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The Fda turned down Gilead Sciences’ application for a would-be hit arthritis drug Tuesday night, blindsiding financiers. One analyst called the advancement a “near-worst-case situation” and a “shock.”
Dreamstime.
The Food and Drug Administration decision to decline.
Gilead Sciences
‘ application for a would-be blockbuster arthritis drug, announced Tuesday night, blindsided financiers Wednesday morning, rushing shares of a handful of significant biopharma companies.
The drug, a so-called JAK inhibitor called filgotinib, was set to be a significant product for Gilead (ticker: GILD). J.P. Morgan analyst Cory Kasimov composed Tuesday night that he had actually previously estimated that the drug would generate $2 billion annually in sales at its peak; FactSet consensus estimates have the drug hitting $989 million in sales by 2025.
Now, that’s all been thrown into concern. Gilead stated Tuesday evening that the company had released a so-called total action letter to the company’s application for filgotinib, stating that it wanted data from ongoing research studies on the drug’s impact on patients’ sperm counts before it made a decision on the drug.
Cowen analyst Phil Nadeau composed Tuesday night that the advancement delays filgotinib’s launch in the U.S. by at least a year.
Gilead stock was down 3.2%on Wednesday early morning, while shares of GIlead’s partner on filgotinib,.
Galapagos
( GLPG), were down 24.3%. Shares of.
AbbVie
( ABBV), which sells Rinvoq, a member of the very same class of medications as filgotinib, were up 1.3%, while shares of.
Pfizer
( PFE), which likewise offer drugs of the same types, were up 0.3%. The.
S&P 500
was up 0.2%.
In a note out Tuesday night, Kasimov called the advancement a “near-worst-case situation” and a “shock.”
In addition to the concerns around the drug’s influence on sperm count, Gilead said that the FDA had “revealed issues” about the risk/benefit profile of a 200 milligram dosage of the drug.
” The potential absence of dosing versatility might impact filgo’s competitive profile,” Kasimov composed. “Even more, this provides rivals another year in which to construct on their market lead.”
Rheumatoid arthritis is a tremendously competitive indicator, offered the big patient population.
For Galapagos, the European biotech working with Gilead, the picture is especially worrying. “We continue to remain confident in the scientific profile of filgotinib, however we find regulative decisions such as these very tough to handicap,” wrote Cantor Fitzgerald analyst Eliana Merle in a note out Wednesday.
In a statement Tuesday night, Gilead’s primary medical officer, Dr. Merdad Parsey, said that the company was disappointed, however still thinks “in the benefit/risk profile of filgotinib in [rheumatoid arthritis].” Galapagos’s chief medical officer, Dr. Walid Abi-Saab, stated that the letter was “extremely disappointing given the robust and extensive data plan offered.”
Write to Josh Nathan-Kazis at josh.nathan-kazis@barrons.com
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source https://jobsearchtips.net/potential-gilead-blockbusters-rejected-by-fda-why-thats-the-near-worst-case-situation-for-gilead-stock/
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