Omeros Corporation (OMER) stock prices closed the trading day on October 16th 2021 at USD$7.73. Subsequent premarket fluctuations have seen the stock plummet by 18.24%, bringing it down to USD$6.32.
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FDA’s Complete Response Letter
October 18th 2021 saw OMER stock announce the reception of a Complete Response Letter (CRL) from the United States Food and Drug Administration. The CRL was in regard to the company’s Biologics License Application for narsoplimab, which is used to treat hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA). Patients are generally administered complex clinical courses following the HSCT and the ensuring severe illness. HSCT-TMA further exacerbates this complexity, while also worsening outcomes. The CRL saw the FDA express challenges in estimating the treatment effect of narsoplimab in HSCT-TMA. Further information was deemed necessary to support regulatory approval. Notably, there were no chemistry, manufacturing and controls (CMC), safety, or non-clinical issues precluding approval raised in the CRL.
Development of Narsoplimab
The company is confident in the efficacy and safety data for narsoplimab in HSCT-TMA. OMER stock continues to work closely with the U.S. Food and Drug Administration on the clinical development plan. This includes both the single-arm trial to support approval, as well as the definition of response as the primary endpoint. The company expects to request a Type A meeting with the FDA as soon as possible to discuss the CRL and determine the most efficient path forward for the commercial approval of narsoplimab.
About OMER Stock
OMER stock is a commercial stage biopharmaceutical company that is committed to the discovery, development, and commercialization of small molecule and protein therapeutics. These therapies are for both large market and orphan indications that target inflammation, immunologic diseases and central nervous system disorders. The company’s proprietary commercial product OMIDRIA 1%/0.3% is continuing to show increased market share being gained in cataract surgery. The company’s lead MASP-2 inhibitor narsiplimab is designed to target the lectin pathway of complement, with FDA approval being sought as a treatment for HSCT-TMA.
Future Outlook for OMER Stock
The company is keen to push for the accelerated development and commercialization of its proprietary narsoplimab treatment. OMER stock is poised to capitalize on the massive scope of opportunities afforded it from the hopeful approval of narsoplimab by the U.S FDA. Current and potential investors are confident that management will be able to effectively leverage the resources at their disposal. This is hoped to facilitate significant and sustained increases in shareholder value over the long term.