The goal of this research study is to evaluate how well and safely the study drugs sasanlimab, palbociclib, and axitinib work for treatment of participants with advanced clear cell renal cell carcinoma (ccRCC) or translocation renal cell carcinoma (tRCC).
The name of the study drugs involved in this research study is:
* Sasanlimab (a type of monoclonal antibody)
* Palbociclib (a type of kinase inhibitor)
* Axitinib (a type of Vascular endothelial growth factor inhibitor)

Start Date01 Feb 2026

Sponsor / Collaborator

Dana-Farber Cancer Institute, Inc.

[+1]

NCT07191977

/ Not yet recruitingPhase 2IIT

Neoadjuvant Camrelizumab With Palbociclib for the Treatment of Resectable Esophageal Squamous Cell Carcinoma: A Single-Arm Phase 2 Trial

The goal of this Phase 2 clinical trial is to learn if the combination of Camrelizumab and Palbociclib is a safe and effective treatment when given before surgery (neoadjuvant therapy) for patients with esophageal squamous cell carcinoma (ESCC) that can be surgically removed. Camrelizumab is an immunotherapy drug that helps the immune system fight cancer, and Palbociclib is a targeted therapy drug that stops cancer cells from growing.
The main questions it aims to answer are:
Is the combination of Camrelizumab and Palbociclib safe for patients to receive before their surgery? How effective is this treatment combination in shrinking tumors prior to surgery?

Start Date01 Jan 2026

Sponsor / Collaborator

West China Hospital

NCT07174336

/ RecruitingPhase 3

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of LY4064809 Combined With a CDK4/6 Inhibitor and Endocrine Therapy in Adults With HR+, HER2-Advanced Breast Cancer With a PIK3CA Mutation Who Received No Prior Treatment for Advanced Breast Cancer (PIKALO-2)

The purpose of the study is to assess the efficacy and safety of the addition of LY4064809 to other anti-cancer drugs as first treatment for advanced hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) breast cancer. Participants can remain in the study as long as the drug is helping the cancer without unbearable side effects.

Start Date27 Oct 2025

Sponsor / Collaborator

Eli Lilly & Co.

[+1]

100 Clinical Results associated with Palbociclib

100 Translational Medicine associated with Palbociclib

100 Patents (Medical) associated with Palbociclib

3,273

Literatures (Medical) associated with Palbociclib

01 Jan 2026·EUROPEAN JOURNAL OF MEDICINAL CHEMISTRY

Design and synthesis of novel cyclin-dependent kinase 4/6(CDK4/6) and histone deacetylase (HDAC) dual inhibitors: In vitro and in vivo anticancer activity

Article

Author: Neerasa, Jayaprakash ; Kim, Bongsu ; Chung, Hunsuk ; Kang, Wonku ; Kantha, Chandra

Resistance to CDK4/6 inhibitors in certain tumors arises from the upregulation of cyclin D1 and the downregulation of the cell cycle regulator p21. Conversely, HDAC inhibitors can counteract this resistance by upregulating acetyl-histone H3 and p21 expression levels. To address this challenge, we developed a series of novel dual-targeting inhibitors that simultaneously inhibit CDK4/6 and HDAC1. Among these, selected compounds MFDCH016, MFDCH022 and MFDCH025 potently inhibited CDK4 and HDAC1/6 at nM levels, inducing apoptosis and cell cycle arrest in G2/M and G₀/G₁ phase and promote apoptosis in MCF-7 cells. This effect was mediated through the modulation of the HDAC-p21-CDK signalling pathway, as evidenced by increased acetyl-H3 and p21 levels. Compound MFDCH016 demonstrated significant anti-tumor activity in breast cancer cell line and in MCF-7 xenograft model without apparent toxicity. More importantly MFDCH016 show highly selective against CDK4 over CDK2 compare to standard drug Palbociclib. Our data demonstrated that compound MFDCH016 as a single agent could be novel dual-targeting CDK4/6-HDAC inhibitor could be a promising drug candidate for cancer therapy.

