis or Guillain-Barré syndrome
• are pregnant or plan to become pregnant. Tecentriq and Tecentriq Hybreza can harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with Tecentriq or Tecentriq Hybreza. Females who are able to become pregnant:
  • Your healthcare provider should do a pregnancy test before you start treatment with Tecentriq or Tecentriq Hybreza.
  • You should use an effective method of birth control during your treatment and for at least 5 months after the last dose of Tecentriq or Tecentriq Hybreza.
• are breastfeeding or plan to breastfeed. It is not known if Tecentriq or Tecentriq Hybreza passes into your breast milk. Do not breastfeed during treatment and for at least 5 months after the last dose of Tecentriq or Tecentriq Hybreza.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

The most common side effects of Tecentriq when used alone include:

• feeling tired or weak
• decreased appetite
• nausea
• cough
• shortness of breath

The most common side effects of Tecentriq Hybreza when used alone include:

• feeling tired or weak
• muscle or bone pain
• cough
• shortness of breath
• decreased appetite

The most common side effects of Tecentriq and Tecentriq Hybreza when used in lung cancer with other anti-cancer medicines include:

• feeling tired or weak
• nausea
• hair loss
• constipation
• diarrhea
• decreased appetite

Tecentriq and Tecentriq Hybreza may cause fertility problems in females, which may affect the ability to have children. Talk to your healthcare provider if you have concerns about fertility.

These are not all the possible side effects of Tecentriq and Tecentriq Hybreza. Ask your healthcare provider or pharmacist for more information about the benefits and side effects of Tecentriq and Tecentriq Hybreza.

You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at 1-888-835-2555.

Please see full Prescribing Information for Tecentriq and Tecentriq Hybreza and the Medication Guides for Tecentriq and Tecentriq Hybreza for additional Important Safety Information.

About Genentech in cancer immunotherapy

To learn more about Genentech’s scientific-led approach to cancer immunotherapy, please follow this link: https://www.gene.com/cancer-immunotherapy.

About Genentech

Founded nearly 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.

ZEPZELCA is a trademark of Pharma Mar, S.A. used by Jazz Pharmaceuticals under license.

All trademarks used or mentioned in this release are protected by law.

Contacts

Media Contact: Andrea Wallace (650) 467-6800

Advocacy Contact: Katie Creme Henry (202) 258-8228

Investor Contacts: Loren Kalm (650) 225-3217

Bruno Eschli +41 616875284

Pharmanovia Appoints Stephan Eder as Chief Executive Officer




Pharmanovia Appoints Stephan Eder as Chief Executive Officer

BASILDON, England–(BUSINESS WIRE)–Pharmanovia today announced the appointment of Stephan Eder as Chief Executive Officer (CEO) of Pharmanovia, effective today.

Stephan is a highly experienced leader, with over two decades leading teams and businesses in senior roles in multi-national pharma. Most recently, he served on the Executive Committee at Stada, a private equity backed company focusing on Generics, Specialty and Consumer Healthcare, in several commercial roles, most importantly as Head of Europe, leading a business with sales of EUR 3.5bn and over 6,000 employees. Prior to that, Stephan worked at Novartis and latterly moved over to Sandoz and Hexal, where he held a number of senior positions including CEO, Hexal/Sandoz Germany.

Guido Oelkers, Chair of Pharmanovia, commented: “Stephan has a strong track record delivering sustainable growth across diverse businesses. He has demonstrated a high degree of ambition and urgency and is passionate about building strong teams.

“The board welcomes Stephan as the incoming CEO and looks forward to the company’s future development under his leadership.”

Stephan Eder added, “I am excited to join an organisation that not only owns trusted established brands but is poised to launch some exciting innovative medicines in the next couple of years. I am impressed by the team and see a very strong commitment to making a difference to patient’s lives. This sense of purpose coupled with the ongoing support from our shareholders, gives me conviction to lead the company to the next phase of growth.”

