NUVB: Nuvation Bio - Update #11

All of Nuvation Bio's previous posts, can be found here Nuvation Posts.  The company is addressing the unmet need of ROS1 and high grade glioma, with two unique drugs. 

From recent investor conferences that the company has participated, we were given some updated pipeline information. Two updates of interest, include the following for second drug candidate safusidenib. 

1. The 40 patient Grade 3 oligodendroglioma which is part of the SIGMA study NCT05303519, has objective response rate as the primary endpoint. The goal of achieving a 20% + response rate in this population, would be seen as positive over standard of care chemotherapy for these patients. The study will be conducted as an Open-Label single arm. 

 2. Yet To Be Announced: Safusidenib treatment for those patients that have been on approved drug vorasidenib, and over time have failed. The endpoint again would be objective response rate, with a goal of achieving 20%. 

 

Both trials could benefit from ORR as a quicker endpoint read-out, a smaller number of patients, with potential 2027 data. The daily chart of Nuvation below displays a consolidation range over the past two and a half months. The high of $5.29 and low support at $4.05. This consolidation chart pattern has the potential to have a strong breakout.  

Gold and Oil - Negative Correlation Updated

In response to the current correlation. Yes, the negative correlation of gold and oil is holding up strong today. Oil (brent oil) has fallen in price today, and gold has accelerated higher. The current negative correlation is at -0.97.

NUVB: Nuvation Bio - Update #10

Nuvation Bio is addressing unmet medical need in cancer with lead approved drug Ibtrozi, and clinical testing Safusidenib for high grade glioma. The company released first quarter financial results after the close of trading today. The company is gaining traction with new patients for lead drug Ibtrozi. The drug has been FDA approved for ROS1 NSCLC since June of 2025. Some key highlights from the first quarter results below. 

- 18.5 million in first quarter Ibtrozi revenue

- Greater than 50% of new patients were early line diagnosis

- China / Japan royalty revenue of $1.7 million

- Cash equivalents of $533.7 million

- Current Market cap of $1.5B

Essentially it was a breakeven quarter for Nuvation due to a one time collaboration payment from European partner Eisai, which combined with quarterly revenue, covered the research and SGA costs for the quarter. 

Second drug Safusidenib is currently in phase 3 testing with the SIGMA trial for high grade glioma, with expected completion around 2029. The trial can be viewed here NCT05303519. 

All prior Nuvation posts can be viewed here Nuvation Bio Posts. Thank you for reading. 

Auvelity FDA Approval for Alzheimer's Disease Agitation

We first wrote about the unmet need for ADA here Agitation In Alzheimer's Disease - An Unmet Need. Axsome Therapeutics was given approval for the indication of Alzheimer's Disease Agitation (ADA), with drug Auvelity from the FDA. This addresses an unmet need, and the first non-antipsychotic approval for ADA. This is the second approval for Auvelity, as it was granted approval for MDD in 2022. Axsome currently has three in-house drug approvals as follows. 

• Auvelity for MDD  8/19/22
• Symbravo for Acute Migraine  1/30/25
• Auvelity for ADA  4/30/26

The stock as expected, had a positive reaction to the news per chart below. Thank you for reading.