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AGTC Awaits Data In Jan., EVFM Walks The Talk, Today's A Big Day For ALDX

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Today's Daily Dose brings you news about Applied Genetic Technologies' near-term catalysts; the acquisition of Audentes by Astellas; Aldeyra's immediate catalyst; Evofem's AMPREVENCE study results and Lexicon Pharma's setback.

Read on…

Applied Genetic Technologies Corp.'s (AGTC) Chief Medical Officer, Theresa Heah, has resigned from the company to pursue other opportunities.

Given that the clinical results for the upcoming data releases are still being processed at external vendors and not yet available for internal review, Dr. Heah's resignation does not relate to any knowledge of pending results, the Company noted.

So, what are the upcoming data releases?

-- Interim six-month data from the expansion group of a phase I/II study of gene therapy for X-linked Retinitis Pigmentosa is expected in January 2020.
-- Interim six-month data from two parallel phase I/II studies of gene therapy for Achromatopsia, namely CNGB3 trial and CNGA3 trial, are also expected in January 2020.

The Company is exploring options to fill the role of Chief Medical Officer. In the interim, Dr. Matt Feinsod, who currently serves as Executive Vice President of Global Strategy and Development, and Dr. Nnenna Ihekoromadu, who recently joined the company as VP Clinical Research and Medical Affairs, will continue to provide medical oversight for the XLRP and ACHM clinical programs.

AGTC closed Monday's trading at $2.75, up 0.36%.

Shares of Audentes Therapeutics Inc. (BOLD) soared more than 100% in extended trading on Monday as the Company is all set to be acquired by Astellas for a price of US$60.00 per share in cash, representing a total equity value of approximately US$3 billion.

Audentes Therapeutics is an AAV-based genetic medicines company focused on developing and commercializing innovative products for serious rare neuromuscular diseases. Its lead program is AT132 for the treatment of X-Linked Myotubular Myopathy.

The offer price of US$60 per share represents a premium of 110% to Audentes' closing share price of US$28.61 on December 2, 2019. The transaction is expected to be consummated in the first calendar quarter of 2020.

BOLD closed Monday's trading at $28.61, down 1.45%. In after-hours, the stock was up 106.22% to $59.

Aldeyra Therapeutics Inc. (ALDX) is scheduled to host a conference call and webcast at 8:00 a.m. ET Tuesday, December 3, 2019, to provide top-line results from Part 1 of the adaptive phase III clinical trial of 0.25% topical ocular Reproxalap in patients with dry eye disease, dubbed RENEW.

The other catalysts to watch out for are:

-- Patient enrollment in Part 1 of the adaptive Phase 3 Clinical Trial of ADX-2191 in proliferative vitreoretinopathy, dubbed GUARD, is expected to begin in the fourth quarter of 2019.
-- A phase III study of Reproxalap in Allergic Conjunctivitis, dubbed INVIGORATE, is expected to be initiated in the first half of 2020.
-- A phase I clinical trial of ADX-629, a novel orally administered RASP inhibitor in development for the treatment of systemic autoimmune disease and potentially other serious medical conditions is underway.
-- A phase II trial of ADX-1612 in patients with post-transplant lymphoproliferative syndrome, a rare and potentially fatal immunological disease that can occur following solid organ transplant, is slated to begin in the fourth quarter of 2019.

ALDX closed Monday's trading at $7.49, down 6.14%. In after-hours, the stock was up 8.14% to $8.10.

Evofem Biosciences Inc.'s (EVFM) phase IIb clinical trial evaluating the efficacy and safety of its lead product candidate Amphora for the prevention of urogenital chlamydia and gonorrhea in women, dubbed AMPREVENCE, has yielded positive results.

In the study, the infection rate of chlamydia among women who used Amphora for the four-month study period was 4.9% compared to 9.8% among those who used placebo for four months, a relative risk reduction of 50% in the primary endpoint. Among the reported cases of gonorrhea infection, the infection rate was 0.7% in the Amphora arm compared to 3.2% in the placebo arm, a relative risk reduction of 78% in the secondary endpoint.

We alerted our readers to EVFM on October 4, 2019, when it was trading around $5.

Related Reading

Will Second Time Prove A Charm For Evofem?

The stock closed Monday's trading at $6.86, up 12.27%.

The FDA has denied Lexicon Pharmaceuticals Inc.'s (LXRX) appeal of the Complete Response Letter in relation to the New Drug Application for sotagliflozin (Zynquista) in type 1 diabetes.

The U.S. regulatory agency refused to approve the drug in March of this year. Zynquista was approved in Europe in April of 2019.

Lexicon intends to appeal the decision to the Center for Drug Evaluation and Research, or CDER.

The Company has a couple of catalysts to watch out for this month.

-- A phase Ib multiple ascending dose trial for LX 921 in neuropathic pain is underway, with topline data due this quarter.
-- The topline phase III data from the remainder of the core studies for sotagliflozin in type 2 diabetes from the InSynchrony program are expected in Q4 2019 or early 2020. The InSynchrony clinical program consists of three phase III trials of Zynquista (sotagliflozin) in adults living with type 2 diabetes.
-- Completion of patient enrollment of the initial safety cohort in a phase II study of Telotristat ethyl in biliary tract cancer is due this quarter.

LXRX closed Monday's trading at $3.16, down 10.48%.

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