01 Jan 2026·JOURNAL OF AFFECTIVE DISORDERS

Real-world pharmacovigilance analysis of depression associated with antineoplastic agents

Article

Author: Shang, Jinlu ; Chen, Weiyi ; Wang, Ke ; Guo, Ling ; Zhou, Meiling ; Li, Ruixiao ; Tao, Chao

Cancer remains a major global health threat. Although antineoplastic agents have significantly improved survival outcomes, growing evidence indicates that they may also induce neuropsychiatric adverse events (AEs), particularly depressive symptoms. Such effects can severely compromise patients' quality of life and adherence to therapy. However, this issue has not been systematically evaluated. In this study, we investigated depression-related AEs submitted to the FDA Adverse Event Reporting System from Q1 2004 to Q4 2024. We included reports involving antineoplastic agents (Anatomical Therapeutic Chemical [ATC] code L01) with oncology-related indications and excluded those with concomitant antidepressant use (ATC N06A) for depression-related indications. Disproportionality analyses were performed using the Reporting Odds Ratio (ROR) and the Bayesian Confidence Propagation Neural Network. A total of 211 antineoplastic agents potentially associated with depression and suicide/self-injury were identified, and class-specific risks were evaluated. Most reports involved female patients, and 56.3 % concerned individuals older than 45 years. Protein kinase inhibitors and other antineoplastics exhibited the strongest associations. Notably, significant signals were observed for docetaxel (ROR = 3.7; IC025 = 1.8), palbociclib (ROR = 2.03; IC025 = 0.98), and ibrutinib (ROR = 1.83; IC025 = 0.83). These signals call for heightened clinical vigilance and may inform safer prescribing. Prospective, multicenter studies integrating pharmacovigilance, mechanistic, and clinical data are needed to guide personalized strategies aimed at improving patient outcomes.

01 Dec 2025·Eating Behaviors

Medications as precipitating factors for potential eating disorders: A disproportionality analysis using FDA adverse event reports

Article

Author: Zhang, Shuang ; Zheng, Liyun

OBJECTIVE:

Compared to psychosocial factors, medications remain less well recognized as precipitating factors for eating disorders. This study aims to identify medications potentially associated with eating disorders using the U.S. Food and Drug Administration's Adverse Event Reporting System (FAERS) database.

METHODS:

FAERS reports related to potential eating disorders from January 2004 to December 2024 were retrieved. Reporting odds ratios (RORs) were calculated to detect disproportionate signals, with Fisher's exact test and Bonferroni correction applied for adjustments in multiple comparisons. Drugs exhibiting significant positive signals (ROR 95 % confidence interval lower bound >1, adjusted p-value < 0.01) with over 100 reports were selected for LASSO regression analysis. Logistic regression, adjusted for age, sex, and reporter type, was employed to identify precipitating drugs.

RESULTS:

Among 20,145 reports, 62.7 % involved females, with a median age of 59 years (interquartile range: 42-71). Thirty drugs showed significant positive signals. Nine potential precipitating medications were identified through LASSO and logistic regression, including octreotide, ribociclib, sunitinib, rivastigmine, everolimus, quetiapine, palbociclib, esomeprazole, and pregabalin.

CONCLUSION:

This study identifies certain medications that may act as precipitating factors for potential eating disorders, particularly in middle-aged and older populations. Clinicians should monitor these medications that affect appetite, weight, or carry abuse potential to prevent harm, especially in patients with eating disorders or at-risk populations.

