Rhythm Pharmaceuticals

Rhythm Pharmaceuticals, Inc. is a biopharmaceutical company, which engages in developing and commercializing peptide therapeutics for the treatment of gastrointestinal diseases and genetic deficiencies. The firm focuses on the treatment for Prader-Willi Syndrome and Pro-Opiomelanocortin deficiency obesity. Its product candidate includes setmelanotide, an MC4R agonist designed to restore impaired MC4R pathway function caused by genetic variants that occur upstream of the MC4R. The company was founded by Bart Henderson in November 2008 and is headquartered in Boston, MA.

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Rhythm Pharmaceuticals reports robust Q4 performance and eyes growth

Rhythm Pharmaceuticals had a strong performance in Q4 2022, driven by increased IMCIVREE sales and strategic pipeline expansions.
While facing challenges in logistics and reimbursement, the company's strengths lie in its geographic expansion, pipeline diversification, and patient-focused approach.
Opportunities for growth include upcoming launches, patient identification efforts, and maximizing the potential of the BBS commercial opportunity.

Rhythm Pharmaceuticals excels in Q1 with IMCIVREE revenue surge

Rhythm Pharmaceuticals demonstrated strong financial performance and market acceptance of IMCIVREE, supported by robust revenue growth and cash reserves.
While facing challenges in pricing negotiations and patient transitions, the company is well-positioned to capitalize on opportunities for further growth and development.
The identification of key genes in the DAYBREAK trial and positive patient feedback highlight the company's commitment to innovation and patient-centric care.
Overall, Rhythm Pharmaceuticals' Q1 earnings call showcases a promising outlook with solid performance, strategic strengths, addressable challenges, and growth opportunities.

Rhythm Pharmaceuticals excels in Q2, eyes international growth opportunities

Rhythm Pharmaceuticals delivered a strong Q2 performance with notable achievements in commercial execution and clinical development. Despite challenges in market ramp-up and reimbursement delays, the company remains well-capitalized and focused on strategic priorities. Opportunities for growth through international expansion and new drug formulations position Rhythm for continued success.

Rhythm Pharmaceuticals excels in Q3, faces discontinuation challenges

Rhythm Pharmaceuticals is making significant progress in commercial expansion and clinical trials, supported by strong financial position. Challenges include administrative hurdles and managing discontinuation rates. Opportunities exist in expanding prescriber base, educating specialties, and advancing clinical trials for younger patients.

Rhythm Pharmaceuticals surpasses revenue expectations, eyes international expansion and patient-centric innovation

Rhythm Pharmaceuticals delivered strong financial performance, highlighted by solid commercial execution and international market successes, despite challenges with Medicaid coverage.
The company's focus on innovation, unique value propositions, and upcoming milestone achievements position it for continued growth and market leadership.
Addressing discontinuation rates, Medicaid issues, and maximizing opportunities in international markets are key priorities for Rhythm Pharmaceuticals to drive sustained success.

Rhythm Pharmaceuticals reports strong Q1 performance and international growth

Rhythm Pharmaceuticals' Q1 performance reflects strong commercial traction, international growth, and strategic advancements in clinical programs.
While facing challenges like Medicaid changes and discontinuations, the company's proactive measures and focus on patient care position it well for growth.
Opportunities in new markets, patient populations, and improved retention strategies offer avenues for future expansion and revenue growth.
Overall, Rhythm Pharmaceuticals' earnings call highlights a balanced outlook with a focus on innovation, patient support, and international expansion.

