Neoadjuvant Imlunestrant Plus Abemaciclib Treatment Guided by Ki67 Index After 2 Weeks for ER-Positive HER2-Negative Breast Cancer: A Randomized Phase 2 Trial (IMPATIENS)

This is a prospective, open-label, single-center, randomized controlled Phase II clinical study aimed at evaluating the efficacy and safety of neoadjuvant imlunestrant combined with abemaciclib guided by the Ki67 index after 2 weeks in patients with ER+/HER2- breast cancer.

Start Date01 Jul 2026

Sponsor / Collaborator

Fudan University

NCT07428018

/ Not yet recruitingPhase 2IIT

The VIOLET Trial: A Pragmatic Phase II Study to Optimize Neoadjuvant Treatment and Surgical De-escalation in HR+/HER2- Early Breast Cancer Using Oncotype DX and Abemaciclib

This is a pragmatic phase 2 study to determine the proportion of patients with ER+ (≥10%)/HER2- EBC in whom neoadjuvant chemotherapy can be replaced by NET plus abemaciclib based on the results of the ODX RS obtained in the initial diagnostic biopsy and according to the MDT decision and to evaluate the proportion of patients undergoing breast conservative surgery and/or sentinel node biopsy

Start Date30 Apr 2026

Sponsor / Collaborator

Istituto di Ricerche Farmacologiche Mario Negri

[+2]

NCT07191717

/ Not yet recruitingPhase 2IIT

Phase II Minimal Residual Disease Study of Selective Estrogen Receptor Degrader Imlunestrant With Cyclin-Dependent Kinase (CDK) 4/6 Inhibitor Abemaciclib in Patients With ER+ Breast Cancer (MIRI)

This phase II trial studies how well imlunestrant and abemaciclib work in treating patients with estrogen receptor positive (ER+) breast cancer who have tumor remaining in the blood following treatment (minimal residual disease). Estrogen can cause the growth of breast cancer cells. Imlunestrant lowers the amount of estrogen made by the body. This may help stop the growth of tumor cells that need estrogen to grow. Abemaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Imlunestrant and abemaciclib may be effective in treating patients with ER+ breast cancer who have minimal residual disease.

Start Date30 Apr 2026

Sponsor / Collaborator

Jonsson Comprehensive Cancer Center

100 Clinical Results associated with Abemaciclib

100 Translational Medicine associated with Abemaciclib

100 Patents (Medical) associated with Abemaciclib

1,402

Literatures (Medical) associated with Abemaciclib

01 Apr 2026·BREAST

Effectiveness comparison of first-line CDK4/6 inhibitors in patients with hormone-positive HER2-negative advanced breast cancer according to tumor histology: a sub-analysis of the real-world, multicenter, Italian study PALMARES-2

Article

Author: Zurlo, Christian ; Chiappe, Edoardo ; Mariani, Luigi ; Sartori, Donata ; Pedersini, Rebecca ; Jacobs, Flavia ; Gennari, Alessandra ; De Angelis, Carmine ; Armani, Giovanna ; Criscitiello, Carmen ; Giordano, Monica ; Vernieri, Claudio ; Griguolo, Gaia ; Menichetti, Alice ; Sirico, Marianna ; Schianca, Ambra Carnevale ; Toss, Angela ; Rizzo, Gianpiero ; Ligorio, Francesca ; Marra, Antonio ; Capasso, Camilla ; Tagliaferri, Barbara ; Scagnoli, Simone ; Provenzano, Leonardo ; Guarneri, Valentina ; Curigliano, Giuseppe ; Dieci, Maria Vittoria ; Arpino, Grazia ; Faso, Valeria ; Piras, Marta ; Botticelli, Andrea ; Munzone, Elisabetta ; Generali, Daniele ; Fotia, Giuseppe ; La Verde, Nicla ; Pisegna, Simona ; Giuliano, Mario ; De Monte, Matteo ; Mazzoli, Giacomo ; Pruneri, Giancarlo ; Lambertini, Matteo ; Zambelli, Alberto

INTRODUCTION:

Invasive lobular breast cancer (ILC) is the second most common breast cancer subtype, with distinctive biological and epidemiologic features. Although phase III trials of cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) in hormone receptor-positive, HER2-negative advanced breast cancer (HR+/HER2-aBC) included patients with ILC, their real-world effectiveness in this population remains poorly characterized.

MATERIAL AND METHODS:

In this sub-analysis of the multicenter, real-world PALMARES-2 study (NCT06805812), we assessed the predictive and prognostic value of lobular histology in HR+/HER2-aBC treated with first-line endocrine therapy (ET) plus CDK4/6i. The primary endpoint was real-world progression-free survival (rwPFS). Associations between histology and outcomes were adjusted for 15 covariates using multivariable Cox-regression and inverse probability of treatment weighting.

RESULTS:

Among 1982 patients, 367 (18.5 %) had ILC and 1481 (74.7 %) non-special type (NST). Median follow-up was 29.8 and 31.2 months, respectively. ILC was associated with shorter rwPFS versus NST (adjusted hazard ratio [aHR]: 1.24, 95 %CI:1.04-1.47, P=0.017). Palbociclib efficacy was not affected by lobular histology (P for interaction = 0.553) while abemaciclib was less effective in ILC (P = 0.009). All three CDK4/6i achieved similar rwPFS in ILC (ribociclib vs palbociclib: aHR: 1.01, 95 %CI: 0.67-1.45, P = 0.949; abemaciclib vs palbociclib: aHR: 1.13, 95 %CI: 0.75-1.71, P = 0.551; abemaciclib vs ribociclib: aHR: 1.15, 95 %CI: 0.73-1.80, P = 0.549).

CONCLUSIONS:

Tumor histology affects the real-world effectiveness of first line ET plus CDK4/6i. In ILC, all three CDK4/6i performed similarly; therefore, treatment selection should prioritize tolerability, manageability, drug-drug interactions, and patient preferences.

