Theratechnologies Inc T.TH

FDA approved Gilead’s AD

[scarlet1967]

The drug can cause severe neutropenia yet it got approved due to lukewarm results, now they want to go global. It shows a drug used as a last line of defence can get approved even with serious adverse effects and..,,

“Today’s approval is the culmination of a multi-year development program and validates the clinical benefit of this important treatment in metastatic TNBC,” said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. “Building upon this milestone, we are committed to advancing Trodelvy with worldwide regulatory authorities so that, pending their decision, Trodelvy may become available to many more people around the world who are facing this difficult-to-treat cancer.”

 

https://www.gilead.com/news-and-press/press-room/press-releases/2021/4/fda-approves-trodelvy-the-first-treatment-for-metastatic-triplenegative-breast-cancer-shown-to-improve-progressionfree-survival-and-overall-surviv

 

Trodelvy also may cause serious side effects, including:

• Severe neutropenia: Neutropenia means you have abnormally low levels of neutrophils, a type of white blood cell. People with neutropenia have a much higher risk of getting serious infections. Your doctor will monitor your neutrophil counts while you are being treated with Trodelvy. If you develop neutropenia, you may be treated with a granulocyte-colony stimulating factor medicine such as Neupogen (chemical name: filgrastim), Neulasta (chemical name: pegfilgrastim), or Zarxio (chemical name: filgrastim-sndz).
• Severe diarrhea: Severe diarrhea can cause dehydration, low blood pressure, and severe kidney problems. Tell your doctor about any diarrhea you have so it can be treated right away.

 

Trodelvy (sacituzumab govitecan): Side Effects, How it Works, and More

[scarlet1967]

ADC

[Wino115]

This is the Immunomedics drug they bought in the $21bil deal. I think this is also why that KOL said a 3L/4L TNBC drug with a 20-30% response rate and 2 months of PF survival is a huge improvement.  That seems to be the bar to meet or exceed with TH1902 for the TNBC indication.

[scarlet1967]

  As per our old friend Brian Abrahams to justify the 21 billion price tag the peak sales should be around 5 billion for breast cancer indication, one has to wonder if THTX’s PDC lines get approved chasing 5 or 6 cancers what the price tag would be?   “A renowned oncologist who directs the breast cancer division at a major research hospital and institute in the U.S. labeled

[Wino115]

You'll recall I used some projected revenue numbers from a firm on various cancer indications on each of the 5 in the basket portion of the trial. I discounted them for starting just as 4L.  What I came up with was that mTNBC would be the largest at around $2bil and the others would each be around $1-$1.5bil.  So it could be in that $5bil+ range for peak.  If you moved it down

[scarlet1967]

That post was great I believe someone reposted on Stocktwits too.

[scarlet1967]

This is BA’s report at the time. On 'Trop' of the World: Updating Our Model to Reflect Transformative IMMU Trop-2 ADC Deal Our view: Yesterday evening GILD announced a $21B acquisition of IMMU, primarily for their lead asset Trovaldy, and we are now incorporating sales and related opex from the transaction into our model. Based on our new ests., we see $4B out-year probability-weighted

[Wino115]

Funny how he gets the name of the drug wrong.  Anyway, he's got $6.5bil globally for the three indications listed (breast, bladder, lung).  Fairly similar to the Barclays numbers, but a tad lighter on the TNBC, but discounts for probabilities and various stages it could be used for.  So they're all around the same general level.  I think this supports the SORT1

[qwerty22]

I think it's worth drilling down on that data just to see where that value comes from. I'm no expert on this so assume some of it might be wrong. https://www.gilead.com/news-and-press/press-room/press-releases/2021/4/fda-approves-trodelvy-the-first-treatment-for-metastatic-triplenegative-breast-cancer-shown-to-improve-progressionfree-survival-and-overall-surviv The most clinically