Replies to post #233337 on Biotech Values

[DewDiligence]

ICPT cuts workforce 25%—170 jobs—due to NASH CRL on 6/29/20 (#msg-156582910):

https://www.sec.gov/ix?doc=/Archives/edgar/data/1270073/000110465920101204/tm2029969d1_8k.htm

The stock was +4% today (investors like cost-cutting); however, the stock is -64% from its Jan 2020 high and an astonishing -91% from its all-time high in Jan 2014.

Ocaliva sales in PBC will probably put a floor under the share price, but the chance of Ocaliva being resurrected for NASH is close to nil, IMO.

[DewDiligence]

ICPT—FDA identifies new Ocaliva safety signal:

$ICPT —This language about a new safety signal is "hidden" insofar as it was inserted in the middle of a paragraph that addresses an unrelated subject (the 2018 black-box warning in the PBC label). My view of Ocaliva continues to be as tweeted in Dec 2019: https://t.co/7WUUuQDrxT

— Roy Friedman (@DewDiligence) October 6, 2020

(scan up)

[DewDiligence]

ICPT +14% on “productive meeting with FDA” about the possibility of resubmitting the rejected NDA for Ocaliva in NASH sometime in 2021:

https://finance.yahoo.com/news/intercept-pharmaceuticals-reports-third-quarter-120000280.html

Caveat emptor.

[DewDiligence]

ICPT CEO/co-founder quits:

https://finance.yahoo.com/news/intercept-pharmaceuticals-announces-leadership-transition-130000475.html

[DewDiligence]

ICPT will resubmit Ocaliva NDA in NASH based_on_new_data_analyses:

https://www.globenewswire.com/news-release/2022/07/07/2475765/23024/en/Intercept-Announces-Positive-Data-in-Fibrosis-due-to-NASH-from-a-New-Analysis-of-its-Phase-3-REGENERATE-Study-of-Obeticholic-Acid-OCA.html

Good look with that! New data analyses can’t alter the fact that Ocaliva is simply a bad drug for NASH.