Certara Simcyp® Simulator Results Replace Ten Human Trials for Chronic Myeloid Leukemia (CML) Therapy asciminib

Rhea-AI Summary

Certara (Nasdaq: CERT) said its Simcyp Simulator PBPK modeling was accepted by the U.S. FDA in lieu of clinical studies to support the NDA for asciminib (Scemblix) for chronic myeloid leukemia. The modeling reportedly replaced at least ten dedicated clinical pharmacology studies and characterized asciminib pharmacokinetics across healthy volunteers and cancer patients.

The simulations bridged tested and untested scenarios, assessed drug–drug interactions, and supported dosing-regimen evaluation, reflecting a decade-long modeling effort and regulatory acceptance that reduced clinical study needs and development time.

Positive

• U.S. FDA accepted PBPK modeling for asciminib NDA
• Replaced at least ten clinical pharmacology studies
• Characterized asciminib pharmacokinetics across patient groups
• Modeled drug–drug interactions and multiple dosing regimens
• Decade-long modeling effort informed optimal dosing regimen

Negative

• None.

News Market Reaction – CERT

+2.70%

1 alert

+2.70% News Effect

On the day this news was published, CERT gained 2.70%, reflecting a moderate positive market reaction.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

CML incidence: one case in 100,000 population Leukemia share: approximately 15% Trials replaced: at least ten clinical pharmacology studies

3 metrics

CML incidence one case in 100,000 population Global incidence rate of Chronic Myeloid Leukemia in 2018

Leukemia share approximately 15% Share of newly diagnosed adult leukemia cases accounted for by CML

Trials replaced at least ten clinical pharmacology studies PBPK modeling with Simcyp used instead of dedicated human trials in NDA

Market Reality Check

Price: $6.33 Vol: Volume 4047651 vs 20-day ...

normal vol

$6.33 Last Close

Volume Volume 4047651 vs 20-day avg 3421204 (relative volume 1.18x) ahead of this news. normal

Technical Price at 7.05 was trading below the 200-day MA of 10.26, and 54.16% below the 52-week high.

Peers on Argus

Before this announcement, CERT was down 0.42% over 24h while several software/he...

1 Down

Before this announcement, CERT was down 0.42% over 24h while several software/health peers (OMCL, TXG, PHR, TDOC, GDRX) showed mixed moves, including GDRX up . Only TXG appeared in the momentum scanner, moving down 5.49% without news, suggesting CERT’s setup looked stock-specific rather than a broad sector rotation.

Historical Context

5 past events · Latest: Feb 27 (Neutral)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Feb 27	Investor conferences	Neutral	+4.1%	Management scheduled to speak at three healthcare investor conferences in early March.
Feb 26	Earnings & guidance	Neutral	+3.2%	Reported FY2025 growth with mixed Q4 metrics and cautious 2026 revenue and margin guidance.
Jan 29	Earnings date set	Neutral	-1.5%	Announced timing and webcast details for upcoming Q4 and full-year 2025 earnings release.
Dec 11	CEO transition	Neutral	-5.1%	Named Jon Resnick as next CEO effective Jan 1, 2026, with outgoing CEO staying on as advisor.
Nov 06	Earnings & guidance	Positive	-23.1%	Delivered Q3 2025 revenue growth, higher software sales and raised full-year 2025 guidance.

Pattern Detected

Recent earnings and conference headlines often saw sizeable price moves, with at least one clear case where strong earnings and raised guidance coincided with a sharp selloff, indicating a tendency for occasional negative reactions to fundamentally positive updates.

Recent Company History

Over the last six months, Certara has reported steady growth and active investor engagement. Q3 and Q4 2025 earnings showed revenue expansion and solid adjusted EBITDA, though guidance for 2026 was cautious. A major CEO transition to Jon Resnick was announced and later formalized, alongside continued participation in investor conferences. One notably positive earnings report in Nov 2025 with raised guidance drew a steep negative price reaction, highlighting that market expectations and positioning have at times overshadowed operational progress. Today’s FDA-related validation of its biosimulation capabilities fits the theme of regulatory and scientific credibility.

Market Pulse Summary

This announcement highlights the FDA’s acceptance of Certara’s Simcyp PBPK simulations in lieu of at...

