Calluna Pharma Announces U.S. FDA Orphan Drug Designation Granted to CAL101 for the Treatment of Idiopathic Pulmonary Fibrosis (IPF)




Calluna Pharma Announces U.S. FDA Orphan Drug Designation Granted to CAL101 for the Treatment of Idiopathic Pulmonary Fibrosis (IPF)

CAL101 is a first-in-class monoclonal antibody targeting S100A4, a DAMP protein implicated in severe, life-threatening fibrotic diseases

CAL101 being investigated in Phase 2 IPF Study; enrollment ongoing at sites in the USA, UK, EU, Turkey and South Korea

OSLO, Norway & BOSTON–(BUSINESS WIRE)–Calluna Pharma AS, a clinical stage biotechnology company pioneering first-in-class antibodies to treat inflammatory and fibrotic diseases, today announced that it has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for CAL101, its lead clinical candidate currently being evaluated in patients with idiopathic pulmonary fibrosis (IPF).

“Orphan drug designation speaks to the importance of developing new treatments for debilitating rare diseases like IPF, for which treatment options are limited,” said Margrethe Sørgaard, Calluna Pharma’s Senior Vice President of Clinical Operations and Pharmacovigilance. “Our ongoing IPF study (AURORA) aims to demonstrate that CAL101 prevents the disease-specific activation of fibroblasts that lead to decreased lung function, and the progressive decline these patients face.”

The FDA grants Orphan Drug Designation to support the development and evaluation of new treatments for rare diseases, conditions affecting fewer than 200,000 people in the USA. Benefits of this designation include potential eligibility for expedited review pathways, tax credits for qualified clinical trials, fee waivers, and seven years of market exclusivity after approval.

AURORA is a randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of CAL101 in patients with IPF. The study aims to enroll 150 individuals with IPF across more than 50 sites, primarily in the USA, UK, EU, Turkey and South Korea. After an initial 28-day screening period, patients will be randomized to receive seven monthly intravenous infusions of CAL101 or placebo at a randomization ratio of 3:2, respectively. The study’s primary endpoint is lung function, measured by forced vital capacity, or how much air can forcibly be exhaled, versus an individual’s baseline.

About CAL101

CAL101 is a systemically administered monoclonal antibody targeting the DAMP protein S100A4. S100A4 is activated when tissue is stressed or injured, triggering multiple downstream pathways. It is associated with pathological activation and proliferation of fibroblasts (the key effector cells driving progression of fibrosis), and pro-fibrotic immune response connected to fibrotic disease. Targeting S100A4 has the potential to re-establish tissue homeostasis by switching off the downstream pathways involved in the persistent and maladaptive scar tissue formation characteristic of IPF.

A randomized, double-blind, placebo-controlled Phase 1 study of CAL101 demonstrated a favorable safety profile, with balanced frequency and types of AEs, compared to placebo, across all dose levels. Preclinical studies have shown CAL101 to prevent and treat fibrosis and modify the disease-specific activation of fibroblasts.

About IPF

Idiopathic pulmonary fibrosis (IPF) is a progressive lung disease where an inappropriately activated wound-healing response causes the lung tissue to become thickened and scarred, making it difficult to breathe. The exact triggers of IPF are unknown, but it is believed to be a combination of genetic and environmental factors. Over time, the scarring in the lungs worsens, leading to respiratory failure and ultimately death, with a 3-5-year median survival rate. Primarily found in older adults, the disease impacts approximately 233,000 people in the USA and EU.

About Calluna Pharma www.callunapharma.com

Calluna Pharma is a global clinical stage company pioneering a breakthrough approach to treating inflammatory and fibrotic diseases by leveraging the body’s innate immune system. The Company’s therapeutic approach targets upstream amplifiers of disease, offering potential applicability across a diverse array of medical conditions. Calluna Pharma has a pipeline of selective antibodies targeting immunological diseases with enhanced efficacy and tolerability.

Calluna Pharma is incorporated in Oslo, Norway and operates globally.

Contacts

Media Contact:
Jason Glashow

Glashow Strategic Communications

Email: Jason@glashowstrategic.com
Tel: +1 617-510-1800

Arcus Biosciences Announces Pricing of $250 Million Public Offering of Common Stock




Arcus Biosciences Announces Pricing of $250 Million Public Offering of Common Stock

HAYWARD, Calif.–(BUSINESS WIRE)–Arcus Biosciences, Inc. (NYSE: RCUS), a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules and combination therapies for patients with cancer, inflammatory and autoimmune diseases, today announced the pricing of an underwritten public offering of 13,700,000 shares of its common stock at a price to the public of $18.25 per share. Gross proceeds to Arcus Biosciences from the offering are expected to be $250 million, before deducting underwriting discounts and commissions and offering expenses. All of the shares of common stock are being offered by Arcus Biosciences. In addition, Arcus Biosciences has granted the underwriters a 30-day option to purchase up to 2,055,000 additional shares of its common stock at the public offering price, less underwriting discounts and commissions. The offering is expected to close on November 3, 2025, subject to customary closing conditions.

Leerink Partners, Goldman Sachs & Co. LLC, Cantor, Mizuho and Truist Securities are acting as joint bookrunning managers for the offering.

A shelf registration statement relating to these securities was filed with the U.S. Securities and Exchange Commission (SEC) on February 28, 2023, and automatically became effective upon filing. This offering is being made solely by means of a prospectus. A copy of the final prospectus supplement and the accompanying prospectus relating to this offering may be obtained for free by visiting EDGAR on the SEC’s website at www.sec.gov. Alternatively, a copy of the final prospectus supplement and the accompanying prospectus relating to this offering may be obtained by contacting: Leerink Partners LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, or by telephone at (800) 808-7525 ext. 6105, or by email at syndicate@leerink.com; Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, New York 10282, by telephone at (866) 471-2526, or by email at prospectus-ny@ny.email.gs.com; or Cantor Fitzgerald & Co., Attention: Capital Markets, 110 East 59th Street, 6th Floor, New York, NY 10022, or by emailing prospectus@cantor.com.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

About Arcus Biosciences, Inc.

Arcus Biosciences is a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules and combination therapies for patients with cancer, inflammatory and autoimmune diseases.

Forward Looking Statements

This press release contains forward-looking statements. All statements regarding events or results to occur in the future contained herein are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding: the timing and completion of the offering and the satisfaction of customary closing conditions related to the offering. All forward-looking statements involve known and unknown risks and uncertainties and other important factors that may cause Arcus’s actual results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to risks associated with: the consummation of the offering; the completion of the offering on the anticipated terms or at all; uncertainties related to market conditions; the satisfaction of customary closing conditions related to the offering; and the impact of general economic, health, industrial or political conditions in the United States or internationally. Risks and uncertainties facing Arcus are described more fully in the “Risk Factors” section of Arcus’s most recent periodic report filed with the SEC. You are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date of this press release. Arcus disclaims any obligation or undertaking to update, supplement or revise any forward-looking statements contained in this press release except to the extent required by law.

The Arcus name and logo are trademarks of Arcus Biosciences, Inc. All other trademarks belong to their respective owners.

