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FDA Accepts Celcuity's Breast Cancer Therapy, But Analyst Pumps the Brakes

MarketDash Editorial Team
21 days ago
The FDA accepted Celcuity's application for advanced breast cancer therapy gedatolisib, which should be good news. But HC Wainwright just downgraded the stock to Neutral, saying the 600% rally has priced in perfection and the risk-reward no longer favors buyers.

Good news doesn't always mean buy the stock. Celcuity Inc. (CELC) just got FDA acceptance of its application for gedatolisib, a therapy for advanced breast cancer. That's the kind of regulatory milestone that usually sends biotech investors into celebration mode. Instead, HC Wainwright downgraded the stock.

When Success Gets Ahead of Itself

Analyst Swayampakula Ramakanth moved his rating from Buy to Neutral, though he did raise his price target from $77 to $94. The reason? The stock has already rocketed more than 600% year to date, and Ramakanth thinks it's now "priced for perfection" with "more downside risk than upside."

The FDA decision on gedatolisib isn't expected until the third quarter of 2026. Any approval delay could make the market "turn skittish," according to the analyst. And while gedatolisib has real potential to change clinical practice, it'll be going up against large cap pharma companies with "proven commercial infrastructure in breast cancer."

What Comes Next

The next big moment for Celcuity will be topline data beyond gedatolisib's current indication, expected early next year. A positive result could expand the total addressable market by 40%. A negative result could trigger a valuation drop.

So the FDA acceptance is real progress, but the stock has already run hard on anticipation. Sometimes the best news is already in the price.

CELC Price Action: Shares of Celcuity had declined by 0.56% to $92.16 at the time of publication on Monday.

Back to News

FDA Accepts Celcuity's Breast Cancer Therapy, But Analyst Pumps the Brakes

MarketDash Editorial Team
21 days ago
The FDA accepted Celcuity's application for advanced breast cancer therapy gedatolisib, which should be good news. But HC Wainwright just downgraded the stock to Neutral, saying the 600% rally has priced in perfection and the risk-reward no longer favors buyers.

Good news doesn't always mean buy the stock. Celcuity Inc. (CELC) just got FDA acceptance of its application for gedatolisib, a therapy for advanced breast cancer. That's the kind of regulatory milestone that usually sends biotech investors into celebration mode. Instead, HC Wainwright downgraded the stock.

When Success Gets Ahead of Itself

Analyst Swayampakula Ramakanth moved his rating from Buy to Neutral, though he did raise his price target from $77 to $94. The reason? The stock has already rocketed more than 600% year to date, and Ramakanth thinks it's now "priced for perfection" with "more downside risk than upside."

The FDA decision on gedatolisib isn't expected until the third quarter of 2026. Any approval delay could make the market "turn skittish," according to the analyst. And while gedatolisib has real potential to change clinical practice, it'll be going up against large cap pharma companies with "proven commercial infrastructure in breast cancer."

What Comes Next

The next big moment for Celcuity will be topline data beyond gedatolisib's current indication, expected early next year. A positive result could expand the total addressable market by 40%. A negative result could trigger a valuation drop.

So the FDA acceptance is real progress, but the stock has already run hard on anticipation. Sometimes the best news is already in the price.

CELC Price Action: Shares of Celcuity had declined by 0.56% to $92.16 at the time of publication on Monday.