FDA requires second Phase 3 trial for Reviva's brilaroxazine in schizophrenia; NDA delayed to late 2027

REVIVA PHARMACEUTICALS HOLDINGS, INC.

FDA recommends RECOVER-2 Phase 3 trial (30/50 mg) before NDA submission; similar to RECOVER design.
RECOVER-2 initiation planned H1 2026, data Q2 2027; NDA target Q4 2027, potential approval Q4 2028; est. cost ~$60M.
Stockholders approved authorized share increase from 315M to 515M and reverse stock split (1:2 to 1:20, Board discretion).
Warrant exercises Oct–Dec 2025: 19.8M shares, ~$6.7M net; cash ~$14.7M as of Dec 16, sufficient through Q2 2026 ex-RECOVER-2.
Long-term safety data from RECOVER open-label extension over 52 weeks shows favorable tolerability and adherence.

item 5.03 item 5.07 item 7.01 item 8.01 item 9.01

Key facts

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Governance Changes SEC 8-K Item 5.03/5.05/5.06 confidence 0.9

REVIVA PHARMACEUTICALS HOLDINGS, INC.: Stockholders approved an amendment to the Certificate of Incorporation to increase authorized shares of Common Stock from 315,000,000 to 515,000,000, filed and effective December 18, 2025 (effective 2025-12-18).

Change: charter amendment
Effective: 2025-12-18

Exact text from the filing

On December 18, 2025, the Company filed the Increase in Authorized Charter Amendment with the Secretary of State of the State of Delaware and such amendment became effective immediately.

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REVIVA PHARMACEUTICALS HOLDINGS, INC. filing history →

Source: SEC EDGAR

accession 0001437749-25-038602

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