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, Nov. 06, 2024 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a global commercial-stage biopharmaceutical company focused on transforming the lives of patients living with rare neuroendocrine diseases, today announced that David Meeker, M.D., Chair, President and Chief Executive Officer, will participate in fireside chats at two upcoming investor conferences:

Rhythm Pharmaceuticals Announces Participation in Upcoming Investor Conferences

Rhythm Pharmaceuticals, Inc. (NASDAQ:RYTM ) Q3 2024 Earnings Conference Call November 5, 2024 5:00 PM ET Company Participants David Connolly - Head of Investor Relations and Corporate Communications David Meeker - Chairman, President and Chief Executive Officer Jennifer Lee - Executive Vice President and Head of North America Yann Mazabraud - Executive Vice President and Head of International Hunter Smith - Chief Financial Officer Conference Call Participants Philip Nadeau - TD Cowen Corinne Johnson - Goldman Sachs Group, Inc. Seamus Fernandez - Guggenheim Securities Dae Gon Ha - Stifel, Nicolaus & Company, Inc. Whitney Ijem - Canaccord Genuity Corp. Jeff Hung - Morgan Stanley Tazeen Ahmad - Bank of America Merrill Lynch Joseph Stringer - Needham & Company Raghuram Selvaraju - H.C. Wainwright & Co. Operator Good day, and thank you for standing by.

Rhythm Pharmaceuticals, Inc. (RYTM) Q3 2024 Earnings Call Transcript

Rhythm Pharmaceuticals, Inc. (RYTM) came out with a quarterly loss of $0.73 per share versus the Zacks Consensus Estimate of a loss of $0.80. This compares to loss of $0.76 per share a year ago.

Rhythm Pharmaceuticals, Inc. (RYTM) Reports Q3 Loss, Tops Revenue Estimates

-- Third quarter 2024 net revenue from global sales of IMCIVREE ® (setmelanotide) of $33.3 million -- -- Adult patients with acquired hypothalamic obesity (N=8) achieved mean BMI reduction of 12.8% on setmelanotide therapy at three months in French early-access program --

Rhythm Pharmaceuticals Reports Third Quarter 2024 Financial Results and Business Update

-- Real-world data showed mean BMI decrease of 12.8% in adult patients with acquired hypothalamic obesity (N=8) at three months on setmelanotide therapy; mean BMI decrease of 21.3% in patients (n=5) who reached six months -- -- Greater reduction in fat mass (29.7%) versus reduction in lean muscle mass (7.7%) reported from Phase 2 trial extension in patients with acquired hypothalamic obesity (n=11) after 12 months --

Rhythm Pharmaceuticals Announces Five New Data Presentations at ObesityWeek® 2024

Rhythm Pharmaceuticals (RYTM) possesses the right combination of the two key ingredients for a likely earnings beat in its upcoming report. Get prepared with the key expectations.

Rhythm Pharmaceuticals, Inc. (RYTM) Expected to Beat Earnings Estimates: What to Know Ahead of Q3 Release

BOSTON and LONDON, Oct. 24, 2024 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM) and Axovia Therapeutics Ltd. today announced a joint research collaboration designed to advance the understanding of Bardet-Biedl syndrome (BBS).

Rhythm Pharmaceuticals and Axovia Therapeutics Announce Joint Research Collaboration in Bardet-Biedl Syndrome

BOSTON, Oct. 08, 2024 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a commercial-stage biopharmaceutical company focused on transforming the lives of patients living with rare neuroendocrine diseases, today announced that on October 4, 2024, the Compensation & Management Development Committee of Rhythm's Board of Directors granted inducement restricted stock units, or RSUs, covering an aggregate of 30,050 shares of its common stock to nine new employees.

Rhythm Pharmaceuticals Announces New Employment Inducement Grants

IMCIVREE is FDA-approved for obesity due to genetic mutations and aims to expand its label to include children as young as 2 years old. The company is also exploring IMCIVREE for hypothalamic obesity in a phase 3 study, with data expected in the 1st half of 2025. Financially, Rhythm has $319.1 million in cash, but may need to raise more funds within the next 12 months.

Rhythm: Upcoming sNDA Label Expansion IMCIVREE Isn't The Only Catalyst On Deck

Rhythm Pharmaceuticals (RYTM) was a big mover last session on higher-than-average trading volume. The latest trend in earnings estimate revisions might not help the stock continue moving higher in the near term.

Strength Seen in Rhythm Pharmaceuticals (RYTM): Can Its 7.4% Jump Turn into More Strength?

Rhythm Pharmaceuticals is near a buy point after strong sales in the second quarter.

Biotech Stock Near Buy Point Amid Impressive Sales Track Record

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Rhythm Pharmaceuticals' Q2 revenue rose to $29.1 million, driven by global sales of Imcivree, its treatment for rare genetic obesity disorders. The company's cash and investments totaled $319 million by June 30, 2024, ensuring a cash runway into 2026, according to Rhythm's projections. Imcivree is currently undergoing a Phase 3 trial for hypothalamic obesity, with results expected in 1H 2025, crucial for its potential blockbuster status.

