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Press releases published on October 17, 2025

Rani Therapeutics Announces Oversubscribed $60.3 Million Private Placement Priced At-the-Market under Nasdaq Rules
Financing led by Samsara BioCapital, L.P. (“Samsara”) with participation from additional investors, including RA Capital Management, Anomaly, Special Situations Funds, Invus and Mr. Mir Imran At the closing of the financing, each of Samsara and Anomaly …

Paratek Pharmaceuticals to Present New Data on NUZYRA® (omadacycline) at IDWeek 2025 and CHEST 2025
Highlights include clinical data from Phase 3 studies in Community Acquired Pneumonia (CABP) and microbiologic data from a Phase 2 study in nontuberculous mycobacterial pulmonary disease (NTM-PD) caused by Mycobacterium abscessus complex (MABc), as well as …

Libtayo® (cemiplimab) Recommended for EU Approval by the CHMP for Adjuvant Treatment of Cutaneous Squamous Cell Carcinoma (CSCC) with a High Risk of Recurrence After Surgery and Radiation
TARRYTOWN, N.Y., Oct. 17, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Libtayo® ( …

Prelude Therapeutics Announces Appointment of Katina Dorton, J.D., MBA to its Board of Directors
WILMINGTON, Del., Oct. 17, 2025 (GLOBE NEWSWIRE) -- Prelude Therapeutics Incorporated (Nasdaq: PRLD), a clinical-stage precision oncology company, today announced the appointment of Katina Dorton to its Board of Directors, effective today. Ms. Dorton has …

Achieve Life Sciences Receives FDA Commissioner's National Priority Voucher for Cytisinicline for Treatment of Nicotine Dependence for E-cigarette or Vaping Cessation
Potential First-in-Class Treatment for Nicotine E-cigarette or Vaping Cessation Receives Unprecedented Expedited Review Pathway One of Only Nine Therapies Chosen for the FDA’s Inaugural National Priority Voucher Program SEATTLE and VANCOUVER, British …

Rani Therapeutics Announces up to $1.085 Billion Collaboration with Chugai Pharmaceutical Co. for Multiple High-Value Therapeutics Including Rare Disease and Immunology Programs and Announces Concurrent Oversubscribed $60.3 Million Financing
Rani will receive $10 million upfront payment and is eligible to receive up to $75 million in technology transfer and development milestones, up to $100 million in sales milestones and single digit royalties on product sales for the first license agreement …

Communiqué de presse : Wayrilz de Sanofi recommandé par le CHMP pour être approuvé par l’UE dans le cadre du traitement de la thrombocytopénie immunitaire
Wayrilz de Sanofi recommandé par le CHMP pour être approuvé par l’UE dans le cadre du traitement de la thrombocytopénie immunitaire Recommandation fondée sur l’étude de phase 3 LUNA 3 démontrant une réponse plaquettaire rapide et durable, ainsi que des …

Press Release: Sanofi’s Wayrilz recommended for EU approval by the CHMP to treat immune thrombocytopenia
Sanofi’s Wayrilz recommended for EU approval by the CHMP to treat immune thrombocytopenia Recommendation based on LUNA 3 phase 3 study demonstrating rapid and durable platelet response and significant improvements in bleeding, quality of life measures, and …

Communiqué de presse : Sanofi fournit une mise à jour de l’examen réglementaire du Rezurock dans l’UE pour le traitement de la maladie chronique du greffon contre l’hôte
Sanofi fournit une mise à jour de l’examen réglementaire du Rezurock dans l’UE pour le traitement de la maladie chronique du greffon contre l’hôte Paris le 17 octobre 2025. Le Comité des médicaments à usage humain (CHMP) de l’Agence européenne des …

Press Release: Sanofi provides update on regulatory review in the EU for Rezurock to treat chronic graft-vs-host disease
Sanofi provides update on regulatory review in the EU for Rezurock to treat chronic graft-vs-host disease Paris, October 17, 2025. The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a negative opinion on the …

