Celcuity appoints David gryska to its Board of Directors. Mr. Gryska brings decades of strategic and financial leadership experience to Celcuity's Board. October 02, 2026 08:00 ET | Source: Celcuity Inc. MINNEAPOLIS, Oct. 02, 2026 (GLOBE NEWSWIRE) - Celcuity Inc. (Nasdaq: CELC), a biotechnology company focused on developing and commercializing targeted therapies for the treatment of multiple solid tumor indications, today announced the appointment of David W. Gryska to its Board of Directors. Mr. Gryska is a seasoned executive who brings over 35 years of strategic and financial leadership experience in the life sciences industry to Celcuity, including advising early-stage biotechnology companies. "On the heels of our first FDA approval for REVTORPYK(TM), we are pleased to welcome David to our Board of Directors as we transition into a commercial-stage company," said Brian Sullivan, Chief Executive Officer and co-founder of Celcuity. "David's extensive experience as a Chief Financial Officer and board member of a number of pharmaceutical companies, through periods of significant clinical development and commercial growth makes him an outstanding addition to our Board. We are confident he will provide valuable expertise as we execute the launch of REVTORPYK, advance our clinical development programs, and continue building the capabilities needed to support long-term growth." Prior to his retirement, Mr. Gryska served as Executive Vice President and Chief Financial Officer of Incyte Corporation; and Senior Vice President and Chief Financial Officer of Celgene Corporation. Mr. Gryska also served as Senior Vice President and Chief Financial Officer as well as Vice President of Finance and Chief Financial Officer at Scios, Inc. Earlier in his career, Mr. Gryska served as a partner at Ernst & Young LLP in California. Throughout the past 25 years, Mr. Gryska has served on the Boards of eight public biotechnology companies and currently serves on the Board of Directors of Definium Therapeutics. He previously served on the Boards of Directors of Seagen Inc. for more than 15 years, Forte Biosciences, Aerie Pharmaceuticals, and GW Pharmaceuticals. Mr. Gryska holds a B.A. in Accounting and Finance from Loyola University and an MBA from Golden Gate University. "Celcuity is entering an exciting new chapter, with the company poised for significant growth over the next few years following the FDA approval and commercial launch of REVTORPYK in advanced breast cancer," said Mr. Gryska. "I look forward to supporting Brian and Celcuity's experienced leadership team as we build on this momentum, advance gedatolisib in additional solid tumor indications, and work to bring meaningful benefits to more patients." About Celcuity Celcuity is a biotechnology company focused on developing and commercializing targeted therapies for the treatment of multiple solid tumor indications. The company's first FDA-approved product is REVTORPYK (gedatolisib), a potent, pan-PI3K and mTORC1/2 inhibitor that comprehensively blockades the 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, evaluated gedatolisib in combination with fulvestrant, with or without palbociclib, for the treatment of patients with HR+/HER2- ABC. Data from this trial is the basis for FDA approval of REVTORPYK for use in adult patients with HR+/HER2- ABC without a PIK3CA mutation detected following progression on or after treatment with at least one line of endocrine therapy in the metastatic setting. Results for the PIK3CA mutant cohort of the VIKTORIA-1 study have been released. Our Phase 3 clinical trial, VIKTORIA-2, is an ongoing trial incorporating two independent studies, Study 1 and Study 2, in two separate cohorts of patients with ABC who are treatment-naive in the advanced setting. Study 1 is evaluating gedatolisib in combination with palbociclib and fulvestrant as first-line treatment for patients with endocrine-resistant HR+/HER2- ABC. Study 2 is evaluating gedatolisib in combination with palbociclib and letrozole as first-line treatment for patients with endocrine-sensitive HR+/HER2- ABC. A Phase 1b/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 www.celcuity.com. 