On November 9, 2026 Mereo BioPharma Group plc (NASDAQ: MREO) ("Mereo" or the "Company"), a clinical-stage biopharmaceutical company focused on rare diseases, reported financial results for the third quarter ended September 30, 2026, and provided an update on its late-stage programs.

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"During the third quarter, we have made meaningful progress on our two core programs, setrusumab and alvelestat. These developments have the potential to set the stage for a transformational 2027 for Mereo, our shareholders and the patients we aim to serve," said Denise Scots-Knight, Chief Executive Officer of Mereo BioPharma. "In collaboration with our partner Ultragenyx, we are continuing to work closely with the regulators, to determine the necessary data to support a regulatory submission for setrusumab in OI and if there is a potential path forward. We believe that the data from post-hoc fracture analyses presented at the recent American Society for Bone and Mineral Research (ASBMR) Annual Meeting further support setrusumab’s potential to provide meaningful benefit, particularly in pediatric, higher fracturing patients. We are also advancing our regulatory interactions on alvelestat for AATD-LD alongside Sentynl Therapeutics to streamline the Phase 3 design and are working to be in a position to initiate the Phase 3 study in early 2027. We continue to expect that our current cash position, which totaled $26.1 million as of September 30, will provide runway into late-2027, exclusive of the potential $40 million in upfront and R&D payments associated with the exercise of the alvelestat option by Sentynl and any other milestone payments which would further extend the runway."

Recent Developments and Anticipated Milestones

Setrusumab (UX143) for osteogenesis imperfecta (OI)

Following the results of the Orbit and Cosmic Phase 3 studies of setrusumab in OI, reported in December 2025, Mereo and its partner, Ultragenyx Pharmaceutical, Inc. (Ultragenyx), have engaged with regulatory agencies to determine a potential path forward for setrusumab in pediatric OI patients. These interactions have focused on understanding the necessary data to support a regulatory filing and if there is a potential path forward.
Data from pre- and post-hoc analyses from both the Orbit and Cosmic studies were presented at the 2026 ASBMR Annual Meeting held in October. These data included baseline characteristics, as well as annual fracture rate (AFR) analyses in certain patient subgroups. These pre- and post-hoc analyses on total fractures in patients enrolled with at least 3 fractures in the prior 2 years showed a meaningful benefit on fractures, bone mineral density and other endpoints in the two Phase 3 studies.

Alvelestat (MPH-966) for alpha-1 antitrypsin deficiency-associated lung disease (AATD-LD)

In August, Mereo announced an option and license agreement with Sentynl Therapeutics, Inc. (Sentynl), a wholly owned subsidiary of Zydus Lifesciences Limited, which granted Sentynl the right to acquire a license for the U.S. commercial and global manufacturing rights to alvelestat for AATD-LD.
Should Sentynl exercise its option during the short option period, Mereo would receive $40 million in upfront and R&D payments which would provide funding for the Phase 3 study. Mereo would also be eligible to receive up to $435 million in regulatory and commercial milestones, as well as double-digit tiered royalties on U.S. net sales of alvelestat. Mereo will lead the global Phase 3 study and all regulatory interactions until study completion.
Since signing the option and license agreement, the companies have been collaborating to streamline the design of the planned Phase 3 study. In parallel, Mereo has been working to be in a position to initiate the Phase 3 study in early 2027.
Based on ongoing FDA interactions, Mereo expects to provide an update before the end of the year.

Vantictumab (OMP18R5) for autosomal dominant osteopetrosis type 2 (ADO2)

āshibio, Inc. (āshibio), Mereo’s development and commercial partner for vantictumab, reported clinical biomarker data from a legacy study of vantictumab in patients with cancer at the 2026 ASBMR Annual Meeting.
These data showed that low doses of vantictumab (0.5-5mg/kg) administered once weekly or once every two or three weeks, increased osteoclast activity without inhibiting osteoblast activity at these low doses.
Results were consistent with the findings from an ADO2 mouse study presented by āshibio at the 2025 ASBMR Annual Meeting showing that low doses of vantictumab increased osteoclast activity and rescued the osteopetrotic bone phenotype in this animal model.
āshibio is continuing to advance vantictumab toward clinical trials in patients with ADO2 and intends to initiate trials in the first half of 2028.