462

News (Medical) associated with Palbociclib

10 Nov 2025

·www.globenewswire.com

Olema Oncology Reports Third Quarter 2025 Financial and Operating Results

Announced new clinical trial agreement with Pfizer to evaluate palazestrant in combination with atirmociclib in ER+/HER2- metastatic breast cancerInitiated OPERA-02 Phase 3 trial of palazestrant in combination with ribociclib in frontline ER+/HER2- metastatic breast cancerPresented compelling new data from Phase 1b/2 study of palazestrant plus ribociclib at ESMO 2025Ended the quarter with $329.0 million in cash, cash equivalents, and marketable securities SAN FRANCISCO, Nov. 10, 2025 (GLOBE NEWSWIRE) -- Olema Pharmaceuticals, Inc. (“Olema” or “Olema Oncology”, Nasdaq: OLMA), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted therapies for breast cancer and beyond, today reported financial and operating results for the third quarter ended September 30, 2025. "We have made significant progress advancing our programs this quarter, highlighted by the initiation of the Phase 3 OPERA-02 trial evaluating palazestrant in combination with ribociclib in the frontline setting and the presentation of compelling data at ESMO that further positions palazestrant to become a potential best-in-class backbone endocrine therapy for ER+/HER2- metastatic breast cancer,” said Sean P. Bohen, M.D., Ph.D., President and Chief Executive Officer of Olema Oncology. “Our clinical trial agreement with Pfizer to combine palazestrant with atirmociclib further underscores our confidence in palazestrant’s activity in combination with other agents in the metastatic setting.” Bohen continued, “Enrollment in the OPERA-01 trial evaluating palazestrant as a monotherapy in second- and third-line ER+/HER2- metastatic breast cancer continues to progress well and we remain on track for top-line data in the second half of next year. The Phase 1/2 study of our KAT6 inhibitor, OP-3136, recently expanded into combinations with fulvestrant and palazestrant and continues to benefit from strong investigator interest. As we look ahead to 2026, we remain focused on sustaining positive momentum across the business, transforming the breast cancer treatment paradigm, and bringing palazestrant to market.” Recent Progress Announced a clinical trial collaboration and supply agreement with Pfizer to evaluate the safety and combinability of palazestrant plus atirmociclib, Pfizer’s investigational, highly selective-CDK4 inhibitor, in a Phase 1b/2 study in patients with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) metastatic breast cancer.Initiated the OPERA-02 Phase 3 trial of palazestrant in combination with ribociclib in frontline ER+/HER2- metastatic breast cancer.Presented updated data from the Phase 1b/2 study of palazestrant plus ribociclib at the European Society for Medical Oncology (ESMO) Congress 2025, demonstrating encouraging activity in both ESR1 mutant and wild-type patients.Continued enrollment in the OPERA-01 Phase 3 trial of palazestrant as a monotherapy in second- and third-line ER+/HER2- metastatic breast cancer.Advanced the Phase 1 study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of OP-3136, as a monotherapy and in combination with fulvestrant and palazestrant, in participants with advanced solid tumors. Anticipated Upcoming Events Initiate the Phase 1b/2 study evaluating palazestrant with atirmociclib in ER+/HER2- metastatic breast cancer in Q4 2025.Present trial-in-progress poster entitled “OPERA-02: a phase 3 randomized, double-blind, active-controlled study of palazestrant with ribociclib versus letrozole with ribociclib for the first-line treatment of ER+, HER2- advanced breast cancer” at the San Antonio Breast Cancer Symposium (SABCS) in December 2025.Report initial clinical results for OP-3136 in mid-2026.Report top-line data from OPERA-01 in the second half of 2026. Third Quarter 2025 Financial ResultsCash, cash equivalents, and marketable securities of $329.0 million as of September 30, 2025. Net loss for the quarter ended September 30, 2025 was $42.2 million, as compared to $34.6 million for the quarter ended September 30, 2024. The increase in net loss for the third quarter was primarily related to increased spending on research and development activities as a result of the ongoing late-stage clinical trials for palazestrant and the advancement of OP-3136, partially offset by higher interest income earned from marketable securities. GAAP research and development (R&D) expenses were $40.0 million for the quarter ended September 30, 2025, as compared to $33.2 million for the quarter ended September 30, 2024. The increase in R&D expenses was primarily related to increased spending on clinical development-related activities as Olema continues to advance palazestrant through late-stage clinical trials, and the advancement of OP-3136, partially offset by decreases in stock-based compensation expense of $1.7 million. Non-GAAP R&D expenses were $37.4 million for the quarter ended September 