Nuvalent Outlines Recent Pipeline Progress, Reiterates Key Anticipated Milestones, and Reports Fourth Quarter and Full Year 2025 Financial Results

Rhea-AI Summary

Nuvalent (Nasdaq: NUVL) reported pipeline progress and 2025 results. Key items: FDA accepted an NDA for zidesamtinib with a PDUFA date of Sept 18, 2026; an NDA for neladalkib in pre-treated ALK-positive NSCLC is planned H1 2026. The company raised $500.0M in Nov 2025 and held $1.4B cash as of Dec 31, 2025, providing runway into 2029.

Ongoing trials include ALKAZAR (Phase 3), HEROEX-1 (Phase 1a/1b), and a planned label expansion submission for zidesamtinib in H2 2026.

Positive

• FDA accepted NDA for zidesamtinib with PDUFA 9/18/2026
• Planned neladalkib NDA submission in H1 2026
• Completed public offering raising $500.0M gross proceeds
• Cash, cash equivalents and marketable securities of $1.4B (12/31/2025) supporting runway into 2029

Negative

• Net loss of $425.4M for year ended 12/31/2025
• Research and development expense of $307.0M in 2025
• General and administrative expense of $107.3M in 2025

News Market Reaction – NUVL

-0.57%

1 alert

-0.57% News Effect

On the day this news was published, NUVL declined 0.57%, reflecting a mild negative market reaction.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Cash & securities: $1.4 billion Public offering proceeds: $500.0 million Shares offered: 4,950,496 shares +5 more

8 metrics

Cash & securities $1.4 billion Cash, cash equivalents and marketable securities as of Dec 31, 2025

Public offering proceeds $500.0 million Gross proceeds from Nov 20, 2025 common stock offering

Shares offered 4,950,496 shares Class A common stock sold in Nov 20, 2025 offering

Offer price $101.00 per share Price to public in Nov 20, 2025 stock offering

R&D expenses 2025 $307.0 million Research and development expenses for year ended Dec 31, 2025

G&A expenses 2025 $107.3 million General and administrative expenses for year ended Dec 31, 2025

Net loss 2025 $425.4 million Net loss for year ended Dec 31, 2025

PDUFA date September 18, 2026 FDA target action date for zidesamtinib NDA in ROS1-positive NSCLC

Market Reality Check

Price: $101.95 Vol: Volume 360,513 is at 0.73...

normal vol

$101.95 Last Close

Volume Volume 360,513 is at 0.73x the 20-day average of 494,705, indicating subdued trading ahead of the release. normal

Technical Shares at $104.53 are trading above the 200-day MA of $89.22 and 7.51% below the 52-week high of $113.02.

Peers on Argus

Biotech peers show mixed moves with some up (e.g., LEGN, RNA, RYTM) and others d...

1 Up 1 Down

Biotech peers show mixed moves with some up (e.g., LEGN, RNA, RYTM) and others down (e.g., AXSM, ABVX, ABVX also in momentum scanner), supporting a stock-specific setup around this earnings and pipeline update.

Previous Earnings Reports

5 past events · Latest: Oct 30 (Positive)

Same Type Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Oct 30	Q3 2025 earnings	Positive	-4.7%	Completed rolling zidesamtinib NDA and highlighted strong cash and trial progress.
Aug 07	Q2 2025 earnings	Positive	-6.6%	Initiated zidesamtinib NDA, launched ALKAZAR Phase 3, and maintained $1.0B cash.
May 08	Q1 2025 earnings	Positive	+7.3%	Outlined plans for first NDA and pivotal data with $1.1B cash runway to 2028.
Feb 27	FY 2024 earnings	Positive	-2.8%	Projected 2025 pivotal data for ROS1 and ALK NSCLC plus first NDA in mid‑2025.
Nov 12	Q3 2024 earnings	Positive	-3.6%	Reported $1.2B cash including $575M raise and ongoing Phase 2 trial progress.

Pattern Detected

Earnings and pipeline updates have often been followed by negative price reactions, despite generally positive operational progress and strong cash balances.

Recent Company History

Across prior earnings releases from Nov 2024 through Oct 2025, Nuvalent consistently highlighted strong cash positions (e.g., $1.0–$1.2 billion) and runway into 2028, alongside steady advancement of zidesamtinib and neladalkib toward pivotal data and NDA submissions. Those updates typically coincided with continued trial enrollment and corporate strengthening. Today’s Q4/FY 2025 results and reiterated milestones, with cash of $1.4 billion and runway into 2029, extend that trajectory, marking a transition from pivotal data and rolling submissions to an accepted NDA and defined PDUFA date.

