Kadmon Starts Mid-Stage Study for Graft-Versus-Host disease- Kadmon Holdings commenced its Phase 2 study on Wednesday as the first subject took the dose of lead candidate KD025 for treating chronic graft-versus-host-disease (cGVHD). The randomized 24-week trial would evaluate the efficacy of treatment which involves three dosing regimens (200 mg once/day; 200 mg twice/day and 400 mg once/day) of KD025 in 48 cGVHD patients in the U.S. The primary endpoint is the overall response (partial responders + complete responders) from baseline to Week 24. The projected final data collection date for the primary endpoint is August, 2018, according to ClinicalTrials.gov.
Sarepta Looking To Raise Capital- Sarepta $SRPT is considering raising capital by $225 million through a common stock sale, with an underwriter raising additional 15% of that amount. Investment Banks Goldman Sachs and JP Morgan are overseeing the offering.
Buyers Line-up for German Pharmaceutical Company Bayer’s Dermatology Business- Bayer’s $BAYRY plan to exit its dermatology business in order to fund its Monsanto deal, is generating considerable interest among probable buyers. Even though the discussion are in initial stages, apparently several parties have shown interest. Along with skincare-focused companies such as Allergan $AGN, Almirall and Nestle, Teva Pharmaceutical Industries $TEVA, Perrigo $PRGO and Sun Pharma are also apparently in the fray. On the institutional investor side, KKR $KKR, Nordic Capital, Bain Capital, Blackstone Group (NYSE:BX) and Cinven are also reportedly interested to buy the business which, analysts say, could fetch $1.1 billion.
Cerecor’s Enrollment for Phase 2 Study on Depressive Order is Complete- Cerecor $CERC said on Wednesday that it reached its enrollment target in a Phase 2 clinical Trial, Clin301-203, assessing CERC301 for the adjunctive treatment of major depressive disorder (MDD). The top-line data of the trial, which is a fast-track designated indication by the FDA, should be available in November. The double-blind, placebo-controlled study enrolled 115 patient suffering with MDD. These subjects experienced severe depressive incidences despite steady ongoing treatment with either a serotonin reuptake inhibitor or a serotonin norepinephrine reuptake inhibitor. The subjects have been randomized to take intermittent 12 mg or 20 mg oral doses of CERC-301 or placebo seven days apart followed by a 14-day observation period.
The Medicines Company Gets Government Funding of up to $132 Million- The Medicines Company $MDCO signed an agreement with the U.S. Department of Health and Human Services' Biomedical Advanced Research and Development Authority (BARDA) to provide funding for the development of new antibiotics to fight drug-resistant Gram-negative infections. According to the agreement, the authority would give $32 million in initial funding, followed by an additional $100 million over course of next five years, should all options to extend the collaboration are agreed upon by the financier.
Mylan Chief to Appear Before the House Committee on Oversight and Government Reform- Heather Bresch, CEO of Mylan $MYL testified on Wednesday before the House Committee on Oversight and Government Reform over the issue of EpiPen prices, which rose more than $600 for a two-pack from about $100 in less than 10 years. She appeared to the committee just a day after when West Virginia disclosed a probe into whether Mylan violated antitrust laws or deceive the state’s Medicad program.