{"id":818916,"date":"2025-02-27T06:34:45","date_gmt":"2025-02-27T11:34:45","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/nuvalent-outlines-pipeline-and-business-progress-reiterates-key-anticipated-milestones-and-reports-fourth-quarter-and-full-year-2024-financial-results\/"},"modified":"2025-02-27T06:34:45","modified_gmt":"2025-02-27T11:34:45","slug":"nuvalent-outlines-pipeline-and-business-progress-reiterates-key-anticipated-milestones-and-reports-fourth-quarter-and-full-year-2024-financial-results","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/nuvalent-outlines-pipeline-and-business-progress-reiterates-key-anticipated-milestones-and-reports-fourth-quarter-and-full-year-2024-financial-results\/","title":{"rendered":"Nuvalent Outlines Pipeline and Business Progress, Reiterates Key Anticipated Milestones, and Reports Fourth Quarter and Full Year 2024 Financial Results"},"content":{"rendered":"
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PR Newswire<\/p>\n<\/p><\/div>\n

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\n Topline pivotal data expected in 2025 for both TKI pre-treated ROS1-positive and TKI pre-treated ALK-positive NSCLC populations<\/i>\n <\/p>\n

\n First NDA submission planned for mid-year 2025 towards potential first approval in 2026 for zidesamtinib in TKI pre-treated ROS1-positive NSCLC population<\/i>\n <\/p>\n

\n Development strategies in place for TKI-na\u00efve populations, including planned initiation of ALKAZAR Phase 3 randomized, controlled trial of neladalkib for front-line ALK-positive NSCLC in first half of 2025<\/i>\n <\/p>\n

\n Implemented global Expanded Access Programs for zidesamtinib and neladalkib, in line with goal of prioritizing patient access<\/i>\n <\/p>\n

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\n CAMBRIDGE, Mass.<\/span>
\n <\/span>, Feb. 27, 2025<\/span><\/span> \/PRNewswire\/ — Nuvalent, Inc.<\/a><\/u> (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating\u00a0precisely<\/i>\u00a0targeted therapies for clinically proven kinase targets in cancer, today outlined pipeline and business progress, reiterated key anticipated milestones,\u00a0 and reported fourth quarter and full year 2024 financial results.<\/p>\n

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\n \"Nuvalent,
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“The efficient execution by the Nuvalent team to date reflects a shared sense of urgency driven by patient need for additional treatment options \u2013 a need that we believe has been clearly demonstrated by the robust enrollment momentum in our ARROS-1 and ALKOVE-1 trials,” said Darlene Noci<\/span>, A.L.M., Chief Development Officer at Nuvalent<\/b>. “We believe we are on track to report pivotal data for TKI pre-treated patients from both trials this year and to submit our first NDA by mid-year 2025.”<\/p>\n

\n Ms. Noci continued<\/b>, “In parallel to advancing initial registration paths for zidesamtinib and neladalkib for TKI pre-treated patients, we continue to work with regulators towards our goal of bringing new therapies to all patients with ROS1-positive or ALK-positive NSCLC. Development programs for TKI-na\u00efve patients are underway for both our ROS1 and ALK programs. To ensure patient access to these therapies, we are also pleased to announce the recent launch of global Expanded Access Programs for patients who are eligible and have no other treatment options outside of a clinical trial.”<\/p>\n

“As we transition towards becoming a fully integrated commercial-stage biopharmaceutical company, we reiterate our commitment to meeting the medical needs of patients by advancing our programs as quickly as possible,” said James Porter<\/span>, Ph.D., Chief Executive Officer at Nuvalent.<\/b> “This is an important time for Nuvalent and with a steady cadence of anticipated milestones across our pipeline this year, a strong balance sheet and a dedicated and proven team at the helm, we believe we are well-positioned to deliver on our near-, mid- and long-term goals.”<\/p>\n

\n Recent Pipeline Progress and Anticipated Milestones<\/b>\n <\/p>\n

\n ROS1 Program <\/i>\n <\/p>\n