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, Inc. (NASDAQ: EVOK) announced that the USPTO has issued a Notice of Allowance for U.S. Application No. 17/100,664 concerning GIMOTI, its nasal spray formulation of metoclopramide. The patent, entitled "Nasal Formulation of Metoclopramide," will be issued on April 18, 2023, and is set to expire in 2030. GIMOTI is the first FDA-approved nasal formulation of metoclopramide, specifically for adults suffering from acute and recurrent diabetic gastroparesis. This new patent strengthens Evoke's existing patent portfolio and reflects the innovation of GIMOTI in improving treatment outcomes for patients, as stated by President & COO Matt D’Onofrio.
Evoke Pharma (NASDAQ: EVOK) has presented real-world data at the AMCP Annual Meeting that highlights the benefits of GIMOTI (metoclopramide nasal spray) in reducing healthcare resource utilization (HCRU) among patients with diabetic gastroparesis (DGP). The study involved 294 patients and demonstrated a significant decrease in physician office visits from an average of 2.2 pre-treatment to 2.0 post-treatment (p=0.03). Additionally, outpatient visits decreased from 1.6 to 1.0 (p<0.01). This finding underscores the potential of GIMOTI to improve patient outcomes and reduce healthcare costs, solidifying its position as an innovative treatment option.
Evoke Pharma, Inc. (NASDAQ: EVOK) announced significant growth in 2022 with net product sales from prescriptions rising 179% to $2.5 million. Patient enrollments increased by 149%. Despite a slight decline in Q4 sales to $796,000, overall prescription fills surged 178% for the year. The company expanded its prescriber base by 25% to 1,017. Evoke's strategic initiatives include enhanced market access via partnerships and telehealth integration. However, net losses for 2022 stood at $8.2 million or $2.62 per share. As of December 31, 2022, cash reserves were approximately $9.8 million, projected to sustain operations into Q3 2023.
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.