FDA Snubs TXMD, AGRX To Try Luck Again, CYTK Abuzz, ROKA Surges After-Hours

(RTTNews) - Your Daily Dose today : TherapeuticsMD's regulatory disappointment; Cytokinetics' public offering; ROKA Biosciences' distribution partnership and update on Fibrocell's Recessive Dystrophic Epidermolysis Bullosa drug candidate.

Agile Therapeutics Inc. (AGRX) is all set to resubmit its NDA for Twirla, an investigational low-dose combined hormonal contraceptive patch, by the end of the second quarter of 2017.

Twirla was turned down by the FDA in 2013.

At March 31, 2017, Agile had cash of $41.7 million, which is expected to be sufficient to meet its operating requirements into the second quarter of 2018.

AGRX closed Monday's trading at $3.38, up 0.30%.

Achaogen Inc.'s (AKAO) net loss for the first quarter of 2017 widened to $33.3 million or $0.93 per share from $12.2 million or $0.66 per share for the first quarter of 2016.

Contract revenue totaled $7.5 million for the first quarter of 2017, up from $5.8 million in the year-ago quarter, helped by increased research and development activities under the contract Option 3 with BARDA.

The Company plans to submit a New Drug Application for Plazomicin to the FDA in the second half of 2017 and to submit a Marketing Authorization Application to the European Medicines Agency in 2018.

Plazomicin is Achaogen's lead product candidate for the treatment of serious bacterial infections due to multi-drug resistant Enterobacteriaceae, including carbapenem-resistant Enterobacteriaceae.

AKAO closed Monday's trading at $23.49, down 2.53%. In after-hours, the stock was down 4.17% to $22.51.

Cytokinetics Inc. (CYTK) has offered to sell 5.26 million shares of its common stock to the public at a price of $14.25 each.

The gross proceeds to Cytokinetics from the offering are expected to be approximately $75.0 million. The offering is expected to close on May 12, 2017, subject to customary closing conditions.

The Company has granted Morgan Stanley, the sole underwriter for the offering, a 30-day option to purchase up to an additional 789,000 shares of common stock at the public offering price, less underwriting discounts and commissions.

CYTK closed Monday's trading at $15.65, up 1.62%.

Fibrocell Science Inc.'s (FCSC) Phase 1/2 clinical trial of FCX-007 for the treatment of Recessive Dystrophic Epidermolysis Bullosa will continue as planned, following the Data Safety Monitoring Board's review of safety data from the first patient treated.

According to the Company, 6 adult patients are targeted for the Phase 1 portion of the trial. Twelve-week post-treatment data for safety, mechanism of action and efficacy for multiple patients in the Phase 1 portion of this trial are expected in the third quarter of 2017.

FCSC closed Monday's trading at $1.80, down 1.64%.

Pain Therapeutics Inc. (PTIE) announced a 7-for-1 reverse split of its outstanding shares of common stock that came into effect at the close of business Eastern Time on May 9, 2017.

The Company's common stock will open for trading on The Nasdaq Global Market on May 10, 2017 on a split-adjusted basis under the existing trading symbol "PTIE".

PTIE closed Monday's trading at $0.62, down 23.51%.

Shares of Roka Bioscience Inc (ROKA) were up more than 14% in extended trading on Monday, following a distribution partnership with FoodChek Systems Inc.

The 5-year non-exclusive distribution agreement allows Roka Bioscience to expand its product menu aimed at food safety labs to include both technically advanced enrichment and detection solutions.

Mary Duseau, President and CEO of Roka, said, " By pairing the innovative enrichment media products in FoodChek's Actero Media line with the advanced detection capabilities of the Atlas® system, we can further our goal to deliver industry leading accuracy and faster time-to-result for pathogen testing in the food industry."

ROKA closed Monday's trading at $3.49, down 3.32%. In after-hours, the stock was up 14.61% to $4.00.

SCYNEXIS Inc. (SCYX) now expects to commence phase II study of IV Formulation of SCY-078 for the treatment of patients with invasive Candida infections only next year.

On March 2, 2017, the FDA asked the Company to hold the initiation of any new clinical studies with the intravenous (IV) formulation of SCY-078 until it completes a review of all available pre-clinical and clinical data of the IV formulation of SCY-078.

The clinical hold decision was issued by the FDA following a review of three mild-to-moderate thrombotic events in healthy volunteers receiving the IV formulation of SCY-078 at the highest doses and highest concentrations in a Phase 1 study.

SCYX closed Monday's trading at $2.54, down 4.15%. In after-hours, the stock was down 18.11% to $2.08.

TherapeuticsMD Inc. (TXMD) has failed to get FDA approval for its investigational product TX-004HR, also known as Yuvvexy.

TX-004HR is an applicator-free vaginal estradiol softgel for the treatment of moderate-to-severe vaginal pain during sexual intercourse (dyspareunia), a symptom of vulvar vaginal atrophy (VVA) in postmenopausal women.

The lack of long-term endometrial safety data for TX-004HR beyond the 12-weeks studied in the pivotal phase 3 study has been cited as the reason for the FDA rejecting TX-004HR.

TXMD closed Monday's trading at $4.18, down 10.49%. In after-hours, the stock fell another 2.87% to $4.06.

Valeant Pharmaceuticals International Inc.'s (VRX) (VRX.TO) wholly owned subsidiary, Bausch + Lomb, said that its New Drug Application for Luminesse has been accepted for review by the FDA.

The regulatory agency's decision is expected to be announced on December 27, 2017.

Luminesse, a brimonidine tartrate ophthalmic solution, 0.025%, is a topical vasoconstrictor formulation to be used Over-the-Counter (OTC) as an eye drop to relieve redness of the eye due to minor eye irritations. If approved, this will be the first OTC product developed with brimonidine tartrate for the treatment of ocular redness.

VRX closed Monday's trading at $9.71, down 3.57%.