Third Quarter 2026 Financial Results

Total research and development ("R&D") expenses decreased by $2.2 million, from $4.3 million in the third quarter of 2025 to $2.1 million in the third quarter of 2026. The decrease was primarily due to reductions of $1.6 million in R&D expenses for setrusumab and $0.4 million for alvelestat. The decrease in program expenses for setrusumab was primarily driven by reductions of, and delays to, investment in manufacturing and ongoing activities, including medical affairs activities in Europe during the third quarter of 2026. The decrease in program expenses for alvelestat was primarily due to the completion of activities undertaken in 2025 in preparation for a potential Phase 3 study.

General and administrative ("G&A") expenses decreased by $1.1 million, from $6.0 million in the third quarter of 2025 to $4.9 million in the third quarter of 2026. The decrease was primarily due to reductions in investment in pre-commercial activities to lay the foundation for the potential commercial launch of setrusumab in Europe, and other realized net cost savings.

Net loss for the third quarter of 2026 was $5.9 million, compared to $7.0 million for the third quarter of 2025, primarily reflecting reductions in R&D and G&A expenses, partially offset by a lower net foreign currency translation gain.

As of September 30, 2026, the Company had cash and cash equivalents of $26.1 million, compared to $41.0 million as of December 31, 2025. The Company expects, based on current operational plans, that its existing cash and cash equivalents balance will enable it to fund its currently committed clinical trials, operating expenses, and capital expenditure requirements into late 2027. This guidance does not include any future potential payments associated with business development activity around any of the Company’s programs.

Total ordinary shares issued as of September 30, 2026 were 798,454,864. Total ADS equivalents as of September 30, 2026 were 159,690,972, with each ADS representing five ordinary shares of the Company.

(Press release, Mereo BioPharma, NOV 9, 2026, View Source [SID1234674528])

On November 9, 2026 iDEL Therapeutics reported that it has entered into a research collaboration with Daiichi Sankyo (TSE: 4568) to utilize iDEL’s synthetic shuttle platform for the evaluation of a multi-drug conjugate (MDC) for select solid tumor indications.

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Under the terms of the agreement, the multi-year collaboration will focus on the preclinical evaluation of a new class of MDC. The research, led by iDEL and scientists at the Daiichi Sankyo Research Institute Munich, will assess the potential of the MDC relative to an antibody-drug conjugate (ADC) with a comparable payload. Further details of the agreement were not disclosed.

"As one of the world leaders in the development of targeted cancer medicines and ADCs, Daiichi Sankyo is the ideal collaborator to support the research and future development of this novel MDC, enabled by iDEL’s synthetic shuttle technology. The collaboration is a validation of the broad potential of our modular platform," said Marcus Kostka, PhD, Co-Founder and CEO of iDEL Therapeutics. "Our technology is being developed to explore approaches that may help mitigate challenges associated with drug uptake and endosomal entrapment."

Beyond this collaboration, iDEL remains focused on optimizing its differentiated delivery technology to unlock previously undruggable intracellular targets, broaden therapeutic windows and increase treatment flexibility and options for patients with cancer. The company has validated its delivery approach in multiple preclinical in vivo proof-of-concept studies using small molecules, peptide and VHH payloads for intracellular targets and has translated this progress into its preclinical pipeline of MDC and single-domain antibody programs for solid tumors.

(Press release, iDEL Therapeutics, NOV 9, 2026, https://www.globenewswire.com/news-release/2026/11/09/3398086/0/en/idel-therapeutics-enters-global-research-collaboration-with-daiichi-sankyo-to-develop-multi-drug-conjugate-with-targeted-cytosolic-delivery-into-solid-tumor-cells.html [SID1234674527])

On November 9, 2026 Tango Therapeutics, Inc. (NASDAQ: TNGX) a clinical-stage biotechnology company committed to delivering breakthrough targeted therapies that extend and improve the lives of patients with cancer, reported financial results for the third quarter ended September 30, 2026, and provided business highlights.

