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AGRX Fails To SECURE Investor Confidence, ITEK Hit Hard, CBAY Rises On Kowa Deal


Shares of Agile Therapeutics Inc. (AGRX) got pounded in extended trading on Tuesday despite positive results from SECURE, the company's phase III trial of its once-weekly contraceptive patch Twirla.

SECURE was conducted to address issues raised by the FDA in its 2013 Complete Response Letter to the company.

In the SECURE trial, the PEARL-index score of Twirla was 4.80 in subjects 35 years of age and under. The Pearl Index is the number of failures that will occur among 100 women using a contraceptive method for a year.

Johnson & Johnson's Ortho Evra patch, greenlighted in 2001, was the first transdermal contraceptive to be approved by the FDA. According to results presented by Johnson & Johnson in 2011, Ortho Evra patch had scored 1.24 on the PEARL index in a controlled North American study and scored 0.88 in a controlled European/South African study.

However, Johnson & Johnson discontinued the production of that birth control patch when Mylan was granted FDA approval in April 2014 to market a generic version of the Ortho Evra patch, under the name Xulane.

Agile plans to resubmit its new drug application for Twirla in the first half of 2017 on the basis of the SECURE results and other information relating to the manufacture of the contraceptive patch.

AGRX closed Tuesday's trading at $5.00, down 12.28%. In after-hours, the stock was down 72.20% to $1.39.

Ardelyx Inc. (ARDX) has initiated a Phase 3 clinical trial and an onset-of-action clinical trial evaluating RDX7675 in patients with hyperkalemia, a potentially life-threatening condition common in patients with cardiorenal disease.

The Phase 3 clinical trial will enroll about approximately 300 adult patients with hyperkalemia and include a long-term, open-label safety extension. The onset-of-action trial will enroll roughly 60 patients with hyperkalemia.

The company expects to report data from the onset-of-action study in the first half of this year.

ARDX closed Tuesday's trading at $14.55, up 2.46%.

Allergan plc (AGN) has received FDA approval to market NATRELLE INSPIRA SoftTouch breast implants, adding yet another option within its NATRELLE portfolio.

The NATRELLE portfolio offers implants with differing gel firmness for differing levels of form stability. The NATRELLE INSPIRA breast implants are fuller than Allergan's round, gel-filled breast implants currently available in the U.S.

AGN closed Tuesday's trading at $216.19, up 2.94%.

Shares of CymaBay Therapeutics Inc. (CBAY) were up more than 56% in after-hours session on Tuesday after announcing an exclusive license agreement, worth $205 million, with Kowa Pharmaceuticals America Inc. for the development and commercialization of gout drug candidate Arhalofenate in the U.S.

Arhalofenate is a phase III-ready compound for the treatment of gout.

As per the agreement terms, CymaBay will receive up to $15 million in upfront and near-term milestone payments and is eligible to receive up to an additional $190 million in payments based upon the achievement of specific development, regulatory and sales milestones. CymaBay is also eligible to receive tiered, double digit royalties on future sales of Arhalofenate products. All development and commercialization costs will be borne by Kowa.

CBAY closed Tuesday's trading at $1.90, up 9.83%. In after-hours, the stock was up 56.84% to $2.98.

Dermira Inc. (DERM) has initiated a Phase 3 program, consisting of two trials, evaluating the safety and efficacy of Olumacostat glasaretil in patients with acne vulgaris.

Olumacostat glasaretil, formerly known as DRM01, is a novel, small molecule designed to reduce sebum production following topical application.

The two Phase III trials are expected to enroll a total of 1,400 patients and topline results are anticipated in the first half of 2018.

DERM closed Tuesday's trading at $30.70, up 1.22%.

The FDA has approved Hologic Inc.'s (HOLX) Aptima HIV-1 Quant assay, a nucleic acid amplification test for the quantitative detection of RNA from HIV in plasma specimens.

The Aptima HIV-1 Quant assay is not approved for HIV-1 diagnosis in the United States. Outside the U.S., the Aptima HIV-1 Quant Dx assay is CE-IVD marked for both diagnostic and monitoring claims, according to the company.

HOLX closed Tuesday's trading at $40.15, up 0.07%.

Shares of Inotek Pharmaceuticals Corp. (ITEK) touched a new low, plummeting nearly 73% on Tuesday, following disappointing results from its first pivotal phase III trial of Trabodenoson for glaucoma.

The trial, dubbed MATrX-1, did not achieve its primary endpoint of superiority in reduction of intraocular pressure (IOP) compared with placebo at all 12 time points.

Additional data from this trial are expected to be reported later this quarter.

ITEK touched an all-time low of $1.65 on Tuesday, before closing the day's trading at $1.75, down 71.31%.

TRACON Pharmaceuticals (TCON) is all set to begin dosing the first patients in its phase III 3 study of TRC105 for the treatment of patients with advanced angiosarcoma during early 2017.

The trial, dubbed TAPPAS, will evaluate TRC105 in combination with Votrient versus Votrient alone, and will initially enroll 124 patients.

TCON closed Tuesday's trading at $5.30, up 8.16%.

Zynerba Pharmaceuticals Inc. (ZYNE) has initiated an exploratory Phase 2 clinical trial of ZYN002 cannabidiol (CBD) gel in children with Fragile X syndrome.

ZYN002 CBD gel is the first and only patent-protected, synthetic CBD that is formulated as a permeation-enhanced gel for transdermal delivery.

The top line results from the Phase 2 clinical trial, dubbed FAB-C, are expected late in the first half of 2017.

ZYNE closed Tuesday's trading at $17.95, up 15.14%.

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