BioXcel's $220M Volume Spike Propels 3.47% Rally Ranks 416th in Market Activity as FDA Aligns on Home-Use Label Expansion

BioXcel Therapeutics (NASDAQ: BTAI) surged 3.47% on August 18, with a trading volume of $220 million, marking a 373.59% increase from the previous day and ranking it 416th in market activity. The stock’s momentum followed positive regulatory developments, including FDA alignment on its supplemental New Drug Application (sNDA) for expanding IGALMI’s label to at-home use for treating agitation linked to bipolar disorders or schizophrenia. The sNDA submission remains on track for Q1 2026, with the company confirming the pre-sNDA meeting’s objectives were achieved without requiring an in-person session.

The FDA’s feedback validated BioXcel’s regulatory package, which includes pivotal data from the Phase 3 SERENITY At-Home trial. This 12-week study evaluated the safety of a 120 mcg dose of BXCL501 in outpatient settings, with top-line results expected later this month. The trial design was finalized in a March 2024 Type C meeting with the FDA, and its completion represents a critical step toward label expansion. BXCL501 has already received Fast Track Designation, positioning it as a potential first-in-class therapy for a treatment gap in at-home psychiatric care.

Management emphasized the significance of this milestone, highlighting the potential to transform treatment paradigms for patients with agitation. The current IGALMI label is restricted to medically supervised settings, and expanding it to outpatient use could unlock broader market access. However, the company cautioned that final approval remains contingent on the FDA’s review of the complete sNDA filing and the SERENITY trial’s outcomes. Despite these risks, the regulatory alignment and Fast Track status suggest a streamlined path forward.

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