Celcuity: REVTORPYK Is Now A Commercial Story
Celcuity Inc. remains a Buy as the REVTORPYK/gedatolisib FDA approval and rapid NCCN Category 1 inclusion de-risk clinical and commercial adoption. CELC's financials reflect a front-loaded commercial investment, with SG&A surging for launch, but a strengthened $754M cash position provides funding visibility into 2029. VIKTORIA-1 data show REVTORPYK delivers a step-change in efficacy and tolerability, supporting rapid physician adoption and a potential blockbuster franchise.
Celcuity Inc. (CELC) Q2 2026 Earnings Call Transcript
Celcuity Inc. (CELC) Q2 2026 Earnings Call Transcript
Celcuity Q2 Earnings Call Highlights
Celcuity NASDAQ: CELC said it remains on track to begin commercial shipments of REVTORPYK, its gedatolisib therapy for certain patients with advanced breast cancer, late in the third quarter of 2026 following its recent FDA approval.
Why CELC Stock Declined 15% in a Week Despite a Major FDA Win
Celcuity slides 15% despite FDA approval of Revtorpyk as investors focus on a late Q3 2026 launch that delays commercial sales and near-term revenues.
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.
