Alkermes Plc (NASDAQ: ALKS) was down slightly in after-hours after seeing strong gains yesterday. However, those declines have diminished over the past few minutes as the company released positive clinical data, exciting investors. Today, we’ll talk about
- The data;
- what we’re seeing from ALKS as a result; and
- what we’ll be watching for ahead.
ALKS Reports Positive Clinical Data
As mentioned above, Alkermes has made up for after-hours losses and seems to be headed for the green after announcing positive clinical data. In a press release issued early this morning, the company announced positive topline results from its ENLIGHTEN-2 trial. The trial is a pivotal Phase 3 study of ALKS 3831.
ALKS 3831 is an investigational treatment that is being developed by the company as an option for patients with schizophrenia. In the release, the company reminded investors that ENLIGHTEN-2 is the second of two phase 3 studies in the ALKS 3831 registration program. The study was designed to confirm the drug’s favorable weight profile compared to olanzapine.
During the study, 561 patients were evaluated over the course of six months. Through the study, the company met its co-primary endpoints of demonstrating a lower mean percentage weight gain from baseline and a lower proportion of patients who gained 10% or more from baseline when compared to the olanzapine group.
Considering the successful completion of the clinical trial, the company said that it plans on submitting a New Drug Application for the treatment to the FDA in mid-2019. In a statement, Criag Hopkinson, MD, CMO and SVP of Medicines Development and Medical Affairs at ALKS, had the following to offer:
These unequivocal results from ENLIGHTEN-2 provide evidence of a clinically meaningful, differentiated weight profile for ALKS 3831 compared to olanzapine. Importantly, ALKS 3831 favorably shifted the weight gain distribution curve compared to olanzapine, both in terms of mean weight gain and patients experiencing extreme weight gain… These findings build on the positive safety and efficacy profile seen throughout the ENLIGHTEN development program, and underscore the potential of ALKS 3831 to provide an important benefit for people living with schizophrenia. With these data now in hand, we will meet with the FDA and plan to submit a New Drug Application in mid-2019.
The above statement was followed up by Christoph Correll, M.D., Professor of Psychiatry and Molecular Medicine at Hofstra Northwell School of Medicine. Here’s what he had to offer:
Significant unmet patient need remains in schizophrenia despite the number of treatment options available. A new agent that offers the robust efficacy of olanzapine but with a favorable weight profile that stabilizes within weeks of treatment initiation would be an important and differentiated addition to the treatment armamentarium for schizophrenia… People living with schizophrenia deserve treatment options that do not sacrifice tolerability for efficacy. A new therapeutic option with the profile demonstrated by ALKS 3831 in this study would be clinically meaningful for patients and their healthcare providers.
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 Alkermes, the news proved to be overwhelmingly positive. After all, the strong data will likely support the submission of an NDA with the FDA, bringing the company one step closer to commercialization of the treatment. As a result, it’s not surprising to see that excited invetors are sending the stock upward. Although it is not in the green yet, the stock has recovered, making up all of the losses that we saw in after-hours and seems to be headed for the green shortly. As is normally the case, our partners at Trade Ideas were the first to alert us to the gains. Currently (7:34), ALKS is trading at $36.88 per share, the same price at which it closed yesterday.
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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 ALKS. In particular, we’re interested in following the story surrounding the company’s continued work to bring ALKS 3831 to market following the release of today’s overwhelmingly positive data. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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