Historical Comparison

-2.0% avg move · Past earnings and milestone updates for NUVL led to an average move of -2.05%, often skewing negativ...

earnings

-2.0%

Average Historical Move earnings

Past earnings and milestone updates for NUVL led to an average move of -2.05%, often skewing negative despite positive cash and pipeline progress, framing expectations for similar announcements.

Earnings releases have tracked Nuvalent’s evolution from Phase 2/early pivotal data to rolling NDAs, and now to an accepted zidesamtinib NDA with a defined PDUFA date and extended cash runway into 2029.

Market Pulse Summary

This announcement combines Q4 and full-year 2025 results with clear regulatory milestones, including...

Analysis

This announcement combines Q4 and full-year 2025 results with clear regulatory milestones, including a PDUFA date of September 18, 2026 for zidesamtinib and a planned neladalkib NDA in the first half of 2026. Nuvalent reported cash of $1.4 billion and expects its runway to extend into 2029, following a $500.0 million equity raise. Investors may watch execution on NDA timelines, ongoing Phase 3 and Phase 1 programs, and the scale of R&D and G&A spending relative to net losses of $425.4 million.

Key Terms

pdufa, nda, nsclc, tki, +3 more

7 terms

pdufa regulatory

"and assigned a Prescription Drug User Fee Act (PDUFA) target action date of September 18, 2026."

PDUFA, short for the Prescription Drug User Fee Act, is a law that allows drug companies to pay fees to the government to speed up the review process for new medicines. This helps bring important drugs to market more quickly, which can impact their availability and pricing. For investors, PDUFA timelines can influence the timing of a drug’s approval and potential market success.

nda regulatory

"The U.S. Food and Drug Administration (FDA) accepted the New Drug Application (NDA) for zidesamtinib..."

An NDA, or nondisclosure agreement, is a legal contract that keeps certain information private between parties. It’s like a promise not to share sensitive details, helping protect business ideas, strategies, or data from being leaked or used without permission. For investors, NDAs help ensure that confidential information remains secure, enabling trust and open communication during business discussions.

nsclc medical

"locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who received at least 1 prior..."

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.

tki medical

"who received at least 1 prior ROS1 tyrosine kinase inhibitor (TKI), and assigned a ..."

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.

phase 3 medical

"global Phase 3 randomized, controlled trial designed to evaluate neladalkib..."

Phase 3 is the late-stage clinical testing step for a new drug or medical treatment, where the product is given to large groups of patients to confirm effectiveness, monitor side effects, and compare it to standard care. Successful Phase 3 results are often the final scientific hurdle before regulators decide on approval and market launch—like passing a final exam before graduation—and can sharply change a company's valuation and future revenue prospects.

phase 1a/1b medical

"HEROEX-1 Phase 1a/1b clinical trial evaluating the overall safety and tolerability of NVL-330..."

Phase 1a/1b are the earliest human clinical trial stages that test a new drug’s safety, how the body handles it, and the right dosage. Think of phase 1a as a careful test drive in healthy volunteers to find safe dosing, and phase 1b as expanded testing—often in people with the target condition—to confirm dosing and look for early signs the treatment works; investors watch these stages because they determine safety, dosing decisions, and the next funding or development milestones.

pharmacokinetic medical

"Additional objectives include determination of the recommended Phase 2 dose, characterization of NVL-330's pharmacokinetic profile..."

Pharmacokinetic describes how a drug moves through and leaves the body — how it is absorbed, spread to tissues, broken down and excreted — like tracking a package from pickup to delivery and disposal. For investors, these properties determine effective dose, safety risks, how often a medicine must be taken, and how reliably it works, which in turn influence clinical trial success, regulatory approval chances, production complexity and a drug’s commercial value.

AI-generated analysis. Not financial advice.

Commercial preparations well underway to support potential U.S. launch of zidesamtinib in TKI pre-treated advanced ROS1-positive NSCLC population, pending FDA review; PDUFA target action date of September 18, 2026

NDA submission for neladalkib in TKI pre-treated advanced ALK-positive NSCLC population planned for the first half of 2026

Submission for potential label expansion of zidesamtinib in TKI-naïve advanced ROS1-positive NSCLC population planned for the second half of 2026

Strong financial position with operating runway anticipated into 2029

CAMBRIDGE, Mass., Feb. 26, 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 outlined pipeline progress, reiterated key anticipated milestones, and reported fourth quarter and full year 2025 financial results.

