FDA Action Date for Lexicon Pharmaceuticals’ Telotristat Etiprate NDA Extended- Lexicon Pharmaceuticals (LXRX) announced that the FDA requires more time to review its New Drug Application (NDA) for telotristat etiprate for the treatment of carcinoid syndrome. Its action date has been extended 90 days to February 28, 2017 from November 30, 2016. Per the agency's request, the company submitted additional analyses of the clinical data which will require additional time to review.
Epizyme Earns Milestone Payment from GlaxoSmithKline- Epizyme (EPZM) announced that it has earned a $6 million milestone payment from GlaxoSmithKline (GSK). The milestone payment was triggered after the British drug maker initiated a Phase 1 clinical trial evaluating cancer therapy candidate GSK3326595 (formerly EPZ015938). According to the two companies collaboration and license agreement, GSK has exclusive global rights to methyltransferase inhibitors directed to three targets. GSK3326595 is the first one to enter the clinic.
Rigel Pharmaceuticals Announces Workforce Reduction- Rigel Pharmaceuticals (RIGL) announced that it is eliminating 38% of its workforce as it looks to build a commercial organization to support the potential launch of lead product candidate fostamatinib. The job cuts will mostly impact the company’s research department. Rigel expects annual savings of between $17 million and $20 million from the workforce reduction. The company expects to take a charge of $5.7 million due to the restructuring in its third quarter.
Merck and Pfizer’s Diabetes Candidate Succeeds in Late-Stage Study- Merck & Co. (MRK) and Pfizer (PFE) announced positive results from a Phase 3 clinical trial, VERTIS SITA2, evaluating ertugliflozin in patients with type 2 diabetes on a background of sitagliptin and stable metformin. The data were presented today at the 52nd Annual Meeting of the European Association for the Study of Diabetes in Munich, Germany. The study met its primary endpoint of a statistically valid reduction in HbA1c at Week 26 compared to placebo. Secondary endpoints met included the proportion of patients achieving HbA1c levels less than 7.0%, placebo-adjusted mean reduction in body weight, placebo-adjusted mean reductions in fasting plasma glucose and placebo-adjusted mean reductions in systolic blood pressure.
Full Results from GlaxoSmithKline’s Late-Stage Study of Shingles Vaccine Candidate Published in NEJM- GlaxoSmithKline (GSK) announced that the full results of its Phase 3 study, ZOE-70, evaluating its shingles vaccine candidate Shingrix have been published in the New England Journal of Medicine (NEJM). Headline results were initially reported in October 2015. The study showed that the two-dose regimen of Shingrix had 90% efficacy versus placebo in participants over 70 years old. Vaccine efficacy was maintained across the age groups in the trial: 90% in ages 70 - 79 and 89% in ages 80 and above.
Cara Therapeutics Commences Mid-Stage Study of Lead Product Candidate- Cara Therapeutics (CARA) announced that patient enrollment in a Phase 2b study evaluating an oral tablet formulation of lead product candidate CR845 for the treatment of pain related to osteoarthritis. Top-line data should be available in H1 2017. The primary endpoint is the change from baseline in the weekly average of the daily pain intensity score as measured by a scale called NRS. Positive top-line results from a Phase 2a study were reported in late 2015.
Calithera Biosciences Initiates Early Stage Study of CB-1158- Calithera Biosciences (CALA) announced that patient dosing has begun in a Phase 1 study of arginase inhibitor CB-1158, in development for the treatment of advanced solid tumors. Results will be reported next year. The company signed an exclusive license agreement with Mars Corp's Symbioscience Division in December 2014 to develop its portfolio of arginase inhibitors for human use.
KemPharm Updates Development Timelines- KemPharm (KMPH) has extended its views for regulatory submissions for its product candidates, KP415 and KP201/IR in 2018 and an extended-release formulation of KP511 in 2019. The development timelines have been extended after an FDA Advisory Committee thumbs down on abuse-deterrent labeling for Apadaz (benzhydrocodone hydrochloride and acetaminophen). The company says it will submit a Formal Dispute Resolution Request with the agency after receiving a Complete Response Letter (CRL) related to abuse-deterrent labeling for Apadaz. The process may take up to a year to complete.
Novavax Tumbles on Disappointing Results from Vaccine Trials- Novavax (NVAX) shares tumbled in after-hours trading on Thursday, loising more than 80% of its value, after the company reported disappointing data from two vaccine trials. Topline data from the Resolve Phase 3 trial didn't meet the efficacy objectives (primary or secondary) the company had set. Data from the Phase 2 rollover trial suggested improved vaccine efficacy from a second year of dosing.