Vertex Pharmaceuticals, FDA and Alyftrek

Vertex snags FDA nod for once-daily cystic fibrosis triplet Alyftrek as switch from Trikafta kicks off
As Vertex Pharmaceuticals reels from a painful trial readout for its pain candidate suzetrigine, the Boston biotech has chalked up a win in its specialty area of cystic fibrosis. | The FDA has approved Vertex’s Alyftrek,
Vertex Secures FDA Approval for New Cystic Fibrosis Drug Alyftrek
Vertex Pharmaceuticals VRTX announced that the FDA has approved its next-in-class vanza triple therapy for treating people with cystic fibrosis (CF) aged six years and above. The drug will be marketed under the brand name Alyftrek.
Vertex Wins FDA Approval for New Cystic Fibrosis Option but Stock Still Down
The new combination, dubbed Alyftrek, is designed to improve on the Trikafta, a product that generated sales of $8.9 billion in 2023. It’s welcome good news for Vertex following last week’s subpar clinical results for its non-opioid analgesic.
Alyftrek Gets FDA Approval for Cystic Fibrosis
The Food and Drug Administration (FDA) has approved Alyftrek (vanzacaftor/tezacaftor/deutivacaftor) for the treatment of cystic fibrosis (CF) in patients aged 6 years and older who have at least one F508del mutation or another responsive mutation in the CFTR gene.
Vertex drug for cystic fibrosis wins approval
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Vertex Wins An Early Approval; Why It Might Not Move Vertex's Beleaguered Stock
The Food and Drug Administration signed off on Vertex Pharmaceuticals' next-generation triple drug for cystic fibrosis late Friday.
FDA approves Alyftrek once-daily oral combination for cystic fibrosis
The US Food and Drug Administration has approved Alyftrek, a once-daily oral combination of vanzacaftor, tezacaftor, and deutivacaftor, for the treatment of cystic fibrosis (CF) in adults
Vertex wins approval for new once-daily CF drug
Vertex Pharmaceuticals Inc. notched two FDA victories late Friday for its cystic fibrosis medicines, increasing the number of patients eligible for its drugs and likely boosting its own future revenue.
Vertex secures two FDA wins for cystic fibrosis, both with boxed warnings
Vertex has won two cystic fibrosis approvals from the FDA, but the agency included high-level safety warnings.
Vertex black box warning for Alyftrek ‘somewhat a surprise,’ says Barclays
After Vertex Pharmaceuticals (VRTX) announced early FDA approval of Alyftrek in cystic fibrosis ahead of a PDUFA deadline on January 2, ...
Vertex Pharmaceuticals: Alyftrek Is An 'Accretive Opportunity' On Top- And Bottom-Lines, Says Bullish Analyst
Vertex Pharmaceuticals announced FDA approval for Alyftrek, which expands the company's CF franchise to address around 6,000 ...
Vertex Pharmaceuticals price target lowered to $460 from $550 at Truist
Truist analyst Joon Lee lowered the firm’s price target on Vertex Pharmaceuticals (VRTX) to $460 from $550 and keeps a Buy ...