Contacts

Investor Inquiries:
Pia Eaves

VP of Investor Relations & Strategy

(617) 459-2006

peaves@arcusbio.com

Media Inquiries:
Holli Kolkey

VP of Corporate Affairs

(650) 922-1269

hkolkey@arcusbio.com

Maryam Bassiri

AD, Corporate Communications

(510) 406-8520

mbassiri@arcusbio.com

DESTINY-Lung06 Phase 3 Trial of ENHERTU® Initiated as First-Line Therapy in Patients with HER2 Overexpressing Metastatic Non-Squamous Non-Small Cell Lung Cancer




DESTINY-Lung06 Phase 3 Trial of ENHERTU® Initiated as First-Line Therapy in Patients with HER2 Overexpressing Metastatic Non-Squamous Non-Small Cell Lung Cancer

TOKYO & BASKING RIDGE, N.J.–(BUSINESS WIRE)–The first patient has been dosed in the DESTINY-Lung06 phase 3 trial evaluating ENHERTU^® (trastuzumab deruxtecan) plus pembrolizumab versus pembrolizumab, platinum-based chemotherapy and pemetrexed as a first-line treatment in patients with unresectable, locally advanced or metastatic HER2 overexpressing and PD-L1 TPS <50% non-squamous non-small cell lung cancer (NSCLC).

ENHERTU is a specifically engineered HER2 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).

One of the current recommended first-line treatments for patients with HER2 overexpressing metastatic non-squamous NSCLC is pembrolizumab plus platinum-based chemotherapy and pemetrexed.^1,2,3 Improved outcomes for immunotherapy-based treatments correlate with higher PD-L1 levels, underscoring the need for more targeted treatment options for patients with PD-L1 TPS <50%.⁴ There currently are no HER2 directed medicines approved in the first-line setting of metastatic NSCLC.^1,2,3,5

“DESTINY-Lung06 is evaluating a targeted treatment strategy for patients with HER2 overexpressing metastatic non-squamous non-small cell lung cancer with low PD-L1 expression,” said Abderrahmane Laadem, MD, Head, Late-Stage Oncology Clinical Development, Daiichi Sankyo. “In the trial, we are evaluating whether replacing traditional chemotherapy with ENHERTU and combining it with standard of care immunotherapy could potentially improve outcomes for patients in the first-line metastatic setting.”

About DESTINY-Lung06

DESTINY-Lung06 is a multicenter, randomized, open-label, phase 3 trial evaluating the efficacy and safety of ENHERTU (5.4 mg/kg) in combination with pembrolizumab versus pembrolizumab, platinum-based chemotherapy (cisplatin or carboplatin) and pemetrexed as a first-line treatment in patients with unresectable, locally advanced or metastatic HER2 overexpressing and PD-L1 TPS <50% non-squamous NSCLC without known actionable genomic alterations. Patients will be randomized 1:1 to receive either ENHERTU plus pembrolizumab or pembrolizumab, platinum-based chemotherapy and pemetrexed.

The primary endpoint is progression-free survival (PFS) as assessed by blinded independent central review (BICR). The key secondary endpoint is overall survival. Additional secondary endpoints include PFS as assessed by investigator, objective response rate and duration of response as assessed by BICR and investigator and safety.

DESTINY-Lung06 will enroll approximately 686 patients across multiple sites in Asia, Europe, North America and South America. For more information about the trial, visit ClinicalTrials.gov.

About Non-Small Cell Lung Cancer

Lung cancer is the most common cancer globally and is the leading cause of cancer-related death in both men and women.⁶ More than 2.48 million lung cancer cases were diagnosed in 2022, with 1.8 million deaths globally.⁶ NSCLC is the most common type of lung cancer, accounting for approximately 85% of cases.⁷ Prognosis is particularly poor for patients with metastatic NSCLC as only approximately 10% will live beyond five years after diagnosis.^8,9

HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of multiple tumor types.¹⁰ HER2 overexpressing NSCLC occurs in up to approximately 20% of patients with NSCLC and is associated with poor treatment response and worse clinical outcomes.^{11,12,13,14,15} For patients with HER2 overexpressing metastatic non-squamous NSCLC, one of the current recommended first-line treatments is pembrolizumab plus platinum-based chemotherapy and pemetrexed.^1,2,3 Improved outcomes for immunotherapy-based treatments correlate with higher PD-L1 levels, underscoring the need for more targeted treatment options for patients with PD-L1 TPS <50%.⁴ There currently are no HER2 directed medicines approved in the first-line setting for HER2 overexpressing NSCLC.^1,2,3,5

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) is approved in more than 85 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2 positive (immunohistochemistry [IHC] 3+ or in-situ hybridization [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 85 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 45 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 60 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 70 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-Gastric06 trials. Continued approval in China for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

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 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 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.

ENHERTU U.S. Important Safety Information

Indications

ENHERTU is a HER2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with:

• Unresectable or metastatic HER2-positive (IHC 3+ or ISH positive) 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

• 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
  
  – 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

• Unresectable or metastatic non-small cell lung cancer (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.

• 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

• 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.

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. 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)

In patients with metastatic breast cancer, HER2-mutant NSCLC, and other solid tumors 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.

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. 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)

In patients with metastatic breast cancer, HER2-mutant NSCLC, and other solid tumors 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.

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 20%, interrupt ENHERTU and repeat LVEF assessment within 3 weeks. If LVEF 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)

In patients with metastatic breast cancer, HER2-mutant NSCLC, and other solid tumors 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.

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, no clinical adverse events of heart failure were reported; however, on echocardiography, 8% were found to have asymptomatic Grade 2 decrease in LVEF.

Embryo-Fetal Toxicity

ENHERTU can cause fetal harm when administered to a pregnant woman. Advise patients of the potential risks to a fetus. Verify the pregnancy status of females of reproductive potential prior to the initiation of ENHERTU. Advise females of reproductive potential to use effective contraception during treatment and for 7 months after the last dose of ENHERTU. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with ENHERTU and for 4 months after the last dose of ENHERTU.

Additional Dose Modifications

Thrombocytopenia

For Grade 3 thrombocytopenia (platelets <50 to 25 x 10⁹/L) interrupt ENHERTU until resolved to Grade 1 or less, then maintain dose. For Grade 4 thrombocytopenia (platelets <25 x 10⁹/L) interrupt ENHERTU until resolved to Grade 1 or less, then reduce dose by 1 level.

Adverse Reactions

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

The pooled safety population reflects exposure to ENHERTU 5.4 mg/kg intravenously every 3 weeks in 2233 patients in Study DS8201-A-J101 (NCT02564900), DESTINY-Breast01, DESTINY-Breast02, DESTINY-Breast03, DESTINY-Breast04, DESTINY-Breast06, DESTINY-Lung01, DESTINY-Lung02, DESTINY-CRC02, and DESTINY-PanTumor02. Among these patients, 67% were exposed for >6 months and 38% were exposed for >1 year. In this pooled safety population, the most common (≥20%) adverse reactions, including laboratory abnormalities, were decreased white blood cell count (73%), nausea (72%), decreased hemoglobin (67%), decreased neutrophil count (65%), decreased lymphocyte count (60%), fatigue (55%), decreased platelet count (48%), increased aspartate aminotransferase (46%), increased alanine aminotransferase (44%), increased blood alkaline phosphatase (39%), vomiting (38%), alopecia (37%), constipation (32%), decreased blood potassium (32%), decreased appetite (31%), diarrhea (30%), and musculoskeletal pain (24%).

HER2-Positive Metastatic Breast Cancer

DESTINY-Breast03

The safety of ENHERTU was evaluated in 257 patients with unresectable or metastatic HER2-positive breast cancer who received at least 1 dose of ENHERTU 5.4 mg/kg intravenously once every 3 weeks in DESTINY-Breast03. The median duration of treatment was 14 months (range: 0.7 to 30) for patients who received ENHERTU.

Serious adverse reactions occurred in 19% of patients receiving ENHERTU. Serious adverse reactions in >1% of patients who received ENHERTU were vomiting, ILD, pneumonia, pyrexia, and urinary tract infection. Fatalities due to adverse reactions occurred in 0.8% of patients including COVID-19 and sudden death (1 patient each).

