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.

BOSTON, July  20, 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 David Meeker, M.D., the Chairman of Rhythm’s Board of Directors, has been appointed as the President and Chief Executive Officer (CEO) of the company, effective immediately. Dr. Meeker succeeds Hunter Smith, the Company’s Interim President and CEO and Chief Financial Officer (CFO), who will continue in his role as CFO.  

Rhythm Pharmaceuticals Announces Appointment of David Meeker, M.D., as Chief Executive Officer

-- Study demonstrated that treatment with setmelanotide reduced body weight and hunger in individuals living with Bardet-Biedl syndrome --   BOSTON, July  16, 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 its Phase 2 study evaluating setmelanotide for the treatment of obesity and insatiable hunger, known as hyperphagia, in patients living with Bardet-Biedl Syndrome (BBS) were published in the peer-reviewed journal Diabetes, Obesity and Metabolism. As previously reported, data from the study demonstrate that treatment with setmelanotide, the company’s melanocortin-4 receptor (MC4R) agonist, reduced body weight and hunger in individuals with BBS.

Rhythm Pharmaceuticals Announces Publication of Results from Phase 2 Study of Setmelanotide in Bardet-Biedl Syndrome in Diabetes, Obesity and Metabolism

BOSTON, July  01, 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 the U.S. Food and Drug Administration (FDA) has granted rare pediatric disease designations for setmelanotide, an investigational melanocortin-4 receptor (MC4R) agonist, for the treatment of pro-opiomelanocortin (POMC) deficiency obesity and leptin receptor (LEPR) deficiency obesity. As previously announced, the Company’s New Drug Application (NDA) for setmelanotide was accepted for filing with priority review by the FDA and assigned a Prescription Drug User Fee Act (PDUFA) goal date of November 27, 2020.

Rhythm Pharmaceuticals Receives Rare Pediatric Disease Designation from U.S. Food and Drug Administration for Setmelanotide for Treatment of POMC and LEPR Deficiency Obesities

Rhythm's Setmelanotide Data And Other News: The Good, Bad And Ugly Of Biopharma

-- Once-weekly formulation of setmelanotide achieved weight loss efficacy comparable to daily-dosing formulation –

Rhythm Pharmaceuticals Announces Positive Results from Phase 2 Study of Once-weekly Formulation of Setmelanotide in Healthy Obese Volunteers

– FDA grants Priority Review of application and sets PDUFA goal date of November 27, 2020 –

Rhythm Pharmaceuticals Announces FDA Acceptance of New Drug Application for Setmelanotide for the Treatment of POMC and LEPR Deficiency Obesities

 Hunter Smith, Chief Financial Officer, appointed Interim Chief Executive Officer following completion of NDA submission to FDA 

Rhythm Pharmaceuticals Provides Updates on Leadership Transition and Business Operations

BOSTON, March  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, today announced that it has completed its rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for setmelanotide for the treatment of pro-opiomelanocortin (POMC) deficiency obesity and leptin receptor (LEPR) deficiency obesity.

Rhythm Pharmaceuticals Completes Rolling Submission of New Drug Application to U.S. Food and Drug Administration for Setmelanotide in POMC and LEPR Deficiency Obesities

BOSTON, March  18, 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 the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to setmelanotide for the treatment Alström syndrome. People living with Alström syndrome may experience an insatiable hunger, also known as hyperphagia, and severe obesity beginning early in life. Rhythm is currently evaluating setmelanotide’s ability to reduce hunger and affect weight loss in an ongoing pivotal Phase 3 trial in patients living with Alström and Bardet-Biedl syndromes.

Rhythm Pharmaceuticals Receives Orphan Drug Designation from U.S. FDA for Setmelanotide for the Treatment of Alström Syndrome

Shares of Rhythm Pharmaceuticals Inc. RYTM, -2.64% were down 3% in trading on Tuesday, the day after the company announced that president and CEO Keith Gottesdiener plans to step down.

Rhythm Pharmaceuticals stock falls on news CEO is leaving

Keith Gottesdiener, M.D. to Step Down as Chief Executive Officer Following  NDA Submission for Setmelanotide in POMC and LEPR Deficiency Obesities Expected in the First Quarter of 2020

Rhythm Pharmaceuticals Announces Leadership Transition

-- Topline data expected in the fourth quarter of 2020 or early in the first quarter of 2021 --    -- Supplemental cohort continues enrollment to meet patient demand --

Rhythm Pharmaceuticals Completes Enrollment of Pivotal Cohort in Phase 3 Clinical Trial Evaluating Setmelanotide in Bardet-Biedl and Alström Syndromes

Rhythm Pharmaceuticals has been struggling lately, but the selling pressure may be coming to an end soon.

Rhythm Pharmaceuticals Sees Hammer Chart Pattern: Time to Buy?

BOSTON, Oct.  18, 2019  (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq:RYTM), a biopharmaceutical company focused on the development and commercialization of therapeutics for the treatment of rare genetic disorders of obesity, today announced the closing of its public offering of 9,324,324 shares of its common stock at a price to the public of $18.50 per share, which includes the exercise in full by the underwriters of their option to purchase up to an additional 1,216,216 shares of common stock.  The aggregate gross proceeds to Rhythm from the offering were approximately $172.5 million, before underwriting discounts, commissions, and offering expenses.  All of the shares in the offering were offered by Rhythm.

Rhythm Pharmaceuticals, Inc. Announces Closing of Public Offering and Full Exercise of the Underwriters’ Option to Purchase Additional Shares

Liver Therapy Forum weekly digest provides an overview of what's happening in therapeutics for obesity in 2019. The focus this week is Rhythm Pharmaceuticals.

Rhythm Pharmaceuticals And Setmelanotide In Rare Obesity

-- Four new MC4R pathway obesity indications added to Phase 2 Basket Study and enrolling patients --    -- Genetic sequencing of 13,567 individuals with severe obesity yields 11.7 percent (1,584 individuals) who have a rare genetic variant within MC4R pathway eligible for Phase 2 Basket Study --

Rhythm Pharmaceuticals Provides Update on Research and Development Programs

-- Plan to expand ongoing Phase 2 Basket Study with four additional rare indications -- -- Sequenced nearly 14,000 people with early-onset, severe obesity; Yield suggests potential significant opportunity for setmelanotide across new indications --  -- Rhythm to host and webcast R&D breakfast event on Wednesday, Sept. 25 --  BOSTON, Sept.  09, 2019  (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq:RYTM), a biopharmaceutical company aimed at developing and commercializing therapies for the treatment of rare genetic disorders of obesity, today announced plans to expand its Phase 2 Basket Study evaluating setmelanotide to include four additional rare melanocortin-4 receptor (MC4R) pathway-driven disorders. The company will host and webcast a Research & Development (R&D) event to provide an update on genetic sequencing results and the Phase 2 Basket Study on Wednesday, Sept. 25, from 8 to 10 a.m. in New York.

Rhythm Pharmaceuticals to Provide an Update on Genetic Sequencing Efforts and Expansion of Phase 2 Basket Study with Four Additional Rare MC4R Pathway-driven Disorders 

BOSTON, Sept.  03, 2019  (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (NASDAQ:RYTM), a biopharmaceutical company aimed at developing and commercializing therapies for the treatment of rare genetic disorders of obesity, today announced that company management will participate in two investor conferences in September:

News for Rhythm Pharmaceuticals Stock (RYTM)