Rhythm Pharmaceuticals reports robust Q2 revenues, eyes European growth

Rhythm Pharmaceuticals demonstrated solid revenue performance in Q2 2024 driven by IMCIVREE sales
The company maintains a strong cash position and is progressing well with its pipeline development
Challenges include managing expenses to ensure profitability and sustaining operations until 2026
Opportunities lie in product expansion, successful trial outcomes, and operational optimization

Rhythm Pharmaceuticals excels in Q3 with revenue growth and clinical progress

Rhythm Pharmaceuticals demonstrated strong performance in Q3 2024 with revenue growth and positive clinical trial outcomes.
The company's focus on expansion, engagement, and milestone achievements positions it well for future growth and market penetration.
While facing challenges in managing expenses and addressing analyst inquiries, Rhythm Pharmaceuticals has opportunities for international expansion and therapeutic advancements.
Overall, Rhythm Pharmaceuticals' strategic approach and financial stability indicate a promising outlook for continued success and innovation.

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Rhythm Pharmaceuticals, Inc. is a commercial-stage biopharmaceutical company, which engages in the development and commercialization of therapeutics for patients with rare diseases. The firm offers IMCIVREE (setmelanotide), a precision medicine designed to treat hyperphagia and severe obesity caused by rare melanocortin-4 receptor (MC4R) diseases. It is also involved in the clinical development program for setmelanotide in other rare MC4R pathway diseases, as well as a preclinical suite of investigational candidates for the treatment of congenital hyperinsulinism. The company was founded by Bart Henderson in November 2008 and is headquartered in Boston, MA.

RYTM has a label expansion for its lead molecule. The molecule is approved in another indication for over a year.

Rhythm Pharmaceuticals: PDUFA Ahead, But Commercialization Concerns Remain

-- DAYBREAK is the most comprehensive Phase 2 trial ever initiated in rare genetic diseases of obesity -- -- DAYBREAK is evaluating setmelanotide in patients with severe obesity and hyperphagia caused by variants in one of 31 pre-identified genes -- -- First patient also dosed in Phase 3 switch trial evaluating a weekly formulation of setmelanotide -- BOSTON, Jan. 13, 2022 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a commercial-stage biopharmaceutical company committed to transforming the care of people living with rare genetic diseases of obesity, today announced the first patient has been dosed with setmelanotide, the company's melanocortin-4 receptor (MC4R) agonist, in the Phase 2 DAYBREAK clinical trial to treat the severe obesity and hyperphagia potentially caused by a genetic variant that impairs function of the MC4R pathway. The company also announced the dosing of the first patient in the Phase 3 trial evaluating a switch from the daily to a novel weekly formulation of setmelanotide.

Rhythm Pharmaceuticals Announces First Patients Dosed in DAYBREAK and Weekly Trials Evaluating Setmelanotide for Rare Genetic Diseases of Obesity

-- RareStone to seek marketing authorization for IMCIVREE to treat obesity due to biallelic POMC, PCSK1 and LEPR deficiencies and Bardet-Biedl and Alström syndromes in mainland China, Hong Kong and Macau ---- Rhythm to receive $12 million upfront in cash and equity, up to $63.5 million in future milestone payments and sales royalties -- BOSTON, Dec. 06, 2021 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a biopharmaceutical company aimed at developing and commercializing therapies for the treatment of rare genetic diseases of obesity, and RareStone LTD, formerly Citrine Medicine, a China-based rare disease company, today announced an exclusive licensing agreement for the development and commercialization of IMCIVREE® (setmelanotide) in China, including mainland China, Hong Kong and Macau. This licensing agreement marks the first expansion of Rhythm's pipeline into Asia and is designed to accelerate patient access to IMCIVREE where there remains significant unmet need to address the severe, early-onset obesity and hyperphagia that characterize both acquired and genetic diseases of the melanocortin-4 receptor (MC4R) pathway.

