NUVL - Nuvalent, Inc.

Nuvalent Highlights Upcoming Data Presentations for Neladalkib and Zidesamtinib at the 2026 American Society of Clinical Oncology Annual Meeting

Presentation of pivotal data for neladalkib in TKI pre-treated patients with advanced ALK-positive NSCLC from ALKOVE-1 trial TKI pre-treated data from ALKOVE-1 trial of neladalkib support recent NDA submission and ongoing investigation in Phase 3 ALKAZAR trial for TKI-naïve patients with advanced ALK-positive NSCLC First presentation of encouraging preliminary data for zidesamtinib in patients with advanced ROS1-positive solid tumors other than NSCLC from ARROS-1 trial CAMBRIDGE, Mass., May 21, 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 highlighted pivotal data for neladalkib, an investigational ALK-selective inhibitor, in TKI pre-treated patients with advanced ALK-positive non-small cell lung cancer (NSCLC) from the global, single-arm ALKOVE-1 Phase 1/2 clinical trial, and preliminary data in patients with advanced ROS1-positive solid tumors other than NSCLC from the global, single-arm ARROS-1 Phase 1/2 clinical trial of zidesamtinib, an investigational ROS1-selective inhibitor, to be presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting from May 29 – June 2, 2026, in Chicago.

May 21, 2026 01:23 PM • prnewswire.com

Nuvalent Highlights Recent Pipeline Progress, Reiterates Key Anticipated Milestones, and Reports First Quarter 2026 Financial Results

NDA submitted for neladalkib in TKI pre-treated advanced ALK-positive NSCLC NDA for zidesamtinib in TKI pre-treated advanced ROS1-positive NSCLC under FDA review with PDUFA target action date of September 18, 2026 Submission for potential label expansion of zidesamtinib in TKI-naïve advanced ROS1-positive NSCLC planned for the second half of 2026 Strengthened leadership team with key internal promotions CAMBRIDGE, Mass., May 7, 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 first quarter 2026 financial results.

May 07, 2026 02:30 AM • prnewswire.com

Nuvalent: A Precision Oncology Platform With Two Near-Term Shots On Goal

Nuvalent is positioned as a high-quality late-stage biotech with two near-commercial precision oncology assets, not a traditional value play. NUVL's robust $1.37B cash position and recent $500M raise provide operational runway through 2029, supporting commercialization and expansion without near-term financing risk. Zidesamtinib's NDA for ROS1-positive NSCLC is accepted with a PDUFA date of September 2026; neladalkib NDA submission is planned for 1H 2026, targeting major unmet needs.

Apr 30, 2026 10:22 AM • seekingalpha.com

Guardant Health Announces Multi-Year Strategic Collaboration with Nuvalent to Develop Companion Diagnostics and Support Potential Commercialization of Targeted Cancer Therapies Using the Guardant Infinity™ Platform

PALO ALTO, Calif.--(BUSINESS WIRE)--Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced a multi-year strategic collaboration with Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, to support the development and potential commercialization of Nuvalent's oncology pipeline using the tissue and liquid offerings of the Guardant Infinity™ platf.

Apr 30, 2026 04:05 AM • businesswire.com

Evergreen Capital Management LLC Purchases New Position in Nuvalent, Inc. $NUVL

Evergreen Capital Management LLC purchased a new stake in shares of Nuvalent, Inc. (NASDAQ: NUVL) during the undefined quarter, according to its most recent disclosure with the SEC. The fund purchased 8,584 shares of the company's stock, valued at approximately $863,000. Several other hedge funds and other institutional investors also recently made changes

Apr 25, 2026 12:03 AM • defenseworld.net

Nuvalent to Present Pivotal Data from ALKOVE-1 Trial of Neladalkib in TKI Pre-treated Advanced ALK-positive NSCLC at the 2026 American Society of Clinical Oncology Annual Meeting

Company to also present preliminary data for zidesamtinib in advanced ROS1-positive solid tumors outside of NSCLC from the global ARROS-1 trial CAMBRIDGE, Mass., April 21, 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 that pivotal data for neladalkib, an investigational ALK-selective inhibitor, in TKI pre-treated patients with advanced ALK-positive non-small cell lung cancer (NSCLC) from the global ALKOVE-1 Phase 1/2 clinical trial, in addition to preliminary data for TKI-naïve patients, will be presented during an oral presentation at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting from May 29 – June 2, 2026, in Chicago.

