MC4R x MC1R

Dry Eye Disease (DED): PL9643 MELODY-2 & MELODY-3 Phase 3 Pivotal Clinical Studies FDA Confirms Protocols and Endpoints Targeting Enrollment Start in 4Q Calendar Year 2024 Topline Results Anticipated 4Q Calendar Year 2025 Potential Collaboration/Funding Discussions Ongoing Obesity: Phase 2 Clinical Study with Melanocortin-4 Receptor (MC4R) Agonist + Glucagon Like Peptide-1 (GLP-1) Patient Dosing Commenced 3Q Calendar Year 2024 Topline Results Expected 1Q Calendar Year 2025 Male Sexual Dysfunction: Development and Clinical Program with Bremelanotide Co-Formulated with a PDE5i for the Treatment of Erectile Dysfunction (ED) in Patients That Do Not Respond to PDE5i Monotherapy Pharmacokinetics Study Expected to Start 1Q Calendar Year 2025 Patient Recruitment in Phase 3 Study Anticipated in 2H Calendar Year 2025 Ulcerative Colitis (UC): Oral PL8177 Phase 2 Clinical Study in Active UC Patients Interim Analysis Readout Expected in 4Q Calendar Year 2024 Topline Results Anticipated 1Q Calendar Year 2025 Potential Collaboration Discussions Ongoing CRANBURY, N.J. , Sept. 9, 2024 /PRNewswire/ -- Palatin Technologies, Inc. (NYSE American: PTN), a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin receptor system, today provided an update on its clinical programs, strategic priorities, and anticipated milestones. "We continue to execute on the clinical development front and expect several key milestones from multiple programs over the next twelve months," said Carl Spana, Ph.D., President and Chief Executive Officer of Palatin. "Patient dosing has commenced in our Phase 2 clinical study of an MC4R agonist plus a GLP-1 in obese patients. Our clinical program evaluating bremelanotide co-formulated with a PDE5i for the treatment of ED in patients who do not respond to PDE5i monotherapy is expected to begin in the first half of calendar year 2025. An interim analysis readout on our Phase 2 clinical trial of PL8177 in patients with UC is expected later this calendar year. Additionally, as a result of a positive Type C meeting with the FDA and agreement on PL9643 for DED Phase 3 trial protocols and endpoints, we anticipate the initiation of pivotal clinical studies MELODY-2 and MELODY-3 in the fourth quarter of this calendar year." Dr. Spana further commented, "We are focused on the continued development of melanocortin receptor system treatments for obesity and male sexual dysfunction. We are actively engaging in discussions with potential partners and companies that have the financial and operational resources to progress PL9643 for DED, our other ocular programs, and our ulcerative colitis program, through development, approval, and into commercialization. Program Updates and Anticipated Milestones Ocular Programs (melanocortin receptor agonists): Phase 3 PL9643 clinical program for the treatment of dry eye disease (DED): Potential collaboration/funding discussions ongoing MELODY-2 & MELODY-3 Phase 3 pivotal clinical studies Concluded a positive Type C meeting with the FDA and reached an agreement on sign and symptom endpoints on the remaining two Phase 3 pivotal trial protocols Targeting 4Q calendar year 2024 to begin patient enrollment Topline results anticipated 4Q calendar year 2025 Potential NDA submission 1H calendar year 2026 Successful Phase 3 MELODY-1 pivotal study successfully completed Statistical significance (p<0.025) met for co-primary symptom endpoint of pain Statistical significance (p,0.05) met for 7 of 11 secondary symptom endpoints at the 12-week treatment period Statistical significance (p<0.05) met for rapid onset of efficacy and multiple symptom endpoints, including the co-primary pain endpoint at the 2-week treatment period and continued to improve over the 12-week treatment period Statistical significance (p<0.05) met for multiple sign endpoints, including 4 fluorescein staining endpoints at the 2-week treatment period Corneal fluorescein staining is used to measure corneal epithelial damage and reductions in corneal fluorescein staining with treatments like PL9643 indicate improvement in corneal health Excellent safety and tolerability profile Obesity Program: Phase 2 clinical study for the co-administration of melanocortin agonist bremelanotide (MC4R) with tirzepatide (GLP-1) in obese patients for the treatment of obesity: Initiated 2Q of calendar year 2024 Patient dosing commenced 3Q calendar year 2024 Topline results expected 1H calendar year 2025 The study is designed to enroll up to 60 patients at four trial sites in the United States with the Primary endpoint of the trial to demonstrate the safety and increased efficacy of co-administration of bremelanotide with tirzepatide on reducing body weight Patients will be treated with tirzepatide-only for four weeks, have eligibility confirmed, then randomized to one of four treatment regimens Patients will undergo multiple assessments of safety and efficacy to help profile the effectiveness of bremelanotide in treating general obesity as a stand-alone treatment or in conjunction with GLP-1/GIP therapy Additional trial information, including inclusion and exclusion criteria, can be found