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BSTC Finds New Use For Old Drug, FHCO Gets A Boost, SUPN Put On Notice

Pharma 111816

BioSpecifics Technologies Corp.'s (BSTC) phase 2b study of XIAFLEX for the treatment of edematous fibrosclerotic panniculopathy, commonly known as cellulite, has demonstrated statistically significant levels of improvement in the appearance of cellulite.

Cellulite is a condition in which the skin has a dimpled appearance because of underlying fat deposits.

XIAFLEX, known generically as collagenase clostridium histolyticum or "CCH", is a biologic approved in the U.S., EU, Canada, Australia and Japan for the treatment of adult Dupuytren's contracture (DC) patients with a palpable cord and in the U.S. and EU for the treatment of adult men with Peyronie's disease (PD) with a palpable plaque and penile curvature deformity of at least 30 degrees at the start of therapy. It is marketed as Xiapex in Europe.

XIAFLEX is marketed in the U.S. by BioSpecifics' partner, Endo International plc. (ENDP). For the third quarter of 2016, U.S. net sales of XIAFLEX were $47.7 million, an increase of 19 percent compared to the third quarter of 2015.

BSTC closed Thursday's trading at $49.14, up 3.52%.

Champions Oncology Inc. (CSBR) has been awarded a $2 million contract by a pharmaceutical customer, the identity of which has not been disclosed.

The contract represents the largest pre-clinical pharmacology contract in Champions' history and is almost double the size of the largest previous contract.

CSBR closed Thursday's trading at $1.75, up 1.16%.

EyeGate Pharmaceuticals Inc. (EYEG) is all set to release top-line results from its initial pilot study evaluating the ability of EyeGate OBG to accelerate ocular surface re-epithelialization following photorefractive keratectomy by the end of this year.

The company plans to pursue U.S. regulatory clearance of its EyeGate Ocular Bandage Gel ("EyeGate OBG") via the De Novo 510(k) pathway.

EYEG closed Thursday's trading at $1.45, down 0.68%.

Shares of The Female Health Co. (FHCO) were up over 19% on Thursday, following positive top line interim analysis of clinical study of PREBOOST product for the management of premature ejaculation.

PREBOOST is a new, proprietary OTC male genital desensitizer used for the treatment of premature ejaculation.

According to the study results, PREBOOST had statistically significant improvement in their ability to control ejaculation, with a mean increase in duration of almost four minutes, which was significantly greater than men on placebo. After treatment with PREBOOST, 80% of men were no longer considered to have PE, noted the company.

PREBOOST is expected to be launched in the US before year-end.

FHCO closed Thursday's trading at $1.19, up 19.00%.

Neos Therapeutics Inc. (NEOS) has submitted a New Drug Application to the FDA for its Amphetamine XR oral suspension drug candidate, NT-0201, for the treatment of attention-deficit hyperactivity disorder.

NT-0201 is the company's second extended-release amphetamine product candidate for the treatment of ADHD. The company's first ADHD medication, Adzenys XR-ODTTM, was approved by the FDA in January and was launched in May 2016.

NEOS closed Thursday's trading at $8.75, up 5.42%.

Regeneron Pharmaceuticals Inc.'s (REGN) phase III trial assessing the potential of Praluent to demonstrate cardiovascular benefit will continue as planned based on the recommendation of an independent Data Monitoring Committee.

The trial, dubbed ODYSSEY OUTCOMES trial, involves more than 18,000 patients from 57 countries.

Praluent, jointly developed by Sanofi and Regeneron, is an approved drug for the treatment of heterozygous familial hypercholesterolemia, or patients with atherosclerotic heart disease who require additional lowering of LDL-cholesterol.

In the third quarter of 2016, global net sales of Praluent were $38 million compared to $4 million in the third quarter of 2015.

REGN closed Thursday's trading at $404.56, down 3.69%.

Shares of Supernus Pharmaceuticals Inc. (SUPN) fell more than 9% in extended trading on Thursday after being notified of non-compliance with the NASDAQ's filing requirement.

The company has failed to timely file its Quarterly Report on Form 10-Q for the period ended September 30, 2016. It has been given time until January 13, 2017, or within 60 calendar days to regain compliance.

SUPN closed Thursday's trading at $24.70, up 4.55%. In after-hours, the stock was down 9.31% to $22.40.

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