Châtillon, France, December 16, 2025 DBV Technologies Announces Positive Topline Results from Phase 3 VITESSE Trial of VIASKIN® Peanut Patch in Peanut Allergic Children Aged 4-7 Years VITESSE met its primary endpoint: the lower bound of the 95% confidence interval (CI) of the difference between treatment arms was 24.5%, exceeding the prespecified threshold of 15% 46.6% of children treated with the VIASKIN® Peanut patch met response criteria at 12 months, compared to 14.8% of children in the placebo arm Sa ...

SAN FRANCISCO--(BUSINESS WIRE)--Vir Biotechnology, Inc. (Nasdaq: VIR) today announced that the Company has granted Norgine Pharma UK Limited, an affiliate of Norgine, a leading European specialty pharmaceutical company, an exclusive license for the commercial rights to the combination of tobevibart and elebsiran for the treatment of chronic hepatitis delta (CHD) in Europe, Australia and New Zealand. 1 Per the terms of the agreement, Vir Biotechnology will receive an initial reimbursement payment of EUR 55 m ...

Provided Update on R&D Engine Now On Track to Deliver Multiple First- and Best-in-Class Medicines, Positioning Company for Long-Term Value Creation Across Therapeutic Modalities Reviewed Positive Data Across Late-Stage Neuropsychiatry Pipeline Including Osavampator and Direclidine; Topline Phase 3 Data from Both Programs Expected in 2027 Announced Expansion of CRF Platform as Foundation of New Class of Medicines for Metabolic Diseases, Including Obesity SAN DIEGO, Dec. 16, 2025 /PRNewswire/ -- Neurocrine B ...

SOUTH SAN FRANCISCO, Calif., Dec. 16, 2025 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (NASDAQ:CYTK) today announced that on December 15, 2025 it granted stock options to purchase an aggregate of 21,399 shares of common stock and 14,422 restricted stock units (RSUs) that will be settled in shares of common stock upon vesting to 10 employees, whose employment commenced in November and December 2025 as a material inducement to their employment.The RSUs will vest over 3 years, with 40% of the RSUs vesting o ...

Neurocrine Biosciences (NasdaqGS:NBIX) 2025 R&D Day December 16, 2025 12:00 PM ET Speaker0Good morning and good afternoon. My name is Todd Tushla. I'm the Vice President of Investor Relations at Neurocrine Biosciences, and on behalf of our entire company, welcome to our 2025 R&D Day. Whether you're here in person, on the webcast, or reading the transcript, we're grateful for your time. We will be making forward-looking statements today to refer you to our latest SEC disclosures. Our speakers for today from ...

Sanofi (NasdaqGS:SNY) Update / Briefing December 16, 2025 11:15 AM ET Company ParticipantsLouisa Hector - Head of Global Pharma Equity ResearchThomas Kudsk Larsen - Head of Investor RelationsSachin Jain - VPSarita Kapila - Co-Head European Pharmaceuticals Equity ResearchSimon Baker - Head of Global Biopharma ResearchNone - Company RepresentativeJames Quigley - Executive DirectorGraham Parry - Managing Director and Head of European Pharmaceuticals Biotechnology Equity ResearchJean-François Toussaint - Global ...

