CELC▼
Celcuity Q2 GAAP EPS misses by $0.28
Celcuity reported a second-quarter 2026 GAAP loss of $1.44 per share, missing expectations by $0.28. Total operating expenses rose to $66.1 million from $44.0 million a year earlier, driven by a $27.4 million increase in selling, general and administrative expenses to $35.0 million as the company ramped up commercial launch activities for REVTORPYK. Research and development expenses fell to $31.1 million from $36.4 million, primarily due to lower clinical trial costs for the VIKTORIA-1 Phase 3 trial and reduced license milestone costs. Net cash used in operating activities was $55.4 million, and the company ended the quarter with $754.0 million in cash, cash equivalents and short-term investments, which it expects will fund operations at least into 2029.
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Biotech & Genomic Medicine▼
Bragar Eagel & Squire Investigates Celcuity Over Delayed Launch of FDA-Approved Breast Cancer Therapy
Bragar Eagel & Squire, P.C. is investigating potential claims against Celcuity Inc. on behalf of stockholders. The investigation concerns whether Celcuity violated federal securities laws or engaged in unlawful business practices. On July 14, 2026, Celcuity announced FDA approval of its breast cancer therapy Revtorpyk with a commercial launch anticipated in late Q3 2026, a timeline that analysts described as extended relative to expectations. Following the news, Celcuity's stock fell $19.54 per share, or 17.6%, to close at $91.51 per share on July 15, 2026. The law firm encourages investors who suffered losses to contact them.
GlobeNewswire·36dRead more ▾
Biotech & Genomic Medicine▼
Celcuity Stock Falls 15% Despite FDA Approval of First Drug
Celcuity shares declined about 15% over the past week even after the FDA approved its first marketed product, Revtorpyk, for certain breast cancer patients. The approval covers two Revtorpyk-based combination therapies for adults with HR-positive, HER2-negative, PIK3CA wild-type, locally advanced or metastatic breast cancer following progression on or after endocrine therapy. Management plans to launch Revtorpyk in the late third quarter of 2026 to ensure sufficient drug inventory, a timeline that disappointed investors and delays near-term revenue. The company estimates a U.S. commercial opportunity exceeding $6 billion, with nearly 37,000 patients receiving second-line treatment annually. Celcuity is also pursuing label expansion into PIK3CA-mutant patients and developing Revtorpyk for first-line and prostate cancer indications.
Zacks Investment Research·36dRead more ▾
CELC▼
Kirby McInerney investigates Celcuity over delayed Revtorpyk launch
Kirby McInerney LLP announced an investigation into Celcuity Inc. over potential securities fraud. The investigation concerns whether Celcuity or its senior management violated federal securities laws following the company's July 14, 2026 press release announcing FDA approval of its breast cancer therapy Revtorpyk with an anticipated commercial launch in late Q3 2026, a timeline analysts described as delayed. On July 15, 2026, Celcuity's stock fell $19.54 per share, or 17.6%, to close at $91.51 per share. No lawsuit has been filed, and the investigation is ongoing.
GlobeNewswire·37dRead more ▾
Biotech & Genomic Medicine▲impact 4
Celcuity Wins FDA Approval for REVTORPYK in HR+/HER2- PIK3CA Wild-Type Advanced Breast Cancer
Celcuity announced that the FDA has approved REVTORPYK, or gedatolisib, for the treatment of HR-positive, HER2-negative, PIK3CA wild-type locally advanced or metastatic breast cancer following progression on at least one line of endocrine therapy. REVTORPYK is the first and only FDA-approved therapy that inhibits all class I PI3K isoforms and both mTOR complexes, mTORC1 and mTORC2. The approval is based on the Phase 3 VIKTORIA-1 trial, where the REVTORPYK triplet with palbociclib and fulvestrant reduced the risk of disease progression or death by 76 percent compared to fulvestrant alone, and the doublet with fulvestrant reduced risk by 67 percent. Celcuity expects a commercial launch in late Q3 2026 and plans to submit a supplemental New Drug Application for the PIK3CA-mutated population in the same quarter.
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Biotech & Genomic Medicine
QURE Surges 81% on FDA Reversal, Spotlighting Five Biotech Catalysts
UniQure NV shares surged 81% on Wednesday after the FDA reversed course and accepted its Huntington's disease therapy data for an accelerated approval filing, a move flagged days earlier by unusual options activity. The stock jumped from a prior close of $26.99 to an intraday high of $48.88, closing in the high $47s, after the agency indicated AMT-130 data would support a filing, reversing a March decision that had sent shares from $25 to $9. The rally was preceded by weeks of institutional call buying, including a multi-million dollar order on June 9 across October 33 and 43 strikes, which a trader highlighted as a signal of smart-money positioning. The same catalyst-driven approach is now being applied to five other biotech names: Celcuity faces a July 17 FDA decision for gedatolisib in breast cancer, with major funds holding through a prior drawdown; Ionis has two PDUFA dates—June 30 for olezarsen and September for zilganersen—though insider selling of $57.8 million warrants caution; Celldex awaits Phase 3 barzolvolimab data in chronic spontaneous urticaria in Q4 next year, with a Phase 2 readout this summer, but rich options premiums keep it on watch; Travere already won approval for FILSPARI in FSGS in April and is now a commercial execution and takeout story with Overweight ratings from Citi and JPMorgan; and Replimune resubmitted its BLA for RP1 after a second Complete Response Letter, with FDA alignment on May 29, drawing Baker Bros and other funds, though it remains the lowest-conviction name on the board.
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