#rytm

StockTitan

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2 weeks ago

Rhythm Pharmaceuticals Announces Additional Positive Data from Phase 3 TRANSCEND trial of Setmelanotide in Patients with Acquired Hypothalamic Obesity 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.

#RYTM Rhythm Pharmaceuticals Announces Additional Positive Data from Phase 3 TRANSCEND trial of Setmelanotide in Patients with Acquired Hypothalamic Obesity

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StockTitan

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2 weeks ago

Rhythm Pharmaceuticals Reports Fourth Quarter and Full Year 2025 Financial Results and Business Update 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.

#RYTM Rhythm Pharmaceuticals Reports Fourth Quarter and Full Year 2025 Financial Results and Business Update

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StockTitan

@stocktitan.net

2 months ago

Rhythm Pharmaceuticals Announces Preliminary, Unaudited Fourth Quarter and Full Year 2025 Net Product Revenues and Upcoming Milestones 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.

#RYTM Rhythm Pharmaceuticals Announces Preliminary, Unaudited Fourth Quarter and Full Year 2025 Net Product Revenues and Upcoming Milestones

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StockTitan

@stocktitan.net

3 months ago

Rhythm Pharmaceuticals Announces Preliminary Data from Exploratory Phase 2 Trial that showed Setmelanotide Demonstrated Positive Efficacy Signal in Prader-Willi Syndrome -- Company initiated

#RYTM Rhythm Pharmaceuticals Announces Preliminary Data from Exploratory Phase 2 Trial that showed Setmelanotide Demonstrated Positive Efficacy Signal in Prader-Willi Syndrome

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StockTitan

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3 months ago

Rhythm Pharmaceuticals to Announce Preliminary Data from Exploratory Phase 2 Trial Evaluating Setmelanotide in Prader-Willi Syndrome 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.

#RYTM Rhythm Pharmaceuticals to Announce Preliminary Data from Exploratory Phase 2 Trial Evaluating Setmelanotide in Prader-Willi Syndrome

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StockTitan

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4 months ago

Rhythm Pharmaceuticals Announces Presentation of Four Datasets at ObesityWeek® 2025 – Phase 3 TRANSCEND trial data showed setmelanotide achieved significant BMI reductions in patients with acquired hypothalamic obesity on concomitant treatment with GLP-1 therapy – – Analysis of data from Phase 3 TRANSCEND trial show clinically meaningful changes in cardiometabolic parameters in

#RYTM Rhythm Pharmaceuticals Announces Presentation of Four Datasets at ObesityWeek® 2025

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StockTitan

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4 months ago

Rhythm Pharmaceuticals Announces FDA Extension of Review Period for IMCIVREE® (setmelanotide) for Patients with Acquired Hypothalamic Obesity Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a global commercial-stage biopharmaceutical company focused on transforming the lives of patients

#RYTM Rhythm Pharmaceuticals Announces FDA Extension of Review Period for IMCIVREE® (setmelanotide) for Patients with Acquired Hypothalamic Obesity

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StockTitan

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4 months ago

Rhythm Pharmaceuticals Announces Public Reimbursement for IMCIVREE® (setmelanotide) in Canada in Five Provinces and Under the Federal Non-Insured Health Benefits Program 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.

#RYTM Rhythm Pharmaceuticals Announces Public Reimbursement for IMCIVREE® (setmelanotide) in Canada in Five Provinces and Under the Federal Non-Insured Health Benefits Program

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StockTitan

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6 months ago

Rhythm Pharmaceuticals Announces FDA Acceptance of sNDA for Setmelanotide in Acquired Hypothalamic Obesity Rhythm Pharmaceuticals (NASDAQ:RYTM) announced significant regulatory progress for setmelanotide in treating acquired hypothalamic obesity. The FDA has accepted the company's sNDA with Priority Review, setting a PDUFA date of December 20, 2025. Additionally, the EMA validated the Type II variation submission for the same indication.The applications are supported by the Phase 3 TRANSCEND trial results, which demonstrated a significant -19.8% placebo-adjusted reduction in BMI. The trial showed strong efficacy in both adult patients (-19.2% BMI reduction) and pediatric patients (-20.2% BMI reduction). Setmelanotide, already approved as IMCIVREE® for other rare genetic obesity conditions, was generally well-tolerated in the study.

#RYTM Rhythm Pharmaceuticals Announces FDA Acceptance of sNDA for Setmelanotide in Acquired Hypothalamic Obesity

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StockTitan

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7 months ago

Rhythm Pharmaceuticals Reports Second Quarter 2025 Financial Results and Business Update Rhythm Pharmaceuticals (NASDAQ:RYTM) reported strong Q2 2025 financial results, with IMCIVREE® global sales reaching $48.5 million, up 29% from Q1 2025. The company successfully raised $189.2 million through a public offering of common stock at $85 per share.Key clinical achievements include positive Phase 2 results for bivamelagon and Phase 3 TRANSCEND trial data for setmelanotide in acquired hypothalamic obesity. The Phase 2 trial showed significant BMI reductions of 9.3% in the 600mg cohort and 7.7% in the 400mg cohort. The company plans to complete regulatory submissions for setmelanotide in acquired hypothalamic obesity to FDA and EMA in Q3 2025.Q2 2025 resulted in a net loss of $48.0 million ($0.75 per share), compared to $33.6 million ($0.55 per share) in Q2 2024. The company projects $285-315 million in Non-GAAP Operating Expenses for 2025.