01 Apr 2026·BREAST

Epigenetic and fragment-based profiling across CDK4/6 inhibitors in first-line HR+/HER2– metastatic breast cancer. An ancillary analysis of the MAGNETIC.1 study

Article

Author: Della Rossa, Serena ; Cudia, Giulia ; Bonotto, Marta ; Giudici, Fabiola ; Minisini, Alessandro Marco ; Da Ros, Lucia ; Noto, Claudia ; Pastò, Brenno ; Tessitori, Martina ; Bolzonello, Silvia ; Molteni, Elisabetta ; Puglisi, Fabio ; Foffano, Lorenzo ; Belletti, Barbara ; Scudeler, Elena ; Bortot, Lucia ; Gerratana, Lorenzo ; Damante, Giuseppe ; Franzoni, Alessandra ; Cucciniello, Linda

BACKGROUND:

CDK4/6 inhibitors (CDK4/6i) in combination with endocrine therapy (ET) represent the standard of care for hormone receptor-positive, HER2-negative (HR+/HER2-) metastatic breast cancer (MBC) patients. However, no head-to-head randomized trials have directly compared palbociclib, ribociclib, and abemaciclib. Moreover, predictive biomarkers of resistance to CDK4/6i remain largely undefined. This study aimed to evaluate circulating tumor DNA (ctDNA)-based epigenetic and fragmentomic biomarkers as potential predictors of response and resistance in patients receiving CDK4/6i.

METHODS:

We conducted a biomarker-driven analysis within the prospective, multicenter MAGNETIC.1 study, enrolling 149 patients with HR+/HER2- MBC treated with first-line endocrine therapy and a CDK4/6 inhibitor. Plasma samples were collected at baseline and during treatment (3 and 6 months). Droplet digital PCR was used to assess ESR1 promoter methylation and ACTB fragmentomic profiles. Progression-free survival (PFS) and overall survival (OS) were evaluated, and molecular dynamics were compared between treatment groups.

RESULTS:

After a median follow-up of 34.8 months, no statistically significant differences in PFS or OS were observed between ribociclib and palbociclib treated patients, although ribociclib was associated with numerically longer PFS and higher survival rates. At the molecular level, palbociclib treatment was characterized by transient increases in ESR1 promoter methylation at the first evaluation and a rebound in ACTB_short fragment levels at six months relative to baseline. These dynamic patterns were not observed among patients receiving ribociclib.

CONCLUSIONS:

ctDNA-based methylation and fragmentomic profiling revealed exploratory, treatment specific molecular dynamics, highlighting biological differences between CDK4/6 inhibitors. These findings support the feasibility of liquid biopsy-based biomarker studies in this setting, although their potential clinical relevance remains preliminary and requires validation in larger cohorts with earlier and more granular on-treatment timepoints.

01 Mar 2026·CLINICAL PHARMACOLOGY & THERAPEUTICS

Extent and Incidence of Pseudo‐Worsening of Kidney Function Due to Oral Antitumor Therapeutics in the AMBORA Cohort: An Analysis of Real‐World Data

Article

Author: Mackensen, Andreas ; Sponfeldner, Michael I. ; Dörje, Frank ; Dürr, Pauline ; Beckmann, Matthias W. ; Berking, Carola ; Gessner, Katja ; Wullich, Bernd ; Lensker, Phyllis ; Pavel, Marianne ; Neurath, Markus F. ; Fietkau, Rainer ; Cuba, Lisa ; Fromm, Martin F.

A considerable number of oral antitumor therapeutics (OAT) has the potential for causing pseudo‐worsening of kidney function (PW) due to inhibition of renal creatinine secretion, i.e., kidney function is unaffected, while creatinine‐based calculation of glomerular filtration rate (eGFR) erroneously indicates an impaired kidney function. Nonrecognition of PW can lead to dose reductions, interruptions, or discontinuations of OAT. The extent and incidence of PW has so far not been studied for a broad set of OAT in clinical routine. In this retrospective, multicenter cohort study, 694 AMBORA patients newly started on OAT were assessed for eligibility. eGFR values were compared between baseline and within 30 days of treatment. OAT were separated into the groups unlikely causing and likely causing/with proven PW. The usage of cystatin C measurements as an alternative method for assessing kidney function was evaluated. A total of 238 patients received 38 OAT likely causing PW/with proven PW. In this group, eGFR decreased significantly (−6.8 ml/min, p < 0.001). In 17.2% of these patients, eGFR decreased by ≥20 ml/min. Significant decreases in eGFR were observed for patients receiving, for example, abemaciclib, ribociclib, and osimertinib. Cystatin C measurements were not performed in 95.8% of the patients. In the group of 67 patients receiving OAT unlikely causing PW, there was no significant change in eGFR. In clinical routine, multiple OAT associated with PW are prescribed. A very low rate of usage of creatinine‐independent methods for assessing kidney function (cystatin C) indicates that further training of oncologists is required on OAT‐induced PW to further improve patient safety.

422

News (Medical) associated with Abemaciclib

11 Feb 2026

·www.biospace.com

Atossa Therapeutics Issues Letter to Shareholders Highlighting 2025 Accomplishments and 2026 Outlook

