FDA Panel Nod For PFE, INSM Withdraws MAA, FCSC's Voice Fades Out

(RTTNews) - Shares of Insmed Inc. (INSM) were down over 19% in extended trading on Wednesday, following the company's withdrawal of its Marketing Authorization Application from the European Medicines Agency for ARIKAYCE for the treatment of nontuberculous mycobacteria lung disease.

The Marketing Authorization Application was filed based on the company's completed phase II study. A global phase III study of ARIKAYCE, dubbed CONVERT, is underway, and Insmed intends to resubmit its MAA when clinical data from the study are available.

INSM closed Wednesday's trading at $12.01, up 0.33%. In after hours, the stock was down 19.57% to $9.66.

Pfizer Inc.'s (PFE) ALO-02 has been recommended by an FDA panel for its proposed indication, "management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate".

The panel voted 11 to 4 recommending the inclusion of abuse-deterrent labeling for intranasal 9 to 6 for the intravenous routes of abuse. They voted 6 to 9 against inclusion of abuse-deterrent labeling for the oral route.

The FDA usually follows the recommendations of its advisory panels, although it is not required to do so.

PFE closed Wednesday's trading at $35.25, up 1.18%.

Shares of Fibrocell Science Inc. (FCSC) plunged over 36% on Wednesday as the company's phase II clinical trial of Azficel-T for the treatment of vocal cord scarring resulting in chronic or severe dysphonia failed to meet primary endpoints.

Vocal cord scarring is caused by damage to the fibroblast layer of the vocal cords which reduces vocal cord elasticity and airflow, affecting voice tone and volume. This reduction in vocal capacity is referred to as dysphonia, severe cases of which can lead to a total loss of voice.

FCSC closed Wednesday's trading at $1.26, down 36.68%.

SCYNEXIS Inc.'s (SCYX) proof-of-concept phase II study of oral SCY-078 has demonstrated antifungal activity in patients with acute vulvovaginal candidiasis, also known as vaginal yeast infection.

The study was a pilot investigation and not powered to demonstrate a statistically significant difference in any of the parameters tested.

Efficacy was evaluated based on the proportion of patients achieving clinical cure, mycological eradication and therapeutic at day 24 (+/-3) after initiation treatment, in line with draft guidelines from the FDA.

SCYX closed Wednesday's trading at $4.11, up 0.24%.

Trevena Inc. (TRVN) has commenced enrollment in its phase III APOLLO-1 and APOLLO-2 studies of Oliceridine in patients suffering moderate to severe acute pain following bunionectomy and abdominoplasty, respectively.

The company continues to expect to report top-line data from both APOLLO studies in the first quarter of 2017, and to file an NDA for Oliceridine in the second half of 2017.

Trevena is optimistic that its available cash and investments will be sufficient to fund operations into 2018. The company had cash of $163.5 million as of March 31, 2016.

TRVN closed Wednesday's trading at $7.44, down 0.27%.