Bevacizumab

MINNEAPOLIS, Feb. 12, 2026 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced the appointment of Charles (Chip) R. Romp to its Board of Directors. Mr. Romp brings over 25 years of experience in the pharmaceutical industry to Celcuity, including leadership of sales teams and commercial organizations in the oncology setting. “Chip brings a wealth of oncology-related commercial expertise to our Board,” said Brian Sullivan, Chief Executive Officer and co-founder of Celcuity. “Chip’s deep experience commercializing significant oncology drugs will provide valuable insight to Celcuity as we advance our programs and prepare for the potential approval and launch of gedatolisib later this year.” Mr. Romp is currently Chief Executive Officer of Secura Bio, an integrated, commercial-stage pharmaceutical company dedicated to the worldwide development and commercialization of oncology therapies. Mr. Romp previously served as Executive Vice President, Commercial U.S., at Seagen, Inc., where he was a member of the Executive Committee and oversaw the company's entire commercial organization before its sale to Pfizer. He joined Seagen in 2010 as one of its first commercial employees, where he managed the growth and expansion of ADCETRIS ® (brentuximab vedotin), PADCEV ® (enfortumab vedotin-ejfv), TUKYSA ® (tucatinib), and TIVDAK ® (tisotumab vedotin-tftv). Prior to Seagen, Mr. Romp held several senior sales leadership positions at Genentech, Inc, where he was responsible for both oncology and immunology products, including AVASTIN ® (bevacizumab), RITUXAN ® (rituximab), and XOLAIR ® (omalizumab). Mr. Romp received a Bachelor of Arts from the University of Florida and an MBA from Saint Leo University in Florida. “Gedatolisib has tremendous potential to enhance outcomes for women with breast cancer, which gives Celcuity a very significant opportunity to build an important franchise in oncology,” said Mr. Romp. “I am very excited to join the Board at this important moment in Celcuity’s history and work with Brian and the Board to share my experience commercializing a number of pathbreaking oncology therapeutics." About Celcuity Celcuity is a clinical-stage biotechnology company pursuing the development of targeted therapies for the treatment of multiple solid tumor indications. The company's lead therapeutic candidate is gedatolisib, a potent, pan-PI3K and mTORC1/2 inhibitor that comprehensively blockades the PI3K/AKT/mTOR (“PAM”) pathway. Its mechanism of action and pharmacokinetic properties are differentiated from other currently approved and investigational therapies that target PI3Kα, AKT, or mTORC1 alone or together. A Phase 3 clinical trial, VIKTORIA-1, evaluating gedatolisib in combination with fulvestrant, with or without palbociclib, in patients with HR+/HER2- advanced breast cancer (“ABC”), has completed enrollment, and the company has reported detailed results for the PIK3CA wild-type cohort. A Phase 3 clinical trial, VIKTORIA-2, evaluating gedatolisib plus a CDK4/6 inhibitor and fulvestrant as first-line treatment for patients with HR+/HER2- ABC, is currently enrolling patients. A Phase 1/2 clinical trial, CELC-G-201, evaluating gedatolisib in combination with darolutamide in patients with metastatic castration resistant prostate cancer, is ongoing. More detailed information about Celcuity’s active clinical trials can be found at ClinicalTrials.gov . Celcuity is headquartered in Minneapolis. Further information about Celcuity can be found at . Follow us on LinkedIn and X . Forward-Looking Statements This press release contains statements that constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 including statements relating to the potential therapeutic benefits of gedatolisib; the size, design and timing of our clinical trials; our interpretation of clinical trial data; the ability of our data to support the filing of a new drug application (“NDA”) with the U.S. Food and Drug Administration (the “FDA”); our expectations regarding the timing of and our ability to obtain FDA approval under the Real-Time Oncology Review program and to commercialize gedatolisib; and other expectations with respect to gedatolisib. Words such as, but not limited to, “look forward to,” “believe,” “expect,” “anticipate,” “estimate,” “intend,” “confidence,” “encouraged,” “potential,” “plan,” “targets,” “likely,” “may,” “will,” “would,” “should” and “could,” and similar expressions or words identify forward-looking statements. The forward-looking statements included in this press release are based on management's current expectations and beliefs which are subject to a number of