Omeros Corporation (NASDAQ: OMER) is having a pretty strong start to the trading session in the pre-market hours this morning, and for good reason. The company announced FDA news that seems to be a source of excitement among investors. Today, we’ll talk about the news, what we’re seeing from the stock, and what we’ll be watching for with regard to OMER ahead.
OMER Gains On FDA News
As mentioned above, Omeros Corporation is having a strong start to the trading session this morning after announcing that it has reached an agreement with the United States Food and Drug Administration. The agreement surrounded the company’s Phase 3 clinical trial, which is designed to evaluate OMS721 in patients with IgA nephropathy (IgAN). The company said that enrollment in the study is expected to begin early next month.
In the press release, OMER said that the Phase 3 trial is a randomized, double-blind, placebo-controlled trial in patients that are at least 18 years of age. The patients included will have biopsy-confirmed IgAN and 24-hour urine protein excretion greater than 1 g/day at baseline.
OMER said that patients will initially receive 12 weekly intravenous doses of the drug and additional weekly dosing can be administered for partial responders as well as relapsers. The primary endpoint of the treatment is a reduction in proteinuria at 24 weeks after the start of dosing. Of course, Omeros Corporation has been informed by the FDA that this primary endpoint could suffice for approval. In a statement, Gregory A. Demopulos, M.D., Chairman and CEO at OMER, had the following to offer:
“We’re pleased to have received agreement from FDA for our OMS721 Phase 3 protocol in IgA nephropathy… Final preparations to begin the trial can now be completed and enrollment is expected to open in early February. To our OMS721 Phase 3 programs in IgA nephropathy and aHUS, we have recently added a third Phase 3 program in stem cell transplant-associated TMA. We look forward to ongoing discussions with both the FDA and EMA regarding the HCT-TMA Phase 3 trial as well as breakthrough and PRIME designations. In the meantime, enrollment in the Phase HCT-TMA trial has progressed with patients expected to have a very high mortality rate doing well on OMS721.”
How The Market Reacted To The News
As investors, one of the first things that we learn is that the news moves the market. With such positive news surrounding Omeros Corporation, it’s no surprise that we’re seeing gains in the value of the stock this morning. At the moment (8:29), OMER is trading at $21.00 per share after a gain of $0.84 per share (4.19%) thus far today.
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What We’ll Be Watching For Ahead
Moving forward, the CNA Finance team will continue to keep a close eye on OMER. In particular, we’re interested in following not only the Phase 3 trial that is the center of the news today, but the rest of the clinical development the company is doing across the board. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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