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"In 2026, Tango has made significant strides towards bringing vopimetostat to patients with pancreatic cancer," said Malte Peters, MD, President and Chief Executive Officer of Tango. "This progress is rooted first in the data. Last month at ESMO (Free ESMO Whitepaper), we shared promising data from the combination of vopimetostat plus daraxonrasib that reinforced the potential of this program to raise the bar for patients with MTAP-deleted and RAS-mutant pancreatic cancer. Based on those data, we have engaged with the FDA on our plans for a registrational study in the front-line setting and plan to initiate that study in the first half of next year. In addition, we plan to engage with regulators on the possibility of seeking accelerated approval of this combination in second line pancreatic cancer. Beyond pancreatic cancer, we look forward to sharing our strategy in lung cancer, supported by data from vopimetostat and TNG456, in January of next year. I am grateful to the dedicated Tango team for the progress we have made in 2026 thus far and look forward to advancing our mission of bringing these important therapies to patients with cancer."

Clinical Pipeline Updates

ESMO DATA. In October 2026, Tango reported promising updated data from vopimetostat in combination with Revolution Medicines’ RAS(ON) inhibitors daraxonrasib or zoldonrasib in patients with MTAP-deleted, RAS-mutant pancreatic cancer. Data demonstrated that vopimetostat in combination with daraxonrasib achieved an 82% objective response rate (ORR) and 88% nine-month progression-free survival (PFS) rate in efficacy-evaluable patients with second and third line pancreatic ductal adenocarcinoma (PDAC), and median PFS was not yet reached. Efficacy-evaluable patients are those patients who received their first dose of treatment at least 14 weeks prior to the data cutoff date of August 20, 2026. As of the data cutoff date, the combination had a generally well-tolerated safety profile at dose level one (vopimetostat 200 mg/daraxonrasib 100 mg QD).

PIVOTAL STUDY PLANS. Based upon the encouraging Phase 1/2 data and discussions with the US Food and Drug Administration (FDA), Tango intends to initiate a pivotal Phase 3 study of the combination of vopimetostat plus daraxonrasib in front-line MTAP-deleted pancreatic cancer. The Company anticipates that this will be a global, randomized study of vopimetostat 200 mg plus daraxonrasib 100 mg, once-daily vs. standard-of-care chemotherapy. The planned study has dual primary endpoints of ORR and PFS, with overall survival as a key secondary endpoint. The Company plans to initiate the study in the first half of 2027. In addition, Tango intends to discuss the possibility of pursuing approval of this combination in patients with second line PDAC with regulatory authorities.

ERASCA STUDY START. In November 2026, the Company announced that the Phase 1/2 study of oral PRMT5 inhibitor vopimetostat in combination with pan-RAS molecular glue ERAS-0015 in patients with MTAP-deleted PDAC and MTAP-deleted/RAS-mutant non-small cell lung cancer (NSCLC) has initiated enrollment.

LEADERS IN PRMT5 INHIBITION. In October 2026, the Company announced that it plans to initiate a Phase 1/2 combination study of vopimetostat plus panRAS inhibitors in patients with MTAP-wild type pancreatic cancer in the first half of 2027. This study of approximately 25 patients will explore the Company’s hypothesis, based on a strong biological rationale and emerging clinical and preclinical data, that the synergy observed in MTAP-deleted cancers has the potential to extend to MTAP-wild type cancers.

Corporate Updates

FOCUS ON PRMT5. In October 2026, Tango disclosed a strategic reprioritization of the Company’s research and development activities to focus on the advancement of PRMT5-targeted therapies.

Upcoming Expected Milestones

Disclose vopimetostat lung cancer monotherapy data in January 2027
Disclose TNG456 data in lung cancer, glioblastoma and other cancers in January 2027
Initiate a Phase 3 randomized-controlled trial of vopimetostat plus daraxonrasib in front-line MTAP-deleted pancreatic cancer in 1H 2027
Initiate Phase 1/2 vopimetostat plus panRAS inhibitor study in MTAP-wild type pancreatic cancer in 1H 2027

Financial Results

As of September 30, 2026, the Company held $977.5 million in cash, cash equivalents and marketable securities, which the Company expects to fund its current operating plan.

Collaboration revenue was $0 for the three months ended September 30, 2026, compared to $53.8 million for the same period in 2025, and $0 for the nine months ended September 30, 2026, compared to $62.4 million for the same period in 2025. All remaining deferred revenue from the upfront and research option-extension payments under the Gilead collaboration was recognized as collaboration revenue during the year ended December 31, 2025 as a result of the truncation of the collaboration agreement which concluded all research activities in August 2025.

Research and development expenses were $48.9 million for the three months ended September 30, 2026, compared to $30.8 million for the same period in 2025, and $119.7 million for the nine months ended September 30, 2026, compared to $100.1 million for the same period in 2025. The change was primarily due to increased spend related to the advancement of the vopimetostat and TNG456 clinical programs. This increase was partially offset by decreased spend due to the Company’s portfolio prioritization efforts.

