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 breakout strong.  

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.

Gold and Oil - Negative Correlation

The daily gyrations of one asset class may have an effect on the performance of another global asset. In this case the rising price of Brent Crude Oil has put downside pressure on the price of gold, creating a negative correlation between the two assets. The global price increase of brent oil, is a result of supply constraints from the Straight of the Hormuz region. The decreased availability has driven the price of Brent Crude higher. 

Below is a chart depicting the two assets (oil and gold) represented by the exchange traded security BNO Exchange -Traded Security and exchange-traded fund GLD. Simply put, as the price of Brent Oil (representative of BNO) moves higher, the price of gold lower, creating a negative correlation at this time of post at -0.93. A correlation of 1.00 is perfectly correlated, and -1.00 a strong negative correlation. Thank you for reading.

Psychedelic Sector Update

Late last year we wrote about psychedelic stocks here Psychedelic Therapeutics. Here is quick update in the sector, of the five most advanced companies pursuing therapies.

ATAI is entering phase 3 clinical trials for lead drug candidate BLP-003 for TRD in 2026. The company is also exploring social anxiety disorder (SAD) with EMP-01, having just competed a phase 2 trial.

GHRS is also tackling TRD with an inhalant device, and will be entering phase 3 clinical trials in 2026. Both ATAI and GHRS are utilizing psychedelic mebufotenin for TRD with an inhaling device. 

CMPS is preparing for NDA filing with COMP360 for TRD through FDA discussions. They are also advancing COMP360 for PTSD, with phase 3 studies scheduled in 2026.

DFTX is using LSD for GAD and MDD, with MDD readout of the EMERGE study late second quarter.  They have BTD for GAD. GAD is their primary program.  DT120 had an effect on MDD also, in their phase 2 study. 

HELP is the only adjunctive for MDD, as concomitant is allowed in their phase 3 clinical trials. Their first phase 3 read-out for trial APPROACH is anticipated for the 4th quarter of 2026. 

DXFT’s MDD readout, anticipated by the end of the second quarter is the next catalyst for the sector.

A chart below of the five companies and their stock performance year to date. 

GOLD and Geopolitical Risks

GOLD sold off on 2/28/26, which was the day geopolitical risks were elevated, due to military strikes on Iran. Gold sold off -24.4% from a recent high of $5,400 / ounce all the way down to $4100 per ounce, then has since recovered up to present prices around $4,600 per ounce. Gold's sell-off was due to profit taking after reaching all-time high in price, US dollar strength, and fear of rising interest rates. Once geopolitical risks alleviate, we expect gold to continue it's march higher, or stabilize in prices near term. Below is a chart of M2 money supply, and a daily chart of gold depicting the sell-off beginning 2/28/26. Thank you for reading.

Axsome Therapeutics - Market Capitalization In Charts

A stocks market cap is simply the current stock price multiplied by the current number of shares outstanding, and is a rough assessment of the companies worth. 

Axsome has received FDA approval for in-house developed Auvelity (depression) and Symbravo (migraine). The company also has a pipeline of drugs in various stages with the notable exception of AXS-05, which has pending approval for Alzheimer's Disease Agitation (ADA). That pending approval has a decision date of April 30th. 

With potential AXS-05 approval for ADA, the likelihood for patients remaining in their homes becomes more favorable, easier on caregivers, and reducing overburdened nursing care facilities. Below is a chart of Axsome over the past two years, with market cap in red at various stock prices. Thank you for reading. 

Definium Therapeutics

Definium Therapeutics (DFTX)  formerly MindMed, is in late stage psychedelic-based development, with drug DT120 for General Anxiety Disorder (GAD) and depression (MDD). We wrote about psychedelic drug companies last year, Psychedelic Therapeutics.  DT120 was granted FDA Breakthrough Therapy Designation for GAD, after they completed phase 2 testing. The year is full of catalyst's of clinical data readout, with expected timelines below. 

Catalysts:

- Phase 3 MDD study Emerge expected to read-out topline in late 2nd quarter
- Phase 3 GAD study Voyage expected to read-out topline early 3rd quarter
- Phase 3 GAD study Panorama expected to read-out topline 2nd half 2026

Clinical Trials: 

- Emerge NCT06941844

- Voyage NCT06741228

- Panorama NCT06809595

Financial Statistics:

- US $411 million of cash on hand (approximation)

- Debt - minimal

- 104 million shares outstanding

- 1.8 billion market cap

Intellectual Property: 

- DT120 Expected to expire in 2041

Definium's lead indication GAD, looks to be the only psychedelic company on the verge of completing pivotal clinical trials for that indication. The stock is a high risk investment at this time, as they have zero commercial assets, and are in late stage clinical development, with results expected in 2026. Thank you for reading.

NUVB: Nuvation Bio - Update #9

Nuvation Bio held their 4th quarter conference call today to update investors, on the progress of their cancer drug development programs. Just some key points below, as they will be a multi-year investment, with updates along the way.

• 4th quarter revenue of $41 million, a combination of product and license
• Net loss of $36 million, or 0.11 cents per share with 344 million shares outstanding
• The company is well funded with $529 million in cash and equivalents
• Partner Eisai to file for Ibtrozi ROS1 approval in EU by mid-year 2026
• SIGMA safusidenib 40 patient exploratory cohort, grade 3 oligodendroglioma study with readout expected in 2027
• No revenue guidance announced by the company at this time

The stock has been stable, trading in the $5.00 to $6.00 per share range in the last month, with chart below.  Thank you for reading.

Axsome 4th Quarter Financial Results

Today, Axsome Therapeutics released fourth quarter 2025 financial results. Another impressive quarter as the company is getting closer to becoming profitable, on a cash and earnings per share basis. 4th quarter highlights below.  

• FDA decision date of 4/30/26 for Alzheimer's Disease Agitation 
• $196 million in fourth quarter total revenue
• 65% year over year revenue growth
• 322.9 million in cash
• 50,882 million shares outstanding

Daily chart below of Axsome Therapeutics. Thank you for reading.

GOLD - New High $4,800

Gold hit another new all-time high in price, now over $4,800 per ounce. What's driving the price higher? A reshaping of our geo-political world, in addition to the US debt which continues to climb, now over 38 trillion National Debt. The cost of servicing debt (which consists of making regular interest and principle payments on borrowed funds), is 1.2 trillion annually. Chart of federal government interest payments below, followed by a weekly chart of $GOLD.