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. develops and commercializes therapies for rare neuroendocrine diseases, centered on IMCIVREE (setmelanotide), an MC4R agonist for hyperphagia and severe obesity linked to rare MC4R pathway disorders. Company updates commonly cover U.S. and international commercialization of setmelanotide, regulatory authorizations and label expansions for acquired hypothalamic obesity, Bardet-Biedl syndrome, POMC/PCSK1 deficiency and LEPR deficiency, and safety information tied to approved uses.
Rhythm news also follows clinical data from setmelanotide studies, including acquired hypothalamic obesity and genetically caused MC4R pathway diseases, along with development of investigational MC4R agonists bivamelagon and RM-718 and preclinical small molecules for congenital hyperinsulinism. Recurring corporate items include financial results, specialty-pharmacy access arrangements, healthcare conference presentations and board governance changes.
PANTHERx Rare was chosen by Rhythm Pharmaceuticals (Nasdaq: RYTM) as the exclusive U.S. specialty pharmacy for the expanded indication of IMCIVREE (setmelanotide) for adults and children aged 4 and older with acquired hypothalamic obesity, announced March 20, 2026.
PANTHERx will deploy its RxARECARE model for individualized case management, education, and financial and insurance navigation. PANTHERx has served as IMCIVREE's exclusive pharmacy for certain genetic obesity indications since 2020.
Rhythm Pharmaceuticals (NASDAQ: RYTM) announced FDA approval of IMCIVREE (setmelanotide) for acquired hypothalamic obesity (HO) in adults and pediatric patients aged 4 years and older. Approval was based on the Phase 3 TRANSCEND trial showing a -18.4% placebo-adjusted BMI reduction.
IMCIVREE is available immediately in the U.S.; Rhythm estimates ~10,000 people in the U.S. live with acquired HO. The company will host a conference call today at 7:00 p.m. ET.
Rhythm Pharmaceuticals (Nasdaq: RYTM) reported topline Phase 3 EMANATE results: the four genetic substudies did not meet prespecified primary endpoints for placebo-adjusted BMI change at Week 52.
Post hoc LOCF analyses showed statistically significant BMI reductions in POMC/PCSK1 Hets (−5.5%, p=0.0010) and SRC1 (NCOA1) (−6.2%, p<0.0001). No new safety signals were observed. A conference call was scheduled for 4:30 p.m. ET on March 16, 2026.
Rhythm Pharmaceuticals (Nasdaq: RYTM) reported additional positive 52-week data from its global Phase 3 TRANSCEND trial of setmelanotide in acquired hypothalamic obesity. Results showed a -18.8% placebo-adjusted BMI reduction (N=142) and mean BMI change of -16.4% on drug versus +2.4% on placebo (p<0.0001).
The dataset adds 12 Japanese patients and 10 supplemental patients. The company set a PDUFA goal date of March 20, 2026 for its supplemental NDA and will submit the final data package to the FDA on March 2, 2026. EMA CHMP opinion is anticipated in Q2 2026.
Rhythm Pharmaceuticals (Nasdaq: RYTM) reported Q4 2025 IMCIVREE net product revenue of $57.3 million and full-year 2025 product revenue of $194.8 million. Cash, cash equivalents and short-term investments were $388.9 million as of Dec 31, 2025.
The company disclosed a PDUFA goal date of March 20, 2026 for a sNDA seeking approval of setmelanotide in acquired hypothalamic obesity (HO), reported positive Phase 2 open-label extension data for bivamelagon, and plans multiple March 2026 topline readouts.
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.