Nuvalent to Present New Preclinical and Clinical Data for Zidesamtinib, an Investigational ROS1-Selective Inhibitor, at AACR Annual Meeting 2026

Rhea-AI Summary

Nuvalent (Nasdaq: NUVL) will present new preclinical and clinical data for zidesamtinib, an investigational ROS1-selective inhibitor, at the AACR Annual Meeting 2026 in San Diego on April 21, 2026.

Two poster sessions report clinical data from TKI pre-treated ROS1+ NSCLC patients in the ARROS-1 Phase 1/2 trial and preclinical brain penetrance and intracranial activity comparisons versus other ROS1 inhibitors.

Poster details include authors Geoffrey Liu, M.D. and Anupong Tangpeerachaikul, Ph.D., abstract numbers CT248 and LB366, and poster locations and times for April 21, 2:00-5:00 p.m. PT.

Key Figures

AACR meeting dates: April 17–22, 2026 Clinical poster session time: April 21, 2026, 2:00–5:00 p.m. PT Clinical poster board: Poster Board 13 +5 more

8 metrics

AACR meeting dates April 17–22, 2026 American Association for Cancer Research Annual Meeting 2026

Clinical poster session time April 21, 2026, 2:00–5:00 p.m. PT ARROS-1 TKI pre-treated ROS1+ NSCLC poster

Clinical poster board Poster Board 13 Zidesamtinib in ROS1+ NSCLC pretreated with repotrectinib or taletrectinib

Clinical abstract number CT248 Zidesamtinib in patients with ROS1+ NSCLC poster

Preclinical session time April 21, 2026, 2:00–5:00 p.m. PT Late-breaking preclinical brain penetrance poster

Preclinical poster board Poster Board 231 Brain penetrance and intracranial activity vs other ROS1 inhibitors

Preclinical abstract number LB366 Late-breaking research abstract on zidesamtinib brain penetrance

Pre-news price change 1.63% Move before AACR data announcement, vs prior close

Market Reality Check

Price: $97.43 Vol: Volume 453,288 is at 0.86...

normal vol

$97.43 Last Close

Volume Volume 453,288 is at 0.86x the 20-day average of 529,803, indicating subdued trading ahead of the AACR data. normal

Technical Shares at 98.97 are trading above the 200-day MA of 91.05 and about 12.43% below the 113.02 52-week high.

Peers on Argus

NUVL’s 1.63% gain contrasts with mixed peer moves: AXSM +1.68%, ABVX +2.56%, whi...

NUVL’s 1.63% gain contrasts with mixed peer moves: AXSM +1.68%, ABVX +2.56%, while LEGN -2.62% and RYTM -1.8%, suggesting stock-specific interest around upcoming AACR data rather than a sector-wide biotech move.

Previous Clinical trial Reports

5 past events · Latest: Nov 19 (Positive)

Same Type Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Nov 19	NDA acceptance	Positive	+0.8%	FDA accepted NDA for zidesamtinib in ROS1-positive NSCLC with set PDUFA date.
Nov 17	Topline pivotal data	Positive	+11.9%	Positive pivotal ALKOVE-1 data for neladalkib in ALK-positive NSCLC.
Nov 14	Data timing update	Neutral	+11.9%	Announcement of webcast timing to present upcoming neladalkib pivotal data.
Sep 07	Pivotal data WCLC	Positive	-1.3%	Presentation of pivotal ARROS-1 zidesamtinib data at WCLC 2025.
Jul 21	Phase 3 initiation	Positive	-1.1%	Initiation of ALKAZAR Phase 3 trial of neladalkib versus alectinib.

Pattern Detected

Clinical and regulatory data for zidesamtinib and neladalkib have often been followed by notable but mixed price reactions, with some positive trial milestones drawing double‑digit moves while other pivotal readouts and NDA milestones saw muted or negative responses.

