SUMMARY
Ocaliva's approval in PBC required post-approval studies
ICPT reported out 1 positive and 1 negative clinical trial result for some post-approval studies
The market could have reacted more negatively to the news
There are a number of competitors in clinical trials for PBC
For a more detailed analysis of this event, and our Amp's ICPT trading strategy based on this data, and the upcoming ICPT Phase 3 catalysts in NASH, see our expanded version of this article available to Pro subscribers. (SIGN UP NOW (free trial))
Today, #ICPT announced (INTERCEPT ANNOUNCES NEW CLINICAL TRIAL AND REAL-WORLD OUTCOMES DATA FOR OCALIVA IN PBC) one negative (COBALT) and one positive real-world study (HEROES-US) results for its lead asset, #Ocaliva, in its currently approved indication, primary biliary cirrhosis (#PBC). ICPT was down 7.2% today on the news. The market could have even been more negative on the news based on the fact that the COBALT study did not demonstrate a statistically significant difference between Ocaliva and placebo on the primary endpoint. Although the COBALT study was stopped early because of recruitment issues, it was the post-marketing study intended to support continued approval of Ocaliva, which was initially approved on an accelerated basis. Thus, there is more risk now, that ICPT will lose its approval of Ocaliva in PBC, which generated $363.5M in sales in 2021 (subscribers see the Ocaliva in PBC BPIQ card).
The market is at least partially giving ICPT the benefit of the doubt of continued approval based on the positive HEROES-US data, despite the negative COBALT readout and the fact that HEROES-US is not a placebo-controlled study. Rather it compares real-world Ocaliva data to a control group based on prior data in a database registry. That study showed a statistically significant and clinically meaningful reduction in all-cause death, liver transplant, or hospitalization for hepatic decompensation among Ocaliva-treated patients compared to the control group. The question now is whether the FDA will continue to approve Ocaliva for PBC given the negative COBALT results, based on HEROES-US and another positive open label study reported last year.
As far as PBC, UDCA is the current standard of care, but ~40% of patients have an inadequate response to UDCA (See Chascsa et al. 2020). Ocaliva is an FXR agonist that is approved for treatment of PBC in combo with UDCA or as a monotherapy for patients unable to tolerate UDCA (See Ocaliva label). A review of the BPIQ pipeline screener reveals CALT's Setanaxib (Ph2/3), CBAY's Seladelpar (Ph3), and GNFT's Elafibranor (Ph3), as ICPT's primary smid-cap company PBC therapeutics in clinical trials. From BPIQ's catalyst calendar it looks like 2023 should be a big year for report-outs of clinical trials for these assets. Today's negative news for ICPT possibly had a negative effect on these stocks with CALT (+0.35%), CBAY (+0.99%), GNFT (+0.32%) by illustrating the difficulties of PBC trials. Smid-cap biotech stocks were generally up much higher today, with XBI up 3.55%. Over the past year, ICPT (-9%) has actually fared much better than these other PBC/liver stocks (CALT -33%)) (CBAY -53%) (GNFT -13%), as well as smid-cap biotech more generally (XBI -44%).
For a more detailed analysis of this event, and our Amp's ICPT trading strategy based on this data, and the upcoming ICPT Phase 3 catalysts in NASH, see our expanded version of this article available to Pro subscribers. (SIGN UP NOW (free trial)).
If you are serious about investing in biotech stocks BPIQ is the research companion that will take you to the next level.
Save yourself time by accessing our database of over 550 companies, 1,800+ of their drug assets, and tools including: Catalyst Calendar, Big Movers, Company Pipelines, and more!
See what our members are saying about us:
Mike from United States
“Really loving the site over the competitor... like the layout and speed over the competition...like the individual pages for each drug/treatment”
Carl from United States
“I like your service. I haven’t seen anyone else doing something similar...nothing like this available for retail.”
Essey from Canada
“Love what you’re doing, this website is awesome.”
James from United States
"Great site and I see it’s a family run business, great job.”
This article is NOT legal, investment or tax advice. Please do your own diligence before making any investments.