Shares of Ocera Therapeutics $OCRX vaulted in aftermarket hours on Wednesday after it announced completion of the enrollment target for its lead candidate OCR-002 meant to cure patients with acute liver failure. The Phase 2 clinical trial, STOP-ALF is overseen by an NIH-sponsored network of liver transplant sites called the Acute Liver Failure Study Group. Ocera is supporting and supplying product. So far during clinical trials, no serious treatment-related safety issues surfaced at any dose level. Top-line results have been submitted for presentation at The Liver Meeting in Boston, November 11 - 15.

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
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.

The European Medicines Agency (EMA) approved access for bluebird bio’s $BLUE LentiGlobin BB305 gene therapy, meant to cure transfusion-dependent beta thalassemia, an inherited blood disorder—to Priority Medicines (PRIME) Scheme. The candidate is being studied in Phase 3. According to, the expected completion date of the 15-subject clinical trial is January 2020.

The FDA on Wednesday approved Janssen Pharmaceuticals’ $JNJ type 2 diabetes treatment, INVOKAMET XR (canagliflozin/metformin hydrochloride extended release). An adult could improve his blood glucose levels by taking this once-a-daily dose, supported by diet control and exercise.

No patents to report.

Epizyme Inc. $EPZM announced on Wednesday that its decision to collaborate with Foundation Medicine Inc for tazemetostat Phase 2 trial. The collaboration agreement includes identifying subjects for the trial and enrollment. Initial clinical study showed that tazemetostat has encouraging clinical efficacy and favorable safety profile in enrolments with relapsed, refractory NHL.  It plans to start the Phase 2 trial later this year.

Eleven Biotherapeutics (NASDAQ: EBIO) entered in an agreement with Canadian firm Viventia Bio to buy the Winnipeg-based company in an all-stock deal. Eleven would issue 4,103,431 shares onfnewly issued EBIO common stock. The drug-maker said that selling shareholders would be eligible to get unspecified amount of cash payments in milestones, should Viventia’s lead candidate Vicinium, a recombinant fusion protein in Phase 3 development for the treatment non-muscle invasive bladder cancer-- shows successful clinical trial. The top-line data from the late-stage clinical trial is anticipated in H1 2018. In a Phase 2 study, patients treated with Vicinium showed a 40% complete response rate after three months of treatment with no drug-related serious adverse events observed. The merged entity would continue its operations as Eleven Biotherapeutics and trade under the same ticker on NASDAQ.

Bayer $BAYRY and Evotec signed a five-year multi-target research collaboration agreement to develop clinical candidates intended to treat kidney disease. Both drug-makers would share novel drug targets and technology platforms to jointly research and develop potential treatments. According to terms of the agreement, Bayer would get exclusive access to selected candidates along with Evotec’s CureNephron target pipeline. Bayer would have rights to clinical trials, development and commercialization. During the contract period, Evotec would receive at least euro 14 million, which includes unspecified license fee and research payments, milestones payments up to euro 300 million along with low double-digit royalties on net sales.

No secondary offerings to report.

Shares of Novan (NOVN) catapulted 42% from the issue price of $11 on the first day. However, the turnover was only about 170k shares.

No earnings to report.

No insider buys to report.

No insider sells to report.

Insys Therapeutics $INSY President & CEO, Dr. John Kapoor announced that he would leave the company to purse some other interests. He would however serve the board until a replacement is found. Meanwhile, the search for his successor got commenced. The stock performed badly since last year. Shares fell as low as $11.45 on June 27, about 75% drop from July 2015 before gaining some of the lost ground. But last month, the company reported positive results from a Phase 3 trial of pain candidate Buprenorphine Sublingual Spray. It is considering meeting with the FDA by year end to clarify the requirements for a New Drug Application (NDA).

Dr.Edward Kaye got appointed as Sarepta President & permanent Chief Executive with an immediate effect by the board on Wednesday. He had served on an interim basis since March 2015. Dr Kaye would continue to serve as Chief Medical Officer as well. The employment contract showed that he would draw an annual salary of $550K with an annual bonus target of 65% of his base salary ($357.5K)