Recent Company History

Over the past year, Nuvalent has advanced a pipeline focused on targeted kinase inhibitors. For zidesamtinib, pivotal ARROS‑1 data and subsequent NDA acceptance with a September 18, 2026 PDUFA date marked key milestones in ROS1‑positive NSCLC. Neladalkib has progressed through ALKOVE‑1 with positive topline data and into the ALKAZAR Phase 3 trial. Today’s AACR-focused announcement extends this pattern by adding preclinical and clinical detail, particularly around TKI‑pretreated patients and brain penetrance.

Historical Comparison

+4.4% avg move · Across the last 5 clinical-trial headlines, NUVL’s average 1-day move was 4.44%, showing that trial ...

clinical trial

+4.4%

Average Historical Move clinical trial

Across the last 5 clinical-trial headlines, NUVL’s average 1-day move was 4.44%, showing that trial and NDA updates have often been meaningful trading catalysts.

Clinical-trial news has tracked a clear progression: early neladalkib and zidesamtinib trials, pivotal ARROS-1 and ALKOVE-1 data, NDA acceptance for zidesamtinib, and now additional ARROS-1 subset and brain-penetrance data supporting potential future label expansion.

Market Pulse Summary

This announcement highlights upcoming ARROS-1 clinical and preclinical presentations for zidesamtini...

Analysis

This announcement highlights upcoming ARROS-1 clinical and preclinical presentations for zidesamtinib in ROS1-positive NSCLC, focusing on TKI-pretreated patients and brain penetrance. Historically, Nuvalent’s clinical-trial updates, including pivotal ARROS-1 and ALKOVE-1 data and zidesamtinib’s NDA acceptance with a September 18, 2026 PDUFA date, have been key milestones. Investors may watch for intracranial activity details, safety signals, and how these AACR data support potential label expansion and differentiation versus existing ROS1 inhibitors.

Key Terms

ros1-selective inhibitor, nsclc, phase 1/2, brain penetrance, +2 more

6 terms

ros1-selective inhibitor medical

"zidesamtinib, an investigational ROS1-selective inhibitor, during two poster..."

A ROS1-selective inhibitor is a drug designed to block the activity of the ROS1 protein, an abnormal molecular switch that drives growth in certain cancers. Like replacing a single faulty part in a machine to stop it from breaking, these drugs aim to shut down the precise cancer driver while sparing other functions, which can improve effectiveness and reduce side effects. Investors watch them because their success depends on clear patient tests, regulatory approval, and the potential for premium pricing in a well-defined patient group.

nsclc medical

"TKI pre-treated patients with ROS1-positive NSCLC treated in the ARROS-1..."

NSCLC stands for non-small cell lung cancer, which is the most common type of lung cancer. It develops in the lungs and can spread to other parts of the body, making it serious but often treatable if caught early. Understanding NSCLC helps people recognize the importance of lung health and early detection.

phase 1/2 medical

"ROS1-positive NSCLC treated in the ARROS-1 Phase 1/2 clinical trial..."

Phase 1/2 is a combined early-stage clinical trial that first tests a new drug or treatment for safety and the right dose, then quickly expands to check if it shows any signs of working in patients. For investors, results from a Phase 1/2 study offer an early read on both risk and potential reward—like a prototype test that both confirms a product won’t harm users and suggests whether it could sell—helping guide valuation and development decisions.

brain penetrance medical

"preclinical data further characterizing zidesamtinib's brain penetrance and..."

Brain penetrance describes how well a drug or biological compound can cross the blood–brain barrier and reach the brain tissue. For investors, it matters because high penetrance can mean a therapy is more likely to work for brain diseases (or cause central nervous system side effects), which affects a drug’s market potential, development risk and regulatory hurdles—think of it like a key fitting through a narrow doorway to reach its target room.

intracranial activity medical

"characterizing zidesamtinib's brain penetrance and intracranial activity."

Intracranial activity describes a drug’s ability to reach and affect disease inside the skull, such as tumors or infections in the brain and central nervous system. Investors care because demonstrating intracranial activity means a treatment can cross the body’s natural barriers to the brain and produce a measurable benefit there, which can increase a drug’s clinical value, regulatory chances, and potential market size—like a key that actually fits and turns a locked door.

tki medical

"subset of TKI pre-treated patients with ROS1-positive NSCLC treated in..."

