AEZS Disappoints, EVOK Gets New Lease Of Life, GNMX Calls For Attention

(RTTNews) - Shares of Aeterna Zentaris Inc. (AEZS) plunged over 39% in extended trading on Wednesday on disappointing results from its phase III trial of Macrilen.

The trial failed to achieve its objective of validating a single oral dose of Macrilen for the evaluation of growth hormone deficiency in adults, using the insulin tolerance test (the "ITT") as a comparator.

The company will decide whether or not to continue with the development of Macrilen very soon.

AEZS closed Wednesday's trading at $3.65, up 4.29%. In after-hours, the stock fell 38.36% to $2.25.

Aevi Genomic Medicine Inc. (GNMX) has completed enrollment in its phase 2/3 efficacy study for AEVI-001 in adolescents with attention deficit hyperactivity disorder.

In the study, dubbed SAGA, patients have been randomized 1:1 to receive either a six-week course of AEVI-001 or placebo, with a one-week follow-up. Top-line results from the study are expected this quarter (Q1, 2017).

GNMX closed Wednesday's trading at $5.50, up 1.10%.

BioPharmX Corp. (BPMX) has completed enrollment in OPAL, a phase 2b dose finding clinical trial to assess the efficacy and safety of BPX-01 for the treatment of acne vulgaris, on time.

The 12-week trial has enrolled 225 individuals, aged 9 to 40, who have moderate-to-severe inflammatory, non-nodular acne vulgaris. The topline results from the study are expected in the first half of 2017.

BPMX closed Wednesday's trading at $0.400, up 4.63%.

Cidara Therapeutics Inc. (CDTX) has completed enrollment in its phase 2 randomized trial of two topical treatment regimens of the novel echinocandin antifungal, CD101, in women with moderate to severe acute vulvovaginal candidiasis.

The trial, dubbed RADIANT, has enrolled 125 patients. Top-line results from the study are expected this quarter (Q1, 2017).

CDTX closed Wednesday's trading at $10.75, up 5.91%.

Shares of Evoke Pharma Inc. (EVOK) rose as much as 69% on Wednesday, following promising additional data from its phase III trial of investigational agent Gimoti for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in adult women.

According to the data released on Wednesday, the patients responded statistically significantly better when treated with Gimoti than those treated with placebo at multiple time points. There were also clinically and statistically significant improvements in nausea and abdominal pain, which are two of the more severe and debilitating symptoms of gastroparesis, noted the company.

The topline results from the study were reported on July 18, 2016. The trial did not achieve its primary endpoint of symptom improvement at Week 4. The news sent the stock plunging 73% to $2.89 that day.

EVOK closed Wednesday's trading at $2.69, up 29.95%.

Bristol-Myers Squibb Co. (BMY) has exercised its option to extend the research term of its discovery collaboration agreement with Five Prime Therapeutics Inc. (FPRX) to discover novel immuno-oncology therapies that target 3 immune checkpoint pathways.

The research collaboration, originally focused on two undisclosed immune checkpoint pathways, was established in March 2014 and was supposed to end in March 2017. In January 2016, the companies added a third immune checkpoint pathway to the collaboration. Now, the research term has been extended to March 2018, and Bristol-Myers will provide additional research funding for the 12-month extension period.

Bristol-Myers has committed to paying up to $300 million in future milestones per target, among others.

FPRX closed Wednesday's trading at $51.05, up 5.04%.

Heron Therapeutics Inc.'s (HRTX) phase II study of its investigational agent HTX-011 in subjects undergoing abdominoplasty has met the endpoint.

According to the trial results, HTX-011 has demonstrated statistically significant reductions in both pain intensity and the use of opioid rescue medications following abdominoplasty (tummy tuck) through 96 hours post-surgery.

Last August, the company reported preliminary, positive, top-line efficacy results from two Phase 2 clinical studies of HTX-011 - one in post-operative pain in patients undergoing bunionectomy and the other in post-operative pain in patients undergoing inguinal hernia repair.

A conference call and webcast is scheduled for 8:30 a.m. ET on January 5, 2017.

HRTX closed Wednesday's trading at $13.80, up 2.99%. In after-hours, the stock was down 9.42% to $12.50.

Ironwood Pharmaceuticals Inc's (IRWD) New Drug Application for DUZALLO for the treatment of hyperuricemia in patients with uncontrolled gout has been accepted for review by the FDA.

The DUZALLO NDA was submitted by Ardea BioSciences, a wholly owned subsidiary of AstraZeneca plc (AZN) on behalf of Ironwood.

The FDA is scheduled to announce its decision on DUZALLO in the second half of 2017 and, if approved, the drug is expected to be commercially available in late 2017.

IRWD closed Wednesday's trading at $15.35, up 3.23%.