ALNY's ENDEAVOUR Goes In Vain, ALQA Gains Big In After-Hrs, SCYX On The Move

(RTTNews) - Shares of Alnylam Pharmaceuticals Inc. (ALNY) plunged more than 41% in extended trading on Wednesday on news of the company's decision to discontinue its phase III study of Revusiran for the treatment of hereditary ATTR amyloidosis with cardiomyopathy.

The decision to suspend the phase III trial, dubbed ENDEAVOUR, was based on the recommendation of the Data Monitoring Committee, which found that the benefit-risk profile for Revusiran no longer supported continued dosing.

ALNY closed Wednesday's trading at $70.30, up 2.52%. In after-hours, the stock was down 41.62% to $41.04.

Shares of Alliqua Biomedical Inc. (ALQA) climbed more than 19% in extended trading on Wednesday, following encouraging revenue growth in the third quarter of fiscal year 2016.

Releasing the preliminary third quarter revenue results, the company said it expects Q3 revenue to be $4.85 million compared to $4.19 million last year, representing growth of approximately 16% year-over-year.

The full financial and operating results are expected to be released on November 4th.

In other news, Alliqua is all set to acquire privately-held Soluble Systems LLC. As part of the deal, Soluble will receive consideration with a total value of approximately $35 million, plus warrants to purchase 4 million shares of New Alliqua common stock at an exercise price of $1.07.

ALQA closed Wednesday's trading at $0.84, down 1.18%. In after-hours, the stock was up 19.05% to $1.00.

Capricor Therapeutics Inc. (CAPR) has completed patient enrollment in its phase II trial of CAP-1002 in adults with cardiac dysfunction, following a large heart attack.

In the trial, dubbed ALLSTAR, one hundred forty-two subjects were randomized to the active or control treatment groups in a 2:1 ratio, respectively, of whom 134 received a single infusion of either CAP-1002 or placebo into the infarct-associated coronary artery.

The company expects to report top-line 12-month primary efficacy outcome results in the fourth quarter of 2017.

CAPR closed Wednesday's trading at $3.45, up 9.18%.

The Medicines Co.'s (MDCO) phase II trial of single or multiple subcutaneous injections of PCSK9si in patients with atherosclerotic cardiovascular disease, dubbed ORION-1, has exceeded its enrollment target of 480 patients ahead of schedule, enrolling a total of 501 patients.

The company noted that an interim analysis of Day 90 follow-up for all 501 patients and top-line data from Day 180 follow-up for up to 200 patients will be conducted and presented on November 15, 2016.

The top-line data for all 501 patients in the ORION-1 trial will be disclosed before the end of 2016.

MDCO closed Wednesday's trading at $38.51, up 0.84%. In after-hours, the stock fell 10.41% to $34.50.

Shares of SCYNEXIS Inc. (SCYX) rose over 20% in extended trading on Wednesday, following encouraging complete results of its two recently completed phase II studies of Oral SCY-078 in patients with Candida infections.

One is a phase II proof-of-concept study of Oral SCY-078 in patients with acute vulvovaginal candidiasis, the top line results of which were announced in June of this year. The second is a phase II study evaluating the pharmacokinetics, safety, and tolerability of SCY-078, as an oral step-down treatment in patients with invasive candidiasis, and its interim results were reported in August of 2016.

The company added that the study results confirm the overall antifungal activity of Oral SCY-078 in patients with Candida infections. SCY-078 has also been found to be well tolerated with evidence of efficacy and lower relapse rates compared to standard of care (oral fluconazole) in patients with vulvovaginal candidiasis.

In other news, SCYNEXIS announced that it has raised additional capital by closing a $15 million term loan with Solar Capital Ltd. (SLRC). Including the term loan, the company's cash on hand as of September 30, 2016, is estimated to be $58.4 million.

SCYX closed Wednesday's trading at $4.80, up 6.90%. In after-hours, the stock gained another 20.83% to $5.80.

Shares of Tenax Therapeutics Inc. (TENX) dropped over 12% on Wednesday, following failure of a phase IIb study of Levosimendan in septic shock, dubbed LeoPARDS, to meet the trial goals.

The trial did not achieve the primary endpoint of reducing the incidence and severity of acute organ dysfunction in adult patients who have septic shock, as well as the pre-specified secondary endpoints.

A phase III trial of Levosimendan in low cardiac output syndrome, known as LEVO-CTS, has so far enrolled 833 patients. The trial is expected to enroll 880 patients, with top-line data readout expected near end of this year.

TENX closed Wednesday's trading at $2.11, down 11.72%.