TKAI Laying Off Staff Big Time, MCRB Plunges, FDA Says No To ADMA

(RTTNews) - Shares of ADMA Biologics Inc. (ADMA) were down over 30% in extended trading on Friday, following the receipt of FDA's Complete Response Letter for RI-002, an intravenous immune globulin, for the treatment of patients with Primary Humoral Immunodeficiency Disease.

The regulatory agency has cited certain outstanding inspection issues and deficiencies at ADMA's third-party contract manufacturers in the Complete Response Letter. However, no additional clinical studies or clinical safety and efficacy issues have been raised by the FDA related to RI-002.

ADMA closed Friday's trading at $7.85, down 7.39%. In after hours, the stock was down 31.85% to $5.35.

Shire plc's (SHPG) experimental drug SHP626, for the treatment of adults who have nonalcoholic steatohepatitis with liver fibrosis, has been granted fast track designation by the FDA.

The company is all set to initiate its phase II trial with SHP626 in adult patients with nonalcoholic steatohepatitis, and it will be conducted in the U.S., Canada and the United Kingdom.

SHPG closed Friday's trading 1.41% higher at $194.12.

Shares of Seres Therapeutics Inc. (MCRB) plummeted over 69% on Friday as the company's phase II study of SER-109 for the prevention of multiply recurrent Clostridium difficile infection failed to achieve the primary endpoint.

The study, dubbed ECOSPOR, evaluated the primary endpoint of reducing the relative risk of Clostridium difficile infection recurrence at up to 8-weeks.

MCRB closed Friday's trading at $10.94, down 69.42%.

Tokai Pharmaceuticals Inc. (TKAI), which recently discontinued its pivotal phase III study of Galeterone in treatment-naïve metastatic castration-resistant prostate cancer patients, is reducing its workforce by approximately 60% to a total of 10 full-time equivalent employees.

This workforce reduction is designed to reduce operating expenses while the company conducts a comprehensive evaluation of strategic options for Galeterone and its pipeline.

The pivotal trial, dubbed ARMOR3-SV, was evaluating Galeterone against Enzalutamide, and the trial's independent Data Monitoring Committee determined that the trial will likely not succeed in meeting its primary endpoint.

TKAI closed Friday's trading at $1.26, up 1.61%. In after hours, the stock was down 12.70% to $1.10.