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Rhythm Pharmaceuticals, Inc. (RYTM)

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21.17-0.32 (-1.49%)
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Previous close21.49
Open21.33
Bid20.90 x 1300
Ask28.00 x 900
Day's range20.50 - 21.95
52-week range12.99 - 32.24
Volume331,785
Avg. volume295,818
Market cap933.991M
Beta (5Y monthly)1.29
PE ratio (TTM)N/A
EPS (TTM)-3.26
Earnings date03 Aug 2020
Forward dividend & yieldN/A (N/A)
Ex-dividend dateN/A
1y target est34.25
  • Rhythm Pharmaceuticals Announces Publication of Results from Phase 3 Clinical Trials of Setmelanotide in The Lancet Diabetes & Endocrinology
    GlobeNewswire

    Rhythm Pharmaceuticals Announces Publication of Results from Phase 3 Clinical Trials of Setmelanotide in The Lancet Diabetes & Endocrinology

    Largest studies in POMC and LEPR deficiency obesities demonstrate that treatment with setmelanotide reduced body weight and hungerBOSTON, Oct. 30, 2020 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq:RYTM), a late-stage biopharmaceutical company aimed at developing and commercializing therapies for the treatment of rare genetic disorders of obesity, announced today that results from two pivotal Phase 3 studies evaluating setmelanotide in proopiomelanocortin (POMC) deficiency obesity and leptin receptor (LEPR) deficiency obesity were published in The Lancet Diabetes & Endocrinology. As previously reported, data from the studies demonstrate that treatment with setmelanotide, the company’s melanocortin-4 receptor (MC4R) agonist, led to statistically significant and clinically meaningful reductions of weight and hunger. “Results from Rhythm’s pivotal Phase 3 studies, which are the largest studies to date in POMC and LEPR deficiency obesities, provide evidence regarding the safety and efficacy of setmelanotide and we believe they validate its potential long-term use as a novel treatment for severe obesity and hyperphagia,” said co-author Peter Kühnen, M.D., Institute for Experimental Pediatric Endocrinology, Charité Universitätsmedizin Berlin, Germany. “It is important to recognize the signs of these rare genetic disorders because we may soon have a targeted treatment option available for the first time for obesity disorders caused by impairments of the MC4R pathway.”Rhythm initially reported positive topline data from the Phase 3 studies in August 2019 and subsequently presented updated data in a late-breaking research forum during the 37th Annual Meeting of The Obesity Society at ObesityWeek® 2019.Eight of 10 participants with POMC deficiency obesity (80%; P<0.0001 compared with historical data) and five of 11 participants with LEPR deficiency obesity (45%; P=0.0001 compared with historical data) achieved at least 10 percent weight loss at approximately one year. The mean percent change in “most hunger” score in participants aged 12 years and older was -27.1 percent (n=7; P=0.0005) in POMC deficiency obesity and -43.7 percent (n=7; P<0.0001) in LEPR deficiency obesity. Consistent with prior clinical experience, setmelanotide was generally well-tolerated in both trials. The most common adverse events were injection site reaction, skin hyperpigmentation, and nausea.“These results are significant because, as we know from natural history data, individuals living with POMC or LEPR deficiency obesity consistently experience substantial weight gain each year beginning in early childhood, and we would not expect any of these patients to be able to achieve 10 percent weight loss over the course of a year without continued treatment,” said co-author Karine Clément, professor of nutrition at Pitié-Salpêtrière hospital and Sorbonne University in Paris. “These data and the significant unmet need to address the obesity and hyperphagia caused by rare genetic disorders of obesity underscore the importance of testing for genetic variants that may impair MC4R activation and lead to severe obesity.”In May 2020, Rhythm announced that the U.S. Food and Drug Administration (FDA) accepted the company's New Drug Application (NDA) for setmelanotide for the treatment of POMC deficiency obesity and LEPR deficiency obesity, granted Priority Review of the NDA and assigned a Prescription Drug User Fee Act (PDUFA) goal date of November 27, 2020. In July 2020, the Company announced the submission of its Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for the treatment of POMC deficiency obesity and LEPR deficiency obesity.