Theratechnologies Inc T.TH

Intercept slips due SAFETY of Ocaliva

[scarlet1967]

"

Intercept Pharma slips 5% on FDA inquiry into safety of obeticholic acid

Oct. 08, 2020 11:41 AM ETIntercept Pharmaceuticals, Inc. (ICPT)By: Douglas W. House, SA News Editor9 Comments

• Intercept Pharmaceuticals (ICPT -5.1%) is down on 60% higher volume in reaction to a report that the FDA is investigating a potential safety signal related to Ocaliva (obeticholic acid), specifically, the risk of liver injury. The inquiry began in May and could take a year to complete.
• The agency granted accelerated approval of the farnesoid X receptor agonist in May 2016 for primary biliary cholangitis which slowly destroys the bile ducts. Two Phase 3 studies in NASH patients are ongoing."

As per their latest Quarter:
"Net Loss

In the second quarter of 2020 we reported a net loss of $63.3 million, a decrease compared to a net loss of $71.4 million in the second quarter 2019.

Cash Position

As of June 30, 2020, we had cash, cash equivalents, restricted cash, and investment debt securities available for sale of approximately $540.6 million.  As of December 31, 2019, we had cash, cash equivalents, restricted cash, and investment debt securities available for sale of approximately $657.4 million."

They seem to have major safety issue with their drug and significant negative cash flow!(cash burn between 60 to 70 M per quarter)
ICPT market cap 1,25 B VS THTX 172 M??

[Wino115]

This highlights a significant benefit that THTX has and should pitch like heck in their books, and that is SAFETY. I don't know what the appropriate weight of safety versus efficacy should be in analyzing the progression of a drug through trials, but it seems in NASH they have been sort of equal in all the various failed trials.  Gilead's ASK1 inhibitor had no efficacy, same for

[qwerty22]

There is research that can shed light on safety versus efficacy, I read a while ago. My memory is that of trials that fail/stop a small percentage stop for 'commercial' reasons. Of the rest about 1/3 fail because of safety at Ph3 and 2/3 fail for efficacy. As you say safety more commonly comes to light earlier but it's still a big risk at Ph3. I did my own personal wonky logic

[qwerty22]

Ok those numbers are wrong. When you strip out commercial/strategic stoppages then the overall failure (at any phase) split 2/3 efficacy 1/3 safety. In phase 3 when you strip away the "others" then the failures are roughly split 80% efficacy and 20% safety. So while safety is still a big source of risk it's not so big at Ph3. It still worth Theratech shouting about this because I

[realitycheck4u]

This post has been removed in accordance with Community Policy

[ggg088]

Who can estimate the time of the submission to FDA?

[SPCEO1]

Based on what the company has said on this subject, sometime this week would be likely. The fact that they chose to release their Q3 financials later than normal tells me they are likely trying to have the protocol submitted  by10/15 so they can announce that at the same time. But, these things are pretty complicated so don't be surprised if we have to wait a bit longer than 10/15.

[palinc2000]

The delay in releasing the Q3 financials coupled with the pre announcement of the bad sales results indicate that the odds of submitting the NDA are high imo,The CC will be about the future and not on the sub par results but at the same time I hope they adress the sales trajectory for the coming quarters .....We need soon 20 million in Quaeterly sales trending towars 25 million by 3 rd Quarter

[scarlet1967]

That's why I have been repeating myself many times re marketing the R&D programs,if the company can increase the sales using different strategies it's great failing that both protocols require funds sooner or later so the company either bite the bullet and issue an offering before the SP moves higher or possibly a partnership agreement. If they manage to close the valuation gap

[scarlet1967]

"The anti-fibrotics have really faded bigtime", I think you might have a good point there both in the conference and in the investor presentation they are trying to link the reduction of liver fat to reduction of inflammation/fibrosis. For instance GH decreases reactive oxygen species (causing cell death) inducing mitochondrial function thus less inflammation AND fibrosis, study done on

[Wino115]

Two questions for you (or others). 1. What 800 patient study was done on tesamorelin? Is that the one where Takara Stanley went back and followed up on a hundreds of past users and got various readings.  I'm guessing that's the one you're referring to. 2. Does anyone have thoughts on what the Akero guys are daying about their drugs MOA stoping both lipolysis and lipogenesis

[scarlet1967]

https://pubmed.ncbi.nlm.nih.gov/28832410/ [/quote]

[scarlet1967]

It sounded like he tried to link the outcome of the study to a healthy liver( reduction of inflammation/fibrosis)

[qwerty22]

It's a 2ndary analysis of the Lipo Ph3 patients looking at liver enzyme. Maybe I should look this up but what is the mechanism behind raised ALT/AST. Is that just dead/damaged hepatocytes releasing the enzymes? [/quote]

[qwerty22]

  [/quote]

[scarlet1967]

It seems as both of you mentioned they need to coordinate all these data putting together a convincing protocol before submission explaining the LONG wait. It might be more to it such as additional data as it seems they have been adding/revealing a little bit more whenever they discussed the program publicly. I really hope they DO NOT wait too long before starting the marketing of the R$D programs