30, 2025, excluding $2.6 million non-cash stock-based compensation expense. Non-GAAP R&D expenses were $28.9 million for the quarter ended September 30, 2024, which excluded $4.3 million non-cash stock-based compensation expense. A reconciliation of GAAP to non-GAAP financial measures used in this press release can be found at the end of this press release. GAAP general and administrative (G&A) expenses were $5.9 million for the quarter ended September 30, 2025, as compared to $4.4 million for the quarter ended September 30, 2024. The increase in G&A expenses was primarily due to corporate-related costs, including increases in stock-based compensation expense of $0.3 million. Non-GAAP G&A expenses were $4.3 million for the quarter ended September 30, 2025, excluding $1.7 million non-cash stock-based compensation expense. Non-GAAP G&A expenses were $3.0 million for the quarter ended September 30, 2024, excluding $1.3 million non-cash stock-based compensation expense. A reconciliation of GAAP to non-GAAP financial measures used in this press release can be found at the end of this press release. About Olema OncologyOlema Oncology is a clinical-stage biopharmaceutical company committed to transforming the standard of care and improving outcomes for patients living with breast cancer and beyond. Olema is advancing a pipeline of novel therapies by leveraging our deep understanding of endocrine-driven cancers, nuclear receptors, and mechanisms of acquired resistance. Our lead product candidate, palazestrant (OP-1250), is a proprietary, orally available complete estrogen receptor antagonist (CERAN) and a selective estrogen receptor degrader (SERD), currently in two Phase 3 clinical trials. In addition, Olema is developing OP-3136, a potent lysine acetyltransferase 6 (KAT6) inhibitor, now in a Phase 1 clinical study. Olema is headquartered in San Francisco and has operations in Cambridge, Massachusetts. For more information, please visit www.olema.com. About Palazestrant (OP-1250)Palazestrant (OP-1250) is a novel, orally available small molecule with dual activity as both a complete estrogen receptor antagonist (CERAN) and selective estrogen receptor degrader (SERD). It is currently being investigated in patients with recurrent, locally advanced or metastatic ER-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer. In clinical studies, palazestrant completely blocks ER-driven transcriptional activity in both wild-type and mutant forms of metastatic ER+ breast cancer and has demonstrated anti-tumor efficacy along with attractive pharmacokinetics and exposure, favorable tolerability, central nervous system penetration, and combinability with cyclin-dependent kinase 4/6 (CDK4/6) inhibitors. Palazestrant has been granted U.S. Food and Drug Administration (FDA) Fast Track designation for the treatment of ER+/HER2- metastatic breast cancer that has progressed following one or more lines of endocrine therapy with at least one line given in combination with a CDK4/6 inhibitor. It is being evaluated as a single agent in the ongoing pivotal Phase 3 clinical trial, OPERA-01, and in combination with ribociclib in the ongoing pivotal Phase 3 clinical trial, OPERA-02. Palazestrant is also being evaluated in multiple Phase 1/2 studies in combination with ribociclib, palbociclib, alpelisib, everolimus, and atirmociclib. About OP-3136OP-3136 is a novel, orally available small molecule that potently and selectively inhibits lysine acetyltransferase 6 (KAT6), an epigenetic target that is dysregulated in breast and other cancers. In preclinical studies, OP-3136 has demonstrated significant anti-proliferative activity in ER+ breast cancer models and is combinable and synergistic with endocrine therapies including palazestrant and cyclin-dependent kinase 4/6 (CDK4/6) inhibitors. The Investigational New Drug (IND) application for OP-3136 was cleared by the U.S. Food and Drug Administration (FDA) in December 2024 and patients are currently enrolling in the Phase 1 clinical study. Non-GAAP Financial InformationThe results presented in this press release include both GAAP information and non-GAAP information. As used in this release, non-GAAP R&D expense is defined by Olema as GAAP R&D expense excluding stock-based compensation expense, and non-GAAP G&A expense is defined by Olema as GAAP G&A expense excluding stock-based compensation expense. We use these non-GAAP financial measures to evaluate our ongoing operations and for internal planning and forecasting purposes. We believe that non-GAAP financial information, when taken collectively, may be helpful to investors because it provides consistency and comparability with past financial performance. However, non-GAAP financial information is presented for supplemental informational purposes only, has limitations as an analytical tool, and should not be considered in isolation or as a substitute for financial information presented in accordance with GAAP. Other companies, including companies in our industry, may