“We are grateful to the authors and the investigators involved in our pivotal Phase 3 clinical trials for their continued partnership in advancing setmelanotide to address significant unmet needs facing people with rare genetic disorders of obesity,” Murray Stewart, M.D., Chief Medical Officer of Rhythm, said.The article is available online here: http://www.thelancet.com/journals/landia/article/PIIS2213-8587(20)30364-8/fulltext.To request a copy of the article, email medinfo@rhythmtx.com.About Setmelanotide Setmelanotide is an investigational, melanocortin-4 receptor (MC4R) agonist. The MC4R is part of the key biological pathway that independently regulates hunger, caloric intake, and energy expenditure. Variants in genes may impair the function of the MC4R pathway, potentially leading to hyperphagia and early-onset, severe obesity. Rhythm is currently developing setmelanotide as a targeted therapy to potentially restore the function of an impaired MC4R pathway and, in so doing, potentially reduce hunger and weight in patients with rare genetic disorders of obesity. Currently, no pharmacologic therapies exist to treat these conditions.The FDA has granted Breakthrough Therapy designation to setmelanotide for the treatment of obesity associated with genetic defects upstream of the MC4R pathway, which includes POMC deficiency obesity, LEPR deficiency obesity, Bardet-Biedl Syndrome (BBS) and Alström syndrome. The EMA has also granted PRIority MEdicines (PRIME) designation for setmelanotide for the treatment of obesity and the control of hunger associated with deficiency disorders of the MC4R pathway. Both the FDA and EMA have granted orphan drug status to setmelanotide for POMC and LEPR deficiency obesities. Rhythm is also evaluating setmelanotide for reduction in hunger and body weight in a pivotal Phase 3 trial in people living with BBS and Alström syndromes, with topline data from this trial expected in the fourth quarter of 2020 or early in the first quarter of 2021.About Rhythm Pharmaceuticals Rhythm is a late-stage biopharmaceutical company focused on the development and commercialization of therapies for the treatment of rare genetic disorders of obesity. Rhythm is leveraging the Rhythm Engine -- comprised of its Phase 2 basket study, TEMPO Registry, GO-ID genotyping study and Uncovering Rare Obesity program -- to improve the understanding, diagnosis and potentially the treatment of rare genetic disorders of obesity. For healthcare professionals, visit www.UNcommonObesity.com for more information. For patients and caregivers, visit www.LEADforRareObesity.com for more information. The company is based in Boston, MA.Forward-Looking Statements This 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 our business strategy and plans, including regarding commercialization of setmelanotide; the potential, safety, efficacy, and regulatory and clinical progress of setmelanotide, including anticipated timing of data readouts and our expectations surrounding potential regulatory approvals and timing thereof. Statements using words such as “expect”, “anticipate”, “believe”, “may”, “will” and similar terms are also forward-looking statements. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the impact of our management transition, our ability to enroll patients in clinical trials, the design and outcome of clinical trials, the impact of competition, the ability to achieve or obtain necessary regulatory approvals, risks associated with data analysis and reporting, our liquidity and expenses, the impact of the COVID-19 pandemic on our business and operations, including our preclinical studies, clinical trials and commercialization prospects, and general economic conditions, and other important factors discussed under the caption “Risk Factors” in our Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2020 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 Connolly Head of Investor Relations and Corporate Communications Rhythm Pharmaceuticals, Inc. 857-264-4280 dconnolly@rhythmtx.comInvestor Contact: Hannah Deresiewicz Stern Investor Relations, Inc. 212-362-1200 hannah.deresiewicz@sternir.comMedia Contact: Adam Daley Berry & Company Public Relations 212-253-8881 adaley@berrypr.com

