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July 24, 2024 -- ConSynance Therapeutics, Inc., a clinical-stage biopharmaceutical company developing first-in-class therapies for rare central nervous system (CNS) disorders, today announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation (RPDD) to its investigational drug CSTI-500 for the treatment of Prader-Willi Syndrome (PWS) in children and adolescents. “Receiving RPDD from the FDA is a significant regulatory milestone for ConSynance as we prepare for the Phase 2 study of CSTI-500 for PWS,” said Shuang Liu, PhD, Founder and CEO of ConSynance. “PWS is a rare neurodevelopmental disorder characterized by hyperphagia and severe temper outbursts, among other neuropsychiatric behaviors. CSTI-500 targets the imbalance of three key neurotransmitters, serotonin, dopamine and norepinephrine associated with these behaviors. CSTI-500 stands out as the first drug candidate for PWS designed to address both hyperphagia and severe temper outbursts, providing a potential breakthrough and comprehensive treatment solution for this challenging disorder.” The FDA defines rare pediatric diseases as conditions affecting fewer than 200,000 individuals in the United States, which are serious or life-threatening and primarily impact those under 18 years of age. This designation makes ConSynance eligible to receive a transferable Priority Review Voucher if CSTI-500 receives FDA approval for PWS. Priority Review Vouchers have recently sold for approximately $100 million, highlighting their significant value. More About CSTI-500: CSTI-500 is a phase 2-ready, first-in-class, orally administered Triple Monoamine Reuptake Inhibitor (TRI). It is designed to optimally increase the levels of three critical neurotransmitters, serotonin, dopamine, and norepinephrine in the synaptic clefts of neurons. Human and animal data suggest that PWS is associated with low levels of these neurotransmitters. Deficiencies in these neurotransmitters are also implicated in many other neuropsychiatric disorders, as evidenced by the approval of selective serotonin reuptake inhibitors, selective norepinephrine reuptake inhibitors, and dopamine norepinephrine reuptake inhibitors in conditions like binge eating disorder (BED), obsessive compulsive disorders (OCD), attention deficit hyperactivity disorder (ADHD), among others. CSTI-500 has demonstrated brain target engagement in healthy volunteers via positron emission tomography (PET). These data, along with the corresponding pharmacokinetics data, predict the efficacy of CSTI-500 in PWS and other neuropsychiatric indications, and enable a personalized dosing approach to ensure optimal safety and efficacy. CSTI-500 has been studied in nearly 100 humans across three Phase 1 clinical trials, including 10 PWS patients, setting the stage for a Phase 2 study expected to commence in 2025. About PWS: PWS is a rare, complex genetic neurodevelopmental disorder that affects approximately 1 in 15,000 live births. Initially characterized by severe hypotonia and failure to thrive, it evolves into a life-threatening hyperphagia beginning in early childhood, compounded by other debilitating neuropsychiatric behaviors, notably severe temper outbursts. Despite significant challenges faced by PWS patients and their families, there are currently no approved therapies that address the core dysfunctional brain networks associated with abnormal levels of monoamines and consequent neuropsychiatric behaviors in PWS. Normalizing these neurotransmitters may restore functional neural circuits, alleviating hyperphagia, temper outbursts, among other behavioral symptoms that significantly impact the patients and their families. About ConSynance Therapeutics: ConSynance is a New York-based biopharmaceutical company dedicated to developing innovative therapies for rare CNS disorders. ConSynance is a member of the PWS Clinical Trial Consortium and engaged in an ongoing partnership with Harmony Biosciences to develop HBS-102 (formerly known as CSTI-100) for the treatment of a variety of rare neurological diseases. These partnerships underscore the company's collaborative approach and its drive to bring effective therapies to patients in need. The content above comes from the network. if any infringement, please contact us to modify.

