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.

NUVB: Nuvation Bio - Update #8

Nuvation Bio has updated investors with the good news of a European partnership, to sell newly FDA approved and commercialized drug Ibtrozi in Europe and other countries outside of the US, for patients with Ros1 NSCLC. Like many other US based companies, they utilize partnerships outside the US who already have a footprint of sales professionals actively selling similar products in the field. Under this agreement completed today with Eisai, there is upfront, milestones and a royalty kick back to the owner of the product, in this case Nuvation Bio. The selling partner reaps the revenue abroad. A win / win cost effective scenario. Below are the Royalty agreements that are now in place outside of the US for Nuvation Bio (NUVB). 

China: Innovent Biologics 
(Dovbleron) First and second-line approval.

-Milestone payments up to $189 million

-Tiered royalty payments based on annual net sales of Taletrectinib

Europe: Eisai

-60 million upfront 

-170 million milestone payments

-10% to 19% tiered royalty payments from net sales of Taletrectinib

Japan: Nippon Kayaku
-Milestone payments based on domestic sales exceeding certain amounts

-Royalty based on domestic net sales

HELUS Pharma: Formerly Cybin - Update #4

Cybin whom we wrote about here Cybin history, has changed their name and ticker symbol as they have moved from the NYSE exchange to the Nasdaq exchange starting on January 5th. The companies name is now Helus Pharma with ticker symbol HELP. The move suits the companies prospects better trading on the Nasdaq, because of their focus on growth-oriented development. Chart of HELP below. 

Axsome - Priority Review for Alzheimer's Disease Agitation

We first wrote about the prospect of the company addressing this unmet need here Agitation in Alzheimer's Disease - An Unmet Need. The therapy, if approved could allow easier caregiver services, that keep patients in their home setting, avoiding institutional care. The company completed all phases of clinical trials, and filed a new drug application recently (NDA) for AXS-05 for the indication of Alzheimer's Disease Agitation. Axsome was notified by the FDA that the application has been accepted with priority review and a decision date (PDUFA) of April 30th, 2026. This is great news as it could be the only non-antipsychotic drug to be approved for this indication.  Receiving priority review, which includes a shortened time frame for review, increases the chances of approval significantly. The stocks reaction as anticipated, is very positive chart below. 

NUVB: Nuvation Bio - Update #7

Past Nuvation Bio posts can be found in date order, by clicking here Nuvation Bio. 

There are different ways to calculate a stock price target. One way is to use a comparison valuation method. This post considers the current market valuation ($2.932 billion) for Nuvation Bio. 

For comparison valuation; In June of 2022 Bristol Myer Squibb offered 4.1 billion to buy Turning Point Therapeutics for their lead drug candidate Repotrectinib a TKI inhibitor for the same indication that Nuvation has been FDA approved for ROS1 NSCLC, BMS News. 

Their interest was lead drug Repotrectinib for ROS1 NSCLC. At the time Repotrectinib had only completed phase 1/2 testing of the drug, and not FDA approved, until 11/23, then again 6/24 for NTRK gene-fusion positive tumors.

 

If we were to apply the 4.1 billion that Turning Point was acquired for, and relate it to NUVB today, it would calculate out to $4100B / 343m shares outstanding = $11.95 per share price target.

- Keeping in mind that Nuvation's lead drug Ibtrozi has already received FDA approved for ROS1 NSCLC and has a global footprint in place to distribute the drug, something that Turning Point did not have at the time of acquisition by BMS.

- Nuvation has already achieved revenues for newly approved Ibtrozi. 

- This comparison is void of any efficacy discussions of Ibtrozi vs Repotrectinib, which should be viewed in another post altogether.

- Nuvation's second drug candidate Safusidenib has entered pivotal phase 3 testing for another unmet need, in glioma.

 

Comparison's can be tricky, but in this case, I would consider the $11.95 stock price of Nuvation Bio ($4.1 billion valuation) the minimum price target, based on this comparison. Chart below, thank you for reading. 

Psychedelic Therapeutics

Second generation therapies using psychedelic drugs to treat mental health, is moving to the forefront at a rapid pace. The conversation now is which psychedelic will hit the market first, to serve their unmet need. We initially wrote about the subject here Psychedelic-Based Therapeutics. 

Not all psychedelics are identical in nature. Psilocin, DMT, and MDMA are the popular ones, all produced to act quickly with minimal dosing requirements. Here’s a list of five companies furthest along in their clinical trials, that have successfully raised the needed capital to progress further toward FDA approval, and commercialization.

ATAIBeckley, Compass Pathways, Cybin, GH Research, and MindMed.

ATAIBeckley - BLP-003

ATAI is addressing treatment resistant depression with their psychedelic drug (BLP-003) mebufotenin benzoate, and their means of dosing is an intranasal inhalant. The company has completed Phase 2b Results and is now in the process of meeting with the FDA to discuss the design of their phase 3 clinical trials. Those phase 3 trials are expected to commence in the second quarter of 2026. BLP-003 has Breakthrough Therapy Designation.

Compass Pathways - COMP360

Compass is furthest along in their clinical trials addressing treatment resistant depression with their lead oral candidate psilocybin COMP360. Completion their first phase 3 clinical trial (COMP005) is posted here COMP360 Phase 3  With their second phase 3 clinical trial with (COMP006), to be completed in the first quarter of 2026. COMP360 has Breakthrough Therapy Designation.

