Nash’s drugs suffer another blow, but hope remains

A negative vote by an FDA advisory panel on Friday seemed to spell the end of long-held hopes that Intercept Pharmaceuticals’ drug obeticholic acid would lead a pack of FDA-approved drugs to treat a liver condition known as non-alcoholic steatohepatitis, or NASH.

Even as the much-dwindled drug industry dreams that NASH will become a mega-category that took one more hit on Friday, analysts say there are some opportunities remaining.

It’s a far cry from the all-out madness of 2019, when dozens of drugs were in development, and all biopharmaceutical companies large and small were placing big bets on the NASH cure.

The field has seen disappointment after disappointment since then, with failed trials of NASH drugs from Gilead Sciences (ticker: GILD), Genfit (GNFT), Bristol Myers Squibb (BMY), NGM Biopharmaceuticals (NGM), and others.

Friday’s meeting of an outside panel of FDA advisors, who voted 12-to-0 with two abstentions that obeticholic acid’s benefits did not outweigh its risks, will all but ensure that the FDA will deny Intercept’s (ICPT) application for fast-track approval of the drug. .

Announcement – scroll to continue

One of the panelists, Dr. Christopher Coffey, a professor at the University of Iowa School of Public Health, said in remarks to the panel after his vote.

However, analysts Monday argued forcefully that comments at the meeting left room for approval of other NASH drugs, particularly Madrigal Pharmaceuticals’ remeasurement (MDGL), which produced very positive Phase 3 data in December.

Taken together, we see that the negative score from AdCom is quite reflective [obeticholic acid’s] “The clinical profile is not an indication that the agency is shifting goalpost,” William Blair analyst Andy Hsieh said in a note Monday. Intercept stock does not cover.

At midday Monday, Intercept shares were down 30.1%, Madrigal shares were up 1.2%, and Viking Therapeutics shares were up 1.2%.

Announcement – scroll to continue

(VKTX), which is also developing a NASH treatment, was up 2.1%.

Nonalcoholic steatohepatitis leads to scarring of the liver in its most advanced stage. Scarring of the liver can, in turn, lead to fatal conditions such as cancer or decompensated cirrhosis. Symptoms of non-alcoholic steatohepatitis do not appear until its terminal stage, and it usually takes patients years, or even decades, to develop into an incurable disease. By then, patients with nonalcoholic steatohepatitis are more likely to die of something else first.

Pharmaceutical companies have been dazzled by the newly identified condition, which afflicts large numbers of the adult population in Western countries. Barron He argued in late 2019 that investors should exercise caution, given the complexities involved in prognosis, and discuss whether treatment is necessary.

Announcement – scroll to continue

Friday’s vote provided further evidence that the skepticism was justified. While many of the counselors seemed satisfied with the effectiveness of Intercept, they were concerned about the drug’s safety concerns. While the FDA is not bound by its advisors’ decision, it is now unlikely that the agency will grant fast-track approval to the drug on its June 22 decision date.

For the Intercept, that likely means a strategic pivot. The company reiterated in a call to investors Monday that it may not complete an ongoing trial of obeticholic acid at NASH without prompt approval. The drug is already approved as a treatment for a liver condition called primary cholangitis. CEO Jerome D’Urceau said The Intercept will decide in the coming weeks whether to adopt a new strategy to “focus on profitability” while focusing on its approved index.

“If we’re in that scenario where we don’t get quick approval, again, we’re going to be ready to focus on profitability,” D’Urso said.

Announcement – scroll to continue

As for the rest of the sector, analysts said Monday they still see opportunity. Comments from FDA officials at the meeting seemed to confirm that the agency still believes NASH is a legitimate unmet medical need.

“Acting Divisional Director Frank Ananya’s letter… sounds like a message to the field: affirming that the FDA recognizes NASH as an unmet need, affirming that the FDA adheres to its guidelines, but asserting its benefit/risk bar is much higher.” Who is showing the drug Intercept, Raymond James analyst Stephen Seidhouse wrote in a note on Sunday, rating Intercept stock in Market Perform.

This is important to Madrigal and Vikings, who are hoping the FDA will look more favorably at their bids.

“the [FDA] It does not cover Intercept stock,” Lisa Baiko, an analyst at Evercore ISI, wrote in a note on Friday.

Write to Josh Nathan Kazis at [email protected]

#Nashs #drugs #suffer #blow #hope #remains

Leave a Comment

Your email address will not be published. Required fields are marked *

Scroll to Top