ENHERTU was permanently discontinued in 14% of patients, of which ILD/pneumonitis accounted for 8%. Dose interruptions due to adverse reactions occurred in 44% of patients treated with ENHERTU. The most frequent adverse reactions (>2%) associated with dose interruption were neutropenia, leukopenia, anemia, thrombocytopenia, pneumonia, nausea, fatigue, and ILD/pneumonitis. Dose reductions occurred in 21% of patients treated with ENHERTU. The most frequent adverse reactions (>2%) associated with dose reduction were nausea, neutropenia, and fatigue.

The most common (≥20%) adverse reactions, including laboratory abnormalities, were nausea (76%), decreased white blood cell count (74%), decreased neutrophil count (70%), increased aspartate aminotransferase (67%), decreased hemoglobin (64%), decreased lymphocyte count (55%), increased alanine aminotransferase (53%), decreased platelet count (52%), fatigue (49%), vomiting (49%), increased blood alkaline phosphatase (49%), alopecia (37%), decreased blood potassium (35%), constipation (34%), musculoskeletal pain (31%), diarrhea (29%), decreased appetite (29%), headache (22%), respiratory infection (22%), abdominal pain (21%), increased blood bilirubin (20%), and stomatitis (20%).

HER2-Low and HER2-Ultralow Metastatic Breast Cancer

DESTINY-Breast06

The safety of ENHERTU was evaluated in 434 patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) or HER2-ultralow (IHC 0 with membrane staining) breast cancer who received ENHERTU 5.4 mg/kg intravenously once every 3 weeks in DESTINY-Breast06. The median duration of treatment was 11 months (range: 0.4 to 39.6) for patients who received ENHERTU.

Serious adverse reactions occurred in 20% of patients receiving ENHERTU. Serious adverse reactions in >1% of patients who received ENHERTU were ILD/pneumonitis, COVID-19, febrile neutropenia, and hypokalemia. Fatalities due to adverse reactions occurred in 2.8% of patients including ILD (0.7%); sepsis (0.5%); and COVID-19 pneumonia, bacterial meningoencephalitis, neutropenic sepsis, peritonitis, cerebrovascular accident, general physical health deterioration (0.2% each).

ENHERTU was permanently discontinued in 14% of patients. The most frequent adverse reaction (>2%) associated with permanent discontinuation was ILD/pneumonitis. Dose interruptions due to adverse reactions occurred in 48% of patients treated with ENHERTU. The most frequent adverse reactions (>2%) associated with dose interruption were COVID-19, decreased neutrophil count, anemia, pyrexia, pneumonia, decreased white blood cell count, and ILD. Dose reductions occurred in 25% of patients treated with ENHERTU. The most frequent adverse reactions (>2%) associated with dose reduction were nausea, fatigue, decreased platelet count, and decreased neutrophil count.

The most common (≥20%) adverse reactions, including laboratory abnormalities, were decreased white blood cell count (86%), decreased neutrophil count (75%), nausea (70%), decreased hemoglobin (69%), decreased lymphocyte count (66%), fatigue (53%), decreased platelet count (48%), alopecia (48%), increased alanine aminotransferase (44%), increased blood alkaline phosphatase (43%), increased aspartate aminotransferase (41%), decreased blood potassium (35%), diarrhea (34%), vomiting (34%), constipation (32%), decreased appetite (26%), COVID-19 (26%), and musculoskeletal pain (24%).

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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QIAGEN Launches New Automated Sexual Assault Sample Processing Kit at ISHI 2025




QIAGEN Launches New Automated Sexual Assault Sample Processing Kit at ISHI 2025

• New EZ2 DNA Investigator Sep&Prep Kit automates sexual assault sample processing, improving sperm DNA recovery and separation from victim DNA
• Workflow on EZ2 Connect Fx delivers high-quality DNA in under 2.5 hours, minimizing hands-on time and variability with current manual process
• QIAGEN to showcase new kit and forensics portfolio at upcoming ISHI 2025 meeting

GERMANTOWN, Md. & VENLO, Netherlands–(BUSINESS WIRE)–$QGEN #QIAGEN–QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the launch of the EZ2 DNA Investigator Sep&Prep Kit, a fully automated solution for processing sexual assault samples, at the upcoming International Symposium on Human Identification 2025 (ISHI) from November 3-6 in Palm Beach, Florida.

Developed specifically for forensic laboratories, the EZ2 DNA Investigator Sep&Prep kit enhances the separation of sperm from non-sperm fractions and the preparation of sperm-derived DNA for direct downstream use in forensic DNA profiling or next-generation sequencing.

The workflow is designed for processing on EZ2 Connect Fx, a key system for forensics labs worldwide that can process up to 24 samples in parallel. The new kit delivers DNA ready for analysis in under 2.5 hours, significantly reducing the hands-on time and variability typically seen with current manual methods.

“This kit may be one of the most important advances in sex assault sample processing since differential extraction was introduced some 40 years ago,” said Keith Elliott, Senior Director of Strategic Marketing Human Identification at QIAGEN. “For decades, labs have relied on a complex manual process that often limits DNA quality. Our new kit delivers a standardized and efficient approach that could help transform this critical area of forensic work.”

Forensic scientists often work with sexual assault evidence samples that often contain low amounts of sperm DNA and high levels of DNA from the victim, making it difficult to obtain clear profiles. This challenge led Dominic O’Neil, Director of HID and Microbiome Product Development at QIAGEN, and his team to develop a new approach aimed at improving sperm recovery while minimizing contamination from non-sperm DNA.

The new EZ2 kit introduces a novel lysis buffer that efficiently releases sperm cells from cotton and flocked swabs. This is combined with proprietary bead technology that binds and protects the sperm during a thorough wash process to remove non-sperm DNA. The result is a high yield of sperm-derived DNA with minimal victim carryover. The workflow also reduces manual handling and produces sperm fractions that are ready for direct downstream use with standard DNA profiling or next-generation sequencing kits without the need for additional purification.

To learn more about the new EZ2 kit: https://www.qiagen.com/products/human-id-and-forensics/investigator-solutions/ez2-dna-investigator-sep-prep-kit.

To learn more about QIAGEN’s presence at ISHI 2025:https://www.qiagen.com/applications/human-identity-and-forensics/ishi-2025.

About QIAGEN

QIAGEN N.V., a Netherlands-based holding company, is a global leader in Sample to Insight solutions that enable customers to extract and analyze molecular information from biological samples containing the building blocks of life. Our Sample technologies isolate and process DNA, RNA and proteins from blood, tissue and other materials. Assay technologies prepare these biomolecules for analysis, while bioinformatics support the interpretation of complex data to deliver actionable insights. Automation solutions integrate these steps into streamlined, cost-effective workflows. QIAGEN serves more than 500,000 customers worldwide in the Life Sciences (academia, pharmaceutical R&D and industrial applications such as forensics) and Molecular Diagnostics (clinical healthcare). As of June 30, 2025, QIAGEN employed approximately 5,700 people across more than 35 locations. For more information, visit www.qiagen.com.

