COMMUNIQUÉS West-GlobeNewswire

Dyne Therapeutics Announces Positive Topline Results from Phase 1/2 DELIVER Trial of Z-Rostudirsen in Duchenne Muscular Dystrophy (DMD)
08/12/2025
- Registrational Expansion Cohort (REC) met primary endpoint, demonstrating statistically significant increase in dystrophin to 5.46% at 6 months (muscle content-adjusted; p<0.0001), replicating the same 7-fold [...]
Monaghan Medical Earns 2025 AARC Zenith Award — A Decade of Trust and Innovation Recognized by Respiratory Care Professionals
08/12/2025
PLATTSBURGH, N.Y., Dec. 08, 2025 (GLOBE NEWSWIRE) -- Monaghan Medical Corporation is proud to announce it has once again been recognized by the American Association for Respiratory Care (AARC) with the Zenith Award, [...]
Syndax Highlights Leadership in Menin Inhibition at ASH 2025 with Multiple Revuforj® (revumenib) Presentations Spanning the Acute Leukemia Treatment Continuum
08/12/2025
– First real-world evidence for a menin inhibitor shows 77% ORR (10/13), 31% (4/13) CR/CRh, 75% (9/12) MRD negativity, and favorable tolerability among primarily R/R NPM1m, KMT2Ar, and NUP98r acute leukemia pts – – [...]
Kamada Announces Discontinuation of its Phase 3 Inhaled AAT Clinical Trial; Reiterates 2025 Full-Year Guidance and Projects Double-Digit Growth in Revenues and Profitability in 2026
08/12/2025
Based on the Results of a Planned Interim Futility Analysis the Inhaled AAT Trial is Unlikely to Demonstrate a Statistically Significant Benefit in its Primary Endpoint K amada Continues to Supply GLASSIA®, its AAT-IV [...]
Vaxcyte Doses First Participants in the OPUS Phase 3, Noninferiority Trial Evaluating VAX-31 for the Prevention of Invasive Pneumococcal Disease and Pneumonia in Adults
08/12/2025
Trial Design Finalized in Consultation and Alignment with U.S. Food and Drug Administration Study Designed to Establish a New Standard for Adult Pneumococcal Conjugate Vaccines Through Head-to-Head Safety, Tolerability [...]
Ocular Therapeutix™ Announces Plans to Accelerate NDA Submission Timeline for AXPAXLI™ in Wet AMD
08/12/2025
Ocular intends to submit AXPAXLI New Drug Application (NDA) for wet AMD shortly after year one data from SOL-1, if positive SOL-1 topline data remain on track for 1Q 2026 Ocular plans to leverage the 505(b)(2) [...]
Agios Provides Update on U.S. sNDA for Mitapivat in Thalassemia
08/12/2025
CAMBRIDGE, Mass., Dec. 08, 2025 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a commercial-stage biopharmaceutical company focused on delivering innovative medicines for patients with rare diseases, [...]
Cardiff Oncology to Present at Sidoti’s Year-End Virtual Investor Conference
08/12/2025
SAN DIEGO, Dec. 08, 2025 (GLOBE NEWSWIRE) -- Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, today announced [...]
Kymera Therapeutics Announces Positive Results from BroADen Phase 1b Clinical Trial of KT-621, a First-in-Class, Oral STAT6 Degrader, in Patients with Moderate to Severe Atopic Dermatitis
08/12/2025
KT-621 achieved deep STAT6 degradation across both the 100 mg and 200 mg dose groups tested, with median reductions of 94% and 98% in skin and blood, respectively, demonstrating strong translation from healthy [...]
Orchestra BioMed Announces AVIM Therapy and Virtue SAB Program Presentations at ICI Meeting
08/12/2025
Joint presentation by Orchestra BioMed and Medtronic leadership to discuss ongoing strategic collaboration for development and commercialization of AVIM Therapy for treatment of uncontrolled hypertension in patients [...]
Iridex Announces New Thermal Dynamics Study That Strengthens Clinical Foundation and Market Potential of MicroPulse® Technology and Continuous-Wave Laser for Glaucoma Treatment
08/12/2025
MOUNTAIN VIEW, Calif., Dec. 08, 2025 (GLOBE NEWSWIRE) -- Iridex Corporation (Nasdaq: IRIX), a worldwide leader providing innovative and versatile laser-based medical systems, delivery devices, and accessories for the [...]
Kraig Biocraft Laboratories Secures Usage Rights to Strategic Government-Owned Mulberry Gardens to Support Major Spider Silk Production Expansion
08/12/2025
ANN ARBOR, Mich., Dec. 08, 2025 (GLOBE NEWSWIRE) -- Kraig Biocraft Laboratories, Inc. (OTCQB: KBLB) ("Company" or "Kraig Labs"), a world leader in spider silk technology*, today announced that it has been granted usage [...]
Positive Phase 1b/2 Results from Ongoing REC-4881 TUPELO Trial Demonstrate Rapid and Durable Reductions in Polyp Burden in Familial Adenomatous Polyposis (FAP) at 25 Weeks
08/12/2025
REC-4881 (4 mg QD) achieved rapid clinical activity, with 75% of evaluable patients showing reductions in total polyp burden and a 43% median reduction after 12 weeks of treatment (n=12) After 12 weeks off therapy (week [...]
Wave Life Sciences Announces Positive Interim Data from Phase 1 INLIGHT Trial of WVE-007 (INHBE) for Obesity; Single Dose Resulted in Improvement in Body Composition With Fat Loss Similar to GLP-1 at Three Months Without Muscle Loss
08/12/2025
Following a single subcutaneous 240 mg dose, WVE-007 (INHBE GalNAc-siRNA) improved body composition at three months compared to baseline, with a 9.4% reduction in visceral fat (p=0.02), a 4.5% reduction in total body [...]
Cogent Biosciences Announces Positive Top-line Results of APEX Trial of Bezuclastinib in Patients with Advanced Systemic Mastocytosis (AdvSM)
08/12/2025
-- Bezuclastinib demonstrated rapid and deep clinical benefit in AdvSM patients resulting in an objective response rate (CR+CRh+PR+CI) of 57% per mIWG criteria and 80% per PPR criteria -- -- Bezuclastinib demonstrated a [...]
BiomX Announces Discontinuation of Phase 2b BX004 Trial Following Internal Review
08/12/2025
Following internal analysis and Data Monitoring Committee (DMC) feedback, the Company has elected to discontinue the BX004 Cystic Fibrosis (CF) Phase 2b trial BiomX continues to see potential in BX011, its phage program [...]
Abeona Therapeutics® Announces First Patient Treatment with ZEVASKYN® Gene Therapy
08/12/2025
CLEVELAND, Dec. 08, 2025 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced the first commercial patient treatment with FDA-approved ZEVASKYN (prademagene zamikeracel), a first-of-its-kind, [...]
Beta Bionics to Pre-Announce Topline Fourth Quarter 2025 Financial Results the Week of January 5, 2026
08/12/2025
IRVINE, Calif., Dec. 08, 2025 (GLOBE NEWSWIRE) -- Beta Bionics, Inc. (Nasdaq: BBNX) (the “Company”), a pioneering leader in the development of advanced diabetes management solutions, today announced that it plans to pre [...]
Zelluna ASA: New share capital registered
08/12/2025
Oslo, Norway, 8 December, 2025: Reference is made to the stock exchange announcement made by Zelluna ASA (the "Company") on 3 November 2025 regarding the successful private placement of 5,500,000 new shares (the " [...]

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