STOUGHTON, Mass., April 29, 2024 (GLOBE NEWSWIRE) --Collegium Pharmaceutical, Inc. (Nasdaq: COLL), a leading, diversified specialty pharmaceutical company committed to improving the lives of people living with serious medical conditions, today announced it has entered into an authorized generic agreement with Hikma Pharmaceuticals USA Inc. (“Hikma”), pursuant to which Hikma will have the exclusive right to sell the authorized generic versions of Nucynta® and Nucynta® ER (“the Nucynta Franchise”) in the United States. “Our agreement with Hikma bolsters the value of the Nucynta Franchise through 2025 and beyond,” said Joe Ciaffoni, President and Chief Executive Officer of Collegium. “Collegium is pleased to work with Hikma, an industry leader, to ensure that these important products continue to be manufactured to the highest quality standards and remain broadly and consistently accessible to appropriate patients.” Under the terms of the agreement: Collegium will manufacture and supply Hikma with all authorized generic product for sale on an exclusive basis during the term of the agreement. Hikma will sell the authorized generic forms of the Nucynta Franchise in the United States, commencing 30 days prior to the anticipated loss of exclusivity for each product, or earlier under certain circumstances. Collegium will receive a meaningful share of net profits of the authorized generic products, that declines based on the number of generic entrants, if any. About Collegium Pharmaceutical, Inc. Collegium is a leading, diversified specialty pharmaceutical company committed to improving the lives of people living with serious medical conditions. Collegium’s headquarters are located in Stoughton, Massachusetts. For more information, please visit the Company’s website at Forward-Looking Statements This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. We may, in some cases, use terms such as "predicts," "forecasts," "believes," "potential," "proposed," "continue," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "should" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Examples of forward-looking statements contained in this press release include, among others, statements related to current and future market opportunities for our products and our assumptions related thereto, expectations (financial or otherwise) and intentions, and other statements that are not historical facts. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results, performance, or achievements to differ materially from the company's current expectations, including risks relating to, among others: unknown liabilities; risks related to future opportunities and plans for our products, including uncertainty of the expected financial performance of such products; our ability to commercialize and grow sales of our products; our ability to manage our relationships with licensors; the success of competing products that are or become available; our ability to maintain regulatory approval of our products, and any related restrictions, limitations, and/or warnings in the label of our products; the size of the markets for our products, and our ability to service those markets; our ability to obtain reimbursement and third-party payor contracts for our products; the rate and degree of market acceptance of our products; the costs of commercialization activities, including marketing, sales and distribution; changing market conditions for our products; the outcome of any patent infringement or other litigation that may be brought by or against us; the outcome of any governmental investigation related to our business; our ability to secure adequate supplies of active pharmaceutical ingredient for each of our products and manufacture adequate supplies of commercially saleable inventory; our ability to obtain funding for our operations and business development; regulatory developments in the U.S.; our expectations regarding our ability to obtain and maintain sufficient intellectual property protection for our products; our ability to comply with stringent U.S. and foreign government regulation in the manufacture of pharmaceutical products, including U.S. Drug Enforcement Agency, or DEA, compliance; our customer concentration; and the accuracy of our estimates regarding expenses, revenue, capital requirements and need for additional financing. These and other risks are described under the heading "Risk Factors" in our Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q and other filings with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release. Investor Contact: Christopher James, M.D. Vice President, Investor Relations ir@collegiumpharma.com Media Contact: Marissa Samuels Vice President, Corporate Communications communications@collegiumpharma.com

