Earnings summaries and quarterly performance for Nuvalent.
Executive leadership at Nuvalent.
Board of directors at Nuvalent.
Research analysts covering Nuvalent.
Recent press releases and 8-K filings for NUVL.
Nuvalent Discusses Pipeline Progress and Commercialization Strategy
NUVL
Product Launch
Guidance Update
- Nuvalent is on track with its OnTarget 2026 operating plan, targeting its first potential approval in 2026, and has achieved key 2025 milestones including the NDA acceptance for zidesamtinib (ROS1 program) for TKI pretreated patients.
- The ALK program's NVL-655 has treated over 1,000 patients and shown durable responses, including an 18-month duration of response in third-line patients, which is double lorlatinib's durability, and maintains a clean CNS safety profile. The phase 3 ALCAZAR trial for frontline ALK is enrolling as planned, with estimated data availability in the second half of 2029.
- The company is actively building its commercial presence and aims to become a fully integrated company, possessing the necessary team and capital, while remaining open to strategic partnerships for ex-U.S. markets.
16 hours ago
Nuvalent Outlines 2026 Approval Path and Program Milestones
NUVL
Product Launch
New Projects/Investments
Guidance Update
- Nuvalent's OnTarget 2026 operating plan aims for its first potential drug approval in 2026, supported by 2025 milestones including pivotal data sets for ROS1 and ALK programs, and the initiation of the phase 3 ALCAZAR study for frontline ALK.
- The company's New Drug Application (NDA) for zidesamtinib (ROS1 program) for TKI pretreated patients was recently accepted for standard review.
- The ALK program, NVL-655, has shown durable responses in second and third-line settings, with an 18-month duration of response in third-line patients post-lorlatinib, which is double the durability of lorlatinib in that setting.
- The phase 3 ALCAZAR study for frontline ALK is enrolling as planned, with an estimated data availability in the second half of 2029.
- Nuvalent is actively building its commercial presence to become a fully integrated company, possessing the necessary team and capital, while also considering strategic partnerships for ex-U.S. markets.
17 hours ago
Nuvalent Prices Public Offering of Common Stock
NUVL
- Nuvalent, Inc. announced the pricing of an underwritten public offering of its Class A common stock at $101.00 per share on November 18, 2025.
- The company is selling 4,950,496 shares, with expected gross proceeds of approximately $500.0 million and estimated net proceeds of approximately $471.9 million.
- Underwriters have been granted a 30-day option to purchase up to an additional 742,574 shares from selling stockholders, from which Nuvalent will not receive any proceeds.
- The offering is expected to close on November 20, 2025.
Nov 20, 2025, 11:01 AM
Nuvalent's NDA for Zidesamtinib Accepted by FDA
NUVL
Product Launch
New Projects/Investments
- Nuvalent, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted for filing its New Drug Application (NDA) for zidesamtinib.
- Zidesamtinib is an investigational ROS1-selective inhibitor intended for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who have received at least one prior ROS1 tyrosine kinase inhibitor (TKI).
- The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of September 18, 2026.
- The NDA submission is based on results from the global registrational ARROS-1 Phase 1/2 clinical trial.
Nov 19, 2025, 9:19 PM
Nuvalent Announces Pricing of Public Offering
NUVL
- Nuvalent, Inc. announced the pricing of an underwritten public offering of 4,950,496 shares of Class A common stock at a price of $101.00 per share.
- The offering is expected to generate approximately $500.0 million in gross proceeds for Nuvalent, before deducting underwriting discounts and other expenses.
- The offering is anticipated to close on November 20, 2025.
- The Selling Stockholders have granted the underwriters a 30-day option to purchase up to an additional 742,574 shares, from which Nuvalent will not receive any proceeds.
Nov 19, 2025, 4:50 AM
Nuvalent announces public offering of common stock
NUVL
New Projects/Investments
- Nuvalent, Inc. (Nasdaq: NUVL) has commenced an underwritten public offering of its Class A common stock, aiming to offer $500.0 million of shares.
- The offering includes an option for underwriters to purchase up to an additional 15% of shares from selling stockholders, Deerfield Healthcare Innovations Fund, L.P. and Deerfield Private Design Fund IV, L.P..
- Nuvalent will not receive any proceeds from the sale of shares by the selling stockholders.
- J.P. Morgan, Jefferies, TD Cowen, and Cantor are acting as joint book-running managers for the offering.
