Abivax, a biotechnology company, announced positive Phase 3 results from its ABTECT-1 and ABTECT-2 induction trials evaluating obefazimod, an oral miR-124 enhancer, in patients with moderate to severely active ulcerative colitis. The 50 mg once-daily dose achieved a 16.4% pooled placebo-adjusted clinical remission rate at eight weeks, meeting all key secondary endpoints with a favorable safety profile. These results represent a major advancement for the treatment of ulcerative colitis, a chronic inflammatory bowel disease. Following the announcement, Abivax shares surged dramatically, rising over 500% in pre-market and after-hours trading, with the stock price reaching as high as $60 from a previous close around $10.20. The company’s market capitalization increased to approximately €2.8 billion. Abivax has also launched a public offering, which has been fully exercised by underwriters, generating gross proceeds of $747.5 million (€637.5 million). A maintenance trial for obefazimod is ongoing, and Abivax plans to submit regulatory applications to the FDA and EMA in the second half of the year. Trading of Abivax shares has resumed on Euronext Paris following the halt after the trial results.
$BTAI - BioXcel Therapeutics Announces Last Patient Last Visit in SERENITY At-Home Pivotal Phase 3 Safety Trial for Acute Treatment of Agitation Associated with Bipolar Disorders or Schizophrenia - https://t.co/t1ciym9L0J
Upside: $BTAI +26% (completes last patient last visit (LPLV) in the pivotal Phase 3 SERENITY At-Home clinical trial) $FIG +17% (momentum following IPO) $RDDT +16% (earnings, guidance) $APPF +14% (earnings, guidance) $FIVN +8.0% (earnings, guidance) $WEAV +5.6% (earnings,
$BTAI (+34.4% pre) BioXcel completes phase 3 trial for at-home agitation treatment https://t.co/K9QFKQHYOE