Biotech Stock Roundup: REGN Gets FDA Nod For Dupixent & Other Pipeline News
Zacks Investment Research | Mar 12, 2019 10:46PM ET
The past week was busy for the biotech sector with several pipeline updates as the reporting cycle ended. Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) won the FDA approval for the label expansion of its leading asthma drug Dupixent while Celgene (NASDAQ:CELG) made a notable progress with its MS (multiple sclerosis) candidate.
Meanwhile, AMAG Pharmaceuticals (NASDAQ:AMAG) suffered a setback with Makena.
Recap of the Week’s Top Stories:
Regeneron/Sanofi Get FDA Nod for Label Expansion: Regeneron and partner Sanofi (NASDAQ:SNY) pipeline candidate ozanimod . The company is seeking an approval for ozanimod, an oral, sphingosine 1-phosphate (S1P) receptor modulator, for the treatment of adults with relapsing-remitting multiple sclerosis (RRMS). The application was based on results from the SUNBEAM and RADIANCE part B phase III, multicenter, randomized, double-blind, double-dummy, active-controlled studies. Celgene intends to submit a New Drug Application (NDA) to the FDA for the relapsing forms of MS (RMS) by the end of this month.
Celgene also announced updates on Abraxane. The FDA gave a nod to the immuno-oncology drug Tecentriq in combination with Abraxane for treating adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC), whose tumors express PD-L1, determined by an FDA-approved test. According to the company, this is the second FDA approval of a PD-1/PD-L1 antibody combined with Abraxane. However, the phase III Apact study, evaluating Abraxane in combination with gemcitabine following surgical resection (adjuvant treatment) in patients with pancreatic cancer did not achieve the primary endpoint of improvement in disease-free survival as confirmed by independent radiological review in comparison to gemcitabine alone.
Celgene currently sports a Zacks Rank #1 (Strong Buy). You can see two phase III studies evaluating its next-generation CFTR corrector, VX-445 in combination with tezacaftor and Kalydeco (ivacaftor) attained the primary endpoint of significant improvement in lung function in patients suffering from cystic fibrosis (CF). While one study is evaluating the triple combination regimen in patients with one F508del mutation and one minimal function mutation, the other study is evaluating patients with two F508del mutations.
In the study evaluating patients with one F508del mutation and one minimal function mutation, the interim data showed that the triple combination regimen led to a mean absolute improvement in ppFEV1 of 13.8 percentage points from baseline through week four of treatment as compared to placebo. The second study yielded a mean absolute improvement in ppFEV1 of 10.0 percentage points from baseline at week four when VX-445 was added in patients already receiving tezacaftor and ivacaftor compared with placebo plus tezacaftor and ivacaftor. Vertex believes that safety and efficacy profile observed in the study supports a potential NDA submission.
Zafgen Tanks on Discontinuation of Candidate: Shares of Zafgen (NASDAQ:ZFGN) plummeted following the company’s decision to suspend plans to file an investigational new drug (IND) application for ZGN-1258. The candidate was being evaluated for rare metabolic disorders including Prader-Willi syndrome (PWS). This decision was based on a recent, unexpected finding in muscle tissue from four- and six-month long-term rodent toxicology studies. Nonclinical data showed degeneration and other anomalies in rat muscle tissue to different degrees in both vehicle and dose arms of the studies.
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Biotech Stock Roundup: BIIB to Acquire Nightstar, Other Pipeline News & More )
What's Next in Biotech?
Stay tuned for regular pipeline updates.
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