SELLAS Life Sciences Group Inc (NASDAQ: SLS) is having a strong start to the trading session this morning, and for good reason. The company announced an update with regard to the late-stage clinical development of one of its lead candidates. Of course, the news excited investors, sending the stock on a run for the top. Today, we’ll talk about:
- The news;
- what we’re seeing from SLS as a result; and
- what we’ll be watching for ahead.
SLS Announces FDA News
As mentioned above, SELLAS Life Sciences Group is having a strong start to the trading session this morning after announcing FDA news. In a press release, the company provided an update on its late-stage clinical development program surrounding galinpepimut-S (GPS). The treatment is being assessed as a possible option for patients with acute myeloid leukemia (AML).
In the release, SLS said that following a clinical and regulatory strategy defining Type C meeting with the FDA, it plans on Moving forward, The company will proceed with a clinical study design and biostatistical plan to support a Phase 3 registration study for maintenance therapy for AML patients. The therapy is specifically targeted for patients who have achieved a complete remission after second line antileukemic therapy, or CR2.
The hope is that the study will provide strong data, supporting the submission of a Biologics License Application (BLA) with the FDA. Of course, the BLA cannot be submitted unless the results of the study are both statistically significant and reflective of an effect of sufficient magnitude to be clinically meaningful.
In a statement, Dr. Angelos M. Stergiou, MD, ScD h.c., President and CEO at SLS, had the following to offer:
Following discussion with the FDA, we are embarking upon a revised Phase 3 study for GPS in the monotherapy maintenance setting for AML patients who have achieved CR2. The new design is expected to streamline sample size, time to accrual completion, primary endpoint readout and potential time to market, as well as costs. We believe this new study design provides SELLAS with a quicker path to approval, provided the study is positive… In addition to a statistical analysis plan which we believe accords a viable pathway for meeting the primary endpoint, we have built in an adaptive design, thus further enhancing the probability of a positive study.
What We’re Seeing From The Stock
One of the first lessons that we learn when we start to work in the market is that the news leads to moves. In the case of SLS, the news proved to be positive. After all, the Type C meeting with the FDA outlined the path toward regulatory approval for its GPS product. So, it’s not surprising that investors are excited and sending the stock upward. As is normally the case, our partners at Trade Ideas were the first to alert us to the gains. Currently (10:28), SLS is trading at $1.66 per share after a gain of $0.04 per share or 2.46% thus far today.
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What We’ll Be Watching For Ahead
Moving forward, the iWatch Markets team will continue to keep a close eye on SLS. In particular, we’re interested in following the story surrounding the company’s continued work to bring its GPS product to market as it enters into the Phase 3 registration trial. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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