A TKI (tyrosine kinase inhibitor) is a type of drug that blocks specific enzymes cells use to send growth signals, effectively slowing or stopping the proliferation of certain cancer and disease cells. For investors, TKIs matter because they are often central to a biotech company's product pipeline and revenue potential: successful TKIs can win regulatory approval, command premium pricing, and shift competitive dynamics in treatment markets, much like a key component that can make or break a new technology's commercial success.

AI-generated analysis. Not financial advice.

CAMBRIDGE, Mass., March 17, 2026 /PRNewswire/ -- Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced the presentation of new data for zidesamtinib, an investigational ROS1-selective inhibitor, during two poster presentations at the American Association for Cancer Research (AACR) Annual Meeting 2026, being held April 17-22 in San Diego. The posters will highlight clinical data from a subset of TKI pre-treated patients with ROS1-positive NSCLC treated in the ARROS-1 Phase 1/2 clinical trial and preclinical data further characterizing zidesamtinib's brain penetrance and intracranial activity.

Details of the poster presentations are as follows:

Title: Zidesamtinib in Patients with ROS1+ NSCLC Previously Treated with Repotrectinib or Taletrectinib
Presenting Author: Geoffrey Liu, M.Sc., M.D.¹
Abstract Number: CT248
Session Title: Phase II Clinical Trials
Session Date and Time: Tuesday, April 21, 2026, 2:00-5:00 p.m. PT
Location: Poster Section 50
Poster Board Number: 13

Title: Zidesamtinib Has Differentiated Preclinical Brain Penetrance and Intracranial Activity Compared to Other ROS1 Inhibitors
Presenting Author: Anupong Tangpeerachaikul, Ph.D.²
Abstract Number: LB366
Session Title: Late-Breaking Research: Experimental and Molecular Therapeutics 3
Session Date and Time: Tuesday, April 21, 2026, 2:00-5:00 p.m. PT
Location: Poster Section 53
Poster Board Number: 23

¹ Princess Margaret Hospital, Toronto, Ontario, Canada; ² Nuvalent, Inc., Cambridge, MA, USA

About Zidesamtinib
Zidesamtinib is an investigational, brain-penetrant, ROS1-selective inhibitor created with the aim to overcome limitations observed with currently available ROS1 inhibitors. Zidesamtinib is designed to remain active in tumors that have developed resistance to currently available ROS1 inhibitors, including tumors with treatment-emergent ROS1 mutations such as G2032R. In addition, zidesamtinib is designed for central nervous system (CNS) penetrance to improve treatment options for patients with brain metastases, and to avoid inhibition of the structurally related tropomyosin receptor kinase (TRK) family. Together, these characteristics have the potential to avoid TRK-related CNS adverse events seen with dual TRK/ROS1 inhibitors and to drive deep, durable responses for patients across all lines of therapy.

Based on results for tyrosine kinase inhibitor (TKI) pre-treated patients with advanced ROS1-positive non-small cell lung cancer (NSCLC) enrolled in the global registrational ARROS-1 Phase 1/2 clinical trial, the U.S. Food and Drug Administration (FDA) has accepted for filing Nuvalent's NDA submission for zidesamtinib for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC who received at least 1 prior ROS1 TKI. The application has been assigned a Prescription Drug User Fee Act (PDUFA) target action date of September 18, 2026. Zidesamtinib has received breakthrough therapy designation for the treatment of patients with ROS1-positive metastatic NSCLC who have been previously treated with 2 or more ROS1 TKIs and orphan drug designation for ROS1-positive NSCLC. 