calculate similarly titled non-GAAP measures differently or may use other measures to evaluate their performance, all of which could reduce the usefulness of our non-GAAP financial measures as tools for comparison. Investors are encouraged to review the related GAAP financial measures and the reconciliation of these non-GAAP financial measures to their most directly comparable GAAP financial measures and not rely on any single financial measure to evaluate our business. Forward-Looking StatementsStatements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Words such as “anticipate,” “believe,” “could,” “expect,” “goal,” “intend,” “may,” “on track,” “potential,” “upcoming,” “will” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These statements include those related to the potential for palazestrant to become a best-in-class, backbone endocrine therapy for metastatic breast cancer, potential beneficial characteristics including but not limited to safety, tolerability, activity, efficacy and therapeutic effects of palazestrant or OP-3136, the combinability of palazestrant or OP-3136 with other drugs, including in the metastatic setting, timelines for initiation and enrollment for potential and current clinical studies and for the receipt and presentation of results of clinical trials of palazestrant and OP-3136 each as a monotherapy and in combination trials, Olema’s ability to transform the breast cancer paradigm, Olema’s potential commercial capabilities, Olema’s leadership and ability to develop novel therapies for breast cancer and beyond, and Olema’s financial condition and resources, results of operations, cash position and balance sheet strength. Because such statements deal with future events and are based on Olema’s current expectations, they are subject to various risks and uncertainties, and actual results, performance, or achievements of Olema could differ materially from those described in or implied by the statements in this press release. These forward-looking statements are subject to risks and uncertainties, including, without limitation, those discussed in the section titled “Risk Factors” in Olema’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2025, and future filings and reports that Olema makes from time to time with the U.S. Securities and Exchange Commission. Except as required by law, Olema assumes no obligation to update these forward-looking statements, including in the event that actual results differ materially from those anticipated in the forward-looking statements. Media and Investor Relations ContactCourtney O’KonekVice President, Corporate CommunicationsOlema Oncologymedia@olema.com Olema Pharmaceuticals, Inc.Condensed Consolidated Balance Sheets Data(Unaudited)(In thousands) September 30, December 31, 2025 2024 Cash, cash equivalents and marketable securities $ 328,960 $ 434,086Total assets 352,453 450,979 Total current liabilities 41,655 41,758Total liabilities 44,965 42,015Total stockholders’ equity 307,488 408,964Total liabilities and stockholders’ equity $ 352,453 $ 450,979 Olema Pharmaceuticals, Inc.Condensed Consolidated Statements of Operations (Unaudited)(In thousands, except for share and per share data) Three Months Ended September 30, Nine Months Ended September 30, 2025 2024 2025 2024 Operating expenses: Research and development (1)$39,951 $33,226 $114,477 $92,218General and administrative (2)5,926 4,395 14,137 13,272Total operating expenses45,877 37,621 128,614 105,490Loss from operations(45,877) (37,621) (128,614) (105,490)Other income: Interest income3,648 2,928 12,214 9,388Other income12 138 10 195Total other income3,660 3,066 12,224 9,583Net loss$(42,217) $(34,555) $(116,390) $(95,907)Net loss per share, basic and diluted$(0.49) $(0.60) $(1.36) $(1.80)Weighted average shares used to compute net loss per share, basic and diluted (3)85,732,221 57,262,803 85,553,078 53,194,081 (1) Research and development expenses for the nine-months ended September 30, 2025 include a $10.0 million milestone payment in connection with the Aurigene Agreement.Research and development expenses for the nine-months ended September 30, 2024 include a $5.0 million milestone payment in connection with the Aurigene Agreement.(1) and (2) Used to reference to the table below.(3) The weighted average shares used to compute net loss per share, basic and diluted include the effect from the pre-funded warrants. Reconciliation of GAAP to Non-GAAP Information(In thousands) Three Months Ended September 30, Nine Months Ended September 30, 2025 2024 2025 2024 (1) Research and development reconciliation GAAP research and development$39,951 $33,226 $114,477 $92,218Less: stock-based compensation expense2,582 4,280 9,592 11,925Non-GAAP research and development$37,369 $28,946 $104,885 $80,293 (2) General and administrative reconciliation GAAP general and administrative$5,926 $4,395 $14,137 $13,272Less: stock-based compensation expense1,668 1,346 3,728 4,334Non-GAAP general and administrative$4,258 $3,049 $10,409 $8,938

