Pfizer expands TALZENNA approval. Pfizer stock stands 1.81 percent below its 52-week high

Published on 10/27/2026 at 12:45 | Editorial responsibility: Rafael Müller, Editor-in-Chief AD HOC NEWS

Pfizer won FDA approval for an earlier TALZENNA setting on October 26, 2026. Pfizer stock costs EUR 26.63, 1.81 percent below its 52-week high.

Approval broadens oncology reach

Pfizer announced FDA approval on October 26, 2026, based on a 52 percent reduction in progression risk.
XTANDI has treated more than 1.5 million patients across more than 80 countries.
Pfizer stock trades at EUR 26.63 at 12:40 p.m. CET at Lang & Schwarz on October 27, 2026, 0.04 percent below the Xetra close of October 26, 2026.

Pfizer Inc., US7170811035, Illustration mit AI erstellt.

Pfizer Inc. (ISIN US7170811035) announced on October 26, 2026, that the U.S. Food and Drug Administration expanded approval of TALZENNA plus XTANDI for men with HRR gene-mutated metastatic prostate cancer in an earlier treatment setting, according to Pfizer. Pfizer stock was EUR 26.63 at Lang & Schwarz at 12:40 p.m. CET on October 27, 2026, 1.81 percent below its 52-week high of EUR 27.12.

FDA approval moves treatment earlier

The approval is based on the Phase 3 TALAPRO-3 study, in which TALZENNA plus XTANDI reduced the estimated risk of radiographic progression or death by 52 percent versus placebo plus XTANDI, Pfizer said in the release. The decision moves the combination beyond its earlier U.S. use in metastatic androgen pathway modulation-resistant prostate cancer and into an androgen pathway modulation-naive or sensitive setting.

Pfizer said the application received FDA Priority Review, while an application for the same combination remains under review by the European Medicines Agency. The company described the move as part of its effort to bring precision medicines into earlier stages of disease, but its release also warns that additional regulatory decisions and clinical data could affect commercial success.

What does the approval change?

The commercial opportunity is tied to a broader treatment population rather than a new drug. XTANDI has been approved in more than 80 countries and has treated more than 1.5 million patients, according to Pfizer. The release says TALZENNA plus XTANDI is approved in more than 60 countries, although indications vary by market.

Pfizer stock stays near its yearly high

Pfizer's market capitalization was EUR 151.9 billion on October 27, 2026, while the 52-week range was EUR 20.72 to EUR 27.12. The current quote is 0.04 percent below the Xetra close of October 26, 2026, which was EUR 26.64.

At Lang & Schwarz, Pfizer stock was trading at EUR 26.63 on October 27, 2026, at 12:40 p.m. CET, 0.04 percent below the Xetra close of October 26, 2026 (EUR 26.64). The further course of trading is shown by the continuously updated real-time quote of Pfizer stock.