Nuvation Bio Executives Make Significant Stock Purchases Amid FDA Approval of Cancer Drug

Nuvation Bio's CEO and Chief Regulatory Officer made significant stock purchases, valued at $890,000 and $89,740, respectively. The FDA approved the company's drug, Ibtrozi, for treating ROS1-positive non-small cell lung cancer, but the stock fell 9% due to market concerns over potential challenges in launching the drug. Despite this, analysts remain positive about Ibtrozi's potential long-term benefits.

Nuvation Bio's CEO and Chief Regulatory Officer have made substantial stock purchases, signaling their confidence in the company's future. David Hung, CEO, purchased 500,000 shares at a weighted-average price of $1.787 per share, totaling $893,500 [2]. Meanwhile, Kerry Wentworth, Chief Regulatory Officer, bought 50,000 shares at prices ranging from $1.79 to $1.8 per share, amounting to $89,740 [2].

The significant purchases come amid the FDA's approval of Ibtrozi, Nuvation Bio's oral ROS1 inhibitor for non-small cell lung cancer. The approval, based on the robust TRUST clinical program, marks a milestone in targeted therapy for advanced ROS1-positive NSCLC [1]. However, the stock fell 9% in after-hours trading on June 12, 2025, due to market concerns over potential challenges in launching the drug [3].

Despite the stock's drop, analysts remain optimistic about Ibtrozi's long-term potential. Jefferies analysts noted that the drug's "broad label" is beneficial for Nuvation, despite the company's stock trading near cash [1]. The analysts believe patience may be needed by investors, as several quarters are required to demonstrate strong launch momentum.

Ibtrozi's approval was backed by data from the Phase II TRUST-I and TRUST-II trials, which together enrolled over 300 patients. The confirmed overall response rate (cORR) in TKI-naïve patients was 90% in TRUST-I and 85% in TRUST-II [1]. The drug demonstrated high rates of treatment response in patients with brain metastases, a common and devastating complication in ROS1-positive NSCLC [1].

The FDA approval of Ibtrozi is supported by one of the largest global clinical trial programs in ROS1+ NSCLC to date [3]. The drug's safety and tolerability profile was well-established in the pivotal program, with most adverse events being low-grade and manageable [3].

References:
[1] https://www.biospace.com/fda/nuvation-scores-first-fda-nod-with-oral-lung-cancer-drug
[2] https://www.tradingview.com/news/tradingview:58cccd0b39fc7:0-nuvation-bio-executives-make-significant-stock-purchases/
[3] https://quantisnow.com/insight/us-food-and-drug-administration-approves-nuvation-bio%27s-ibtrozi%E2%84%A2lagetrectinib-a-nextgeneration-oral-treatment-6081848