Artificial Intelligence in Drug Development

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BioXcel Therapeutics Announces Database Lock in SERENITY At-Home Pivotal Phase 3 Safety Trial for Acute Treatment of Agitation Associated with Bipolar Disorders or Schizophrenia
Globenewswire· 2025-08-19 11:00
Data from more than 2,600 agitation episodes collected Topline data readout is on track for August BXCL501 was granted Fast Track Designation for the acute treatment of agitation associated with bipolar disorders or schizophrenia. There are no FDA-approved therapies for the acute treatment of agitation in the at- home setting. About the SERENITY At-Home Phase 3 Trial The trial was designed to study 200 patients with a history of agitation episodes despite being on stable treatment for their underlying bipol ...
Corporate Update, August 2025
Globenewswire· 2025-08-04 12:30
NEW YORK, Aug. 04, 2025 (GLOBE NEWSWIRE) -- From Dr. Neil Maresky, CEO, Psyence BioMed (NASDAQ: PBM) Dear Shareholders, Thank you for your continued support as we advance our mission to develop safe, effective, and naturally derived psychedelic therapies for people living with serious mental health challenges. Over the past few months, Psyence BioMed (PBM) has made meaningful progress across several fronts: clinical development, strategic positioning, regulatory compliance, and manufacturing stability. Thes ...