Welcome to our dedicated page for Nuvalent news (Ticker: NUVL), a resource for investors and traders seeking the latest updates and insights on Nuvalent stock.
Nuvalent, Inc. (Nasdaq: NUVL) is a clinical-stage biopharmaceutical company developing precisely targeted kinase inhibitors for oncogene-driven cancers, with a focus on non-small cell lung cancer (NSCLC). The NUVL news feed on Stock Titan aggregates company announcements, press releases, and related coverage so readers can follow how its pipeline and regulatory interactions progress over time.
According to Nuvalent’s disclosures, its lead investigational programs include zidesamtinib, a ROS1-selective inhibitor for ROS1-positive NSCLC, and neladalkib, an ALK-selective inhibitor for ALK-positive NSCLC. News items often highlight pivotal and preliminary data from the ARROS-1 and ALKOVE-1 Phase 1/2 trials, updates on the ALKAZAR Phase 3 trial in TKI-naïve ALK-positive NSCLC, and information about design features such as brain penetrance and activity against resistance mutations.
Investors and observers can also find coverage of Nuvalent’s regulatory milestones, including FDA breakthrough therapy and orphan drug designations, New Drug Application (NDA) submissions and acceptances, and PDUFA target action dates. Corporate developments such as public equity offerings, cash runway guidance, royalty arrangements on future net sales of zidesamtinib and neladalkib, and board appointments are regularly disclosed through press releases and Form 8-K filings and are reflected in the news flow.
For those tracking NUVL, this news stream provides a centralized view of clinical trial readouts, conference presentations, financing activities, and strategic updates that shape the company’s outlook in targeted oncology. Bookmarking the NUVL news page on Stock Titan can help readers quickly review new disclosures and place them in the context of Nuvalent’s broader development strategy.
Nuvalent (NUVL) has provided updates on its pipeline progress and financial results for Q4 and full year 2024. The company expects to report topline pivotal data in 2025 for both ROS1-positive and ALK-positive NSCLC populations. Their first NDA submission is planned for mid-2025 for zidesamtinib.
Key developments include:
- 430 patients enrolled in ARROS-1 Phase 1/2 trial for zidesamtinib
- 596 patients enrolled in ALKOVE-1 Phase 1/2 trial for neladalkib
- Implementation of global Expanded Access Programs for both therapies
- Planned initiation of ALKAZAR Phase 3 trial in first half 2025
Financial highlights: Cash position of $1.1 billion as of December 31, 2024, expected to fund operations into 2028. R&D expenses were $217.8 million and G&A expenses $62.6 million for 2024, with a net loss of $260.8 million for the year.
Nuvalent (NUVL) has outlined its 'OnTarget 2026' plan, targeting its first potential FDA approval in 2026. Key 2025 milestones include: reporting pivotal data for zidesamtinib in ROS1-positive NSCLC patients in H1 2025, submitting an NDA by mid-2025, and reporting pivotal data for neladalkib in ALK-positive NSCLC patients by year-end 2025.
The company has shown strong enrollment progress, with 430 patients enrolled in the ARROS-1 trial for zidesamtinib and 596 patients in the ALKOVE-1 trial for neladalkib as of December 31, 2024. The company plans to initiate the ALKAZAR Phase 3 trial for neladalkib in H1 2025 and continues to progress its HEROEX-1 trial for NVL-330.
Nuvalent reports having sufficient cash runway into 2028 to support clinical programs and commercial infrastructure development.
Nuvalent (Nasdaq: NUVL), a clinical-stage biopharmaceutical company developing targeted cancer therapies, has announced its participation in the 43rd Annual J.P. Morgan Healthcare Conference. James Porter, Ph.D., the company's Chief Executive Officer, will deliver a presentation on Tuesday, January 14, 2025, at 9:00 a.m. PT in San Francisco. The presentation will be accessible via live webcast through the Investors section of Nuvalent's website and will remain available for 30 days afterward.
