Evoke Pharma Inc Stock Price, News & Analysis

Evoke Pharma (NASDAQ: EVOK), a specialty pharmaceutical company focusing on gastrointestinal (GI) treatments, has announced the issuance of US patent No. 11,628,150 for its GIMOTI® (metoclopramide) nasal spray. This patent, expiring in 2029, covers specific formulations of metoclopramide. The company intends to list this patent in the FDA Orange Book shortly, enhancing its patent portfolio alongside existing patents in the EU, Japan, Canada, and Mexico. CEO Matt D'Onofrio emphasized the importance of this patent in protecting GIMOTI's proprietary administration route, vital for commercial success. GIMOTI addresses symptoms of diabetic gastroparesis, a serious GI disorder affecting many patients globally. This approval reinforces Evoke's commitment to innovation in the GI space.

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.