Celcuity: 'Buy' REVTORPYK FDA Approval First And sNDA Label Expansion Q3 2026
Celcuity Inc. secured FDA approval for REVTORPYK, the first pan-PI3K, mTORC1/2 inhibitor for 2nd-line PIK3CA wild-type HR+/HER2- advanced breast cancer. I downgrade CELC from Strong Buy to Buy due to phase 3 mutant cohort data underperforming prior results and rising competitive threats from Relay Therapeutics. REVTORPYK demonstrated strong efficacy in both wild-type and mutant cohorts, but delayed commercial launch and potential for superior competitor data temper near-term enthusiasm.
Celcuity Enters Commercial Stage as FDA Approves REVTORPYK for Advanced Breast Cancer
Celcuity NASDAQ: CELC said the U.S. Food and Drug Administration has granted full approval to gedatolisib, now branded as REVTORPYK, for certain patients with advanced breast cancer, marking the company's transition to a commercial-stage business.
Celcuity Inc. (CELC) Presents at Goldman Sachs 47th Annual Global Healthcare Conference 2026 Transcript
Celcuity Inc. (CELC) Presents at Goldman Sachs 47th Annual Global Healthcare Conference 2026 Transcript
Celcuity: Selloff On Yesterday's Data Unwarranted - Buy Rating Upheld
Celcuity (CELC) shares dropped over 25% despite Phase 3 VIKTORIA-1 data confirming gedatolisib's best-in-class efficacy in advanced breast cancer. Gedatolisib demonstrated superior progression-free survival and objective response rates versus current standards, supporting blockbuster potential in a $6bn market. FDA approval for HR+/HER2- PIK3CA wild-type breast cancer is expected by July 2026, with a supplementary NDA for the mutant cohort planned.
Celcuity Inc. (CELC) Discusses VIKTORIA-1 Trial Results for PIK3CA Mutant Advanced Breast Cancer and Gedatolisib Efficacy Transcript
Celcuity Inc. (CELC) Discusses VIKTORIA-1 Trial Results for PIK3CA Mutant Advanced Breast Cancer and Gedatolisib Efficacy Transcript
Celcuity Inc. (CELC) Q1 2026 Earnings Call Transcript
Celcuity Inc. (CELC) Q1 2026 Earnings Call Transcript
Celcuity Q1 Earnings Call Highlights
Celcuity NASDAQ: CELC reported a wider first-quarter loss as the biotechnology company increased spending tied to commercial launch preparations and continued development of gedatolisib, its investigational therapy for hormone receptor-positive, HER2-negative advanced breast cancer.
Celcuity: Best-In-Class Potential With 2-3x Upside If Mutant Data Delivers
Celcuity (CELC) is rated a cautious Buy, with upside contingent on positive mutant cohort data for gedatolisib in 2L HR+/HER2- advanced breast cancer. Current $6B valuation already prices in significant success, assuming $1–1.5B peak sales; management's $2.5B target requires broad label and strong market adoption. VIKTORIA-1 phase 3 data show gedatolisib offers best-in-class efficacy and manageable safety in wild-type patients, but mutant cohort results in Q2 2026 are the key catalyst.
Celcuity Inc. (CELC) Q4 2025 Earnings Call Transcript
Celcuity Inc. (CELC) Q4 2025 Earnings Call Transcript
Celcuity, Inc. (NASDAQ:CELC) Receives Consensus Recommendation of “Moderate Buy” from Analysts
Shares of Celcuity, Inc. (NASDAQ: CELC - Get Free Report) have received an average rating of "Moderate Buy" from the ten research firms that are covering the company, Marketbeat Ratings reports. One analyst has rated the stock with a sell recommendation, one has assigned a hold recommendation and eight have given a buy recommendation to the
Inside One Fund's $170 Million Bet on a Biotech Stock Up 1,040% in a Year Amid FDA Review for Breast Cancer Drug
Celcuity develops targeted cancer therapies and diagnostics, leveraging proprietary technology to advance precision oncology solutions.
Celcuity Inc. (CELC) Presents at Leerink Global Healthcare Conference 2026 Transcript
Celcuity Inc. (CELC) Presents at Leerink Global Healthcare Conference 2026 Transcript