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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 REVTORPYK and the potential therapeutic benefits of gedatolisib; the size, design and timing of the Company's clinical trials; the Company's interpretation of clinical trial data; the status and timing of the submission, and the FDA's review, of the Company's supplemental New Drug Application ("sNDA") for REVTORPYK, and for making comparable filings with other regulatory authorities outside the U.S.; the market opportunity for REVTORPYK; the Company's expectations regarding the timing of and its ability to commercialize REVTORPYK; the Company's strategy, marketing and commercialization plans, including the benefits of strategic decisions regarding studies and trials; other expectations with respect to gedatolisib, including subcutaneous formulations to support potential future indications for gedatolisib regimens; the Company's anticipated use of cash; and the strength of its balance sheet. 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 the Company's topline clinical results are based on an ongoing analysis of efficacy and safety data and such data may change following a more comprehensive review of the data related to the clinical trial; unforeseen delays in the Company's clinical trials or the submission, and FDA's review of, its sNDA for REVTORPYK; the Company's ability to obtain regulatory approval of its sNDA and maintain regulatory approvals to commercialize REVTORPYK in the U.S. and obtain regulatory approval of gedatolisib outside the U.S., and the market acceptance of REVTORPYK; the development of therapies and tools competitive with gedatolisib; and the Company's ability to access capital upon favorable terms. In addition, all forward-looking statements are subject to other risks detailed in the Company's Annual Report on Form 10-K for the year ended December 31, 2025, as such risks may be updated in its 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 the Company undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. Celcuity Inc. Brian Sullivan, [email protected] Vicky Hahne, [email protected] (763) 392-0123 Jodi Sievers, [email protected] (415) 494-9924

Mission Bio showcases Tapestri across drug discovery and clinical development at World CDx Summit. South San Francisco, CA (BUSINESS WIRE) - Mission Bio, the single-cell multiomics leader, today announced that Merck & Co. and Incyte will each present new data generated using Mission Bio's Assay Services and Tapestri(R) Platform at the 16th World Clinical Biomarkers & Companion Diagnostics Summit (World CDx), alongside a third presentation from Mission Bio featuring new clinical data in acute myeloid leukemia. Together, the presentations demonstrate the use of single-cell multiomics from early-stage target validation through clinical mechanism-of-action studies and measurable residual disease assessment. Sydney Hart, PhD, Principal Scientist Functional Genomics at Merck & Co. (Merck), will present new functional genomics findings supporting its drug development programs, partnering with Mission Bio's Assay Services team using the Tapestri(R) Platform. Incyte's Erin Crowgey, PhD, Director of Translational Medicine, will present new single-cell data on INCA033989, an antibody targeting mutant calreticulin (CALR)-positive cells in myeloproliferative neoplasms disease subtypes. Mission Bio's Chief Medical Officer, Dr. Zivjena Vucetic, will present new clinical data demonstrating how single-cell measurable residual disease (MRD) profiling improves standard-of-care compared to current methods for acute myeloid leukemia (AML) patients. The presentations from Merck and Incyte reflect the growing use of Tapestri and Mission Bio's Assay Services by pharmaceutical companies to answer pipeline-specific questions across drug discovery and clinical development. MERCK: A SINGLE-CELL PLATFORM FOR LINKING CRISPR-EDITED VARIANTS TO TRANSCRIPTIONAL OUTCOMES * Date: October 8, 2026 * Time: 12:20 PM ET * Track: Biomarker Discovery & Translation * Speaker: Sydney Hart, Scientist, Merck & Co. Merck scientist Sydney Hart, PhD, partnered with Mission Bio's Assay Services team to build a targeted DNA and RNA single-cell assay on the Tapestri(R) Platform to study how CRISPR-edited genetic variants affect immune cell function in autoimmune and inflammatory disease. Evaluating several single-cell platforms, Merck ultimately selected Mission Bio's Tapestri Platform for its ability to capture targeted genomic and transcriptional information from the same cell while preserving cell yield, confirming expected disease effects and establishing a mechanistic link for target validation to improve drug development decision-making. INCYTE: CHARACTERIZING MECHANISM OF ACTION FOR MYELOPROLIFERATIVE NEOPLASMS TARGETED THERAPY (INCA033989) USING SINGLE-CELL MULTIOMICS IN THE CLINIC * Date: October 8, 2026 * Time: 11:30 AM ET * Track: Clinical & CDx Development * Speaker: Erin Crowgey, Director of Translational Medicine, Incyte Incyte's Erin Crowgey, PhD, will present new single-cell clinical data on their monoclonal antibody, INCA033989, that targets mutant calreticulin (CALR)-positive cells in essential thrombocythemia and myelofibrosis, which are disease subtypes of myeloproliferative neoplasms. These data were generated using a custom Tapestri assay designed by Mission Bio's Assay Services to measure 46 proteins and 37 genes in the same cell. The single-cell analysis demonstrated depletion of mutant CALR-positive cells and repopulation by wild-type cells with relevant clinical improvements. This illustrates how single-cell multiomics can help characterize the mechanism of action for targeted therapies and track target cell populations and their responses to therapy in the clinic. MISSION BIO: SINGLE-CELL MRD ASSESSMENT IN AML: ADVANCING BEYOND STANDARD CARE * Date: October 7, 2026 * Time: 2:10 PM ET * Track: Clinical & CDx Development * Speaker: Zivjena Vucetic, Chief Medical Officer, Mission Bio Addressing limitations of standard-of-care AML MRD assays like bulk NGS and flow cytometry due to complex clonal evolution and overlapping immunophenotypes, Dr. Vucetic will present clinical study data showing that single-cell multiomics achieved 93% sensitivity compared to 43% for flow cytometry and 71% for other molecular methods. Additional evidence presented will also support that single-cell MRD profiling provides more accurate stratification of relapse-free survival in AML patient samples. Single-cell multiomic approaches are redefining how functional genomic and clinical readouts are applied across drug development. In discovery, these approaches link genetic edits to their functional consequences to support target validation. In the clinic, they characterize how a targeted therapy acts on disease-driving cells and track molecular response over time. For MRD monitoring, single-cell data offer evidence to better anticipate relapse. Together, the three presentations illustrate how single-cell multiomics can connect genetic variation to cellular function, characterize treatment response in individual cell populations, and identify residual disease with greater resolution across drug development pipelines. All talks are open to registered World CDx attendees. Full agenda and registration details are available at https://world-cdx.com/. About Mission Bio Mission Bio is the single-cell multiomics leader. The company's Tapestri Platform is unique in its capabilities, offering an unparalleled level of granularity and precision that is critical for complex research areas such as cancer studies, pharmaceutical development, and advanced cell and gene therapies. Unlike traditional standard of care methods, Tapestri provides a level of precision that opens the door for more tailored and effective treatment strategies, notably by advancing the clinical utility of measurable residual disease (MRD) monitoring in diseases like acute myeloid leukemia (AML). Researchers globally depend on Tapestri to identify rare cell populations, understand mechanisms of therapeutic resistance and response, and establish key quality metrics for next-generation medical treatments. With the Tapestri Platform, Mission Bio continues to set the standard in the field, contributing significantly to the progress of personalized medicine and targeted therapies. To learn more about Mission Bio and the Tapestri Platform, please visit missionbio.com. (C) 2026 Business Wire, Inc. Like what you are reading?

The US Food and Drug Administration has approved Atebrioz (zilurgisertib) for adult and paediatric patients aged 12 and older with fibrodysplasia ossificans progressiva, a rare genetic disease affecting approximately 300 people in the United States. Mirum Pharmaceuticals and Incyte announced the approval, which makes Atebrioz the latest treatment option for the progressive condition that causes bone to form in muscles, tendons, and other soft tissues. The once-daily oral tablet works by inhibiting ALK2, targeting the disease-driving pathway. Clinical trial data showed that at 24 weeks, mean total new heterotopic ossification volume decreased by 3.2 cm³ in patients receiving the drug compared with an increase of 24.6 cm³ in placebo-treated patients. Atebrioz is expected to be commercially available in October through Mirum Access Plus, with eligible patients paying as little as $0 per month.