"As we advance toward the culmination of our OnTarget 2026 operating plan with a first potential FDA approval targeted for later this year, our focus remains on applying the disciplined, patient-centric approach that has enabled rapid progress in discovery and development across our pipeline towards building the capabilities needed to effectively deliver new medicines to patients," said James Porter, Ph.D., Chief Executive Officer at Nuvalent. "We are executing against our initial registration paths for zidesamtinib and neladalkib in TKI pre-treated patients and are well underway with launch readiness efforts to ensure we have the commercial infrastructure in place to deliver these medicines to patients, if approved. In parallel, we continue to pursue label expansion opportunities for TKI-naïve patients towards our goal of bringing new therapies to all patients with ROS1-positive or ALK-positive NSCLC, and advance our earlier-stage and discovery programs. With a steady cadence of anticipated milestones across our pipeline in 2026 and a strong balance sheet, we believe we are positioned to become an enduring leader in precision oncology across the full continuum of discovery, development, and delivery, built to serve patients for years to come."

Recent Pipeline Achievements and Anticipated 2026 Milestones

ROS1 Program

• The U.S. Food and Drug Administration (FDA) accepted the New Drug Application (NDA) for zidesamtinib for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who received at least 1 prior ROS1 tyrosine kinase inhibitor (TKI), and assigned a Prescription Drug User Fee Act (PDUFA) target action date of September 18, 2026. Pending FDA review, Nuvalent anticipates U.S. commercial launch of zidesamtinib in 2026.
• Nuvalent plans to submit data to the FDA to support a potential label expansion of zidesamtinib in TKI-naïve patients with advanced ROS1-positive NSCLC in the second half of 2026.

ALK Program

• Nuvalent completed its pre-NDA meeting with the FDA and aligned on a submission strategy for neladalkib in TKI pre-treated ALK-positive NSCLC. The company plans to move forward with an NDA submission of the data for TKI pre-treated patients with advanced ALK-positive NSCLC from the ALKOVE-1 study of neladalkib in the first half of 2026.
• Enrollment is ongoing in ALKAZAR, the company's global Phase 3 randomized, controlled trial designed to evaluate neladalkib for the treatment of TKI-naïve patients with advanced ALK-positive NSCLC. Patients are randomized 1:1 to receive neladalkib or alectinib, a front-line standard of care, reflecting input from collaborating physician-scientists and alignment with global regulatory agencies. The company expects to continue to progress the ALKAZAR trial throughout 2026.

HER2 Program

• Enrollment is ongoing in the HEROEX-1 Phase 1a/1b clinical trial evaluating the overall safety and tolerability of NVL-330 for pre-treated patients with HER2-altered NSCLC. Additional objectives include determination of the recommended Phase 2 dose, characterization of NVL-330's pharmacokinetic profile, and preliminary evaluation of anti-tumor activity. The company expects to continue to progress the HEROEX-1 trial throughout 2026.

Discovery Research Programs

• Nuvalent continues to advance its discovery research programs and expects to disclose a new development candidate by year-end 2026.

Business Highlights

• Completed Successful Public Offering of Common Stock Raising $500.0 Million in Gross Proceeds: On November 20, 2025, Nuvalent closed an underwritten public offering of 4,950,496 shares of Class A common stock at a price to the public of $101.00 per share. The gross proceeds to Nuvalent from the offering were approximately $500.0 million, before deducting underwriting discounts and commissions and other offering expenses.
• Ron Squarer Appointed to Board of Directors: Nuvalent appointed Ron Squarer to its board of directors in December 2025. Mr. Squarer brings more than 30 years of proven leadership in oncology drug development and commercialization to the Nuvalent Board.

Upcoming Events

• TD Cowen 46^th Annual Health Care Conference in Boston: Management will be participating in a fireside chat on Wednesday, March 4, 2026, at 9:45 a.m. ET.
• Leerink Global Healthcare Conference 2026 in Miami: Management will be participating in a fireside chat on Monday, March 9, 2026, at 2:20 p.m. ET.
  
  Live webcasts of the fireside chats will be available in the Investors section of Nuvalent's website at www.nuvalent.com, and will be archived for 30 days following each conference.

Fourth Quarter and Full Year 2025 Financial Results

• Cash Position: Cash, cash equivalents and marketable securities were $1.4 billion as of December 31, 2025. Nuvalent continues to believe that its existing cash, cash equivalents and marketable securities will be sufficient to fund its operations into 2029.
• R&D Expenses: Research and development (R&D) expenses were $67.8 million for the fourth quarter of 2025 and $307.0 million for the year ended December 31, 2025.
• G&A Expenses: General and administrative (G&A) expenses were $34.4 million for the fourth quarter of 2025 and $107.3 million for the year ended December 31, 2025.
• Net Loss: Net loss was $118.7 million for the fourth quarter of 2025 and $425.4 million for the year ended December 31, 2025.

