--- title: "Rhythm Pharmaceuticals (RYTM): news, pipeline and catalysts" url: "https://aibio.space/companies/rhythm-pharmaceuticals/" publisher: "aibio.space (Biotech Investor Relations News)" summary: "Rhythm Pharmaceuticals news for investors: Rhythm Pharmaceuticals sells IMCIVREE (setmelanotide), a daily injection that activates the MC4R pathway, for…" --- Desk view · Opinion · Updated Oct 22, 2026 ## Rhythm has an HO launch under way. The pipeline beyond it is unproven Rhythm has a launched, approved drug for a rare disease with no other treatment, and sales rose 19% last quarter. The company is still loss-making and depends on one product, and its efforts to widen the franchise have so far produced one phase 3 miss and modest early data in Prader-Willi syndrome. The oral and weekly follow-on drugs will determine how far it can grow beyond acquired hypothalamic obesity. Read the full desk view aibio.space Investor Rank · Opinion **7** /10 Positive view IMCIVREE sales rose 19% on the HO launch with about two years of cash, but Rhythm is loss-making, depends on one product and EMANATE missed. - **Technology**: 2/2 - **Odds**: 1/2 - **Balance sheet**: 2/2 - **Risk**: 1/2 - **Momentum**: 1/2 Opinion only. The Investor Rank is aibio.space's opinion of the company's business position, drawn from the public sources on this page. It is not a recommendation to buy, sell or hold any security and it is not investment advice. It does not consider the share price, valuation or your circumstances, and it can change at any time. Payments from companies never affect it. [How the rank works](https://aibio.space/disclosures/#rank). - **Technology**: **Validated in rare disease.** Setmelanotide cut BMI 16.5% at 52 weeks against a 3.3% rise on placebo in the phase 3 TRANSCEND trial published in NEJM. - **Odds**: **Strong in HO, mixed beyond.** The HO label is approved in the U.S. and EU, but EMANATE missed all four endpoints and the Prader-Willi data are open label. - **Balance sheet**: **Funded, still loss-making.** Cash was $330.9 million at June 30, enough for at least 24 months by the company's account, against a $50.4 million quarterly loss. - **Main risk**: **Product and customer concentration.** All revenue is IMCIVREE and about 72% of Q2 revenue came from a single U.S. customer. - **Watch next**: **Japan and bivamelagon.** A Japanese decision and the start of a bivamelagon phase 3 are both guided for year-end 2026. ## Top news on Rhythm ## Dates **By year-end 2026** Japanese regulatory decision on IMCIVREE for acquired hypothalamic obesity [Source](https://www.sec.gov/Archives/edgar/data/1649904/000162828026052170/q22026earningspr_draft.htm) **By year-end 2026** Start of phase 3 trial of bivamelagon in acquired HO [Source](https://www.sec.gov/Archives/edgar/data/1649904/000162828026052170/q22026earningspr_draft.htm) **Second half of 2026** Complete enrollment in the congenital HO substudy and in RM-718 Part D (Prader-Willi syndrome) [Source](https://www.sec.gov/Archives/edgar/data/1649904/000162828026052170/q22026earningspr_draft.htm) **October 31, 2026 (estimated)** Estimated primary completion of the setmelanotide Prader-Willi phase 2 trial [Source](https://clinicaltrials.gov/study/NCT06772597) **2027** Country-level European launches of IMCIVREE in acquired HO begin [Source](https://www.sec.gov/Archives/edgar/data/1649904/000162828026052170/q22026earningspr_draft.htm) ## The money $330.9 million in cash, cash equivalents and short-term investments at June 30, 2026, down from $388.9 million at December 31, 2025. Rhythm says this funds planned operations for at least 24 months. A royalty financing with HealthCare Royalty carries a deferred obligation of about $106 million on the balance sheet. [Source](https://www.sec.gov/Archives/edgar/data/1649904/000162828026052533/rytm-20260630.htm) Q2 2026 