Taletrectinib

Nuvation Bio's (NUVB) Taletrectinib is currently in FDA review for Advanced ROS1-Positive NSCLC, with a decision date (PDUFA) of June 23rd. Taletrectinib a (tyrosine kinase inhibitor) TKI, could potentially become an effective treatment for another indication such as Colorectal Cancer (CRC). This paper from Nature with several scientists contributing, have completed a study in vitro using two CRC cell lines, and in vivo in a mouse model. The articles thesis is that Taletrectinib promotes pyroptosis in colorectal carcinoma, via SRC/AKT/mTOR axis inhibition. Nuvation Bio is a high risk investment at this time, as they have zero commercial assets, and are awaiting an FDA decision for their lead drug Taletrectinib. Chart below of Nuvation Bio, thank you for reading. 

NUVB: Nuvation Bio ($2.30)

Nuvation Bio, a development-stage oncology company, focuses on the clinical development for the treatment of cancer. The companies lead drug Taletrectinib, an orally available inhibitor is currently being reviewed by the FDA for Advanced ROS1+NSCLC, with a decision date (PDUFA) of June 23rd. 

Financial Statistics: 

• $461 million cash
• Debt - minimal
• 340 million diluted shares outstanding
• 782 million market cap

Intellectual Property:

• Taletrectinib - Expected to expire from 2033 to 2042
• Safusidenib - Expected to expire from 2035 to 2041

Timeline Catalyst:

• Taletrectinib: FDA approval decision June 23, 2025
• Safusidenib: Begin pivotal phase 3 for diffuse IDH1-mutant glioma, 2025

Axsome First Quarter Financial Results

Axsome Therapeutics is getting closer to becoming a profitable company, on a cash and earnings per share basis.  An impressive quarter, with highlights below. 

• Filed a new drug application for AXS-14 for Fibromyalgia 
• On target to file a supplemental NDA for Alzheimer's Agitation 3rd Q 
• Symbravo for acute migraine launch in June
• 300 million in cash

Chart below, as AXSM had a good day, after posting quarterly results. Thank you for reading.