Astellas, KMPH, SRNE To Face FDA, ALXN Trims Workforce, ALDX Soars On Trial Data

(RTTNews) - Today's Daily Dose brings you news about regulatory catalysts awaiting Astellas, KemPharm and Sorrento; Aldeyra's positive phase IIa clinical trial results in dry eye disease; Inotek's merger with Rocket Pharmaceuticals and Zafgen's progress in phase II trial of ZGN-1061 in type 2 diabetes.

Read on...

Astellas Pharma Inc.'s (ALPMY.OB) supplemental New Drug Application seeking approval for the use of Mirabegron in combination with solifenacin succinate 5 mg for the treatment of overactive bladder has been accepted for review by the FDA - with a decision date set for April 28, 2018.

In the United States, Astellas' Mirabegron and solifenacin succinate are marketed as Myrbetriq and VESIcare, respectively. Each is approved by the FDA as a monotherapy for the treatment of overactive bladder.

For the first quarter ended June 30, 2017, sales of Myrbetriq were 27.2 billion Yen, up 15.6%, and sales of Vesicare were 24.6, down 19.2%, compared to the year-ago quarter.

ALPMY.OB closed Tuesday's trading at $12.80, down 0.16%.

Shares of Aldeyra Therapeutics Inc. (ALDX) rose as much as 73% on Tuesday, following positive results from its phase IIa clinical trial of topical ocular ADX-102 in patients with dry eye disease.

The phase IIa trial investigated three formulations of ADX-102 (0.1% ophthalmic solution, 0.5% ophthalmic solution, and 0.5% lipid formulation) in 51 dry eye disease patients treated for 28 days.

The results from the pooled data over the 28-day treatment period demonstrated statistically and clinically significant improvement across multiple sign and symptom endpoints.

The primary objective of the trial was to select a formulation and dose range for a Phase 2b clinical trial, and 0.1% ADX-102 has been nominated for advancement.

The phase IIb clinical trial of 0.1% ADX-102 in dry eye disease is expected to be initiated in the first half of 2018.

ALDX closed Tuesday's trading at $5.65, up 34.52%.

Alexion Pharmaceuticals Inc. (ALXN), as part of re-alignment, has decided to reduce its global workforce by approximately 20%.

The re-alignment plan also includes reinvesting about $100 million annually to build pipeline through disciplined business development and additional complement indications, and growing and maximizing its rare disease business. The plan is expected to deliver approximately $270 million in GAAP and approximately $250 million in non-GAAP pre-tax savings annually by 2019.

ALXN closed Tuesday's trading at $144.07, up 0.80%.

Evoke Pharma Inc. (EVOK) has completed subject dosing for a comparative exposure pharmacokinetic study comparing Gimoti to the listed drug, Reglan Tablets. Gimoti is the company's lead drug candidate for the treatment of symptoms associated with acute and recurrent diabetic gastroparesis.

The company expects to announce data from the trial in the fourth quarter of 2017, followed by a 505(b)(2) New Drug Application submission by the end of 2017 or early 2018.

EVOK closed Tuesday's trading at $2.95, up 4.24%.

Inotek Pharmaceuticals Corp. (ITEK) is all set to merge with Rocket Pharmaceuticals Ltd., a US-based gene therapy company.

Inotek has also decided to reduce its workforce by approximately 60% to a total of 7 full-time employees, which is expected to be completed in the third quarter. The merger with Rocket Pharmaceuticals is expected to close in the first quarter of 2018, subject to customary closing conditions, including the approval by stockholders of Inotek.

ITEK closed Tuesday's trading at $1.05, up 2.94%.

KemPharm Inc.'s (KMPH) amended New Drug Application for Apadaz, an investigational product candidate that is intended to provide short-term management of acute pain, has been accepted for review by the FDA - with a decision date set for February 23, 2018.

Apadaz was issued a Complete Response Letter on June 13, 2016.

KMPH closed Tuesday's trading at $3.15, down 1.56%.

The NDA for investigational medicated plaster, ZTlido, resubmitted by Sorrento Therapeutics Inc.'s (SRNE) subsidiary SCILEX Pharmaceuticals Inc., has been accepted for review by the FDA, with a decision date set for February 28, 2018.

ZTlido was issued a Complete Response Letter by the U.S. regulatory agency last May.

SRNE closed Tuesday's trading at $1.90, up 4.11%.

Zafgen Inc. (ZFGN) has initiated its phase II trial of ZGN-1061 in patients with type 2 diabetes.

The trial will evaluate three doses of ZGN-1061 for 12 weeks, and will enroll approximately 120 patients with type 2 diabetes who are overweight or obese across 23 study sites in Australia and New Zealand.

The primary objectives of this trial are to assess glycemic control as well as safety and tolerability. ZGN-1061 is the Company's second-generation MetAP2 inhibitor. The interim data are expected to be reported in the first half of next year.

ZFGN closed Tuesday's trading at $3.40, unchanged from the previous day's close.