Forward-Looking Statement

Certain statements in this press release may constitute forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended. These statements, including those regarding QIAGEN’s products, development timelines, marketing and/or regulatory approvals, financial and operational outlook, growth strategies, collaborations and operating results, such as expected adjusted net sales and adjusted diluted earnings, are based on current expectations and assumptions. However, they involve uncertainties and risks. These risks include, but are not limited to, challenges in managing growth and international operations (including the effects of currency fluctuations, tariffs, tax laws, regulatory processes and logistics and supply chain dependencies), variability in operating results, and the commercial development of products for customers in the Life Sciences and clinical healthcare markets; changes in relationships with customers, suppliers or strategic partners; competition and rapid technological change; fluctuating demand for QIAGEN’s products due to factors such as economic conditions, customer budgets and funding cycles; obtaining and maintaining product regulatory approvals; and challenges in integrating QIAGEN’s products into manufacturing process workflows and manufacturing at scale. Additional risks include market acceptance of new products, integration of acquisitions, governmental actions, global or regional economic developments, natural disasters, political or public health crises, and other force majeure events. There is also no guarantee that anticipated benefits from restructuring programs and acquisitions will materialize as expected. For a more complete discussion of risks and uncertainties, please refer to the “Risk Factors” section in our most recent Annual Report on Form 20-F and other reports filed with or furnished to the U.S. Securities and Exchange Commission.

Source: QIAGEN N.V.

Category: HID

Contacts

Contacts QIAGEN:

Investor Relations
e-mail: ir@QIAGEN.com

Public Relations
e-mail: pr@QIAGEN.com

Aptar Reports Third Quarter 2025 Results




Aptar Reports Third Quarter 2025 Results

CRYSTAL LAKE, Ill.–(BUSINESS WIRE)–AptarGroup, Inc. (NYSE:ATR), a global leader in drug delivery and consumer product dosing, dispensing and protection technologies, today reported the following third quarter results for the period ended September 30, 2025, as compared to the corresponding period of the last fiscal year.

Third Quarter 2025 Highlights

(Compared to the prior year quarter; see Non-GAAP section for full definitions; see reconciliation for Non-GAAP measures)

• Reported sales increased 6% and core sales increased 1%
• Strong product volume growth in Closures and Pharma, especially in injectables
• Reported net income increased 28% to $128 million and reported earnings per share increased 30% to $1.92
• Adjusted earnings per share, which also excludes non-ordinary-course litigation costs (see Non-GAAP section for full definition), increased 4% to $1.62
• Adjusted EBITDA, which also excludes non-ordinary-course litigation costs, increased 7% to $223 million
• Adjusted EBITDA margin was 23.2% compared to 22.9% in the prior year
• Returned $70 million to shareholders through share repurchases and dividends

Nine Months Year-to-Date 2025 Highlights

(Compared to the prior year period; see Non-GAAP section for full definitions; see reconciliation for Non-GAAP measures)

• Reported sales increased 3% and core sales increased 1%
• Reported net income increased 16% to $318 million and reported earnings per share increased 17% to $4.75
• Adjusted earnings per share increased 7% to $4.48
• Adjusted EBITDA increased 8% to $624 million, and Adjusted EBITDA margin was 22.2% compared to 21.2% in the prior year
• Returned $279 million to shareholders through share repurchases and dividends

“Aptar delivered solid third quarter results with strong product volume growth in Pharma and Closures. As we anticipated, we are seeing the steady ramp in sales in our injectables division, which grew 18% in the third quarter, indicating an expected strong finish to the year for elastomeric components. Our continued focus on innovation, operational excellence and disciplined capital deployment, positions us well to deliver sustainable value for our customers and shareholders, while expanding our third quarter adjusted EBITDA margin,” said Stephan B. Tanda, Aptar President and CEO.

Third Quarter Results

For the quarter ended September 30, 2025, reported sales increased 6% to $961 million compared to $909 million in the prior year and core sales increased 1%.

Aptar Pharma’s reported sales increased 6% with currency changes contributing 4%, resulting in a 2% increase in core sales in the quarter when compared to the prior year period. Growth was primarily driven by higher volumes in prescription drugs, injectables and active material science solutions. In the prescription division, sales for dispensing systems rose 3% primarily due to strong demand for central nervous system therapies and asthma treatments, as well as moderating demand for emergency medicine. Injectables division sales surged 18%, driven by robust GLP-1 component sales. Active material science solutions grew 3%. Consumer healthcare sales declined 11% due to softer demand in nasal and cold products. This was particularly evident in Europe, the division’s largest market. Adjusted EBITDA margin was 37.2%, which also excludes non-ordinary-course litigation costs, an increase of 120 basis points, reflecting strong sales performance of higher value proprietary drug delivery systems and higher royalties.

Aptar Beauty’s reported sales increased 8% driven by a 4% benefit from currency changes and a 4% contribution from acquisitions, while core sales remained flat compared to the prior year quarter. Strong tooling sales offset mixed performance across markets, with beauty dispensing sales down due to weaker indie skincare demand in North America. Personal care technology sales increased due to demand for hair care and body care applications. Adjusted EBITDA margin was 12.1% a decline of 120 basis points due to the less favorable mix for products and the impact of lower tooling margins.

Aptar Closures’ reported sales rose 1% from the prior year quarter and core sales decreased 1%, with a 2% currency benefit. Product sales volumes were up; however, core sales results were more than offset by lower tooling sales and pass throughs of lower resin pricing. Adjusted EBITDA margin was 16.1% a decline of 110 basis points due to some unscheduled maintenance costs and lower tooling sales.

Aptar reported third quarter earnings per share of $1.92 compared to $1.48 reported a year ago. Reported EPS and the reported effective tax rate were impacted by the remeasurement of the previously held minority equity interest in BTY. Adjusted earnings per share were $1.62, compared to the prior year period’s adjusted earnings per share of $1.56, including comparable exchange rates. The third quarter reported effective tax rate was 17.1% and the adjusted effective tax rate was 20.8%, compared to the prior year period’s reported and adjusted effective tax rate of 23.8%.

Nine Months Year-To-Date Results

For the nine months ended September 30, 2025, reported sales increased 3% to $2.81 billion compared to $2.73 billion in the prior year. Core sales also increased 1%.

For the nine months ended September 30, 2025, Aptar’s reported earnings per share were $4.75, an increase of 17%, compared to $4.05 reported a year ago. For the first nine months of the year, adjusted earnings per share were $4.48 and increased 7% from prior year adjusted earnings per share of $4.19, including comparable exchange rates. The current year had a reported effective tax rate of 20.4% and an adjusted effective tax rate of 21.9% compared to the prior year reported and adjusted effective tax rates of 22.7% and 22.8% respectively.

In the first nine months of 2025, free cash flow was $206 million, with the year-over-year decline primarily driven by higher working capital and pension contributions, partially offset by lower capital expenditures. The company ended September with $265 million in cash and short-term investments, $936 million in net debt, and a leverage ratio of 1.22.

Outlook

Regarding Aptar’s outlook, Tanda stated, “We expect our Pharma pipeline to remain strong and to continue to contribute 7% to 10% of revenue annually, with new launches layered on to a stable base. We also anticipate continued growth in injectables to be driven by accelerating demand for GLP-1, Annex-1 and biologics applications. In the short-term, we expect to face tough comparisons from a one-time naloxone ramp-up. For full year 2025, emergency-use delivery systems are expected to represent about 5% of total company sales. Based on current demand, funding policies and customer inventories, we anticipate full year 2026 revenue from this category will be lower than full year 2025. All three of our segments are expected to contribute positively in Q4. Operational discipline is part of our DNA, sharpening execution and driving efficiency. While the sales mix is expected to be less favorable due to the impact of lower emergency-use dispensing system sales, we believe our diversified portfolio, strong pipeline and disciplined execution position us well for long-term growth and margin resilience.”

