Gilead Sciences acquired the drug Trodelvy when it bought the biotech Immunomedics in 2020.
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Gilead Sciences shares dropped sharply before recovering as the market opened, after a highly anticipated announcement of the results of a trial of the company’s breast cancer drug Trodelvy offered few details on its performance.
The company said the trial of Trodelvy in heavily treated patients with HR+/HER2- metastatic breast cancer succeeded in showing a statistically significant improvement in progression-free survival compared with chemotherapy.
Gilead (ticker: GILD) didn’t disclose what the improvement in progression-free survival was, or provide any other details on the results. It did say that the results were consistent with an earlier study, which found that progression-free survival of patients on the drug was 5.5 months.
The company also said Monday that the study “demonstrated a trend in improvement” in overall survival, but didn’t provide numbers.
In premarket trading, the stock fell as much as 4% from the Friday close of $61.86, hitting a 52-week low of $58.90 as the market opened. By mid morning, the stock had recovered to $61.47, for a loss of 0.6%.
Gilead said it would provide more details of the study at an “upcoming medical conference.”
Jefferies analyst Michael said he expects Gilead to offer more details when the American Society of Clinical Oncology holds its annual meeting in June. “Although top-line is technically positive and removes a worst-case scenario, Street may not get the clarity it needs for the stock to work until at least” then, he said.
“The debate by the Street was not necessarily if GILD could show a [statistically significant] benefit …but rather what magnitude of benefit Trodelvy can show,” Yee wrote.
Gilead acquired Trodelvy in 2020, as part of the $21 billion purchase of the biotech Immunomedics. The company reported $380 million in sales of Trodelvy in 2021.
The results of the trial, known as TROPiCS-02, have been the focus of investor attention for months. The FDA granted accelerated approval to Trodelvy to treat a narrower set of breast cancer patients in 2020, and upgraded it to full approval for that same narrow population last April.
The TROPiCS-02 trial tested the therapy in a more common type of breast cancer; approval could mean a broader population for the drug, and greater sales. Higher sales for Trodelvy would help justify the Immunomedics purchase.
Reading the tea leaves, analysts have suggested in recent months that Gilead management has been growing pessimistic about the trial’s outcome. “TROPiCS-02 messaging sounds bearish,” Raymond James analyst Steven Seedhouse wrote in a note out on Feb. 2.
Gilead shares are down 15% this year.
Write to Josh Nathan-Kazis at [email protected]