Notes to editors

About Pharmanovia

Pharmanovia is a global healthcare company. Our purpose is to make medicines fit for tomorrow, to improve the lives of patients globally.

We do this by rediscovering, repurposing or re-engineering established medicines to improve patient outcomes and experiences as well as identifying new chemical entities that complement our existing portfolio to address unmet need.

With a diverse and growing team in over 160 countries across the globe, we deliver high-quality solutions, ethically and sustainably, across our four core therapeutic areas – Endocrinology, Neurology, Cardiovascular and Oncology.

For more information about Pharmanovia, please visit www.pharmanovia.com.

Contacts

For further information, please contact:

Alison Dyson, Director of Communications, Pharmanovia

07912887250/ communications@pharmanovia.com

LEO Pharma Closes Deal for Spevigo®




LEO Pharma Closes Deal for Spevigo®

• Adding Spevigo^® is a significant step forward in LEO Pharma’s focused growth strategy, to accelerate and expand patients’ access to treatments for medical dermatological conditions, including generalized pustular psoriasis (GPP), a rare and severe skin condition
• Spevigo® (spesolimab) is a first-in-class IL-36R antagonist successfully developed and launched by Boehringer Ingelheim and approved globally for the treatment and prevention of GPP flares
• Spesolimab is also being investigated for the treatment of other IL-36-mediated skin diseases

BALLERUP, Denmark–(BUSINESS WIRE)–GLOBAL RELEASE – NOT INTENDED FOR UK MEDIA

LEO Pharma, a global leader in medical dermatology, has successfully closed the deal for Spevigo® with Boehringer Ingelheim, as announced on July 14, 2025, following approval from all relevant authorities. The terms of the transaction and the financial assumptions outlined in LEO Pharma’s initial press release regarding the deal remain unchanged. LEO Pharma and Boehringer Ingelheim will continue working closely together on finalizing all aspects of the transition of Spevigo® to LEO Pharma.

Spevigo® is an innovative, humanized, and selective monoclonal antibody that targets and blocks the activation of the interleukin-36 (IL-36) receptor – a key signalling pathway in the immune system implicated in the pathogenesis of several autoinflammatory diseases, including generalized pustular psoriasis (GPP).¹²³

Spevigo® will join LEO Pharma’s global dermatology portfolio as its third strategic brand. Spevigo^® is available in more than 40 countries including the U.S., Japan, China, and most European countries to treat GPP flares in adults.⁴

“With our specialization in dermatology, LEO Pharma is uniquely positioned to take over Spevigo® and expand access to care, bringing progress to underserved patients,” said Christophe Bourdon, CEO of LEO Pharma. “We are committed to ensuring this innovative treatment reaches its full potential by building on Boehringer Ingelheim’s pioneering efforts. Bringing Spevigo® to more patients is an important step in helping those living with GPP, a community with limited treatment options.”

GPP is a rare, heterogeneous, and potentially life-threatening skin disease. It is characterized by the accumulation of neutrophils (a type of white blood cell) in the skin, leading to painful, sterile pustules across the body. The disease course varies, with some patients experiencing relapsing episodes with recurrent flares – often accompanied by fever, malaise, fatigue, and a risk of organ failure – while others endure persistent disease with intermittent flares. ^7891011

LEO Pharma will be responsible for commercialization and further development of Spevigo®, leveraging its global commercial platform in medical dermatology to accelerate and expand access to treatment for patients with GPP. Spesolimab is also being investigated for the treatment of other IL-36-mediated skin diseases, including pyoderma gangrenosum.

Spevigo® will be included in the financials for FY 2025 with three months of impact. Preliminary assessment suggests that Spevigo® will contribute less than one percent to revenue growth in 2025. Ongoing costs for Spevigo®, mainly related to development activities, are preliminarily assessed to reduce the adjusted EBITDA margin in 2025 by up to two percentage points. Excluding Spevigo® the outlook for revenue growth of 7-9% at constant exchange rates and an adjusted EBITDA margin of 16-18%, as communicated with the H1 2025 Interim Report, published August 18, 2025, is unchanged.

