Welcome to our dedicated page for Rhythm Pharmaceu news (Ticker: RYTM), a resource for investors and traders seeking the latest updates and insights on Rhythm Pharmaceu stock.
Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM) is a commercial-stage biopharmaceutical company whose news flow centers on rare neuroendocrine diseases and MC4R pathway–targeted therapies. The company’s updates frequently highlight global commercial performance of its lead product IMCIVREE (setmelanotide), regulatory milestones, and clinical data across multiple rare obesity indications.
Investors following RYTM news can expect regular announcements on net product revenues from global sales of IMCIVREE, including the relative contributions from the United States and international markets. Rhythm also issues press releases on reimbursement developments, such as public reimbursement agreements for IMCIVREE in Canadian provinces and under federal programs for patients with Bardet-Biedl syndrome–related obesity.
Clinical and regulatory news is a major focus. Rhythm reports on Phase 3 trials like TRANSCEND in acquired hypothalamic obesity and EMANATE in genetically caused MC4R pathway diseases, as well as exploratory and Phase 2 studies in Prader-Willi syndrome and other rare conditions. Updates often include topline efficacy and safety data, cardiometabolic outcomes, and patient- and caregiver‑reported measures presented at scientific meetings.
Regulatory communications include FDA actions on supplemental New Drug Applications, PDUFA goal dates and extensions, and EMA validation of Type II variations to existing marketing authorizations. Rhythm also provides information on development of investigational MC4R agonists bivamelagon and RM-718 and preclinical small molecules for congenital hyperinsulinism.
For users tracking RYTM, this news feed offers a centralized view of earnings releases, clinical trial readouts, regulatory decisions and access milestones related to IMCIVREE and Rhythm’s broader rare disease pipeline.
Rhythm Pharmaceuticals (Nasdaq: RYTM) will report fourth quarter and full year 2025 financial results on Thursday, February 26, 2026 with a live conference call and webcast at 8:00 a.m. ET. Participants may register to join; joining 10 minutes early is recommended.
CEO David Meeker will participate in a fireside chat at the TD Cowen 46th Annual Health Care Conference in Boston on Monday, March 2, 2026 at 11:10 a.m. ET. Both webcasts will be archived on Rhythm’s Investor Relations website; the earnings call archive will be available about two hours after the call and both recordings will remain for 30 days.
Rhythm Pharmaceuticals (Nasdaq: RYTM) announced that CFO Hunter C. Smith will participate in a fireside chat at the Guggenheim Emerging Outlook: Biotech Summit 2026 on Wednesday, February 11 at 11:00 a.m. ET in New York. The session will be webcast and replayed for 30 days on the company website.
Rhythm Pharmaceuticals (Nasdaq: RYTM) reported preliminary, unaudited net product revenues for IMCIVREE of approximately $57 million in Q4 2025 (an 11% sequential increase) and approximately $194 million for FY2025 (about 50% year‑over‑year growth vs. $130M in 2024). U.S. sales represented ~68% of Q4 and ~69% of FY2025 revenues. The company set a PDUFA goal date of March 20, 2026 for the sNDA in acquired hypothalamic obesity and expects topline Phase 3 readouts in Q1 2026 for a 12‑patient Japanese cohort and the EMANATE trial. Additional 2026 milestones include PWS six‑month data, RM‑718 Part C completion, and potential Phase 3 initiation for bivamelagon pending regulatory feedback. Financial results will be reported in late February 2026 and are subject to final close and audit.
Rhythm Pharmaceuticals (Nasdaq: RYTM) reported positive preliminary data from an exploratory Phase 2 trial of setmelanotide in Prader-Willi syndrome (PWS) with a data cut-off of Nov. 14, 2025. The 52-week trial enrolled 18 patients (ages 6–65) and remains ongoing. At Month 3 (n=8) and Month 6 (n=5), reductions in BMI and hyperphagia were observed in several patients; key highlights include 6 of 8 patients with BMI reductions at Month 3 and 6 of 7 evaluable patients with meaningful HQ-CT score reductions at Month 3. Seventeen of 18 patients remain on therapy. Safety was consistent with setmelanotide’s known profile. Rhythm plans a registrational Phase 3 trial pending completion of Phase 2 and initiated a Part D arm of RM-718 for PWS with first screening expected in Dec 2025.
