Key highlights of the week include Regeneron announcing positive data on Praluent, Sarepta seeking rapid approval of second DMD drug, while Orexigen filing for bankruptcy.
Recap of the Week’s Most Important Stories
Regeneron/Sanofi Announce Positive Data on Praluent, Cuts Price: Regeneron Pharmaceuticals (REGN - Free Report) and partner Sanofi (SNY - Free Report) announced positive results from the ODYSSEY OUTCOMES trial on Praluent during a late-breaker session at the American College of Cardiology's 67th Annual Scientific Session in Orlando, FL. The trial met the primary endpoint as results showed that Praluent significantly reduced the risk of major adverse cardiovascular events (“MACE”) in patients with a recent acute coronary syndrome (“ACS”) event such as a heart attack. In June 2017, Regeneron and Sanofi announced that two phase IIIb/IV ODYSSEY-DM trials in patients with diabetes met their primary endpoints. Though the uptake of the drug hasn’t been encouraging, the cholesterol management market holds huge commercial potential. Both companies also announced a reduction in net price for Praluent in alignment with a new value assessment for high-risk patients from the Institute for Clinical and Economic Review. Meanwhile, a phase III study evaluating Praluent in homozygous familial hypercholesterolemia was initiated in the fourth quarter of 2017. (Read more: Regeneron and Sanofi Announce Positive Data on Praluent)
Regeneron is a Zacks Rank #1 (Strong Buy) stock. You can see the complete list of today’s Zacks #1 Rank stocks here.
Sarepta to Seek Rapid Approval of Second DMD Drug: Sarepta Therapeutics’ (SRPT - Free Report) stock scaled a fresh 52-week high as the company announced accelerated approval of its second drug, golodirsen, to treat Duchenne Muscular Dystrophy (“DMD”), the most common type of muscular dystrophy. Sarepta had met with the FDA Division of Neurology Products in February 2018 to obtain guidance on the regulatory pathway for golodirsen. Sarepta will file a rolling new drug application (NDA) with the FDA, seeking accelerated approval of golodirsen for DMD in patients who have a confirmed mutation of the DMD gene susceptible to exon 53 skipping. Sarepta intends to complete a rolling NDA submission for golodirsen by year-end 2018. Sarepta’s only approved drug Exondys 51 is approved in the United States as a once-weekly intravenous infusion, specifically targeting patients who have a confirmed mutation of the DMD gene susceptible to exon 51 skipping. (Read more: Sarepta to Seek Rapid Approval for Second DMD Drug, Stock Up)
Orexigen to File for Bankruptcy: Orexigen Therapeutics announced that it has decided to file a voluntary petition under Chapter 11 of the Bankruptcy Code in the U.S. Bankruptcy Court for the District of Delaware. The company also plans to file a motion seeking authorization to pursue an auction and sale process under Section 363 of the U.S. Bankruptcy Code. The bidding process is expected to conclude by May 18. The news comes in the wake of an unimpressive performance of its weight-loss drug Contrave which is marketed as Mysimba in the European Union.
Orexigen has filed a series of motions with the court thereby seeking to ensure the continuation of normal operations during this tenure. (Read more: Orexigen Plummets on Filing of Chapter 11 of Bankruptcy Code)
Biogen to Buy Cognitive Impairment Asset From Pfizer: Biogen (BIIB - Free Report) announced that it will acquire a phase IIb ready AMPA receptor potentiator for cognitive impairment associated with schizophrenia from Pfizer (PFE - Free Report) for an upfront payment of $75 million along with milestone payments of up to $515 million as well as tiered royalties in the low to mid-teen percentages. The company is looking to diversify its portfolio beyond the core therapeutic area — multiple sclerosis — to neurodegenerative disorders. Biogen will initiate a phase IIb study on PF-04958242 to determine if the AMPA receptor potentiator is safe and effective for the treatment of cognitive dysfunction in schizophrenia patients in the second half of 2018. (Read more: Biogen to Buy Mid-Stage Neuropsychiatry Asset From Pfizer)
The NASDAQ Biotechnology Index lost 0.02% over the last five trading sessions. Among major biotech stocks, Vertex gained 2.81%. Over the last six months, Celgene lost 34.88% while Vertex gained 14.1% (see the last biotech stock roundup here: Biotech Stock Round Up: Regeneron Submits sBLA, Biogen to Withdraw Zinbryta).
What's Next in the Biotech World?
Stay tuned for more regulatory and pipeline updates from the ongoing Cowen Healthcare Conference.
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