Celcuity's stock moved lower in premarket trading Wednesday, falling roughly 8% as investors weighed the company's first U.S. drug approval against a delayed commercial rollout and notable safety signals.
The U.S. Food and Drug Administration on Tuesday granted approval for gedatolisib, marketed as Revtorpyk, for a specific group of patients with advanced breast cancer whose tumors do not harbor a PIK3CA mutation. The approval marks the first marketed product for Celcuity.
Company management said the product is expected to reach the market late in the third quarter. Celcuity attributed the timing to the need to ensure an adequate supply of the drug before beginning sales; the company did not provide a launch price. Needham analyst Gil Blum noted that Celcuity indicated Revtorpyk would be positioned at a premium relative to currently available therapies.
Analysts had largely anticipated regulatory approval, but the decision to postpone the commercial introduction surprised some observers given prior comments from the company about being launch-ready. Andrew Berens of Leerink Partners described the approval as expected, but said the later start date was unexpected in light of Celcuity's earlier statements.
Clinical results cited on Revtorpyk's label showed substantial benefit when the drug was given in combination with Pfizer's Ibrance and fulvestrant. In the late-stage trial, the three-drug regimen reduced the risk of disease progression or death by 76% versus fulvestrant alone. Median progression-free survival was 9.3 months for patients on the combination treatment, compared with two months for those receiving only fulvestrant.
However, tolerability is a prominent issue on the label. Twelve percent of patients receiving the three-drug combination discontinued treatment because of adverse effects. The label includes a warning that Revtorpyk can cause severe mouth inflammation and recommends preventive use of a mouthwash. Mouth inflammation occurred in 72% of patients given the three-drug regimen, with 22% experiencing severe cases.
Berens highlighted that Celcuity's commercial success will depend in part on the company's and physicians' ability to manage mucositis and keep patients on therapy. The need for effective management of oral inflammation, and the frequency of treatment discontinuation in the pivotal trial, were cited as central to the product's uptake.
Context and market reaction
- Shares fell about 8% in premarket trading following the approval and announcement of a delayed launch.
- Celcuity did not disclose pricing but indicated Revtorpyk would command a premium to existing options, according to an analyst.
- Analysts observed that approval was expected but the launch delay contrasted with earlier company statements about being ready to commercialize.
Clinical highlights from the label
- Risk of progression or death reduced by 76% with Revtorpyk plus Ibrance and fulvestrant versus fulvestrant alone.
- Median progression-free survival: 9.3 months with the three-drug regimen versus 2 months with fulvestrant alone.
- Safety: 12% treatment discontinuation due to adverse events; mouth inflammation in 72% of patients, severe in 22%.