Nuvation Bio's (NUVB) Taletrectinib is currently in FDA review for Advanced ROS1+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.
Saturday, May 31, 2025
Monday, May 19, 2025
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
Monday, May 5, 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
Friday, April 18, 2025
Auvelity Prescription Update
Axsome Therapeutic's drug, Auvelity was approved for depression in 2022, and completed it's first full year in 2023. The chart below is quarterly prescription data derived from a couple different sources, Bloomberg and IQVIA. The numbers are climbing from quarter to quarter, which is positive. The first quarter of 2025 numbers have not been released yet, so a rough estimate has been created. See chart below. Axsome reports first quarter results on May 5th.
Thursday, April 10, 2025
GOLD - New High
Previous gold post's are here Gold Showing Strength and here Gold Revaluation. The tariffs bought a new high to gold, along with wealth preservation amidst fiat currency devaluation, and geo political uncertainty. It would seem all is in favor of owning physical gold, or at the very least, have assets invested in gold funds. Gold hit $3,184 per ounce today with no overhead resistance to higher prices. If you have a chance to read Fiat Money Inflation in France, it would be an eye opener regarding fiat currency and similarities, historically to today. Chart of gold. Thank you for reading.
Wednesday, April 2, 2025
Solriamfetol for ADHD Phase 3 Results
Axsome released phase 3 clinical data from the (FOCUS) study with drug Solriamfetol for Attention Deficit Hyperactivity Disorder (ADHD), with results being statistically significant, rated under the AISRS (primary endpoint) versus placebo with 150mg dose.
FOCUS Phase 3 Results:
- AISRS compared to placebo p=0.039
- CGI-S compared to placebo p=0.017
Saturday, March 15, 2025
Update to Stock Charts
Plenty if volatility in the markets at this time. Some updated charts below. First chart is the asset class performance on a year to date basis, which includes Gold, Bonds, S&P 500, and Bitcoin. Gold has been an outperformer year to date so far versus other assets.
Sunday, February 23, 2025
GOLD Revaluation
Gold is trading at all-time highs, around $2,950 per ounce. Several catalyst may be at play driving the price higher. The revalue of gold reserves to higher prices, was mentioned by new Treasury Secretary Scott Bessent. The US is said to hold 8,133 metric tons of gold, but an audit would be necessary to verify the accuracy. Weekly chart of gold below. Thank you for reading.
Tuesday, February 18, 2025
Axsome Fourth Quarter Financial Results
Axsome released 4th quarter financial results today, a couple of highlights from the quarterly and year end release.
- ADHD phase 3 results, first quarter of 2025
- AXS-05 for Alz Agitation NDA to be submitted 2nd half 2025
- AXS-12 for Narcolepsy NDA to be submitted 2nd half 2025
- $315 million in cash, end of 2024
Thursday, January 30, 2025
Symbravo Receives FDA Approval for Acute Migraine
Sunday, January 5, 2025
MM120 for Generalized Anxiety Disorder
MindMed (MNMD) is a psychedelic company addressing unmet medical need GAD (Generalized Anxiety Disorder) with lead drug MM120. The companies website is here MindMed. Some quick facts regarding MindMed.
- 540 Million Market Cap
- 80M Shares outstanding
- 295 Million cash
- MM120 Breakthrough Therapy Designation
- MM120 Patent to 2041
- MM120 in Phase 3 for GAD
- Share Price $7.20