SEATTLE , Feb. 11, 2026 /PRNewswire/ -- Atossa Therapeutics, Inc. (Nasdaq: ATOS) ("Atossa" or the "Company"), a clinical-stage biopharmaceutical company developing novel therapies in oncology and other areas of high unmet need, today issued a letter to Shareholders from Steven Quay, M.D., Ph.D., Atossa Therapeutics President and Chief Executive Officer, providing an update on the Company's clinical programs and recent events. The full text of the letter follows: To our valued shareholders, In looking back on 2025, Atossa made meaningful progress advancing proprietary oral (Z)-endoxifen toward clear, value-creating regulatory and clinical milestones. Throughout the year, we refined our development strategy within oncology as well identifying areas of opportunity beyond oncology where (Z)-endoxifen can potentially address rare disease conditions with significant unmet need. Additionally, investments were made to continue to strengthen our intellectual property estate and deepen our leadership experience by adding key members to our leadership team that will drive regulatory and clinical progress and support future commercial readiness. ( Atossa Therapeutics Investors ) 2025: Building Momentum Around an Accelerated Regulatory Oncology Strategy Regulatory and Development Strategy - Clarity with the FDA A major strategic milestone in late 2025 was our completion of a Type C meeting with the U.S. Food and Drug Administration (FDA) (November 17, 2025) focused on regulatory strategy for advancing (Z)-endoxifen in the breast cancer setting. We received feedback on potential expedited pathways and development options spanning metastatic disease, neoadjuvant treatment, and risk-reduction settings, helping to clarify potential routes to accelerate development and regulatory review in oncology and non-oncology indications. ( Atossa Therapeutics Investors ) Advancements in Breast Cancer Neoadjuvant Therapy: I-SPY 2 Endocrine Optimization Pilot (EOP) Studies Atossa currently has several "I-SPY 2" studies underway investigating (Z)-endoxifen neoadjuvant activity as a monotherapy as well as (Z)-endoxifen as a combination therapy with two partner drugs: 1) abemaciclib (VERZENIO®), a cyclin-dependent kinase (CDK) 4/6 inhibitor marketed by Eli Lilly and Company; and 2) elagolix (ORILISSA®), a prescription medicine used to treat moderate to severe pain associated with endometriosis marketed by AbbVie, Inc. In the monotherapy arm of this trial, twenty women with newly diagnosed ER+/HER- breast cancer received daily 10 mg doses of (Z)-endoxifen for one month prior to surgery. Preliminary data indicate that (Z)-endoxifen was well tolerated and resulted in reductions in: Ki-67% (a general measure of tumor activity); functional tumor volume or FTV (as measured by MRI); and the longest diameter of the index lesions. Enrollment under the combination therapy arms of this trial involving (Z)-endoxifen with abemaciclib, and in some cases additional ovarian function suppression treatment, is nearly complete, and we expect data to be available during the second half of 2026. Enrollment in the remaining arms, involving (Z)-endoxifen in combination with elagolix and GnRH agonist, are near completion, with preliminary data expected in the second quarter of 2026, and extending into the second half of the year. Metastatic Breast Cancer Update During the fourth quarter of 2025, we submitted an IND application to the FDA, outlining a Phase 2 dosing study with Project Optimus design features, and subsequently received notice that our "Study May Proceed." However, after careful evaluation of the overall cost and timeline required to conduct Phase 2 and Phase 3 clinical trials in this indication, we have decided to pause our investment in (Z)-endoxifen for Metastatic Breast Cancer, allowing us to prioritize and focus our resources on other areas of oncology and other rare diseases with higher potential return on investments. Leveraging (Z)-Endoxifen Beyond Oncology In addition to the oncology focus for (Z)-endoxifen, 2025 also demonstrated the broader potential of (Z)-endoxifen as a therapeutic platform in additional serious diseases. The following indications underscore the growing scientific evidence supporting the role of estrogen signaling modulation in muscle preservation and inflammation and highlights the potential of (Z)-endoxifen beyond oncology. Duchenne Muscular Dystrophy (DMD) DMD is a serious, progressive, and fatal neuromuscular disease that primarily affects boys, leading to loss of muscle function, loss of ambulation, and life-threatening heart and respiratory complications. (Z)-Endoxifen's direct estrogen-receptor modulation, PKC inhibition, and effects on key signaling pathways could be relevant in addressing various pathologies associated with DMD, including inflammation, fibrosis, and cardiomyopathy. Through its potential ability to upregulate utrophin, (Z)-endoxifen can help stabilize muscle health, including muscle growth, repair, and fibrosis. FDA engagement commenced in Q4 2025. In December 2025 and early in 2026, Atossa received two FDA designations for (Z)-endoxifen for the treatment of DMD: 1) Rare Pediatric Disease Designation and 2) Orphan Drug Designation. These designations provide the Company with several potential strategic benefits, including incentives, such as a potential Priority Review Voucher (PRV) for future FDA applications, other regulatory support, and potential market exclusivity for a period of time. PRV's, which were recently reauthorized by legislation, could create significant value to the Company and could represent a meaningful non-dilutive value opportunity, either through use in another Atossa program or monetization through sale to another party. Women Carriers of DMD (Z)-Endoxifen has also shown potential relevance in symptomatic female Duchenne and Becker muscular dystrophy carriers, an under-recognized population in which a subset may experience skeletal-muscle symptoms or develop dilated cardiomyopathy in adult life. The work done in 2025, including our manuscript entitled, " (Z)-Endoxifen as a Modulator of Utrophin Pathways in Duchenne Muscular Dystrophy, " will continue to inform our hypotheses and clinical trial protocols in 2026. McCune-Albright Syndrome (MAS) MAS is a rare, non-inherited genetic disorder caused by a postzygotic GNAS mutation, affecting bones, skin, and the endocrine system, with symptoms typically appearing in early childhood. In young girls (as early as 2 years old), early onset puberty can occur (Precocious Puberty) which can have a very significant effect on quality of life, and limit growth. (Z)-Endoxifen could prove to be an effective hormone blocker significantly reducing the effects of precocious puberty until young girls reach a more typical age for the onset of puberty and related developmental changes. Collectively, we believe these non-oncology target milestones highlight the versatility of our proprietary molecule and demonstrate how Atossa can selectively pursue high-impact opportunities outside breast cancer, without diverting resources from our core clinical and regulatory priorities. 