Rhythm Pharmaceuticals, Inc. (RYTM) shares soared 7.4% in the last trading session to close at $53.17. The move was backed by solid volume with far more shares changing hands than in a normal session. This compares to the stock's 5.1% gain over the past four weeks. Last month, Rhythm announced the FDA's acceptance of the supplemental new drug application for its only marketed drug, Imcivree (setmelanotide), to treat obesity in children as young as two years old. The FDA granted Priority Review to the applic ...

Rhythm Pharmaceuticals' (RYTM) shares gained 8.4% on Aug. 26 after announcing the FDA's acceptance of the supplemental new drug application (sNDA) for its only marketed drug, Imcivree (setmelanotide), to treat obesity in children as young as two years old, under the Priority Review pathway. A filing designated as a Priority Review reduces the review period to four months. A final decision from the FDA is expected on Dec. 26, 2024. Imcivree, an MC4R agonist, is already approved in the United States and EU fo ...

-- Label expansion sought to treat younger children with Bardet-Biedl syndrome or POMC/LEPR deficiency -- -- FDA sets PDUFA goal date of December 26, 2024 -- BOSTON, Aug. 26, 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 the U.S. Food and Drug Administration (FDA) has accepted the company's supplemental New Drug Application ( ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number 001-38223 RHYTHM PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware 46-2159271 (State or ot ...

Rhythm Pharmaceuticals Second Quarter 2024 Financial Results and Business Update August 6, 2024 ® © Rhythm® Pharmaceuticals, Inc. All rights reserved. On Today's Call David Connolly, Executive Director of Investor Relations and Corporate Communications David Meeker, MD, Chair, President and Chief Executive Officer Jennifer Lee, Executive Vice President, Head of North America Yann Mazabraud, Executive Vice President, Head of International Hunter Smith, Chief Financial Officer ® 2 Forward-looking Statements T ...

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 Jos ...

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. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of 21.43%. A quarter ago, it was expected that this company would post a loss of $2.34 per share when it actually produced a loss of $2.35, delivering a surprise of -0.43%. Over the last four quarters, the compa ...

Exhibit 99.1 Rhythm Pharmaceuticals Reports Second Quarter 2024 Financial Results and Business Update -- 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 -- -- Completed sNDA submission seeking to expand U.S. label of IMCIVREE to treat pediatric patie ...

-- 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 -- -- Completed sNDA submission seeking to expand U.S. label of IMCIVREE to treat pediatric patients as young as 2 years old in approved indications -- -- Cash on-hand expected to support planned op ...

"Today marks what we believe to be an important milestone for European patients with BBS and POMC/LEPR deficiencies ages 2 to 6, who now have the opportunity to address the severe and insatiable hunger and early onset obesity associated with their conditions at an early age," said Yann Mazabraud, Executive Vice President, Head of International at Rhythm Pharmaceuticals. "Early-onset obesity that goes untreated can manifest in multiple comorbidities and negatively affect quality of life and life expectancy. ...