AEZS Inches Closer To D-Day, EYEG Catches Investors' Eyes, MCRB On Watch

(RTTNews) - Aeterna Zentaris Inc. (AEZS) has completed its pivotal phase III trial of Zoptrex in women with advanced, recurrent or metastatic endometrial cancer.

The trial, dubbed ZoptEC, has enrolled over 500 patients, and top-line results are expected in April 2017.

AEZS closed Monday's trading at $2.60, up 1.96%.

Shares of DURECT Corp. (DRRX) were down over 9% on Monday after it reported that there was one report of serious adverse event in a high dose cohort of its phase 1b trial of DUR-928 in nonalcoholic steatohepatitis patients.

The serious adverse event of shortness of breath resolved without intervention and is said to be possibly treatment related due to its temporal association with dosing.

DRRX closed Monday's trading at $1.07, down 9.32%.

Shares of EyeGate Pharmaceuticals Inc. (EYEG) rose more than 9% on Monday, following positive topline results from the first-in-human pilot trial of its EyeGate Ocular Bandage Gel in corneal epithelial defects.

The trial assessed the safety and performance of EyeGate Ocular Bandage Gel on its own or combined with a Bandage Contact Lens (BCL) compared to the current standard of care, artificial tears and BCL. The primary endpoint of the study was complete wound closure by Day 3.

According to the trial results, 75% of the subjects treated with EyeGate Ocular Bandage Gel alone achieved complete wound closure by Day 3, compared to 53.8% of patients that received the standard of care.

EYEG closed Monday's trading at $1.79, up 9.82%.

Exelixis Inc. (EXEL) and Takeda Pharmaceutical Co. Ltd. have entered into an exclusive licensing agreement to commercialize and develop novel cancer therapy Cabozantinib in Japan.

Cabozantinib is marketed in the United States and European Union as CABOMETYX tablets for advanced renal cell carcinoma.

Under the terms of the agreement, Exelixis will receive a $50 million upfront payment, and is entitled to receive $95 million in future regulatory and commercial milestones as well as royalties on sales from Takeda.

EXEL closed Monday's trading at $18.28, down 1.56%.

FibroGen Inc.'s (FGEN) two phase III trials of Roxadustat as a treatment of anemia - one in dialysis-dependent chronic kidney disease and the other in non-dialysis-dependent CKD patients - have met the primary endpoints.

The trials, conducted in China, were designed to support new drug application submission in China.

FibroGen and AstraZeneca (AZN) are collaborating for the development and commercialization of Roxadustat in China, the U.S., and other markets.

FGEN closed Monday's trading at $21.80, down 6.44%.

Gemphire Therapeutics Inc. (GEMP) has reported encouraging interim results of 2 patients from its phase 2b trial of Gemcabene in homozygous familial hypercholesterolemia.

In the trial, dubbed COBALT-1, Gemcabene 600 mg lowered mean LDL-cholesterol by 28% and Gemcabene 300 lowered mean LDL-cholesterol by 23%. Both subjects were on a background of high intensity statin therapy.

The top-line results from the COBALT-1 study are expected in June 2017.

GEMP closed Monday's trading at $10.36, down 2.62%.

Mylan NV (MYL) has won the U.S. District Court ruling related to Teva Pharmaceuticals Industries Ltd.'s (TEVA) Copaxone 40 mg/Ml patents.

Copaxone is indicated for relapsing remitting multiple sclerosis. The Court has invalidated all 4 patents relating to Copaxone 40 mg/mL based on obviousness.

Being one of the first companies to have filed a substantially complete abbreviated new drug application for generic Copaxone 40 mg/mL, Mylan expects to be eligible for 180 days of marketing exclusivity in the U.S. upon final FDA approval.

A generic version of Copaxone 20 mg/ mL, developed by Sandoz and Momenta Pharmaceuticals (MNTA), was approved by the FDA in April 2015.

MYL closed Monday's trading at $36.34, down 0.87%. In after-hours, the stock was up 1.27% to $36.80.

Ocera Therapeutics Inc. (OCRX) plunged over 70% on Monday as its phase IIb study of Ornithine Phenylacetate (OCR-002) in hospitalized patients with Hepatic Encephalopathy, dubbed STOP-HE, did not meet the primary endpoint of demonstrating statistical significance in clinical benefit.

Although not statistically significant, OCR-002 demonstrated a 17-hour reduction over placebo for the primary endpoint, which was time to improvement in Hepatic Encephalopathy symptoms, the company said. In addition, OCR-002 demonstrated statistically significant reduction in ammonia levels.

OCRX closed Monday's trading at $0.60, down 70.73%.

Rigel Pharmaceuticals Inc. (RIGL) plans to submit a New drug Application for Fostamatinib in patients with chronic immune thrombocytopenic purpura in the first quarter of this year.

RIGL closed Monday's trading at $2.08, up 5.05%.

Seres Therapeutics Inc. (MCRB) is slated to host a conference call and live audio webcast on Tuesday, January 31, 2017 at 8:00 a.m. ET to discuss the results of its in-depth analyses of the previously reported SER-109 Phase 2 clinical study in patients with multiply recurrent C. difficile infection.

The company reported interim 8-week results from the phase II clinical study last July. The company had then said that the study, dubbed ECOSPOR, did not achieve the primary endpoint of reducing the relative risk of C. difficile infection recurrence at up to 8-weeks.

MCRB closed Monday's trading at $9.41, down 5.14%. In after-hours, the stock was up 5.95% to $9.97.