Celcuity

CELC

Market cap $4.31B

NEW YORK, July 16, 2026 /PRNewswire/ -- Pomerantz LLP is investigating claims on behalf of investors of Celcuity Inc. ("Celcuity" or the "Company") (NASDAQ: CELC).  Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext.

Celcuity Inc. (CELC) Discusses FDA Approval of REVTORPYK for Advanced HR+/HER2- Breast Cancer and Commercial Launch Plans Transcript

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 stock crashed Wednesday after the biotech delayed the launch of its just-approved breast cancer treatment until the third quarter.

Shares of Celcuity fell about 8% in premarket trading on Wednesday, as the delayed commercial launch of its newly ​approved breast cancer drug and treatment-tolerability concerns overshadowed the ‌company's first U.S. approval.

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.

MINNEAPOLIS, July 14, 2026 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a biotechnology company focused on developing and commercializing targeted therapies for multiple solid tumor indications, today announced that the U.S. Food and Drug Administration (“FDA”) approved REVTORPYK™ (gedatolisib) for the treatment of patients with hormone receptor positive (“HR+”), human epidermal growth factor receptor 2 negative (“HER2-”), locally advanced or metastatic breast cancer without a PIK3CA mutation detected following progression on or after treatment with at least one line of endocrine therapy in the metastatic setting. REVTORPYK is the only inhibitor of class I PI3K isoforms (α, β, δ, γ) and mTOR complexes mTORC1 and mTORC2 to receive FDA approval.

The U.S. ​Food and ‌Drug Administration ​has ​approved Celcuity's drug ⁠for ​an advanced ​form of breast cancer, ​the ​regulator said on ‌Tuesday, ⁠making it the ​company's ​first ⁠product to ​gain ​market ⁠entry.

Celcuity Inc. (CELC) Presents at Goldman Sachs 47th Annual Global Healthcare Conference 2026 Transcript

MINNEAPOLIS, June 03, 2026 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC) (“Celcuity” or the “Company”), a clinical-stage biotechnology company focused on the development of targeted therapies for the treatment of multiple solid tumor indications, today announced the pricing of its upsized underwritten public offering of $500,000,000 aggregate principal amount of its 0.250% convertible senior notes due 2032 (the “Convertible Notes”). The aggregate principal amount of the offering was increased from the previously announced offering size of $400,000,000.