FibroGen Staring At Multi-Year Lows Following Adverse Roxadustat AdCom Verdict; How Hard Will The Stock Likely Fall?

FibroGen, Inc.’s FGEN shares are sinking to their lowest level since late June 2016.

FibroGen’s AdCom Snub  FibroGen said late Thursday that the Food and Drug Administration’s Cardiovascular and Renal Drugs Advisory Committee met to discuss the new drug application for roxadustat, and voted against approval of the drug.

Roxadustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor being evaluated to treat anemia due to chronic kidney disease in adult patients. The company is codeveloping the drug with U.K. pharma giant AstraZeneca plc AZN.

The committee voted 13-to-1 against approval of roxadustat for non-dialysis-dependent patients and 12-to-2 against approval for dialysis-dependent indications.

AdCom based its recommendations on data from a global Phase 3 program encompassing more than 8,000 patients.

The FDA would take into account AdCom recommendations but is not bound to follow the vote.

“While we are disappointed with today’s outcome, we believe the scientific evidence supports roxadustat approval in the U.S. and will work with the FDA as it completes its review of the New Drug Application for roxadustat,” said Enrique Conterno, CEO of FibroGen.

Roxadustat is approved in China, Japan, Chile, and South Korea to treat anemia of CKD in both non-dialysis-dependent and dialysis-dependent adult patients. It has also received a positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency.

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AdCom’s Decisive Vote Unlikely to Be Ignored By FDA, SVB Leerink Says:  The decisive ‘nay’ votes reflected FDA’s independent analysis of FibroGen’s safety database and their assessment that roxadustat was associated with an increased risk of death, thrombosis, stent occlusion, serious infections, seizures, and metabolic and gastrointestinal adverse events, SVB Leerink analyst Geoffrey Porges said.

Almost all of these imbalances were unknown to investors, who are likely to demand changes to the company’s board, management, staffing, portfolio, and expenses due to the outright rejection, the analyst added.

AdCom was toying with the idea of considering the company’s last-minute suggestions that it could address the issues by changing the dose titration scheme, using the medicine in only certain high unmet need sub-populations, restricting distribution, and conducting phase 4 studies, the analyst noted.

The panel, however, was unwilling to endorse any of these approaches without a large, randomized phase 3 safety and efficacy trial using the different dose titration scheme, he added.

The FDA is unlikely to ignore AdCom concerns, given efficacious alternative is available, Porges said.

According to Porges, the focus for FibroGen will now shift to pamrevlumab, its anti-CTGF antibody in phase 3 trials for pancreatic cancer and Duchenne’s muscular dystrophy. Top-line results for these pamrevlumab trials are not expected until the second half of 2022, he added.

Whither Goes FibroGen Stock?  FibroGen shares, which were halted for trading Thursday, pending the release of the AdCom verdict, were down 37.60% at $15.50 in after-hours trading.

By the after-hours slide, the stock fell below near-term support, around $19.70. Further below, the stock has long-term support at around $15.40. Its all-time low is at $14.38, reached on Feb.8, 2016.

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