FDA Expands Use Of Pfizer's Ibrance, Attack On Titan, Spectrum Gets FDA Date

(RTTNews) - Fate Therapeutics Inc. (FATE) is all set to initiate enrollment in its phase 1/2 clinical trial of its product candidate ProTmune in adult patients with hematologic malignancies in mid-2016.

FATE touched a new 52-week low of $1.46 on Friday before closing the day's trading at $1.55.

Pfizer Inc. (PFE) has received FDA approval for broader use of Ibrance in the indication of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer in combination with AstraZeneca's Faslodex (fulvestrant) in women with disease progression following endocrine therapy.

Ibrance was initially approved by the FDA last February for the treatment of postmenopausal women with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer in combination with Novartis' Femara (letrozole) in women who have not yet received an endocrine-based therapy.

Launched in February of 2015, Ibrance netted $723 million in sales last year.

PFE closed Friday's trading at $29.49, down 0.20%.

Spectrum Pharmaceuticals' (SPPI) New Drug Application for EOquin (apaziquone for intravesical instillation) for the treatment of non-invasive bladder cancer has been accepted for review by FDA, and a decision date has been set for December 11, 2016. Before the FDA's final verdict, an advisory committee meeting regarding the EOquin NDA is expected to be held.

SPPI closed Friday's trading at $4.68, up 5.17%.

Shares of Titan Pharmaceuticals Inc. (TTNP) continued to fall in extended trading too on Friday as Probuphine, the company's investigational subdermal implant to treat opioid addiction, faces another FDA delay.

The FDA has extended the decision date on Probuphine by 3 months to May 27, 2016. Last month, an FDA panel voted 12 to 5 in favor of approving Probuphine for the maintenance treatment of opioid addiction, in stable patients receiving 8mg or less per day of buprenorphine.

This is Probuphine's second go-around with the FDA. The New Drug Application for Probuphine was turned down by the FDA in May of 2013 - with the regulatory agency seeking additional data supporting the efficacy of the product candidate.

TTNP closed Friday's trading at $3.41, down 17.43%. In after hours, the stock fell another 8.80% to $3.11.