About Nuvalent
Nuvalent, Inc. (Nasdaq: NUVL) is a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for patients with cancer, designed to overcome the limitations of existing therapies for clinically proven kinase targets. Leveraging deep expertise in chemistry and structure-based drug design, we develop innovative small molecules that have the potential to overcome resistance, minimize adverse events, address brain metastases, and drive more durable responses. Nuvalent is advancing a robust pipeline with investigational candidates for ROS1-positive, ALK-positive, and HER2-altered non-small cell lung cancer, and multiple discovery-stage research programs.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, implied and express statements regarding Nuvalent's strategy, business plans, and focus; the expected timing of data announcements; the clinical development program for zidesamtinib; the potential benefits and effects of Nuvalent's product development candidates; the design of Nuvalent's clinical trials, including for the ARROS-1 trial its intended pivotal registration-directed design; the potential of Nuvalent's pipeline programs, including zidesamtinib; Nuvalent's research and development programs for the treatment of cancer; and risks and uncertainties associated with drug development. The words "may," "might," "will," "could," "would," "should," "expect," "plan," "anticipate," "aim," "goal," "intend," "believe," "estimate," "seek," "predict," "future," "project," "potential," "continue," "target" or the negative of these terms and similar words or expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. You should not place undue reliance on these statements or the scientific data presented.

Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties, and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation: unexpected concerns that may arise from additional data, analysis, or results obtained during preclinical studies and clinical trials; the risk that results of earlier clinical trials may not be predictive of the results of later-stage clinical trials; the risk that data from our clinical trials may not be sufficient to support registration and that Nuvalent may be required to conduct one or more additional studies or trials prior to seeking registration of our zidesamtinib product candidate; the occurrence of adverse safety events; risks that the FDA may not approve our potential products on the timelines we expect, or at all; risks of unexpected costs, delays, or other unexpected hurdles; risks that Nuvalent may not be able to nominate drug candidates from its discovery programs; the direct or indirect impact of public health emergencies or global geopolitical circumstances on the timing and anticipated timing and results of Nuvalent's clinical trials, strategy, and future operations; the timing and outcome of Nuvalent's planned interactions with regulatory authorities; and risks related to obtaining, maintaining, and protecting Nuvalent's intellectual property. These and other risks and uncertainties are described in greater detail in the section entitled "Risk Factors" in Nuvalent's Annual Report on Form 10-K for the fiscal year ended December 31, 2025, as well as any prior and subsequent filings with the Securities and Exchange Commission. In addition, any forward-looking statements represent Nuvalent's views only as of today and should not be relied upon as representing its views as of any subsequent date. Nuvalent explicitly disclaims any obligation to update any forward-looking statements.

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SOURCE Nuvalent, Inc.

FAQ

When will Nuvalent (NUVL) present zidesamtinib data at AACR 2026?

Nuvalent will present on April 21, 2026 during the AACR Annual Meeting poster sessions. According to the company, both posters are scheduled April 21, 2026, between 2:00-5:00 p.m. PT in assigned poster sections.

What clinical data on zidesamtinib will Nuvalent (NUVL) share from ARROS-1?

The company will present clinical data from TKI pre-treated ROS1+ NSCLC patients enrolled in ARROS-1 Phase 1/2. According to the company, the poster highlights a subset previously treated with repotrectinib or taletrectinib.

What preclinical findings about zidesamtinib will Nuvalent (NUVL) report at AACR?

Nuvalent will report differentiated preclinical brain penetrance and intracranial activity for zidesamtinib compared with other ROS1 inhibitors. According to the company, the poster presents comparative data supporting CNS activity.

Where can investors find the zidesamtinib posters at AACR 2026 for NUVL?

Both Nuvalent posters are displayed April 21 in specific poster sections and board numbers at AACR. According to the company, one is Poster Section 50 (Board 13) and the other is Section 53 (Board 231).

Who are the presenting authors for Nuvalent's zidesamtinib posters at AACR 2026?

Presenting authors are Geoffrey Liu, M.D. and Anupong Tangpeerachaikul, Ph.D. According to the company, Liu presents the clinical ARROS-1 poster and Tangpeerachaikul presents the preclinical brain penetrance poster.