at via the identifier NCT06565611 Novel MC4R selective long-acting agonist: Initiation of investigational new drug (IND) enabling activities expected 4Q of calendar year 2024 Filing of IND anticipated 2H of calendar year 2025 Male Sexual Dysfunction Program: Initiated a development and clinical program for the evaluation of bremelanotide co-formulated with PDE5 inhibitor (PDE5i), for the treatment of erectile dysfunction (ED) in patients that do not respond to PDE5i monotherapy: Pharmacokinetics study initiation expected to start 1Q of calendar year 2025 Patient recruitment in Phase 3 clinical study anticipated 2H calendar year 2025 Topline results targeted for 1H calendar year 2026 Approximately 35% of men with ED have an inadequate response to PDE5i treatments and represent a large underserved market Palatin previously conducted clinical trials showing the synergistic effects of combining bremelanotide with a PDE5i as a treatment for ED Ulcerative Colitis Program (melanocortin receptor agonist): Phase 2 PL8177 oral formulation for the treatment of ulcerative colitis (UC): Potential collaboration discussions ongoing Interim analysis expected in 4Q calendar year 2024 Topline results anticipated 1Q calendar year 2025 Additional trial information, including inclusion and exclusion criteria, can be found at via the identifier NCT05466890 Diabetic Nephropathy Program (melanocortin receptor agonist): Phase 2 bremelanotide BREAKOUT study (BMT 701) in patients with diabetic kidney disease: Topline results expected in the fourth quarter of calendar year 2024 Additional trial information, including inclusion and exclusion criteria, can be found at via the identifier NCT05709444 Vyleesi® (bremelanotide injection) / Hypoactive Sexual Desire Disorder: Asset sale to Cosette Pharmaceuticals for up to $171 million closed in December 2023: $12 million upfront, plus potential sales-based milestones of up to $159 million based on annual net sales ranging from $15 million to $200 million Palatin retained rights and use of bremelanotide for obesity and male erectile dysfunction indications About Melanocortin Receptor Agonists The melanocortin receptor ("MCR") system has effects on inflammation, immune system responses, metabolism, food intake, and sexual function. There are five melanocortin receptors, MC1R through MC5R. Modulation of these receptors, through use of receptor-specific agonists, which activate receptor function, or receptor-specific antagonists, which block receptor function, can have medically significant pharmacological effects. Many tissues and immune cells located in the eye (and other places, for example the gut and kidney) express melanocortin receptors, empowering our opportunity to directly activate natural pathways to resolve disease inflammation. About Palatin Palatin is a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin receptor systems, with targeted, receptor-specific product candidates for the treatment of diseases with significant unmet medical need and commercial potential. Palatin's strategy is to develop products and then form marketing collaborations with industry leaders to maximize their commercial potential. For additional information regarding Palatin, please visit Palatin's website at and follow Palatin on Twitter at @PalatinTech. Forward-looking Statements Statements in this press release that are not historical facts, including statements about future expectations of Palatin Technologies, Inc., such as statements about Palatin products in development, clinical trial results, potential actions by regulatory agencies including the FDA, regulatory plans, development programs, proposed indications for product candidates, and market potential for product candidates are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and as that term is defined in the Private Securities Litigation Reform Act of 1995. Palatin intends that such forward-looking statements be subject to the safe harbors created thereby. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause Palatin's actual results to be materially different from its historical results or from any results expressed or implied by such forward-looking statements. Palatin's actual results may differ materially from those discussed in the forward-looking statements for reasons including, but not limited to, results of clinical trials, regulatory actions by the FDA and other regulatory and the need for regulatory approvals, Palatin's ability to fund development of its technology and establish and successfully complete clinical trials, the length of time and cost required to complete clinical trials and submit applications for regulatory approvals, products developed by competing pharmaceutical, biopharmaceutical and biotechnology companies, commercial acceptance of Palatin's products, and other factors discussed in Palatin's periodic filings with the Securities and Exchange Commission. Palatin is not responsible for updating events that occur after the date of this press release. Palatin Technologies® is a registered trademark of Palatin Technologies, Inc. SOURCE Palatin Technologies, Inc.