R&D Leadership and Organization - Sanofi is building a skilled and thoughtful R&D leadership team and organization[5, 6, 7, 106] - The company is strengthening capabilities across research, translational medicines, development, medical, regulatory affairs, and digital[106] Pipeline Highlights and Approvals - Sanofi achieved three new medicine and vaccine approvals in 2025: Qfitlia, Wayrilz, and Nuvaxovid[12, 13, 106] - Dupixent showed benefit across relevant endpoints in Bullous pemphigoid, with 12.2% difference in patients achieving sustained remission compared to placebo + OCS and 27.8% difference in patients with ≥4-point improvement in PP-NRS[20, 21] - Dupixent clinically meaningfully improved radiographic, endoscopic, and symptoms of Allergic fungal rhinosinusitis, with lower proportion of patients receiving SCS treatment and/or surgery[24] - Amlitelimab (OX40L mAb) in AD: first phase 3 study met primary and key secondary endpoints, showing clinically meaningful improvement in skin clearance and disease severity[26] - Brivekimig (TNFaxOX40L Nanobody®) in HS: phase 2a study achieved primary objective, with 54% of participants achieving HiSCR75[28, 29] - Itepekimab (IL33 mAb) in COPD: AERIFY-1 study showed a significant reduction in moderate or severe exacerbations of 27.1% at Week 52 with Q2W dosing across EOS level[38] - Duvakitug (TL1A mAb) in CD/UC: positive and encouraging phase 2b data presented at ECCO 2025, with 48% clinical remission in Crohn's disease high dose group[46, 47] - Fluzone HD demonstrated superior protection vs standard-dose influenza vaccines against hospitalization in older adults, including a -31.9% reduction in laboratory confirmed influenza hospitalization[75] - Monovalent RSV (mRNA) vaccine showed 74.9% efficacy against RSV LRTD in a phase 2 study[80] Pipeline Replenishment and Digital Transformation - Sanofi is progressing on pipeline entries augmented by strategic business development[107] - The R&D digital plan aims at reducing cycle times across the R&D value chain by more than 40%[94, 95, 107] Upcoming News Flow - Sanofi anticipates >15 regulatory decisions, >30 regulatory submissions, and >15 phase 3 data readouts in 2026 and 2027[108]

Core Insights - Gelteq Limited has announced a partnership with the Hong Kong Flag Football Program to integrate its hydration and sports performance formulations into training and competition for national teams [1][2] - The collaboration highlights the growing interest in high-performance sports programs in the region, supported by a recent sales agreement with Shenzhen Mana Health Management Co. Ltd. worth at least USD $1.3 million [2] - Gelteq's proprietary delivery technology is increasingly being adopted in both sports and wellness applications, driven by demand for research-based products that enhance athlete performance [3] Company Developments - Gelteq's gel-based formulations are designed to aid athletes in managing hydration, energy regulation, and recovery, and are already utilized by elite programs in Australia and Asia [6] - The partnership with Hong Kong's national teams marks a significant step in the development of American football in the region, as all three teams recently achieved their first official international victories [4] - The CEO of Gelteq emphasized the versatility of their gel-based platform and the company's commitment to supporting athlete performance through science-driven innovation [5] Industry Trends - Flag football is recognized as one of the fastest-growing team sports globally, with increasing participation among youth and adults due to its accessibility and low-contact nature [5] - The growth of flag football in the region is bolstered by rising investments in sports science and high-performance training [5] - Gelteq is actively exploring additional opportunities in the region to expand its sports product portfolio and advance commercial discussions regarding its gel-based platform [7]

Regulatory submission marks a significant milestone as the Company advances toward Phase 2/3 trial initiation in Q2 2026 at full speed Application follows recent successful toxicology studies, positive German regulatory feedback, and strong preclinical data demonstrating up to 99.7% cancer cell inhibition Regulatory filings in Germany and the EU are planned for Q1 2026, with U.S. expansion anticipated following the safety run-in Grand Cayman, Cayman Islands, Dec. 16, 2025 (GLOBE NEWSWIRE) -- Silexion Therap ...

Core Insights - PolyPid Ltd. has appointed Brooke Story as Chairman of the Board of Directors, effective December 11, 2025, which is seen as a pivotal moment for the company [1][2] - Ms. Story brings over 25 years of leadership experience in the MedTech industry, having held senior roles at BD and Medtronic, and her expertise is expected to enhance PolyPid's strategic and commercial capabilities [2][3] - The company is preparing for the New Drug Application (NDA) submission of its lead product candidate, D-PLEX100, aimed at preventing abdominal colorectal surgical site infections, expected in early 2026 [5] Company Overview - PolyPid Ltd. is a late-stage biopharma company focused on improving surgical outcomes through its proprietary PLEX technology, which allows for controlled, prolonged-release of therapeutics [5] - The company has a pipeline that includes innovative solutions in oncology, obesity, and diabetes, indicating a broad scope of potential market applications [5] Leadership and Strategy - Brooke Story's appointment is anticipated to support the transformation of PolyPid's clinical success into commercial reality, particularly in the area of surgical infection prevention [2][4] - Ms. Story's previous roles include overseeing global strategy and P&L for BD's Surgery business, which aligns with PolyPid's goals in the surgical market [2][3]