On December 10, 2025 Prelude Corporation (PreludeDx), a leader in precision diagnostics for early-stage breast cancer, reported results from the first independent validation of AidaBreast, a novel multi-omic biosignature developed to predict a woman’s 10-year risk of locoregional recurrence (LRR) and her individualized benefit from adjuvant radiation therapy (RT) following breast-conserving surgery.

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The findings will be presented at the San Antonio Breast Cancer Symposium (SABCS) 2025 by Dr. Bruce Mann, Director of Research at Breast Cancer Trials, Head of Breast Surgical Research at Royal Melbourne Hospital, Professor of Surgery at The University of Melbourne, and Principal Investigator of the study, together with Troy Bremer, PhD, Chief Scientific Officer of PreludeDx.

The validation study, conducted at Royal Melbourne Hospital (RMH) in Australia, evaluated more than 400 women with early-stage HR+ / HER2- invasive breast cancer who underwent breast-conserving surgery and endocrine therapy, with or without radiation therapy. The results confirmed and strengthened PreludeDx’s initial validation:

AidaBreast stratifies women into Low Risk and Elevated Risk groups based on underlying tumor biology.
Within the Elevated Risk group, the test identifies which women are likely to experience significant therapeutic benefit from RT, and which show minimal benefit from RT, despite elevated recurrence risk.
Women in the Low Risk group demonstrated very low 10-year recurrence rates whether or not they received radiation therapy.
"This independent blinded validation confirms the prior results, demonstrating that AidaBreast is prognostic for LRR risk and predictive for RT benefit. The results demonstrated that the test identified patients who are good candidates for the omission of RT and patients who would significantly benefit from radiation therapy," said Dr. Bruce Mann, Principal Investigator of the study. "AidaBreast provides information that cannot be determined from clinicopathology alone and offers a major advance in early-stage invasive breast cancer treatment."

AidaBreast: The First and Only Test Providing Both Prognostic and Predictive Insight for Radiation Therapy

AidaBreast uses multi-omic technology by analyzing RNA and protein expression together with spatial biology, providing a more complete assessment of a patient’s tumor biology.

"AidaBreast provides a new level of clarity for women with early-stage invasive breast cancer," said Dan Forche, President and CEO of PreludeDx. "For the first time, patients and physicians have a tool for Stage I and IIa breast cancer that supports shared treatment decisions, helping women make more confident and informed choices on radiation therapy."

AidaBreast: The Next Generation of Insight for Early-Stage Breast Cancer

AidaBreast assessment of RT benefit is the first in a comprehensive approach for early-stage invasive breast cancer. Future plans include evaluation of endocrine therapy and chemotherapy benefit, enabling a unified, integrated decision-support tool.

"This is the first and only commercially available test developed specifically for RT in Stage I and IIa breast cancer", said Dr. Troy Bremer, CSO. "Prior tests were focused on metastatic risk and chemotherapy benefit. AidaBreast incorporates both RNA and functional proteins that drive tumor biology, giving patients and clinicians the first tool for assessing both recurrence risk and predicting radiation therapy benefit."

Extending the Proven Impact of DCISionRT

AidaBreast builds on PreludeDx’s leadership established with DCISionRT, the widely adopted test that transformed radiation therapy decision-making for women diagnosed with ductal carcinoma in situ (DCIS).

"With AidaBreast, we are bringing the same level of precision and biological insight to early-stage invasive breast cancer," added Forche. "Our goal is to ensure women have the clearest possible understanding of their treatment options so they can make the best decision for their health and quality of life."

About DCISionRT

DCISionRT is the only risk assessment test for patients with ductal carcinoma in situ (DCIS) that predicts radiation therapy benefit. Patients with DCIS have cancerous cells lining the milk ducts of the breast, but they have not spread into surrounding breast tissue. In the US, over 60,000 women are newly diagnosed with DCIS each year. DCISionRT, developed by PreludeDx on technology licensed from the University of California San Francisco, and built on research that began with funding from the National Cancer Institute, enables physicians to better understand the biology of DCIS. The test provides a Decision Score that identifies a woman’s risk as low, elevated, or residual risk. Unlike other risk assessment tools, the DCISionRT test combines protein expression from seven biomarkers and four clinicopathologic factors, using a non-linear algorithm to account for multiple interactions between individual factors to better interpret complex biological information. DCISionRT’s intelligent reporting provides a woman’s recurrence risk after breast conserving surgery alone and with the addition of radiation therapy. In turn, this new information may help patients and their physicians to make more informed, personalized treatment decisions.

