Showing posts with label Taletrectinib. Show all posts
Showing posts with label Taletrectinib. Show all posts

Sunday, December 7, 2025

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. 

Monday, November 3, 2025

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

Sunday, September 21, 2025

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.



Saturday, August 16, 2025

NUVB: Nuvation Bio - 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. 


Wednesday, June 11, 2025

NUVB: Nuvation Bio - 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.

Saturday, May 31, 2025

NUVB: Nuvation Bio - 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. 


Monday, May 19, 2025

NUVB: Nuvation Bio

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