Why This Biotech Stock, With Its First FDA Approval, Just Crashed By Double Digits
Celcuity shares dropped by double digits despite receiving its first FDA approval for a breast cancer drug.
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The brief
The FDA has approved Gedatolisib plus Fulvestrant ± Palbociclib for the treatment of hormone receptor–positive, HER2-negative, locally advanced/metastatic breast cancer. This marks the first FDA approval for Celcuity.
Coverage from Reuters and Investor's Business Daily highlights a double-digit crash in stock price, noting that a launch delay eclipsed the news of the approval. Fierce Pharma reports that the drug is viewed as a potential blockbuster that could make the company an acquisition target for Big Pharma.
Future developments center on the timing of the drug's launch and potential interest from larger pharmaceutical companies.
Synthesized by Archynetys from the headlines below under a strict no-invention contract. ✓ fact-checked: all claims supported by sources Updated 25m ago.
Quick answers
What drug was approved by the FDA?
The FDA approved Gedatolisib Plus Fulvestrant ± Palbociclib.
Which condition does the approved drug treat?
It is used for hormone receptor–positive, HER2-negative, locally advanced/metastatic breast cancer.
Why did Celcuity's stock price fall?
According to Reuters, the stock fell because a launch delay overshadowed the US approval.
Is this the company's first approval?
Yes, according to STAT and other coverage, this is Celcuity's first FDA approval.
Coverage (5)
- Celcuity’s breast cancer drug approved, its first STAT · 7h ago
- FDA Approves Gedatolisib Plus Fulvestrant ± Palbociclib for Hormone Receptor–Positive, HER2-Negative, Locally Advanced/Metastatic Breast Cancer OncLive · 7h ago
- Celcuity shares fall as launch delay eclipses US approval for breast cancer drug Reuters · 7h ago
- With FDA approval for its breast cancer blockbuster hopeful, Celcuity could ‘belong in the hands’ of a Big Pharma Fierce Pharma · 7h ago
- Why This Biotech Stock, With Its First FDA Approval, Just Crashed By Double Digits Investor's Business Daily · 7h ago
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