Gilead Sciences secures key FDA cancer approval, shares trade near recent highs

Gilead Sciences gains a major FDA approval for Trodelvy in first-line triple-negative breast cancer, adding another pillar to its oncology portfolio while the Nasdaq-listed shares consolidate close to this year’s highs.

By Daniel Hoffmann, Chart & Technicals desk. Reviewed prior to publication on 2026-06-25, 15:38.

Gilead Sciences (US3755581036) reports a significant U.S. regulatory win for its oncology franchise. The Nasdaq-listed biotech has received FDA approval for Trodelvy as a first-line treatment option in advanced triple-negative breast cancer, according to recent market commentary and company communications.Investing.com report on the FDA approval

What the FDA decision covers

The new FDA label allows Trodelvy to be used as initial therapy for adult patients with unresectable locally advanced or metastatic triple-negative breast cancer, a particularly aggressive tumor subtype with limited options.Investing.com summary of Trodelvy use Trodelvy is described as a Trop-2-directed antibody-drug conjugate, reflecting Gilead’s push into targeted oncology therapies.MarketScreener news on the FDA approval

The approval includes Trodelvy as monotherapy for patients who are not candidates for PD-1 or PD-L1 inhibitor treatment, and in combination with Merck’s Keytruda when tumors show PD-L1 expression with a Combined Positive Score of at least 10, based on an FDA-approved diagnostic test.Investing.com details on combination use This positioning puts Gilead directly into frontline regimens in a setting that oncologists follow closely.

Oncology and global expansion

Beyond the U.S. decision, Gilead has recently obtained marketing authorization in the European Union for Trodelvy as monotherapy in adults with unresectable or metastatic triple-negative breast cancer, according to reports summarizing the company’s regulatory progress.Investing.com note on EU approval The product is highlighted as the first antibody-drug conjugate approved for first-line treatment in this indication in the EU.

Analyst and market commentary points out that Gilead, with a market value around 155 billion dollars, is using Trodelvy to deepen its footprint in solid tumors alongside its established antiviral portfolio.AltIndex snapshot on Gilead valuation In parallel, the company has filed Yeztugo, a once-weekly oral HIV prevention pill, with the FDA, with a decision expected in the coming period, underlining the dual focus on oncology and infectious diseases.Investing.com mention of Yeztugo filing

The product behind the approval

Trodelvy is a targeted antibody-drug conjugate built around Trop-2, a protein commonly expressed on the surface of certain cancer cells, including triple-negative breast tumors.MarketScreener description of Trodelvy The drug delivers a cytotoxic payload directly to the tumor, aiming to improve efficacy while managing systemic toxicity compared with conventional chemotherapy.

Where the stock trades today

Gilead Sciences shares (US3755581036) closed on Nasdaq at 125.16 US dollars on 2026-06-24 at 15:59 Eastern time, based on recent market data.Financial Times equity summary for GILD At that level, the stock trades roughly 19.8 percent above its 52-week low of 104.46 dollars set in June 2025 and below the 52-week high of 157.29 dollars recorded in February 2026.FT data on 52-week range

Gilead Sciences at a glance

• Company: Gilead Sciences, Inc.
• ISIN: US3755581036
• WKN: 885823
• Ticker: GILD
• Trading venue: NASDAQ
• Price (as of 2026-06-24, 15:59): 125.16 USD
• Market cap: 155.0 billion USD (as of 2026-06-24)
• Sector / industry: Health Care / Biotechnology
• Index membership: S&P 500
• Next earnings date: not officially scheduled

Disclaimer: This article provides factual information and context on Gilead Sciences and does not contain investment advice, recommendations, or price targets. Past performance and regulatory outcomes are not guarantees of future results.