Cybin - CYB003

Cybin is addressing adjunctive major depression disorder (MDD) with their lead deuterated psilocybin oral candidate CYB003. The company has completed Phase 2 Results and has recently raised the needed cash to fund the operation through phase 3 readouts. Cybin is currently running three phase 3 clinical trials with CYB003 as an adjunctive therapy for patients. The first phase 3 APPROACH will have data by the fourth quarter 2026. EMBRACE to begin a global phase 3 in the fourth quarter of 2025, and EXTEND which is the long-term open label study currently enrolling the completers of APPROACH and EMBRACE to confirm long-term safety and efficacy. CYB003 has Breakthrough Therapy Designation.

GH Research - GH001

Similar to ATAI, GH Research is addressing TRD with an intranasal inhalant with psychedelic mebufotenin. The company has completed Phase 2b Results, and is on schedule to meet with the FDA for a post phase 2 meeting to discuss phase 3 clinical design. The company is well funded, having raised capital after the announcement of phase 2 results. Their goal is to commence phase 3 testing in 2026.

MindMed - MM120

Mind Medicine’s lead candidate is lysergide D-tartrate (LSD) with MM120 for generalized anxiety disorder (GAD). The company has completed Phase 2b Results and currently has two phase 3 clinical trials running called Voyage and Panorama. The potential completion for Voyage is late 2026 and Panorama mid-year 2027. The long-term open label 40-week extension study Part B, is available for the completers of Voyage and Panorama. The company is well financed and has Breakthrough Therapy Designation for MM120 and GAD.

The companies listed have set up intervention protocols for the patients, after the dosing of their therapeutic. The five companies written about here hold great potential for new innovative therapeutics for mental health, and at the same time, there are many challenges getting the therapies approved. At this writing we are only interested in Cybin for investment. Thank you for reading. 

CYBN: Cybin - Update #3

Psychedelic drug company Cybin is tackling two unmet medical needs, MDD and GAD with investigative psychedelic drugs CYB003 and CYB004. We wrote about psychedelic based therapeutics here Psychedelic Based Therapeutics. Today, Cybin updated investors on their recent quarter ending September 30. Below are some highlights from the conference call.

CYB003 

• Phase 3 dosing for clinical trial APPROACH NCT06564818 continues
• APPROACH to complete and report results by 4th quarter 2026
• Global Phase 3 EMBRACE to begin 4th quarter 2025
• EXTEND long term safety study is currently enrolling completers 

CYB004

• Phase 2 study for GAD to report results first quarter 2026

CYB005

• Under early investigational studies

Financial

• $226 million current cash on hand
• 49,894 million shares outstanding
• 16,810 million warrants outstanding, avg weighted conversion price of $10.11

NUVB: Nuvation Bio - Update #6

This morning Nuvation Bio gave investors a nice update of 3rd quarter financial results. In just their first quarter of commercialization with the FDA approved drug Ibtrozi (taletrectinib) for ROS1 NSCLC, the company achieved 7.7 million in total revenue. The company also guided on their pipeline which includes oral drug Safusidenib for IDH1 high-grade gliomas. Key points of progress in the 3rd quarter report and conference call. 

Ibtrozi (taletrectinib)

• Ibtrozi 3rd quarter sales of $7.7 million 
• Ibtrozi DOR (duration of response) has reached 50 months

Safusidenib

• Begin Phase 3 Safusidenib maintenance treatment high-grade 3 or 4 gliomas
• No other market entrants have been approved for high-grade gliomas
• Global phase 3 safusidenib trial has registrational potential

NUV-1511

• Clinical trial update 4th quarter

Financial

• $549 million cash on hand, end of 3rd quarter
• $25 million milestone payment fourth quarter
• 543 million shares outstanding

NUVB: Nuvation Bio - Update #5

A purely technical post regarding Nuvation Bio (NUVB). Technical analysis is the practice of using historical data and current price action, to predict future price movements. Since March of 2024 the stock has hit the $4.00 ceiling level and has turned back down on three occasions. It could be investors taking profits, or short sellers looking for opportunity at that level. NUVB finally broke out higher of that level this week, bringing in new technical strength of higher prices to the stock, chart below. The company will report third quarter earning's on November 3rd, when we'll get the fundamental investment details. 

 

Auvelity Prescription Update - 3rd Quarter

Axsome Therapeutic's drug, Auvelity was approved for depression in 2022, and completed it's first full year of commercialization 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 third quarter of 2025 numbers have not been released yet, so a rough estimate (2221,000) has been created based on data tracking. See chart below of prescription data. Axsome reports third quarter results on November 3rd.

NUVB: Nuvation Bio - Update #4

Nuvation Bio's (NUVB) recently FDA approved drug (taletrectinib) known commercially as Ibtrozi, has only been on the market for three month's since approval in June. Expectations for revenues are now just being released by research firms. S&P Global has released an estimated revenue projection for Ibtrozi for ROS1-positive non-small cell lung cancer (NSCLC), versus it's competitors in the same space. Graph below is from Visible Alpha, part of S&P Global market intelligence. The entire article can be viewed here ROS1 Lung Cancer Market.

GOLD - New High $3,448

You don't hear a lot about gold from the general press, but gold closed at an all-time, new high last week at $3448 / ounce. The usual reasons we posted here Gold - New High are in play and haven't changed. Chart below of gold, thank you for reading.