VSTM's Blues Continue, CLCD Well Armed, Titan Makes Big Leap, NYMX On Watch

(RTTNews) - AcelRx Pharmaceuticals Inc. (ACRX), which had a telephonic meeting with the Division of Anesthesia, Analgesia, and Addiction Products of the FDA in early September 2015, has been asked to provide clinical data to complement other data the company has developed to assess the overall performance of its investigational drug-device combination Zalviso.

Zalviso for the treatment of moderate-to-severe acute pain in adult patients in the hospital setting was issued a complete response letter by the FDA last July.

The company is planning to submit a protocol to the Division for a clinical study in post-operative patients designed to evaluate the effectiveness of changes made to enhance product performance. AcelRx expects to be ready to initiate the study in the first quarter of 2016, and likely will await comments on the protocol from the Division.

ACRX closed Thursday's trading at $3.47, down 5.45%.

Aduro Biotech Inc. (ADRO) received a milestone payment from Janssen Biotech Inc. for submission of an Investigational New Drug Application to the FDA for ADU-214, a LADD immunotherapy in development for the treatment of non-small cell lung cancer.

Janssen - Aduro's license partner for ADU-214 - expects to initiate a multi-center phase 1 trial by the end of 2015.

The company's most advanced program is a combination of CRS-207 and GVAX Pancreas for patients with metastatic pancreatic cancer, which is currently under evaluation in ECLIPSE, a phase 2b clinical trial. Top line results from this study are expected in the first half of 2016.

Aduro went public as recently as April 15, 2015, offering its shares at a price of $17 each. The stock closed Thursday's trading at $21.74, up 2.40%.

CoLucid Pharmaceuticals Inc. (CLCD) has initiated a phase III, open label clinical trial of its lead product candidate, Lasmiditan, for the acute treatment of migraine headaches in adults.

The trial, dubbed GLADIATOR, is expected to enroll up to a total of 2,580 subjects, who will be randomized to receive 100 mg or 200 mg of Lasmiditan, and treated for up to eight migraine attacks per month for one year.

The company initiated the first of two phase III pivotal clinical trials of Lasmiditan, dubbed SAMURAI, in April of this year. The second phase 3 pivotal trial is scheduled to commence in the first half of 2016.

CoLucid went public on May 6, 2015, offering its shares at a price of $10 each. The stock closed Thursday's trading at $4.23, down 4.08%.

Nu Skin Enterprises Inc. (NUS) has introduced two new products under its flagship anti-aging brand, ageLOC.

The two products are ageLOC Me, a unique anti-aging skin care system that provides a personalized daily regimen based on individual preferences and skin care needs, and ageLOC Youth, the company's most advanced anti-aging supplement, which helps revitalize the body's aging defense mechanisms to promote healthy aging.

The products will be launched in a staggered manner in the remainder of this year and throughout 2016.

Nu Skin shares touched a new 52-week low of $34.03 on October 7, 2015 after the company forecast its third quarter revenue to fall short of analysts' expectation on weak Chinese economy. The stock closed Thursday's trading at $35.48, up 2.48%.

There's a good reason to keep an eye on Nymox Pharmaceutical Corp. (NYMX) as it is expected to report results from a phase II study of NX-1207 for low grade localized prostate cancer this quarter.

The trial, which was initiated in 2012, has enrolled 146 men, and all the participants have neared completion of the study's 18 month post-treatment assessments.

NYMX closed Thursday's trading at $3.67, up 7%.

Tenax Therapeutics Inc. (TENX) hit the milestone of enrolling the 200th patient in its ongoing phase 3 LEVO-CTS trial on October 1, 2015.

The LEVO-CTS trial is a double-blind, randomized, placebo-controlled study that is evaluating the use of its investigational drug levosimendan administered before and during cardiac surgery to reduce the incidence of low cardiac output syndrome and associated morbidity and mortality.

As of October 8, 2015, 206 patients have been enrolled out of the estimated 760 patients, according to the company.

A phase II study to determine whether or not levosimendan reduces the incidence and severity of acute organ dysfunction in adult patients who have septic shock, dubbed LeoPARDS trial, has enrolled 445 patients out of an estimated 516.

Formerly known as Oxygen Biotherapeutics Inc., trading under the ticker OXBT, the company changed its name to Tenax Therapeutics Inc. and ticker to TENX on September 19, 2014.

TENX closed Thursday's trading at $3.42, up 2.40%.

Titan Pharmaceuticals Inc. (TTNP.OB) has received approval to list its common stock on the NASDAQ Capital Market effective at the opening of trading on Monday, Oct.12, 2015. The company's stock will trade under the symbol TTNP.

The company's resubmitted NDA for Probuphine, a six-month subdermal implant containing buprenorphine hydrochloride for the long-term maintenance treatment of opioid addiction, is under FDA review, with a decision expected on February 27, 2016.

TTNPD closed Thursday's trading at $4.01, up 5.53%.

Verastem Inc. (VSTM) is reducing its workforce by approximately 50% to 20 full time employees.

The company projects annual savings of about $4.9 million in cash operating expenses on a going forward basis, with estimated one-time severance and related costs of roughly $825,000 over the fourth quarter of 2015 and the first quarter of 2016.

Verastem suffered a blow on September 28, 2015, with the stock losing 67% of its value, after the company announced that it had stopped enrollment in its phase II study evaluating its lead drug candidate VS-6063 for patients with mesothelioma, dubbed COMMAND, as there was not a sufficient level of efficacy to warrant continuation of the study.

VSTM closed Thursday's trading at $1.98, down 6.60%. In after hours, the stock fell another 4.04% to $1.90%.