SSH Shines, First Generic MS Drug Approved, MNOV On Fast Track, ALDX On Watch

(RTTNews) - Aldeyra Therapeutics Inc. (ALDX) has enrolled the first patient in its phase II clinical trial of NS2 for the treatment of noninfectious anterior uveitis. The company opened enrollment for its phase II clinical trial of NS2 for patients with Sjgren-Larsson Syndrome last month.

Aldeyra expects to provide data from the two phase II trials by the end of 2015.

ALDX closed Thursday's trading at $10.59, up 0.95%.

Adamis Pharmaceuticals Corp.'s (ADMP) efficacy trial that was conducted outside of the United States for APC-2000, a generic HFA bronchodilator, has met the primary endpoint.

The primary objective of the study was to evaluate the therapeutic equivalence of Adamis' APC-2000 HFA with GlaxoSmithKline's (GSK) Ventolin Evohaler HFA.

Ventolin HFA is approved for the treatment or prevention of bronchospasm in adults and children four years of age and older with reversible obstructive airway disease, and for the prevention of exercise-induced bronchospasm in patients four years of age and older.

ADMP closed Thursday's trading 6.03% higher at $4.92.

Shares of MediciNova Inc. (MNOV) surged more than 41% on Thursday, following receipt of FDA's Fast Track designation for the company's phase II-ready compound - MN-001 - for the treatment of patients with nonalcoholic steatohepatitis with fibrosis.

Fast Track status can potentially lead to a shortened timeline to ultimate drug approval.

MNOV closed Thursday's trading at $4.96, up 41.31%.

The FDA has approved Glatopa, a generic equivalent of Teva Pharmaceuticals Industries Ltd's (TEVA) blockbuster multiple sclerosis drug Copaxone.

Glatopa was developed under a collaboration agreement between Momenta Pharmaceuticals, Inc. (MNTA) and Sandoz. Glatopa, which becomes the first generic multiple sclerosis product to be approved in the United States, will be commercialized under the Sandoz brand.

Under the terms of its collaboration agreement with Sandoz, Momenta is eligible to receive up to $140 million in milestone payments upon the achievement of certain U.S. regulatory, commercial and sales-based milestones for Glatopa, including a $10.0 million payment earned upon the FDA approval of Glatopa, and another $10.0 million milestone payment upon first commercial sale.

Sandoz is currently evaluating launch timing of Glatopa. Global sales of Copaxone in 2014 was $4.24 billion, a decrease of 2% compared to 2013.

MNTA touched a new 52-week high of $20.43 on Thursday, before closing the day's trading at $17.08.

Nektar Therapeutics' (NKTR) partner Baxter International Inc. has submitted a new drug application to Japan's Ministry of Health, Labour and Welfare for the approval of BAX 855, an investigational, extended half-life recombinant factor VIII (rFVIII) treatment based on ADVATE [Antihemophilic Factor (Recombinant)] for patients over 12 years of age with hemophilia A.

Baxter submitted its application for US FDA approval Of BAX 855, based on ADVATE for Hemophilia A last December.

NKTR closed Thursday's trading at $12.13, up 0.25%.

StemCells Inc. (STEM) has completed transplanting the six patients comprising the first cohort of its phase II Pathway Study, and the six month interim data on the first cohort are expected to be released later this year.

The first cohort is an open-label dose escalation arm to determine the cell dose to be used for the second cohort of the study. The second cohort of the study is a single-blind arm in 40 patients that will assess efficacy of the company's proprietary HuCNS-SC (purified human neural stem cells) platform technology for the treatment of cervical spinal cord injury.

STEM closed Thursday's trading at $0.94, down 2.88%.

Sunshine Heart Inc.'s (SSH) U.S. pivotal study of its C-Pulse system for the treatment of NYHA Class III and ambulatory Class IV heart failure, which was temporarily paused last month, may soon commence as the Data Safety Monitoring Board has recommended continuing the study.

The study, dubbed COUNTER HF, was paused in keeping with the study protocol, which required that in the event more than three of the first twenty subjects pass away for any reason, including non-device related deaths, the company will work with the FDA to discuss a plan to resume enrollment.

The FDA, which has reviewed the company's submission regarding the COUNTER HF's U.S. pivotal study pause, has requested only minor protocol changes be submitted in order to receive approval to resume patient enrollment. No concerns regarding the safety of the device have been raised by the regulatory agency.

The company noted that it will be submitting the required protocol modifications by early next week.

SSH closed Thursday's trading at $4.80, up 0.42%. In after-hours, the stock was up another 5.83% at $5.08.

Targacept Inc.'s (TRGT) phase 1/2 exploratory study of TC-6499 as a treatment for diabetic gastroparesis, a chronic disorder that slows or stops the passage of food from the stomach to the small intestine, has failed to meet the primary endpoint.

The company has decided to pull the plug on TC-6499 in the indication of diabetic gastroparesis.

TRGT closed Thursday's trading at $2.41, up 0.42%.