Analysis

This announcement highlights the FDA’s acceptance of Certara’s Simcyp PBPK simulations in lieu of at least ten human clinical pharmacology studies for asciminib’s NDA, reinforcing the role of model-informed approaches in drug development. It underscores growing regulatory comfort with biosimulation and the practical benefits of time and cost savings. In context of prior earnings and leadership changes, investors may watch for how such high-profile case studies translate into software adoption, bookings and longer-term revenue growth.

Key Terms

physiologically-based pharmacokinetic (PBPK) modeling, PBPK modeling, new drug application (NDA), Chronic Myeloid Leukemia (CML), +4 more

8 terms

physiologically-based pharmacokinetic (PBPK) modeling medical

"Simcyp® Simulator enabled physiologically-based pharmacokinetic (PBPK) modeling predictions accepted"

Physiologically-based pharmacokinetic (PBPK) modeling is a computer simulation that uses biological and physical data to predict how a drug is absorbed, distributed, metabolized and eliminated in the body — like mapping traffic through a city by accounting for roads, speeds and bottlenecks. Investors care because PBPK can lower uncertainty about safe doses, drug interactions and likely trial outcomes, helping estimate development costs, timelines and the odds of regulatory approval.

PBPK modeling medical

"PBPK modeling uses virtual biological systems to predict how drugs are absorbed"

Physiologically based pharmacokinetic (PBPK) modeling is a computer simulation that predicts how a drug moves through the body by combining anatomy, blood flow and simple chemical behavior into a virtual human or animal. For investors, it matters because these simulations help developers estimate safe doses, anticipate drug interactions and reduce the need for some early human tests, lowering time, cost and regulatory risk before large clinical trials or market launch.

new drug application (NDA) regulatory

"studies to support the new drug application (NDA) for asciminib (Scemblix®)"

A new drug application (NDA) is a formal request submitted to regulatory authorities to gain approval for a new medication to be sold and used by the public. It is a comprehensive review process that examines the drug’s safety, effectiveness, and manufacturing quality. For investors, an NDA approval can signal a potential breakthrough product and influence a company's stock value.

Chronic Myeloid Leukemia (CML) medical

"used to treat patients with Chronic Myeloid Leukemia (CML). The global incidence rate"

Chronic myeloid leukemia (CML) is a type of blood cancer in which bone marrow cells produce an overabundance of immature white blood cells, often driven by a specific genetic change. It progresses more slowly than some cancers but can become serious without treatment. Investors watch CML closely because new drugs, trial results, approvals or long-term treatment costs can significantly affect pharmaceutical revenues and healthcare spending — think of it like a factory that begins making too many defective parts and needs a costly retooling.

allosteric inhibitor medical

"Asciminib is the first-in-class allosteric inhibitor that specifically binds the BCR::ABL1"

An allosteric inhibitor is a molecule, often a drug, that attaches to a spot on a protein away from its main active site and changes the protein’s shape so it works less effectively or stops working. For investors, these compounds matter because they can offer greater selectivity and fewer side effects than drugs that block the active site directly, potentially improving clinical success, reducing safety risks, and extending the commercial value of a therapy.

BCR::ABL1 medical

"allosteric inhibitor that specifically binds the BCR::ABL1 myristoyl pocket used to treat"

A BCR::ABL1 fusion is a genetic abnormality where parts of two genes join to create a single hybrid gene that makes an abnormal protein driving uncontrolled growth in certain blood cancers. Investors care because this specific, identifiable target determines which drugs and diagnostic tests will work, influencing clinical trial success, drug sales and diagnostic revenue — like finding a particular lock that a new key (therapy) is built to fit.

drug-drug interactions medical

"Given its potential for drug-drug interactions and the need to evaluate multiple dosing"

When two or more medicines are taken together and one changes how the other works, that is a drug-drug interaction. For investors this matters because such interactions can reduce a drug’s effectiveness or increase side effects, potentially leading to additional testing, label warnings, limits on use, or lost sales—similar to how combining ingredients can ruin a recipe or make it unsafe, altering the product’s value and market prospects.

pharmacokinetics medical

"assessment of asciminib’s pharmacokinetics across diverse patient populations, dosing regimens"

Pharmacokinetics is the study of how a substance, such as a drug or chemical, moves through and is processed by the body over time. It tracks how it is absorbed, distributed, broken down, and eventually eliminated. For investors, understanding pharmacokinetics helps gauge the effectiveness, safety, and potential risks of new medications or treatments, which can influence a company’s success and valuation in the healthcare industry.

AI-generated analysis. Not financial advice.

Biosimulation results highlight how model-informed approaches for drug development and regulatory decision-making save time and money. 