(Press release, PreludeDx, DEC 10, 2025, View Source [SID1234661361])

On December 10, 2025 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a late-stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors and viruses, reported it has entered into agreements with certain holders of its existing warrants for the immediate exercise of certain outstanding warrants to purchase up to an aggregate of 727,969 shares of common stock of the Company originally issued in February 2025 at an exercise price of $6.63 per share and 316,360 shares of common stock of the Company originally issued in August 2025 at an exercise price of $6.3219 per share. The shares of common stock issuable upon exercise of the outstanding warrants are registered pursuant to effective registration statements on Form S-1 (File No. 333-286276) and Form S-3 (File No. 333-290418). The aggregate gross proceeds from the exercise of the existing warrants is expected to total approximately $6.5 million, before deducting financial advisory fees.

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Roth Capital Partners and Maxim Group LLC are acting as the Company’s financial advisors for this transaction.

In consideration for the immediate exercise of the warrants for cash, the Company will issue new unregistered warrants to purchase shares of common stock. The new warrants will be exercisable for an aggregate of up to 2,610,823 shares of common stock, at an exercise price of $6.63 per share and will be exercisable upon shareholder approval and for a term of five years from the date of shareholder approval.

The transaction is expected to close on or about December 11, 2025, subject to satisfaction of customary closing conditions. The Company intends to use the net proceeds from the offering for working capital and general corporate purposes.

The new warrants described above were offered in a private placement pursuant to an applicable exemption from the registration requirements of the Securities Act of 1933, as amended (the "1933 Act") and, along with the shares of common stock issuable upon their exercise, have not been registered under the 1933 Act, and may not be offered or sold in the United States absent registration with the Securities and Exchange Commission ("SEC") or an applicable exemption from such registration requirements. The Company has agreed to file a registration statement with the SEC covering the resale of the shares of common stock issuable upon exercise of the new warrants.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.

(Press release, Moleculin, DEC 10, 2025, View Source [SID1234661346])

On December 10, 2025 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, together with Alliance Foundation Trials, LLC (AFT) and the Austrian Breast and Colorectal Cancer Study Group (ABCSG), reported initial translational research results from the international randomized Phase III PALLAS study.

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Presented today at the San Antonio Breast Cancer Symposium (SABCS), these first data, generated from a U.S. biomarker cohort of 420 patients, show that molecular residual disease (MRD) status, measured by the Signatera Genome test after surgery (and adjuvant chemotherapy +/- radiation if administered), is a highly prognostic biomarker for distant recurrence risk in stage II–III, HR+/HER2- breast cancer. The findings support Natera’s strategy to integrate MRD testing into routine post‑surgical risk assessment, enabling a more personalized approach to managing early-stage HR+ breast cancer. Data from a parallel ex-US cohort will be presented in conjunction with a treatment subgroup analysis at a later date.

In PALLAS, patients with stage II–III HR+/HER2- breast cancer were randomized to receive two years of palbociclib, a CDK4/6 inhibitor, in combination with endocrine therapy. Signatera MRD assessments were performed after surgery at three key postoperative timepoints: on the first day of protocol-directed experimental therapy (baseline), on-treatment at approximately 6 months (C6D1), and at the end of the 2-year interventional treatment period (EOT). Key findings from this initial analysis include:

Signatera correctly identified patients with low risk of recurrence.

At baseline, approximately 92% of patients were MRD-negative and had excellent outcomes, with 5-year distant recurrence-free interval (DRFI) of 93%. Measured starting at EOT, MRD-negative patients had a 5-year DRFI of 95%. This underscored that MRD-negativity after surgery and adjuvant endocrine therapy is associated with an exceptionally low risk of distant recurrence.
MRD-positive patients had very poor outcomes with current therapy.

Baseline MRD positivity was observed in roughly 8% of this stage II–III HR+/HER2- population. These patients had 5-year DRFI of 28%, corresponding to a markedly elevated hazard of distant recurrence compared with MRD-negative patients (hazard ratio [HR] ~15). At the end of protocol-directed therapy, MRD-positive patients had a 5-year DRFI of 32%, with hazard ratios exceeding 20 versus MRD-negative patients.
There was strong prognostic value across all postoperative timepoints tested in the analysis.

Signatera ctDNA status at baseline, C6D1 and EOT was consistently and strongly associated with distant recurrence risk, even when accounting for clinical and pathologic features. Across these timepoints, MRD-positive patients had hazard ratios well into the double digits (13.4-21.5) compared with MRD-negative patients, demonstrating much larger risk separation than is typically seen with individual clinicopathologic factors alone.
"ctDNA has emerged as one of the most promising biomarkers in early-stage breast cancer, and the TransPALLAS collaboration gives us a uniquely powerful opportunity to study ctDNA in the adjuvant setting," said Heather Parsons, M.D., MPH, first author, Trans-PALLAS member, and associate professor of the clinical research division and program head of the breast oncology program at Fred Hutch Cancer Center. "We are excited to share these findings with the breast oncology community and advance a better understanding of recurrence risk for patients with HR+/HER2- disease."