Rhythm Pharmaceuticals (NASDAQ: RYTM) will disclose preliminary data from an exploratory Phase 2 trial of setmelanotide in patients with Prader-Willi syndrome (PWS). The company will host a live conference call and webcast on Thursday, December 11, 2025 at 8:00 a.m. ET to present the update.
Participants can register for the conference call and join the live webcast via the company's Investor Relations website. An archived webcast will be posted about two hours after the call and will remain available for 30 days.
Rhythm Pharmaceuticals (Nasdaq: RYTM) presented four datasets at ObesityWeek 2025 on Nov 10, 2025 highlighting Phase 3 TRANSCEND results in acquired hypothalamic obesity. A post‑hoc TRANSCEND analysis showed a −27.1% mean placebo‑adjusted BMI reduction (p<0.0001; n=9) for patients on setmelanotide plus GLP‑1 therapy versus GLP‑1 plus placebo (n=6), and a −19.0% mean placebo‑adjusted BMI reduction (p<0.0001; setmelanotide n=72 vs placebo n=33) in patients not on GLP‑1 therapy. Presentations also reported significant improvements in cardiometabolic parameters and patient‑reported outcomes, and a separate POWER registry analysis of 212 pediatric participants examined hyperphagia and genetic variants.
Rhythm Pharmaceuticals (NASDAQ: RYTM) said the FDA extended the PDUFA goal date for the sNDA for IMCIVREE (setmelanotide) for acquired hypothalamic obesity from Dec 20, 2025 to Mar 20, 2026.
The FDA requested additional sensitivity analyses of Phase 3 efficacy data; no new data were requested and the amendment did not include safety or manufacturing information. Rhythm said it continues to collaborate with the FDA and is preparing for potential patient access.
The company will host a live conference call and webcast on Nov 7, 2025 at 8:00 a.m. ET; an archived webcast will be available about two hours after the call for 30 days.
Rhythm Pharmaceuticals (Nasdaq: RYTM) announced public reimbursement agreements for IMCIVREE (setmelanotide) in Ontario, Alberta, British Columbia, Saskatchewan, Nova Scotia and with the Federal Non-Insured Health Benefits (NIHB) program for weight management in eligible patients aged 6 years and older with clinically or genetically confirmed Bardet-Biedl syndrome (BBS) and obesity.
IMCIVREE was approved by Health Canada in May 2023 after priority review and was recently added to the Common Drug List for rare diseases under Canada’s National Strategy for Drugs for Rare Diseases, supporting broader public access.
Rhythm Pharmaceuticals (NASDAQ: RYTM) reported Q3 2025 net product revenue of $51.3M from global IMCIVREE (setmelanotide), a 6% sequential increase, with $38.2M (74%) from the U.S. and $13.1M (26%) outside the U.S. Rhythm announced FDA Priority Review acceptance of an sNDA for acquired hypothalamic obesity with a PDUFA goal date of December 20, 2025. Cash, cash equivalents and short-term investments were $416.1M as of September 30, 2025. Additional updates: planned preliminary Phase 2 Prader-Willi results in Q4 2025, EMA validation of a Type II variation, a one-time $3.2M France price-adjustment charge, and multiple upcoming clinical milestones into 2026.
Rhythm Pharmaceuticals (Nasdaq: RYTM) will report third quarter 2025 financial results and provide a corporate update via a live conference call and webcast on Tuesday, November 4, 2025 at 8:00 a.m. ET. Participants may register to access the live call and are advised to join 10 minutes early. Archived webcasts will be available on Rhythm's Investor Relations website for at least 30 days after the call.
Additionally, Rhythm executives will appear in two fireside chats on Wednesday, November 12, 2025: David Meeker, M.D., at the Guggenheim Healthcare Innovation Conference at 9:30 a.m. ET, and Hunter Smith with Alastair Garfield at the Stifel Healthcare Conference at 4:00 p.m. ET. Live webcasts of both events will be posted under Events and Presentations on the company website.