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.
Company Overview
Evoke Pharma Inc is a biotechnology and specialty pharmaceutical company strategically located at 505 Lomas Santa Fe Dr, Solana Beach, California. The company is dedicated to advancing therapies in the treatment of gastrointestinal disorders, with a primary focus on addressing the challenges of diabetic gastroparesis. By harnessing innovative nasal drug delivery technology, Evoke Pharma has developed a unique formulation of metoclopramide in its proprietary product, GIMOTI, which is designed to overcome the limitations of traditional oral medications.
Core Business and Product Innovation
Evoke Pharma has positioned itself in the competitive healthcare and biotechnology sectors by developing GIMOTI, an investigational metoclopramide nasal spray. This product offers a novel approach for patients suffering from acute and recurrent diabetic gastroparesis by delivering the active molecule systemically through the nasal mucosa. This method addresses a fundamental issue in the treatment of gastroparesis: the delayed gastric emptying that often impedes the effective absorption of orally administered drugs.
Key industry-specific benefits of this approach include:
- Nasal Drug Delivery: Eliminates dependence on gastrointestinal absorption, ensuring that patients receive effective and timely relief.
- Non-Oral Administration: Particularly meaningful in diabetic gastroparesis where conventional oral therapies may not be optimal.
- Enhanced Patient Outcomes: The innovative formulation has demonstrated potential in reducing healthcare resource utilization, including lower emergency room visits and hospitalizations.
Market Position and Strategic Partnerships
Evoke Pharma is recognized for its specialized focus on GI disorders. It has established a robust market position through strategic collaborations with pharmacy networks and commercial service providers. For instance, its recent transition to a streamlined distribution partner underscores the company’s commitment to improving prescription fill rates and ensuring that GIMOTI is readily accessible to healthcare providers and patients alike.
The company’s strategic initiatives include:
- Pharmacy Distribution Enhancement: Collaborations with partners such as ASPN Pharmacies and regional pharmacy networks improve coverage and reimbursements, ensuring patients receive their medications promptly.
- Operational Efficiency: Leadership enhancements and lean business models aid in streamlining operations and reducing overhead costs.
- Capital and Strategic Developments: Recent capital infusions via warrant exercises have reinforced the company’s balance sheet and supported ongoing commercial growth.
Expertise in Gastrointestinal Therapeutics
At the core of Evoke Pharma's mission is its commitment to addressing the unmet needs within the gastrointestinal healthcare landscape. With GIMOTI, the company focuses on alleviating the symptomatic burden of diabetic gastroparesis—a condition that significantly impairs patient quality of life. By providing an alternative to oral metoclopramide, which can be compromised by delayed gastric emptying, Evoke Pharma’s innovative approach demonstrates a deep understanding of the pathophysiology of the disease and the challenges faced by both patients and healthcare providers.
This focus is augmented by a strategic emphasis on building evidence and partnerships that reinforce the clinical and economic benefits of GIMOTI. The company leverages real-world clinical data and feedback from healthcare professionals to continually refine its therapeutic approach, ensuring that its product not only meets regulatory standards but also provides tangible benefits in reducing hospitalizations and improving patient adherence.
Competitive Landscape and Industry Differentiation
Within the biotechnology and specialty pharmaceuticals sectors, Evoke Pharma distinguishes itself as a pioneer in the non-oral treatment of gastroparesis. Unlike traditional therapies that rely on oral formulations, GIMOTI's intranasal delivery system provides a clinically validated solution to overcome the limitations imposed by compromised gastrointestinal function. This distinct mode of action, supported by real-world data, positions the company as a critical player in a market where effective symptom management can lead to reduced overall healthcare costs.
By focusing on a niche yet significant patient population and establishing a strong network of pharmacy partnerships, Evoke Pharma not only underscores its innovative approach but also builds a sustainable competitive advantage in the evolving pharmaceutical landscape.
Commitment to Quality and Regulatory Excellence
Evoke Pharma maintains an unwavering commitment to quality, regulatory compliance, and clinical excellence. Its product development process is underpinned by rigorous research, strategic operational enhancements, and adherence to established industry standards. As the sole developer of a nasal spray formulation of metoclopramide approved for the treatment of diabetic gastroparesis, the company continues to invest in initiatives that bolster its intellectual property portfolio and broaden its market access.
In summary, Evoke Pharma Inc represents a well-positioned entity in the biotechnology and specialty pharmaceutical industries. With its innovative GIMOTI product, the company addresses a critical gap in gastroparesis treatment through a novel, non-oral delivery system. Its strategic partnerships, focus on operational efficiency, and commitment to enhancing patient outcomes cement its role as an authoritative source of innovation in gastrointestinal therapeutics.
Investor and Healthcare Provider Insights
For investors and healthcare professionals seeking to understand the dynamics of the GI therapeutic landscape, Evoke Pharma offers an exemplary case study of targeted innovation. By leveraging its unique product formulation and strategic market initiatives, the company not only meets an urgent medical need but also reinforces its position within a competitive and rapidly evolving sector.
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.
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