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Rhythm Pharmaceuticals Faces FDA Review Extension

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Rhythm Pharmaceuticals Faces FDA Review Extension

Meet Your ETF AI Analyst

Rhythm Pharmaceuticals ( (RYTM) ) has provided an announcement.

On November 7, 2025, Rhythm Pharmaceuticals announced that the FDA extended the review period for the supplemental New Drug Application for IMCIVREE® (setmelanotide) for acquired hypothalamic obesity by three months, moving the PDUFA goal date to March 20, 2026. This extension follows the FDA’s request for additional sensitivity analyses of clinical efficacy data, which were considered a major amendment. The company remains confident in the drug’s potential and is preparing to deliver it to a patient community with no approved treatment options.

The most recent analyst rating on (RYTM) stock is a Hold with a $106.00 price target. To see the full list of analyst forecasts on Rhythm Pharmaceuticals stock, see the RYTM Stock Forecast page.

Spark’s Take on RYTM Stock

According to Spark, TipRanks’ AI Analyst, RYTM is a Neutral.

Rhythm Pharmaceuticals’ overall stock score is driven by its strong revenue growth and positive technical indicators, suggesting potential for future gains. However, the company’s ongoing profitability challenges and negative valuation metrics weigh heavily on the score. The optimistic sentiment from the earnings call provides some support, but the financial performance remains a significant concern.

To see Spark’s full report on RYTM stock, click here.

More about Rhythm Pharmaceuticals

Rhythm Pharmaceuticals is a commercial-stage biopharmaceutical company focused on transforming the lives of patients with rare neuroendocrine diseases. The company’s lead product, IMCIVREE® (setmelanotide), is designed to treat hyperphagia and severe obesity and is approved for specific genetic conditions in both the U.S. and Europe. Rhythm is also advancing a clinical development program for setmelanotide in other rare diseases and developing investigational MC4R agonists and small molecules for congenital hyperinsulinism.

Average Trading Volume: 613,423

Technical Sentiment Signal: Buy

Current Market Cap: $6.64B

For an in-depth examination of RYTM stock, go to TipRanks’ Overview page.

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