net product revenue from IMCIVREE was $71.3 million (U.S. $51.0 million, ex-U.S. $20.3 million), up 19% from Q1. First-half revenue was $131.4 million. Q2 net loss attributable to common stockholders was $50.4 million. [Source](https://www.sec.gov/Archives/edgar/data/1649904/000162828026052170/q22026earningspr_draft.htm) ## Risks on the record - All revenue comes from IMCIVREE, about 72% of Q2 revenue came from a single U.S. customer, and Rhythm relies on third-party manufacturers and genetic testing providers. [Source](https://www.sec.gov/Archives/edgar/data/1649904/000162828026052533/rytm-20260630.htm) - The EMANATE phase 3 missed its primary endpoint in all four genetic substudies, and the Prader-Willi phase 2 showed a modest 3.06% mean BMI reduction at six months in an open-label design. [Source](https://www.sec.gov/Archives/edgar/data/1649904/000162828026018211/ex991rytm20260616emanatepr.htm) - Rhythm still loses about $50 million a quarter, and its royalty financing requires minimum payments to HealthCare Royalty in March 2027 and March 2029. [Source](https://www.sec.gov/Archives/edgar/data/1649904/000162828026052533/rytm-20260630.htm) ## Questions investors ask ### What is aibio.space's Investor Rank for Rhythm Pharmaceuticals? 7 out of 10, our positive view. IMCIVREE sales rose 19% on the HO launch with about two years of cash, but Rhythm is loss-making, depends on one product and EMANATE missed. This is opinion only, not a recommendation to buy, sell or hold, and it does not consider the share price or valuation. [Source](https://aibio.space/disclosures/#rank) ### What does IMCIVREE treat? IMCIVREE (setmelanotide) is approved in the U.S. to reduce excess body weight in patients aged 4 and older with acquired hypothalamic obesity, and in patients aged 2 and older with obesity due to Bardet-Biedl syndrome or genetically confirmed POMC, PCSK1 or LEPR deficiency. [Source](https://www.sec.gov/Archives/edgar/data/1649904/000162828026052170/q22026earningspr_draft.htm) ### How much revenue did Rhythm report in the second quarter of 2026? Rhythm reported IMCIVREE net product revenue of $71.3 million for the second quarter, up 19% from the first quarter, with $51.0 million in the U.S. and $20.3 million outside it. [Source](https://www.sec.gov/Archives/edgar/data/1649904/000162828026052170/q22026earningspr_draft.htm) ### How long does Rhythm's cash last? Rhythm held $330.9 million in cash, cash equivalents and short-term investments at June 30, 2026, and says that is enough to fund planned operations for at least 24 months. [Source](https://www.sec.gov/Archives/edgar/data/1649904/000162828026052533/rytm-20260630.htm) ### What happened in the EMANATE trial? On March 16, 2026, Rhythm said the four substudies of its phase 3 EMANATE trial of setmelanotide in genetic obesities did not meet their primary endpoints. The company pointed to post hoc analyses in two substudies as encouraging. [Source](https://www.sec.gov/Archives/edgar/data/1649904/000162828026018211/ex991rytm20260616emanatepr.htm) ### What are Rhythm's next-generation drugs? Bivamelagon is an oral MC4R agonist that Rhythm plans to take into a phase 3 trial in acquired hypothalamic obesity by year-end 2026. RM-718 is a weekly injection that cut mean BMI by 11.6% at 16 weeks in seven patients in a preliminary phase 2 analysis. [Source](https://www.sec.gov/Archives/edgar/data/1649904/000162828026052170/rytmq22026rm-718.htm) ### What is Rhythm Pharmaceuticals's market cap? We do not publish live share prices. In its annual report, Rhythm Pharmaceuticals, Inc. put the market value of shares held by non-affiliates (public float) at $3.80 billion as of Jun 30, 2025. Source ### Is Rhythm Pharmaceuticals a smaller reporting company? SEC records list Rhythm Pharmaceuticals, Inc.'s filer category as: Large accelerated filer. Source ### Where is