ARNA Heartened By Phase II Trial, BMY To Face FDA In Nov., Concert Back In Play

Pharma 071117

Today's Daily Dose brings you news about Arena Pharma's pulmonary arterial hypertension trial results; Bristol-Myers' regulatory catalyst related to leukemia drug Sprycel; the progress in Concert Pharma's phase 2a clinical trial of CTP-543 for alopecia areata; Ocular's amendment of its DEXTENZA NDA and Neothetics' review of strategic alternatives.

Read on...

Shares of Arena Pharmaceuticals Inc. (ARNA) surged more than 41% in extended trading on Monday, following positive top line results from its phase II trial of Ralinepag in patients with pulmonary arterial hypertension.

According to the trial results, Ralinepag was associated with a statistically significant absolute change from baseline in pulmonary vascular resistance (PVR) compared to placebo. The drug candidate also demonstrated numerical improvement in 6-minute walk distance (6MWD).

The Company plans to move Ralinepag expeditiously toward a phase III clinical program.

Arena implemented a 1-for-10 reverse stock split, which came into effect on June 19, 2017.

ARNA closed Monday's trading at $18.39, down 4.47%. In after-hours, the stock climbed 41.33% to $25.99.

Bristol-Myers Squibb Co.'s (BMY) supplemental New Drug Application seeking approval of Sprycel to treat children with Philadelphia chromosome-positive chronic phase chronic myeloid leukemia, as well as a powder for oral suspension formulation of Sprycel has been accepted for priority review by the FDA.

The U.S. regulatory agency's decision on Sprycel is slated for November 9, 2017.

Sprycel is already indicated for the treatment of Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia and Philadelphia chromosome-positive acute lymphoblastic leukemia in adults.

Sprycel recorded global revenue of $1.82 billion in 2016, up 13% over the prior year.

BMY closed Monday's trading at $55.93, up 0.04%.

The FDA has lifted the clinical hold on Concert Pharmaceuticals Inc.'s (CNCE) Phase 2a clinical trial of CTP-543 for alopecia areata, also known as spot baldness.

The trial was put on hold in May of this year, with the regulatory agency requiring a review of certain recently completed non-clinical toxicology studies before the Company proceeded with dosing in the trial. Safety concerns were not the reason for the FDA's decision to impose the clinical hold.

The Company will amend the protocol for the phase 2a trial to evaluate two doses of CTP-543, each for 24 week duration. Concert will resume enrollment in the Phase 2a trial later this month and expects to complete the trial in the second half of 2018.

CNCE closed Monday's trading at $13.64, down 3.54%.

Ocular Therapeutix Inc. (OCUL), which is awaiting FDA decision on the approvability of its resubmitted NDA for DEXTENZA, has submitted details of a manufacturing equipment change, to potentially extend the decision date by 3 months.

Dextenza, proposed for treatment of ocular inflammation and pain following cataract surgery, is under FDA review, with a decision date set for July 19, 2017. The U.S. regulatory agency had refused to approve Dextenza last July, raising concerns pertaining to manufacturing process and controls.

OCUL closed Monday's trading at $6.49, down 8.85%. In after-hours, the stock was up 11.71% to $7.25.

Neothetics Inc. (NEOT) is all set to review a range of strategic alternatives focusing on seeking an acquisition, business combination or partnership, and has engaged Oppenheimer and Co., Inc for the same.

A reduction in workforce as part of streamlining operations in order to preserve its capital and cash resources is also on the cards.

On June 26, 2017, the Company announced that its phase 2 proof-of-concept trial of LIPO-202 for the reduction of submental subcutaneous fat did not meet the endpoints.

NEOT closed Monday's trading at $0.53, down 5.33%. In after-hours, the stock was up 9.39% to $0.57.

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