Vertex Pharmaceuticals Inc. (NASDAQ:VRTX) stock is falling on Tuesday after the company’s pain data overshadowed strong second-quarter earnings.
See real-time price for VRTX stock here.
On Monday, the company released data from the Phase 2study evaluating the safety and efficacy of its investigational selective NaV1.8 pain signal inhibitor, VX-993, in treating acute pain after bunionectomy surgery. Treatment with VX-993 did not result in a statistically significant improvement on the primary endpoint of the time-weighted Sum of the Pain Intensity Difference from zero to 48 hours (SPID48) compared to placebo.
“This proof-of-concept study was powered to test whether VX-993 would result in higher clinical efficacy than previously demonstrated with the NaV1.8 pathway,” said Carmen Bozic, Vertex’s chief medical officer, and executive vice president of Global Medicines Development and Medical Affairs.
“Based on these results, as well as the totality of preclinical data and results from our previous bunionectomy clinical studies, VX-993 is not expected to be superior to our existing NaV1.8 inhibitors, and therefore, we will not be advancing it as monotherapy in acute pain,” Bozic added in a statement on Monday.
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The Boston-based biotech’s 367-patient study enrolled bunionectomy (toe correction) surgery participants. All three doses failed to improve pain intensity over 48 hours. Based on these results, Vertex will not progress VX-993 into pivotal development as monotherapy in acute pain..
In January, the Food and Drug Administration approved Vertex’s Journavx, a non-opioid oral pain signal inhibitor for acute pain.
Vertex reported second-quarter revenue of $2.97 billion versus estimates of $2.90 billion, with adjusted earnings of $4.52 per share versus estimates of $4.29.
Total revenue climbed 12% year-over-year, primarily driven by the continued performance of cystic fibrosis (CF) therapies and early contributions from three ongoing launches. U.S. revenue was up 14% year-over-year, and revenue outside the U.S. increased 8% year-over-year.
BofA Securities analyst Tazeen Ahmad in an investor note on Tuesday said, “We see any weakness in share price as a particularly attractive buying opportunity given stronger than expected results for Casgevy and Journavx, and more importantly continued strength in the CF franchise, which is the main driver of our valuation.”
BofA Securities reiterates the Buy rating with a price forecast of $565.
Vertex will now focus on diabetic peripheral neuropathy (DPN) as its main target for chronic pain treatment after the FDA said it doesn’t currently support a broader label for peripheral neuropathic pain (PNP).
The company plans to start a second Phase 3 trial for DPN and expects to finish enrolling patients by the end of 2026.
Management noted that DPN accounts for about 2 million of the 10 million people with PNP and said it still aims to pursue a broader PNP label.
William Blair writes, “Vertex maintains a competitive moat.” Vertex’s current franchise in cystic fibrosis continues to grow from $9 billion yearly revenue towards William Blair’s over $12 billion peak sales estimate.
VRTX Price Action: Vertex stock is down 18.89% at $383.07 at publication on Tuesday.
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