2025: Strengthening our Foundation Intellectual Property Expansion The (Z)-endoxifen intellectual property estate continues to be reinforced, as demonstrated by the issuance of a U.S. patent covering enteric oral formulations and methods of use, supporting the differentiated oral approach designed to preserve the active (Z)-isomer and enable consistent systemic exposure. ( Atossa Therapeutics Investors ) We are vigorously defending Atossa's intellectual property, which is subject of the ongoing U.S. Patent and Trademark Office (USPTO) proceedings with Intas Pharmaceuticals Ltd. This litigation seeks to invalidate certain patents owned by the Company related to the manufacturing processes for (Z)-endoxifen. The Company is pursuing multiple paths for resolution through the USPTO, as well as potential settlement terms that would be mutually acceptable to both parties. Future updates pertaining to this matter are anticipated in the first half of 2026. Team Strengthening for Execution and Commercial Readiness Execution is strategy. During 2025, we added experienced leaders to support regulatory execution and long-term commercial preparation—most notably: Janet R. Rea, MSPH, appointed SVP, R&D, to oversee late-stage (Z)-endoxifen programs with near-term priorities of advancing clinical development and defining pathways to commercialization. ( Atossa Therapeutics Investors ) Appointment of Mark Daniel, CPA as Chief Financial Officer to lead finance, systems, and capital strategy aligned to commercial readiness. ( Atossa Therapeutics Investors ) Recognition We were honored to receive the 2025 Clinical Trials Arena R&D Excellence Award in the Precision Endocrine Therapy category, reflecting growing awareness of the utility of (Z)-endoxifen across oncology and other indications, as well as external validation of our focus and progress. ( Atossa Therapeutics Investors ) Financial Discipline and Focus Throughout 2025, we emphasized efficiency, disciplined capital allocation, and operational focus. In our Q3 2025 update, we reiterated our intent to execute against planned regulatory submissions and advance our clinical programs toward key milestones, supported by a strong balance sheet and financial discipline. ( Atossa Therapeutics Investors ) We entered 2026 with more than $40 million in cash and cash equivalents, which we believe supports more than one year of working capital. Additionally, in late 2025, we initiated the process to affect a reverse stock split, which was effective on February 2, 2026. We believe this will allow us to regain compliance with Nasdaq listing requirements early in 2026. With this behind us, and a strong balance sheet, we plan to continue to execute the priorities of the Company with resources aligned to those activities with the highest return on investment to the Company. 2026 Outlook: Selective Expansion with Capital Discipline In 2026, our priorities are designed to convert strategic clarity into measurable progress: Regulatory Execution Building on FDA feedback received in 2025, we expect 2026 to include continued regulatory interactions to further clinically-related activities for accelerated development strategy, including drug combinations and opportunities beyond oncology where appropriate. ( Atossa Therapeutics Investors ) Oncology Priorities, Partnership-first Approach a) I-SPY 2: (Z)-Endoxifen Combination Therapy Partnering Opportunities We plan to complete enrollment in the combination therapy arms of the neo-adjuvant I-SPY 2 EOP in the first half of 2026, with preliminary data becoming available throughout the year as enrollment and treatment concludes. With this data, we plan to cultivate meaningful partnership opportunities for (Z)-endoxifen as a combination therapy with existing partners (Lilly and AbbVie) as well as potential new partner candidates. b) EVANGELINE: Complete Enrollment and Data Generation with the Mayo Clinic Enrollment in the EVANGELINE study will conclude by mid-year with preliminary data becoming available in late 2026. ( Atossa Therapeutics Investors ) Non-oncology Focused Priorities a) Evaluate funding and non-dilutive partnering opportunities related to non-oncology indications, including DMD, women carriers of DMD, MAS, and other exploratory programs, where appropriate. b) Advance strategic planning for DMD, including assessment of development pathways and clinical trial designs that leverage the Rare Pediatric Disease and Orphan Drug designations while minimizing upfront capital requirements. c) Preserve focus on capital efficiency, so that any expansion beyond oncology is aligned with shareholder value creation and does not detract from execution of our oncology programs. Ongoing IP Strengthening and Business Development Readiness We will continue investing in a durable IP foundation and the operational capabilities required to support late-stage development and, if supported by clinical data, future commercialization. ( Atossa Therapeutics Investors ) Closing Atossa enters 2026 with a clear regulatory roadmap, expanded clinical evidence in oncology and areas of significant unmet need in non-oncology, strengthened leadership, and a sharpened focus on the milestones that matter. Our mission remains straightforward: develop a differentiated, patient-centered endocrine therapy that can meaningfully improve outcomes across the breast cancer spectrum and other therapeutic areas with significant unmet need, and create sustainable value for shareholders along the way. ( Atossa Therapeutics Investors ) Thank you for your continued support. Sincerely, Steven Quay, M.D., Ph.D. President and Chief Executive Officer Atossa Therapeutics, Inc. About (Z)-Endoxifen (Z)-Endoxifen is a potent Selective Estrogen Receptor Modulator/Degrader (SERM/SERD) with demonstrated activity across multiple mechanisms of interest. Atossa is evaluating its potential applications in oncology and rare diseases. The Company's proprietary oral formulation has shown a favorable safety pro pharmacology distinct from tamoxifen, including ER-targeted effects and PKC inhibition. Atossa's (Z)-endoxifen is not approved for any indication. Atossa's (Z)-endoxifen program is supported by a growing global intellectual property portfolio, including multiple recently issued U.S. patents and numerous pending applications worldwide. About Atossa Therapeutics Atossa Therapeutics, Inc. (Nasdaq: ATOS) is a clinical-stage biopharmaceutical company developing innovative medicines in oncology and other areas of significant unmet need. The Company's lead product candidate, (Z)-endoxifen, is currently in development across several clinical settings. More information is available at . Forward-Looking Statements This press release contains certain "forward-looking statements" within the meaning of applicable securities laws, including but not limited to, our 2026 outlook and our expectations regarding the Company's development and regulatory strategy and related milestones, the potential indications that the Company may pursue for (Z)-endoxifen, the potential for (Z)-endoxifen to receive regulatory approval and the timing thereof, the expected design and enrollment of trials and timing of data and related publications, the Company's progress across its pipeline, the strength of the Company's patent portfolio, the Company's potential eligibility for the Rare Pediatric Disease Priority Review Voucher (PRV) program and the value of a future PRV, the Company's ability to successfully defend litigation and other similar complaints, the Company's ability to establish and maintain its intellectual property rights, and the potential market and growth opportunities for the Company. Words such as "expect," "potential," "continue," "may," "will," "should," "could," "would," "seek," "intend," "plan," "estimate," "anticipate," "believe," "design," "predict," "future," or other similar expressions or statements regarding intent, belief or current expectations, are forward-looking statements. Forward-looking statements in this press release are subject to risks and uncertainties that may cause actual results, outcomes, or the timing of actual results or outcomes to differ materially from those projected or anticipated, including, without limitation, risks and uncertainties associated with: our ability to successfully execute our strategy to shorten our clinical development timelines and pursue a DMD indication or other indications for our lead program, (Z)-endoxifen; expected timing, completion and results of our preclinical studies, clinical trials and research and development programs; the unpredictable relationship between preclinical study results and clinical study results; the timing or likelihood of regulatory filings and approvals; the outcome or timing of necessary regulatory approvals; our ability to receive orphan-drug exclusivity for (Z)-endoxifen for DMD; our ability to regain and maintain compliance with Nasdaq listing requirements; our ability to establish and maintain intellectual property rights covering our products; the impact of general macroeconomic conditions on our business; our ability to raise capital; and other risks and uncertainties detailed from time to time in Atossa's filings with the SEC, including, without limitation, its Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q. Forward-looking statements are presented as of the date of this press release. Except as required by law, we do not intend to update any forward-looking statements. View original content to download multimedia: SOURCE Atossa Therapeutics Inc

