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Non-alcoholic steatohepatitis (NASH), a severe anatomy of non-alcoholic fatty alarmist disease, is calmly the world’s bigger beginning biologic market. NASH biologic sales, in fact, could beat an agitative $62 billion as anon as 2028, according to assorted Wall Street analysts and industry insiders.
Which biotech companies are in the best position to account from this astronomic bartering opportunity? Intercept Pharmaceuticals (NASDAQ:ICPT) and Viking Therapeutics (NASDAQ:VKTX) arguably action two of the best able beginning NASH therapies in their corresponding pipelines. As such, let’s breach bottomward which of these NASH-oriented biotech stocks is the bigger buy appropriate now.
Intercept’s NASH applicant is Ocaliva, a selective farnesoid X receptor agonist that’s already accustomed for addition alarmist ache — primary biliary cholangitis (PBC) — in Australia, Canada, the EU, Israel, and the United States. Last February, the biotech apparent an 18-month acting assay of Ocaliva’s late-stage NASH trial, dubbed Regenerate. That acting blink at the abstracts appear that patients accepting the 25 mg dosage of the biologic met one of the study’s two co-primary endpoints — namely, advance in alarmist fibrosis by at atomic one stage, with no deepening of NASH.
Intercept is advancing to book authoritative applications for Ocaliva’s NASH adumbration in the U.S. and the EU afore the end of 2019. If it receives that expended approval, Ocaliva’s sales ability hit $5 billion aural a few abbreviate years. That’s a amazing bartering befalling for a aggregation with a bazaar cap today of about $2 billion.
What’s the catch? Intercept’s flagship alarmist ache medication produced awkward levels of pruritus (itching) in the high-dose (25 mg) arm of Regenerate. While this accurate ancillary aftereffect apparently won’t derail its approval for NASH, it could ultimately put it at a aggressive disadvantage. The acceptable news, though, is that Ocaliva stands to authority a basic cartel in the massive NASH bazaar for at atomic a year, if not longer.
Vikings’ NASH adversary is the mid-stage thyroid hormone receptor-beta agonist VK2809. In 2018, the biotech formed out an absorbing top-line readout for VK2809’s mid-stage balloon in patients with nonalcoholic blubbery alarmist disease.
This abstraction showed that VK2809 can bear abundant reductions in alarmist fat, after any austere ancillary effects, alike at low doses. Viking has been advancement VK2809 as a accessible “best-in-class” NASH analysis anytime aback that balloon abstracts was released.
The aggregation is anon gearing up for a Phase 2b abstraction to appraise VK2809 in biopsy-confirmed NASH patients. If things go according to plan, Viking should be able to advertise its abutting accumulation of NASH abstracts no after than the summer of 2020.
Based on this adorning timeline, VK2809 could be on clue for a bartering admission in mid-2022. By then, there could be two or three NASH drugs already on the market.
From a risk-vs.-reward standpoint, Intercept is the hands-down champ in this head-to-head matchup. Ocaliva has the best attempt at acceptable the aboriginal biologic to be accustomed for NASH, and the biotech additionally sports a adequately advantageous acquirement beck through Ocaliva’s PBC indication. Viking, on the added hand, could about-face out to be a late-comer to the NASH party, and it lacks an accustomed artefact to abatement aback on in the accident things don’t go according to plan.
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