Apr 21, 2026 06:32 AM • prnewswire.com

New Clinical and Preclinical Data for Investigational Candidate Zidesamtinib Presented at AACR Annual Meeting 2026

Zidesamtinib demonstrated meaningful clinical activity in subset of TKI pre-treated ROS1-positive NSCLC patients from ARROS-1 trial previously treated with repotrectinib or taletrectinib, including in those with CNS disease or ROS1 resistance mutations Preclinical data support differentiated brain penetrance and intracranial activity as compared to repotrectinib and taletrectinib CAMBRIDGE, Mass., April 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 new clinical and preclinical data for zidesamtinib, an investigational ROS1-selective inhibitor, to be presented during poster sessions at the American Association for Cancer Research (AACR) Annual Meeting 2026 being held April 17-22 in San Diego.

Apr 17, 2026 12:01 PM • prnewswire.com

Nuvalent Announces Submission of New Drug Application to FDA for Neladalkib in TKI Pre-treated Advanced ALK-positive NSCLC

New Drug Application (NDA) based on data in TKI pre-treated patients from the global ALKOVE-1 Phase 1/2 clinical trial CAMBRIDGE, Mass., April 7, 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 submission to the U.S. Food and Drug Administration (FDA) of the Company's NDA for neladalkib, an investigational ALK-selective inhibitor, in TKI pre-treated advanced ALK-positive NSCLC.

Apr 07, 2026 02:30 AM • prnewswire.com

Alexandra Balcom Sells 11,430 Shares of Nuvalent (NASDAQ:NUVL) Stock

Nuvalent, Inc. (NASDAQ: NUVL - Get Free Report) CFO Alexandra Balcom sold 11,430 shares of Nuvalent stock in a transaction on Wednesday, April 1st. The shares were sold at an average price of $105.21, for a total transaction of $1,202,550.30. Following the transaction, the chief financial officer owned 85,533 shares in the company, valued at approximately

Apr 05, 2026 12:50 AM • defenseworld.net

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

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.

Mar 17, 2026 01:15 PM • prnewswire.com

Nuvalent, Inc. (NASDAQ:NUVL) Given Average Rating of “Moderate Buy” by Analysts

Nuvalent, Inc. (NASDAQ: NUVL - Get Free Report) has earned an average recommendation of "Moderate Buy" from the sixteen research firms that are presently covering the company, Marketbeat.com reports. One equities research analyst has rated the stock with a sell recommendation and fifteen have assigned a buy recommendation to the company. The average 12 month price

Mar 16, 2026 10:24 PM • defenseworld.net

This Investor Sold $104 Million of Nuvalent Stock Amid Cancer Drug Developer's Nearly 30% Rally

Vestal Point Capital sold 1,054,000 Nuvalent shares in the fourth quarter, an estimated $103.93 million trade based on quarterly average pricing. The fund's quarter-end Nuvalent position value declined by $90.50 million, reflecting both trading activity and stock price movement.

Mar 16, 2026 04:00 PM • fool.com

Nuvalent, Inc. $NUVL Shares Sold by ArrowMark Colorado Holdings LLC

ArrowMark Colorado Holdings LLC cut its stake in Nuvalent, Inc. (NASDAQ: NUVL) by 2.0% in the undefined quarter, according to its most recent Form 13F filing with the Securities and Exchange Commission (SEC). The institutional investor owned 362,585 shares of the company's stock after selling 7,273 shares during the period. ArrowMark Colorado Holdings

Mar 15, 2026 12:26 AM • defenseworld.net

Does Nuvalent (NUVL) Have the Potential to Rally 37.26% as Wall Street Analysts Expect?

The average of price targets set by Wall Street analysts indicates a potential upside of 37.3% in Nuvalent (NUVL). While the effectiveness of this highly sought-after metric is questionable, the positive trend in earnings estimate revisions might translate into an upside in the stock.

Feb 27, 2026 05:55 AM • zacks.com

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

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.

Feb 26, 2026 01:30 AM • prnewswire.com

Biotech Fund Dumps $84 Million of Nuvalent With Stock Up 29%

Commodore Capital reduced its Nuvalent stake by 850,000 shares in the fourth quarter; the estimated trade size was $83.81 million based on quarterly average pricing. Meanwhile, the quarter-end position value dropped by $65.75 million, reflecting both share sales and stock price movement.

Feb 23, 2026 05:01 AM • fool.com

Nuvalent Details FDA Timelines for ROS1, ALK Drugs as $1.4B Cash Fuels Global Launch Plans

Nuvalent (NASDAQ: NUVL) executives highlighted ongoing regulatory milestones for the company's lead oncology programs and discussed commercialization strategy, pipeline plans, and financial positioning during a conference fireside chat. Company focus and lead programs Chief Executive Officer Jim Porter described Nuvalent as a company built around deep chemistry and structure-based drug design expertise, with an emphasis on

Feb 15, 2026 08:02 PM • defenseworld.net

Nuvalent to Participate in the Guggenheim Emerging Outlook: Biotech Summit 2026

CAMBRIDGE, Mass., Feb. 5, 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 that James Porter, Ph.D.

