The Food and Drug Administration signed off on Vertex Pharmaceuticals' next-generation triple drug for cystic fibrosis late Friday. But it might not help beleaguered Vertex stock.
The drug will sell under the brand name, Alyftrek. It will treat patients age 6 and older with specific genetic mutations tied to the lung disease.
The approval comes roughly two weeks ahead of time and follows a major setback Thursday for Vertex's pain drug. Vertex stock slumped 11% after the non-opioid pain drug showed little difference from a placebo in a midstage test.
RBC Capital Markets analyst Brian Abrahams noted analysts largely expected the approval.
"Importantly, today's early approval also avoids any potential delays from a potentially drawn-out Federal government shutdown," he said in a report. "As we had anticipated, Alyftrek will be priced at a premium to Trikafta."
Trikafta is Vertex Pharmaceuticals' biggest moneymaker. It's another triple drug that treats cystic fibrosis. Trikafta goes for $346,043 a year — before insurance reimbursement and rebates — while Alyftrek will cost $370,269, Abrahams said. Alyftrek is a once-daily pill.
But Abrahams says the approval of Alyftrek is unlikely to move the needle for Vertex stock.
"Much of this was anticipated and the next-gen is priced at a premium that we also believe many were expecting," he said, noting the boxed warning for liver injury and failure is "new and unexpected, though we do not believe will meaningfully impact uptake."
In late trades, Vertex stock slipped a fraction to 394.54.
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