Then, the market decided to sell off for six months and put small-cap healthcare tickers under pressure, which pushed OMER into the oversold territory and de-risked the investment. So, OMER remained a "Bio Boom" candidate for my Seeking Alpha Marketplace Service, Compounding Healthcare. Meanwhile, I was waiting for an opportunity to establish a speculative position in OMER for a profitable trade, but the negative headlines prevented me from pulling the trigger. As a result, OMER's share price plummeted from around $20 per share to $2 per share in roughly 16 months. The FDA set narsoplimab’s PDUFA for October of 2021, but the FDA delayed the PDUFA… and ultimately issued a CRL. Omeros (OMER) had a rough go over the last two years after the FDA accepted the company’s BLA filing for narsoplimab for HSCT-TMA back in January of last year. I discuss my plans for my "house money" OMER position. Now I have to determine how I am going to manage my OMER position. OMER rocketed through my sell targets leaving me with a “house money” position. I took advantage of the oversold and undervalued opportunity. The market sell-off put OMER under additional selling pressure and moved the ticker into the oversold territory. OMER plummeted from around $20 per share to $2. Omeros has had it rough over the last two years after the FDA delayed narsoplimab’s PDUFA and eventually sent a CRL. Omeros: Managing An Investment After A Winning Trade The first drug candidate submitted to FDA for approval in HSCT-TMA, narsoplimab has Breakthrough Therapy and Orphan-Drug designations in this disorder as well as in IgA nephropathy. There is no approved treatment for HSCT-TMA. According to FDA’s interim response, the deciding official is collecting additional information, and a response to Omeros’ appeal will be provided within 30 days from the date that the additional information is collected and any required follow-up is conducted by the deciding official. Per FDA guidelines for formal dispute resolution, a final decision from OND was to be rendered within 30 calendar days of the meeting unless the deciding official in OND required additional information. As part of FDA’s standard procedures for dispute resolution, Omeros and OND met last month to discuss the appeal. Formal dispute resolution is an official pathway that enables a sponsor to appeal a decision by an FDA division to a higher authority within the Agency, in this case the Office of New Drugs (OND). Omeros Corporation announced that the United States Food and Drug Administration (FDA) provided an interim response to the company’s formal dispute resolution request submitted to the Agency in June, appealing the earlier decision by the FDA review division to issue a complete response letter for the biologics license application (BLA) for narsoplimab in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA). Omeros Corporation Receives Interim Response from FDA on Formal Dispute Resolution Request for Narsoplimab However, the trial did not indicate that narsoplimab dropped the time to recovery. The addition of narsoplimab cut the mortality risk (hazard ratio =0.81, with probability equal to 0.77) and its experimental therapy was linked to the biggest drop in mortality risk among all drugs tested in the trial so far, OMER said. All patients had received standard of care including dexamethasone and remdesivir. The investigators of I-SPY randomized 91 to the narsoplimab arm and 116 to the control arm. The I-SPY COVID Trial, sponsored by Quantum Leap Healthcare Collaborative was designed to measure the time to recovery the risk of mortality in critically ill COVID patients as primary endpoints. The shares of commercial-stage biopharma, Omeros Corporation (NASDAQ:OMER) fell ~11% in the morning hours Thursday after the company reported data from a clinical trial involving critically ill COVID-19 patients who received its experimental therapy narsoplimab in addition to standard of care. Omeros falls 11% after reporting clinical data for COVID-19 therapy
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