Feb 05, 2026 01:30 AM • prnewswire.com

Nuvalent, Inc. (NASDAQ:NUVL) Given Consensus Recommendation of “Moderate Buy” by Brokerages

Shares of Nuvalent, Inc. (NASDAQ: NUVL - Get Free Report) have earned an average rating of "Moderate Buy" from the sixteen research firms that are currently covering the company, Marketbeat reports. One equities research analyst has rated the stock with a sell rating and fifteen have issued a buy rating on the company. The average 12-month

Jan 25, 2026 09:23 PM • defenseworld.net

3 Biotech Stocks That Could Double In 2026

The biotech sector is one that's become red-hot, at least in recent years. After around a decade of stagnation, investors appear to be intent on increasing their exposure to top biotech names in the market, as growth in other sectors of the economy have led to valuations that now look more elevated than the biotech sector (in many cases).

Jan 20, 2026 05:42 AM • 247wallst.com

Nuvalent initiated with an Outperform at Bernstein

$189.00 (was $101.24)

Bernstein

May 21, 2026 04:23 PM • TheFly

Nuvalent initiated with a Buy at Truist

$140.00 (was $105.88)

Truist Financial

Nov 24, 2025 07:25 AM • TheFly

Nuvalent price target raised to $152 from $112 at Barclays

$152.00 (was $108.00)

Etzer Darout · Barclays

Nov 17, 2025 01:25 PM • TheFly

Nuvalent price target raised to $149 from $140 at Leerink

$149.00 (was $110.56)

Leerink Partners

Nov 17, 2025 11:23 AM • TheFly

Nuvalent price target raised to $155 from $130 at H.C. Wainwright

$155.00 (was $110.60)

H.C. Wainwright

Nov 17, 2025 08:48 AM • TheFly

Canaccord starts 'best-in-class' Nuvalent with Buy rating

$126.00 (was $96.16)

Canaccord Genuity

Nov 12, 2025 06:36 AM • TheFly

Nuvalent price target raised to $120 from $105 at Goldman Sachs

$120.00 (was $98.17)

Goldman Sachs

Oct 31, 2025 09:26 AM • TheFly

Nuvalent (NUVL) PT Raised to $132 at UBS

$132.00 (was $98.17)

David Dai · UBS

Oct 31, 2025 06:03 AM • StreetInsider

Nuvalent price target raised to $128 from $112 at Piper Sandler

$128.00 (was $93.39)

Kelsey Goodwin · Piper Sandler

Oct 27, 2025 06:55 AM • TheFly

Nuvalent initiated with an Overweight at Cantor Fitzgerald

$135.00 (was $89.35)

Josh Schimmer · Cantor Fitzgerald

Oct 15, 2025 09:27 AM • TheFly

Nuvalent assumed with a Buy at Guggenheim

$122.00 (was $79.54)

Guggenheim

Sep 03, 2025 04:26 PM • TheFly

Nuvalent initiated with an Outperform at Raymond James

$105.00 (was $76.90)

Raymond James

Sep 02, 2025 04:38 PM • TheFly

Nuvalent price target raised to $130 from $110 at H.C. Wainwright

$130.00 (was $76.88)

Swayampakula Ramakanth · H.C. Wainwright

Jun 24, 2025 10:13 AM • TheFly

Nuvalent (NUVL) PT Raised to $134 at BMO Capital

$134.00 (was $69.99)

Etzer Darout · BMO Capital

Nov 13, 2024 07:27 AM • StreetInsider

UBS Starts Nuvalent (NUVL) at Neutral

$100.00 (was $93.71)

David Dai · UBS

Oct 23, 2024 11:23 PM • StreetInsider

Nuvalent price target raised to $105 from $99 at Guggenheim

$105.00 (was $110.25)

Kelsey Goodwin · Guggenheim

Sep 16, 2024 05:33 AM • TheFly

Nuvalent (NUVL) PT Raised to $135 at Stifel

$135.00 (was $87.45)

Bradley Canino · Stifel Nicolaus

Sep 16, 2024 04:04 AM • StreetInsider

Piper Sandler Reiterates Overweight Rating on Nuvalent (NUVL)

$100.00 (was $87.45)

Christopher Raymond · Raymond James

Sep 16, 2024 03:45 AM • StreetInsider

Nuvalent price target raised to $115 from $103 at Stifel

$115.00 (was $73.63)

Bradley Canino · Stifel Nicolaus

Jul 10, 2024 03:43 AM • TheFly

Jefferies Starts Nuvalent (NUVL) at Buy, 'Precisely Targeted Oncology Aiming for Firstline Treatment'

$97.00 (was $64.75)

Roger Song · Jefferies

Apr 16, 2024 08:18 PM • StreetInsider