Celcuity Inc. (NASDAQ: CELC) surged more than 100% in pre-market trading Monday after announcing historic results from its Phase 3 VIKTORIA-1 trial for gedatolisib, a targeted therapy for advanced breast cancer.
Breakthrough results in hard-to-treat patients
The trial targeted women with hormone receptor-positive, HER2-negative, PIK3CA wild-type advanced breast cancer, a common yet difficult-to-treat form of the disease. Gedatolisib, tested in combination with existing drugs fulvestrant and palbociclib, achieved results that could redefine standards of care:
- Gedatolisib triplet therapy reduced the risk of disease progression or death by 76% (HR=0.24)
- Gedatolisib doublet therapy reduced risk by 67% (HR=0.33)
- Median progression-free survival (PFS):
- Triplet: 9.3 months
- Doublet: 7.4 months
- Control (fulvestrant alone): 2.0 months
These results mark the first time a PI3K/AKT/mTOR pathway inhibitor has shown such positive Phase 3 data in PIK3CA wild-type breast cancer patients, who previously lacked effective targeted therapies.
“To my knowledge, we have not seen Phase 3 results where survival without disease progression quadrupled,” said Dr. Sara Hurvitz, co-principal investigator and SVP at Fred Hutchinson Cancer Center.
Favorable safety profile sets the drug apart
In addition to efficacy, gedatolisib demonstrated a favorable safety profile, with lower rates of hyperglycemia and stomatitis—two common toxicities in similar drugs. Fewer patients discontinued treatment due to side effects compared to prior trials or currently approved alternatives.
- Better tolerated than Phase 1b results
- Discontinuation rates lower than other Phase 3 combo therapies
These findings could increase the drug’s suitability for broader clinical use.
Next steps: FDA submission and full data
Celcuity plans to file a New Drug Application (NDA) with the FDA in Q4 2025. Full clinical data from the wild-type cohort will be presented at a medical conference later this year. Data from the PIK3CA mutation cohort is expected by year-end.
Key milestones ahead:
- Q4 2025: NDA filing
- Late 2025: Full data presentation + additional Phase 3 results
What makes gedatolisib different?
Unlike most targeted therapies that inhibit only one component of the PI3K/AKT/mTOR (PAM) pathway, gedatolisib is a multi-target PAM inhibitor. It blocks:
- All four class I PI3K isoforms
- mTORC1
- mTORC2
This broad mechanism reduces tumor resistance and increases treatment efficacy—even in wild-type patients typically unresponsive to single-target drugs.
“Gedatolisib’s mechanism of action is differentiated and addresses a critical unmet need,” said Dr. Igor Gorbatchevsky, Celcuity’s Chief Medical Officer.
Market reaction: CELC spikes 100%
Following the announcement, CELC stock skyrocketed, positioning Celcuity among the top biotech movers of the day. The stock now trades near $16.19, more than double its value prior to the news.
Analyst sentiment:
- Buy rating with a $29 price target
- Technical sentiment: Bullish
- Institutional ownership: 82%
- Market cap: $532M
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