NASDAQ:CELC

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Celcuity Falls 23% Despite Strong Phase 3 Breast Cancer Data as Investors Lock In Gains

Shares of Celcuity (NASDAQ: CELC) fell 23% despite reporting highly positive Phase 3 results for gedatolisib in advanced breast cancer and receiving significant attention at the ASCO annual meeting.

The company announced detailed results from the Phase 3 VIKTORIA-1 trial in patients with HR-positive, HER2-negative, PIK3CA-mutated advanced breast cancer. Gedatolisib combined with fulvestrant and palbociclib reduced the risk of disease progression or death by 50% compared with alpelisib plus fulvestrant, while median progression-free survival nearly doubled to 11.1 months from 5.6 months. The treatment also achieved an objective response rate of 48.9% versus 26.0% for the comparator regimen.

The gedatolisib doublet also delivered strong results, reducing the risk of progression or death by 49% and extending median progression-free survival to 11.3 months. According to the company, the trial marked the first Phase 3 study to demonstrate superiority of one PI3K/AKT/mTOR pathway inhibitor over another in this patient population.

Safety results were also encouraging. Treatment discontinuation rates due to adverse events were lower for both gedatolisib regimens than for the alpelisib-based control arm, while rates of hyperglycemia and rash compared favorably to the comparator treatment.

Despite the strong clinical data, shares declined sharply following the announcement. Several biotechnology analysts noted that expectations had risen significantly ahead of the ASCO presentation and that investors were looking for clearer overall survival data, which remains immature. Market participants also focused on the company's upcoming FDA decision, with a PDUFA date of July 17, 2026, for gedatolisib in a related breast cancer indication.

Nevertheless, the results strengthened the case for gedatolisib as a potential new standard of care in advanced breast cancer and support Celcuity's plans for commercialization if regulatory approvals are obtained.
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Author
European Investor 06-02-26
Celcuity Barely Moves as Phase 3 Win Already Priced In and Investors Await ASCO Data

May 14, 2026 | NASDAQ: CELC

Celcuity is essentially flat in premarket, down just 0.21%, in a reaction that reflects a stock where the most important catalyst — positive Phase 3 VIKTORIA-1 results — had already been disclosed and partially priced in before today's financial release. With the detailed data not arriving until ASCO on June 2, the market is in a holding pattern.

The clinical news is genuinely significant. VIKTORIA-1 achieved its primary endpoint in the PIK3CA mutant cohort, with gedatolisib in combination with fulvestrant and palbociclib demonstrating a statistically significant and clinically meaningful improvement in progression-free survival versus alpelisib plus fulvestrant — the current standard of care. Importantly, the gedatolisib doublet also beat alpelisib on the secondary endpoint. Both regimens showed manageable safety profiles with no new signals. A late-breaking oral presentation at ASCO on June 2 will be the next major catalyst, followed by an sNDA submission to the FDA in Q3 targeting a potential approval around the July 17 PDUFA date already assigned for the PIK3CA wild-type indication.

The VIKTORIA-2 expansion is also strategically important. The addition of Study 2 — evaluating gedatolisib plus palbociclib plus letrozole in approximately 740 treatment-naive endocrine-sensitive patients — opens the door to first-line positioning across nearly all HR+/HER2- advanced breast cancer patients regardless of PIK3CA status or endocrine sensitivity. The addressable population of approximately 60,000 newly diagnosed US patients annually with endocrine-sensitive disease is a meaningful commercial expansion of the original target.

On the financial side, net loss widened to $52.8 million from $37 million a year ago, with SG&A jumping from $6.3 million to $17.4 million as commercial launch preparations accelerate ahead of the anticipated Q3 approval. Cash of $387.1 million, combined with the debt facility, is guided to finance operations through 2027. The burn is intentional and appropriate — this is a company spending to be ready for launch.

The flat premarket reaction is simply a function of timing. June 2 at ASCO is the next true catalyst, and the FDA decision in July is the one that will define the year. Today's release is a financial housekeeping report for a company whose story is entirely clinical.
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Author
Global Finance News 05-15-26
Celcuity Stock Surges ~19% — Here's Why

May 4, 2026

Shares of Celcuity Inc. (Nasdaq: CELC) are surging today following a major clinical breakthrough. The company's Phase 3 VIKTORIA-1 trial met its primary endpoint, with the gedatolisib triplet showing a statistically significant improvement in progression-free survival in advanced breast cancer patients. Both regimens were well tolerated with manageable safety profiles.

The company plans to submit findings to the FDA as a supplemental New Drug Application, with a goal date of July, 2026, and the FDA had already granted Priority Review earlier this year.

Analyst sentiment is bullish. Some project peak annual revenue exceeding $2.5 billion if the drug secures approval across multiple lines of therapy. CELC has rallied over 1,200% in the past 12 months.
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Author
WS Investor 05-04-26