Brilaroxazine is a new chemical entity targeting serotonin and dopamine receptors implicated in various conditions, including schizophrenia. The company plans to submit a New Drug Application (NDA) to the FDA based on the long-term safety data from at least 100 patients who have completed one year of treatment. Despite current losses with a negative EPS of $1.09, InvestingPro's Financial Health assessment rates the company as 'FAIR' with a score of 2.16, suggesting potential for future growth. Despite current losses with a negative EPS of $1.09, InvestingPro's Financial Health assessment rates the company as 'FAIR' with a score of 2.16, suggesting potential for future growth.
The open-label extension (OLE) of the Phase 3 RECOVER trial assessed the long-term safety and tolerability of brilaroxazine, which is administered once daily. The results indicated that the drug was generally well-tolerated, with a low rate of side effects and a 35% discontinuation rate over the course of the year. With analyst price targets ranging from $14 to $17, significantly above the current trading price, InvestingPro subscribers can access detailed financial analysis and 12 additional exclusive tips about RVPH's potential.
In the OLE study, 435 patients with stable schizophrenia were enrolled across three dosage groups. Preliminary efficacy results for 113 patients who completed one year of treatment showed significant decreases in the Positive and Negative Syndrome Scale (PANSS) scores, which measure the severity of schizophrenia symptoms. The total PANSS scores decreased by 18.6 points on average, with positive symptoms reducing by 5.2 points and negative symptoms by 4.5 points.
The safety profile of brilaroxazine was favorable, with no drug-related serious adverse events reported. The most common treatment-related adverse events were weight increase, insomnia, and somnolence, which affected no more than 3.2% of participants. Additionally, no clinically meaningful changes in movement disorder scales were observed.
The full data set from the OLE, which will include additional safety and efficacy data along with vocal and blood biomarker data, is expected in the first quarter of 2025.
Brilaroxazine is a new chemical entity targeting serotonin and dopamine receptors implicated in various conditions, including schizophrenia. The company plans to submit a New Drug Application (NDA) to the FDA based on the long-term safety data from at least 100 patients who have completed one year of treatment.
Reviva aims to further develop brilaroxazine for other neuropsychiatric indications and has also received Orphan Drug Designation by the U.S. FDA for the treatment of pulmonary arterial hypertension (PAH) and idiopathic pulmonary fibrosis (IPF).
This news is based on a press release statement from Reviva Pharmaceuticals Holdings, Inc.
In other recent news, Reviva Pharmaceuticals has made significant strides in its ongoing study for brilaroxazine, a treatment for schizophrenia. The company has reported that 108 patients have completed a full year of treatment in the open-label extension (OLE) trial, with over 250 patients reaching the six-month mark. This data is key to the company's planned New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA).
Reviva has also made progress in its Phase 3 RECOVER trial for brilaroxazine, with positive results indicating significant reductions in symptom domains. Furthermore, the company has been granted U.S. and European patents for brilaroxazine, strengthening its intellectual property rights.
In terms of analyst coverage, EF Hutton has initiated a Buy rating on Reviva with a price target of $15.00, primarily driven by the potential of brilaroxazine. H.C. Wainwright also maintains a Buy rating on the company, with an adjusted 12-month price target of $14.
Reviva has completed an equity offering, resulting in the sale of approximately 1.9 million shares of common stock. The company is preparing to file an NDA in the first quarter of 2026 and plans to develop brilaroxazine for other neuropsychiatric indications. These are among the recent developments at Reviva Pharmaceuticals.
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