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; Nuvalent's estimated cash runway; the expected timing of potential new product candidate announcements, clinical trial advancements, FDA submissions, product approvals and commercial launch, including the projections in our OnTarget 2026 operating plan; the clinical development programs for zidesamtinib, neladalkib and NVL-330; the potential clinical effects of Nuvalent's product development candidates; the design, timing and enrollment of Nuvalent's clinical trials, including for the ARROS-1, ALKOVE-1 and ALKAZAR trials their intended pivotal registration-directed design; the potential of Nuvalent's pipeline programs, including zidesamtinib, neladalkib and NVL-330 and expectations regarding Nuvalent's discovery pipeline; Nuvalent's potential commercialization of its product candidates, if approved; the implications of data readouts and presentations; timing and content of potential discussions with FDA; 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: risks that Nuvalent may not fully enroll its clinical trials or that enrollment will take longer than expected; 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 zidesamtinib or neladalkib; risks that Nuvalent may not achieve the goals and milestones set forth in its OnTarget 2026 operating plan; 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, including the ARROS-1, ALKOVE-1, ALKAZAR and HEROEX-1 trials; 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 Quarterly Report on Form 10-Q for the quarterly period ended September 30, 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.

CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except share and per share amounts)
(Unaudited)
	Three Months Ended December 31,				Year Ended December 31,
	2025		2024		2025		2024
Operating expenses
Research and development	$                  67,796		$                  69,423		$                306,970		$                217,774
General and administrative	34,432		16,876		107,337		62,594
Total operating expenses	102,228		86,299		414,307		280,368
Loss from operations	(102,228)		(86,299)		(414,307)		(280,368)
Other income (expense)
Change in fair value of related party revenue share liability	(27,940)		(1,340)		(55,220)		(17,940)
Interest income and other income (expense), net	11,614		13,047		44,735		38,316
Total other income (expense), net	(16,326)		11,707		(10,485)		20,376
Loss before income taxes	(118,554)		(74,592)		(424,792)		(259,992)
Income tax provision	151		171		585		764
Net loss	$             (118,705)		$               (74,763)		$             (425,377)		$              (260,756)
Net loss per share attributable to common stockholders, basic and diluted	$                   (1.58)		$                   (1.05)		$                   (5.85)		$                    (3.93)
Weighted average shares of common stock outstanding, basic and diluted	75,119,584		71,156,489		72,686,749		66,408,807

 

SELECTED BALANCE SHEET DATA
(In thousands)
(Unaudited)
	December 31,
	2025		2024
Cash, cash equivalents and marketable securities	$                    1,371,952		$                     1,118,302
Working capital	$                    1,301,255		$                     1,078,428
Total assets	$                    1,412,705		$                     1,141,752
Total liabilities	$                       164,366		$                          71,960
Total stockholders' equity	$                    1,248,339		$                     1,069,792

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SOURCE Nuvalent, Inc.

FAQ

What is Nuvalent's PDUFA date for zidesamtinib (NUVL)?

The PDUFA target action date for zidesamtinib is September 18, 2026. According to the company, the FDA accepted the NDA for zidesamtinib in TKI pre-treated ROS1-positive NSCLC.

When will Nuvalent (NUVL) submit the neladalkib NDA for ALK-positive NSCLC?

Nuvalent plans an NDA submission for neladalkib in the first half of 2026. According to the company, this follows a pre-NDA meeting and an agreed submission strategy.

How strong is Nuvalent's cash position as of December 31, 2025 (NUVL)?

Nuvalent held $1.4 billion in cash, cash equivalents and marketable securities as of Dec 31, 2025. According to the company, this cash is expected to fund operations into 2029.

How much did Nuvalent (NUVL) raise in its November 2025 public offering?

Nuvalent completed a public offering that raised approximately $500.0 million in gross proceeds. According to the company, the offering closed Nov 20, 2025 at $101.00 per share.

What are Nuvalent's 2025 operating expenses and net loss (NUVL)?

For 2025, Nuvalent reported R&D expense of $307.0M, G&A expense of $107.3M, and a net loss of $425.4M. These figures are reported for the year ended Dec 31, 2025.

What near-term clinical milestones should investors watch for Nuvalent (NUVL) in 2026?

Key milestones include the PDUFA decision 9/18/2026, neladalkib NDA planned H1 2026, and a potential zidesamtinib label expansion submission in H2 2026. According to the company, multiple trials will progress through 2026.