General and administrative expenses were $29.2 million for the three months ended September 30, 2026, compared to $8.9 million for the same period in 2025, and $67.0 million for the nine months ended September 30, 2026, compared to $31.7 million for the same period in 2025. The increase was primarily due to increased spend on personnel-related costs, including share-based compensation expense which included increases derived from the modification of previously issued equity awards for former executive officers.

Net loss for the three months ended September 30, 2026 was $68.4 million, or $0.39 per share (basic and diluted), compared to a net income of $15.9 million, or $0.14 per share (basic) and $0.13 per share (diluted), in the same period in 2025. Net loss for the nine months ended September 30, 2026 was $169.2 million, or $1.08 per share (basic and diluted), compared to a net loss of $62.8 million, or $0.57 per share (basic and diluted), in the same period in 2025.

(Press release, Tango Therapeutics, NOV 9, 2026, View Source [SID1234674526])

On November 9, 2026 Bicara Therapeutics Inc. (Nasdaq: BCAX), a clinical-stage biopharmaceutical company committed to bringing transformative bifunctional therapies to patients with solid tumors, reported financial results for the third quarter ended September 30, 2026 and provided a business update.

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"Ficerafusp alfa was purpose-built for HPV-negative head and neck cancer by inhibiting both EGFR and TGF-β, and the depth and durability of response it has demonstrated to date continue to set it apart in a disease with significant unmet need," said Ryan Cohlhepp, President, Interim Chief Executive Officer and Chief Operating Officer of Bicara Therapeutics. "Achieving substantial enrollment in the FORTIFI-HN01 pivotal trial reflects strong execution by our team and growing recognition among investigators that HPV-negative disease requires a targeted approach grounded in its distinct biology. As we advance toward our planned interim analysis, our focus is twofold: moving with speed and aiming for ficerafusp alfa to enter the market with a competitive profile that gives physicians, patients, and payers a clear reason to choose it. At the same time, we are evaluating less-frequent dosing through FORTIFI-FLEX, which has the potential to further enhance ficerafusp alfa’s profile. With our commercial leadership team now in place, we are well-positioned as we continue to prepare to bring ficerafusp alfa to patients."

Third Quarter 2026 Highlights and Recent Progress

Ficerafusp Alfa in 1L R/M HPV-Negative HNSCC

Achieved substantial enrollment in the FORTIFI-HN01 pivotal trial in first-line (1L) recurrent or metastatic (R/M) human papillomavirus (HPV)-negative head and neck squamous cell carcinoma (HNSCC), to enable topline results from an interim analysis in mid-2027.
Continue to enroll FORTIFI-FLEX, a randomized, open-label clinical trial that is evaluating ficerafusp alfa, administered as a 12-week loading dose of 1500mg weekly (QW) followed by maintenance dosing of 2250mg every three weeks (Q3W) as compared to 1500mg QW of ficerafusp alfa, each in combination with pembrolizumab. The company expects to have results from this study by the time of a potential U.S. approval in 1L R/M HPV-negative HNSCC.
Key Anticipated Upcoming Milestones

HNSCC

Expect topline results from an interim analysis of the FORTIFI-HN01 pivotal trial in 1L R/M HPV-negative HNSCC in mid-2027.
Other Solid Tumors and Translational Data

Present data from Phase 1b expansion cohort evaluating ficerafusp alfa both as monotherapy and in combination with pembrolizumab in patients with 3L+ mCRC (RAS/BRAF wild type MSS) in January 2027.
Present preclinical data evaluating the effect of tumor-targeted TGF-β neutralization with ficerafusp alfa on fibrosis and drug penetration at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Immuno-Oncology & Advanced Therapies Congress 2026, taking place December 14-16 in London, United Kingdom.
Third Quarter 2026 Financial Results