Phase 1Phase 3Financial StatementFast TrackClinical Result

10 Nov 2025

·www.pharmaceutical-technology.com

Pfizer clinches $10bn Metsera deal as Novo Nordisk retreats

Pfizer CEO Albert Bourla won the race for Metsera, beating an aggressive approach by Novo Nordisk led by their recently appointed CEO Maziar Mike Doustdar. Photo by Win McNamee via Getty Images. One of the most compelling acquisition sagas in the pharma industry in recent times has come to an end, with Pfizer prevailing over Novo Nordisk in a fierce bidding war to acquire obesity biotech Metsera. After mulling over competing offers from both Pfizer and Novo Nordisk, Metsera has decided to go with the former’s $10bn offer. As per the agreed merger deal, Pfizer will acquire Metsera for up to $86.25 per share, consisting of $65.60 per share in cash and a contingent value right (CVR) of up to $20.65 per share. Novo Nordisk said it does not intend to make an increased offer to acquire Metsera. In a statement, Metsera said it “determined that [Pfizer’s] revised terms represent the best transaction for shareholders, both from the perspective of value and certainty of closing.” The agreement marks the final chapter in an intense fight, which included lambasting statements and legal retaliation, to buy a company whose technology could unlock the next frontier of the obesity market. Metsera’s offerings centre around longer-lasting injectable and oral peptides for weight loss. The biotech has developed a platform that allows for less frequent dosing – targeting monthly administration. This would be a significant improvement on the weekly dosing seen with approved weight loss therapies. GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence The crown jewel in Metsera’s portfolio is MET-097i, an injectable glucagon-like peptide-1 receptor agonist (GLP-1RA) touted as having the potential for both weekly and monthly dosing schedules. Both frequencies are in Phase II development (NCT06897202 and NCT06973720). Phase IIa data with MET-097i dosed on both a weekly and monthly regimen have demonstrated robust weight loss after 12 weeks. Not only does the Metsera buyout provide an avenue into the lucrative obesity market, but it also shores up revenue streams as patent expiries loom for Pfizer. The big pharma company is expected to lose market exclusivity for Eliquis (apixaban), Ibrance (palbociclib), and Xtandi (enzalutamide) over the coming years. Blood thinner Eliquis alone generated $13.3bn in global sales in 2024. Metsera’s choosing of Pfizer means the two companies will continue a relationship that already has well-formed communication channels. Pfizer originally agreed to buy the biotech for up to $7.3bn in September 2025, and for a while it looked like the deal would close without a hitch. However, Novo Nordisk swooped in with an unsolicited bid for up to $8.5bn at the tail-end of October, in what Metsera called a “superior offer”. Pfizer called the Danish drugmaker’s proposal “reckless and unprecedented” and pointed to a violation of US antitrust laws. As part of its retaliation, the big pharma company filed lawsuits against Novo Nordisk, accusing the Danish drugmaker and Metsera of contractually breaching the merger agreement. The war of words between the companies even spilled over in the White House. While in the Oval Office announcing new pricing deals for weight loss drugs, Novo’s CEO, Maziar Mike Doustdar, indirectly told Pfizer to bid higher for Metsera if it wanted a deal to go through. Both Pfizer and Novo wound up placing offers of $10bn on the table , but legal considerations ultimately appear to have been the tipping point. The US Federal Trade Commission (FTC) waved through Pfizer’s bids but found problems with elements of Novo’s approach. Metsera said in a statement: “In light of recent circumstances, including the receipt by Metsera of a call from the US Federal Trade Commission regarding potential risks from proceeding with the proposed Novo Nordisk structure under US antitrust laws, the Metsera Board of Directors has further determined that the transaction proposed by Novo Nordisk presents unacceptably high legal and regulatory risks to Metsera and its stockholders compared to the proposed merger with Pfizer.” Pfizer prevailing in the deal means it has been a chastening week for Novo Nordisk. The company has maintained that its merger agreement offer was compliant with antitrust laws, though now it is ultimately reeling from a failed attempt to gain Metsera’s technology for its own pipeline. Novo once again trimmed its 2025 outlook as sales for its GLP-1RAs underwhelmed, with Doustdar’s aggressive M&A strategy evidently an avenue to turn fortunes around. One deal it did push over the line was the $5.2bn buyout of metabolic dysfunction-associated steatohepatitis (MASH) specialist Akero Therapeutics in October 2025. Pharmaceutical Technology Excellence Awards - The Benefits of Entering Gain the recognition you deserve! The Pharmaceutical Technology Excellence Awards celebrate innovation, leadership, and impact. By entering, you showcase your achievements, elevate your industry profile, and position yourself among top leaders driving pharmaceutical advancements. Don’t miss your chance to stand out—submit your entry today! Nominate Now

Phase 2Acquisition

05 Nov 2025

·www.prnewswire.com

Delphi Diagnostics® Announces Four Abstracts and one General Session Presentation Featuring the Endocrine Activity Index™ to be Presented at the San Antonio Breast Cancer Symposium