#RYTM Rhythm Pharmaceuticals Reports Second Quarter 2025 Financial Results and Business Update

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StockTitan

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8 months ago

Rhythm Pharmaceuticals Presents Data on MC4R Agonists Setmelanotide and Bivamelagon at ENDO 2025 Rhythm Pharmaceuticals (NASDAQ:RYTM) presented significant clinical data for two MC4R agonists - setmelanotide and bivamelagon - in treating acquired hypothalamic obesity at ENDO 2025. The Phase 2 SIGNAL trial for bivamelagon showed significant BMI reductions of up to 9.3% in the highest dose cohort. The Phase 3 TRANSCEND trial for setmelanotide demonstrated a remarkable 19.8% placebo-adjusted BMI reduction across 120 patients.Notably, setmelanotide showed consistent efficacy across age groups and genders, with significant results even in patients using GLP-1s. Patients with prior and concomitant GLP-1 use achieved a 25.1% BMI reduction compared to 2.0% in the placebo group. In patients under 18, the treatment led to a 26.2% reduction in the 95th percentile BMI at week 52.

#RYTM Rhythm Pharmaceuticals Presents Data on MC4R Agonists Setmelanotide and Bivamelagon at ENDO 2025

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StockTitan

@stocktitan.net

8 months ago

Rhythm Pharmaceuticals, Inc. Announces Pricing of Upsized Public Offering of Common Stock Rhythm Pharmaceuticals (NASDAQ:RYTM), a global biopharmaceutical company focused on rare neuroendocrine diseases, has announced the pricing of its upsized public offering of 2,058,824 shares at $85.00 per share.The company expects to raise approximately $175 million in gross proceeds before deducting underwriting costs and other expenses. Additionally, underwriters have a 30-day option to purchase up to 308,823 additional shares at the public offering price. The offering is expected to close around July 11, 2025.Morgan Stanley, BofA Securities, Stifel, and Wells Fargo Securities are serving as joint book-running managers, while Canaccord Genuity and Citizens Capital Markets act as lead managers for the offering.

#RYTM Rhythm Pharmaceuticals, Inc. Announces Pricing of Upsized Public Offering of Common Stock

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StockTitan

@stocktitan.net

8 months ago

Rhythm Pharmaceuticals, Inc. Announces Proposed Public Offering of Common Stock Rhythm Pharmaceuticals (NASDAQ: RYTM), a global biopharmaceutical company focused on rare neuroendocrine diseases, has announced a proposed public offering of $150 million of its common stock. The company will also grant underwriters a 30-day option to purchase up to an additional $22.5 million of shares.The offering will be managed by joint book-runners Morgan Stanley, BofA Securities, Stifel, and Wells Fargo Securities, with Canaccord Genuity and Citizens Capital Markets acting as lead managers. The offering will be made through a shelf registration statement on Form S-3 that became effective on March 2, 2023.

#RYTM Rhythm Pharmaceuticals, Inc. Announces Proposed Public Offering of Common Stock

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Market Wire News

@marketwirenews.com

8 months ago

News; ( NASDAQ: #RYTM ) PRISM Mid-Day Movers: Hydrogen Momentum and Crypto Strategy Diverge Indices

StockTitan

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8 months ago

Rhythm Pharmaceuticals to Reveal Crucial Phase 2 Data for Revolutionary Oral Obesity Treatment First oral MC4R agonist trial results for hypothalamic obesity treatment to be unveiled. Key efficacy data and safety profile coming July 9. Get exclusive insights.

#RYTM Rhythm Pharmaceuticals To Announce Topline Results from Phase 2 Trial Evaluating Oral MC4R Agonist Bivamelagon in Acquired Hypothalamic Obesity

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StockTitan

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8 months ago

Rhythm Pharmaceuticals Announces Three Late-breaking Data Abstracts Accepted for Presentation at ENDO 2025 Rhythm Pharmaceuticals (NASDAQ:RYTM) announced the acceptance of three late-breaking abstracts for presentation at ENDO 2025 in San Francisco. The presentations will showcase data from multiple clinical trials focused on acquired hypothalamic obesity treatments.Key presentations include: the Phase 3 TRANSCEND trial results evaluating setmelanotide, patient experience interviews from the TRANSCEND trial, and results from a Phase 2 trial of bivamelagon, an oral MC4R agonist. The presentations will take place between July 12-15, 2025, with all materials becoming available on the company's healthcare professional website afterward.

