May 1 (Reuters) – AstraZeneca shares fell nearly 2% on Friday after a U.S. Food and Drug Administration advisory panel voted overnight against recommending an experimental cancer treatment the drugmaker sees as key to its long-term growth ambitions.
The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted six to three against camizestrant, being developed for a type of breast cancer in which tumours have a specific mutation, citing concerns about study design rather than safety or efficacy itself.
The camizestrant setback came on the same day the ODAC voted in favour of AstraZeneca’s Truqap drug for metastatic prostate cancer.
The drugmaker expressed disappointment over the camizestrant vote, but remained confident in its potential, saying it would continue working with the FDA, which typically follows the advice of its experts but is not bound by their recommendations.
Analysts appeared largely unfazed by the FDA move, as the panel did not question camizestrant’s potential but rather the trial design. That suggests the drug could still win approval based on data from other studies, they said.
‘MINOR’ SETBACK TO TARGETS
JPMorgan called the ODAC decision a “minor negative,” noting camizestrant would represent only about 1% of AstraZeneca’s overall valuation.
AstraZeneca expects up to 20 new medicine launches by 2030 to hit its $80 billion revenue target, including potential U.S. approval this year for camizestrant, the drug seen by the firm as generating over $5 billion in peak sales.
“The panelists’ concerns were focused on the trial design, its endpoints, and its ability to establish clinical benefit. This leaves the door open for other (camizestrant) programs,” Leerink analysts said in a note.
Shares of the FTSE 100-listed drugmaker, which exceeded first-quarter profit expectations on Wednesday, have gained nearly 30% over the past year and outperformed the benchmark index, which was down 0.5% on Friday.
(Reporting by Raechel Thankam Job and Pushkala Aripaka in Bengaluru; Editing by Sherry Jacob-Phillips and Emelia Sithole-Matarise)
Comments