Aptar currently expects adjusted earnings per share for the fourth quarter of 2025 to be in the range of $1.20 to $1.28. This guidance is based on an effective tax rate range of 19.5% to 21.5%. The earnings per share guidance range is assuming a 1.17 Euro to USD exchange rate.

Cash Dividends and Share Repurchases

As previously announced, Aptar’s Board of Directors approved a quarterly cash dividend of $0.48 per share. The payment date is November 13, 2025, to stockholders of record as of October 23, 2025. During the third quarter, Aptar repurchased 286,000 shares for $40 million. Aptar may repurchase shares through the open market, privately negotiated transactions or other programs, subject to market conditions.

Open Conference Call

There will be a conference call held on Friday, October 31, 2025 at 8:00 a.m. Central Time to discuss the company’s third quarter results for 2025. The call will last approximately one hour. Interested parties are invited to listen to a live webcast by visiting the Investor Relations website at investors.aptar.com. Replay of the conference call can also be accessed for a limited time on the Investor Relations page of the website.

About Aptar

Aptar is a global leader in drug delivery and consumer product dosing, dispensing and protection technologies. Aptar serves a number of attractive end markets including pharmaceutical, beauty, food, beverage, personal care and home care. Using market expertise, proprietary design, engineering and science to create innovative solutions for many of the world’s leading brands, Aptar in turn makes a meaningful difference in the lives, looks, health and homes of millions of patients and consumers around the world. Aptar is headquartered in Crystal Lake, Illinois and has more than 13,000 dedicated employees in 20 countries. For more information, visit www.aptar.com.

Presentation of Non-GAAP Information

This press release refers to certain non-GAAP financial measures, including current year adjusted earnings per share and adjusted EBITDA, which exclude the impact of restructuring initiatives, acquisition-related costs, certain purchase accounting adjustments related to acquisitions and investments and net unrealized investment gains and losses related to observable market price changes on equity securities, and other special items. Core sales and adjusted earnings per share also neutralize the impact of foreign currency translation effects when comparing current results to the prior year. Adjusted EBITDA is defined as earnings before net interest, taxes, depreciation, amortization, restructuring initiatives, acquisition-related costs, net unrealized investment gains and losses related to observable market price changes on equity securities and other special items. For the three and nine months ended September 30, 2025, “Other special items” include costs incurred related to non-ordinary-course litigation, specifically: lawsuits between Aptar and ARS Pharmaceuticals, Inc., involving Aptar’s claims of trade-secret misappropriation and contractual breaches and ARS’s counterclaims under U.S. antitrust laws; and patent infringement actions filed by Nemera La Verpillière SAS in Germany and France relating to certain of Aptar’s ophthalmic products. These costs are excluded because they do not reflect our core operating performance. Please refer to “Legal Proceedings” within Note 12 – Commitments and Contingencies within Aptar’s Form 10-Q for the quarterly period ended September 30, 2025 for more information. Adjusted EBITDA margin is adjusted EBITDA divided by reported net sales. Non-GAAP financial measures may not be comparable to similarly titled non-GAAP financial measures provided by other companies. Aptar’s management believes these non-GAAP financial measures provide useful information to our investors because they allow for a better period over period comparison of operating results by removing the impact of items that, in management’s view, do not reflect Aptar’s core operating performance. These non-GAAP financial measures also provide investors with certain information used by Aptar’s management when making financial and operational decisions. Free cash flow is calculated as cash provided by operating activities less capital expenditures plus proceeds from government grants related to capital expenditures. We believe that it is meaningful to investors in evaluating our financial performance and measuring our ability to generate cash internally to fund our initiatives. These non-GAAP financial measures should not be considered in isolation or as a substitute for GAAP financial results but should be read in conjunction with the unaudited condensed consolidated statements of income and other information presented herein. A reconciliation of non-GAAP financial measures to the most directly comparable GAAP measures is included in the accompanying tables. Our outlook is provided on a non-GAAP basis because certain reconciling items are dependent on future events that either cannot be controlled, such as exchange rates and changes in the fair value of equity investments, or reliably predicted because they are not part of the company’s routine activities, such as restructuring, acquisition costs and other special items.

This press release contains forward-looking statements, including certain statements set forth under the “Outlook” section of this press release. Words such as “expects,” “anticipates,” “believes,” “estimates,” “future,” “potential,” “continues” and other similar expressions or future or conditional verbs such as “will,” “should,” “would” and “could” are intended to identify such forward-looking statements. Forward-looking statements are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and are based on our beliefs as well as assumptions made by and information currently available to us. Accordingly, our actual results or other events may differ materially from those expressed or implied in such forward-looking statements due to known or unknown risks and uncertainties that exist in our operations and business environment including, but not limited to: geopolitical conflicts worldwide and the resulting indirect impact on demand from our customers selling their products into these countries, as well as rising input costs and certain supply chain disruptions; cybersecurity threats against our systems and/or service providers that could impact our networks and reporting systems; the availability of raw materials and components (particularly from sole sourced suppliers for some of our Pharma solutions) as well as the financial viability of these suppliers; our ability to protect and defend our intellectual property rights, as well as litigation involving intellectual property rights; the outcome of any legal proceeding that has been or may be instituted against us and others;lower demand and asset utilization due to an economic recession either globally or in key markets we operate within; economic conditions worldwide, including inflationary conditions and potential deflationary conditions in other regions we rely on for growth; competition, including technological advances; significant tariffs and other restrictions on foreign imports imposed by the U.S. and related countermeasures taken by impacted foreign countries; our ability to successfully implement facility expansions and new facility projects; fluctuations in the cost of materials, components, transportation cost as a result of supply chain disruptions and labor shortages, and other input costs; significant fluctuations in foreign currency exchange rates or our effective tax rate; the impact of tax reform legislation, changes in tax rates and other tax-related events or transactions that could impact our effective tax rate; financial conditions of customers and suppliers; consolidations within our customer or supplier bases; changes in customer and/or consumer spending levels; loss of one or more key accounts; our ability to offset inflationary impacts with cost containment, productivity initiatives and price increases; changes in capital availability or cost, including rising interest rates; loss of royalty revenue due to contract expirations; volatility of global credit markets; our ability to identify potential new acquisitions and to successfully acquire and integrate such operations, including the successful integration of the businesses we have acquired; our ability to build out acquired businesses and integrate the product/service offerings of the acquired entities into our existing product/service portfolio; direct or indirect consequences of acts of war, terrorism or social unrest; the impact of natural disasters and other weather-related occurrences; fiscal and monetary policies and other regulations; changes, difficulties or failures in complying with government regulation, including FDA or similar foreign governmental authorities; changing regulations or market conditions regarding environmental sustainability; our ability to retain key members of management and manage labor costs; work stoppages due to labor disputes; our ability to meet future cash flow estimates to support our goodwill impairment testing; the demand for existing and new products; the success of our customers’ products, particularly in the pharmaceutical industry; our ability to manage worldwide customer launches of complex technical products, particularly in developing markets; difficulties in product development and uncertainties related to the timing or outcome of product development; significant product liability claims; and other risks associated with our operations. For additional information on these and other risks and uncertainties, please see our filings with the Securities and Exchange Commission, including the discussion under “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Form 10-K and Form 10-Qs. We undertake no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

Contacts

Investor Relations Contact:
Mary Skafidas

mary.skafidas@aptar.com
815-479-5530

Media Contact:
Katie Reardon

katie.reardon@aptar.com
815-479-5671

Read full story here

FUJIFILM Biotechnologies’ Lars Petersen Named “CEO of the Year” at CPHI Pharma Awards 2025




FUJIFILM Biotechnologies’ Lars Petersen Named “CEO of the Year” at CPHI Pharma Awards 2025

FRANKFURT, Germany–(BUSINESS WIRE)–FUJIFILM Biotechnologies, a world-leading contract development and manufacturing organization for biologics, vaccines, and advanced therapies, is proud to celebrate that its president and CEO Lars Petersen has been named “CEO of the Year” at the CPHI Pharma Awards 2025 in Frankfurt, Germany. The annual global CPHI event brings together 62,000 professionals from the entire pharmaceutical supply chain.

