Bayer Stock: Impact on Approval and Market Potential

FDA delays Bayer’s elinzanetant review to Oct 2025 amid liver safety concerns; global approvals still on track.

29 July 2025, 15:07 published Updated 29 July 2025, 15:07

Bayer Stock- FDA Flags Bayer’s Elinzanetant for Major Amendment

Bayer Stock– Last week, the U.S. Food and Drug Administration (FDA) officially extended its review timeline for Bayer’s elinzanetant, pushing the Prescription Drug User Fee Act (PDUFA) date back to October 26, 2025. This comes after the FDA labeled Bayer’s latest response to an information request as a Major Amendment, a move that resets the clock on the drug’s regulatory review.

Originally, the FDA was expected to make its decision by July 26, 2024. This delay is fueling questions among investors, analysts, and patients eagerly awaiting the drug’s approval, especially given elinzanetant’s promise in treating moderate to severe vasomotor symptoms linked to menopause—a condition with few effective treatments.

What Triggered the FDA’s Major Amendment Designation?

The FDA’s decision to treat Bayer’s submission as a Major Amendment essentially means the agency found Bayer’s response significant enough to require a full reassessment. While not uncommon in drug approvals, this designation often indicates the FDA is scrutinizing key aspects of the drug’s safety or efficacy data more closely.

Barclays analysts see this as a “small negative” but remain largely optimistic about Bayer’s chances. The bank points out that despite the delay, Bayer’s 2025 sales guidance for elinzanetant remains intact, with anticipated global peak sales around €1 billion.

The Crucial Liver Toxicity Concern: Black Box Warning at Stake

The primary concern revolves around the potential need for a liver toxicity black box warning, which represents the FDA’s most serious safety alert. This cautionary label can significantly impact a drug’s market adoption and prescriber confidence.

Bayer’s elinzanetant is being compared to Astellas’ rival drug Veozah, which did receive a black box warning after a post-marketing case of liver injury. Avoiding this label could be a critical differentiator for Bayer in the competitive menopause treatment landscape.

Clinical Trial Data: What Does It Show About Liver Safety?

So far, Bayer’s clinical trials have not flagged any serious liver toxicity signals. In the OASIS-4 trial, five cases of reversible liver enzyme elevations were reported, but importantly, none met the criteria for Hy’s Law, a stringent indicator of potential severe liver damage.

An independent safety monitoring board overseeing the trials has supported the conclusion that elinzanetant’s liver safety profile remains manageable.

Still, Barclays warns that the delay may increase concerns that a black box warning could be inevitable, underscoring the FDA’s cautious stance on liver safety.

Global Regulatory Progress: Elinzanetant Gains Traction Outside the U.S.

While the FDA review extends, Bayer has made notable progress internationally. Elinzanetant, marketed under the brand name Lynkuet, has already been approved in the United Kingdom and Canada. Further regulatory submissions are underway in the European Union and other key markets.

These approvals and ongoing applications reflect the drug’s potential to fill a significant gap in treating menopausal vasomotor symptoms, offering hope to millions of women worldwide who face limited therapeutic options.

What This Means for Investors and Patients

From an investment perspective, the FDA’s delay represents a minor setback but not a derailment. Bayer’s sales forecasts for elinzanetant remain robust, and the company’s pipeline strategy includes strong global positioning.

For patients, especially those suffering from severe menopausal symptoms, elinzanetant’s promise lies in its potential to offer relief where few options exist. The regulatory delay means longer waits but also signals thorough safety scrutiny, which ultimately benefits end users.

Final Thoughts: Will Bayer Clear FDA’s Hurdles?

The path to FDA approval is rarely straightforward, especially for drugs addressing complex hormonal conditions. Bayer’s elinzanetant now faces heightened scrutiny on liver safety—a pivotal factor that could shape its market success.

The coming months leading up to October 2025 will be critical. If Bayer can convince regulators that elinzanetant’s benefits outweigh risks without severe labeling, the drug could emerge as a market leader in menopausal symptom treatment.

Until then, all eyes will remain on Bayer and the FDA as this important decision unfolds.