On Friday, H.C. Wainwright reaffirmed its Buy rating and $110.00 price target for Nuvalent shares (NASDAQ:NUVL), following the company's recent presentation of its anticipated milestones for 2025.
According to InvestingPro data, analysts maintain a strong bullish consensus on the $5.4 billion market cap company, with price targets ranging from $100 to $137. The presentation, which took place on January 13, outlined Nuvalent's strategy to secure its first potential FDA approval for zidesamtinib, a ROS1-targeting tyrosine kinase inhibitor (TKI), by 2026.
Nuvalent shared its plans to release pivotal data from the Phase 1/2 ARROS-1 study in the first half of 2025. This study is assessing zidesamtinib for the treatment of advanced ROS1-positive non-small cell lung cancer (NSCLC) in patients who have previously undergone TKI therapy. The company aims to submit a New Drug Application (NDA) for zidesamtinib in mid-2025.
The Phase 1 dose-escalation portion of the ARROS-1 study showed promising results, with an overall response rate (ORR) of 44% in patients who had received prior therapy. Specifically, the ORR was 38% in patients with confirmed resistance mutations who had previously been treated with repotrectinib, and 72% in patients who had not received repotrectinib.
Notably, the intracranial (IC)-ORR was 50% among patients with measurable IC lesions of 10mm or more at baseline, including those who had been treated with brain-penetrant ROS1 TKIs.
Nuvalent's management has indicated that they are in discussions with the FDA to pursue a line-agnostic approval for zidesamtinib. This strategy is supported by data from the TKI-naïve cohort in the ongoing Phase 2 segment of the ARROS-1 trial. H.C. Wainwright's analyst reiterated the firm's positive stance on Nuvalent with the maintained Buy rating and price target, citing the company's progress and potential for FDA approval.
InvestingPro analysis shows the company maintains a strong financial position with a current ratio of 23.07 and an overall FAIR financial health rating. Want deeper insights? Access the comprehensive Pro Research Report, available exclusively to InvestingPro subscribers, covering all crucial aspects of Nuvalent's financial health and market position.
In other recent news, Nuvalent has been the focus of several analyst firms, including BMO Capital Markets and UBS. BMO Capital Markets maintained an Outperform rating and raised its price target to $134. However, UBS initiated coverage with a Neutral rating, suggesting the current stock price already reflects the near-term opportunity in non-small cell lung cancer treatments.
Nuvalent has also seen significant developments in its corporate structure and ongoing clinical trials. The company recently appointed Grant Bogle as an independent director to its board. This move aligns with Nuvalent's established policies for board membership.
Nuvalent's lead drug candidates, zidesamtinib and NVL-655, are being evaluated for the treatment of ROS1-positive and ALK-positive non-small cell lung cancer, respectively. Both studies are expected to produce pivotal data in 2025. Furthermore, Nuvalent is planning to initiate a randomized Phase 3 study named ALKAZAR in the first half of 2025.
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