Cash, Cash Equivalents and Marketable Securities: As of September 30, 2026, Bicara had cash, cash equivalents and marketable securities of $442.3 million, compared to $414.8 million in cash, cash equivalents and marketable securities as of December 31, 2025. Based on its current operating and development plans, the company expects that its existing cash, cash equivalents and marketable securities will fund operations into the first half of 2029.
Research and Development Expenses: Research and development expenses were $56.5 million for the third quarter of 2026 as compared to $33.0 million for the third quarter of 2025. The increase was primarily due to costs associated with the ongoing FORTIFI-HN01 pivotal trial, FORTIFI-FLEX trial, Phase 1/1b dose expansion cohorts, and an increase in personnel costs.
General and Administrative Expenses: General and administrative expenses were $19.2 million for the third quarter of 2026 as compared to $7.7 million for the third quarter of 2025. The increase was primarily due to additional personnel costs and professional fees associated with expanding the organization as the company advances its pivotal trial and prepares for potential commercialization.
Net Loss: Net loss totaled $71.2 million for the third quarter of 2026 compared to $36.3 million for the third quarter of 2025.
Upcoming Investor Conferences

Bicara will participate in the following upcoming investor conferences:

Stifel Healthcare Conference 2026 on November 11 at 9:20 a.m. ET
Jefferies Global Healthcare Conference on November 16 at 12:00 p.m. GMT
Piper Sandler 38th Annual Healthcare Conference on December 2 at 8:30 a.m. ET
Live webcasts of the fireside chats will be accessible through the Investor Relations section of Bicara’s website under Events and Presentations. Replays of the webcasts will be archived and available for 30 days following each event.

Conference Call Information
Bicara will host a live conference call and webcast at 8:30 a.m. ET today to discuss third quarter 2026 financial results and business updates. Individuals may register for the conference call by clicking the link here. Once registered, participants will receive dial-in details and a unique PIN that will allow them to access the call. An audio webcast will be accessible through the Investor Relations section of Bicara’s website under Events and Presentations. An archived replay will also be available for 30 days following the event.

(Press release, Bicara Therapeutics, NOV 9, 2026, View Source [SID1234674525])

On November 9, 2026 Celcuity Inc. (Nasdaq: CELC), a commercial-stage biotechnology company focused on developing and commercializing targeted therapies for the treatment of multiple solid tumor indications, reported that the U.S. Food and Drug Administration ("FDA") has accepted for review its supplemental New Drug Application ("sNDA") for REVTORPYK (gedatolisib) for the treatment of patients with hormone receptor positive ("HR+"), human epidermal growth factor receptor 2 negative ("HER2-"), locally advanced or metastatic breast cancer ("ABC") with a PIK3CA mutation, following progression on or after treatment with at least one line of endocrine therapy in the metastatic setting. The FDA assigned a Prescription Drug User Fee Act ("PDUFA") goal date of June 25, 2027.

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The submission is based on clinical data from the PIK3CA mutant-type cohort of the Phase 3 VIKTORIA-1 clinical trial. Gedatolisib previously received both Breakthrough Therapy and Fast Track designations based on promising preliminary clinical data.

"The FDA’s acceptance of this sNDA takes us one step closer to bringing REVTORPYK to more patients living with HR+/HER2- locally advanced or metastatic breast cancer," said Brian Sullivan, CEO and co-founder of Celcuity. "If approved, REVTORPYK would become available to patients as second-line therapy regardless of the PIK3CA status of a tumor, reflecting both the strength of our clinical development program and the potential to address a meaningful unmet need for a broader population of patients."

On July 14, 2026, REVTORPYK in combination with fulvestrant, with or without palbociclib, received FDA approval for the treatment of 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.

About HR+/HER2- Breast Cancer
Breast cancer is the second most common cancer and one of the leading causes of cancer-related deaths worldwide.1 More than two million breast cancer cases were diagnosed globally in 2022.1 While survival rates are high for those diagnosed with early breast cancer, only approximately 30% of patients who are diagnosed with or who progress to metastatic disease are expected to live five years after their diagnosis.2 HR+/HER2- breast cancer is the most common subtype of breast cancer, accounting for approximately 70% of all breast cancers.2 Among this breast cancer subtype, approximately 40% have PIK3CA mutations.3

About REVTORPYK (gedatolisib)
REVTORPYK is a kinase inhibitor of class I PI3K isoforms (α, β, δ, γ) and mTOR complexes mTORC1 and mTORC2, resulting in downstream inhibition of multiple effectors, including AKT.4,5,6

REVTORPYK is in development for the first-line treatment of HR+/HER2- locally advanced or metastatic breast cancer and for the second-line treatment of metastatic castration-resistant prostate cancer.