  • Rhythm Pharmaceuticals Appoints Jennifer Chien as Executive Vice President, Head of North America
    GlobeNewswire

    Rhythm Pharmaceuticals Appoints Jennifer Chien as Executive Vice President, Head of North America

    Rhythm Pharmaceuticals Appoints Jennifer Chien as Executive Vice President, Head of North America Jennifer Chien, Executive Vice President, Head of North AmericaBOSTON, Oct. 28, 2020 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq:RYTM), a late-stage biopharmaceutical company aimed at developing and commercializing therapies for the treatment of rare genetic disorders of obesity, today announced that Jennifer Chien has been appointed as Executive Vice President, Head of North America, effective November 9, 2020. As EVP North America, Ms. Chien will co-lead global integrated commercial strategies in close collaboration with Yann Mazabraud, who was recently appointed EVP, Head of International. “Jennifer joins Rhythm at a critical inflection point as we prepare to bring setmelanotide, potentially the first approved therapy for rare genetic disorders of obesity, to patients throughout the world,” said David Meeker, M.D., Chair, President and Chief Executive Officer of Rhythm. “With her passion for science and patients, as well as her deep experience in rare disease, Jennifer will play a crucial role in driving patient identification and delivering setmelanotide to individuals who might benefit from therapy. Jennifer understands the challenges patients, families, health care providers and the community as a whole face in trying to get the appropriate care for their devastating rare disease. We are excited to welcome her to Rhythm.”Ms. Chien brings more than 20 years of experience in rare diseases. Most recently, she was the Chief Commercial Officer at Krystal Biotech. Prior to that, she served as Vice President, Head of Genetic Diseases at Sanofi Genzyme, where she was responsible for the U.S. commercial strategy and implementation for seven brands and launch preparation within rare diseases. During her time at Sanofi Genzyme, Ms. Chien also held leadership roles as Vice President, Head of Global Nephrological Diseases, Senior Director of Global Marketing in Fabry disease, Senior Director of Global Market Access and International Marketing for the cardiovascular business, and Director of Business Development. Ms. Chien holds a bachelor’s of science degree from Massachusetts Institute of Technology and a master’s in public health from Harvard University.“This is an exciting time to join Rhythm,” said Ms. Chien. “With setmelanotide nearing its first potential approvals in the United States and Europe, I look forward to working with the Rhythm team to transform the care of individuals living with rare genetic disorders of obesity and bring them a much needed therapy.”About Rhythm Pharmaceuticals Rhythm is a late-stage biopharmaceutical company focused on the development and commercialization of therapies for the treatment of rare genetic disorders of obesity. The Company is developing setmelanotide, its investigational, melanocortin-4 receptor (MC4R) agonist, for the treatment of severe obesity and hyperphagia associated with rare genetic disorders of obesity. The U.S. Food and Drug Administration (FDA) has accepted for filing Rhythm’s New Drug Application (NDA) for setmelanotide for the treatment of POMC deficiency obesity and LEPR deficiency obesity with Priority Review and a Prescription Drug User Fee Act (PDUFA) goal date of November 27, 2020. Rhythm also submitted a Marketing Authorization Application (MAA) for setmelanotide to treat individuals living with POMC deficiency obesity or LEPR deficiency obesity to the European Medicines Agency (EMA) in June 2020. Rhythm is also evaluating setmelanotide for reduction in hunger and body weight in a pivotal Phase 3 trial in people living with Bardet-Biedl and Alström syndromes, with topline data from this trial expected in the fourth quarter of 2020 or early in the first quarter of 2021. Rhythm is leveraging the Rhythm Engine -- comprised of its Phase 2 basket study, TEMPO Registry, GO-ID genotyping study and Uncovering Rare Obesity program -- to improve the understanding, diagnosis and potentially the treatment of rare genetic disorders of obesity. For healthcare professionals, visit www.UNcommonObesity.com for more information. For patients and caregivers, visit www.LEADforRareObesity.com for more information. The company is based in Boston, MA.Forward-Looking Statements This 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 our business strategy and plans, including regarding commercialization of setmelanotide; the potential, safety, efficacy, and regulatory and clinical progress of setmelanotide, including anticipated timing of data readouts and our expectations surrounding potential regulatory approvals and timing thereof; and management changes. Statements using words such as “expect”, “anticipate”, “believe”, “may”, “will” and similar terms are also forward-looking statements. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the impact of our management transition, our ability to enroll patients in clinical trials, the design and outcome of clinical trials, the impact of competition, the ability to achieve or obtain necessary regulatory approvals, risks associated with data analysis and reporting, our liquidity and expenses, the impact of the COVID-19 pandemic on our business and operations, including our preclinical studies, clinical trials and commercialization prospects, and general economic conditions, and other important factors discussed under the caption “Risk Factors” in our Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2020 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 Connolly Head of Investor Relations and Corporate Communications Rhythm Pharmaceuticals, Inc. 857-264-4280 dconnolly@rhythmtx.comInvestor Contact: Hannah Deresiewicz Stern Investor Relations, Inc. 212-362-1200 hannah.deresiewicz@sternir.comMedia Contact: Adam Daley Berry & Company Public Relations 212-253-8881 adaley@berrypr.comA photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/917fe36f-5096-40b5-8c0d-de8b14bac65e.

  • We Think Rhythm Pharmaceuticals (NASDAQ:RYTM) Can Afford To Drive Business Growth
    Simply Wall St.

    We Think Rhythm Pharmaceuticals (NASDAQ:RYTM) Can Afford To Drive Business Growth

    There's no doubt that money can be made by owning shares of unprofitable businesses. For example, although Amazon.com...