RADNOR, Pa., March 03, 2026 (GLOBE NEWSWIRE) -- Certara, Inc. (Nasdaq: CERT), a global leader in model-informed drug development, today announced its Simcyp^® Simulator enabled physiologically-based pharmacokinetic (PBPK) modeling predictions accepted by the U.S. FDA in lieu of clinical studies to support the new drug application (NDA) for asciminib (Scemblix^®). PBPK modeling uses virtual biological systems to predict how drugs are absorbed, distributed, metabolized, and eliminated by the body, and is increasingly being applied in place of certain clinical studies where appropriate. The results published in “Physiologically Based Pharmacokinetic Modeling and Simulations in Lieu of Clinical Pharmacology Studies to Support the New Drug Application of Asciminib” (Loisios-Konstantinidis et al.), highlight the growing impact and business benefits of model-informed drug development approaches for regulatory decision-making.

Asciminib is the first-in-class allosteric inhibitor that specifically binds the BCR::ABL1 myristoyl pocket used to treat patients with Chronic Myeloid Leukemia (CML). The global incidence rate of CML was close to one case in 100,000 population in 2018,¹ and it accounts for approximately 15% of newly diagnosed cases of leukemia in adults. Given its potential for drug-drug interactions and the need to evaluate multiple dosing regimens, PBPK modeling with the Simcyp Simulator enabled a mechanistic assessment of asciminib’s pharmacokinetics across diverse patient populations, dosing regimens and clinical scenarios. These simulations provided evidence that complemented and, in some cases, replaced clinical pharmacology studies in the NDA.

“As a member of the Simcyp Consortium, we have firsthand experience with Simcyp’s capabilities and value its leading scientific rigor essential for enabling regulatory acceptance of PBPK models,” said Ioannis Loisios-Konstantinidis, Senior Principal Scientist, PK Sciences, Novartis Biomedical Research.

Key results from the PBPK modeling included:

• Bridging between clinically tested and untested scenarios
• Replacement of at least ten dedicated clinical pharmacology studies
• Accurate characterization of asciminib pharmacokinetics across healthy volunteers and cancer patients
• Predicting how medicines work in real-life patients taking other medications

“This collaboration exemplifies the scientific partnership that the Simcyp Simulator enables,” said Rob Aspbury, President, Certara Predictive Technologies. “The modeling work for asciminib evolved over a decade and contributed to richer understanding its optimal dosing regimen and drug interaction profile, ultimately supporting regulatory approval and an important new treatment for patients with CML.”

Learn more about the asciminib case study here.

About Certara  
Certara accelerates medicines using biosimulation software, technology and services to transform traditional drug discovery and development. Its clients include more than 2,600 biopharmaceutical companies, academic institutions, and regulatory agencies across 70 countries. Visit us at www.certara.com.  

Certara contact:

Sheila Rocchio
Sheila.rocchio@certara.com

Media contact:

Alyssa Horowitz
certara@pancomm.com

¹ https://ascopubs.org/doi/pdfdirect/10.1200/GO.21.00194

FAQ

What did Certara announce about asciminib (CERT) on March 3, 2026?

Certara announced its Simcyp PBPK modeling was accepted by the U.S. FDA to support the asciminib NDA. According to Certara, the modeling replaced at least ten dedicated clinical pharmacology studies and helped characterize pharmacokinetics across populations.

How did Simcyp PBPK modeling affect clinical studies for asciminib (CERT)?

The modeling reduced the need for multiple clinical pharmacology studies by replacing at least ten studies. According to Certara, simulations bridged tested and untested scenarios and complemented clinical data used in the NDA.

Did Certara say the Simcyp Simulator evaluated drug–drug interactions for asciminib (CERT)?

Yes, the company reported the PBPK models predicted interactions and pharmacokinetics in patients taking other medications. According to Certara, this mechanistic assessment informed dosing and safety in diverse clinical scenarios.

What regulatory impact did the Simcyp results have for asciminib (Scemblix) and CERT?

The Simcyp results were accepted by the U.S. FDA in place of certain clinical studies for the NDA. According to Certara, that regulatory acceptance reduced trial requirements and supported approval-related evidence.

What practical benefits did Certara claim from using Simcyp for asciminib (CERT)?

Certara said PBPK modeling saved time and costs by replacing dedicated clinical studies and informing dosing strategies. According to Certara, the approach provided mechanistic PK insights across patient groups and scenarios.