CYBN: Cybin ($6.28) - 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 ($5.09) - 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 Obtrozi (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. 

Obtrozi (taletrectinib)

• Obtrozi 3rd quarter sales of $7.7 million 
• Obtrozi 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

NUVB: Nuvation Bio ($4.50) - 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 ($3.22) - Update #4

Nuvation Bio's (NUVB) recently FDA approved drug (taletrectinib) known commercially as Obtrozi, 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 Obtrozi 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 $3448

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. 

NUVB: Nuvation Bio ($2.75) - Update #3

An update on Nuvaton Bio's progress the past few months, as the company and stock have been performing well since receiving FDA approval of Taletrectinib, a drug for ROS1-positive non small cell lung cancer (NSCLC). Another drug in their pipeline NUV-1511 is in clinical studies for five indications. 

 Financial Statistics: 

• $608 million cash
• Debt - minimal
• 341 million diluted shares outstanding
• 938 million market cap

Intellectual Property:

• Taletrectinib - Expected to expire from 2033 to 2042
• Safusidenib - Expected to expire from 2035 to 2041
• NUV-1511 - Expected to expire 2039 to 2043

Nuvation Bio's pipeline includes NUV-1511 a drug known as a DCC (drug-drug conjugate), which is in a phase 1/2 being tested for patients with advanced solid tumors in five separate indications here NUV-1511. This large study will include 466 patients to conclude in early 2027. The company expects more details forthcoming. Weekly chart below of Nuvation, thank you for reading. 

Axsome 2nd Quarter Financial Results ($103.59)

Axsome Therapeutics is getting closer to becoming a profitable company, on a cash and earnings per share basis.  An impressive 2nd quarter, with highlights below. 

• On target to file a supplemental NDA for Alzheimer's Agitation 3rd quarter
• 150 million in second quarter revenue
• 303 million in cash

Chart below of Axsome Therapeutics, with corrections that the stock has endured the last few years. The average correction falls in the range of around 30%. Thank you for reading.

Auvelity Prescription Update - 2nd 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 second quarter of 2025 numbers have not been released yet, so a rough estimate has been created based on data tracking. See chart below of prescription data. Axsome reports second quarter results on August 4th.

CYBN: Cybin ($7.94)

Cybin is in late stage psychedelic-based development, with drug CYB003 for depression. We wrote about psychedelic drug emergence last year, Psychedelic-Based Therapeutics. The drug was granted FDA Breakthrough Therapy Designation, after they completed phase 2 testing.

Current developments: The company raised $50 million US Dollars with a financing agreement with High Trail Special Situations on June 30th. With this current financing completed, their financial situation for ongoing clinical development is estimated to be.

Financial Statistics:

- US $120 million of cash on hand (approximation)

- Debt - minimal

- 23 million shares outstanding

- 182 million market cap

- 50 million convertible debt

Intellectual Property: 

- CYB003 Expected to expire in 2041

- CYB004 Expected to expire in 2041

Cybin is a high risk investment at this time, as they have zero commercial assets, and are in late stage clinical development with lead drug CYB003 with results expected in 2026. Thank you for reading. 

NUVB: Nuvation Bio ($2.20) - Update #2

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.

NUVB: Nuvation Bio ($2.12) - Update #1

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.