Rhythm Pharmaceuticals and RareStone Ltd. Announce Exclusive Licensing Agreement for the Development and Commercialization of IMCIVREE (setmelanotide) in China

FDA sets PDUFA goal date of March 16, 2022 FDA sets PDUFA goal date of March 16, 2022

Rhythm Pharmaceuticals Announces FDA Acceptance for Filing and Priority Review of Supplemental New Drug Application for IMCIVREE® (setmelanotide) for Patients with Bardet-Biedl Syndrome and Alström Syndrome

Rhythm Pharmaceuticals, Inc. (RYTM) CEO David Meeker on Q3 2021 Results - Earnings Call Transcript

-- U.S. and EU regulatory filings submitted for IMCIVREE ® (setmelanotide) for treatment of Bardet-Biedl and Alström syndromes; launch preparations underway -- -- Delivered a total of 22 presentations at three major medical conferences -- -- New presentations include first-ever data showing improvements in health-related quality of life in rare genetic diseases of obesity -- -- IMCIVREE third quarter net sales reach $1M -- -- Management to Host Conference Call at 8:00 a.m. ET -- BOSTON, Nov. 02, 2021 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a biopharmaceutical company aimed at developing and commercializing therapies for the treatment of rare genetic diseases of obesity, today reported financial results and provided a business update for the third quarter ended September 30, 2021.

Rhythm Pharmaceuticals Reports Third Quarter 2021 Financial Results

-- Additional oral presentation details safety and efficacy data from Phase 3 trial of setmelanotide in BBS -- -- Also presenting new hunger data from SRC1 and SH2B1 cohorts in Phase 2 Basket Trial and new data on utilization of URO ® genetic testing program –

Rhythm Pharmaceuticals Presents First-ever Data Showing Improvements in Health-related Quality of Life for Patients Living with Bardet-Biedl Syndrome at ObesityWeek® 2021

BOSTON, Oct. 20, 2021 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a commercial-stage biopharmaceutical company committed to transforming the care of people living with rare genetic diseases of obesity, today announced that it will host a live conference call and webcast at 8:00 a.m. ET on Tuesday, November 2, 2021 to report its third quarter 2021 financial results and provide a corporate update.

Rhythm Pharmaceuticals to Report Third Quarter 2021 Financial Results on Tuesday, November 2, 2021

BOSTON, Oct. 14, 2021 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a commercial-stage biopharmaceutical company committed to transforming the care of people living with rare genetic diseases of obesity, today announced that it has submitted its Type II variation application to the European Medicines Agency (EMA) for IMCIVREE® (setmelanotide) for the treatment of obesity and control of hunger in adult and pediatric patients six years of age and older with Bardet-Biedl syndrome (BBS) or Alström syndrome.

Rhythm Pharmaceuticals Completes Submission of Type II Variation Application to the European Medicines Agency for IMCIVREE® (setmelanotide) for Bardet-Biedl and Alström Syndromes

-- New data in patients with POMC or LEPR deficiency obesity show setmelanotide led to clinically meaningful improvements in health related quality of life measures and hunger --   -- Updated results from Uncovering Rare Obesity ® testing program suggest up to 64.5 percent of individuals with early-onset, severe obesity may carry variants linked to rare genetic diseases of obesity --  -- Additional posters include encore presentations of data from Phase 3 trial evaluating setmelanotide in BBS and Phase 2 trial in HET obesity, as well as Phase 1b trial evaluating once-weekly setmelanotide -- BOSTON, Oct. 14, 2021 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a commercial-stage biopharmaceutical company committed to transforming the care of people living with rare genetic diseases of obesity, today presented the first-ever data on the health related quality of life (HRQOL) and experience of patients with obesity due to POMC or LEPR deficiency and updated results from the Uncovering Rare Obesity® (URO) genetic testing program at the Obesity Medicine Association's Overcoming Obesity 2021 Conference and its Digital Experience (DX) Oct. 14-23.

