News

Opus Genetics Receives FDA Agreement Under Special Protocol Assessment for Phase 3 Trial of APX3330 in Diabetic Retinopathy

Agreement Reached on Primary Endpoint and Phase 3 Trial Design Oral APX3330 is a Late-Stage Clinical Asset Available for Partnering FARMINGTON…

1 week ago

Pluri Congratulates Mesoblast on FDA Approval of First Mesenchymal Stromal Cell Therapy for Steroid-Refractory Acute Graft-Versus-Host Disease

HAIFA, Israel, Dec. 19, 2024 (GLOBE NEWSWIRE) -- Pluri Inc. (Nasdaq: PLUR) (TASE: PLUR) ("Pluri" or the “Company"), an innovator…

1 week ago

Clene Improves Cash Position and Runway by Securing New Debt Facility to Pay Off Existing Senior Loan

Secures new $10.0 million debt facility to replace remaining $7.85 million of Avenue Capital debt Improves cash position enabling Clene…

1 week ago

Assembly Biosciences Announces $30.1 Million Equity Investment and Accelerated Funding from Gilead to Advance Clinical Development Programs

—Assembly Bio to receive approximately $20.1 million equity investment and $10 million in accelerated funding under the collaboration, extending cash…

1 week ago

Bionano Announces the Publication of Stockholder Letter Regarding Support for Proxy Proposal

SAN DIEGO, Dec. 19, 2024 (GLOBE NEWSWIRE) -- Bionano Genomics, Inc. (BNGO), today announced that on December 19, 2024, it published an…

1 week ago

Alumis Announces Positive Phase 1 Data for CNS Penetrant TYK2 Inhibitor, A-005

– A-005 was well tolerated and demonstrated ability to cross blood-brain barrier – – Maximal TYK2 inhibition achieved with favorable…

1 week ago

Aquestive Therapeutics Receives U.S. FDA Orphan Drug Exclusivity for Libervant® (diazepam) Buccal Film in Pediatric Patients with Seizure Clusters Ages Two to Five

U.S. FDA Orphan Drug exclusivity provides seven years of market exclusivity for Libervant® (diazepam) Buccal Film in the United States…

1 week ago

Ultragenyx Submits Biologics License Application to the U.S. FDA for UX111 AAV Gene Therapy for the Treatment of Sanfilippo Syndrome Type A (MPS IIIA)

If approved, UX111 would be the first approved therapy in the U.S. for Sanfilippo Syndrome Type ANOVATO, Calif., Dec. 19,…

1 week ago

Artios Pharma to Present at the 43rd Annual J.P. Morgan Healthcare Conference

CAMBRIDGE, United Kingdom and NEW YORK, December 19, 2024 – Artios Pharma Limited (“Artios”), a clinical-stage biotech company led by…

1 week ago

Rakovina Therapeutics: Reflecting on 2024 Success and Building Momentum for a Transformative 2025

VANCOUVER, British Columbia, Dec. 19, 2024 (GLOBE NEWSWIRE) -- Rakovina Therapeutics Inc. (“Rakovina” or the “Company”) (TSX-V: RKV) a biopharmaceutical…

1 week ago