Evoke Pharma, Inc. (EVOK - Free Report) announced that the FDA has accepted its resubmission of 505(b)(2) new drug application (NDA) for the nasal spray product candidate, Gimoti. The company is seeking approval of the candidate for treating symptoms in adult women with acute and recurrent diabetic gastroparesis.
The regulatory body has set a new action date of Jun 19, 2020 for announcing its verdict.
Gimoti will be administered as a nasal spray upon its successful approval. A potential nod and prosperous commercialization of Gimoti will be a major boost to the company as the same will provide it with a fixed revenue stream.
Shares of Evoke Pharma have plunged 44.9% in the past year compared with the industry’s decline of 6.9%.
We remind investors that in August 2018, the FDA accepted the first NDA for Gimoti related to the given indication and set an action date of Apr 1, 2019.
In March 2019, the FDA issued a multi-disciplinary review (DR) letter to Evoke Pharma, conveying its preliminary thoughts on deficiencies identified in connection with the NDA filing of Gimoti. Following this, Evoke Pharma submitted its response in the same month and requested a meeting with the regulatory body to discuss supplemental materials ahead of the action date set for Gimoti.
However, last April, the company received a Complete Response Letter (CRL) from the FDA regarding the NDA for Gimoti. The regulatory agency decided not to approve the NDA in its present form and recommended an NDA resubmission. The decision was based on clinical pharmacology and the product quality/device quality issues.
In December 2019, Evoke Pharma refiled the NDA for Gimoti to address the given patient population. The application was resubmitted, based on the feedback received from FDA officials during the Type A meeting held in July 2019.
Gastroparesis is a severe and episodic condition causing slow or delayed gastric emptying of the stomach following a meal, especially affecting adult women. It is characterized by nausea, vomiting, abdominal pain and bloating. Per the press release, if approved, Gimoti will be the first non-oral outpatient drug treatment for symptoms associated with acute and recurrent diabetic gastroparesis in adult women.
Zacks Rank & Stocks to Consider
Evoke Pharma currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the biotech sector include PDL BioPharma, Inc. (PDLI - Free Report) , Denali Therapeutics Inc. (DNLI - Free Report) and Epizyme, Inc. (EPZM - Free Report) , all sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
PDL BioPharma’s earnings estimates have been revised 37.5% upward for 2020 over the past 60 days. The stock has inched up 3.2% in the past year.
Denali’s loss per share estimates have narrowed 0.4% for 2020 over the past 60 days. The stock has risen 4.1% in the past year.
Epizyme’s loss per share estimates have narrowed 2.5% for 2020 over the past 60 days. The stock has skyrocketed 188.8% in the past year.
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