Reviva Pharmaceuticals (RVPH) cae 55,93% mientras que la FDA exige un ensayo adicional para el fármaco para esquizofrenia

The share price fell to its lowest level since September 2025 today, with an intraday decline of 55.93%. Reviva Pharmaceuticals (RVPH) has seen a sharp selloff after the U.S. Food and Drug Administration mandated a second Phase 3 trial for its schizophrenia drug candidate, brilaroxazine. The requirement, revealed in pre-New Drug Application feedback, has pushed back the NDA timeline to at least 2027, raising concerns over extended development costs and capital needs.

The FDA cited insufficient data to support approval, demanding additional efficacy and safety evidence, including long-term outcomes. This has forced Reviva to allocate $60 million for the new trial, RECOVER-2, against a backdrop of a $57 million market capitalization. The company’s cash runway remains uncertain, with prior capital raises—such as a $9 million offering in September—linked to sharp stock declines. A pending reverse stock split, allowing a 1-for-2 to 1-for-20 adjustment by year-end, has further fueled investor anxiety over liquidity risks.

Market sentiment has turned sharply bearish, compounded by H.C. Wainwright’s recent price target cut from $11.00 to $4.00. Retail traders on platforms like Stocktwits have amplified pessimism, with high message volumes reflecting doubts over Reviva’s ability to fund trials without dilution. The stock’s collapse to $0.30 intraday underscores the sector’s sensitivity to regulatory delays, particularly for companies reliant on a single pipeline asset. With brilaroxazine’s commercialization now years away, Reviva’s survival hinges on securing financing while navigating a stringent regulatory landscape.