Rhythm: Pivotal Moment Approaching In Hypothalamic Obesity (Rating Upgrade)

RYTM gains 8% as FDA accepts Imcivree sNDA seeking label expansion of the drug to treat obesity in kids as young as two years old.

Rhythm Stock Up as FDA Accepts Obesity Drug sNDA for Younger Kids

-- Label expansion sought to treat younger children with Bardet-Biedl syndrome or POMC/LEPR deficiency -- -- FDA sets PDUFA goal date of December 26, 2024 --

Rhythm Pharmaceuticals Announces FDA Acceptance for Priority Review of Supplemental New Drug Application for IMCIVREE® (setmelanotide) in Patients as Young as 2 years old

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Rhythm Pharmaceuticals, Inc. (NASDAQ:RYTM ) Q2 2024 Earnings Conference Call August 6, 2024 8:00 AM ET Company Participants David Connolly - IR & Corporate Communications David Meeker - Chairman, CEO & President Jennifer Lee - EVP & Head, North America Hunter Smith - CFO Yann Mazabraud - EVP & Head, International Conference Call Participants Jeff Hung - Morgan Stanley Phil Nadeau - TD Cowen Whitney Ijem - Canaccord Genuity Dae Gon Ha - Stifel Corinne Johnson - Goldman Sachs Tazeen Ahmad - BofA Securities Joseph Stringer - Needham & Company Michael Higgins - Ladenburg Thalmann Operator Good day and thank you for standing by. Welcome to the Rhythm Pharmaceuticals Second Quarter 2024 Earnings Conference Call.

Rhythm Pharmaceuticals, Inc. (RYTM) Q2 2024 Earnings Call Transcript

Rhythm Pharmaceuticals, Inc. (RYTM) came out with a quarterly loss of $0.55 per share versus the Zacks Consensus Estimate of a loss of $0.70. This compares to loss of $0.82 per share a year ago.

Rhythm Pharmaceuticals, Inc. (RYTM) Reports Q2 Loss, Tops Revenue Estimates

-- Second quarter 2024 net revenue from global sales of IMCIVREE ® (setmelanotide) of $29.1 million -- -- Dosed first patients in supplemental, 12-patient Japanese cohort in global Phase 3 trial evaluating setmelanotide in hypothalamic obesity; On track for topline data from 120-patient, pivotal cohort in 1H 2025 --

Rhythm Pharmaceuticals Reports Second Quarter 2024 Financial Results and Business Update

IMCIVREE now authorized as treatment of obesity and control of hunger in adult patients and pediatric patients 2 years old or older with Bardet Biedl syndrome or POMC, PCSK1, or LEPR deficiency IMCIVREE now authorized as treatment of obesity and control of hunger in adult patients and pediatric patients 2 years old or older with Bardet Biedl syndrome or POMC, PCSK1, or LEPR deficiency

Rhythm Pharmaceuticals Announces European Commission Expands ▼IMCIVREE® (setmelanotide) Marketing Authorization to include Children as Young as 2 Years Old

BOSTON, July 23, 2024 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a commercial-stage biopharmaceutical company focused on transforming the lives of patients and their families living with rare neuroendocrine diseases, today announced that it will host a live conference call and webcast at 8:00 a.m. ET on Tuesday, August 6, 2024 to report its second quarter 2024 financial results and provide a corporate update.

Rhythm Pharmaceuticals to Report Second Quarter 2024 Financial Results on Tuesday, August 6, 2024

- European Commission decision anticipated in the second half of 2024 - BOSTON, June 28, 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 that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the marketing authorization for IMCIVREE® (setmelanotide) include children between 2 and younger than 6 years old with obesity due to Bardet Biedl syndrome (BBS) or pro-opiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency. “We continue to work closely with health authorities throughout the European Union to make IMCIVREE available to eligible patients with uncontrolled hunger and early-onset, severe obesity associated with these rare neuroendocrine diseases,” said Yann Mazabraud, Executive Vice President, Head of International at Rhythm Pharmaceuticals.

Rhythm Pharmaceuticals Receives Positive CHMP Opinion for ▼IMCIVREE® (setmelanotide) for the Treatment of Obesity and Control of Hunger in Patients between 2 and 6 years old with Bardet Biedl Syndrome or POMC, PCSK1, or LEPR Deficiency

- 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.

Rhythm Pharmaceuticals Presents Patient-reported Experiences with Hyperphagia in Hypothalamic Obesity at ENDO 2024

BOSTON, June 03, 2024 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a commercial-stage biopharmaceutical company focused on transforming the lives of patients and their families living with rare neuroendocrine diseases, today announced that David Meeker, M.D., Chair, President and Chief Executive Officer, will participate in a fireside chat at Goldman Sachs 45th Annual Global Healthcare Conference on Monday, June 10, 2024 at 9:20 a.m.

Rhythm Pharmaceuticals Announces Participation at Upcoming Investor Conference

IMCIVREE expected to be funded and available for use in England and Wales within three months through the National Health Service in specialist centres IMCIVREE expected to be funded and available for use in England and Wales within three months through the National Health Service in specialist centres

Rhythm Pharmaceuticals Receives Positive Recommendation from NICE for ▼IMCIVREE® (setmelanotide) for Treatment of Obesity and Hyperphagia in Patients with Bardet-Biedl Syndrome

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