On Friday, the U.S. Food and Drug Administration (FDA) extended the review period for Exelixis Inc.‘s (NASDAQ:EXEL) new drug application (NDA) for zanzalintinib, in combination with atezolizumab, for metastatic colorectal cancer by three months.
• Exelixis stock is under selling pressure. Why is EXEL stock retreating?
In response to an FDA information request, Exelixis submitted updated safety and efficacy data, which the FDA has deemed a major amendment.
The updated Prescription Drug User Fee Act action date is March 3, 2027.
Analyst View
William Blair on Friday wrote, “While we are surprised by the three-month delay, we believe the risk of rejection remains low, given that the combination of zanzalintinib plus Tecentriq demonstrated an overall survival (OS) benefit across the intent-to-treat population in the Phase 3 STELLAR-303 study.”
Although analyst Andy Hsieh acknowledged the challenge of pinpointing the exact motives of the regulator, he outlined three plausible reasons for the request.
First, regulators might require additional clinical data comparing the 100 mg dose against the 60 mg dose of zanzalintinib.
Second, health officials could be seeking clearer evidence regarding the individual therapeutic contributions of zanzalintinib and Tecentriq.
Third, regulators may be addressing a specific technical query that Wall Street observers had not previously highlighted during earlier review phases.
Market Reaction and Commercial Impact
Despite the regulatory hurdle, Hsieh emphasized that the three-month postponement should not significantly diminish long-term revenue potential for zanzalintinib.
However, the analyst warned that investors should prepare for heightened equity volatility in the short term.
EXEL Stock Price Activity: Exelixis shares were down 1.81% to $56.39 at the time of publication on Friday, according to Benzinga Pro data.
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