Nov 17, 2025, 9:01 PM
Nuvalent Presents Top-Line Pivotal Data from ALKOVE-1 Trial for Neladalkib
NUVL
New Projects/Investments
Guidance Update
- Nuvalent presented top-line pivotal data from the ALKOVE-1 trial for its ALK-selective inhibitor, neladalkib, which enrolled 781 patients across Phase I and Phase II, with 656 patients receiving the recommended Phase II dose of 150 mg once daily.
- In the pivotal primary efficacy analysis population of 253 TKI pretreated patients, the Objective Response Rate (ORR) was 31%, and the median Duration of Response (DOR) was not reached. For Lorlatinib-experienced patients, ORR was 26% with a median DOR of 17.6 months, and for Lorlatinib-naive patients, ORR was 46% with an unreached median DOR.
- Neladalkib was generally well tolerated, with the most common Treatment-Emergent Adverse Events (TEAEs) being transaminase elevations (ALT increased in 47%, AST increased in 44%). Dose reductions due to TEAEs occurred in 17% of patients, and treatment discontinuation due to TEAEs was 5%.
- Nuvalent plans to discuss these data with the FDA at an upcoming pre-NDA meeting, aiming for an initial indication for TKI pretreated patients. The company also initiated the Phase III ALKAZAR trial in July to evaluate neladalkib versus Alectinib for TKI naive patients.
- The company has achieved all milestones outlined in its OnTarget 2026 operating plan for the second year in a row, with a goal of a first potential product approval in 2026.
Nov 17, 2025, 1:00 PM
Nuvalent Presents Positive Top-Line Data for Neladalkib from ALKOVE-1 Trial
NUVL
New Projects/Investments
Revenue Acceleration/Inflection
- Nuvalent (NUVL) announced positive top-line pivotal data from its ALKOVE-1 trial for neladalkib, an ALK-selective inhibitor for ALK-positive non-small cell lung cancer.
- In 253 TKI pretreated patients, neladalkib demonstrated an Objective Response Rate (ORR) of 31%, with a median Duration of Response (DOR) not reached. For lorlatinib-experienced patients, an ORR of 26% and a median DOR of 17.6 months were observed.
- Preliminary data from 44 TKI naive patients showed a high ORR of 86% and a 91% DOR rate at 6 and 12 months.
- Nuvalent plans to discuss these results with the FDA at an upcoming pre-NDA meeting, aiming for an NDA submission for a potential indication in TKI pretreated patients with advanced ALK-positive non-small cell lung cancer.
Nov 17, 2025, 1:00 PM
Nuvalent Announces Positive Top-Line Pivotal Data for Neladalkib from ALKOVE-1 Trial
NUVL
New Projects/Investments
Revenue Acceleration/Inflection
- Nuvalent announced positive top-line pivotal data from its ALKOVE-1 trial for neladalkib, an ALK-selective inhibitor for ALK-positive non-small cell lung cancer.
- In the overall TKI pretreated population of 253 patients, neladalkib achieved an Objective Response Rate (ORR) of 31% and a median Duration of Response (DOR) that was not reached.
- For lorlatinib-experienced patients, an ORR of 26% was observed with a median DOR of 17.6 months, demonstrating activity where no other approved therapies have.
- The drug was generally well tolerated, with 17% of patients experiencing dose reductions and only 5% discontinuing treatment due to treatment-emergent adverse events (TEAEs).
- Nuvalent plans to engage with the FDA in a pre-NDA meeting to discuss the NDA submission plan for neladalkib in TKI pretreated patients.
Nov 17, 2025, 1:00 PM
Nuvalent Announces Positive Topline Pivotal Data for Neladalkib in ALK-positive NSCLC
NUVL
New Projects/Investments
- Nuvalent, Inc. announced positive topline 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 ALKOVE-1 Phase 1/2 clinical trial on November 17, 2025.
- In the pivotal primary analysis of 253 TKI pre-treated patients, neladalkib achieved an objective response rate (ORR) of 31% (79/253).
- Preliminary data from an exploratory cohort of 44 TKI-naïve patients showed an ORR of 86% (38/44).
- Neladalkib demonstrated a generally well-tolerated safety profile in 656 patients, with 17% experiencing dose reductions and 5% discontinuing treatment due to treatment-emergent adverse events (TEAEs).
- The company plans to discuss the pivotal data with the U.S. Food and Drug Administration (FDA) at a pre-New Drug Application (NDA) meeting.
Nov 17, 2025, 11:36 AM
Quarterly earnings call transcripts for Nuvalent.
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