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Investing.com -- The U.S. Food and Drug Administration (FDA) last week extended its review of Bayer’s elinzanetant, delaying the Prescription Drug User Fee Act (PDUFA) date to October 26, 2025.
The decision came after the FDA designated Bayer’s (ETR:BAYGN) recent response to an information request as a Major Amendment. The original review deadline was set for July 26.
Barclays (LON:BARC) views the development as “a small negative for Bayer,” though analysts remain positive on the drug’s approval prospects. The bank said the delay likely won’t affect Bayer’s 2025 sales guidance, noting the company still anticipates global peak sales of €1 billion for elinzanetant.
The main issue now is whether the drug can avoid the FDA’s most severe labeling requirement. “We see the key debate being the potential to avoid a liver tox black box warning (vs. Veozah),” analysts wrote, referencing Astellas’ rival product, which received such a warning after a post-marketing case of liver injury.
To date, Bayer’s clinical trials have not shown serious liver toxicity signals. While five cases of reversible liver enzyme elevations were reported in the OASIS-4 trial, they did not meet the criteria for Hy’s Law, according to an independent safety board.
Still, Barclays cautioned that the current delay “likely adds concern that this may be inevitable.”
Elinzanetant has already received approval in the U.K. and Canada under the brand name Lynkuet, with further submissions pending in the European Union and other markets. The drug targets moderate to severe vasomotor symptoms due to menopause, an area with significant unmet need.
Bayer is expected to provide further clarity during its second-quarter earnings call on August 6. Analysts at Barclays continue to see elinzanetant as approvable and potentially positioned for competitive differentiation—if it clears the review without a black box warning.