Melanocortin receptors on neurons in the brain control feeding and weight lossPatented peptide molecules delivered orally as a pill can control feeding disorders and weight loss NEW YORK, Aug. 09, 2024 (GLOBE NEWSWIRE) -- ANEW MEDICAL, INC. (NASDAQ: WENA) has announced that, as a result of its worldwide licensing agreement with Teleost Biopharmaceuticals and the University of Arizona, it plans to pursue the development of therapeutics using novel proprietary peptides that selectively bind and activate melanocortin receptors on neuronal cells in the brain. The neurobiology of overeating and obesity is well known, and the melanocortin-3 and melanocortin-4 receptors are definitively involved in the control of eating disorders and obesity. Data from the World Health Organization (WHO) indicate that the state of being overweight and obese constitutes the fifth leading risk for death globally. At least 2.8 million adults die each year as a result of being overweight. In addition, 44% of diabetes mellitus cases are attributed to excess weight. Certainly, the discovery by Novo and Lilly of the diabetes medicines based on semaglutide (Ozempic™, Wagovy™, Rebelsus™) have had a major impact on weight loss and obesity, both healthwise for obese patients and financially for the pharmaceutical companies. Semaglutide acts like something your body naturally produces called glucagon-like peptide 1 (GLP-1). This drug binds to the GLP-1 receptors in your body, making you feel less hungry and more full. It also helps lower blood sugar levels, similar to the function of insulin which it releases from the pancreas. However the side effects of the acute and chronic use of these GLP-1 agonists may, in certain cases, be problematic and not fully understood. Dr. Joseph Sinkule, Founder and CEO of ANEW, commented: "Through our agreements with Teleost and the University of Arizona, we have licensed patents and know-how to develop pharmaceutical products for weight loss and eating disorders. This program fits in well with our other neuroscience programs and we believe this program is quite compelling. The eating disorders we plan to target will include obesity (overeating) but also cachexia (anorexia or sarcopenia). Studies in animal models of obesity show that we can administer the peptide formulations by mouth (orally) instead of by injection (e.g. the semaglutides) and the authors of those studies have observed weight loss and improved energy levels. Small peptides can be synthesized and administered orally, which we expect to enable these medications to be significantly more affordable than the retail cost of the semaglutides.” The central melanocortin system in the brain plays a critical role in regulation of body weight. Melanocortins are bioactive peptides derived from a common pre-hormone produced in the brain’s hypothalamic region called “POMC” that is converted to α-melanocyte stimulating hormone (α-MSH), a major regulator in the brain of feeding and weight loss. Numerous studies have demonstrated that the hypothalamic melanocortin system is critical for the maintenance of body weight and energy homeostasis. About ANEW MEDICAL, INC.:ANEW MEDICAL, INC. (NASDAQ: WENA) is a biopharmaceutical company specializes in the development of patented, novel disease-modifying technologies targeting the brain and central nervous system (CNS). The Company has obtained exclusive worldwide rights to platform technologies and knowhow to develop cutting-edge peptide, protein, gene and cell therapies to treat age-related pathologies such as Alzheimer’s and Parkinson’s Disease, ALS, multiple sclerosis and rare neurodegenerative diseases. The Company is also pursuing other programs and product candidates in the general area of neurosciences. ANEW Medical is managed by a team of individuals and advisors that are highly experienced in biopharmaceutical product development and commercialization. For more information, contact:Investor RelationsEric BoydEmail: IR@anewmeds.com Forward-Looking Statements:This press release contains forward-looking statements. These statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements generally are identified by the words “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “strategy,” “future,” “opportunity,” “plan,” “may,” “should,” “will,” “would,” “will be,” “will continue,” “will likely result,” and similar expressions. Without limiting the generality of the foregoing, the forward-looking statements in this press release include descriptions of the Company’s future commercial operations. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this press release, such as the Company’s inability to implement its business plans, identify and realize additional opportunities, or meet or exceed its financial projections and changes in the regulatory or competitive environment in which the Company operates. You should carefully consider the foregoing factors and the other risks and uncertainties described in the documents filed or to be filed by the Company with the U.S. Securities and Exchange Commission (the “SEC”) from time to time, which could cause actual events and results to differ materially from those contained in the forward-looking statements. Copies of these documents are available on the SEC’s website, www.sec.gov. All information provided herein is as of the date of this press release, and the Company undertakes no obligation to update any forward-looking statement, except as required under applicable law.

