No Pain, Only Gain For INNL, FDA Panel Backs SNY, Wait Continues For SRPT

(RTTNews) - A phase II trial of investigational antibiotic Solithromycin in Japanese patients with community acquired bacterial pneumonia or CABP in short, conducted by Cempra Inc.'s (CEMP) partner Toyama Chemical has successfully met its safety and efficacy measures.

Cempra completed its rolling submission of the New Drug Application for Solithromycin to the FDA for the treatment of CABP earlier this month. The FDA has a 60-day filing review period to determine whether the NDA is complete.

CEMP closed Wednesday's trading 3.43% higher at $17.49. In after hours, the stock was up another 4.35% to $18.25.

Shares of Innocoll (INNL) rose as much as 70% on Wednesday, following positive results from two phase III pivotal studies evaluating XARACOLL as a postoperative pain relief treatment immediately following open abdominal hernia repair.

The two studies, MATRIX-1 and MATRIX-2, achieved statistical significance in the primary efficacy endpoint, i.e. the sum of pain intensity over 24 hours.

Click here for stocks with pending phase III results.

INNL closed Wednesday's trading at $10.51, up 47.82%.

An FDA panel has voted 12 to 2 recommending approval of Sanofi's (SNY) iGlarLixi, an investigational fixed-ratio combination of Lixisenatide and basal insulin glargine 100 Units/mL, for the treatment of type 2 diabetes.

Lixisenatide is a once-daily prandial GLP-1 receptor agonist, invented by Zealand Pharma A/S with global development and commercial rights licensed to Sanofi while basal insulin glargine 100 Units/mL is marketed as Lantus by Sanofi.

Lixisenatide was also reviewed at the Advisory Committee meeting. However, the FDA had not requested a vote on Lixisenatide.

The FDA's final decision on Lixisenatide is expected to be announced in July 2016 and that of iGlarLixi in August 2016.

Lixisenatide is currently approved in more than 60 countries outside the U.S. under the proprietary name Lyxumia.

SNY closed Wednesday's trading at $40.97, up 1.89%.

Sarepta Therapeutics Inc. (SRPT) will have to wait longer to know the FDA's decision on its Duchenne Muscular Dystrophy drug candidate Eteplirsen as the review is yet to be completed.

The regulatory agency was supposed to announce its decision on May 26, 2016.

SRPT closed Wednesday's trading at $23.35, up 26.63%.

Seattle Genetics Inc. (SGEN) has initiated a pivotal phase 3 clinical trial, called CASCADE, evaluating its investigational Vadastuximab talirine in combination with approved drugs Vidaza or Dacogen in older patients with newly diagnosed acute myeloid leukemia.

The trial is designed to enroll approximately 500 patients globally, and the primary endpoint will be overall survival.

SGEN closed Wednesday's trading at $40.27, up 0.75%.