Mylan Announces Launch of First Generic EpiPen- Mylan (MYL) announced the launch of first generic to its allergy auto-injector at a discount of more than 50% to the branded product's list price. Mylan expects to release the $300 two-pack carton in several weeks, pending completion of labeling revisions.
CTI BioPharma Announces Data From Late-Stage Study of Lead Product Candidate- CTI BioPharma (CTIC) announced top-line data from a Phase 3 clinical trial, PERSIST-2, evaluating lead product candidate pacritinib against physician-specified best available therapy (BAT), including Novartis' (NYSE:NVS) Jakavi (ruxolitinib), in patients with advanced myelofibrosis showed statistically valid results in one of two co-primary endpoints. The results were generated from 221 patients who reached the primary analysis time point of Week 24 at the time the clinical hold was imposed by the FDA. Preliminary results showed a statistically significant response rate as measured by minimum spleen volume reduction (SVR) of 35% compared to BAT, including Jakavi (p<0.01). The other primary endpoint, at least a 50% reduction in Total Symptom Score (TSS) was not met (p=0.0791). The FDA suspended the company's clinical development of pacritinib in February because of an abnormal number of deaths from intracranial hemorrhage, cardiac failure and cardiac arrest. The company has withdrawn its New Drug Application (NDA) for the drug.
Amgen Reports Positive Data from Late-Stage Study of Prolia- Amgen (AMGN) announced top-line data from a Phase 3 study assessing its Prolia (denosumab) compared to risedronate n patients with glucocorticoid-induced osteoporosis met all primary and secondary endpoints at Month 12. Patients receiving Prolia experienced greater gains in bone mineral density at the lumbar spine and total hip versus those treated with risedronate (4.4% vs. 2.3% at the lumbar spine and 2.1% vs. 0.6% at the total hip). The results also favored Prolia over risedronate in patients just starting glucocorticoid therapy (3.8% vs. 0.8% at the lumbar spine and 1.7% vs . 0.2% at the total hip).
Amgen also announced new clinical data presented at the European Society of Cardiology Congress in Rome reinforce Repatha's (evolocumab) efficacy in lowering low-density lipoprotein cholesterol (LDL-C) in patients across cardiovascular (CV) risk subgroups and in those with familial (inherited) hypercholesterolemia (FH).
Regeneron and Sanofi Announce Data from ODYSSEY ESCAPE- Regeneron Pharmaceuticals (REGN) and its partner, French drug maker Sanofi (SNY) announced that a Phase 3 clinical trial, ODYSSEY ESCAPE, evaluating their PCSK9 inhibitor Praluent (alirocumab) in patients with heterozygous familial hypercholesterolemia (HeFH) who require weekly/bi-weekly apheresis treatment, showed adding Praluent to existing therapy lowered LDL cholesterol (LDL-C) by ~50% from baseline versus a 2% increase for placebo. In addition, treatment with Praluent reduced the need for apheresis treatment by 75% compared to placebo (p<0.0001), the primary endpoint. The results were presented at the European Society of Cardiology Congress in Rome.
Shkreli Sells Entire Stake in KaloBios- KaloBios Pharmaceuticals (KBIO) said in a statement that its former CEO Martin Shkreli has sold his entire stake in the company to other investors in private transactions. KBIO emerged from Chapter 11 Bankruptcy on June 30th.
Cerecor Commences Second Mid-Stage Study of CERC-501- Cerecor (CERC) announced that it has launched its second Phase 2 clinical trial evaluating CERC-501's ability to help smokers kick the habit. The study, funded in part by the National Institutes of Health, is exploring the premise that reducing stress can reduce the urge to smoke. The co-primary endpoints are the latency to the time of first cigarette smoking during the delay period and the number of cigarettes smoked during the self-administration period.
Kadmon Commences Mid-Stage Study of Tesevatinib- Kadmon Holdings (KDMN) announced that a Phase 2 clinical trial evaluating lead oncology candidate tesevatinib in patients with recurrent glioblastoma. The open-label study will enroll up to 40 subjects in the U.S. Tesevatinib is also under development for the treatment of polycystic kidney disease and EGFR-positive non-small cell lung cancer.
Inovio Commences Early-Phase Zika Vaccine Study- Inovio Pharmaceuticals (INO) announced that it has commenced a clinical study in Puerto Rico evaluating the safety, immune responses and signals of efficacy of GLS-5700, its Zika vaccine candidate. If successful, the company plans to meet with regulators next year to clarify a development path to registration.
Neurocrine Biosciences Submits NDA for Valbenazine- Neurocrine Biosciences (NBIX) announced that it has submitted a New Drug Application (NDA) o the FDA seeking approval of once-daily valbenazine for the treatment of tardive dyskinesia, a neurological disorder characterized by involuntary repetitive movements of the face. The FDA's formal notice of acceptance should happen in October.
Syros Pharma Soars on Update About New Drug Candidate- Syros Pharmaceuticals (SYRS) shares surged in after-hours trading on Monday after the company announced that its scientific founders Nathanael Gray and Richard Young have employed a novel chemistry approach to design the first selective inhibitor of difficult-to-drug enzymes cyclin-dependent kinase 12 (CDK12) and CDK13. The chemistry method is the same one that created SY-1365, a selective CDK7 inhibitor in development for the treatment of blood cancers and others. The scientists showed that selectively inhibiting CDK12 and CDK13 with a small molecule decreases the expression of DNA damage response genes and super-enhancer-associated transcription factors implicated in cancer, including leukemia, breast cancer and ovarian cancer. The research was published in a paper in the journal Nature Chemical Biology.