Evoke Pharma Inc Stock Price, News & Analysis

Evoke Pharma, Inc. (NASDAQ: EVOK) has received a key patent from the Canadian Intellectual Property Office for its nasal spray formulation of metoclopramide, GIMOTI®, aimed at treating diabetic gastroparesis. This patent, expiring in 2029, enhances Evoke's intellectual property portfolio, complementing other U.S. patents that expire in 2029 and 2030. Following prior FDA exclusivity granted in April 2022, Evoke holds exclusive rights to market GIMOTI® for three years against generics, positioning the product as a significant treatment solution for this GI disorder.

Evoke Pharma (NASDAQ: EVOK) announced that Florida's Medicaid Pharmaceutical & Therapeutics Committee has approved the inclusion of GIMOTI, its nasal spray for treating diabetic gastroparesis, in the state's Preferred Drug List, effective immediately. This decision enhances patient access to GIMOTI, particularly for adults unable to use oral metoclopramide due to delayed gastric emptying. With approximately 5 million beneficiaries in Florida's Medicaid, this approval marks a significant milestone for Evoke in expanding GIMOTI's market presence and improving treatment options for patients suffering from this GI disorder.

Evoke Pharma (NASDAQ: EVOK) announced it has regained compliance with Nasdaq's minimum bid price requirement, closing the matter previously raised on December 29, 2021. The company's stock was under the $1.00 threshold but achieved compliance by maintaining a minimum closing bid price of $1.00 for 10 consecutive days post a 1-for-12 reverse stock split. In May, Evoke raised approximately $7.1 million through its at-the-market program, extending its cash runway into the second quarter of 2023. The company aims to leverage this funding to boost GIMOTI sales.

Evoke Pharma (NASDAQ: EVOK) presented a study at Digestive Disease Week 2022 highlighting a 98.8 per 100,000 incidence of tardive dyskinesia (TD) among gastroparesis patients treated with metoclopramide, a significant reduction from earlier reports. This analysis, based on a database of 80 million patients from 2011-2020, supports the safety profile of GIMOTI®, the FDA-approved nasal spray formulation of metoclopramide for diabetic gastroparesis. The study received a “Poster of Distinction” award, emphasizing GIMOTI's potential in managing this condition.

Evoke Pharma, Inc. (NASDAQ: EVOK) announced its participation in the H.C. Wainwright Global Investment Conference from May 23-26, 2022. The management team will present a virtual overview of the commercial progress of their flagship product, GIMOTI (metoclopramide nasal spray), on May 24, 2022, available on demand for registered attendees starting at 7:00 a.m. ET. Investors can also request one-on-one meetings with management during the event. GIMOTI addresses symptoms of acute and recurrent diabetic gastroparesis in adults, a condition affecting millions globally.

Evoke Pharma reported a net revenue of approximately $418,000 for Q1 2022, a 16% increase year-over-year, driven by higher sales of GIMOTI. The company saw a 41% rise in new prescribers and a 22% increase in prescriptions. Notably, GIMOTI received added state Medicaid programs in New York and Texas, expanding patient access. However, the net loss was approximately $2.2 million, an improvement from the $2.6 million loss in Q1 2021. Current cash reserves are about $7.7 million, projected to support operations into Q2 2023.

Evoke Pharma (NASDAQ: EVOK) plans to release its Q1 2022 financial results on May 10, 2022, after market close. A conference call will follow at 4:30 p.m. ET for discussion of the results. The company's flagship product, GIMOTI, is the only FDA-approved nasal spray for treating symptoms of diabetic gastroparesis. This GI disorder affects many worldwide and poses significant challenges in medication absorption. Investors can follow Evoke's updates on their official website and social media channels.

Evoke Pharma (NASDAQ: EVOK) announced on April 26, 2022, that the FDA granted new drug product exclusivity for GIMOTI (metoclopramide) nasal spray. This exclusivity allows Evoke to market GIMOTI solely for three years, shielding it from generic competition. Evoke holds two Orange Book-listed patents for GIMOTI, expiring in 2029 and 2030, along with additional gender-specific patents in the E.U., Japan, and Mexico, extending coverage until 2032. The company aims to deliver a non-oral treatment for diabetic gastroparesis, addressing a significant market need.