Rhythm Pharmaceuticals Presents New Data on Experience of People Living with Rare Genetic Diseases of Obesity and Provides Updates on Uncovering Rare Obesity® Genetic Testing Program

-- New subgroup analysis of Phase 3 data show setmelanotide achieved statistically significant weight loss and hunger reduction compared with placebo at 14 weeks in patients with Bardet-Biedl syndrome -- -- Efficacy results from complete topline analyses of Rhythm's Phase 2 Basket Study show weight loss and hunger reduction at three months on therapy in patients with SRC1 or SH2B1 deficiency -- -- Data from Phase 2 Basket Study also show clear separation between responders and non-responders in change in weight for adults and in BMI-Z scores for children and adolescents -- BOSTON, Sept. 22, 2021 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a commercial-stage biopharmaceutical company committed to transforming the care of people living with rare genetic diseases of obesity, today presented new data and analyses from phase 2 and 3 trials evaluating setmelanotide at the 59th Annual European Society for Paediatric Endocrinology (ESPE) Meeting, which is being held virtually this week.

Rhythm Pharmaceuticals Presents New Data from Phase 2 and 3 Trials Evaluating Setmelanotide in Multiple Rare Genetic Diseases of Obesity at the 59th Annual ESPE Meeting

BOSTON, Sept. 21, 2021 (GLOBE NEWSWIRE) -- In a release issued on Wednesday, September 21 by Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), please note that the symbol ▼ was erroneously omitted from the headline. The corrected release follows:

CORRECTION: Rhythm Pharmaceuticals, Inc.

– IMCIVREE is indicated for treatment of obesity and control of hunger associated with genetically confirmed loss-of-function biallelic pro-opiomelanocortin (POMC), including PCSK1, deficiency or biallelic leptin receptor (LEPR) deficiency in adults and children six years of age and above –

Rhythm Pharmaceuticals Announces Marketing Authorisation of IMCIVREE® (setmelanotide) in Great Britain

BOSTON, Sept. 20, 2021 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a biopharmaceutical company aimed at developing and commercializing therapies for the treatment of rare genetic diseases of obesity, today announced that it has completed its supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for IMCIVREE® (setmelanotide) for the treatment of obesity and control of hunger in adult and pediatric patients 6 years of age and older with Bardet-Biedl syndrome (BBS) or Alström syndrome.

Rhythm Pharmaceuticals Completes Submission of Supplemental New Drug Application to U.S. Food and Drug Administration for IMCIVREE® (setmelanotide) for the treatment of obesity and control of hunger in Bardet-Biedl and Alström Syndromes

Expanded access program may allow access for eligible patients in the United States who have no authorized treatment options Expanded access program may allow access for eligible patients in the United States who have no authorized treatment options

Rhythm Pharmaceuticals Announces Expanded Access Program for Setmelanotide for Patients with Bardet-Biedl Syndrome

-- Linda Shapiro Manning, M.D., Ph.D., promoted to Chief Medical Officer, effective Sept. 10 -- -- CMO Murray Stewart, M.D., to transition to Senior Medical Advisor -- BOSTON, Sept. 02, 2021 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a biopharmaceutical company aimed at developing and commercializing therapies for the treatment of rare genetic diseases of obesity, today announced Linda Shapiro Manning, M.D., Ph.D., Senior Vice President, Clinical, will be promoted to Chief Medical Officer (CMO) effective September 10, 2021. She will succeed Murray Stewart, M.D., who will transition from his current role to Senior Medical Advisor effective as of the same date.

Rhythm Pharmaceuticals Announces CMO Transition

BOSTON, Sept. 02, 2021 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a biopharmaceutical company aimed at developing and commercializing therapies for the treatment of rare genetic diseases of obesity, today announced that David Meeker, M.D., Chair, President and Chief Executive Officer, will participate in a fireside chat at the Morgan Stanley 19th Annual Global Healthcare Conference on Thursday, September 9, 2021 at 8:45 a.m. ET.