- Participants from the completed Phase 2 hypothalamic obesity trial reported positive changes in sleep, energy levels during setmelanotide therapy in qualitative interviews - - Separate analysis of patients across MC4R pathway diseases showed one year of treatment with setmelanotide improved NIH, WHO weight classifications - - Previously reported stage one results from Phase 2 DAYBREAK trial showed potential setmelanotide efficacy in multiple MC4R pathway variants; stage two data expected in Q3 2024 - - Preclinical data demonstrated potential of RM-718 to reduce body weight and hunger - - Additional posters feature design of Phase 1 trial of RM-718 and real-world RESTORE study - BOSTON, June 03, 2024 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a global commercial-stage biopharmaceutical company focused on transforming the lives of patients and their families living with rare neuroendocrine diseases, today announced the presentation of the first patient and caregiver reported experiences from qualitative interviews following the completion of a Phase 2 trial that evaluated treatment with setmelanotide in hypothalamic obesity (HO). These results were among six Rhythm presentations at the Endocrine Society Annual Meeting & Expo (ENDO 2024) being held June 1-4 in Boston. “We continue to advance what we believe to be the most comprehensive clinical research program ever initiated for the treatment of hyperphagia and severe obesity associated with rare melanocortin-4 receptor (MC4R) pathway diseases,” said David Meeker, M.D., Chair, President and Chief Executive Officer of Rhythm. “For the first time, we presented patient and caregiver reported results showing that setmelanotide therapy in patients with hypothalamic obesity was associated with meaningful improvements in their lives beyond clinical outcomes and reductions in body mass index (BMI).” Christian Roth, M.D., Seattle Children’s Research Institute and Division of Endocrinology, Department of Pediatrics, University of Washington, presented, “Patient- and Caregiver-reported Experiences of Hunger, Weight and Energy in Acquired Hypothalamic Obesity Before and During Setmelanotide Therapy.” In qualitative interviews before setmelanotide therapy, five participants (three patients, two caregivers) all reported experiencing substantial weight gain, unrelenting hunger, drastically reduced energy or physical activity, and interrupted nighttime sleep, primarily due to hunger associated with acquired hypothalamic obesity. In their experiences following initiation of setmelanotide therapy, all study participants reported improved energy and ability and desire to be more active, and four of five participants reported reductions in hunger, positive changes in eating behavior and improvements in sleep. Rhythm and its collaborators also delivered two rapid-fire oral presentations and accompanying posters at ENDO 2024: Dr. Roth presented results from an analysis of the clinical characteristics of 58 individuals who participated in trials of setmelanotide across MC4R pathway diseases including hypothalamic obesity, proopiomelanocortin (POMC) or leptin receptor (LEPR) deficiency obesities, or Bardet-Biedl syndrome (BBS). After one year of treatment with setmelanotide, improvements of at least one obesity class were observed across all cohorts (HO: 92%; POMC deficiency: 89%; LEPR deficiency: 36%; BBS: 42%). Patients with LEPR deficiency and BBS had more severe weight categories at baseline but still showed general improvement in weight categories after one year of treatment.Danica Grujic, Ph.D., Senior Director, Non-Clinical Development, Translational Research & Development, Rhythm Pharmaceuticals, presented results from a preclinical study that evaluated treatment with RM-718, a selective MC4R agonist designed to be administered weekly with potential to avoid MC1R-related hyperpigmentation, in a rodent model of obesity, hyperphagia, and insulin resistance. Treatment was well-tolerated and stable weight and food intake reductions and improved insulin sensitivity were observed after three weeks. Rhythm and its collaborators also presented three additional posters at ENDO 2024: Elif Oral, M.D., Associate Professor in the Division of Metabolism, Endocrinology and Diabetes (MEND) at The University of Michigan, presented previously reported stage one results from the two-stage, double-blind, placebo-controlled DAYBREAK trial that show potential setmelanotide efficacy in individuals who carry variants in SEMA3[A-G], PLXNA[1-4], PHIP, TBX3, MAGEL2, or SIM1. At least one patient in each of those cohorts