"The results from this preplanned analysis of the PALLAS trial support Natera’s vision for individualizing the management of early-stage HR+/HER2- breast cancer," said Minetta Liu, M.D., chief medical officer of oncology and early cancer detection at Natera. "Implementation of longitudinal post-surgical ctDNA testing with Signatera advances us beyond a one‑size‑fits‑all management approach based solely on initial tumor characteristics. Instead, we can start to imagine treatment algorithms where ctDNA-negative patients are spared unnecessary treatment with related toxicity, and ctDNA-positive patients are prioritized for more intensive or novel therapies. It’s a fundamental shift toward truly MRD‑informed care."

About the PALLAS Trial

PALbociclib CoLlaborative Adjuvant Study (PALLAS) (NCT02513394) is a randomized (1:1), prospective, international, multicenter, open-label Phase 3 study comparing the combination of palbociclib in combination with endocrine therapy (ET) versus ET alone for adults with HR+, HER2- Stage II and Stage III EBC, including those at moderate to high risk of recurrence. MRD detection via ctDNA testing was a predefined biomarker analysis to identify patients at highest risk of recurrence. The previously reported trial which did not include MRD analysis, co-sponsored by the ABCSG and the AFT as part of a clinical research collaboration with Pfizer, Breast International Group (BIG), German Breast Group (GBG), National Surgical Adjuvant Breast and Bowel Project (NSABP), and PrECOG, LLC (PrECOG), did not meet its primary endpoint, showing no benefit of palbociclib plus endocrine therapy in the adjuvant setting in patients with histologically confirmed HR+/HER2- invasive EBC. Palbociclib is not approved in EBC.

(Press release, Natera, DEC 10, 2025, View Source [SID1234661362])

On December 10, 2025 NEC Bio Therapeutics reported results from the Phase I basket clinical trial of an orally administered cancer vaccine, NECVAX-NEO1, used in combination with checkpoint inhibitors (CPIs) for treating patients with solid tumors. The findings are being presented in a poster at the ESMO (Free ESMO Whitepaper) Immuno-Oncology Congress in London, United Kingdom, from December 10 to 12, 2025.

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NECVAX-NEO1 is a personalized bacteria-based oral DNA therapeutic vaccine, developed using AI prediction of the most immunogenic patient-specific neoepitopes. This vaccine is designed to activate a patient’s immune system, prompting a T-cell response that can precisely target and eliminate tumor cells based on an individual’s unique neoantigens.

In the phase I study, 6 patients with melanoma, renal cell cancer, or head and neck cancer, who have been on CPI treatment for at least three months, were treated with NECVAX-NEO1. The safety run-in phase showed no treatment-related toxicities, allowing a dose increase. Clinically, 83% of the patients achieved stable disease at the end of 24 weeks of treatment, which was followed by a 12 week follow-up period. In all patients immunogenic neoepitopes used in the vaccine, were detected, as demonstrated by ELISPOT analysis.

Regarding the results of the clinical study, Dr. Heinz Lubenau, CEO of NEC Bio Therapeutics, commented, "Our clinical Phase I data are demonstrating promising immune responses in treated cancer patients. The translational biomarker data are in line with the clinical data so that we are presenting a consistent data set. The progress is encouraging as we advance two additional clinical studies in 3 European countries in both early- and later-stage cancer settings. We look forward to further evaluating NECVAX-NEO1 as a potential treatment option for cancer patients with hard-to-treat tumors."

Motoo Nishihara, Corporate Executive Vice President and CTO of NEC Corporation, further commented, "We are proud to present the progress of the NECVAX-NEO1 trial, which demonstrates safety as well as signs of immunogenicity and early efficacy. NECVAX-NEO1 is the first oral cancer vaccine asset to be clinically developed by NEC. The results of this trial are a testament to our proprietary AI predictive software that supports immunological and clinical readouts. This development aligns closely with NEC’s broader mission to deliver global healthcare solutions using state-of-the-art technologies developed in-house."