— LEO Pharma A/S —

About Spevigo®

Spevigo® is a humanized, selective antibody that specifically blocks the activation of the IL-36R, a signalling pathway within the immune system shown to be involved in the pathogenesis of several autoinflammatory diseases, including GPP. It is the first targeted therapy for the treatment of GPP and has been evaluated in the largest clinical program specifically for the treatment of patients with GPP.¹²³

About generalized pustular psoriasis (GPP)

GPP is a chronic, heterogenous, neutrophilic inflammatory disease associated with skin and systemic symptoms that is distinct from plaque psoriasis. GPP is recognized as a separate clinical entity from other forms of psoriasis, with the IL-36 pathway being a key driver of GPP and triggering response to treatment.⁵⁶ GPP can become life-threatening (mortality rates ranging from 2% to 16%) due to severe complications, such as multisystem organ failure and sepsis requiring urgent hospital care; many GPP patients also suffer from various comorbidities, which contribute to the ongoing burden for the patient and healthcare systems.⁸⁷ GPP symptoms appear unpredictable and present on a continuum, which greatly impacts a patient’s quality of life, and may cause fear and anxiety over the disease course, as well as long-term impacts on quality of life related to work/school, emotional health, social activities, and finances.⁸⁸⁹

About LEO Pharma

LEO Pharma is a global leader in medical dermatology. We deliver innovative solutions for skin health, building on a century of experience with breakthrough medicines in healthcare. We are committed to making a fundamental difference in people’s lives, and our broad portfolio of treatments serves close to 100 million patients in over 70 countries annually. Headquartered in Denmark, LEO Pharma has a team of 4,000 people worldwide. LEO Pharma is co-owned by majority shareholder the LEO Foundation and, since 2021, Nordic Capital. For more information, visit www.leo-pharma.com.

¹ Morita A, Strober B, Burden AD, et al. Efficacy and safety of subcutaneous spesolimab for the prevention of generalised pustular psoriasis flares (Effisayil 2): an international, multicentre, randomised, placebo-controlled trial. Lancet. 2023;402:1541–1551.

² Choon SE, Lebwohl MG, Marrakchi S, et al. Study protocol of the global Effisayil 1 Phase II, multicentre, randomised, double-blind, placebo-controlled trial of spesolimab in patients with generalized pustular psoriasis presenting with an acute flare. BMJ Open. 2021;11:e043666.

³ Bachelez H, Choon SE, Marrakchi S, et al. Trial of spesolimab for generalized pustular psoriasis. N Engl J Med. 2021;385:2431–2440.

⁴ Record on file.

⁵ Marrakchi S, Puig L. Pathophysiology of generalized pustular psoriasis. Am J Clin Dermatol. 2022;23:13–19.

⁶ Prinz JC, Choon SE, Griffiths CEM, et al. Prevalence, comorbidities and mortality of generalized pustular psoriasis: A literature review. J Eur Acad Dermatol Venereol. 2023;37:256–273.

⁷ Choon SE, Navarini AA, Pinter A. Clinical course and characteristics of generalized pustular psoriasis. Am J Clin Dermatol. 2022;23:21–29.

⁸ Gooderham MJ, Van Voorhees AS, Lebwohl MG. An update on generalized pustular psoriasis. Expert Rev Clin Immunol. 2019;15:907–919.

⁹ Reisner DV, Johnsson FD, Kotowsky N, et al. Impact of generalized pustular psoriasis from the perspective of people living with the condition: Results of an online survey. Am J Clin Dermatol. 2022;23:65–71.

Contacts

Investors

Christian Sørup Ryom, Investor Relations

E-mail: chsoe@leo-pharma.com
Phone: +45 3089 9083

Media

Jeppe Ilkjær, Global Communications

E-mail: jeilk@leo-pharma.com
Phone: +45 3050 2014