CEMP Plunges, ALDR Promises Data In 1H 2017, AERI Withdraws NDA, AZN, CYH Abuzz

(RTTNews) - Adamas Pharmaceuticals Inc. (ADMS) has submitted a New Drug Application to the FDA for ADS-5102 extended-release capsules, a potential treatment of levodopa-induced dyskinesia in patients with Parkinson's disease.

Levodopa-induced dyskinesia refers to involuntary hyperkinetic movements that usually occur after prolonged treatment with Levodopa, the most commonly prescribed treatment in Parkinson's disease patients.

ADMS closed Thursday's trading at $14.33, down 0.14%.

Alder Biopharmaceuticals Inc. (ALDR) expects top-line data read out from its first phase III study of ALD403 in patients with chronic migraine, known as PROMISE 1, in the first half of 2017.

The top line results from the second phase III study of ALD403 in patients with chronic migraine, dubbed PROMISE 2, are expected in the first half of 2018.

The submission of the company's Biologics License Application for ALD403 to the FDA is planned for the second half of 2018.

ALDR closed Thursday's trading at $26.80, down 2.37%.

Aerie Pharmaceuticals Inc.'s (AERI) phase III clinical trial of glaucoma product candidate Rhopressa, dubbed Rocket 4, has yielded positive results.

The Rocket 4 data pertains to 90-day topline efficacy results of Rhopressa, and is designed to provide adequate six-month safety data for European regulatory filing purposes. Rocket 4, which is expected to be completed in the second quarter of 2017, is not necessary for NDA filing purposes.

Separately, the company announced that it is withdrawing the Rhopressa NDA, filed on September 6, 2016 with the FDA, following a few minor routine inquiries, none of which were related to safety or efficacy of Rhopressa.

The company plans to refile the Rhopressa NDA in January of 2017.

AERI closed Thursday's trading at $33.28, down 2.46%. In after hours, the stock was up 3.61% to $34.48.

The FDA has placed a partial clinical hold on the enrolment of new patients in AstraZeneca plc's (AZN) head and neck squamous cell carcinoma clinical trials of Durvalumab as monotherapy and in combination with Tremelimumab or other potential medicines, following reports of bleeding events in two phase III trials.

The bleeding events were observed in the two trials, dubbed KESTREL and EAGLE, on routine safety monitoring of the studies.

The partial clinical hold is only for the head and neck squamous cell carcinoma studies. The trials for Durvalumab in other cancer types, as monotherapy or in combination with Tremelimumab or other potential medicines, are ongoing, with pivotal data in lung cancer anticipated in the first half of 2017.

AZN closed Thursday's trading at $28.54, down 3.55%.

Corindus Vascular Robotics Inc. (CVRS) has received FDA clearance for its CorPath GRX, the second generation robotic system for use in interventional procedures. The company expects to commence commercialization of the device in the first quarter of 2017.

Corindus' CorPath 200 system was first approved in July 2012 for use in performing percutaneous coronary interventions. It was approved for expanded indications - say for radial PCI in October 2015 and for use in peripheral vascular interventions in March 2016.

According to the company, its CorPath System is the first and only FDA-cleared medical device to bring robotic precision to Percutaneous Coronary Interventions and protects medical professionals from radiation exposure occurring in hospital cath labs.

CVRS closed Thursday's trading at $0.94, down 3.89%.

Shares of Cempra Inc. (CEMP) plunged nearly 15% in extended trading on Thursday after the company announced that the FDA may not allow it to use the active product ingredient or API, manufactured at India-based Wockhardt Ltd. for approval and commercial supply of Solithromycin, suggesting the launch of the drug, if approved, could be delayed by a few months than originally planned. However, the company added that it has additional supply sources for the API of Solithromycin.

If approved, the company was previously planning to launch Solithromycin in the U.S. in the first quarter of 2017.

An outside panel of FDA experts is scheduled to review Cempra's New Drug Applications for intravenous and oral Solithromycin for community-acquired bacterial pneumonia, or CABP, on November 4, 2016. The FDA's final decision on oral and intravenous Solithromycin is slated for December 27, and December 28, 2016, respectively.

CEMP closed Thursday's trading at $23.44, down 0.51%. In after-hours, the stock was down 14.25% to $20.10.

Shares of Community Health Systems (CYH) tumbled over 49% on Thursday after the company projected a loss and a decline in operating revenue for the third quarter ended September 30, 2016.

The loss from continuing operations before income taxes for Q3, 2016 is anticipated to be approximately $83 million on net operating revenues $4.380 billion. This is in sharp contrast to income from continuing operations before income taxes of $121 million and net operating revenues of $4.846 billion in the year-ago quarter.

CYH closed Thursday's trading at $5.05, down 49.65%.

Lannett Co. Inc.'s (LCI) placebo-controlled phase III clinical study of C-Topical 4% and 10% as a local anesthetic for diagnostic procedures or surgeries on or through the inside of the nose has met the primary endpoint.

The company is planning to submit a new drug application for the C-Topical product to the FDA after completing the toxicology and pharmacokinetic studies.

LCI closed Thursday's trading at $21.15, down 1.17%.

ProQR Therapeutics N.V.'s (PRQR) first clinical study of QR-010 in CF patients, which is a proof-of-concept study, dubbed PQ-010-002, met its primary endpoint in a cohort of homozygous F508del cystic fibrosis patients, as measured by a change in total chloride response following 4 weeks of treatment with QR-010.

In the compound heterozygous F508del cystic fibrosis patients, no meaningful difference was found. QR-010 was observed to be safe and well-tolerated in both cohorts, the company said.

The second clinical study, known as PQ-010-001, is a phase 1b randomized, double-blind, placebo-controlled, dose-escalation 28-day study, and it has completed all four single-dose cohorts. The multiple dose cohorts in this study are ongoing and topline safety, tolerability and exploratory efficacy data from this study are expected in mid-2017.

PRQR closed Thursday's trading at $6.15, unchanged from the previous day's close.

Medical device company Skyline Medical Inc. (SKLN) implemented a 1-for-25 reverse stock split, which came into effect as of the close of business on October 27, 2016. The reverse stock split has been done with the aim of regaining compliance with the minimum $1.00 continued listing requirement for the listing of its common stock on The NASDAQ Capital Market.

SKLN closed Thursday's trading at $0.12, down 96.03%.

TESARO Inc.'s (TSRO) Marketing Authorisation Application for Niraparib has been submitted to and accepted for review by the European Medicines Agency for the maintenance treatment of patients with platinum-sensitive, recurrent ovarian cancer who are in response to platinum-based chemotherapy.

The company initiated rolling submission of the Niraparib NDA to the FDA in September of this year - with the submission expected to be completed during this quarter (Q4).

TSRO closed Thursday's trading at $118.15, down 0.76%.