Nuvalent (NUVL) has appointed Grant Bogle to its Board of Directors, bringing nearly four decades of biotechnology leadership experience. Bogle's previous roles include CEO of Epizyme and Chief Commercial Officer at TESARO, both of which were successfully acquired by larger pharmaceutical companies.
The appointment comes as Nuvalent prepares for potential pivotal data readouts in 2025 from two parallel-lead programs: the ARROS-1 trial of zidesamtinib (ROS1-selective inhibitor) and the ALKOVE-1 trial of NVL-655 (ALK-selective inhibitor). The company anticipates its first pipeline approval in 2026 and plans to initiate the Phase 3 ALKAZAR trial in early 2025, comparing NVL-655 to ALECENSA for ALK-positive NSCLC treatment.
Nuvalent (NUVL), a clinical-stage biopharmaceutical company developing targeted cancer therapies, has announced its participation in the Piper Sandler 36th Annual Healthcare Conference. The company's CEO James Porter and CFO Alexandra Balcom will engage in a fireside chat on December 3, 2024, at 3:30 p.m. ET in NYC. The presentation will be accessible via live webcast on Nuvalent's website investor section and will remain available for 30 days afterward.
Nuvalent (NUVL) reported Q3 2024 financial results and pipeline achievements. The company maintains a strong cash position of $1.2 billion, including proceeds from a $575 million public offering, extending operating runway into 2028. Key highlights include ongoing enrollment in Phase 2 trials for both ROS1 and ALK programs, with pivotal data expected in 2025. The company reported Q3 net loss of $84.3 million, with R&D expenses of $60.6 million and G&A expenses of $15.8 million. Notable appointment includes Dr. Alice Shaw to Scientific Advisory Board.
Nuvectis Pharma (NASDAQ: NVCT) showcased promising results at the AACR-NCI-EORTC Symposium, where its drug candidate NXP900 demonstrated strong synergy with ALK inhibitors in resistant non-small cell lung cancer (NSCLC) cells. The drug effectively targets SRC/YES1 kinases, addressing resistance mechanisms in cancer treatment.
The company is also anticipating data updates from NXP800's Phase 1b study in platinum-resistant, ARID1a-mutated ovarian cancer. With a current market valuation of approximately $150 million, Nuvectis is positioning itself alongside industry players like Summit Therapeutics ($15B) and Nuvalent ($6.6B) in the precision oncology space.
Nuvalent (Nasdaq: NUVL) has successfully closed its upsized public offering of Class A common stock. The biopharmaceutical company, focused on developing targeted cancer therapies, sold 5,750,000 shares at $100.00 per share, including the full exercise of the underwriters' option to purchase additional shares. The offering generated gross proceeds of approximately $575.0 million, before deducting underwriting discounts, commissions, and other expenses.
The offering was conducted through an automatically effective shelf registration statement filed with the SEC. J.P. Morgan, TD Cowen, Jefferies, and Stifel acted as joint book-running managers for the transaction. The shares were offered pursuant to a prospectus and prospectus supplement, which are available on the SEC's website and from the underwriters.
Nuvalent (Nasdaq: NUVL), a clinical-stage biopharmaceutical company, has announced the pricing of an upsized public offering of 5,000,000 shares of Class A common stock at $100.00 per share. The offering is expected to generate gross proceeds of approximately $500.0 million for Nuvalent. The underwriters have a 30-day option to purchase up to an additional 750,000 shares. The offering is anticipated to close on September 18, 2024, subject to customary closing conditions. J.P. Morgan, TD Cowen, Jefferies, and Stifel are acting as joint book-running managers for the offering.
Nuvalent (Nasdaq: NUVL), a clinical-stage biopharmaceutical company, has announced a $350 million public offering of Class A common stock. The company is offering all shares and plans to grant underwriters a 30-day option to purchase up to an additional 15% of shares. J.P. Morgan, TD Cowen, Jefferies, and Stifel are acting as joint book-running managers for the offering.
The offering is being made through an automatically effective shelf registration statement filed with the SEC. A preliminary prospectus supplement will be filed, detailing the terms of the offering. The completion, size, and terms of the offering are subject to market conditions and cannot be guaranteed.