Phase 2Orphan Drug

04 Feb 2026

·www.fiercepharma.com

Even with pricing headwinds, Eli Lilly expects sales surge to continue in 2026

Eli Lilly acknowledged that it will be impacted significantly by pricing pressures in 2026 for its juggernaut tirzepatide products Mounjaro and Zepbound. But the company's momentum is such that it still expects revenues to reach between $80 billion and $83 billion, which would be a 25% increase at the midpoint on 2025 sales. After Novo Nordisk projected yesterday that its revenue could decline by as much as 13% in 2026, its share price has plummeted by 20%.Because the Danish company attributed much of the shortfall to pricing pressures, its rival in the diabetes and obesity market, Eli Lilly, also sustained a slide in its share price of 5% on Tuesday, as investors assumed the pricing effects would also apply to the Indianapolis company.Today, when Lilly presented its quarterly earnings, it acknowledged the negative pricing factors but also projected a significant increase in sales this year. The guidance, combined with its report of booming sales in the fourth quarter, prompted a 10% surge in Lilly’s shares, more than compensating for their decline the previous day.Such is the momentum of the world’s most valuable drugmaker, which three months ago became the first in industry history to achieve a market cap of $1 trillion.Lilly is projecting 2026 sales to come in at between $80 billion and $83 billion. The midpoint of the window represents a 25% increase on Lilly's 2025 sales of $65.2 billion. The 2026 projection sounds conservative, given that the company increased its sales by 45% last year.“We expect to deliver industry-leading volume growth, driven by our key products, partially offset by our lower realized prices,” Lucas Montarce, Lilly’s chief financial officer, explained on a conference call. “Price is expected to be a drag on growth in the low- to mid-teens.”Montarce specified three factors playing into Lilly’s price projections for its juggernaut metabolic products—diabetes treatment Mounjaro, obesity drug Zepbound and investigational weight-loss pill orforglipron, which is expected to reach the market in the first half of this year.One of the factors is Lilly’s agreement with the White House to sell Zepbound and orforglipron at cut-rate prices to U.S. patients. Another is the company’s direct-to-patient pricing plan for multi-dose pens of Zepbound. Additionally, Mounjaro’s inclusion on China’s national reimbursement drug list for type 2 diabetes will bring down prices, as well.One more factor Lilly cited is lower Medicaid pricing for later-lifecycle products, such as the psoriasis drug Taltz, the diabetes medicine Trulicity and the breast cancer treatment Verzenio.“We believe these price concessions will be more than offset by increased volume over time as we expand the number of people who can benefit from Lilly medicines,” Montarce said.In a note to investors, Cantor Fitzgerald analyst Carter Gould said Lilly "delivered the standout print" of the fourth quarter, "easily bettering Street estimates with broad geographic strength across the tirzepatide franchise, and an assertive ’26 guide that should counter critics."Gould added that Lilly's report "stands in stark contrast" to the market "optics" presented by Novo."The high-end, the low-end, the narrower guide—all of it—express a far more confident view of the market than most of the Street were anticipating," Gould added. Sales of Lilly’s tirzepatide products continued to scale up remarkably in the fourth quarter of 2025, smashing analyst expectations. Mounjaro generated $7.4 billion in the period, which was up 110% year over year and an increase sequentially from $6.5 billion. Analyst consensus had pegged Q4 sales of Mounjaro at $6.7 billion. Additionally, Mounjaro chalked up sales outside of the U.S. of $3.3 billion.Meanwhile, Zepbound raked in $4.3 billion in the quarter, which was up 123% year over year and an increase from $3.6 billion in the third quarter. The Q4 figure exceeded the analyst estimate of $3.8 billion.For 2025 overall, combined sales of Mounjaro and Zepbound reached $36.5 billion, which accounted for 56% of Lilly’s revenue and made tirzepatide the world’s best-selling drug. The tirzepatide duo outpaced Novo’s semaglutide treatments Ozempic and Wegovy, which generated combined sales of $33 billion, and Merck’s cancer therapy Keytruda, which pulled in sales of $31.7 billion. As for how the potential approval of orforglipron will affect the overall sales of Lilly's cardiometabolic treatments, CEO David Ricks called it a “bit of a wild card in our short- and mid-term outlook.”“I am hard pressed to think of an analog where you have this many people paying out of pocket for a prescription medication,” Ricks added.