Details of the poster are below:

Poster title: NECVAX-NEO1, a bacteria-based personalized neoepitope vaccine combined with PD-1/PD-L1 checkpoint inhibition in a phase I, open-label, multicenter study: safety, immunogenicity and early efficacy signals. NCT05354323

Authors: D. Vaitiekus, E. Juozaityte, L. Puzauskienė, S. Tulyte-Kirzova, L. Gatijatullin, M. Platten, I. Poschke, I.Hülsmeyer, A. Kuhn, A. Aranguren, H. Lubenau, R. Stratford, T. Clancy, H. Fontenelle, B. Simovski, Y. Yamashita, C. Chaput, A. Meiser, V. Urbonas

Poster Number: 258P

(Press release, NEC, DEC 10, 2025, View Source [SID1234661347])

On December 10, 2025 Pfizer Inc. (NYSE: PFE) reported detailed results from the Phase 3 HER2CLIMB-05 trial of the tyrosine kinase inhibitor TUKYSA (tucatinib) as part of an investigational first-line maintenance treatment combination, following chemotherapy-based induction, in patients with human epidermal growth factor receptor 2-positive (HER2+) metastatic breast cancer (MBC). The primary endpoint analysis showed a 35.9% reduction in the risk of disease progression or death among patients treated with TUKYSA, trastuzumab, and pertuzumab compared to those treated with placebo, trastuzumab, and pertuzumab, as assessed by the investigator (hazard ratio [HR] of 0.641, 95% confidence interval (CI): 0.514-0.799; 2-sided p<0.0001). These findings were published today in the Journal of Clinical Oncology, shared in an oral presentation at the 48th San Antonio Breast Cancer Symposium (SABCS), and highlighted in the SABCS official press program.

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In HER2CLIMB-05, the median progression-free survival (PFS) was 24.9 months (95% CI: 21.3-not reached) in the TUKYSA arm and 16.3 months (95% CI:12.6-18.7) in the placebo arm, representing an extension in median PFS of 8.6 months. A PFS benefit was observed across all prespecified patient subgroups, including de novo or recurrent diagnosis, hormone receptor (HR)-positive or HR-negative disease, and with or without the presence or history of brain metastases at baseline. The key secondary endpoint of overall survival was not mature at the time of the analysis (20% of the required events have occurred to date) but showed a numerical trend for improvement with TUKYSA.

"Most patients with HER2-positive metastatic breast cancer face disease progression within two years of starting first-line treatment, often requiring a transition to chemotherapy," said Erika Hamilton, M.D., principal investigator of HER2CLIMB-05 and Director of Breast Cancer Research for Sarah Cannon Research Institute (SCRI). "These results demonstrate that adding tucatinib to first-line maintenance therapy extends the time patients live without their disease progressing, while maintaining a manageable safety profile, suggesting a promising new potential approach that could advance the current standard of care for HER2-positive disease."

TUKYSA in combination with trastuzumab and pertuzumab demonstrated a safety profile generally consistent with the established safety profiles of each individual therapy, except for a higher rate of asymptomatic Grade ≥3 liver transaminases, which were typically manageable and reversible with TUKYSA dose modifications and/or discontinuations. The most common adverse events observed in the TUKYSA combination arm were diarrhea, hepatic events, and nausea.

"TUKYSA has become a trusted standard of care for patients with later-line HER2-positive metastatic breast cancer, and the results from HER2CLIMB-05 support its potential use as part of a chemotherapy-free, front-line maintenance strategy," said Jeff Legos, Chief Oncology Officer, Pfizer. "At Pfizer, we are committed to advancing treatment options that meaningfully improve the lives of people with metastatic breast cancer, and we are proud to share these promising results for patients and their families."

TUKYSA is not currently approved for first-line treatment. The results from HER2CLIMB-05 will be discussed with regulatory authorities. Since its initial approval in 2020, TUKYSA in combination with trastuzumab and capecitabine has become a standard of care for HER2+ MBC patients in the third-line setting. TUKYSA is currently approved in more than 50 countries; in the United States, TUKYSA is approved for use in combination with trastuzumab and capecitabine for adult patients with advanced unresectable or metastatic HER2+ breast cancer, including patients with brain metastases, who have received one or more prior anti-HER2-based regimens in the metastatic setting.

About HER2-Positive Metastatic Breast Cancer (MBC)
HER2 is overexpressed in up to 15-20% of breast cancers and is associated with poor prognosis, with an estimated five-year survival rate for HER2+ MBC of 41-47%, depending on HR status.1-3 First-line standard-of-care maintenance treatment has remained unchanged since 2012, and the majority of patients with HER2+ MBC face disease progression within two years of initiating therapy.4 Until recently, there have been limited advancements for these patients.