CPHI’s “CEO of the Year” award recognizes outstanding leadership within the pharma industry. The jury is comprised of independent, senior industry experts from around the world, and evaluation criteria is based on examples of exceptional leadership.

Petersen was awarded “CEO of the Year” for his transformational leadership within the CDMO industry. Since taking the helm as CEO of FUJIFILM Biotechnologies two years ago, Petersen has advocated for trust-based partnerships with employees, customers and industry, and pioneered a “people first” culture within the organization. Additionally, under Petersen’s leadership, FUJIFILM Biotechnologies is rapidly scaling with the recent opening of its US commercial-scale manufacturing hub, and additional expansions coming online across its global network in 2026 – which will fulfill Petersen’s vision of creating the industry’s largest interconnected modular network of biomanufacturing facilities.

“I am truly honored for this recognition and want to thank the CPHI and Informa Markets teams, as well as the panel of judges. This recognition belongs to FUJIFILM Biotechnologies’ incredible team of 5,000 professionals across the globe. Each of you embodies Fujifilm’s purpose of ‘Giving our world more smiles’ by making medicines possible,” said Petersen. “Together we are evolving the CDMO industry to help our partners to create a healthier world.”

About FUJIFILM Biotechnologies

FUJIFILM Biotechnologies, a subsidiary of FUJIFILM Corporation, is a world-leading contract development and manufacturing organization (CDMO) for biologics, vaccines and advanced therapies. With over 30 years of experience, the Company specializes in developing and manufacturing biopharmaceuticals using microbial, mammalian, and host/virus systems. With over 5,000 employees, FUJIFILM Biotechnologies operates a fully integrated, kojoX™ global network with major facilities in the United States, the United Kingdom, and Denmark. The Company’s kojoX manufacturing network ensures supply chain agility for its customers through modular facilities and standardized processes for seamless scaling and technology transfers. FUJIFILM Biotechnologies offers comprehensive services, ranging from proprietary cell line development, to process and analytical development, and through to clinical and commercial manufacturing. For more information, go to: fujifilmbiotechnologies.fujifilm.com

About FUJIFILM Holdings Corporation

FUJIFILM Corporation is a subsidiary of FUJIFILM Holdings Corporation. FUJIFILM Holdings Corporation, headquartered in Tokyo, leverages its depth of knowledge and proprietary core technologies to deliver innovative products and services across the globe through the four key business segments of healthcare, electronics, business innovation, and imaging with over 70,000 employees. Guided and united by our Group Purpose of “giving our world more smiles,” we address social challenges and create a positive impact on society through our products, services, and business operations. For more information, please visit: www.fujifilmholdings.com. For further details about our commitment to sustainability and Fujifilm’s Sustainable Value Plan 2030, click here.

About Informa Markets

Informa Markets creates platforms for industries and specialist markets to trade, innovate, and grow. As part of Informa PLC, it delivers more than 450 B2B events annually across key sectors including healthcare, life sciences, construction, and fashion. The company’s mission is to foster global communities, enabling meaningful connections and commercial success.

About CPHI and The Pharma Awards

CPHI Frankfurt brings together the entire pharmaceutical supply chain at Europe’s most significant industry event. As the flagship event in CPHI’s portfolio, Frankfurt delivers unparalleled access to pharmaceutical innovation, with attendees gaining competitive advantage through face-to-face connections with thousands of suppliers and manufacturers. CPHI Frankfurt serves as pharma’s premier platform for deal-making, partnership building, and advancing patient outcomes through industry collaboration.

The CPHI Pharma Awards celebrate the forefront of innovation, excellence, and collaboration in the pharmaceutical industry. These prestigious awards honor the pioneers and trailblazers driving advancements in drug development, revolutionizing manufacturing processes, championing sustainability, and shaping the future of pharma on a global scale. This year’s entries have set a remarkable standard, each embodying the profound theme of ‘transformation’ – a testament to the industry’s relentless pursuit of progress. It is this unique narrative that shapes the essence of this year’s CPHI Awards: Powering Transformation.

Contacts

Media Contacts:

Christine Jackman

FUJIFILM Biotechnologies

christine.jackman@fujifilm.com
+1 914-261-4959

Megan Augustine

FUJIFILM Holdings America Corporation

megan.augustine.contractor@fujifilm.com

Resilience Announces Long-Term Financing of up to $825 Million to Accelerate CDMO Strategy




Resilience Announces Long-Term Financing of up to $825 Million to Accelerate CDMO Strategy

New Capital from Oak Hill Advisors to Drive Investment in Go-Forward Manufacturing Operations

CINCINNATI–(BUSINESS WIRE)–National Resilience (“Resilience”), a technology-focused biomanufacturing company dedicated to broadening access to complex medicines, today announced long-term debt financing of up to $825 million from Oak Hill Advisors (“OHA”) to strengthen its balance sheet and fuel its growth plans. This new capital will enable Resilience to accelerate its CDMO business strategy and invest in its go-forward manufacturing operations anchored in Cincinnati and Toronto.

This financing underscores Resilience’s critical role as a CDMO manufacturing sterile drugs at scale and on shore. OHA brings more than three decades of investment experience and a proven track record of supporting growth in the life sciences sector. Resilience remains focused on high-growth segments in the biopharmaceutical market to advance cell-based medicines, primarily biologics, and aseptic drug product operations. The company is in the process of expanding its Cincinnati facility into one of the largest, most advanced sterile injectable and device assembly and packaging operations in North America.

William S. Marth, President and Chief Executive Officer of Resilience, said, “This financing is a pivotal step forward for our enterprise and positions us well to advance our ongoing transformation efforts backed by favorable industry tailwinds in the CDMO sector. This new capital will support the continued buildout of our core manufacturing operations and enable us to serve our customers with stability and excellence into the future, particularly at a time when pharmaceutical onshoring is a national priority. Partnering with OHA and our supportive long-time shareholders, we are confident that Resilience now has the right focus, footprint and financial profile to capitalize on the exciting strategic growth opportunities ahead.”

“We believe Resilience is uniquely positioned to scale its advanced manufacturing capabilities and meet the increasing demand for complex medicines,” said Joe Goldschmid, Managing Director at OHA. “Our investment reflects conviction in the company’s leadership team, strategic positioning and ability to generate long-term value in a sector undergoing rapid transformation. We look forward to supporting Resilience as it expands its footprint and strengthens its role in the global biomanufacturing ecosystem.”

The financing includes a $600 million first lien commitment from OHA. The initial tranche of $525 million is expected to be funded later in the fourth quarter, with the remainder of the financing in subsequent years as needed. Financing is subject to satisfaction of customary conditions.

In addition to obtaining the new term loan, Resilience has successfully resolved the lease obligations related to its underutilized sites, further optimizing its balance sheet.

Jefferies LLC is serving as financial advisor and Kirkland & Ellis LLP is serving as legal counsel to Resilience on the financing transaction.

About Resilience

Resilience is a North American contract development and manufacturing organization (CDMO) focused on delivering high-quality, scalable manufacturing solutions for advanced therapies. With capabilities spanning biologics drug substance, cell-based therapies, and aseptic drug product manufacturing for both small and large molecules, Resilience partners with leading biopharma companies to bring complex medicines to market faster and more reliably. The company is building a streamlined, high-performance network designed to meet the evolving needs of clinical and commercial-stage innovators. For more information, visit https://resilience.com/ and follow us on social media: Resilience on LinkedIn.

