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Nuvalent
Nuvalent (NUVL) investor relations material
Nuvalent Guggenheim Securities Emerging Outlook: Biotech Summit 2026 summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Guggenheim Securities Emerging Outlook: Biotech Summit 2026 summary12 Feb, 2026
Company overview and strategy
Focuses on structure-based drug design targeting clinically validated kinases, aiming to address unmet needs in oncology through innovative chemistry.
Building a global, sustainable biotech company with capabilities in drug discovery, development, and delivery.
Shifting to an independent global commercialization strategy, building ex-US infrastructure and recruiting leadership for international expansion.
Strategic approach to ex-US launches, prioritizing geographies based on regulatory, pricing, and market access dynamics.
Open to partnerships if they create more value, but currently focused on independent execution.
Regulatory and clinical progress
NDA for zidesamtinib in TKI-pretreated ROS1-positive NSCLC accepted by FDA, with a PDUFA date of September 18 and US launch preparations underway.
Data submission for TKI-naive ROS1 indication planned for the second half of the year, aiming for a line-agnostic extension.
NDA for NVL-655 in TKI-pretreated ALK-positive NSCLC on track for submission in the first half of the year.
Ongoing global phase 3 ALCAZAR study in TKI-naive ALK and phase 1b/2 HER2 exon 20 study in HER2-altered NSCLC.
New development candidate expected to be disclosed by year-end.
Product differentiation and market opportunity
Zidesamtinib uniquely targets ROS1 fusions and mutations, penetrates the CNS, and offers a well-tolerated profile, driving strong trial enrollment and commercial potential.
NVL-655 demonstrates durable responses in ALK-positive NSCLC, with superior durability compared to lorlatinib, including in second-line settings.
Both drugs show high CNS activity, a key differentiator in lung cancer treatment.
ROS1 market could grow to resemble the current ALK market ($2B+), while ALK could expand toward the EGFR market ($4-6B).
65-70% of ALK and ROS1 market opportunity is ex-US, supported by strong global trial enrollment and demand.
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Next Nuvalent earnings date
Q4 202527 Feb, 2026
Nuvalent
Next Nuvalent earnings date
Q4 202527 Feb, 2026
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Frequently asked questions
Nuvalent, Inc. is a clinical-stage biopharmaceutical company focused on developing targeted therapies for cancer patients. The company specializes in the creation of small molecule inhibitors that are designed to target specific kinases with high precision. Its leading product candidates include NVL-520, which targets ROS1-positive non-small cell lung cancer, and NVL-655, aimed at addressing ALK-positive cancers. Both candidates are designed to overcome resistance and minimize adverse events associated with existing treatments. The company is headquartered in Cambridge, Massachusetts, and its shares are listed on the NASDAQ.
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