Suicidal Ideation

Patent expected to be Orange Book listable, if granted NRX-100, preservative free, IV ketamine, is designed to avoid potential toxicity concerns linked to benzethonium chloride, used in currently available formulations of ketamine Filing strengthens NRx's leadership in advancing safe and effective treatments for suicidal depression WILMINGTON, Del., May 5, 2025 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the "Company"), a clinical-stage biopharmaceutical company, today announced the filing of a patent application for NRX-100, its preservative-free intravenous ketamine formulation for the treatment of suicidal depression. The application discloses pharmaceutical compositions, methods of treatment and methods of manufacture and currently includes twenty claims. While subject to the patent review process of the US Patent and Trademark Office, if granted, the patent would provide NRX-100 exclusivity into 2045. Continue Reading HOPE Therapeutics, Inc. (PRNewsfoto/NRx Pharmaceuticals, Inc.) NRX-100 is specifically formulated without benzethonium chloride or other preservatives, which have been associated with cytotoxic or neurotoxic effects. Current governmental leadership has expressed strong interest in delivering medications without unnecessary or unproven preservatives. Demonstration of room temperature shelf stability in the absence of toxic excipients represents a novel pharmaceutical composition that has the potential to be listed in the FDA Orange Book. This patent filing builds on the Company's recently initiated filing of an NDA for NRX-100 and its prior Fast Track Designation, with NRX-101, from the FDA. If granted, the patent will help protect the innovation behind this formulation as NRx advances its commercialization strategy. "We are committed to delivering safer, more effective treatments for patients with suicidal depression," said Jonathan Javitt MD MPH, CEO of NRx Pharmaceuticals. "NRX-100 eliminates the need for benzethonium chloride, a compound with well-documented safety concerns, and reflects our belief that patients in crisis deserve therapies formulated with their long-term well-being in mind. With the recent FDA fee waiver now in place, we remain on track to complete our NDA submission this quarter — a critical step toward bringing this innovation to patients in need." About NRx Pharmaceuticals, Inc.NRx Pharmaceuticals is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA platform for the treatment of central nervous system disorders, specifically suicidal bipolar depression, chronic pain, and PTSD. The Company is developing NRX-101, an FDA-designated investigational Breakthrough Therapy for suicidal treatment-resistant bipolar depression and chronic pain. NRx plans to file an NDA for Accelerated Approval for NRX-101 in patients with bipolar depression and suicidality or akathisia. NRX-101 additionally has potential to act as a non-opioid treatment for chronic pain, as well as a treatment for complicated UTI.NRx has recently initiated a New Drug Application filing for NRX-100 (IV ketamine) for the treatment of suicidal depression, based on results of well-controlled clinical trials conducted under the auspices of the US National Institutes of Health and newly obtained data from French health authorities, licensed under a data sharing agreement. NRx was awarded Fast Track Designation for development of ketamine (NRX-100) by the US FDA as part of a protocol to treat patients with acute suicidality. About HOPE Therapeutics, Inc.HOPE Therapeutics, Inc. (), a subsidiary of NRx Pharmaceuticals, is a Healthcare delivery company that is building a best-in-class network of interventional psychiatry clinics to offer ketamine, transcranial magnetics stimulation (TMS), and other lifesaving therapies to patients with suicidal depression and related disorders, together with a digital therapeutic-enabled platform designed to augment and preserve the clinical benefit of NMDA-targeted drug therapy. Notice Regarding Forward-Looking Statements The information contained herein includes forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended. These statements include, among others, statements regarding the satisfaction of closing conditions necessary to consummate the acquisition of Kadima and Dura, and obtaining financing necessary to consummate the acquisitions. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as "may," "will," "should," "would," "expect," "plan," "believe," "intend," "look forward," and other similar expressions among others. These statements relate to future events or to the Company's future financial performance, and involve known and unknown risks, uncertainties and other factors that may cause the Company's actual results to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company's control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. Any forward-looking statement reflects the Company's current views with respect to future events and is subject to these and other risks, including the risk that the transactions contemplated by the LOI are not consummated, uncertainties and assumptions relating to the Company's operations, results of operations, growth strategy, liquidity, HOPE Therapeutic's ability to consummate the acquisitions of providers for its national network, the Company's ability to raise adequate capital to fund such acquisitions, and the Company's ability to spin-off HOPE Therapeutics. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's most recent Annual Report on Form 10-K and other filings with the Securities and Exchange Commission. Investors and security holders are urged to read these documents free of charge on the SEC's website at . Except as may be required by applicable law, The Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, whether as a result of new information, future events or otherwise. SOURCE NRx Pharmaceuticals, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

CHICAGO, April 29, 2025 /PRNewswire/ -- Since 1949, the United States has recognized May as Mental Health Awareness Month—a time to spotlight mental health conditions, break the stigma around seeking help, and connect individuals with vital resources. This year's theme, "Turn Awareness into Action," calls for meaningful steps that go beyond conversation to create real change in access and outcomes. Answering that call, Stella Mental Health is proud to announce a major initiative to expand access to care: starting May 1, 2025, Stella will substantially lower the cost of self-pay, non-insurance covered services nationwide—making innovative mental health treatments more affordable and accessible for those who need them most. This initiative comes on the heels of Stella's recent expansion into insurance-covered services, furthering the organization's mission to ensure life-saving treatments are available to as many people as possible. Stella has long recognized that cost and distance are two of the most significant barriers to accessing effective mental health care. With over 20 clinics nationwide—including five new clinics in Utah added through the recent acquisition of Numinus—Stella is committed to closing those gaps. "From the very beginning, Stella has been focused on meeting people where they are—both geographically and financially," said Michael Gershenzon, CEO and Co-Founder of Stella Mental Health. "By being able to lower self-pay costs and expanding insurance coverage, we're making it easier for more people to access the high-quality care they deserve." In addition to more traditional psychiatry and therapy, Stella Mental Health offers a comprehensive range of evidence-based and science-backed biological interventions, including: An advanced Stellate Ganglion Block (SGB) for PTSD/PTSI, anxiety and long COVID called the Dual Sympathetic Reset (DSR) Ketamine Infusion Therapy for depression, PTSD, and suicidality administered in office Transcranial Magnetic Stimulation (TMS)—an insurance-covered, non-invasive treatment for depression and OCD SPRAVATO® (esketamine)—an insurance-covered nasal spray for treatment-resistant depression Each treatment has been shown to provide relief where traditional therapies may have failed, giving patients renewed hope and better outcomes. These expanded treatment options come at a critical time for mental health in America. Recent data from the 2022 National Survey on Drug Use and Health reveals concerning figures about mental health: 59.3 million adults (23.1% of U.S. adults) live with some form of mental illness. 15.4 million adults (6.0%) experience serious mental illness that substantially interferes with major life activities. Young adults aged 18–25 show the highest rates, with 36.2% experiencing mental illness and 11.6% facing serious mental illness. For conditions Stella specifically treats, the numbers highlight significant needs: Anxiety disorders affect approximately 40 million adults annually. Major depression impacts about 21 million adults every year. Post-traumatic stress disorder affects roughly 13 million adults in any given year. These statistics underscore why price reduction initiatives matter—they directly address the financial barriers preventing many Americans from accessing the care they need. "I've seen firsthand over the past five years the incredible challenges our patients face—financial, emotional, and systemic," Gershenzon adds. "That's why we're constantly evolving to meet their needs. Reducing out-of-pocket costs and expanding treatment