Sellas Life Sciences Group Inc (NASDAQ: SLS) is having an overwhelmingly strong start to the trading session this morning, and for good reason. The company announed that it has been granted Fast Track Designation, leading to excitement among investors and sending the stock screaming for the top. Today, we’ll talk about:
- The Fast Track Designation granted by the FDA;
- what we’re seeing from SLS as a result; and
- what we’ll be watching for with regard to the stock ahead.
SLS Announces FDA News
As mentioned above, Sellas Life Sciences is having an incredibly strong start to the trading session this morning after announcing regulatory news. In a press release issued early this morning, the company announced that the United States Food and Drug Administration (FDA) has granted its lead asset, galinpepimut-S (GPS), Fast Track Designation. Currently, SLS is developing GPS as a treatment for multiple myelopma by targeting the Wilms Tumor 1 (WT1) protein. However, should this indication work out, it will be a sign of more to come as WT1 is present in a wide range of cancer types.
The Fast Track Designation provided to the treatment by the FDA is overwhelmingly positive news for SLS. The designation is only given to drugs intended to treat serious conditions and that have the potential to address unmet medical needs. As a result of the designation, SLS will have greater access to the FDA for guidance throughout development and the process to approval is a much faster one. In a statement, Angelos Stergiou, M.D., Sc.D. h.c., President and CEO at SLS, had the following to offer:
The designation of Fast Track for GPS represents important recognition by the FDA of the potential of this novel immunotherapeutic to address the significant unmet need in the treatment of patients with high-risk multiple myeloma in patients with poor-risk cytogenetics at diagnosis who still harbor minimal residual disease (MRD) after autologous stem cell transplant… We are fully committed to working closely with the FDA as we continue development of our potential first-in-class novel WT1-targeting cancer vaccine for select high-risk MM patients in the post-autotransplant maintenance setting after standard first-line treatment.
What We’re Seeing From The Stock
One of the first lessons that we learn when we start to dig into the market is that the news causes moves. In the case of Sellas Life Sciences, the news proved to be overwhelmingly positive. After all, Fast Track Designation will reduce the time it takes for the company to develop its GPS treatment and for the treatment to reach potential approval. So, it comes as no surprise to see that excited investors are sending the stock on a run for the top. Of course, our partners at Trade Ideas were the first to alert us to the gains. urrently (9:42), SLS is trading at $1.81 per share after a gain of $0.31 per share or 20.67% 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 SLS. In particualr, we’re interested in following the story surrounding the company’s continued work to further validate and bring GPS to market. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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