Welcome to our dedicated page for Evoke Pharma news (Ticker: EVOK), a resource for investors and traders seeking the latest updates and insights on Evoke Pharma stock.
Evoke Pharma, Inc. (formerly NASDAQ: EVOK) generated news primarily as a specialty pharmaceutical company focused on gastrointestinal (GI) disorders and diseases, with an emphasis on diabetic gastroparesis. Company press releases repeatedly describe Evoke’s work around GIMOTI, a metoclopramide nasal spray formulation indicated for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in adults. News items often explain why a non-oral formulation matters in a condition where delayed gastric emptying can compromise absorption of orally administered medications.
The EVOK news record includes announcements about GIMOTI’s commercial progress, such as updates on net product sales, prescriber adoption and pharmacy access, as well as business updates tied to Evoke’s GI-focused strategy. Several releases detail intellectual property developments, including a Notice of Allowance and the issuance of U.S. Patent No. 12,377,064 covering the use of intranasal metoclopramide in patients with moderate to severe symptoms of gastroparesis, along with plans to list this patent in the FDA’s Orange Book and extend expected exclusivity.
Regulatory and scientific news also appears in the EVOK feed, including communications about real-world safety data on metoclopramide and tardive dyskinesia and presentations at gastroenterology-focused medical meetings. Later news is dominated by transaction-related announcements, including the definitive agreement under which QOL Medical, LLC agreed to acquire Evoke for cash per share, and subsequent updates on the tender offer and merger process.
For readers reviewing EVOK news today, this page functions as an archive of historical developments: commercial milestones for GIMOTI, GI and diabetic gastroparesis–related research communications, patent and Orange Book updates, quarterly financial press releases, and the sequence of events that culminated in Evoke’s acquisition by QOL Medical and the delisting of its common stock from Nasdaq.
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.
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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.
Evoke Pharma (NASDAQ: EVOK) announced that GIMOTI® (metoclopramide) nasal spray has been added to the Texas Medicaid Preferred Drug List as of April 12, 2022. This inclusion facilitates reimbursement for approximately 5 million Medicaid patients in Texas suffering from diabetic gastroparesis (DGP). The approval aligns with Evoke's commitment to increasing access to non-oral treatment options for DGP, following a similar approval in New York. The company aims to broaden accessibility and remains focused on its commercialization strategy.
Evoke Pharma (NASDAQ: EVOK) announced a virtual fireside chat on March 16, 2022, to discuss gastroparesis and GIMOTI, its nasal spray treatment for the condition, featuring Dr. Viplove Senadhi. The event aims to enhance understanding and awareness of this gastrointestinal disorder affecting millions. GIMOTI is the only FDA-approved drug for diabetic gastroparesis, offering a unique formulation compared to traditional oral and injectable options. Investors can register for the event through Evoke's investor relations site.
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