Keep An Ear Out For OTIC, CAPR Does A Dynamic Warm-up, Spark Blazes

(RTTNews) - Capricor Therapeutics Inc. (CAPR), which was recently up-listed to the Nasdaq Capital Market, expects enrollment in its phase I trial of CAP-1002 in patients with advanced heart failure to be completed in the first half of this year. The initial top-line results from this study, dubbed DYNAMIC, are expected to be reported in the second half.

The company is also planning to evaluate CAP-1002 for the treatment of DMD (Duchenne Muscular Dystrophy)-associated cardiomyopathy, and the submission of an investigational new drug application in this indication is planned for the first half of this year.

CAPR closed Wednesday's trading 19.19% higher at $10.25.

Otonomy Inc. (OTIC) is scheduled to report results from a phase 2b trial of its drug candidate OTO-104 in Ménière's disease during the second quarter of 2015. If results are positive, a second pivotal trial of OTO-104 is planned for this year.

Ménière's disease is a chronic condition that is characterized by acute vertigo attacks (extreme dizziness), tinnitus (ringing of the ear), fluctuating hearing loss, and a feeling of aural fullness.

The company also plans to file an Investigational New Drug application, and initiate a phase 1 clinical trial for OTO-311, a potential treatment for tinnitus, this year.

Otonomy submitted a New Drug Application to the FDA last month seeking approval of its product AuriPro as a treatment of middle ear effusion in pediatric patients undergoing tympanostomy tube placement surgery.

Otonomy went public on August 13, 2014, offering its shares at a price of $16 each.

OTIC closed Wednesday's trading at $38.50, down 0.41%.

Spark Therapeutics (ONCE) is on track to report results of a phase 3 trial of SPK-RPE65, its product candidate intended for the treatment of RPE65-mediated inherited retinal dystrophies, in the second half of 2015.

A phase 1/2 clinical trial of the lead product candidate in the company's SPK-FIX program for hemophilia B is expected to be initiated in the first half of 2015. Spark has a global collaboration agreement with Pfizer Inc. (PFE) for the development and commercialization of product candidates in its SPK-FIX program.

Spark went public on the NASDAQ as recently as January 30, 2015, offering its shares at a price of $23 each. The stock hit a high of $77.33 on Wednesday before closing the day's trading at $76.30.