Rhythm Pharmaceuticals headquartered? SEC records list its business address as 222 BERKELEY STREET, BOSTON, MA, 02116. Source ### When does Rhythm Pharmaceuticals's fiscal year end? Rhythm Pharmaceuticals, Inc.'s fiscal year ends on December 31, per SEC records. Source ### What did Rhythm Pharmaceuticals last file with the SEC? Its most recent filing in our record is a 10-Q filed 2026-08-04. All of its filings are on SEC EDGAR. [Source](https://www.sec.gov/Archives/edgar/data/1649904/000162828026052533/rytm-20260630.htm) ### What was Rhythm Pharmaceuticals called before? SEC records list these former names: RHYTHM METABOLIC, INC.. Source ### What industry is Rhythm Pharmaceuticals in? Its SEC industry code (SIC 2834) is Pharmaceutical Preparations. Source ## Legal and investor matters Checked against Rhythm Pharmaceuticals filings and press releases. Allegations are allegations; nothing here is a finding of fault. Reviewed Oct 25, 2026. Part II, Item 1 of the 10-Q filed 2026-08-04 states: "We are not currently a party to any material legal proceedings." [Source](https://www.sec.gov/Archives/edgar/data/1649904/000162828026052533/rytm-20260630.htm) 1. 2025-11-06 Other FDA extends Rhythm's IMCIVREE review date by three months On 2025-11-06 the U.S. Food and Drug Administration told Rhythm that the PDUFA goal date for its supplemental New Drug Application for IMCIVREE (setmelanotide) in acquired hypothalamic obesity had moved from 2025-12-20 to 2026-03-20. Rhythm announced on 2026-03-19 that the agency had approved the expanded indication for patients aged 4 years and older. [Rhythm Form 8-K (Item 8.01)](https://www.sec.gov/Archives/edgar/data/1649904/000110465925108154/rytm-20251106x8k.htm) 2. 2025-07-09 Financing Rhythm prices public offering of 2,058,824 shares at $85.00 On 2025-07-09 Rhythm Pharmaceuticals entered into an underwriting agreement with Morgan Stanley and BofA Securities for a public offering of 2,058,824 common shares at $85.00 per share. The agreement also gave the underwriters a 30-day option to buy up to 308,823 additional shares at the public offering price, less discounts and commissions. The company disclosed the terms in a Form 8-K. [Rhythm Form 8-K (Item 8.01)](https://www.sec.gov/Archives/edgar/data/1649904/000110465925067133/tm2520063d4_8k.htm) 3. 2025-06-24 Governance Rhythm stockholders approve officer exculpation amendment At the 2025-06-24 annual meeting, Rhythm Pharmaceuticals stockholders approved an amendment to the company's certificate of incorporation. The amendment updates the exculpation provision for certain officers, as permitted by recent changes to the Delaware General Corporation Law. The board had adopted the amendment earlier, subject to the stockholder vote. [Rhythm Form 8-K (Item 5.03)](https://www.sec.gov/Archives/edgar/data/1649904/000155837025008924/rytm-20250624x8k.htm) 4. 2025-03-14 Other Rhythm and RareStone terminate exclusive license and share purchase agreements On 2025-03-14 Rhythm Pharmaceuticals signed a termination agreement with RareStone Group and RareStone Medicine (Shenzhen). The parties mutually agreed to end the exclusive license agreement and the share purchase agreement, both dated 2021-12-03. Rhythm agreed to pay $6.3 million as repayment of a portion of the upfront payment under the license agreement. Rhythm disclosed the termination under Item 1.02 of a Form 8-K. [Rhythm Form 8-K (Item 1.02)](https://www.sec.gov/Archives/edgar/data/1649904/000155837025003374/rytm-20250314x8k.htm) ## Pipeline | Program | Indication | Stage | |---|---|---| | IMCIVREE (setmelanotide) | Acquired hypothalamic obesity, patients aged 4 and older | Approved in the U.S. (March 19, 2026) and the EU; Japan decision expected by year-end 2026 [Source](https://www.sec.gov/Archives/edgar/data/1649904/000162828026052170/q22026earningspr_draft.htm) | | IMCIVREE (setmelanotide) | Obesity due to Bardet-Biedl syndrome, POMC, PCSK1 or LEPR deficiency | Marketed in the U.S. and Europe [Source](https://www.sec.gov/Archives/edgar/data/1649904/000162828026052170/q22026earningspr_draft.htm) | | Setmelanotide | Congenital hypothalamic obesity (substudy) | Enrolling; enrollment completion expected 2H 2026 [Source](https://www.sec.gov/Archives/edgar/data/1649904/000162828026052170/q22026earningspr_draft.htm) | | Setmelanotide | Prader-Willi syndrome | Phase 2 (18 enrolled); six-month data shown June 2026 [Source](https://www.sec.gov/Archives/edgar/data/1649904/000162828026043170/ex991rytmprpwsatendo2026.htm) | | Bivamelagon (oral MC4R agonist) | Acquired hypothalamic obesity | Phase 2 complete; phase 3 to start by year-end 2026 [Source](https://www.sec.gov/Archives/edgar/data/1649904/000162828026052170/q22026earningspr_draft.htm) | | RM-718 (weekly MC4R agonist) | Acquired hypothalamic obesity; Prader-Willi syndrome (Part D) | Phase 1/2; preliminary acquired HO data August 2026 [Source](https://www.sec.gov/Archives/edgar/data/1649904/000162828026052170/rytmq22026rm-718.htm) | ## Stock chart Price chart and quote supplied by TradingView, delayed as the exchange requires. 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[Open NASDAQ:RYTM on TradingView](https://www.tradingview.com/symbols/NASDAQ-RYTM/). ## SEC filings and registration - **SEC name**: Rhythm Pharmaceuticals, Inc. - **CIK**: 1649904 - **Industry (SIC)**: Pharmaceutical Preparations (2834) - **US tickers**: RYTM (Nasdaq) - **State or country of incorporation**: DE - **Fiscal year ends**: December 31 - **Filer category**: Large accelerated filer - **Business address**: 222 BERKELEY STREET, BOSTON, MA, 02116 - **Phone**: 857-264-4280 - **Shares outstanding**: 68,852,082 as of 2026-08-01 (10-Q filed 2026-08-04) - **Former names**: RHYTHM METABOLIC, INC. ### Recent filings (8-K and 6-K are the company's own announcements) - [10-Q](https://www.sec.gov/Archives/edgar/data/1649904/000162828026052533/rytm-20260630.htm) filed 2026-08-04 - [8-K](https://www.sec.gov/Archives/edgar/data/1649904/000162828026052170/rytm-20260804.htm) filed 2026-08-04 - [8-K](https://www.sec.gov/Archives/edgar/data/1649904/000162828026045569/rytm-20260624.htm) filed 2026-06-25 - [8-K](https://www.sec.gov/Archives/edgar/data/1649904/000162828026043170/rytm-20260613.htm) filed 2026-06-15 - [10-Q](https://www.sec.gov/Archives/edgar/data/1649904/000162828026030549/rytm-20260331.htm) filed 2026-05-05 - [8-K](https://www.sec.gov/Archives/edgar/data/1649904/000162828026030136/rytm-20260505.htm) filed 2026-05-05 - [DEF 14A](https://www.sec.gov/Archives/edgar/data/1649904/000162828026028375/rytm-20260429.htm) filed 2026-04-29 - [8-K](https://www.sec.gov/Archives/edgar/data/1649904/000162828026023606/rytm-20260401.htm) filed 2026-04-03 Source: [SEC EDGAR](https://www.sec.gov/cgi-bin/browse-edgar?action=getcompany&CIK=0001649904), retrieved October 23, 2026. Shares outstanding is the cover-page figure from the latest periodic report. The SEC does not publish share prices. Who manages this page **This page is managed by aibio.space.** The company does not run, edit or pay for this page. News, desk views and Investor Ranks are written and managed independently by aibio.space under our editorial and analytical judgment. Opinion only, not investment advice. [How we work](https://aibio.space/disclosures/#paid) · [Terms](https://aibio.space/terms/#news) · [Request a correction](https://aibio.space/reputation/#update) --- Source page: https://aibio.space/companies/rhythm-pharmaceuticals/. Facts in aibio.space stories are checked against company filings and releases; opinion is labelled. Cite as: aibio.space, "Rhythm Pharmaceuticals (RYTM): news, pipeline and catalysts", 2026-10-31, https://aibio.space/companies/rhythm-pharmaceuticals/