About the HER2CLIMB-05 Trial
HER2CLIMB-05 is a randomized, double blind, placebo-controlled, pivotal Phase 3 study evaluating the efficacy and safety of TUKYSA (tucatinib) compared to placebo, both in combination with trastuzumab and pertuzumab, as maintenance therapy for patients with HER2+ MBC following induction therapy in the first-line setting.

Trial participants who completed induction therapy of trastuzumab, pertuzumab, and a taxane, with no evidence of progression were randomized to receive TUKYSA in combination with trastuzumab plus pertuzumab (n=326), or placebo in combination with trastuzumab plus pertuzumab (n=328). The primary endpoint is progression-free survival (PFS) as assessed by the investigator. Key secondary endpoints include overall survival.

About TUKYSA (tucatinib)
TUKYSA (tucatinib) is an orally administered tyrosine kinase inhibitor of HER2. TUKYSA is approved in combination with trastuzumab and capecitabine to treat adults with HER2-positive advanced unresectable or metastatic breast cancer, including patients with brain metastases who have received one or more prior anti-HER2 breast cancer treatments in the metastatic setting.

The full U.S. Prescribing Information for TUKYSA can be found here.

IMPORTANT TUKYSA (tucatinib) SAFETY INFORMATION FROM THE U.S. PRESCRIBING INFORMATION

Warning and Precautions:

Diarrhea: TUKYSA can cause severe diarrhea including dehydration, hypotension, acute kidney injury, and death. If diarrhea occurs, administer antidiarrheal treatment as clinically indicated. Perform diagnostic tests as clinically indicated to exclude other causes of diarrhea. Based on the severity of the diarrhea, interrupt dose, then dose reduce or permanently discontinue TUKYSA.
In HER2CLIMB, 81% of patients who received TUKYSA experienced diarrhea, including 0.5% with Grade 4 diarrhea and 12% with Grade 3 diarrhea. The median time to onset of the first episode of diarrhea was 12 days and the median time to resolution was 8 days. Diarrhea led to dose reductions of TUKYSA in 6% of patients and discontinuation of TUKYSA in 1% of patients. Prophylactic use of antidiarrheal treatment was not required on HER2CLIMB.
Hepatotoxicity: TUKYSA can cause severe hepatotoxicity. Monitor ALT, AST, and bilirubin prior to starting TUKYSA, every 3 weeks during treatment, and as clinically indicated. Based on the severity of hepatotoxicity, interrupt dose, then dose reduce or permanently discontinue TUKYSA.
In HER2CLIMB, 8% of patients who received TUKYSA had an ALT increase > 5 × ULN, 6% had an AST increase > 5 × ULN, and 1.5% had a bilirubin increase > 3 × ULN (Grade ≥3). Hepatotoxicity led to dose reduction of TUKYSA in 8% of patients and discontinuation of TUKYSA in 1.5% of patients.
Embryo-fetal Toxicity: TUKYSA can cause fetal harm. 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 TUKYSA and for 1 week after the last dose.
Adverse Reactions:
In HER2CLIMB, serious adverse reactions occurred in 26% of patients who received TUKYSA. Serious adverse reactions in ≥ 2% of patients who received TUKYSA were diarrhea (4%), vomiting (2.5%), nausea (2%), abdominal pain (2%), and seizure (2%). Fatal adverse reactions occurred in 2% of patients who received TUKYSA including sudden death, sepsis, dehydration, and cardiogenic shock. Adverse reactions leading to treatment discontinuation occurred in 6% of patients who received TUKYSA. Adverse reactions leading to treatment discontinuation of TUKYSA in ≥1% of patients were hepatotoxicity (1.5%) and diarrhea (1%). Adverse reactions leading to dose reduction occurred in 21% of patients who received TUKYSA. Adverse reactions leading to dose reduction of TUKYSA in ≥2% of patients were hepatotoxicity (8%) and diarrhea (6%). The most common adverse reactions in patients who received TUKYSA (≥20%) were diarrhea, palmar-plantar erythrodysesthesia, nausea, hepatotoxicity, vomiting, stomatitis, decreased appetite, anemia, and rash.

Laboratory Abnormalities:
In HER2CLIMB, Grade ≥3 laboratory abnormalities reported in ≥5% of patients who received TUKYSA were decreased phosphate, increased ALT, decreased potassium, and increased AST. The mean increase in serum creatinine was 32% within the first 21 days of treatment with TUKYSA. The serum creatinine increases persisted throughout treatment and were reversible upon treatment completion. Consider alternative markers of renal function if persistent elevations in serum creatinine are observed.

(Press release, Pfizer, DEC 10, 2025, View Source [SID1234661363])