achieved ≥10% body mass index (BMI) reduction at the end of the 16-week, open-label run-in period. Overall, 49 responders were randomized into stage two, which is a 24-week, double-blind, randomized, placebo-controlled period. Setmelanotide was well tolerated with no new safety concerns.Dr. Roth presented the design of Rhythm’s first-in-human Phase 1 trial of once-weekly RM-718 in individuals with obesity or patients with HO.Caroline Huber, Director, Value & Evidence, Rhythm Pharmaceuticals, presented the design of Real-world Evidence of SeTmelanotide fOr Hyperphagia and ChRonic Weight ManagEment (RESTORE), the first study to assess the real-world effectiveness of setmelanotide to provide a greater understanding of patient outcomes, such as hyperphagia and quality of life, in a clinical practice setting. About Rhythm PharmaceuticalsRhythm is a commercial-stage biopharmaceutical company committed to transforming the lives of patients and their families living with rare neuroendocrine diseases. Rhythm’s lead asset, IMCIVREE® (setmelanotide), an MC4R agonist designed to treat hyperphagia and severe obesity, is approved by the U.S. Food and Drug Administration (FDA) for chronic weight management in adult and pediatric patients 6 years of age and older with monogenic or syndromic obesity due to pro-opiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1) or leptin receptor (LEPR) deficiency confirmed by genetic testing, or patients with a clinical diagnosis of Bardet-Biedl syndrome (BBS). Both the European Commission (EC) and the UK’s Medicines & Healthcare Products Regulatory Agency (MHRA) have authorized setmelanotide for the treatment of obesity and the control of hunger associated with genetically confirmed BBS or genetically confirmed loss-of-function biallelic POMC, including PCSK1, deficiency or biallelic LEPR deficiency in adults and children 6 years of age and above. Additionally, Rhythm is advancing a broad clinical development program for setmelanotide in other rare diseases, as well as investigational MC4R agonists LB54640 and RM-718, and a preclinical suite of small molecules for the treatment of congenital hyperinsulinism. Rhythm’s headquarters is in Boston, MA. Setmelanotide IndicationIn the United States, setmelanotide is indicated for chronic weight management in adult and pediatric patients 6 years of age and older with monogenic or syndromic obesity due to POMC, PCSK1 or LEPR deficiency as determined by an FDA-approved test demonstrating variants in POMC, PCSK1 or LEPR genes that are interpreted as pathogenic, likely pathogenic, or of uncertain significance (VUS) or BBS. In the European Union and United Kingdom, setmelanotide is indicated for the treatment of obesity and the control of hunger associated with genetically confirmed BBS or loss-of-function biallelic POMC, including PCSK1, deficiency or biallelic LEPR deficiency in adults and children 6 years of age and above. In the European Union and United Kingdom, setmelanotide should be prescribed and supervised by a physician with expertise in obesity with underlying genetic etiology. Limitations of UseSetmelanotide is not indicated for the treatment of patients with the following conditions as setmelanotide would not be expected to be effective: Obesity due to suspected POMC, PCSK1 or LEPR deficiency with POMC, PCSK1 or LEPR variants classified as benign or likely benignOther types of obesity not related to POMC, PCSK1 or LEPR deficiency, or BBS, including obesity associated with other genetic syndromes and general (polygenic) obesity. ContraindicationPrior serious hypersensitivity to setmelanotide or any of the excipients in IMCIVREE. Serious hypersensitivity reactions (e.g., anaphylaxis) have been reported. WARNINGS AND PRECAUTIONS Skin Pigmentation and Darkening of Pre-Existing Nevi: Generalized increased skin pigmentation and darkening of pre-existing nevi have occurred because of its pharmacologic effect. Full body skin examinations prior to initiation and periodically during treatment should be conducted to monitor pre-existing and new pigmentary lesions. Heart rate and blood pressure monitoring: In Europe, heart rate and blood pressure should be monitored as part of standard clinical practice at each medical visit (at least every 6 months) for patients treated with setmelanotide. Disturbance in Sexual Arousal: Spontaneous penile erections in males and sexual adverse reactions in females have occurred. Patients who have an erection lasting longer than 4 hours should seek emergency medical attention. Depression and Suicidal Ideation: Depression and suicidal ideation have