JNP Will Bleed On Failed Trial, CERU Crashes, CYTK Progresses With VITALITY

(RTTNews) - Shares of Cerulean Pharma Inc. (CERU) were down over 60% in after-hours on Wednesday, as the company's phase II study of its lead candidate, CRLX101, in combination with Avastin in the treatment of patients with advanced renal cell carcinoma missed the trial goals.

The primary endpoint was progression free survival and secondary endpoints included overall response rate, duration of response and overall survival.

The study demonstrated no statistically significant difference in median PFS and objective response rate for the CRLX101 combination compared to Standard of Care.

CERU closed Wednesday's trading at $2.74, down 4.20%. In after hours, the stock was down 60.95% to $1.07.

Cytokinetics Inc. (CYTK) has completed patient enrollment in its international phase III clinical trial of Tirasemtiv in patients with amyotrophic lateral sclerosis.

The study, dubbed VITALITY-ALS, has enrolled more than 700 patients in 81 centers in 11 countries. It is designed to assess the effects of Tirasemtiv versus placebo on slow vital capacity and other measures of skeletal muscle strength in patients with ALS.

Results from VITALITY-ALS are expected in the second half of 2017.

CYTK closed Wednesday's trading at $11.87, down 0.59%.

Genmab A/S' (GMXAY.OB) licensing partner, Janssen Biotech Inc. has submitted a supplemental Biologics License Application to the FDA seeking second indication for DARZALEX in combination with standard of care regimens for patients with multiple myeloma who have received at least one prior therapy.

In November 2015, DARZALEX was granted accelerated approval as a monotherapy by the FDA for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy, including a PI and an immunomodulatory agent, or who are double-refractory to a PI and an immunomodulatory agent.

Janssen has also submitted a request for Priority Review of the supplemental Biologics License Application, or sBLA. Whether or not, Janssen's request has been accepted will be known within the next 60 days. If the FDA grants Priority Review, the review of the sBLA should be completed within six months.

GMXAY.OB closed Wednesday's trading at $84.75, down 0.41%.

Juniper Pharmaceuticals Inc.'s (JNP) phase 2b clinical trial of COL-1077, a 10% lidocaine bioadhesive vaginal gel, for the reduction of pain intensity in women undergoing an endometrial biopsy with tenaculum placement, has not achieved the primary and secondary endpoints.

The company has decided to discontinue the development of COL-1077.

JNP closed Wednesday's trading at $7.11, down 0.42%.