risks, uncertainties and factors, including that our clinical results are based on an ongoing analysis of key efficacy and safety data and our interpretation of such data may change; unforeseen delays in the review of our NDA for gedatolisib; and our ability to obtain and maintain regulatory approvals to commercialize gedatolisib. In addition, all forward-looking statements are subject to other risks detailed in our Annual Report on Form 10-K for the year ended December 31, 2024, as such risks may be updated in our subsequent filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by these cautionary statements, and we undertake no obligation to revise or update this press release to reflect events or circumstances after the date hereof. Contacts: Celcuity Inc. Brian Sullivan, bsullivan@celcuity.com Vicky Hahne, vhahne@celcuity.com (763) 392-0123 Jodi Sievers, jsievers@celcuity.com (415) 494-9924

Thirteen years after the FDA initially blessed Merck's Keytruda for skin cancer, the U.S. regulator has approved the PD-1 superstar for patients with a certain type of ovarian cancer. For all its success across a wide range of cancer types, Merck’s PD-1 superstar Keytruda has never been able to crack the code for one of the toughest-to-treat indications in oncology—ovarian cancer.But now, 13 years after the FDA initially blessed it for skin cancer, the U.S. regulator has approved Keytruda as a second- or third-line treatment for patients with a certain type of ovarian cancer.With the green light, Keytruda becomes the first immune checkpoint inhibitor approved for this indication. Keytruda is to be used in combination with the chemotherapy paclitaxel and with or without Roche’s targeted cancer therapy Avastin. The endorsement covers those with platinum-resistant recurrent ovarian, fallopian tube or primary peritoneal carcinoma with PD-L1-positive tumors. The nod also covers infused Keytruda and its subcutaneous version, Keytruda Qlex, which the FDA blessed five months ago. “For many patients with ovarian cancer, the disease can become platinum-resistant, at which point recurrence is not just a setback—it’s when options can become limited and the reality patients face can change very quickly,” Bradley Monk, M.D., the medical director of the Late-Stage Clinical Research Program at Florida Cancer Specialists and Research Institute, said in a release. “For patients who have been previously treated with standard platinum-based therapies, the FDA approvals of these [Keytruda]-based regimens offer the possibility of more time.”Paving the way for the green light were results from a phase 3 trial, which demonstrated that the Keytruda regimen, with or without Avastin, reduced the risk of disease progression or death by 28% compared to placebo added to paclitaxel, with or without Avastin, in PD-L1-positive patients. In the same group, the Keytruda regimen also reduced the risk of death by 24% versus the placebo arm.The median progression-free survival (PFS) period was 8.3 months for those on the Keytruda regimen, versus 7.2 months for those in the placebo arm. The median overall survival for Keytruda patients was 18.2 months compared to 14.0 months for the placebo group.“These approvals mark an important moment for the ovarian cancer community, reflecting years of focused investment in Keytruda,” Gursel Aktan, Merck’s VP of clinical development, said in a statement. “Introducing the first PD-1 inhibitors for platinum-resistant ovarian cancer means we’re expanding what’s possible for patients facing this disease.” Of the 643 patients in the trial, 72% were PD-L1-positive. As for Avastin use, 73% of participants received the monoclonal antibody in the study and 46% had received it in a previous line of therapy.Merck presented those results at the European Society for Medical Oncology (ESMO) Congress in October. At the event, Nicoletta Colombo, M.D., from the European Institute of Oncology in Milan, said that the data support the Keytruda regimen as the “new standard of care” in the indication.Interestingly, in the trial—and contrary to historical data in other tumor types—Keytruda’s benefit was more pronounced in participants who were PD-L1-negative, as a subgroup analysis showed a PFS improvement of 44%. Still, this patient group wasn't included in the medicine's official FDA-approved label. Last week, Merck reported 2025 sales of Keytruda at $31.7 billion, an increase of 7% year over year and 49% of the company’s total revenue. Keytruda was the world’s top-selling drug in 2023 and 2024 before being taken over by Eli Lilly’s tirzepatide products last year, which achieved sales of $36.5 billion.