A PDF of the release can be found here HOUSTON, Nov. 4, 2025 /PRNewswire/ -- Delphi Diagnostics announces the upcoming presentation of four scientific abstracts, including one platform presentation highlighting new clinical data supporting the company's innovative breast cancer diagnostic technology, the Endocrine Activity Index (EAI™). The Endocrine Activity Index is known in the scientific literature as the Sensitivity to Endocrine Therapy (SET) Test. These presentations will be featured at the upcoming San Antonio Breast Cancer Symposium (SABCS) held in San Antonio, TX, December 9th-11th, 2025. SABCS is the largest breast cancer research meeting in the world, expecting to draw over 10,000 attendees from 102 countries. The presentations underscore the growing scientific momentum behind Delphi's Endocrine Activity Index (EAI), a next-generation diagnostic tool designed to optimize treatment decisions for patients with HR+ HER2- breast cancer. Delphi Diagnostics will be attending the conference as an exhibitor in booth #1528. The newly accepted abstracts include: GS3-05: Evaluation of the Sensitivity to Endocrine Therapy (SETER/PR) assay to predict benefit from extended endocrine therapy in the NRG/NSABP B-42 trial Author: Eleftherios P Mamounas, AdventHealth Cancer Institute, Orlando, FL General Session 3 oral presentation on Friday, December 12th, 2025, at 9 am CST. PS2-07-23: Predictive markers of distant recurrence from randomized chemotherapy regimens for hormone receptor-positive breast cancer patient in the PACS-01 trial. Author: Frederique Penault-Llorca, Centre Jean Perrin, CLERMONT FERRAND, France PS3-08-13: Exploratory analysis of palbociclib benefit in the PALLAS trial by SETER/PR index and prior chemotherapy regimens (ABCSG-42/AFT-05/BIG-14-13) Author: Otto Metzger, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA PS3-09-21: Evaluation of Sensitivity to Endocrine Therapy (SET) as a Prognostic Biomarker in the Latin American Breast Cancer Cohort Study Author: Marcela Mazo Canola, UT Health San Antonio, San Antonio, TX "Data from these studies, presented by leading investigators in the breast cancer field, deepen the clinical evidence behind the EAI test. The selection of the data on the NRG/NSABP B-42 trial for an oral presentation at a general session underscores the relevance of these results. This data reinforces the role of the endocrine activity pathway as critical to understand when making treatment decisions for breast cancer patients," said Chief Medical Officer at Delphi Diagnostics, Federico A. Monzon, MD. Delphi Diagnostics remains committed to advancing science that ensures patients receive the most effective care possible. Additional details will be shared after the data is made publicly available. About EAI Delphi Diagnostics' Endocrine Activity Index® (EAI™) test can provide actionable information for prognosis and prediction of dose-intense taxane-based chemotherapy benefit in stage II-III, HR+ HER2- breast cancer. The EAI measures endocrine activity in a breast tumor and for prognostic use, the Index Score is adjusted for baseline prognosis using molecular subtype genes (RNA4) and clinical factors such as tumor size and regional lymph node involvement. The EAI test has been shown in various studies to be a consistent prognostic indicator for long-term outcomes in stage II-III breast cancer patients, to be independent of other prognostic tests, as well as to be predictive for response to dose-dense chemotherapy. About Delphi Diagnostics Delphi Diagnostics Inc. is a Texas-based company focused on advancing clinically valid tests for the prognosis and prediction of breast cancer treatment. Delphi Diagnostics, Inc. holds an exclusive license from The University of Texas MD Anderson Cancer Center in Houston, TX to commercialize the Endocrine Activity Index, a technology that was developed by the laboratory of Dr. W. Fraser Symmans**. The Endocrine Activity Index (EAI) test measures endocrine activity in stage II-III, HR+HER2- breast cancer. Delphi's vision is to make the EAI test available to breast cancer patients and open new pathways for personalized breast cancer treatment. To learn more, visit . **Dr. Symmans has a personal financial relationship with Delphi that has been identified as a conflict of interest with this research and is managed by MD Anderson's Conflict of Interest Committee. Media Contact: Emily Granger Delphi Diagnostics Inc. [email protected] 508.341.9331 SOURCE Delphi Diagnostics Inc 21% more press release views with Request a Demo

License out/in

100 Deals associated with Palbociclib

External Link

KEGG	Wiki	ATC	Drug Bank
D10372	Palbociclib	L01XE33	DB09073

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Breast cancer recurrent	Japan	Pfizer Japan, Inc.	27 Sep 2017
Hormone receptor positive HER2 negative breast cancer	United States	Pfizer Inc.	19 Feb 2016
ER-positive/HER2-negative Breast Cancer	United States	Pfizer Inc.	03 Feb 2015

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Human Papillomavirus-Related Squamous Cell Carcinoma	Phase 3	United States	Pfizer Inc.	06 Apr 2022
Squamous Cell Carcinoma of Head and Neck	Phase 3	United States	Pfizer Inc.	06 Apr 2022
Squamous cell carcinoma of head and neck metastatic	Phase 3	United States	Pfizer Inc.	06 Apr 2022
HR Positive/HER2 Negative/Node positive breast cancer	Phase 3	Austria	Pfizer Inc.	27 Aug 2019
HR Positive/HER2 Negative/Node positive breast cancer	Phase 3	France	Pfizer Inc.	27 Aug 2019
HR Positive/HER2 Negative/Node positive breast cancer	Phase 3	Hungary	Pfizer Inc.	27 Aug 2019
HR Positive/HER2 Negative/Node positive breast cancer	Phase 3	Italy	Pfizer Inc.	27 Aug 2019
HR Positive/HER2 Negative/Node positive breast cancer	Phase 3	Spain	Pfizer Inc.	27 Aug 2019
HR Positive/HER2 Negative/Node positive breast cancer	Phase 3	Switzerland	Pfizer Inc.	27 Aug 2019
HER2-negative breast cancer	Phase 3	United States	Pfizer Inc.	16 Jul 2019

