$CELC

Celcuity Inc.

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Celcuity Q2 Earnings Call Highlights

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 Analysts Slash Their Forecasts After Q2 Loss - Celcuity (NASDAQ:CELC)

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.

Celcuity Inc. Stock 12‑Month Price Target Cut to $160.64, Implies 85% Upside

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.

CELC sentiment & insider activity

Over the past 7 days, alphai's AI scored 4 news stories mentioning CELC (Celcuity Inc.). Coverage has skewed bullish: 1 bullish, 3 neutral, and 0 bearish.

Recent CELC coverage spans earnings, financial news and regulation.

What's driving CELC

  • New clinical discontinuation read-through for REVTORPYK, plus launch and manufacturing shipment timing, can shift near-term risk perception and biotech trading sentiment.

    yahoo.com · Aug 15, 2026

  • Earnings beat but sell-side price targets were lowered, implying valuation or forward outlook concerns despite the EPS beat.

    benzinga.com · Aug 14, 2026

  • The article signals a modest downward shift in Street expectations, but consensus remains Buy with a large implied upside versus the Aug. 13 close.

    tradingview.com · Aug 14, 2026

  • Regulatory approval plus commercialization timing and updated Phase 3 efficacy/safety details increase near-term fundamental visibility for CELC.

    SEC EDGAR 8-K · Aug 13, 2026

  • NCCN Category 1 recommendation can improve prescribing confidence and payer/market access expectations for Celcuity’s Revtorpyk regimen.

    thepharmaletter.com · Aug 1, 2026

alphai scores every news story that mentions CELC with an AI model for sentiment and relevance, and aggregates insider trades from Celcuity Inc.'s SEC EDGAR Form 4 filings. Figures refresh continuously.

News on $CELC

Score
$CELCMed

Celcuity Q2 Earnings Call Highlights

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.

$CELCMedAI 8/10

Celcuity Inc. (CELC): Results of Operations and Financial Condition

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

Newly FDA-approved Revtorpyk wins NCCN listing

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.

$CELCMed

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

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.

$CELCMedAI 9/10

REVTORPYK (gedatolisib) for the Treatment of HR+/HER2-, PIK3CA Wild-Type Breast Cancer, US

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.

$CELCMedAI 8/10

Celcuity faces securities fraud probe

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.

$CELCMedAI 8/10

Celcuity (CELC) Is Down 17.4% After FDA Clears First-in-Class REVTORPYK Combo for HR+ Breast Cancer

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%.

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