Vertex Falls After FDA Doubts Broad Use of Chronic Pain Drug
Vertex has been trying to diversify beyond its core business of cystic fibrosis treatments. A key part of that strategy has been its new non-opioid pain drug, Journavx, which got US regulatory clearance in January. It was the first new type of painkiller to reach the US market in more than two decades.
Shares of Vertex Pharmaceuticals fell as much as 14% in premarket trading on Tuesday. The stock is up 17% since the start of the year through Monday's close.
The company is also developing the pill, a safer alternative to addictive opioids, for chronic pain caused by nerve damage. US Food and Drug Administration staff members reviewing a study of the drug said they didn't see a path forward for widespread use in the condition at this time, Vertex said in a statement disclosing its second-quarter earnings results.
The drugmaker also has been studying other drugs in its pipeline to see if they have better efficacy than Journavx. The experimental pain drug VX-993 failed in a mid-stage study for treating acute pain, and Vertex halted its development as a standalone therapy for the condition, it said in a separate statement.
The setback at the FDA and mid-stage trial failure 'should cause a rethink of the overall opportunity and risk profile for the pain franchise,' RBC Capital Markets analyst Brian Abrahams said in a note.
The drugmaker said it would conduct a second trial of Journavx in patients with diabetic peripheral neuropathy, and won't start a final study that was being planned in a different condition. Diabetic peripheral neuropathy is 20% of the neuropathic pain market, Abrahams said.
More than 110,000 prescriptions for the medicine have been written and filled for acute pain conditions since it became available in early March, the company said.
The novel pain drug VX-993 didn't yield a statistically significant benefit for patients getting bunionectomy surgery, the company said. The failure suggests 'it may be more challenging than some expected to iterate and improve upon' Journavx, Abrahams said in a note.
The FDA's stance removes the potential for Vertex to capture the broadest chronic pain market, he said.
The company also reported second-quarter revenue and profit that came in ahead of analyst estimates, and reaffirmed its full-year revenue view.
Chief Scientific Officer David Altshuler announced his plan to retire on Aug. 1, 2026. Mark Bunnage, the current senior vice president of global research, will take over the role on Feb. 1 as part of a transition plan, the company announced.
--With assistance from Subrat Patnaik.
(Updates with premarket shares in the third paragraph.)
More stories like this are available on bloomberg.com
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