Business Wire

Evecxia Therapeutics Announces Successful Completion of Pre-IND Meeting with the FDA Regarding Development of EVX-101 For Depression

RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--Evecxia Therapeutics—the first company dedicated to realizing the therapeutic potential of Serotonin Synthesis Amplification to treat central nervous ...
Seeking Alpha

Annexon: With IGOS Study Completion, Pre-BLA Meeting In 1st Half 2025 On Deck

The last time I wrote about Annexon (ANNX) it was with respect to a Seeking Alpha article entitled "Annexon: Complement Inhibition Of GBS Only The Beginning With Strong Tech In Place". In this article ...
Seeking Alpha

BioXcel Therapeutics Announces Positive FDA Pre-sNDA Meeting Comments for sNDA Submission for BXCL501 in Agitation Associated with Bipolar Disorders or Schizophrenia

NEW HAVEN, Conn., Aug. 18, 2025 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience ...

Gyre Therapeutics Announces Alignment with China’s CDE on Conditional Approval Pathway and Priority Review Eligibility for Hydronidone Following Pre-NDA Meeting

Gyre Pharmaceuticals completed a Pre-NDA meeting with China’s CDE, which agreed that the existing Phase 3 clinical data support a conditional approval filing for Hydronidone and priority review ...
Nasdaq

Purple Biotech Ltd. Reports Final CM24 Phase 2 Data at AACR Annual Meeting 2025, Updates on NT219 and CAPTN-3 Platforms

Purple Biotech Ltd. announced significant progress in its clinical development pipeline during the AACR Annual Meeting 2025, providing updates on its therapies CM24 and NT219, and progressing toward ...