Taletrectinib - Receives FDA Approval for Advanced ROS1-Positive NSCLC

Today, Nuvation Bio's lead drug candidate Taletrectinib was approved for ROS1-Positive Non- Small Cell Lung Cancer. This is good news for cancer patients, good for the company and investors alike. The full press release from Nuvation Bio is here FDA Approval Press Release.  The newly commercialized product name, will be Ibtrozi. Thank you for reading.

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.

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.

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.

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

The company will next have to run a pediatric phase 3 study scheduled for 2025. If positive then can submit to the FDA a new drug application. The advantage over current treatments, is that Solriamfetol is considered a non-stimulant drug, and potential improvement from a safety profile from currently approved ADHD drugs on the market. Thank you for reading.

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.

This next set charts include Axsome Therapeutics, and Cybin, both companies we have wrote about before.  Displayed as 60 minute charts.

Thank you for reading.

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.

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

Good quarter, and great 2024 completed. The stock is at an all-time high level around $130.00 per share chart below. Thank you for reading. 

 

Symbravo Receives FDA Approval for Acute Migraine

Axsome Therapeutics has received FDA approval for migraine drug AXS-07, or known commercially now as Symbravo. The drug's patent extends out to 2040, so there will be plenty years of runway for commercialization. The list of approved drugs that address unmet medical needs now extends to three, which include Auvelity, Sunosi, and now Symbravo. The company is operating at a very high level, of advancing through clinical trials to FDA approval. Click on chart below, as Axsome stock has closed at an all-time high price. Thank you for reading. 

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

The company has successfully completed a phase 2b for GAD, and received Breakthrough Therapy Designation for MM120 afterwards. The company is now in phase 3 for GAD. They will be using the HAM-A assessment at 12 weeks, after a single dose of MM120. Here is where you can find the company's medical Presntations. The goal of MindMed is to have two phase 3 clinical trials and a 40 week long-term extension study all completed by the end of 2026. Their past and current clinical trails MM-120 Clinical Trials. Thank you for reading.