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Biotech Stocks Facing FDA Decision In March 2026

Rhythm Pharmaceuticals
Rhythm Pharmaceuticals

Rhythm Pharmaceuticals Inc. (RYTM) has sought to expand the FDA approval of Imcivree to include the indication of acquired hypothalamic obesity, and a decision is due on March 20, 2026.

Acquired hypothalamic obesity is a rare form of obesity that occurs following damage to the hypothalamic region of the brain, which includes the melanocortin-4 receptor (MC4R) pathway and is responsible for controlling physiological functions such as hunger and weight regulation. It most frequently follows the growth or surgical removal of craniopharyngioma, astrocytoma, or other rare brain tumors.

IMCIVREE is already approved by the FDA to reduce excess body weight and maintain weight reduction long term in adult and pediatric patients 2 years of age and older with syndromic or monogenic obesity due to Bardet-Biedl syndrome (BBS), POMC, PCSK1 or LEPR deficiency as determined by an FDA-approved test demonstrating variants in POMC, PCSK1 or LEPR genes that are interpreted as pathogenic, likely pathogenic, or of uncertain significance.

Global sales of IMCIVREE for the fourth quarter of 2025 are expected to be approximately $57 million, an 11% increase over Q3 2025.

RYTM closed Tuesday’s (Feb.24, 2026) trading at $98.65, up 2.39%.