$CELC

Celcuity (CELC) reported a wider Q2 net loss of $78.86 million and higher basic loss per share in August 2026. The company said Revtopik received FDA approval and a preferred Category 1 NCCN guideline recommendation for HR-positive, HER2-negative advanced breast cancer, which it says could affect its commercialization outlook. The article cites 2029 revenue of $817.9 million and earnings of $267.5 million.

Celcuity (NASDAQ:CELC) reported Q2 earnings call highlights for its gedatolisib programs. In REVTORPYK, adverse-event discontinuations were 5.2% (mutant cohort) for the triplet and 3.8% for the doublet, versus 19% for alpelisib. The company is expanding VIKTORIA-2 and advancing a prostate Phase Ib/II trial with darolutamide. Q2 net loss was $78.9M ($1.44/share). Cash totaled $754M.

Celcuity Inc (NASDAQ:CELC) reported a Q2 loss of $1.07 per share, narrower than the $1.17 consensus estimate, and down from a year-ago loss of 93 cents. Pre-market, shares rose 0.7% to $87.17. After the earnings release, Needham and Stifel kept Buy ratings but cut price targets to $140 and $150.

Analyst estimates for Celcuity Inc. show the average 12-month price target was cut from $163.55 to $160.64, with a range of $140 to $178 per share, according to 11 analysts. Based on the Aug. 13 closing price, the target suggests about 85% upside. The consensus rating remains “Buy” with 12 Buys, 0 Holds, and 0 Sells.

Celcuity Inc. (CELC) filed an SEC Form 8-K — Results of Operations and Financial Condition. EX-99.1 2 celc-ex99_1.htm EX-99.1 EX-99.1 Exhibit 99.1 Celcuity Inc. Reports Release of Second Quarter 2026 Financial Results and Provides Corporate Update • REVTORPYK™ (gedatolisib) approved by the U.S. FDA for the treatment of HR+/HER2- PIK3CA Wild-Type locally advanced or meta

Celcuity (NASDAQ: CELC) said its Revtorpyk (gedatolisib) plus fulvestrant, with or without palbociclib, was added to NCCN Guidelines as a preferred Category 1 option for HR+, HER2- advanced or metastatic breast cancer after endocrine therapy progression. FDA approved Revtorpyk on July 14, 2026 for HR+/HER2- disease without detected PIK3CA mutation.

Celcuity Inc. (NASDAQ: CELC) said it received FDA approval for its breast cancer therapy Revtorpyk (gedatolisib) but expects a commercial launch in late Q3 2026, later than some analyst expectations. The stock fell more than 17% after the announcement. Kessler Topaz Meltzer & Check is investigating potential securities law violations.

Celcuity’s REVTORPYK (gedatolisib) was approved by the US FDA in July 2026 for HR+/HER2- locally advanced or metastatic breast cancer with PIK3CA wild-type, in combination with fulvestrant, with or without palbociclib, after progression on endocrine therapy. VIKTORIA-1 (n=392) showed arm A median PFS 9.3 vs 2.0 months for fulvestrant alone, ORR 32% vs 1%. Commercial launch planned for late Q3 2026.

Pomerantz LLP says it is investigating Celcuity Inc. for possible securities fraud after Celcuity announced a delayed commercial launch for its FDA-approved breast cancer drug Revtorpyk. The launch was pushed to late Q3 2026, later than analysts expected, and Celcuity shares fell 17.6% on July 15, 2026. The probe concerns whether the delay involved unlawful practices.

Celcuity (Nasdaq: CELC) said the FDA approved REVTORPYK (gedatolisib) with fulvestrant, with or without palbociclib, for HR-positive, HER2-negative locally advanced or metastatic breast cancer without a PIK3CA mutation after at least one endocrine therapy line. The VIKTORIA-1 data showed a progression-free survival benefit, with higher stomatitis, rash and metabolic side effects. The stock was reported down 17.4%.