Opexa’s Phase 2b study on multiple sclerosis fails- Nano-cap stock Opexa Therapeutics $OPXA was hammered on Friday amid heavy trading volume after the company said that its Phase 2b clinical trial, Abili-T, evaluating Tcelna (imilecleucel-T) in patients with secondary progressive multiple sclerosis failed to meet the primary endpoint of a reduction in brain volume change (atrophy). The study also failed to meet the secondary endpoint of reduction in the rate of sustained disease progression. However, Tcelna was safe and well-tolerated. The company intends to continue with data analysis and will consider cash preservation scenarios.
Regeneron’s Sarilumab marketing application rejected- The FDA on Friday rejected the marketing application of Regeneron’s $REGN Sarilumab, citing manufacturing issues at Sanofi’s manufacturing site. The agency issued a Complete Response Letter (CRL) to both Regeneron and Sanofi $SNY after REGN disclosed the issues. Sarilumab is meant for the treatment of rheumatoid arthritis. Following the announcement, trading of $RGN shares were briefly halted. Meanwhile, Sanofi has responded to the FDA about the shortcomings and is cooperating with the agency to quickly resolve the issues. Once this is done, a new action date will be announced. The two companies say they remain committed to the development of the drug.
Novo’s cut on long-term profit growth puts slight pressure on Merck- As the insulin leader Novo Nordisk $NVO presented its Q3 results which saw a cut on long-term growth projections from 10% to 5% mainly due to pricing pressure in the U.S, shares of Merck’s $MRK also slipped 4% on Friday . Merck's Januvia/Janumet accounted for about 15% of its Q3 sales.
Amgen Plunges as it rules-out price hikes boosting operating income-Amgen $AMGN sunk amid 2x increase in trading volume in response to its statement that it does not foresee any benefit from price increases in top-seller Enbrel next year with regard to ongoing negotiations with pharmacy benefit managers. The treatment’s price hikes resulted in more than 80% growth in operating income for the past six quarters.
FDA accepts Biogen’s NDA for nusinersen- The FDA accepted under its Priority Review Biogen’s New Drug Application (NDA) for nusinersen meant for the treatment of spinal muscular atrophy (SMA). The treatment also got its Marketing Authorization Application approved in Europe under Accelerated Assessment status. Both statuses will shorten the review clock. SMA is an inherited syndrome characterized by the loss of motor neurons in the spinal cord and lower brain stem, resulting into severe and progressive muscular atrophy and weakness.
EpiPen’s Overpricing Issue: Price hikes added millions to DOD spending- Mylan’s $MYL overpricing on EpiPens added millions to DOD spending since 2008 as the agency covered more prescriptions for the lifesaving allergy shot at almost retail prices, according to Reuters’ report, which cited government data. However, that might change. Both the Pentagon and Mylan told Reuters that discussions are going on, which could extend a military discount to EpiPens filled at retail pharmacies through the use of rebates.