Indication Statement
REVTORPYK (gedatolisib) is a kinase inhibitor indicated in combination with fulvestrant, with or without palbociclib, for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer without a PIK3CA mutation detected following progression on or after treatment with at least one line of endocrine therapy in the metastatic setting.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Stomatitis: REVTORPYK can cause severe stomatitis, including ulcers and oral mucositis. Stomatitis occurred in 72% of patients treated with REVTORPYK with fulvestrant and palbociclib, including Grade 3 events in 22% of patients. Stomatitis occurred in 58% of patients treated with REVTORPYK with fulvestrant, including Grade 3 events in 12% of patients. Initiate a steroid-containing, alcohol-free mouthwash prior to starting treatment with REVTORPYK and continue prophylactically during treatment. Monitor patients for signs and symptoms of stomatitis. Withhold, reduce dose, or permanently discontinue REVTORPYK based on severity.

Dermatologic Adverse Reactions: REVTORPYK can cause severe rash. Rash occurred in 30% of patients treated with REVTORPYK in combination with fulvestrant and palbociclib, including Grade 3 events in 6% of patients. Rash occurred in 40% of patients treated with REVTORPYK with fulvestrant, including 5% of patients with Grade 3 events. Monitor patients for rash and infectious sequelae. Instruct patients to limit sun exposure during REVTORPYK treatment. Withhold, reduce dose, or permanently discontinue REVTORPYK based on severity.

Hyperglycemia: REVTORPYK can cause severe hyperglycemia. Monitor fasting glucose prior to initiating treatment with REVTORPYK and periodically during treatment. Monitor HbA1c level if clinically indicated. Increased fasting glucose occurred in 46% of patients receiving REVTORPYK in combination with fulvestrant and palbociclib (Grade 3: 0.9%) and in 57% of patients receiving REVTORPYK in combination with fulvestrant (Grade 3: 1.8%). The safety of REVTORPYK has not been established in patients with Type 1 or uncontrolled Type 2 diabetes mellitus. Patients with well-controlled Type 2 diabetes may require intensified antihyperglycemic therapy and close monitoring of fasting glucose. Manage hyperglycemia with antihyperglycemic medications as clinically indicated. Evaluate fasting blood glucose and HbA1c levels prior to starting and at regular intervals during treatment. Withhold, reduce dose, or permanently discontinue REVTORPYK based on severity.

Embryo-Fetal Toxicity: Based on its mechanism of action, REVTORPYK can cause fetal harm when administered to a pregnant woman. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with REVTORPYK and for 2 weeks after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 2 weeks after the last dose.
Advise women not to breastfeed during treatment with REVTORPYK and for 2 weeks after the last dose. When REVTORPYK is used in combination, advise patients to use effective contraception during treatment and for the longest post-treatment duration recommended in the Prescribing Information of any of the individual products. Verify the pregnancy status of females of reproductive potential prior to initiating treatment.

ADVERSE REACTIONS
REVTORPYK in Combination with Fulvestrant and Palbociclib: The most common (≥20%) adverse reactions, including laboratory abnormalities when given in combination with fulvestrant and palbociclib were decreased white blood cells, decreased neutrophils, decreased hemoglobin, decreased lymphocytes, stomatitis, nausea, decreased platelets, increased fasting glucose, fatigue, vomiting, rash, constipation, diarrhea, increased alanine aminotransferase (ALT), increased aspartate aminotransferase (AST), musculoskeletal pain, decreased sodium, and increased eosinophils.

REVTORPYK in Combination with Fulvestrant: The most common (≥20%) adverse reactions, including laboratory abnormalities when given in combination with fulvestrant were stomatitis, glucose increased, eosinophils increased, hemoglobin decreased, nausea, rash, ALT increased, fatigue, musculoskeletal pain, lymphocytes decreased, vomiting, AST increased, pruritus, and diarrhea.

USE IN SPECIFIC POPULATION
Lactation: Advise women not to breastfeed during treatment with REVTORPYK and for 2 weeks after the last dose. When used in combination, advise patients not to breastfeed during treatment and for the longest post-treatment duration recommended in the Prescribing Information of any of the individual products.

Infertility: Advise females and males of reproductive potential that REVTORPYK may impair fertility.

Please see full Prescribing Information, including Patient Information, for REVTORPYK.

(Press release, Celcuity, NOV 9, 2026, View Source [SID1234674524])