Biosimilar

04 Feb 2026

·www.prnewswire.com

Lilly reports fourth-quarter 2025 financial results and provides 2026 guidance

Revenue in Q4 2025 increased 43% to $19.3 billion driven by volume growth from Mounjaro and Zepbound. Q4 2025 EPS increased by 51% to $7.39 on a reported basis and increased by 42% to $7.54 on a non-GAAP basis, both inclusive of $0.52 of acquired IPR&D charges. Regulatory progress included FDA approval of Kwikpen for tirzepatide and an expanded indication for Jaypirca, and submissions for orforglipron for obesity to regulatory authorities in the U.S. and Japan and for obesity and type 2 diabetes in the EU. Pipeline progress included positive Phase 3 results from Taltz and Zepbound used together for adults with active psoriatic arthritis and obesity, orforglipron for people who switched from injectable incretins to oral GLP-1 therapy, and retatrutide for people with obesity and knee osteoarthritis. Announced an agreement with the U.S. government to expand access to obesity medicines for millions of Americans. 2026 guidance issued with revenue in the range of $80 billion to $83 billion and non-GAAP EPS in the range of $33.50 to $35.00. INDIANAPOLIS, Feb. 4, 2026 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced its financial results for the fourth-quarter of 2025 and provided 2026 financial guidance. "2025 was an important year for Lilly," said David A. Ricks, Lilly's chair and CEO. "We reached millions more patients—launching Inluriyo, expanding Mounjaro and Kisunla globally, and submitting orforglipron for approval. We expanded our manufacturing capacity, and through our U.S. government agreement, opened new access to obesity medicines. Entering our 150th year with a deep pipeline and platforms like LillyDirect, we're positioned to reach more patients than ever and expand our global health impact." Financial Results A discussion of the non-GAAP financial measures is included below under "Reconciliation of GAAP Reported to Selected Non-GAAP Adjusted Information (Unaudited)." Fourth-Quarter Reported Results In Q4 2025, worldwide revenue was $19.3 billion, an increase of 43% compared with Q4 2024, driven by a 46% increase in volume, partially offset by a 5% decrease due to lower realized prices. Key Products[1] revenue grew to $13.8 billion in Q4 2025, led by Mounjaro and Zepbound. Revenue in the U.S. increased 43% to $12.9 billion, driven by a 50% increase in volume, partially offset by a 7% decrease due to lower realized prices. The increase in U.S. volume and decline in realized prices were driven by Zepbound and Mounjaro. Revenue outside the U.S. increased 43% to $6.4 billion, driven by a 38% increase in volume and to a lesser extent a 4% favorable impact on foreign exchange rates. The volume increase outside the U.S. was driven primarily by Mounjaro, partially offset by Jardiance. Volume growth was negatively impacted by a one-time benefit of $300 million related to Jardiance, associated with an amendment to the company's collaboration with Boehringer Ingelheim, in Q4 2024. Gross margin increased 43% to $15.9 billion in Q4 2025. Gross margin as a percent of revenue was 82.5%, an increase of 0.3 percentage points. The increase in gross margin percent was primarily driven by favorable product mix and improved cost of production, partially offset by lower realized prices. In Q4 2025, research and development expenses increased 26% to $3.8 billion, or 20% of revenue, driven by continued investments in the company's early and late-stage portfolio. Marketing, selling and administrative expenses increased 29% to $3.1 billion in Q4 2025, primarily driven by promotional efforts supporting ongoing and planned launches. The effective tax rate was 19.7% in Q4 2025 compared with 12.5% in Q4 2024 primarily driven by a less favorable jurisdictional mix of earnings in Q4 2025 relative to Q4 2024. Additionally, the effective tax rate for Q4 2025 was unfavorably impacted by U.S. tax law changes enacted earlier in 2025. In Q4 2025, net income and earnings per share (EPS) were $6.6 billion and $7.39, respectively, compared with net income of $4.4 billion and EPS of $4.88 in Q4 2024. EPS in Q4 2025 and Q4 2024 included acquired IPR&D charges of $0.52 and $0.19, respectively. Fourth-Quarter Non-GAAP Measures On a non-GAAP basis, Q4 2025 gross margin increased 42% to $16.0 billion. Gross margin as a percent of revenue was 83.2%, consistent with Q4 2024. Favorable product mix and improved cost of production were offset by lower realized prices. The non-GAAP effective tax rate was 19.7% in Q4 2025 compared with 13.2% in Q4 2024 primarily driven by a less favorable jurisdictional mix of earnings in Q4 2025 relative to Q4 2024. Additionally, the effective tax rate for Q4 2025 was unfavorably impacted by U.S. tax law changes enacted earlier in 2025. On a non-GAAP basis, Q4 2025 net income and EPS were $6.8 billion and $7.54, respectively, compared with net income of $4.8 billion and EPS of $5.32 in Q4 2024. Non-GAAP EPS in Q4 2025 and Q4 2024 included acquired IPR&D charges of $0.52 and $0.19, respectively. For further detail on non-GAAP measures, see the reconciliation below as well as the "Reconciliation of GAAP Reported to Selected Non-GAAP Adjusted Information (Unaudited)" table later in this press release. Selected Revenue Highlights Mounjaro For Q4 2025, worldwide Mounjaro revenue increased 110% to $7.4 billion. U.S. revenue was $4.1 billion, an increase of 57%, reflecting strong demand, partially offset by lower realized prices. Revenue outside the U.S. increased to $3.3 billion compared with $899 million in Q4 2024, primarily driven by volume growth. Zepbound For Q4 2025, U.S. Zepbound revenue increased 122% to $4.2 billion, compared with $1.9 billion in Q4 2024, primarily driven by increased demand, partially offset by lower realized prices. Verzenio For Q4 2025, worldwide Verzenio revenue increased 3% to $1.6 billion. U.S. revenue was $997 million, a decrease of 4%. Revenue outside the U.S. was $608 million, an increase of 18%, primarily driven by volume growth. Lilly shared numerous updates recently on key regulatory, clinical, business development and other events, including: For information on important public announcements, visit the news section of Lilly's website. 2026 Financial Guidance In addition to providing guidance for GAAP revenue, Lilly provides guidance for certain non-GAAP measures. Lilly does not provide reconciliations of forward-looking non-GAAP measures to the most directly comparable GAAP measures because comparable GAAP measures are not reasonably accessible or reliable due to the inherent difficulty in forecasting and quantifying measures that would be necessary for a reconciliation. In particular, Lilly cannot reasonably predict certain items including net gains and losses on equity securities, asset impairment, acquisition or divestiture-related items, restructuring and other adjustments, without unreasonable effort. These items are uncertain, depend on various factors, and could have a material impact on Lilly's reported results in accordance with GAAP. The following table summarizes the company's full-year 2026 financial guidance: Webcast of Conference Call As previously announced, investors and the general public can access a live webcast of the Q4 2025 financial results conference call through a link on Lilly's website at investor.lilly.com/webcasts-and-presentations. The conference call will begin at 10 a.m. Eastern time today and will be available for replay