ADAP Surges As FDA Lifts Clinical Hold, OCUL Catches Eyes, RegeneRx On The Rise

(RTTNews) - Shares of Adaptimmune Therapeutics PLC (ADAP) jumped more than 13% in extended trading on Wednesday, following the removal of partial clinical hold on its planned pivotal study of NY-ESO SPEAR T-cell therapy in myxoid round cell liposarcoma.

The FDA had placed the partial hold on the NY-ESO SPEAR study in myxoid round cell liposarcoma in August of this year, requesting additional CMC (chemistry, manufacturing, and controls) information and answers to certain trial design questions prior to the trial start.

Now that the partial hold has been lifted, Adaptimmune is all set to initiate the study in up to 15 MRCLS patients - with patient screening expected to begin in 4Q 2016.

ADAP closed Wednesday's trading at $4.87, up 8.46%. In after-hours, the stock was up 13.96% to $5.55.

Ocular Therapeutix Inc. (OCUL) is all set to resubmit its New Drug Application for DEXTENZA 0.4 mg, for intracanalicular use in the treatment of ocular pain occurring after ophthalmic surgery by the end of 2016.

DEXTENZA was turned down by the FDA in July of this year - with the regulatory agency citing deficiencies in manufacturing process and controls identified during a pre-NDA approval inspection of the Ocular Therapeutix manufacturing facility.

Another event to watch out for is the release of topline results from the company's third Phase 3 clinical trial for DEXTENZA for post-surgical ocular inflammation and pain that is expected to be available in the fourth quarter of 2016.

OCUL closed Wednesday's trading at $6.00, up 14.50%.

Shares of Prothena Corp. PLC (PRTA) rose nearly 18% on Wednesday, following positive results from a phase 1b multiple ascending dose study of PRX002 in Parkinson's disease.

In the phase I study, PRX002, at all dose levels, was found to have an acceptable safety and tolerability profile in patients with Parkinson's disease, meeting the primary objective of this study.

Prothena has a deal in place with Roche to develop and commercialize PRX002. The companies expect to initiate a phase II study of PRX002 in 2017.

PRTA closed Wednesday's trading at $56.10, up 17.98%.

RegeneRx Biopharmaceuticals, Inc. (RGRX.OB) has enrolled the first patient in its phase III clinical trial of RGN-259 in patients with dry eye syndrome.

The trial, dubbed ARISE-2, is designed to enroll approximately 500 dry eye patients, and is expected to be completed and patient data reported in Q4 2017.

RGRX.OB closed Wednesday's trading at $0.31, up 8.62%.

Synergy Pharmaceuticals Inc. (SGYP) has a couple of catalysts coming its way in the coming months.

The company's lead drug candidate Plecanatide is in late-stage clinical development for the treatment of chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C).

Two phase 3 clinical trials with Plecanatide in IBS-C patients are underway - with top-line data in both trials expected by the end of this year.

The new drug application for Plecanatide in chronic idiopathic constipation is currently under review by the FDA - with a decision date set for January 29, 2017.

SGYP closed Wednesday's trading at $5.15, up 17.58%. In after-hours, the stock was up 0.97% to $5.20.