NEW YORK, March 19, 2024 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced the first patient has been dosed in the PARADIGM Phase 3 trial of solriamfetol, an investigational treatment for major depressive disorder (MDD). PARADIGM (Progressing TAAR-1, Dopamine, and Norepinephrine in Depression Using Solriamfetol) is a Phase 3, randomized, double-blind, placebo-controlled, multicenter trial to assess the efficacy and safety of solriamfetol for the treatment of MDD in adults. Approximately 300 patients will be randomized in a 1:1 ratio to receive solriamfetol (300 mg) or placebo for 6 weeks. The primary endpoint will be change in the Montgomery Åsberg Depression Rating Scale (MADRS). About Major Depressive Disorder Major depressive disorder (MDD) is a debilitating, chronic, biologically based disorder characterized by low mood, inability to feel pleasure, feelings of guilt and worthlessness, low energy, and other emotional and physical symptoms, and which impairs social, occupational, educational, or other important functioning. In severe cases, MDD can result in suicide. According to the National Institutes of Health, an estimated 8.3% of U.S. adults, or approximately 21 million, experience MDD each year1. According to the World Health Organization (WHO), depression is the leading cause of disability worldwide, and is a major contributor to the overall global burden of disease2. Nearly two-thirds of diagnosed and treated patients do not experience adequate treatment response with currently available first-line therapy3, highlighting the need for additional therapies with new mechanisms of action. About Solriamfetol Solriamfetol is a dopamine and norepinephrine reuptake inhibitor and trace amine-associated receptor 1 (TAAR1) agonist. Solriamfetol is not approved by the FDA for the treatment of major depressive disorder. About Axsome Therapeutics, Inc. Axsome Therapeutics, Inc. is a biopharmaceutical company developing and delivering novel therapies for central nervous system (CNS) conditions that have limited treatment options. Through development of therapeutic options with novel mechanisms of action, we are transforming the approach to treating CNS conditions. At Axsome, we are committed to developing products that meaningfully improve the lives of patients and provide new therapeutic options for physicians. For more information, please visit the Company’s website at axsome.com. The Company may occasionally disseminate material, nonpublic information on the company website. Forward Looking Statements Certain matters discussed in this press release are “forward-looking statements”. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. In particular, the Company’s statements regarding trends and potential future results are examples of such forward-looking statements. The forward-looking statements include risks and uncertainties, including, but not limited to, the continued commercial success of our Sunosi® and Auvelity® products and the success of our efforts to obtain any additional indication(s) with respect to solriamfetol and/or AXS-05; the success, timing and cost of our ongoing clinical trials and anticipated clinical trials for our current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including our ability to fully fund our disclosed clinical trials, which assumes no material changes to our currently projected revenues or expenses), futility analyses and receipt of interim results, which are not necessarily indicative of the final results of our ongoing clinical trials, and/or data readouts, and the number or type of studies or nature of results necessary to support the filing of a new drug application (“NDA”) for any of our current product candidates; our ability to fund additional clinical trials to continue the advancement of our product candidates; the timing of and our ability to obtain and maintain U.S. Food and Drug Administration (“FDA”) or other regulatory authority approval of, or other action with respect to, our product candidates, including statements regarding the timing of any NDA submission; whether issues identified by FDA in the complete response letter may impact the potential approvability of the Company’s NDA for AXS-07 for the acute treatment of migraine in adults with or without aura, pursuant to our special protocol assessment for the MOMENTUM clinical trial; the Company’s ability to successfully defend its intellectual property or obtain the necessary licenses at a cost acceptable to the Company, if at all; the successful implementation of the Company’s research and development programs and collaborations; the success of the Company’s license agreements; the acceptance by the market of the Company’s products and product candidates, if approved; the Company’s anticipated capital requirements, including the amount of capital required for the continued commercialization of Sunosi and Auvelity and for the Company’s commercial launch of its other product candidates, if approved, and the potential impact on the Company’s anticipated cash runway; unforeseen circumstances or other disruptions to normal business operations arising from or related to geo-political conflicts or a global pandemic and other factors, including general economic conditions and regulatory developments, not within the Company’s control. The factors discussed herein could cause actual results and developments to be materially different from those expressed in or implied by such statements. The forward-looking statements are made only as of the date of this press release and the Company undertakes no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstance. Axsome Contacts: Investors: Mark Jacobson Chief Operating Officer Axsome Therapeutics, Inc. One World Trade Center, 22nd Floor New York, NY 10007 Tel: 212-332-3243 Email: mjacobson@axsome.com Media: Darren Opland Director, Corporate Communications Axsome Therapeutics, Inc. One World Trade Center, 22nd Floor New York, NY 10007 Tel: 929-837-1065 Email: dopland@axsome.com Media: U.S. Department of Health and Human Services. Key Substance Use and Mental Health Indicators in the United States: Results from the 2020 National Survey on Drug Use and Health. Published October 2021. Baune BT, et al. Neuropsychiatr Dis Treat 2021;17:2995-3006. Wardenaar KJ, et al. J. Affect. Disord 2012; 136:1198-1203.