FDA accepts FYLREVY filing: what it means for Richter Gedeon stock

Published on 10/14/2026 at 12:51 | Editorial responsibility: Rafael Müller, Editor-in-Chief AD HOC NEWS

FDA accepted FYLREVY for U.S. review on October 14, 2026. Richter Gedeon stock costs EUR 34.62 on October 14, 2026.

FYLREVY filing and growth signals

The FDA accepted FYLREVY for U.S. review on October 14, 2026.
Constant-currency revenue growth reached 8.70 percent in the first half of 2026.
Richter Gedeon stock traded at EUR 34.62 at 12:46 p.m. CEST at Lang & Schwarz on October 14, 2026.

Richter Gedeon, HU0000123096, Illustration mit AI erstellt.

Richter Gedeon (HU0000123096) has moved FYLREVY into U.S. regulatory review after the FDA accepted its new drug application on October 14, 2026, according to MarketScreener. The filing gives FYLREVY a route into the U.S. menopause-treatment market, with a regulatory decision expected by the third quarter of 2027.

FYLREVY reaches U.S. review

FYLREVY is an orally administered estetrol-based estrogen therapy designed for vasomotor symptoms linked to menopause. If approved, it would be the first menopausal hormone therapy containing E4 on the U.S. market, while the product is already commercialized in five European countries, according to MarketScreener.

What does the filing mean?

The regulatory step adds a U.S. development milestone to Richter's women's-health portfolio, but approval and commercialization remain future stages. The immediate investor lens is the company's ability to pair innovation milestones with operating growth and cash generation.

Three dated company milestones

On August 7, 2026, management said first-half constant-currency revenue growth reached 8.70 percent and constant-currency Clean EBIT increased 21.00 percent, while 2026 pharma Clean EBIT guidance was upgraded to double-digit growth, according to Yahoo Finance. On October 12, 2026, Richter Gedeon reported HUF 158,432,000 in support raised through its 2026 health program, according to Gedeon Richter. On October 14, 2026, the FDA accepted the FYLREVY application for review, creating the latest dated milestone.

Next reporting date

Gedeon Richter's next earnings release is listed for November 10, 2026, in the company calendar reported by Yahoo Finance. The date gives investors a scheduled checkpoint for the progress of the 2026 operating plan and the next update on women's healthcare.

Stock quote stays in euros

Richter Gedeon stock was trading at EUR 34.62 at Lang & Schwarz on October 14, 2026 at 12:46 p.m. CEST. The company carried a market capitalization of EUR 4.8 billion and sales of EUR 2.3 billion in fiscal year 2025, according to MarketScreener. The further course of trading is shown by the continuously updated real-time quote of Richter Gedeon stock.