COMMUNIQUÉS West-GlobeNewswire

Relmada Therapeutics Provides Regulatory Update Confirming FDA Alignment on Registrational Studies Design for NDV-01 for Two Separate Indications
12/01/2026
FDA written feedback supports: - a single-arm, open-label registrational trial in 2nd-line refractory high-grade NMIBC with CIS - a randomized vs observation single trial in intermediate-risk NMIBC in the adjuvant [...]
Oruka Therapeutics Announces Positive Interim Phase 1 Data for ORKA-002 and Initiation of EVERLAST-B Trial of ORKA-001
12/01/2026
ORKA-002 interim Phase 1 data demonstrates a half-life of 75-80 days supporting potential for twice-per-year dosing in psoriasis and quarterly dosing in hidradenitis suppurativa Phase 2 studies for ORKA-002 expected to [...]
Precede Biosciences Secures $83.5M in Total Financing to Scale Next-Generation Precision Diagnostics Platform
12/01/2026
Financing includes $63.5M Series B equity and $20M strategic non-dilutive credit facility Capital supports accelerated scaling amid strong commercial traction with leading biopharmaceutical developers of next-generation [...]
Protara Therapeutics Highlights Recent Updates and Anticipated 2026 Milestones
12/01/2026
On track to report interim results from approximately 25 six-month evaluable BCG-Unresponsive patients in ADVANCED-2 trial in Q1 2026 Received Breakthrough Therapy and Fast Track designations for TARA-002 in LMs; [...]
Agios Outlines 2026 Strategic Priorities and Key Milestones to Accelerate Rare Disease Portfolio Growth
12/01/2026
AQVESME™ (mitapivat) U.S. commercial launch in thalassemia underway following December 2025 FDA approval Pre-sNDA meeting with FDA for mitapivat in sickle cell disease anticipated in first quarter of 2026, with planned [...]
Syndax Reports Preliminary 2025 Financial Highlights and Provides Business Updates at the 44th Annual J.P. Morgan Healthcare Conference
12/01/2026
– Approximately $44 million and $125 million in preliminary (unaudited) Revuforj ® (revumenib) 4Q25 and full year 2025 net revenue, respectively – – Continued acceleration in demand following approval in R/R NPM1m AML, [...]
BioXcel Therapeutics Expands Leadership Team to Prepare for Launch of IGALMI® in the At-Home Setting
12/01/2026
Mark Pavao to Join BioXcel Therapeutics as Interim Chief Commercial Officer Mr. Pavao Brings Deep Experience in Neuroscience Sales and Marketing to Support Potential Launch of IGALMI® in At-Home Setting as Early as Year [...]
Nurix Therapeutics Outlines 2026 Goals and Objectives for Advancing Bexobrutideg and Its Pipeline of Novel Degrader-Based Medicines in Cancer and Autoimmune Diseases
12/01/2026
Execute a pivotal program for potential best-in-class BTK degrader, bexobrutideg, including Phase 2 and confirmatory Phase 3 studies to support global registration in relapsed/refractory chronic lymphocytic leukemia (r/ [...]
Axsome Therapeutics Provides Preliminary Fourth Quarter and Full Year 2025 Net Product Revenue
12/01/2026
Total preliminary 4Q and full year 2025 net product revenue of $196.0 million and $638.5 million, respectively, representing 65% and 66% annual growth, respectively AUVELITY ® preliminary 4Q and full year 2025 net [...]
Sotera Health to Showcase Continued Revenue Growth and Strategic Value Creation at 44th Annual J.P. Morgan Healthcare Conference
12/01/2026
CLEVELAND, Jan. 12, 2026 (GLOBE NEWSWIRE) -- Sotera Health Company (“Sotera Health” or the “Company”) (Nasdaq: SHC), a leading global provider of mission-critical end-to-end sterilization solutions, lab testing and [...]
Annexon Accelerating Next Generation Targeted Immunotherapy Platform for Treatment of Neuroinflammatory Diseases with Multiple Registrational Milestones in 2026
12/01/2026
Tanruprubart MAA Filed with Potential to Be the First Targeted Fast-Acting Therapy for Guillain-Barré Syndrome ( GBS); BLA Submission with U.S./European Data Planned in 2026 Vonaprument Pivotal Phase 3 Topline Data for [...]
BioCryst Announces Preliminary Full Year 2025 ORLADEYO® (berotralstat) Net Revenue of $601 Million (+37 percent y-o-y), Beating Prior Guidance Range
12/01/2026
–Excluding European ORLADEYO revenue for the full year 2025, preliminary 2025 ORLADEYO net revenue was $563 million (+43 percent y-o-y on a comparable basis)– –ORLADEYO net revenue expected to be between $625 million [...]
MediWound Provides Corporate Update and Financial Outlook Ahead of the J.P. Morgan Healthcare Conference
12/01/2026
MediWound Provides Corporate Update and Financial Outlook Ahead of the J.P. Morgan Healthcare Conference Interim assessment and enrollment completion for the EscharEx ® VALUE Phase III trial in venous leg ulcers (VLUs) [...]
Axogen, Inc. Reports Preliminary Unaudited Revenue for Fourth Quarter and Full-Year 2025
12/01/2026
ALACHUA, Fla. and TAMPA, Fla., Jan. 12, 2026 (GLOBE NEWSWIRE) -- Axogen, Inc. (NASDAQ: AXGN), a global leader in developing and marketing innovative surgical solutions for the restoration of peripheral nerve function, [...]
Apellis Highlights Commercial Execution and Strategic Priorities at the 44th Annual J.P. Morgan Healthcare Conference
12/01/2026
Full-year 2025 preliminary 1 U.S. net product revenues of $689 million SYFOVRE ® (pegcetacoplan injection) total injection demand grew 17% year-over-year; regulatory submission for prefilled syringe planned in 1H 2026 [...]
Lexeo Therapeutics Announces Positive Interim Phase I/II Data for LX2020 for the Treatment of PKP2-Associated Arrhythmogenic Cardiomyopathy
12/01/2026
LX2020 generally well tolerated across ten participants with no clinically significant complement activation LX2020 transduction, transcription, and increased protein expression observed across participants with dose- [...]
RAD Increases Ownership in Radiopharm Ventures to 87.5%
12/01/2026
Radiopharm Ventures, LLC, is a joint venture created in 2022 between MD Anderson Cancer Center and Radiopharm Theranostics Leading candidate Betabart, a monoclonal antibody targeting B7H3, has received FDA IND clearance [...]
Healthy Gut Announces Updated Holozyme Formula Addressing Digestive Sensitivity to Fructan-Containing Foods
12/01/2026
Boulder, CO, Jan. 11, 2026 (GLOBE NEWSWIRE) -- Healthy Gut, a Boulder-based digestive health company, announced the release of an updated formulation of its Holozyme product, reflecting the company’s expanded focus on [...]
Nature Communications reports promising effect of Idorsia’s lucerastat on kidney function in Fabry disease
12/01/2026
In patients with impaired renal function or fast-deteriorating eGFR at baseline, lucerastat was associated with a marked attenuation of kidney function loss, suggesting a potential disease-modifying effect The company [...]

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