Nuvalent

NUVL

Market cap $8.46B

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.

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.

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.

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.

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.

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.

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.

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.

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).

Nuvalent, Inc. (NUVL) Presents at 44th Annual J.P. Morgan Healthcare Conference Transcript