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

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…

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