Reviva Pharmaceuticals Holdings, Inc. (RVPH) experienced a decrease of 6.38% in the premarket. However, the last trading session concluded at $1.88 with an increase of 8.67%.
Letter for Pivotal Phase 3 Clinical Trial – Latest Updates by RVPH
On 10th January 2022, RVPH announced that brilaroxazine has been approved by the US Food and Drug Administration (FDA). It is a critical milestone, that might contribute to the registration and approval of new medicine for use in schizophrenia patients. Furthermore, long-term safety studies will improve the essential trial’s favorable safety data. Finally, RVPH remains confident about the therapeutic potential of brilaroxazine and expects to begin Phase 3 analysis by the end of January 2022.
About Brilaroxazine
Reviva Pharmaceuticals is developing brilaroxazine, commonly known as oxaripiprazole, as an experimental antipsychotic for the treatment of schizophrenia and schizoaffective disorder. It is highly specific because of major serotonin and dopamine receptors linked to schizophrenia and related symptoms. In addition, it has undergone a comprehensive series of regulatory-compliant toxicity and safety pharmacology tests.
Third Quarter 2021 Financial Results by RVPH – What’s new?
RVPH stated third quarter 2021 financial results on 15th November 2021. The net loss came out to be $2.28 million. Moreover, the Company’s cash balance was $33.5 million, $0.35 million more than the previous quarter. Not only this but the company hired a clinical research firm. This was done to oversee the recruiting and trial services for its crucial Phase 3 studies.
In addition, the company is planning to launch a major Phase 3 study examining the efficacy and safety of brilaroxazine. Lastly. the regulatory applications for the start of Phase 2 studies in pulmonary arterial hypertension (PAH) and idiopathic pulmonary fibrosis (IPF) ought to be completed by the end of Q1 2022.
Now what?
RVPH plans to begin two Phase 3 studies to evaluate the brilaroxazine in people with schizophrenia, as well as long-term safety. The company might do it before the end of the year. Furthermore, depending on the therapeutic potential of brilaroxazine, the firm aims to file marketing applications with the FDA.