Clinical Result

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04735367 (Pubmed \| Breast Cancer)	Phase 2	ER-positive/HER2-negative Breast Cancer First line ER+/HER2−	42	Palbociclib plus letrozole	csesazqawo(pkxyjyeelj) = xnftaemnbf hborbkplaf (lhggxkrrrx, 64.3 - NE) View more	Positive	01 Nov 2025
NCT04767594 (PERFORM, ESMO2025)	Not Applicable	Hormone receptor positive HER2 negative breast cancer First line HR+/HER2-	1,171	Palbociclib + Endocrine Therapy	cbxrksmuoh(tpvjrxtymy) = not reached (23.2% events) tymjmdcimk (cgcfpfpprf )	Positive	17 Oct 2025
NCT02947685 (AFT-38, ESMO2025)	Phase 3	Metastatic breast cancer Maintenance HR+ \| HER2+	491	Palbociclib + Maintenance HER2 Therapy + Endocrine Therapy	hsfqwwxmhg(ywdduatmip) = vnwtyzxzoc xpadutfiwj (fabjrvqwrz, 69.4 - 74.0) View more	Positive	17 Oct 2025
				Maintenance HER2 Therapy + Endocrine Therapy	hsfqwwxmhg(ywdduatmip) = vhuouxbxnv xpadutfiwj (fabjrvqwrz, 70.0 - 74.8) View more
NCT04720768 (CELEBRATE, ESMO2025)	Phase 1	Metastatic melanoma BRAFV600m	23	Encorafenib 450mg + Binimetinib 45mg + Palbociclib (75/100/125mg)	mxrqxeylsv(grtkmdzkmg) = One DLT occurred at each palbociclib dose level with G3 hyponatraemia at 75mg, G3 alkaline phosphatase rise at 100mg and G3 hepatic failure at 125mg. dxzhvaoaap (gkblcelvcd ) View more	Positive	17 Oct 2025
				Encorafenib 450mg + Binimetinib 45mg + Palbociclib (75/100/125mg) (prior BRAF/MEKi)
ESMO2025	Not Applicable	PIK3CA mutation/HR-positive/HER2-negative Breast Cancer HR positive \| Her2 negative	105	Palbociclib plus endocrine therapy	fjbozoppvb(xgapancedn) = znxvmydoqp ajjfhtapvx (oxczjwhlhe ) View more	Positive	17 Oct 2025
				Chemotherapy	fjbozoppvb(xgapancedn) = bsauhlbgjs ajjfhtapvx (oxczjwhlhe ) View more
NCT03454035 (ESMO2025)	Phase 1	Metastatic melanoma N(K,H)RAS G12/G13/Q61-mut \| NF1 loss-of-function mutant	9	Ulixertinib plus palbociclib	zfogbfpkft(kexerwxdss) = RRAE of any grade occurring in >=4 pts were rash, serum creatinine increase, fatigue, diarrhea, anemia, vomiting, thrombocytopenia, and neutropenia, resulting in dose reduction in 7 pts. Serious (grade >=3) RRAE occurring in >=3 patients were neutropenia and rash. fdluxtzolc (wtfhhezuhu )	Positive	17 Oct 2025
ESMO2025	Not Applicable	Hormone receptor positive HER2 negative breast cancer First line HR+/HER2-	1,267	Letrozole plus Palbociclib	vccsexecci(wiqquzoibq): HR = 0.59 (95.0% CI, 0.51 - 0.69) View more	Positive	17 Oct 2025
				Letrozole plus Placebo
ESMO2025	Not Applicable	First line \| Second line	239	Palbociclib	mfgwdsvrjw(jqygdkmliy) = buetkguiih zhknipbpbi (plwbhkmken )	Positive	17 Oct 2025
				Ribociclib/Abemaciclib	mfgwdsvrjw(jqygdkmliy) = xnrxabeluk zhknipbpbi (plwbhkmken )
ESMO2025	Not Applicable	Hormone receptor positive HER2 negative breast cancer First line HR+/HER2-	11,557	Palbociclib+AI	nqltwomwqd(seikpaulit) = prisevshsb hsjvaiolgg (iagcrwdgnb ) View more	Positive	17 Oct 2025
				Ribociclib+AI	nqltwomwqd(seikpaulit) = bozhfpequp hsjvaiolgg (iagcrwdgnb ) View more
ESMO2025	Not Applicable	Hormone receptor positive HER2 negative breast cancer HR+ \| HER2-	6,796	Palbociclib + Palbociclibherapy	zcaotjewjy(xddsijjrfh): HR = 0.81 (95.0% CI, 0.66 - 0.99), P-Value = 0.043 View more	Positive	17 Oct 2025
				Ribociclib + RibociclibTherapy

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