Richter accepts FDA review for FYLREVY and Richter Gedeon stock costs EUR 34.90

Published on 10/20/2026 at 10:25 | Editorial responsibility: Rafael Müller, Editor-in-Chief AD HOC NEWS

Clean EBIT rose 21.00 percent in the first half, while 2026 pharma guidance reached double digits. Richter Gedeon stock costs EUR 34.90 on October 20, 2026.

FDA review and earnings outlook

FDA review of FYLREVY is expected to finish by the third quarter of 2027.
Constant-currency Clean EBIT rose 21.00 percent in the first half of 2026.
Richter Gedeon stock trades at EUR 34.90 at 10:14 a.m. CEST at Lang & Schwarz on October 20, 2026.

Richter Gedeon, HU0000123096, Illustration mit AI erstellt.

Richter Gedeon (ISIN HU0000123096) was trading at EUR 34.90 at Lang & Schwarz on October 20, 2026 at 10:14 a.m. CEST as the drugmaker advanced FYLREVY toward a potential U.S. launch. According to Gedeon Richter on October 14, 2026, the FDA accepted the New Drug Application for review.

FYLREVY moves into U.S. review

FYLREVY is an orally administered estetrol-based estrogen therapy for moderate to severe vasomotor symptoms linked to menopause. The FDA is expected to complete its review by the third quarter of 2027, and approval would make FYLREVY the first menopausal hormone therapy containing E4 on the U.S. market, the company said in its October 14 announcement.

The product already has European authorization for specified hormone-replacement uses, while the company said it is commercialized in Hungary, Czech Republic, Slovakia, Finland and Sweden. The U.S. filing therefore adds a regulatory milestone to an existing commercial rollout rather than marking the product's first market entry.

What does the earnings outlook show?

Richter's first-half 2026 operating picture was stronger on a constant-currency basis. In the August 7, 2026 earnings call, Yahoo Finance reported management's statement that constant-currency Clean EBIT rose 21.00 percent in the first half, while constant-currency revenue growth reached 8.70 percent.

The reported first-half revenue figure was HUF 151.8 billion, up 3.00 percent, as foreign-exchange effects weighed on the reported result. Management upgraded 2026 pharma Clean EBIT expectations to double-digit constant-currency growth, with VRAYLAR performance, efficiency measures and improving biotechnology profitability among the cited drivers.

Next regulatory date

The next clearly defined milestone is the FDA decision window, which the company places in the third quarter of 2027. For investors, the key contrast is between the near-term regulatory step and the longer path to commercial execution in the United States.

Stock price and investor perspective

Richter Gedeon was trading at EUR 34.90 at Lang & Schwarz on October 20, 2026 at 10:14 a.m. CEST. The quote gives investors a current euro reference while the FDA review and the upgraded 2026 profitability outlook remain the main company-specific markers.

The further course of trading is shown by the continuously updated real-time quote of Richter Gedeon stock.