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. (NASDAQ: EVOK) is a specialty pharmaceutical company headquartered at 505 Lomas Santa Fe Dr, Solana Beach, California, USA. The company is dedicated to developing and commercializing treatments for gastrointestinal (GI) disorders and diseases. Evoke Pharma's flagship product is Gimoti, an innovative nasal spray formulation of metoclopramide designed to treat symptoms of diabetic gastroparesis (DGP) in women. Unlike traditional oral forms, Gimoti offers a unique delivery method through the nasal mucosa, addressing erratic absorption issues common in DGP patients.
Recently, Evoke Pharma has made significant strides. The company was selected for a Distinguished Oral Plenary Presentation at a prominent medical meeting, showcasing new data that highlight Gimoti's potential to reduce healthcare costs and resource utilization. Research indicates that nasal metoclopramide reduces emergency room visits and hospitalizations, illustrating substantial cost savings compared to oral formulations.
Evoke Pharma has also reported robust financial growth, with net product sales reaching $1.6 million in Q3 2023, an 88% increase year-over-year. The company attributes this success to increased prescription fills, new enrollments, and a growing number of prescribers. To further enhance accessibility, Evoke transitioned its prescription intake system to ASPN Pharmacies, aiming to broaden its reach through extensive pharmacy networks.
With a strong intellectual property portfolio, including four FDA Orange Book-listed patents for Gimoti, Evoke Pharma continues to solidify its market position. The company remains committed to improving patient outcomes and expanding the availability of effective treatments for diabetic gastroparesis.
Evoke Pharma, Inc. (NASDAQ: EVOK) announced it will report its fourth quarter and full year 2022 financial results on March 21, 2023, after market close. A conference call will be hosted at 4:30 p.m. ET on the same day to discuss the results. Dial-in numbers are (800) 245-3047 for domestic calls and (203) 518-9765 for international calls, with conference ID EVOKQ422. A telephonic replay of the call will be available until March 28, 2023. Evoke specializes in treatments for gastrointestinal diseases, notably GIMOTI®, a nasal spray for diabetic gastroparesis, a condition affecting millions globally.
Evoke Pharma, Inc. (NASDAQ: EVOK) announced that its abstract on reducing healthcare resource usage for diabetic gastroparesis (DGP) patients, treated with GIMOTI® nasal spray, was selected for a plenary presentation at Digestive Disease Week (DDW) 2023. The event occurs from May 6-9, 2023, at McCormick Place, Chicago, IL. Dr. David C. Kunkel will present data from a study of 514 patients comparing GIMOTI with oral metoclopramide. GIMOTI is a non-oral FDA-approved formulation designed for DGP treatment, addressing unpredictable absorption issues. This presentation will demonstrate GIMOTI's effectiveness and potential impact on patient care.
Evoke Pharma (NASDAQ: EVOK), a specialty pharmaceutical company, announced the filing of a joint stipulation of dismissal in a patent infringement case concerning GIMOTI (metoclopramide) nasal spray. This dismissal follows Teva Pharmaceuticals' shift from a Paragraph IV to a Paragraph III certification, which delays any ANDA approvals until the relevant patents expire. Importantly, this outcome prevents future ANDA filers from qualifying for 180-day exclusivity for GIMOTI. CEO Dave Gonyer emphasized the defense of GIMOTI's intellectual property against larger competitors and the company's commitment to healthcare innovation.
Evoke Pharma has announced a real-world study to be presented at the AMCP annual meeting regarding its nasal spray treatment, GIMOTI (metoclopramide), for diabetic gastroparesis (DGP). The study analyzed healthcare resource utilization among 294 patients before and after starting GIMOTI. It aims to demonstrate whether GIMOTI reduces the necessity for various healthcare visits, including emergency care. GIMOTI is the first FDA-approved nasal formulation for DGP, designed for patients who struggle with oral medication absorption. This presentation is scheduled for March 23, 2023, in San Antonio, TX, highlighting GIMOTI's potential effectiveness in improving patient outcomes.
Evoke Pharma, Inc. (NASDAQ: EVOK) announced the issuance of US patent No. 11,517,545 for its metoclopramide nasal spray, GIMOTI, aimed at treating moderate and severe gastroparesis. The patent, expiring in 2038, enhances Evoke's intellectual property portfolio, validating efficacy observed in Phase 3 trial results. GIMOTI is currently the only FDA-approved drug for this condition, targeting a significant market of diabetic gastroparesis patients. The company is focused on ensuring long-term availability of GIMOTI to improve patient care.
Evoke Pharma, Inc. (NASDAQ: EVOK), announced that the USPTO issued a Notice of Allowance for its patent application No. 17/100,664 concerning GIMOTI (metoclopramide) nasal spray. This patent is crucial as it will protect GIMOTI's market position until December 2029. As the first FDA-approved nasal formulation for treating diabetic gastroparesis, GIMOTI offers a vital alternative for patients with oral absorption issues. The company expressed optimism regarding the patent's approval, emphasizing the importance of securing GIMOTI's availability for healthcare providers and patients.
Evoke Pharma reported a significant increase in third-quarter financial performance for 2022, with GIMOTI net sales rising 80% to $832,000 compared to Q2 2022. Prescription fills for GIMOTI also saw a 56% increase, along with a 13% growth in new prescribers, totaling 143. The company transitioned its reimbursement program to vitaCare, leading to a 32% increase in inbound prescriptions. The company’s net loss decreased slightly to $2.0 million or $0.60 per share. With cash reserves of $12.4 million, Evoke anticipates sufficient funds to operate into Q2 2023.
Evoke Pharma (NASDAQ: EVOK) is set to release its third-quarter financial results on November 9, 2022, after market closure. A conference call will follow at 4:30 p.m. ET for detailed discussion of the results. Evoke Pharma specializes in gastrointestinal treatments, notably GIMOTI, a nasal spray for diabetic gastroparesis. This product is currently the only FDA-approved treatment for this condition in the United States, targeting a significant market opportunity.
Evoke Pharma (NASDAQ: EVOK) will exhibit its flagship product, Gimoti, at the 2022 American College of Gastroenterology Annual Scientific Meeting from October 21-26, 2022, in Charlotte, North Carolina. The company is also nominated for the Healio Industry Breakthrough Product Award and will participate in the Disruptive Innovators Awards Program on October 23. Gimoti is designed for adults with acute and recurrent diabetic gastroparesis, a condition impairing gastric emptying. The company aims to improve discussions with GI professionals during the meeting.
Evoke Pharma (NASDAQ: EVOK) announced on September 20, 2022, that the USPTO has issued a Notice of Allowance for patent application No. 16/469,092, covering methods to treat moderate-to-severe gastroparesis with its GIMOTI nasal spray. This patent will contribute to existing FDA-listed patents and will expire in 2037. GIMOTI is the first FDA-approved nasal formulation of metoclopramide for diabetic gastroparesis, enabling effective non-oral medication administration. The Chief Business Officer emphasized the patent's role in protecting clinical trial outcomes and enhancing market presence.
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