#RYTM Rhythm Pharmaceuticals Announces Three Late-breaking Data Abstracts Accepted for Presentation at ENDO 2025

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StockTitan

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10 months ago

Rhythm Pharmaceuticals Reports First Quarter 2025 Financial Results and Business Update Rhythm Pharmaceuticals (RYTM) reported strong Q1 2025 results with global IMCIVREE sales reaching $37.7M. The company announced its pivotal Phase 3 TRANSCEND trial met its primary endpoint, showing a significant -19.8% placebo-adjusted BMI reduction in patients with acquired hypothalamic obesity. Key highlights include: U.S. revenue of $24.5M (65%) and international revenue of $13.2M (35%). The company's cash position stands at $314.5M, expected to fund operations into 2027. Q1 net loss was $50.8M ($0.81 per share). Rhythm plans regulatory submissions for setmelanotide in acquired hypothalamic obesity in Q3 2025 and expects topline data from Phase 2 trial of oral MC4R agonist bivamelagon in the same quarter.

#RYTM Rhythm Pharmaceuticals Reports First Quarter 2025 Financial Results and Business Update

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StockTitan

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11 months ago

Major Phase 3 Trial Results: New Hope for Hypothalamic Obesity Patients Key efficacy data from TRANSCEND trial evaluating setmelanotide in hypothalamic obesity to be revealed. Breakthrough potential for rare disease treatment.

#RYTM Rhythm Pharmaceuticals to Announce Topline Results from Pivotal Phase 3 TRANSCEND Trial Evaluating Setmelanotide in Patients with Acquired Hypothalamic Obesity

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StockTitan

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11 months ago

Strategic Win: Rhythm Pharmaceuticals Reclaims IMCIVREE Rights in China, Strengthens Global Position Rhythm Pharmaceuticals consolidates global control of IMCIVREE as it reacquires China rights, advancing worldwide development strategy ahead of crucial Q2 2025 trial data.

#RYTM Rhythm Pharmaceuticals Reacquires Licensing Rights to IMCIVREE® (setmelanotide) in China with Termination of Agreement with RareStone Ltd.

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StockTitan

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11 months ago

Breakthrough for Rare Obesity: Rhythm's Drug Wins Special Status in Japan Setmelanotide gains orphan designation in Japan, targeting 5,000-8,000 hypothalamic obesity patients. Phase 3 trial progresses toward first-ever targeted treatment.

#RYTM Rhythm Pharmaceuticals Announces Orphan Drug Designation Granted to Setmelanotide for Treatment of Hypothalamic Obesity in Japan

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StockTitan

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11 months ago

Major Breakthrough: Rhythm Pharma's New Research Tackles Devastating Fatigue in Brain Tumor Patients New patient registry study explores fatigue impact in craniopharyngioma patients, marking significant progress in understanding rare brain tumor complications.

#RYTM Rhythm Pharmaceuticals and Raymond A. Wood Foundation Announce Research Collaboration

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StockTitan

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1 year ago

Rhythm's IMCIVREE Sales Surge 26% in Q4 - Can Their Rare Disease Drug Maintain Momentum? IMCIVREE now approved for children as young as 2, extending Rhythm's market reach. $75M raised extends cash runway into 2027 despite increased R&D spending.

#RYTM Rhythm Pharmaceuticals Reports Fourth Quarter and Full Year 2024 Financial Results and Business Update

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PIGGMENTS

@piggments.bsky.social

1 year ago

teenage engineering pocket operator drum machine

New toy in my setup. My first TE gear and I’m afraid that not the last. Any recommendations- What PO should I get next?;) #teenageengineering #pocketoperator #gear #synth #rytm #gas

PIGGMENTS

@piggments.bsky.social

1 year ago

What’s your fav Elektron gear? As much as I love Octatrack, Rytm has special place at my heart. #elektron #rytm #octatrack #synth

Under the Wires

@underthewires.bsky.social

1 year ago

January 12 - Forked Yolk composer / producer

You know that feeling when you are chasing the yolk around the bowl and the closer you get the quicker it slips away? Until at the last second you pierce its halo with the fork’s tine?

on.soundcloud.com/gsxjriE8bu66...
#jamuary #jamuary25 #funaday
#composer #electronicmusic #elektron #analog #rytm

StockTitan

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1 year ago

Rhythm Pharmaceuticals Delivers Record $130M Revenue in 2024, Q4 Sales Surge 26% Rhythm Pharmaceuticals reports strong IMCIVREE sales growth with $42M in Q4 2024, while advancing multiple late-stage clinical trials in rare genetic obesity disorders.

#RYTM Rhythm Pharmaceuticals Announces Preliminary Fourth Quarter and Full Year 2024 Net Product Revenues, Pipeline Advancements and Upcoming Milestones

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StockTitan

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1 year ago

Rhythm Pharma's IMCIVREE Wins FDA Approval for Rare Obesity Treatment in Young Children Breakthrough approval expands IMCIVREE treatment to children as young as 2 years old with rare genetic obesity conditions, marking a significant advance in precision medicine.

#RYTM Rhythm Pharmaceuticals Announces FDA Approval of IMCIVREE® (setmelanotide) for Patients as Young as 2 Years Old

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StockTitan

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1 year ago

#RYTM Rhythm Pharmaceuticals Announces New Employment Inducement Grants

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