Acceleron Pharma Inc (NASDAQ: XLRN) and Celgene Corporation (NASDAQ: CELG) are both having a pretty strong start to the trading session this morning, and for good reason. The companies jointly announced positive clinical data from a Phase III trial. Of course, the news excited investors, leading to gains. Today, we’ll talk about:
- The clinical results;
- what we’re seeing from XLRN and CELG; and
- what we’ll be watching for ahead.
XLRN And CELG Announce Clinical Results
As mentioned above, Acceleron Pharma and Celgene Corporation are both having an incredibly strong start to the trading session this morning after announcing results from a collaborative clinical trial the companies are working on together. In a press release issued early this morning, the companies announced results from a Phase III, randomized, double-blind, multi-center clinical study known as MEDALIST.
In the release, XLRN and CELG announced that Luspatercept achieved a highly statistically significant improvement of red blood cell transfusion independence of at least 8 consecutive weeks during the first 24 weeks compared to placebo. This proved to be the primary endpoint on the MEDALIST study. During the study, the companies evaluated both the efficacy and safety of luspatercept compared to placebo in patients with IPSS-R very low, low or intemediate risk myelodysplastic syndromes with crhonic anemia and refractory to, intolerant of, or ineligible for treatment with an erythropoietin-stimulating agent.
In the release, the companies said that the treatment also met its key secondary endpoint. This endpoint was the demonstratation of statistically significant improvement in RBC transfusion independence of at least 12 consecutive weeks during the first 24 weeks. Modified heatologic improvement-erythroid, a meaningful secondary endpoint was also achieved. In a statement Jay Backstrom, M.D. CMO at CELG, had the following to offer:
This result from the phase III MEDALIST trial demonstrates the potential clinical benefit of luspatercept as an erythroid maturation agent for the treatment of chronic anemia in patients with low-to-intermediate risk MDS… Based on these results, we look forward to preparing the dossier for global regulatory submissions and also investigating the clinical potential of luspatercept in ESA-naïve, low-to-intermediate risk MDS patients through the initiation of our phase III COMMANDS study.
The above statement was followed up by Habib Dable, President and CEO at XLRN, had the following to offer:
We are truly encouraged by the top-line results of MEDALIST and the potential to benefit the tens of thousands of patients suffering from low-to-intermediate risk MDS worldwide. We would like to thank the patients and investigators involved in the trial… With other ongoing research in beta-thalassemia and myelofibrosis, we remain committed to exploring the potential of luspatercept to address a range of anemia-related diseases.
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 Acceleron Pharma and Celgene, the news that was released proved to be overwhelmingly positive. After all, strong clinical data in Phase 3 means that approval may be on the way shortly. So, it’s no surprise that excited investors are sending the stocks screaming for the top. Of course, our partners at Trade Ideas were the first to alert us to the gains. Currently (9:14), XLRN is trading at $40.95 per share after a gain of $6.97 per share or 20.51% thus far today. At the same time, CELG is trading at $78.45 per share after a gain of $1.79 per share or 2.33% thus far today.
Stop wasting your time! Start finding winning trades in minutes with Trade Ideas!
What We’ll Be Watching For Ahead
Moving forward, the CNA Finance team will continue to keep a close eye on both XLRN and CELG. In particular, we’re interested in following the story surrounding luspatercept as the treatment is showing overwhelmingly promising results. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
Never Miss The News Again
Do you want real-time, actionable news delivered to your inbox? Join the CNA Finance mailing list below!