CAPR Vaults On Study, CRBP Awaits Data In Q4, OASIS A Shot In The Arm For PRTK

(RTTNews) - Bellerophon Therapeutics Inc. (BLPH) has enrolled the first subject in its phase III trial of INOpulse delivery system for the treatment of patients with Pulmonary Arterial Hypertension.

The trial, dubbed INOvation-1, is anticipated to enroll 188 subjects in 17 countries.

Bellerophon has also enrolled the first subject in a phase II trial evaluating the safety and efficacy of the INOpulse delivery system in patients with pulmonary hypertension associated with Idiopathic Pulmonary Fibrosis (PH-IPF).

BLPH closed Thursday's trading at $1.98, down 4.81%.

Capricor Therapeutics Inc. (CAPR) has reported encouraging preliminary results from its phase I trial of CAP-1002 in patients with Class III heart failure.

In the trial, dubbed DYNAMIC, for the 12 patients available for follow-up at one year, improvements from baseline in key cardiac function and dimensional indices were directionally maintained.

Of the five NYHA Class III subjects who received the highest dose of CAP-1002, two subjects improved by two Classes (to Class I) and three improved by one Class (to Class II) at six months. At 12 months, three of these five subjects were assessed as Class I and two as Class II, demonstrating further improvement and indicating durability of the benefit of CAP-1002 on heart failure status for as long as 12 months following administration, noted the company.

CAPR closed Thursday's trading at $4.75, up 14.46%.

Corbus Pharmaceuticals Holdings Inc. (CRBP) has completed patient enrollment in its phase II clinical trial of Resunab for the treatment of diffuse cutaneous systemic sclerosis. The company expects to report top-line results from this study in the fourth quarter of 2016.

CRBP closed Thursday's trading at $2.98, down 0.67%.

Shares of Paratek Pharmaceuticals Inc. (PRTK) rose over 23% in extended trading on Thursday, following positive results from a phase III study of antibiotic Omadacycline in the treatment of acute bacterial skin and skin structure infections.

In the study, dubbed OASIS, the efficacy and safety of an IV to oral once-daily Omadacycline was compared against twice daily Linezolid over a 7 to 14-day course of therapy in 645 treated patients with acute bacterial skin and skin structure infections (ABSSSI). The study met the primary efficacy endpoint of early clinical response.

The OASIS study is the first of two phase III registration studies designed to support Omadacycline regulatory applications for the FDA and EMA.

PRTK closed Thursday's trading at $16.44, up 0.12%. In after-hours, the stock was up 23.24% to $20.26.

Supernus Pharmaceuticals Inc. (SUPN) has been asked by the FDA to resubmit the Trokendi XR product label with migraine as an indication in a different format as a result of which the decision date has been postponed.

Trokendi XR is already approved for the treatment of epilepsy and the FDA decision date on the Supplemental New Drug Application for the drug in the indication of migraine was initially set for second quarter of 2016.

But now, with the FDA asking the company to resubmit the Trokendi XR product label, the decision date is now likely to be in the third quarter of 2016.

SUPN closed Thursday's trading at $18.52, down 0.27%.