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Evoke Pharma (EVOK) Announces FDA Acceptance of Gimoti NDA

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Evoke Pharma (EVOK) Announces FDA Acceptance of Gimoti NDA

The FDA accepts Evoke Pharma's (EVOK) regulatory application seeking approval of its pipeline candidate, Gimoti, for treating diabetic gastroparesis. Shares up.

Evoke Pharma, Inc. EVOK announced that the FDA has accepted the new drug application (“NDA”) for its pipeline candidate, Gimoti (metoclopramide). The NDA seeks approval of the candidate for treating symptoms in adult women with acute and recurrent diabetic gastroparesis. A decision is expected on Apr 1, 2019.

Gimoti will be administered as a nasal spray upon successful approval. A potential approval and successful commercialization of Gimoti will be a major boost for the clinical-stage pharmaceutical company as it will provide it with a fixed revenue stream.

Evoke Pharma’s shares were up 2.6% on Aug 16 following the news. Meanwhile, shares of the company have gained 4.5% so far this year compared with the industry’s gain of 4.2%.

The NDA included data from a comparative exposure pharmacokinetic study, which evaluated Gimoti nasal spray for similar systemic exposure compared to Reglan, a tablet formulation of metoclopramide available for treating similar indication. Data showed that Gimoti’s bioequivalence with Reglan tablets was slightly lower than the expected range of 80-125%.

Evoke Pharma owes milestone payments to Mallinckrodt MNK as a part of an asset purchase agreement. However, Evoke Pharma amended the agreement in March to defer two milestone payments related to the acceptance of NDA and final approval for Gimoti. The company is now eligible to pay the payments after one year of Gimoti’s approval.

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, vomiting and delayed gastric emptying causes abnormal absorption of oral medication, causing side-effects. The company expects to address 4 million patients annually who are prescribed oral medication for gastroparesis as nasal spray administration may not have the side-effects.

However, Gimoti will have to compete with several established drugs available for the treatment of gastroparesis including several oral and intravenous formulation of metoclopramide.

Evoke Pharma, Inc. Price

 

Evoke Pharma, Inc. Price | Evoke Pharma, Inc. Quote

Zacks Rank & Key Picks

Evoke currently carries a Zacks Rank #2 (Buy). Some other top-ranked stocks from the pharma space are Illumina ILMN and Ligand Pharmaceuticals LGND. Both the stocks carry a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Illumina’s earnings per share estimates increased from $4.88 to $5.41 for 2018 and from $5.61 to $6.10 for 2019 over the past 30 days. The company delivered a positive earnings surprise in all the trailing four quarters with an average beat of 25.23%. The stock has rallied 49.7% so far this year.

Ligand’s earnings per share estimates moved up from $4.93 to $5.64 for 2018 and from $5.39 to $5.59 for 2019 over the past 30 days. The company delivered a positive earnings surprise in all the trailing four quarters with an average beat of 59.54%. The stock has rallied 75.1% so far this year.

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Illumina, Inc. (ILMN) : Free Stock Analysis Report
 
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