Reviva Pharmaceuticals (RVPH) PT Lowered to $4 at H.C. Wainwright

H.C. Wainwright analyst Raghuram Selvaraju lowered the price target on Reviva Pharmaceuticals (NASDAQ: RVPH) to $4.00 (from $11.00) while maintaining a Buy rating.

The analyst commented: 'We remind investors that Reviva management previously indicated an intent to conduct a meeting with FDA reviewers to discuss brilaroxazine’s path to approval in the coming weeks (i.e., this quarter). If the agency is amenable to potential submission of the brilaroxazine dossier without a requirement to conduct a confirmatory Phase 3 trial, potential New Drug Application (NDA) submission for brilaroxazine in schizophrenia could occur in 2Q26. In our view, the written feedback from the FDA could represent a meaningful near-term catalyst; in addition, NDA submission and acceptance for review would also constitute a significant risk-mitigation event and potentially position Reviva for brilaroxazine approval in treatment of schizophrenia for the U.S. market in 1H27. Plans are being assessed to initiate a potential registrational Phase 3 RECOVER-2 trial evaluating brilaroxazine for the treatment of schizophrenia pending FDA recommendation for a path to approval. We note that the established precedent for novel atypical antipsychotic drugs involves submission of data from two pivotal, well-controlled, randomized, double-blinded studies—accordingly, we maintain the view that the confirmatory pivotal trial of brilaroxazine would be needed. Thus, we currently expect brilaroxazine regulatory submission in late 2027, with potential approval and launch in late 2028. This is what we would consider the base case scenario. We remind investors that we previously assessed Reviva's brilaroxazine and its clinical efficacy profile in detail, which has thus far been demonstrated in schizophrenia with positive Phase 3 data from the RECOVER trial (released in late 2023). From our vantage point, brilaroxazine is a more potent drug in schizophrenia than lumateperone. Reiterate Buy rating while reducing PT to $4 from $11 because of dilutive financings."

You May Also Be Interested In

• Workday (WDAY) PT Raised to $220 at Oppenheimer
• Palo Alto Networks (PANW) PT Raised to $400 at Benchmark
• BofA Securities Upgrades Suzano S.A. (SUZ) to Buy