access isn't just a business decision—it's a reflection of our core mission: to break down barriers and ensure every person has a chance to heal." With this latest move to reduce self-pay pricing, Stella reaffirms its commitment to affordability, innovation, and accessibility, helping thousands of people across the U.S. take the first step toward healing. Stella Mental Health has Centers of Excellence across the U.S. (Encinitas, CA; Irvine, CA; Oak Park, IL; Westmont, IL; Boston, MA; New York, NY and five locations throughout Utah) offering the highest level of specialized care for symptoms of post-traumatic stress, anxiety, and depression. With more than 20 locations nationwide, as well as internationally in Israel and Australia, Stella has helped over 30,000 patients reclaim their lives. Through cutting-edge treatments and compassionate support, Stella Mental Health combines the latest advancements in neuroscience and psychological expertise to provide unparalleled care and innovation. For more information, new pricing, and locations, visit . About Stella: Stella is a leading Interventional Psychiatry practice committed to transforming mental health care through advanced, evidence-based protocols for severe trauma, stress, anxiety, depression, and post-traumatic stress injury (PTSI). With a multidisciplinary team of board-certified physicians, advanced psychiatric nurse practitioners, psychologists, psychiatrists, and dedicated advocates, Stella integrates cutting-edge biological, psychological, and psychiatric approaches to deliver personalized care. MEDIA CONTACT: Daphne Ortiz 312.488.3472 [email protected] SOURCE Stella Mental Health WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

SOLANA BEACH, Calif., April 28, 2025 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ: EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) disorders with an emphasis on GIMOTI®, today announced that a new abstract comparing the incidence of tardive dyskinesia (TD) in patients receiving continuous versus intermittent oral metoclopramide (OMCP) treatment has been accepted for presentation at Digestive Disease Week® (DDW) 2025, taking place May 3–6, 2025, in San Diego, CA. The analysis leverages real-world data from over 100 million U.S. patients and highlights differences in TD incidence rates and timing based on metoclopramide dosing patterns. “This research builds on our ongoing commitment to understanding metoclopramide’s long-term safety profile,” said Matt D’Onofrio, CEO of Evoke Pharma. “As the only FDA-approved treatment for diabetic gastroparesis, it’s critical that we continue evaluating both efficacy and safety, particularly around concerns like tardive dyskinesia. This real-world data helps clarify risk profiles and supports more informed prescribing decisions for physicians interested in Gimoti. We’re excited to share these findings with the DDW community.” Details of the poster presentation are as follows: Abstract Title: Comparison of the Incidence of Tardive Dyskinesia in Patients Receiving Continuous vs Intermittent Oral Metoclopramide Presenter & Lead Author: Pierantonio Russo, MD, EVERSANA Life Sciences Presentation Session: Gastroparesis and Small Intestinal Dysmotility Date & Time: Monday, May 5, 2025, from 12:30 – 1:30 p.m. PT The abstract will be available via the DDW ePosters site and accessible to attendees through the DDW meeting planner and mobile app after 12:01 a.m. PT on Sunday, May 4, 2025. Visit Evoke Pharma at DDW 2025:To learn more about GIMOTI and our latest research, visit Evoke Pharma at booth #917 during DDW. About Evoke Pharma, Inc. Evoke is a specialty pharmaceutical company focused primarily on the development of drugs to treat GI disorders and diseases. The company developed, commercialized and markets GIMOTI, a nasal spray formulation of metoclopramide, for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in adults. Diabetic gastroparesis is a GI disorder affecting millions of patients worldwide, in which the stomach takes too long to empty its contents resulting in serious GI symptoms as well as other systemic complications. The gastric delay caused by gastroparesis can compromise absorption of orally administered medications. Prior to FDA approval to commercially market GIMOTI, metoclopramide was only available in oral and injectable formulations and remains the only drug currently approved in the United States to treat gastroparesis. Visit www.EvokePharma.com for more information. Follow Evoke Pharma on LinkedInFollow Evoke Pharma on Twitter About Digestive Disease Week® (DDW) Digestive Disease Week® (DDW) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA), the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW is an in-person and online meeting