via the website. Non-GAAP Financial Measures Certain financial information is presented on both a reported and a non-GAAP basis. Some numbers in this press release may not add due to rounding. Reported results were prepared in accordance with U.S. generally accepted accounting principles (GAAP) and include all revenue and expenses recognized during the periods. Historical non-GAAP measures reflect adjustments for the items described in the reconciliation tables later in the release. Related materials provide certain GAAP and non-GAAP figures excluding the impact of foreign exchange rates. Lilly recalculates current period figures on a constant currency basis by keeping constant the exchange rates from the base period. The company's 2026 financial guidance (other than revenue) is provided on a non-GAAP basis, as described in "2026 Financial Guidance" above. Non-GAAP measures are presented to provide additional insights into the underlying trends in the company's business. About Lilly Lilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for nearly 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit Lilly.com and Lilly.com/news. F-LLY Cautionary Statement Regarding Forward-Looking Statements This press release and the related attachments contain management's intentions and expectations for the future, all of which 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. The words "estimate", "project", "intend", "expect", "believe", "target", "plan", "anticipate", "may", "could", "aim", "seek", "will", "continue", and similar expressions are intended to identify forward-looking statements. Actual results may differ materially due to various factors. The following include some but not all of the factors that could cause actual results or events to differ from those anticipated, including the significant costs and uncertainties in the pharmaceutical research and development process, including with respect to the timing and process of obtaining regulatory approvals and the ability of the company's clinical trials to meet expectations; the impact and uncertain outcome of acquisitions and business development transactions and related costs; intense competition affecting the company's products, pipeline, or industry; market uptake of launched products and indications; continued pricing pressures and the impact of actions of governmental and private actors affecting pricing of, reimbursement for, and patient access to pharmaceuticals, or reporting obligations related thereto; the negotiation and implementation of our voluntary agreement with the U.S. government related to drug pricing and access; Developments or uncertainties related to our or competitive products, including as may relate to safety or efficacy concerns; dependence on relatively few products or product classes for a significant percentage of the company's total revenue and a consolidated supply chain; the expiration of intellectual property protection for certain of the company's products and competition from generic and biosimilar products; the company's ability to protect and enforce patents and other intellectual property and changes in patent law or regulations related to data package exclusivity; information technology system inadequacies, inadequate controls or procedures, security breaches, or operating failures; unauthorized access, disclosure, misappropriation, or compromise of confidential information or other data stored in the company's information technology systems, networks, and facilities, or those of third parties with whom the company shares its data and violations of data protection laws or regulations; issues with product supply, regulatory approvals, or other negative outcomes stemming from manufacturing difficulties, disruptions, or shortages, including as a result of unpredictability and variability in demand, labor shortages, third-party performance, quality, cyber-attacks, or regulatory actions related to the company's and third-party facilities; reliance on third-party relationships and outsourcing arrangements; the use of artificial intelligence or other emerging technologies in various facets of the company's operations, including partnerships related to the use of, or the sharing of such technologies with third parties, which may exacerbate competitive, regulatory, litigation, cybersecurity, and other risks; the impact of global macroeconomic conditions, including uneven economic growth or downturns or uncertainty, trade and other global disputes and interruptions, including related to tariffs, trade protection measures, and similar restrictions, international tension, conflicts, regional dependencies, or other costs, uncertainties, and risks related to engaging in business globally; fluctuations in foreign currency exchange rates, changes in interest rates and inflation or deflation; significant and sudden declines or volatility in the trading price of the company's common stock and market capitalization; litigation, investigations, or other similar proceedings involving past, current, or future products, activities, or intellectual property; changes in tax law and regulations, tax rates, or events that differ from our assumptions related to tax positions; regulatory changes, developments, and uncertainty; regulatory oversight and actions regarding the company's operations and products; regulatory compliance problems or government investigations; risks from the proliferation of counterfeit, misbranded, adulterated, diverted or illegally compounded products; actual or perceived deviation from environmental-, social-, or governance-related requirements or expectations; asset impairments and restructuring charges; and changes in accounting and reporting standards. For additional information about the factors that could cause actual results or events to differ materially from forward-looking statements, please see the company's latest Form 10-K and subsequent Forms 8-K and 10-Q filed with the Securities and Exchange Commission. You should not place undue reliance on forward-looking statements contained in this press release and the related attachments, which, except as otherwise noted, speak only as of the date of this release. Except as is required by law, the company expressly disclaims any obligation to publicly release any revisions to forward-looking statements contained in this press release and the related attachments to reflect events or circumstances after the date of this release. Website Information The information contained on, or that may be accessed through, our website or any third-party website is not incorporated by reference into, and is not a part of, this earnings release. Trademarks and Trade Names All trademarks or trade names referred to in this press release are the property of the company, or, to the extent trademarks or trade names belonging to other companies are referenced in this press release, the property of their respective owners. Solely for convenience, the trademarks and trade names in this press release are referred to without the ® and ™ symbols, but such references should not be construed as any indicator that the company or, to the extent applicable, their respective owners will not assert, to the fullest extent under applicable law, the company's or their rights thereto. We do not intend the use or display of other companies' trademarks and trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies. SOURCE Eli Lilly and Company 21% more press release views with Request a Demo

