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CAMBRIDGE, Mass. - Nuvalent, Inc. (NASDAQ:NUVL), a $6 billion market cap biotech company with a strong financial health score according to InvestingPro, has dosed the first patient in its global Phase 3 randomized trial evaluating neladalkib for previously untreated patients with advanced ALK-positive non-small cell lung cancer (NSCLC), the company announced Monday.
The ALKAZAR trial will compare neladalkib against alectinib, a current front-line standard of care. The study aims to enroll approximately 450 treatment-naïve patients, who will be randomized 1:1 to receive either neladalkib or alectinib monotherapy. With analyst price targets ranging from $100 to $140, market expectations for this trial appear optimistic.
"We have been encouraged by neladalkib’s clinical profile to date," said Darlene Noci, Chief Development Officer at Nuvalent, in the press release. She noted the drug’s potential to address medical needs for both previously treated patients and those in the front-line setting.
The trial’s primary endpoint is progression-free survival based on Blinded Independent Central Review. Secondary endpoints include overall survival, objective response rate, and safety measures.
Neladalkib is designed to overcome limitations of existing ALK inhibitors, including maintaining activity against resistance mutations and providing central nervous system penetration to treat brain metastases. The drug is also being evaluated in the Phase 2 portion of the ALKOVE-1 trial for previously treated ALK-positive NSCLC patients.
The company expects to report topline pivotal data from the Phase 2 portion of ALKOVE-1 by year-end 2025.
Neladalkib has received breakthrough therapy designation for previously treated ALK-positive NSCLC patients and orphan drug designation for ALK-positive NSCLC, according to the company’s statement.
Kirk Smith, President of the Board of ALK Positive Inc., stated in the release that current therapies have limitations that can lead to challenging treatment decisions, adding, "We encourage continued innovation and the investigation of new treatment opportunities."
In other recent news, Nuvalent has reported a series of significant developments. The company plans to initiate a rolling New Drug Application (NDA) submission in July 2025 for its ROS1-selective inhibitor, zidesamtinib, following positive pivotal data in previously treated ROS1-positive non-small cell lung cancer (NSCLC) patients. The global ARROS-1 Phase 1/2 trial data showed an objective response rate of 44% in patients previously treated with tyrosine kinase inhibitors. UBS raised its price target on Nuvalent to $114 from $100, maintaining a Buy rating, citing the drug’s superior performance and safety profile. Goldman Sachs also initiated coverage on Nuvalent with a Buy rating, highlighting the potential for expedited approval of zidesamtinib. Furthermore, Nuvalent has appointed Christy Oliger, a former Genentech executive, to its Board of Directors, enhancing its leadership as it prepares for potential commercialization. Meanwhile, board member Emily Conley announced her resignation, effective at the company’s 2025 annual meeting. The resignation was voluntary and not due to any disagreements with the company.
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