COMMUNIQUÉS West-GlobeNewswire

Septerna Highlights Business Progress and Reports Second Quarter 2025 Financial Results
11/08/2025
Advancing Selection of Next-Generation Oral Small Molecule PTH1R Agonist for Clinical Development Initiating Phase 1 Trial for SEP-631, MRGPRX2 NAM Program, for Mast Cell Diseases Updated Cash Runway Expected to Support [...]
Denali Therapeutics Reports Second Quarter 2025 Financial Results and Business Highlights
11/08/2025
Tividenofusp alfa BLA for Hunter syndrome accepted for priority review and assigned PDUFA target action date of January 5, 2026; company preparing for commercial launch DNL126 accelerated approval path for Sanfilippo [...]
FibroGen Reports Second Quarter 2025 Financial Results and Provides Business Update
11/08/2025
Total consideration for the sale of FibroGen China to AstraZeneca now expected to be approximately $210 million, a $50 million increase from initial guidance Net cash held in China at closing now estimated to be [...]
Alpha Tau Announces Second Quarter 2025 Financial Results and Provides Corporate Update
11/08/2025
- FDA approval of IDE to conduct a U.S. pilot study exploring the use of Alpha DaRT in patients with recurrent glioblastoma multiforme (GBM), a highly aggressive brain cancer - - Multiple U.S. clinical trials, including [...]
TELA Bio Reports Second Quarter 2025 Financial Results
11/08/2025
MALVERN, Pa., Aug. 11, 2025 (GLOBE NEWSWIRE) -- TELA Bio, Inc. ("TELA Bio"), a commercial-stage medical technology company focused on providing innovative soft-tissue reconstruction solutions, today reported financial [...]
Oruka Therapeutics Reports Second Quarter 2025 Financial Results and Provides Corporate Update
11/08/2025
First patients dosed in the EVERLAST-A Phase 2a trial of ORKA-001, with data expected in 2H 2026 ORKA-001 Phase 1 data and EVERLAST-A design to be presented at EADV in September 2025 ORKA-002 Phase 1 trial ongoing, with [...]
BioVie Inc. Announces Closing of $12 Million Public Offering
11/08/2025
CARSON CITY, Nev., Aug. 11, 2025 (GLOBE NEWSWIRE) -- BioVie Inc. (NASDAQ: BIVI, BIVIW), (“BioVie” or the “Company”), a clinical-stage company developing innovative drug therapies to treat chronic debilitating conditions [...]
Assertio Reports Second Quarter 2025 Financial Results
11/08/2025
Second Quarter Total Net Product Sales of $28.8 Million, Cash and Investments Increase to $98.2 Million Narrows Guidance on Continued Progress Implementing Long-Term Business Strategy LAKE FOREST, Ill., Aug. 11, 2025 ( [...]
Sana Biotechnology Reports Second Quarter 2025 Financial Results and Business Updates
11/08/2025
Presented positive 6-month clinical results of ongoing type 1 diabetes study showing that hypoimmune-modified pancreatic islet cells transplanted without immunosuppression overcome immune recognition, while continuing [...]
Capricor Therapeutics Reports Second Quarter 2025 Financial Results and Provides Corporate Update
11/08/2025
Type A meeting with U.S. FDA scheduled to discuss Deramiocel BLA and path toward potential approval Capricor seeks to resubmit its BLA based on its existing dataset, with HOPE-3 data (expected in Q4 2025) potentially [...]
Metagenomi Appoints Laurence Reid, PhD to its Board of Directors
11/08/2025
Dr. Reid brings 30 years of experience in building biotech companies based on innovative scientific platforms and shaping pipeline and business strategy EMERYVILLE, Calif., Aug. 11, 2025 (GLOBE NEWSWIRE) -- Metagenomi, [...]
NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) to Report Second Quarter 2025 Financial Results on August 14, 2025
11/08/2025
WILMINGTON, Del., Aug. 11, 2025 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the "Company"), a clinical-stage biopharmaceutical company, today announced that it will release its [...]
IMDX Reports Q2 2025 Results and Momentum Toward GraftAssureDx Launch
11/08/2025
Reiterating timelines for FDA submission in 2025 Transplant clinical trial has attracted leading transplant hospitals Booked first revenue from first-generation GraftAssureIQ research-use-only kits; began shipping [...]
Crinetics Pharmaceuticals Announces August 2025 Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
11/08/2025
SAN DIEGO, Aug. 11, 2025 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) today announced that on August 10, 2025, the Compensation Committee of the Board of Directors granted non-qualified stock [...]
Maravai LifeSciences Reports Second Quarter 2025 Financial Results
11/08/2025
Announced organizational restructuring and operating cost reduction initiatives targeting more than $50 million in annualized cost savings Quarterly base business revenue, which excludes revenue from high-volume [...]
Tempest Reports Second Quarter 2025 Financial Results and Provides Business Update
11/08/2025
Received clearance to proceed with pivotal trial of amezalpat combination therapy for first-line hepatocellular carcinoma (HCC) in China Granted orphan drug designation from the European Medicines Agency (EMA) for [...]
Tonix Pharmaceuticals Reports Second Quarter 2025 Financial Results and Operational Highlights
11/08/2025
FDA PDUFA goal date of   August   15 , 2025, for TNX ‑ 102   SL for fibromyalgia: if approved by FDA, TNX ‑ 102   SL would be the first new drug for fibromyalgia in more than 16   years   In   June   2025, the Company [...]
Longeveron Announces Closing Of Up To $17.5 Million Public Offering
11/08/2025
$5.0 million upfront with up to an additional $12.5 million of potential aggregate gross proceeds upon the exercise in full of short-term warrants MIAMI, Aug. 11, 2025 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN [...]
Biofrontera Inc. Appoints George Jones as Chief Commercial Officer
11/08/2025
Woburn, MA, Aug. 11, 2025 (GLOBE NEWSWIRE) -- Biofrontera Inc. (Nasdaq: BFRI) (the “Company”) , a biopharmaceutical company focused on the development and commercialization of photodynamic therapy (PDT), today announced [...]

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