Why Rhythm Pharmaceuticals (RYTM) Is Down After FDA Delays IMCIVREE Review for Rare Obesity Treatment

• On November 7, 2025, Rhythm Pharmaceuticals announced that the U.S. FDA extended the review period for the supplemental New Drug Application for IMCIVREE for acquired hypothalamic obesity, shifting the expected review completion from December 2025 to March 2026 after requesting additional analyses of trial efficacy data.
• This extension did not involve any new safety or manufacturing concerns, but it delays regulatory decision-making for a treatment aimed at a rare patient population with no current approved options.
• We'll explore how the updated FDA review timeline and data request may shape Rhythm Pharmaceuticals' outlook for commercializing IMCIVREE.

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Rhythm Pharmaceuticals Investment Narrative Recap

Rhythm Pharmaceuticals remains a story for those who believe in the potential of setmelanotide to address rare genetic and acquired obesity disorders, in particular as its success hinges on regulatory approvals for new indications. The FDA’s decision to extend the review period for IMCIVREE is a setback to the anticipated timeline but does not introduce additional safety or manufacturing risk, so the short-term catalyst, regulatory approval for acquired hypothalamic obesity, is merely delayed, not fundamentally impaired; meanwhile, persistent operating losses still represent the most significant immediate concern for shareholders.

Recent third quarter earnings, reported just days before the FDA news, highlight both progress and challenge: revenue rose to US$51.3 million but net losses widened to US$52.9 million, underscoring the company’s ongoing reliance on future product launches to bolster its path to profitability and reinforce key catalysts for shareholder value.

On the flip side, the risk that Rhythm’s high cash burn could require future capital raises is a factor that investors need to be aware of…

Read the full narrative on Rhythm Pharmaceuticals (it's free!)

Rhythm Pharmaceuticals' outlook anticipates $742.1 million in revenue and $250.7 million in earnings by 2028. This forecast is based on a 68.1% annual revenue growth rate and a $439.1 million increase in earnings from the current level of -$188.4 million.

Uncover how Rhythm Pharmaceuticals' forecasts yield a $121.43 fair value, a 21% upside to its current price.

Exploring Other Perspectives

Simply Wall St Community members offered three fair value estimates for Rhythm Pharmaceuticals from US$33.51 to US$161.87 per share. While many highlight rapid forecast revenue growth, investor perspectives vary widely so be sure to compare several views.

Explore 3 other fair value estimates on Rhythm Pharmaceuticals - why the stock might be worth as much as 61% more than the current price!

Build Your Own Rhythm Pharmaceuticals Narrative

Disagree with existing narratives? Create your own in under 3 minutes - extraordinary investment returns rarely come from following the herd.

• A great starting point for your Rhythm Pharmaceuticals research is our analysis highlighting 3 key rewards that could impact your investment decision.
• Our free Rhythm Pharmaceuticals research report provides a comprehensive fundamental analysis summarized in a single visual - the Snowflake - making it easy to evaluate Rhythm Pharmaceuticals' overall financial health at a glance.

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This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.

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