Omeros Corporation (NASDAQ: OMER) is heading up in the market this morning, and for good reason. The company announced a regulatory update, exciting investors and sending the stock on a run for the top. Today, we’ll talk about:
- The regulatory update;
- what we’re seeing from OMER stock as a result; and
- what we’ll be watching for ahead.
OMER Announces Regulatory Update
As mentioned above, Omeros Corporation is having an incredibly strong start to the trading session this morning after the company announced a regulatory update.
In a press release issued early this morning, the company said that it has streamlined the required work to further advance its preparations for its Biologics License Application for OMS721. The treatment is a potential option for patients with hematopoietic stem cell transplant-associated thrombotic microangiopathy.
OMER reminded investors that OMS721 currently holds FDA Breakthrough Therapy and Orphan Drug designations. The drug has also achieved these designations with the European Medicines Agency.
According to the release, Overall and 100-day survival ratings will become secondary endpoints. The primary endpoint will become the response-based analysis of the Phase 3 trial, eliminating the need for historical control.
The company will be moving forward with a rolling BLA submission for the treatment and it plans to submit its first nonclinical sections relatively soon.
In a statement, Gregory A. Demopulos, M.D., Chairman and CEO at OMER, had the following to offer:
We appreciate FDA’s collaborative approach to the development of OMS721 for patients with stem cell transplant-associated TMA. We now have an even clearer and more streamlined path to submitting our BLA, saving time and crucial resources as we advance toward regulatory review and approval. There’s no FDA-approved treatment for stem cell transplant-associated TMA, and severe cases progress rapidly with a very high mortality rate. We have seen in our ongoing clinical trial the life-saving effects of OMS721 in these patients, a good number of whom had not only TMA but also other components – such as graft-versus-host disease and diffuse alveolar hemorrhage – of broader endothelial-injury syndrome. We remain committed to working closely with FDA and European regulators to make OMS721 available as quickly as possible to patients who need it.
What We’re Seeing From The Stock
As investors, one of the most important lessons that we learn is that the news can lead to big moves. In the case of Omeros Corporation, the news that was released today proved to be great. Think about it, the rolling BLA process is about to start with the FDA and will likely commence with the EMA. As a result, the company is incredibly close to potential accelerated approval and full approval in two of the world’s largest economic regions. So, it’s not surprising to see that excited investors are sending the stock on a run for the top. As is normally the case, our partners at Trade Ideas were the first to alert us to the gains. Currently (10:27), OMER is trading at $14.00 per share after a gain of $0.91 per share or 6.95% 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 the continued regulatory efforts surrounding OMS721 as the treatment inches its way toward regulatory approval. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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