Rhythm Pharma's Stock Tops $100; FDA Decision On IMCIVREE Label Expansion Due In December

(RTTNews) - Shares of Rhythm Pharmaceuticals Inc. (RYTM) have crossed the $100 mark, as the company gears up for a key regulatory decision that is due in December.

This commercial-stage biopharmaceutical company is focused on transforming the lives of patients living with rare neuroendocrine diseases. Its lead asset is IMCIVREE, a once-daily injection, indicated for the treatment of obesity and to help control hunger associated with Bardet-Biedl syndrome or biallelic POMC, PCSK1, or LEPR deficiency. The drug is approved in the U.S. and over 15 other countries.

The company is also pursuing label expansion for IMCIVREE in both the U.S. and Europe to include its use for treating conditions related to acquired hypothalamic obesity. The FDA's decision on the expanded use of IMCIVREE is expected on December 20, 2025.

Acquired hypothalamic obesity is a rare form of obesity that occurs following physical injury or structural abnormality of the hypothalamus with MC4R pathway disruption and other functional impairment. The MC4R pathway is responsible for controlling physiological functions such as energy expenditure, hunger, and weight regulation. There are no FDA-approved treatments specifically for acquired hypothalamic obesity.

IMCIVREE is also being evaluated in the following studies:

-- A phase II trial in Prader-Willi syndrome, with preliminary results anticipated in the second half of 2025. -- A phase III trial in genetically caused MC4R pathway diseases, dubbed EMANATE, with topline results expected in the first quarter of 2026. -- A phase III trial substudy in congenital hypothalamic obesity, with enrolment scheduled for completion in the first half of 2026.

Net product revenues from IMCIVREE sales totaled $86.2 million for the first half of 2025, up from $55.0 million during the same period in 2024.

The company's pipeline also includes Bivamelagon, an oral therapy, and RM-718, a once-weekly subcutaneous injection - both in development as potential treatments for acquired hypothalamic obesity.

RM-718 is currently being evaluated in a phase I trial, while a pivotal phase III trial for Bivamelagon is planned to begin in 2026, pending alignment with U.S. and European regulatory agencies.

When we alerted readers to RYTM on Apr.7, 2025, it was trading at $49. As of this writing, the stock is at $103.68, up 1.97%.

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