About Oak Hill Advisors

Oak Hill Advisors (OHA) is a leading global credit-focused alternative asset manager with over 30 years of investment experience. OHA works with institutions and individuals and seeks to deliver a consistent track record of attractive risk-adjusted returns. The firm has approximately $98 billion in assets under management (AUM) across credit strategies, including private credit, distressed and special situation investments, high yield bonds, leveraged loans and collateralized loan obligations as of June 30, 2025. Additional information on OHA’s AUM calculation methodology can be found on the OHA website. OHA’s emphasis on long-term partnerships with companies, sponsors and other partners allows for the provision of customized credit solutions across market cycles.

With over 420 experienced professionals across six global offices, OHA brings a collaborative approach to offering investors a single platform to meet their diverse credit needs. OHA is the private markets platform of T. Rowe Price Group, Inc. (NASDAQ – GS: TROW). For more information, please visit www.oakhilladvisors.com.

Contacts

Media Contacts

For Resilience:

Kekst CNC

ResilienceMedia@kekstcnc.com

Catherine Hanley

Vice President, Corporate Communications

Resilience

catherine.hanley@resilience.com

For OHA:

Natalie Harvard

Head of Investor Relations & Partner

(212) 326-1505

nharvard@oakhilladvisors.com

Samsung Bioepis to Commercialize BYOOVIZ® (ranibizumab) in Europe from January 2026




Samsung Bioepis to Commercialize BYOOVIZ® (ranibizumab) in Europe from January 2026

• Samsung Bioepis will assume full commercial responsibility for BYOOVIZ^® (ranibizumab) upon full transition of Biogen’s commercialization rights back to Samsung Bioepis effective as of January 2026
• BYOOVIZ, approved by the European Commission (EC) in August 2021 as the first ophthalmology biosimilar in Europe, has been commercially available in several European countries since March 2023

INCHEON, Korea–(BUSINESS WIRE)–#BYOOVIZ–Samsung Bioepis Co., Ltd. announced today that the company has entered into an Asset Purchase Agreement (APA) with Biogen regarding Samsung Bioepis’ two ophthalmology assets: BYOOVIZ^® (ranibizumab), a biosimilar referencing Lucentisⁱ (ranibizumab) and OPUVIZ™ (aflibercept), a biosimilar referencing Eyleaⁱⁱ (aflibercept) — in Europe. Samsung Bioepis will have full responsibility for commercialization of BYOOVIZ upon the transfer of commercial rights from Biogen back to Samsung Bioepis, effective as of January 2026.

“We are pleased to announce our direct commercialization initiative for BYOOVIZ in Europe. We will work closely with Biogen to ensure a seamless transition and the continued delivery of services to our customers and patients in Europe,” said Linda Choi MacDonald, Executive Vice President and Global Head of Commercial, at Samsung Bioepis. “Samsung Bioepis will continue to broaden our reach to patients across Europe by reinforcing our leadership and expertise in biosimilars.”

BYOOVIZ (ranibizumab) was approved by the European Commission (EC) in August 2021 as the first ophthalmology biosimilar in Europe for the treatment of patients with Neovascular (Wet) Age-Related Macular Degeneration (AMD), Macular Edema following Retinal Vein Occlusion (RVO), and Myopic Choroidal Neovascularization (mCNV). BYOOVIZ became commercially available in several countries within Europe from March 2023. OPUVIZ (aflibercept) was approved by the EC in November 2024 and by the Medicines and Healthcare products Regulatory Agency (MHRA) in April 2025 for the treatment of patients with Wet AMD, Visual Impairment due to Macular Oedema Secondary to RVO, Visual Impairment due to Diabetic Macular Edema (DME), and Visual Impairment due to mCNV. OPUVIZ will not be launched until after the lapse or revocation of relevant patent(s) for the reference biologic Eylea that also covers OPUVIZ in Europe.

About Samsung Bioepis Co., Ltd.

Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world’s leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of biosimilar candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, nephrology, and endocrinology. For more information, please visit: www.samsungbioepis.com and follow us on social media – LinkedIn, X.

Contacts

MEDIA CONTACT
Anna Nayun Kim, nayun86.kim@samsung.com
Yoon Kim, yoon1.kim@samsung.com

MedTech Innovator Asia Pacific Names Australis Scientific Top Innovator in 2025 Grand Finals Competition




MedTech Innovator Asia Pacific Names Australis Scientific Top Innovator in 2025 Grand Finals Competition

Medical device company developing smart patch delivering minimally invasive neuromodulation therapy for overactive bladder, is awarded Grand Prize of USD 175,000 at the 7th annual grand finals event

LOS ANGELES & SINGAPORE–(BUSINESS WIRE)–MedTech Innovator (MTI), the world’s largest and most impactful accelerator for medical technology startups, today announced that Australis Scientific has been named the 2025 MedTech Innovator Asia Pacific Grand Prize Winner, receiving USD 175,000 in non-dilutive funding for their innovative smart patch delivering minimally invasive neuromodulation therapy for overactive bladder. The other finalists—F.MED, HemoTag, OsseoLabs—each received USD 10,000 as runner-up prizes.

“We’re honored to have been named the 2025 MedTech Innovator APAC Grand Prize Winner,” said Nicky Agahari, co-founder and CEO, Australis Scientific. “More than the recognition, what we value most is the community we’ve gained including the MTI team, our fellow founders, and our strategic mentors at BD who have shared their experience and support so generously. This journey reminds us that when we work together, we can bring forward medical technologies that truly change lives.”

The 2025 Grand Finals marked the first year MedTech Innovator Asia Pacific hosted the event independently in Singapore, underscoring the accelerator’s growth and maturity as the region’s leading platform for advancing medtech innovation.

“We’re thrilled to recognize Australis Scientific as our 2025 Asia Pacific Grand Prize Winner among a field of truly outstanding companies in this year’s finals,” said Paul Grand, founder and CEO of MedTech Innovator. “Australis Scientific’s smart patch for overactive bladder has the potential to make a significant impact by improving millions of lives. They reflect the innovation and momentum we’re seeing across APAC, with breakthrough solutions that are less invasive, more accessible, and designed for global adoption.”

Following each finalist’s presentation, a panel of distinguished medtech executives engaged in a Q&A session with the finalists, with the winner determined by a live audience vote. The panel included Roger Da, associate director of New Business Development, China, Johnson & Johnson MedTech; Dr. Fu Yongji, vice president, head of R&D, B. Braun Medical; Eric Liu, vice president of R&D, Greater Asia, Becton Dickinson.

In addition to the Grand Prize and runner-up awards, several additional honors were presented to recognize outstanding achievements among this year’s cohort of innovators:

• Cambridge Consultants Product Development Award (USD 25,000): F.MED
• EnterpriseSG STARTUP SG Grant (SGD 50,000): HiCura Medical
• Best Video Competition Award (USD 5,000): Borns Medical Robotics
• One year membership to Johnson & Johnson’s global incubator network at JLABS Singapore: OsseoLabs

The 2025 MedTech Innovator Asia Pacific Accelerator cohort featured 20 startups selected from more than 550 applications across the region. Over the course of four months, participating companies received tailored online coaching, 1:1 mentorship, exposure to investors and industry leaders, and access to MedTech Innovator’s unparalleled global network.