occurred. Patients should be monitored for new onset or worsening depression or suicidal thoughts or behaviors. Consideration should be given to discontinuing setmelanotide if patients experience suicidal thoughts or behaviors, or clinically significant or persistent depression symptoms occur. Hypersensitivity Reactions: Serious hypersensitivity reactions (e.g., anaphylaxis) have been reported. If suspected, advise patients to promptly seek medical attention and discontinue setmelanotide. Pediatric Population: The prescribing physician should periodically assess response to setmelanotide therapy. In growing children, the impact of weight loss on growth and maturation should be evaluated. In Europe, the prescribing physician should monitor growth (height and weight) using age- and sex-appropriate growth curves. Risk of Serious Adverse Reactions Due to Benzyl Alcohol Preservative in Neonates and Low Birth Weight Infants: Setmelanotide is not approved for use in neonates or infants. Serious and fatal adverse reactions including “gasping syndrome” can occur in neonates and low birth weight infants treated with benzyl alcohol-preserved drugs. ADVERSE REACTIONS Most common adverse reactions (incidence ≥20%) included skin hyperpigmentation, injection site reactions, nausea, headache, diarrhea, abdominal pain, vomiting, depression, and spontaneous penile erection. USE IN SPECIFIC POPULATIONS Lactation: Not recommended when breastfeeding. REPORTING OF SIDE EFFECTS If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also contact Rhythm Pharmaceuticals at +1 (833) 789-6337. To report directly via the Yellow Card Scheme please do so via: www.mhra.gov.uk/yellowcard. To report directly to the FDA contact 1-800-FDA-1088 or www.fda.gov/medwatch. [See section 4.8 of the Summary of Product Characteristics for information on reporting suspected adverse reactions in Europe.] By reporting side effects, you can help provide more information on the safety of this medicine. Please see the Summary of Product Characteristics and full Prescribing Information for additional Important Safety Information. Forward-looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding the Company’s participation in and the content of its presentations at conferences including the ENDO 2024 conference; the promise and potential impact of the Company’s preclinical or clinical trial data; the initiation, timing, design, or results of any clinical trials or readouts; and the potential benefits of any of the Company’s products or product candidates for any specific disease indication or at any dosage, including the potential for setmelanotide to treat hyperphagia and severe obesity associated with melanocortin-4 receptor (MC4R) pathway diseases and additional genetic indications, as well as improve patient and caregiver quality of life, and the potential for RM-718 to reduce body weight and hunger and treat obesity. Statements using words such as “expect”, “anticipate”, “believe”, “may”, “will” and similar terms are also forward-looking statements. Such statements are subject to numerous risks and uncertainties, including, but not limited to, the ability to achieve necessary regulatory approvals, risks associated with data analysis and reporting, failure to identify and develop additional product candidates, unfavorable pricing regulations, third-party reimbursement practices or healthcare reform initiatives, risks associated with the laws and regulations governing our international operations and the costs of any related compliance programs, the impact of competition, risks relating to product liability lawsuits, inability to maintain collaborations, or the failure of these collaborations, our reliance on third parties, risks relating to intellectual property, our ability to hire and retain necessary personnel, general economic conditions, and the other important factors discussed under the caption “Risk Factors” in our Quarterly Report on Form 10-Q for the three months ended March 31, 2024 and our other filings with the Securities and Exchange Commission. Except as required by law, we undertake no obligations to make any revisions to the forward-looking statements contained in this release or to update them to reflect events or circumstances occurring after the date of this release, whether as a result of new information, future developments or otherwise. Corporate Contact:David ConnollyHead of Investor Relations and Corporate CommunicationsRhythm Pharmaceuticals, Inc.857-264-4280dconnolly@rhythmtx.com Media Contact:Adam DaleyBerry & Company Public Relations212-253-8881adaley@berrypr.com