Financial StatementClinical ResultPhase 3Drug Approval

100 Deals associated with Abemaciclib

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KEGG	Wiki	ATC	Drug Bank
D10688	Abemaciclib	L01XE50	DB12001

R&D Status

Approved

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Indication	Country/Location	Organization	Date
Advanced breast cancer	Canada	Eli Lilly Canada, Inc.	08 Apr 2019
Metastatic breast cancer	Canada	Eli Lilly Canada, Inc.	08 Apr 2019
HR Positive/HER2 Negative/Node positive breast cancer	European Union	Eli Lilly Nederland BV	26 Sep 2018
HR Positive/HER2 Negative/Node positive breast cancer	Iceland	Eli Lilly Nederland BV	26 Sep 2018
HR Positive/HER2 Negative/Node positive breast cancer	Liechtenstein	Eli Lilly Nederland BV	26 Sep 2018
HR Positive/HER2 Negative/Node positive breast cancer	Norway	Eli Lilly Nederland BV	26 Sep 2018
Hormone receptor positive HER2 negative breast cancer	United States	Eli Lilly & Co.	28 Sep 2017

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Locally advanced breast cancer	Phase 3	United States	Sermonix Pharmaceuticals LLC	20 Feb 2024
Locally advanced breast cancer	Phase 3	China	Sermonix Pharmaceuticals LLC	20 Feb 2024
Locally advanced breast cancer	Phase 3	Australia	Sermonix Pharmaceuticals LLC	20 Feb 2024
Locally advanced breast cancer	Phase 3	Belgium	Sermonix Pharmaceuticals LLC	20 Feb 2024
Locally advanced breast cancer	Phase 3	Canada	Sermonix Pharmaceuticals LLC	20 Feb 2024
Locally advanced breast cancer	Phase 3	France	Sermonix Pharmaceuticals LLC	20 Feb 2024
Locally advanced breast cancer	Phase 3	Germany	Sermonix Pharmaceuticals LLC	20 Feb 2024
Locally advanced breast cancer	Phase 3	Hungary	Sermonix Pharmaceuticals LLC	20 Feb 2024
Locally advanced breast cancer	Phase 3	Israel	Sermonix Pharmaceuticals LLC	20 Feb 2024
Locally advanced breast cancer	Phase 3	Italy	Sermonix Pharmaceuticals LLC	20 Feb 2024

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


SABCS2025	Not Applicable	HR Positive/HER2 Negative/Node positive breast cancer Adjuvant HR+ \| HER2-	1,063	Abemaciclib 150 mg BID	hvyinktacs(pdozahhueb) = neuslfwqcb haodgqwttc (wbhyjyguhq ) View more	Positive	12 Dec 2025
				Abemaciclib 150 mg BID (No Dose reductions)	hvyinktacs(pdozahhueb) = skjqidowuc haodgqwttc (wbhyjyguhq ) View more
SABCS2025	Not Applicable	Hormone receptor positive HER2 negative breast cancer HR+/HER2−	199	Abemaciclib + Fulvestrant or Aromatase Inhibitor (Endocrine resistant (ER))	yotywmxofn(unvtqheavv) = awfqjdwwwo luyspzzxtz (jhungsfxqs ) View more	Positive	12 Dec 2025
				Abemaciclib + Fulvestrant or Aromatase Inhibitor (Endocrine-sensitive (ES))	yotywmxofn(unvtqheavv) = vioukfzdxm luyspzzxtz (jhungsfxqs ) View more
SABCS2025	Not Applicable	Male Breast Neoplasms Adjuvant HR+ \| HER2-	13	Abemaciclib	sdjsfjqpal(etmkafpyvm) = qfluvjaooh rhuaoetwfd (vuardrzruo ) View more	Positive	11 Dec 2025
EMBER-3 (SABCS2025)	Phase 3	ER-positive/HER2-negative Breast Cancer ESR1 mutations	635	Imlunestrant	wftvunquyq(xhhymdojop) = iupsgsqgem pauwpraboo (gwqullwmve ) View more	Positive	11 Dec 2025
				Standard Endocrine Therapy (SOC ET)	wftvunquyq(cgcrwopnrc) = xqhcemdsav hduwgtnohp (wcrbdelvzq )
NCT04158362 (AMBRE, SABCS2025)	Phase 3	First line HR+ \| HER2-	180	Abemaciclib + ET (letrozole or fulvestrant ± OFS)	dhmgxwlwwd(gwnamhawsy) = yvbvtkfmbh iszpoomiqb (cjtrzxkexn ) View more	Positive	11 Dec 2025
				CT (weekly paclitaxel or capecitabine)	dhmgxwlwwd(gwnamhawsy) = rvxrgjnsuj iszpoomiqb (cjtrzxkexn )
SABCS2025	Not Applicable	Hormone receptor positive HER2 negative breast cancer Adjuvant	714	Abemaciclib combined with an aromatase inhibitor	xydgroagmx(grnprzrcnq) = sddwopoosp jgaobwuxqe (ctlysittui ) View more	Positive	11 Dec 2025
SABCS2025	Not Applicable	Hormone receptor positive HER2 negative breast cancer	136	Abemaciclib	usvozhbygk(aesmqavgtw) = dwaitknqvq yfkmaphzrk (qjsjymyvbt ) View more	Positive	10 Dec 2025
				Ribociclib	trsfabuzxr(qobstsxsmf) = wzqbtmtyzq udqnnkvyis (alicfncjqe )
SABCS2025	Not Applicable	Hormone receptor positive HER2 negative breast cancer Neoadjuvant HR+ \| HER2-	70	ET + CDK4/6 inhibitor	kfgzmjmelx(aieiaprqpu) = scbonasfuc ywrgucoahf (igppabhudr ) View more	Positive	10 Dec 2025
				Chemotherapy followed by ET + CDK4/6 inhibitor	kfgzmjmelx(aieiaprqpu) = ccjolkuvik ywrgucoahf (igppabhudr ) View more
SABCS2025	Not Applicable	Early Stage Breast Carcinoma Adjuvant	146	Abemaciclib combined with endocrine therapy (Obese (≥30))	rypoezksck(xoynfgosib) = jhuxltvggk fgghmuasjt (ppjxiqvtrn ) View more	Positive	10 Dec 2025
				Abemaciclib combined with endocrine therapy (Non-Overweight (<25))	rypoezksck(xoynfgosib) = tdypglyufl fgghmuasjt (ppjxiqvtrn ) View more
CONCISE (SABCS2025)	Not Applicable	Early Stage Breast Carcinoma Adjuvant	215	Abemaciclib + Endocrine Therapy	iosyctpyrk(kosxwkfrvw) = izywvpcyog hlyvngcioq (xttlkzueaz ) View more	Positive	10 Dec 2025
				Abemaciclib + Endocrine Therapy	iosyctpyrk(kosxwkfrvw) = qbijotncjv hlyvngcioq (xttlkzueaz ) View more

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