MedTech Innovator’s 2025 Asia Pacific program sponsors include Johnson & Johnson MedTech, B. Braun Medical, Becton Dickinson, Siemens Healthineers, Teleflex, Cambridge Consultants, The Mullings Group, Enterprise Singapore, and Blue Goat Cyber, joining as a 2026 partner to support regional expansion and innovation initiatives.

Applications are now open for the 2026 MedTech Innovator Asia Pacific Accelerator Program, inviting early- and mid-stage medtech and digital health startups from across the region to apply. In collaboration with Korea Health Industry Development Institute (KHIDI), MTI APAC will further expand its regional reach in 2026 with the MedTech Spotlight Pitch Event Road Tour in South Korea, highlighting local innovation ecosystems and fostering greater collaboration across APAC.

About MedTech Innovator

MedTech Innovator is the world’s largest accelerator of medical device, digital health, and diagnostic companies. Its mission is to improve human health by accelerating the growth of companies transforming patient care. MTI has been a catalyst for groundbreaking healthcare solutions, sourcing nearly 14,000 applicants and fostering the growth of 838 graduates. Alumni have collectively raised USD 10.3 billion in follow-on funding and introduced 500+ products to the market, improving the health of millions worldwide. For more information about MedTech Innovator Asia Pacific, its annual programs, portfolio of industry-leading startups, and insights on trends, visit MTI’s website, follow MTI on LinkedIn, and subscribe to its monthly newsletter.

Contacts

Media Contact:
Jenna Kane

Health+Commerce

jennakane@healthandcommerce.com

QIAGEN Marks 4,000th QIAcube Connect Placement, Reaffirming Leadership in Automated Sample Processing




QIAGEN Marks 4,000th QIAcube Connect Placement, Reaffirming Leadership in Automated Sample Processing

• QIAcube Connect drives lab efficiency by automating critical steps in molecular biology workflows for both research and clinical customers

• Milestone builds on nearly 13,000 cumulative placements of QIAcube family since launch

• Momentum building as QIAGEN prepares for three important new instrument launches in 2025 and 2026: QIAsymphony Connect, QIAsprint and QIAmini

VENLO, Netherlands, & GERMANTOWN, Maryland–(BUSINESS WIRE)–$QGEN #QIAGEN–QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the 4,000th placement of its QIAcube Connect instrument, a significant milestone in driving automation adoption for sample processing across life science and diagnostic labs.

This accomplishment is underscored by the nearly 13,000 cumulative placements of QIAcube platforms globally since launch, and evidence of widespread trust given more than 29,900 cumulative placements of QIAGEN Sample technology instruments since 2019.

QIAcube is designed to enable customers shift from manual to automated workflows without revalidating protocols. It fully replicates QIAGEN’s trusted spin-column kits in a hands-off format, delivering efficiency gains and standardization across labs of varying scale.

QIAcube Connect builds on the foundation of the first-generation QIAcube system, and brings it into the digital age. The updated version supports over 80 QIAGEN kits across more than 140 standard protocols, with custom protocols pushing the limit to over 3,000. It adds connectivity, remote run monitoring, automated decontamination, pre-run checks and seamless integration with the QIAsphere platform.

“QIAcube Connect has become an indispensable tool in thousands of laboratories worldwide,” said Justus Krause-Harder, Vice President, Head of Molecular Tools & Oncology at QIAGEN. “Our continued investment in automation is driven by customers who rely on QIAGEN to deliver the speed, reliability and standardization their work demands. We will strengthen this offering with the upcoming launches of new automation systems and continue to build our leadership in this important area.”

The QIAcube family is part of QIAGEN’s broader suite of automated nucleic acid extraction solutions, including QIAsymphony and EZ2 Connect, which together address the full spectrum of laboratory throughput needs: from individual research users to large clinical testing facilities. These systems have become integral to workflows in academic, pharmaceutical, diagnostic and applied testing environments, helping scientists transform biological samples into high-quality molecular insights.

Looking ahead: new automation systems for every lab scale

Building on this strong customer demand for QIAcube Connect and EZ2 Connect, QIAGEN is expanding its automation portfolio with three new instruments launching in 2025 and 2026:

• QIAsymphony Connect: A successor to the proven QIAsymphony platform, this system brings enhanced throughput, connectivity and digital oversight to high-volume laboratories. Designed to process up to 96 samples per run, it offers improved yield and sensitivity for oncology, infectious disease and molecular diagnostic applications.

• QIAsprint: QIAGEN’s entry into the high-throughput segment, QIAsprint enables rapid sample preparation with minimal hands-on time. Capable of processing up to 192 samples per run, the system delivers scalable performance for core facilities and biopharma production environments.

• QIAmini: A compact benchtop instrument that brings walk-away automation to smaller research labs. QIAmini is ideal for labs transitioning from manual processing, providing an accessible, cost-efficient route to standardization and reproducibility.

All these instruments are designed to extend QIAGEN’s leadership in automated sample processing by offering connected, modular solutions for every type of laboratory: from start-up research teams to large-scale testing centers. Each system will integrate with QIAsphere, QIAGEN’s digital ecosystem that enables remote instrument management, maintenance scheduling and performance tracking across multiple devices and sites.

For further information about the QIAcube Connect and how it can support laboratory automation needs, please visit https://www.qiagen.com/qiacube-connect.

About QIAGEN

QIAGEN N.V., a Netherlands-based holding company, is a global leader in Sample to Insight solutions that enable customers to extract and analyze molecular information from biological samples containing the building blocks of life. Our Sample technologies isolate and process DNA, RNA and proteins from blood, tissue and other materials. Assay technologies prepare these biomolecules for analysis, while bioinformatics support the interpretation of complex data to deliver actionable insights. Automation solutions integrate these steps into streamlined, cost-effective workflows. QIAGEN serves more than 500,000 customers worldwide in the Life Sciences (academia, pharmaceutical R&D and industrial applications such as forensics) and Molecular Diagnostics (clinical healthcare). As of June 30, 2025, QIAGEN employed approximately 5,700 people across more than 35 locations. For more information, visit www.qiagen.com.

Forward-Looking Statement

Certain statements in this press release may constitute forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended. These statements, including those regarding QIAGEN’s products, development timelines, marketing and/or regulatory approvals, financial and operational outlook, growth strategies, collaborations and operating results, such as expected adjusted net sales and adjusted diluted earnings, are based on current expectations and assumptions. However, they involve uncertainties and risks. These risks include, but are not limited to, challenges in managing growth and international operations (including the effects of currency fluctuations, tariffs, tax laws, regulatory processes and logistics and supply chain dependencies), variability in operating results, and the commercial development of products for customers in the Life Sciences and clinical healthcare markets; changes in relationships with customers, suppliers or strategic partners; competition and rapid technological change; fluctuating demand for QIAGEN’s products due to factors such as economic conditions, customer budgets and funding cycles; obtaining and maintaining product regulatory approvals; and challenges in integrating QIAGEN’s products into manufacturing process workflows and manufacturing at scale. Additional risks include market acceptance of new products, integration of acquisitions, governmental actions, global or regional economic developments, natural disasters, political or public health crises, and other force majeure events. There is also no guarantee that anticipated benefits from restructuring programs and acquisitions will materialize as expected. For a more complete discussion of risks and uncertainties, please refer to the “Risk Factors” section in our most recent Annual Report on Form 20-F and other reports filed with or furnished to the U.S. Securities and Exchange Commission.

Source: QIAGEN N.V.

Category: Life Sciences

Contacts

Contacts QIAGEN:

Investor Relations
e-mail: ir@QIAGEN.com

Public Relations
e-mail: pr@QIAGEN.com