It was a week that saw Edge Therapeutics crashing on news of discontinuation of its phase III study, Amgen’s Blincyto getting FDA’s nod for label expansion, EMA accepting Regeneron & Sanofi’s application for label expansion of Dupixent.
Recap of the Past Week’s Most Important Stories
Edge Therapeutics Plummets on Failure of Late-Stage Study: Edge Therapeutics, Inc. lost almost 92% after the company announced disappointing results from a phase III study, NEWTON 2 on lead pipeline candidate, EG-1962 for the treatment of adults with aneurysmal subarachnoid hemorrhage (aSAH). NEWTON 2 study compared the efficacy and safety of EG-1962 (nimodipine microparticles) to standard of care oral nimodipine in adult patients with aSAH. A pre-specified interim analysis performed on data from the day 90 visit of the first 210 subjects randomized and treated in the study demonstrated a low probability of achieving a statistically-significant difference compared to the standard of care in the study’s primary endpoint if the study is fully enrolled. The independent Data Monitoring Committee (“DMC”) recommended that the study be stopped based on its conclusion that it has a low probability of meeting its primary endpoint. Consequently, Edge Therapeutics has decided to discontinue the NEWTON 2 study. Moreover, the company will reduce the size of its workforce, in order to preserve cash resources, which were $88.1 million as of Dec 31, 2017 due to the failure of the late-stage study. It was the company’s lead candidate and the failure of the study puts a question on its prospects. (Read more: Edge Therapeutics Loses Edge on Failure of Late-Stage Study)
Alkermes Plunges on FDA’s Refusal to File Letter for ALKS 5461: Shares of Alkermes plc (ALKS - Free Report) plunged significantly after the company received a Refusal to File letter from the FDA regarding its New Drug Application (“NDA”) for anti-depressant ALKS 5461. ALKS 5461 was being evaluated for the adjunctive treatment of major depressive disorder (“MDD”) in patients with an inadequate response to standard antidepressant therapies. The FDA notified the company that the agency was not able to complete a substantive review due to lack of sufficient evidence of overall efficacy of the candidate for the proposed indication. The FDA has also asked the company to conduct additional well-controlled clinical trials to be able to resubmit the NDA. Moreover, the FDA has also requested the company to conduct a bioavailability study to generate additional bridging data between ALKS 5461 and the reference listed drug, buprenorphine. However, Alkermes plans to appeal the FDA's decision, requesting a Type A meeting with the FDA, to determine the next course of action and additional information required for the resubmission of the NDA (Read more: Alkermes Sinks as FDA Refuses Depression Drug Review)
Amgen Gets Approval for Label Expansion of Drugs: The FDA approved a label expansion of Amgen Inc. ’s (AMGN - Free Report) leukemia drug Blincyto for the treatment of adults and children with B-cell precursor acute lymphoblastic leukemia in first or second complete remission with minimal residual disease (“MRD”) greater than or equal to 0.1% under accelerated approval basis. The acclereated approval was based on MRD response rate and hematological relapse-free survival. In addition, the European Commission approved a label expansion of Xvega to include the prevention of skeletal-related events in adults with advanced malignancies involving bone. Xgeva is already approved for the prevention of skeletal-related events in patients with bone metastases from solid tumors. With the latest approval, the European label of Xgeva will be expanded to include patients with multiple myeloma. (Read more: Amgen's Xgeva Gets EU Approval for Expanded Label,Amgen's Blincyto Gets FDA Nod for Minimum Residual Disease)
EMA Accepts Dupixent label expansion and cemiplimab for Review: Regeneron Pharmaceuticals, Inc. (REGN - Free Report) and partner Sanofi (SNY - Free Report) announced that the European Medicines Agency (“EMA”) has accepted the companies’ application for an additional indication for Dupixent. Both companies are seeking the agency’s approval for Dupixent use as an add-on maintenance treatment in certain adults and adolescents (12 years of age or older) with inadequately controlled moderate-to-severe asthma. Dupixent is already approved in the United States and the European Union for the treatment of adults with moderate-to-severe atopic dermatitis. The EMA has also accepted the Marketing Authorization Application for cemiplimab for the treatment of patients with metastatic cutaneous squamous cell carcinoma (“CSCC”) or patients with locally advanced CSCC who are not eligible for surgery. (Read more: EMA Accepts Regeneron/Sanofi's application for Dupixent, Sanofi's Skin Cancer Candidate Filing Accepted in EU)
Regeneron currently sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
The NASDAQ Biotechnology Index lost 2.89% over the last four trading sessions. Among major biotech stocks, Alexion lost 2.83%%. Over the last six months, Celgene lost 40.56% while Vertex gained 3.84% (see the last biotech stock roundup here: Biotech Stock Roundup: PTGX Down, VRNA Up, AMGN's Repatha Gets Positive Opinion).
What's Next in the Biotech World?
Stay tuned for more regulatory and pipeline updates.
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