Celcuity Inc. Common Stock CELC

Celcuity Inc is a clinical-stage biotechnology company developing targeted therapies for multiple solid tumors. Its candidate, gedatolisib, is a kinase inhibitor of the PI3K/AKT/mTOR (PAM) pathway, binding all class I PI3K isoforms and mTORC1/2, offering comprehensive inhibition with a mechanism and pharmacokinetics differentiated from other therapies. The Phase 3 VIKTORIA-1 trial, evaluating gedatolisib with fulvestrant, with or without palbociclib, in HR+/HER2- breast cancer, has completed enrollment and reported results for PIK3CA WT tumors, with cohort 2 (PIK3CA MT) also enrolled. Phase 3 VIKTORIA-2 and Phase 1b/2 CELC-G-201 trials, evaluating combinations in endocrine-resistant HR+/HER2- breast cancer and metastatic castration-resistant prostate cancer, are ongoing.

• The Motley Fool 30 sept

  Why Celcuity Stock Was a Winner on Wednesday

  Celcuity stock gained 2.8% on Wednesday as the biotech company launched its first FDA-approved drug, Revtorpyk, for HR+/HER2 breast cancer treatment. The company also introduced support services for patients and physicians. The stock outperformed the broader market, which saw the S&P 500 decline 0.3%.

  

• GlobeNewswire Inc. 29 jul

  NASDAQ: CELC Investigation: Kessler Topaz Meltzer & Check, LLP Encourages Celcuity Inc. (NASDAQ: CELC) Investors to Contact the Firm

  Law firm Kessler Topaz Meltzer & Check is investigating Celcuity Inc. for potential securities law violations following the company's announcement of a delayed drug launch for its FDA-approved breast cancer therapy Revtorpyk. The delayed launch timeline, announced on July 14, 2026, fell short of analyst expectations and triggered a 17% stock price decline. The firm is encouraging investors who suffered losses to contact them regarding potential legal rights.

  

• GlobeNewswire Inc. 21 jul

  CELCUITY ALERT: Bragar Eagel & Squire, P.C. is Investigating Celcuity Inc. on Behalf of Celcuity Stockholders and Encourages Investors to Contact the Firm

  Law firm Bragar Eagel & Squire is investigating Celcuity Inc. for potential securities violations following the company's announcement of FDA approval for breast cancer therapy Revtorpyk with a delayed commercial launch in late Q3 2026. The delayed timeline, contrary to analyst expectations, triggered a 17.6% stock price decline on July 15, 2026.

  

• GlobeNewswire Inc. 14 jul

  Celcuity Announces FDA Approval of REVTORPYK™ (gedatolisib) for the Treatment of HR+/HER2-, PIK3CA Wild-Type Locally Advanced or Metastatic Breast Cancer

  Celcuity announced FDA approval of REVTORPYK (gedatolisib), the first pan-PI3K and mTORC1/2 inhibitor, for treating HR+/HER2- locally advanced or metastatic breast cancer without PIK3CA mutations. In the Phase 3 VIKTORIA-1 trial, the drug reduced disease progression or death risk by 76% when combined with palbociclib and fulvestrant, and 67% with fulvestrant alone. Commercial launch is anticipated in late Q3 2026.