RVNC Wrinkled, MRNS Jolted As Study Fails, BSTC Abuzz, FDA Snubs KMPH

(RTTNews) - Adamas Pharmaceuticals Inc.'s (ADMS) phase 2 proof-of-concept study designed to evaluate ADS-5102 extended-release capsules in individuals with multiple sclerosis who have impaired walking suggests that the compound is well tolerated and has a significant positive impact on walking speed.

The company said it is now ready to speak with the FDA about a pivotal registration program for impaired walking in people with multiple sclerosis. In addition, Adamas also expects to submit its first NDA for ADS-5102 in 2016 for levodopa-induced dyskinesia associated with Parkinson's disease.

ADMS closed Monday's trading at $15.87, down 0.63%.

Amgen's (AMGN) Biologics License Application for ABP 501, a biosimilar candidate to Humira, will be reviewed by an outside panel of experts before the FDA makes its final decision.

The regulatory agency's final decision is slated for September 25, 2016.

AMGN closed Monday's trading at $153.08, down 1.10%.

BioSpecifics Technologies Corp.'s (BSTC) phase II clinical trial of collagenase clostridium histolyticum for the treatment of human lipoma has met its primary endpoint of reduction in the visible surface area of the target lipomas relative to placebo.

Thomas Wegman, President of BioSpecifics said, "We look forward to the review of these positive results by our partner Endo International plc. Endo has the right to opt-in to this indication, which would transfer responsibility for the future development costs to them and trigger an opt-in payment and potential future milestone and royalty payments to BioSpecifics."

BSTC closed Monday's trading 6.30% higher at $39.48.

Shares of Eleven Biotherapeutics Inc. (EBIO) rose over 27% on Monday after the company inked an exclusive license agreement with F. Hoffmann-La Roche Ltd. and Hoffmann-La Roche Inc.

Under the terms of the agreement, Eleven Bio has agreed to grant an exclusive, worldwide license to Roche to develop and commercialize EBI-031, currently being developed for the potential treatment of ocular diseases, and all other IL-6 antagonist antibody technology owned by Eleven Bio.

Eleven Bio is entitled to an upfront payment of $7.5 million, along with potential future milestone payments of up to $262.5 million from Roche.

EBIO closed Monday's trading at $2.39, up 27.81%.

Shares of KemPharm Inc. (KMPH) were down over 26% in extended trading on Monday, following the receipt of FDA's complete response letter for the company's New drug Application for Apadaz.

Apadaz, formerly known as KP201/APAP, is composed of benzhydrocodone hydrochloride (HCl), a prodrug of hydrocodone and benzoic acid, and acetaminophen. It is an investigational abuse-deterrent product candidate for the short-term management of acute pain.

KMPH closed Monday's trading at $6.29, down 5.41%. In after hours, the stock fell 26.07% to $4.65.

Shares of Marinus Pharmaceuticals Inc. (MRNS) plunged 69.66% on Monday, following disappointing results from its phase III trial of Ganaxolone in adults with drug-resistant focal onset seizures.

The study missed its primary endpoint of percent change in the 28-day seizure frequency from baseline.

Marinus plans to discontinue its program in adult focal onset seizures and focus its efforts on advancing Ganaxolone in status epilepticus and pediatric orphan indications.

MRNS closed Monday's trading at $1.62, down 69.66%.

Masimo's (MASI) O3 regional oximetry has received FDA clearance to monitor cerebral oxygenation in situations in which pulse oximetry alone may not be fully indicative of the oxygen in the brain due to various factors, such as the type of clinical procedure being performed.

O3 regional oximetry is currently intended for use with adults weighing 40 kg (88 lbs) or greater, noted the company.

MASI closed Monday's trading at $51.66, down 0.84%.

Merck's (MRK) two phase III studies evaluating MK-1293, an investigational, follow-on biologic insulin glargine candidate for the treatment of people with type 1 and type 2 diabetes, have achieved the primary endpoint.

In both studies, MK-1293 has demonstrated non-inferiority in change from baseline A1C (a measure of average blood glucose) and similar safety to Lantus (insulin glargine) after 24 weeks in patients with type 1 and type 2 diabetes.

MRK closed Monday's trading at $56.11, down 0.43%.

Revance Therapeutics Inc.'s (RVNC) phase III trial of DaxibotulinumtoxinA Topical Gel to treat patients with moderate to severe lateral canthal lines, or crow's feet, dubbed REALISE 1, has failed to achieve its co-primary and other endpoints.

The co-primary efficacy endpoints in the trial were composite measurements of 2-point or greater and 1-point or greater improvement in lateral canthal lines between baseline and 28 days after treatment, as graded by the Investigator's Global Assessment of Lateral Canthal Lines (IGA-LCL) and the Patient Severity Assessment (PSA).

RVNC closed Monday's trading at $18.35, down 0.60%. In after hours, the stock was down 22.72% to $14.18.

Teva Pharmaceutical Industries Ltd. (TEVA) has suspended sales of Zecuity patch for migraine headaches, following reports of adverse skin reactions like burns and scars.

Approved by the FDA in January 2013, Zecuity is designed to be worn for a four-hour period either on the upper arm or thigh.

TEVA closed Monday's trading at $53.22, up 0.40%.