from May 3-6, 2025. The meeting showcases nearly 6,000 abstracts and 1,000 invited talks on the latest advances in GI research, medicine, and technology. More information can be found at www.ddw.org. About Gimoti® (metoclopramide) nasal spray GIMOTI is indicated for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis. Important Safety Information WARNING: TARDIVE DYSKINESIA Metoclopramide can cause tardive dyskinesia (TD), a serious movement disorder that is often irreversible. The risk of developing TD increases with duration of treatment and total cumulative dosage.Discontinue GIMOTI in patients who develop signs or symptoms of TD. In some patients, symptoms may lessen or resolve after metoclopramide is stopped.Avoid treatment with metoclopramide (all dosage forms and routes of administration) for longer than 12 weeks because of the increased risk of developing TD with longer-term use. GIMOTI is not recommended for use in: Pediatric patients due to the risk of developing tardive dyskinesia (TD) and other extrapyramidal symptoms as well as the risk of methemoglobinemia in neonates.Moderate or severe hepatic impairment (Child-Pugh B or C), moderate or severe renal impairment (creatinine clearance less than 60 mL/minute), and patients concurrently using strong CYP2D6 inhibitors due to the risk of increased drug exposure and adverse reactions. GIMOTI is contraindicated: In patients with a history of tardive dyskinesia (TD) or a dystonic reaction to metoclopramide.When stimulation of gastrointestinal motility might be dangerous (e.g., in the presence of gastrointestinal hemorrhage mechanical obstruction, or perforation).In patients with pheochromocytoma or other catecholamine-releasing paragangliomas. Metoclopramide may cause a hypertensive/pheochromocytoma crisis, probably due to release of catecholamines from the tumor.In patients with epilepsy. Metoclopramide may increase the frequency and severity of seizures.In patients with hypersensitivity to metoclopramide. Reactions have included laryngeal and glossal angioedema and bronchospasm. Potential adverse reactions associated with metoclopramide include: Tardive dyskinesia (TD), other extrapyramidal effects (EPS), parkinsonism symptoms, motor restlessness, neuroleptic malignant syndrome (NMS), depression, suicidal ideation and suicide, hypertension, fluid retention, hyperprolactinemia, effects on the ability to drive and operate machinery. Most common adverse reactions (≥5%) for GIMOTI are: dysgeusia, headache, and fatigue. These are not all of the possible side effects of GIMOTI. Call your doctor for medical advice about whether you should take GIMOTI and the possible risk factors and side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. Safe Harbor Statement Evoke cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should, ”expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negatives of these terms or other similar expressions. These statements are based on the company’s current beliefs and expectations. These forward-looking statements include statements regarding: guidance regarding 2024 net product sales; potential future prescribing trends for GIMOTI based on Evoke’s or EVERSANA’s marketing efforts; Evoke’s commercialization plans, the potential market opportunity for GIMOTI, Evoke’s partnership with ASPN Pharmacies, growth in prescriptions, patients taking GIMOTI and the conversion of prescriptions to fills, and Evoke’s expected cash runway. The inclusion of forward-looking statements should not be regarded as a representation by Evoke that any of its plans will be achieved. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in Evoke’s business, including, without limitation: Evoke may not be able to achieve its guidance for 2024 including as a result of decreased demand for GIMOTI; Evoke’s and EVERSANA’s ability to successfully drive market demand for GIMOTI; Evoke’s ability to obtain additional financing as needed to support its operations; Evoke may use its capital resources sooner than expected; warrant holders may choose not to exercise any of the outstanding warrants; Evoke’s dependence on third parties for the manufacture of GIMOTI; Evoke is entirely dependent on the success of GIMOTI; inadequate efficacy or unexpected adverse side effects relating to GIMOTI that could result in recalls or product liability claims; Evoke’s ability to maintain intellectual property protection for GIMOTI; and other risks and uncertainties detailed in Evoke’s prior press releases and in the periodic reports it files with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Evoke undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Investor & Media Contact:Daniel Kontoh-BoatengDKB PartnersTel: 862-213-1398dboateng@dkbpartners.net