Rhythm Pharmaceuticals to Present at Morgan Stanley 19th Annual Global Healthcare Conference

Company announces acceptance of seven abstracts with data from multiple clinical trials evaluating setmelanotide for rare genetic diseases of obesity Company announces acceptance of seven abstracts with data from multiple clinical trials evaluating setmelanotide for rare genetic diseases of obesity

Rhythm Pharmaceuticals to Present at the 59th Annual ESPE Meeting

Rhythm Pharmaceuticals, Inc. (RYTM) might move higher on growing optimism about its earnings prospects, which is reflected by its upgrade to a Zacks Rank #2 (Buy).

Rhythm Pharmaceuticals, Inc. (RYTM) Upgraded to Buy: Here's Why

Rhythm Pharmaceuticals, Inc. (RYTM) CEO David Meeker on Q2 2021 Results - Earnings Call Transcript

-- Received European Commission authorization of IMCIVREE for treatment of obesity and control of hunger associated with POMC, PCSK1 and LEPR deficiencies -- -- Setmelanotide selected for evaluation as a “Highly Specialised Technology” by Great Britain's National Institute for Health and Care Excellence -- -- On track to submit sNDA to FDA and MAA Type II amendment to EMA for setmelanotide in BBS and Alström syndromes in 2H 2021 -- -- Five new Phase 2 and 3 clinical trials planned to initiate in 2H 2021 -- -- Management to host conference call at 8 a.m. ET -- BOSTON, Aug. 03, 2021 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a biopharmaceutical company aimed at developing and commercializing therapies for the treatment of rare genetic diseases of obesity, today reported financial results and provided a business update for the second quarter ended June 30, 2021.

Rhythm Pharmaceuticals Reports Second Quarter 2021 Financial Results

-- Pivotal Phase 3 EMANATE trial planned in patients with heterozygous POMC, PCSK1 or LEPR, and SRC1 or SH2B1 deficiency obesities -- -- EMANATE, as well as Phase 2 DAYBREAK trial evaluating setmelanotide in 31 new genes, Phase 3 pediatrics trial and Phase 3 trials of weekly setmelanotide formulation all expected to initiate in 2H 2021 -- -- Updated Uncovering Rare Obesity genetic test with expanded gene panel launched in July -- -- Company to host conference call at 8 a.m. ET today -- CAMBRIDGE, Mass., Aug. 03, 2021 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a biopharmaceutical company aimed at developing and commercializing therapies for the treatment of rare genetic diseases of obesity, today announced a significant expansion of its clinical development program for setmelanotide with five new planned Phase 2 and 3 clinical trials. Rhythm will review these updates on its second quarter 2021 financial results and business update conference call today at 8 a.m. ET.

Rhythm Pharmaceuticals Announces Comprehensive Expansion of Clinical Development Program with Five New Phase 2 and 3 Trials Planned to Evaluate Setmelanotide in Rare Genetic Diseases of Obesity

Population study to focus on natural history of weight gain, hyperphagia and quality of life in patients with Bardet-Biedl syndrome Population study to focus on natural history of weight gain, hyperphagia and quality of life in patients with Bardet-Biedl syndrome

Rhythm Pharmaceuticals Announces Collaborative Research Agreement with Clinical Registry Investigating Bardet-Biedl Syndrome

BOSTON, July 27, 2021 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a biopharmaceutical company aimed at developing and commercializing therapies for the treatment of rare genetic diseases of obesity, today announced that it will host a live conference call and webcast at 8:00 a.m. ET on Tuesday, August 3, 2021 to report its second quarter 2021 financial results and provide a corporate update.

Rhythm Pharmaceuticals to Report Second Quarter 2021 Financial Results on Tuesday, August 3, 2021

The European Commission (EC) has approved Rhythm Pharmaceuticals Inc's (NASDAQ: RYTM) Imcivree (setmelanotide) for obesity and the control of hunger. The approval covers obesity associated with genetically confirmed loss-of-function biallelic pro-opiomelanocortin (POMC), including proprotein convertase subtilisin/kexin type 1 (PCSK1), deficiency or biallelic leptin receptor (LEPR) in adults and children six years and above.

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