Rhythm Pharmaceuticals (NASDAQ:RYTM) Reports Third Quarter 2024 Financial Results and Business Update

On November 5, 2024, Rhythm Pharmaceuticals, Inc. (the “Company”) released its financial outcomes for the quarter ended September 30, 2024. The Company declared that the net revenue from global sales of IMCIVREE® (setmelanotide) for the third quarter was recorded at $33.3 million. Adult patients with acquired hypothalamic obesity showcased promising results on setmelanotide therapy, with a mean BMI reduction of 12.8% at three months in a French early-access program. Furthermore, the top-line data readout for the Phase 3 trial evaluating setmelanotide in 120 patients with acquired hypothalamic obesity is on track to be released in the first half of 2025.

The supplemental New Drug Application (sNDA) to expand IMCIVREE’s label to include patients as young as 2 years old has been accepted by the FDA for Priority Review with a Prescription Drug User Fee Act (PDUFA) goal date set for December 26, 2024. As of September 30, 2024, the Company held approximately $298.4 million in cash, cash equivalents, and short-term investments, which are expected to support planned operations into 2026.

David Meeker, M.D., Chair, President, and Chief Executive Officer of Rhythm, mentioned, “Rhythm continued our strong clinical and commercial execution aimed at bringing treatments to patients with rare melanocortin-4 receptor (MC4R) pathway diseases.” He expressed optimism regarding the growth in global sales of IMCIVREE primarily driven by prescriptions for patients with Bardet-Biedl syndrome (BBS), emphasizing the potential expansion of its availability to younger patients pending regulatory approval.

During the third quarter, revenue from global sales of IMCIVREE showed a significant increase of 14% sequentially, reaching $33.3 million. In the United States, revenue amounted to $23.3 million, while outside the U.S., it hit $10.0 million.

The Company also highlighted various presentations and collaborations, including new data from the early-access program in France, joint research with Axovia Pharmaceuticals, and regulatory advancements regarding the expanded use of IMCIVREE.

Rhythm Pharmaceuticals is actively progressing towards completing enrollment in ongoing trials, including the Phase 3 trial evaluating setmelanotide and other investigative studies. The projected milestones include the enrollment completion for various trial phases and the announcement of top-line data for the Phase 3 trial evaluating setmelanotide in acquired hypothalamic obesity in the first half of 2025.

The company also provided financial highlights for the third quarter and year to date 2024, discussing revenues, research and development expenses, selling, general, and administrative expenses, net losses, and cash positions.

Investors interested in further details can access the full information via the attached Exhibit 99.1.

Please note that this article is based on a Form 8-K filing by Rhythm Pharmaceuticals and reflects the official information provided by the company.

This article was generated by an automated content engine and was reviewed by a human editor prior to publication. For additional information, read Rhythm Pharmaceuticals’s 8K filing here.

About Rhythm Pharmaceuticals

Rhythm Pharmaceuticals, Inc, a commercial-stage biopharmaceutical company, focuses on the rare neuroendocrine diseases. The company's lead product candidate is IMCIVREE (setmelanotide), a rare melanocortin-4 receptor for the treatment of pro-opiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1, leptin receptor (LEPR) deficiency obesity, and Bardet-Biedl and Alström syndrome.