Omeros Corporation (NASDAQ:OMER) has announced that its kidney disorder treatment, OMS721 has been given breakthrough designation by the Food and Drug Administration (FDA).
Omeros announced the news yesterday. The drug has been in development for treating immunoglobulin A (IgA) nephropathy. It is the company’s leading monoclonal antibody that targets serine protease-2 (MASP-2) that is associated with mannan-binding lectin. The FDA granted the breakthrough designation based on the data that the company reported from its Phase II trials. The clinical trials evaluated how patients with IgA nephropathy and other kidney diseases responded to OMS721.
The trial results for OMS721 were impressive
Omeros reported that the data from the OMS721 drug trials was impressive. According to the data, there was a significant improvement in proteinuria for patients in just 12 weeks of treatment. The company further added that there was a 73% mean reduction in 24-hour urine protein levels (p = 0.013) and a 77% mean reduction in urine albumin-to-creatinine ratios (p = 0.026).
The positive findings marked a milestone for the company and the FDA’s breakthrough designation offers a positive outlook for the future. The designation offers various advantages such as the company’s review application for the drug being prioritized. The FDA is expected to provide guidance to the firm in order to determine the best route towards approval. Once OMS721 is approved, then the company can go ahead and commercialize it.
Omeros is optimistic about the future of the OMS721 treatment especially because of the positive findings from the Phase II clinical trials. The FDA’s breakthrough destination for the drug has also led to positive sentiments from investors. The company’s stock rallied 2.5% after the announcement. The company has also surpassed the Zacks estimates with the stock gaining 73.3% over the past year compared to the 12.4% gain in the industry. If the OMS721 drug is approved, it will offer a significant boost to the company’s growth prospects.
Omeros stock closed the latest trading session on Wednesday at $21.97 after a 12.21% gain.