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.

-- First U.S. commercial sales of IMCIVREE™ (setmelanotide) completed late in first quarter –

Rhythm Pharmaceuticals Reports First Quarter 2021 Financial Results

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BOSTON, April 07, 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 20th Annual Needham & Co. Virtual Healthcare Conference on Wednesday, April 14, 2021 at 11:45 a.m. ET.

Rhythm Pharmaceuticals to Present at 20th Annual Needham Virtual Healthcare Conference

-- Responders with HET obesity achieved mean weight loss of greater than 12 percent at nine months on setmelanotide therapy -- -- Additional poster presentations include Phase 3 data in Bardet-Biedl and Alström syndromes and analyses of adverse events in Phase 2 and Phase 3 studies in POMC, PCSK1, or LEPR deficiency showing consistent safety results for setmelanotide --

Rhythm Pharmaceuticals Presents New Data from Phase 2 Basket Study Showing Continued Weight Loss at Up to Nine Months in Patients with HET Obesity on Setmelanotide at ENDO 2021

BOSTON, March 09, 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 three late-breaking abstracts have been accepted for presentation at the 103 rd Annual Meeting and Expo of the Endocrine Society (ENDO 2021) to be held virtually March 20-23.

Rhythm Pharmaceuticals Announces Late-Breaking Data Presentations at ENDO 2021

-- Received FDA approval of IMCIVREE™ (setmelanotide), the first-ever therapy for chronic weight management in patients with obesity due to POMC, PCSK1 or LEPR deficiency -- -- Announced positive topline data from Phase 3 pivotal trial evaluating setmelanotide in Bardet-Biedl and Alström syndromes; on-track to complete regulatory submissions to FDA and EMA for BBS in 2H 2021 --

Rhythm Pharmaceuticals Reports Fourth Quarter and Full Year 2020 Financial Results

BOSTON, Feb. 10, 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 the closing of its public offering of 5,750,000 shares of its common stock at a public offering price of $30.00 per share, which includes the exercise in full by the underwriters of their option to purchase up to an additional 750,000 shares of common stock, on February 9, 2021.  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 $172.5 Million Public Offering, Including Full Exercise of the Underwriters' Option to Purchase Additional Shares

BOSTON, Jan. 05, 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 entered into a definitive agreement to sell its Rare Pediatric Disease Priority Review Voucher (PRV) for $100M.

Rhythm Pharmaceuticals Announces Sale of Priority Review Voucher for $100M

-- Study met primary endpoint and all key secondary endpoints with statistically significant and clinically meaningful reductions in weight and hunger -- -- All primary endpoint responders were patients with BBS --

Rhythm Pharmaceuticals Announces Positive Topline Results from Pivotal Phase 3 Clinical Trial Evaluating Setmelanotide in Bardet-Biedl and Alström Syndromes

BOSTON, Dec. 11, 2020 (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 the appointments of Camille L. Bedrosian, M.D., and Lynn Tetrault, J.D., to its Board of Directors.

Rhythm Pharmaceuticals Announces Appointments of Camille L. Bedrosian, M.D.

Rhythm's (RYTM) stock gains as FDA approves its lead product candidate for chronic weight management.

Rhythm (RYTM) Up on FDA Approval of Weight Management Drug

-- Indicated for chronic weight management in adult and pediatric patients 6 years of age and older with obesity due to POMC, PCSK1 or LEPR deficiency confirmed by genetic testing -- -- Approval supports company's approach to address rare genetic diseases of obesity associated with an impaired MC4 receptor pathway --

Rhythm Pharmaceuticals Announces FDA Approval of IMCIVREE™ (setmelanotide) as First-ever Therapy for Chronic Weight Management in Patients with Obesity Due to POMC, PCSK1 or LEPR Deficiency

-- Interim d ata from Phase 2 study showed that once-weekly formulation of setmelanotide achieve d safety and efficacy results comparable to daily-dosing formulation -- -- Additional data from long-term extension study in POMC deficiency obesity showed durable weight loss and reductions in hunger at up to three years on therapy -- -- Setmelanotide was generally well tolerated -- BOSTON, Nov. 04, 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 new clinical data for setmelanotide, its investigational melanocortin-4 receptor (MC4R) agonist, being presented at The Obesity Society's ObesityWeek® 2020, held virtually from November 2-6, 2020.

Rhythm Pharmaceuticals Announces New Clinical Data on Setmelanotide at ObesityWeek® 2020

-- NDA for setmelanotide for POMC and LEPR deficiency obesities under review, with PDUFA goal date of November 27, 2020 --  -- Appointed Jennifer Chien and Yann Mazabraud to co-lead global integrated commercial strategies -- -- On track to announce topline data from pivotal Phase 3 trial in Bardet-Biedl and Alström syndrome s late in fourth quarter of 2020 or early in first quarter 2021 -- -- Plan to announce data from multiple cohorts in ongoing Phase 2 basket study early in first quarter 2021 -- BOSTON, Nov. 02, 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 reported financial results and provided a business update for the third quarter ended September 30, 2020.

Rhythm Pharmaceuticals Reports Third Quarter 2020 Financial Results

Largest studies in POMC and LEPR deficiency obesities demonstrate that treatment with setmelanotide reduced body weight and hunger Largest studies in POMC and LEPR deficiency obesities demonstrate that treatment with setmelanotide reduced body weight and hunger

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

BOSTON, 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.

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

Rhythm Pharmaceuticals (RYTM) saw a big move last session, as its shares jumped more than 5% on the day, amid huge volumes.

Rhythm Pharmaceuticals (RYTM) Looks Good: Stock Adds 5.1% in Session

– Company announces organizational changes designed to accelerate global strategy –

Rhythm Pharmaceuticals Appoints Yann Mazabraud as Executive Vice President, Head of International

Rhythm (RYTM) saw a big move last session, as its shares jumped nearly 9% on the day, amid huge volumes.

Rhythm (RYTM) Soars: Stock Adds 9.4% in Session

BOSTON, Aug.  06, 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., Chair, President and Chief Executive Officer of Rhythm, and Hunter Smith, Chief Financial Officer, will present a corporate overview at the Canaccord Genuity 40th Annual Growth Conference on Thursday, August 13, 2020 at 9:30 a.m. ET.

Rhythm Pharmaceuticals to Present Virtually at Canaccord Genuity 40th Annual Growth Conference

-- Appointed David Meeker, M.D., as President and Chief Executive Officer –

Rhythm Pharmaceuticals Reports Second Quarter 2020 Financial Results

BOSTON, July  27, 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 the appointment of Joseph Shulman as the Company’s Senior Vice President, Technical Operations. Mr. Shulman brings more than 20 years of industry experience in chemistry, manufacturing and controls (CMC) technical development, operations, and program and alliance management.

Rhythm Pharmaceuticals Announces Appointment of Joseph Shulman as Senior Vice President of Technical Operations

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

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