AMPE Severely Hurt, INGN Put On Notice, NYMX On The Rise, SGEN Gets FDA Date

(RTTNews) - Shares of Ampio Pharmaceuticals Inc. (AMPE) cratered on Monday as a multi-center study, dubbed STRIDE, evaluating intra-articular injections of Ampion in patients with severe osteoarthritis of the knee did not reach its primary endpoint against the saline control.

The company said that the SPRING and STRUT studies could be used as "two well conducted trials" necessary for the Biologics License Application filing.

The company announced results from 20 weeks extension of the SPRING study last April. According to the study results, the percentage of patients in the moderate-to-severe subgroup who reported a reduction in pain was significantly higher for patients who received Ampion (50%) compared to those who received vehicle control (25%). A single injection of Ampion was associated with sustained improvements in knee pain over 20 weeks, according to the company.

The results of the STRUT study, which was conducted to assure that multiple injections of Ampion were safe and effective, were announced in February of this year. According to the trial results, the primary endpoint that is required for FDA approval, WOMAC A pain score, improved by 64% from baseline to 20 weeks. There were no drug related serious adverse events reported during the 20 weeks of this trial.

AMPE plunged 65.82% on Monday to close at $2.69.

Bionomics Ltd. (BNOEF.OB) has initiated a phase II clinical study of its drug candidate BNC210 for the treatment of anxiety and depression. The study is expected to be completed by Q2 2016 with results due in Q3 2016.

Medical technology company Inogen Inc. (INGN) has been notified that it is not in compliance with NASDAQ Listing Rule due to a delay in filing its Annual Report on Form 10-K for its fiscal year ended December 31, 2014.

The NASDAQ notice has no immediate effect on the listing or trading of Inogen's common stock on the NASDAQ Global Select Market. Under NASDAQ's listing rules, Inogen has 60 calendar days from the date of the letter to submit a plan to regain compliance.

INGN closed Monday's trading at $36.46, down 0.77%.

Merrimack Pharmaceuticals Inc.'s (MACK) phase I study of MM-302 in HER2-positive metastatic breast cancer has demonstrated that the group of patients treated with 30 mg/m2 or more of MM-302 alone, in combination with Herceptin or with Herceptin and Cyclophosphamide, had a median progression free survival of 7.6 months and an overall response rate of 11%.

The company is enrolling patients in a phase II trial evaluating MM-302, in combination with Herceptin in patients with HER2-positive locally advanced or metastatic breast cancer, dubbed HERMIONE, to support application for accelerated approval in the U.S. and conditional marketing authorization in the E.U. The HERMIONE study is for HER2-positive, metastatic breast cancer patients who are anthracycline-naive and have not been previously treated with pertuzumab and T-DM1-containing regimens.

MACK closed Monday's trading at $12.71, down 2.87%.

Shares of Nymox Pharmaceutical Corp. (NYMX) surged more than 63% on Monday after new results from a phase II study of NX-1207 in prostate cancer demonstrated statistically significant better outcomes at up to 2.8 years for NX-1207 treated patients compared to controls.

A controlled comparison was conducted of patients who required and received radiation and surgery treatments for their prostate cancer. According to the study results, after up to 2.8 years for NX-1207 single-injection treated patients there was a 68.2% reduction compared to controls.

NX-1207 has had an excellent safety profile, according to Nymox. One of the major problems with current prostate treatments for localized prostate cancer (radical prostatectomy, external beam radiation, or brachytherapy) is the relatively high incidence of reported sexual dysfunction post-treatment. In 9 studies, NX-1207 treatment has been shown to have no significant adverse effect post-treatment on sexual function or testosterone levels, noted the company.

NX-1207 has the potential to offer men with the most common form of low-grade prostate cancer a significant tangible benefit in terms of avoidance of radiation and/or surgery and the related risks, discomforts, and permanent side effects, said Paul Averback, CEO of Nymox.

NYMX closed Monday's trading 63.64% higher at $1.62. In after-hours, the stock was up another 7.41% at $1.74.

Seeking to best position the company to achieve its growth objectives, MusclePharm Corp. (MSLP.OB) has announced several corporate governance initiatives.

The corporate governance changes announced include increasing the number of directors on the MusclePharm Board to seven, with five independent directors. The company's Board also intends to separate the role of Chairman and CEO, which is expected to be completed by the end of 2015.

Last week, the company reached an agreement in principle to resolve an investigation by the Securities and Exchange Commission.

MSLP.OB closed Monday's trading at $4.59, up 10.87%.

Syneron Medical Ltd.'s (ELOS) PicoWay picosecond laser has received FDA clearance for yet another indication - this time, for the treatment of pigmented lesions.

The PicoWay picosecond laser previously received FDA clearance for the removal of tattoos in November 2014 and was launched in the U.S. late in the fourth quarter 2014.

The Health Canada has also cleared PicoWay picosecond laser for the treatment of pigmented lesions and tattoo removal. The launch of PicoWay in Canada will begin during the second quarter 2015, said the company.

ELOS closed Monday's trading at $12.28, up 2.08%. In after hours, the stock was up another 11.16% at $13.65.

Seattle Genetics Inc.'s (SGEN) supplemental Biologics License Application for ADCETRIS as consolidation therapy in Hodgkin lymphoma patients at risk of relapse following an autologous stem cell transplant has been accepted by the FDA, and granted Priority Review.

The regulatory agency's decision on the ADCETRIS sBLA is scheduled for August 18, 2015.

Seattle Genetics and Takeda are jointly developing ADCETRIS. Under the terms of the collaboration agreement, Seattle Genetics has U.S. and Canadian commercialization rights and Takeda has rights to commercialize ADCETRIS in the rest of the world.

ADCETRIS logged in net product sales of $178.2 million in U.S. and Canada. Looking ahead, Seattle Genetics anticipates net product sales of ADCETRIS to be in the range of $200 million to $210 million in 2015.

SGEN closed Monday's trading at $36.81, up 1.88%.