Climb Bio to Present Data at American Society of Nephrology (ASN) Kidney Week 2025
Preclinical data for CLYM116, anti-APRIL monoclonal antibody, highlight favorable pharmacokinetic and pharmacodynamic profile, supporting development for IgA nephropathy (IgAN) Long-term follow-up clinical data for budoprutug, anti-CD19 monoclonal antibody …

Tonix Pharmaceuticals Presented Data on TNX-801 Mpox Vaccine at World Vaccine Congress–Europe 2025
TNX-801 is a live virus vaccine investigational candidate, designed to provide durable protection against mpox and smallpox TNX-801 demonstrated favorable safety, immunogenicity, and long-term protection in multiple preclinical models Data support …

Eledon Pharmaceuticals to Present Results from Phase 2 BESTOW Trial of Tegoprubart for the Prevention of Rejection in Kidney Transplantation at the American Society of Nephrology Kidney Week 2025 Annual Meeting
IRVINE, Calif., Oct. 17, 2025 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. (“Eledon”) (Nasdaq: ELDN) today announced an oral presentation will be featured at the American Society of Nephrology’s upcoming Kidney Week 2025 Annual Meeting taking place in …

Sight Sciences Announces Fee Schedule Establishment from Novitas Solutions and First Coast Service Options for the TearCare® Interventional Dry Eye Procedure
MENLO PARK, Calif., Oct. 17, 2025 (GLOBE NEWSWIRE) -- Sight Sciences, Inc. (Nasdaq: SGHT) (Sight Sciences or the Company), an eyecare technology company focused on developing and commercializing innovative, interventional technologies intended to transform …

XORTX Announces Acquisition of Renal Anti-Fibrotic Therapeutic Program from Vectus Biosystems
CALGARY, Alberta, Oct. 17, 2025 (GLOBE NEWSWIRE) -- XORTX Therapeutics Inc. (“XORTX” or the “Company”) (NASDAQ: XRTX | TSXV: XRTX | Frankfurt: ANU), a late stage clinical pharmaceutical company focused on developing innovative therapies to treat gout and …

Tilray Brands Marks Seven Years of Cannabis Legalization in Canada with the #1 Market-Leading Position by Revenue and Pioneering Brands with Growing Market Share in the World’s Largest Federally Legal Cannabis Market
TORONTO, Oct. 17, 2025 (GLOBE NEWSWIRE) -- Tilray Brands, Inc. ("Tilray" or the "Company") (Nasdaq: TLRY; TSX: TLRY), a global lifestyle and consumer packaged goods company at the forefront of the global cannabis, beverage, and wellness industries, proudly …

Chiesi Global Rare Diseases and Protalix Biotherapeutics Acknowledge CHMP Negative Opinion on Every Four Week Dosing Regimen of Elfabrio® (pegunigalsidase alfa) in the EU
PARMA, Italy and CARMIEL, Israel, Oct. 17, 2025 (GLOBE NEWSWIRE) -- Chiesi Global Rare Diseases, a business unit of the Chiesi Group established to deliver innovative therapies and solutions for people living with rare diseases, and Protalix …

AKYNZEO® demonstrates superior prevention of chemotherapy-induced nausea and vomiting compared to the standard of care in patients receiving moderately emetogenic chemotherapy with additional predictive factors
AKYNZEO® demonstrates superior prevention of chemotherapy-induced nausea and vomiting compared to the standard of care in patients receiving moderately emetogenic chemotherapy with additional predictive factors Results from the MyRisk clinical trial, …

ITM to Announce Phase 3 COMPETE Trial Post Hoc Subgroup Analyses and Host Satellite Symposium at NANETS 2025
Garching / Munich, Germany, October 17, 2025 – ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, today announced that post hoc subgroup analyses data from its recent Phase 3 COMPETE trial will be presented in an oral …

TOLREMO therapeutics Completes First In Human Dose Escalation for TT125-802 and Presents Solid Tumor Monotherapy Results at ESMO 2025
Monotherapy shows deep and durable responses in NSCLC and a best-in-class safety profile without thrombocytopenia Completion of monotherapy dose escalation part of the study will be followed by the start of combination studies in EGFRmut, KRAS-G12Cmut and …