Gilead Discontinues Phase 3 Lung Cancer Trial While HDV and Trodelvy Approvals Boost Q2 Results

Gilead Sciences reported its second‑quarter 2026 financial results with a mix of regulatory good news and strategic setbacks. While the company secured approval for Hepcludex, its HDV therapy, and saw a strong rise in Trodelvy sales, it also discontinued its Phase 3 EVOKE‑03 lung cancer trial in collaboration with Merck.

Q2 Highlights: HDV Approval, Trodelvy Momentum, and Trial Discontinuation

Gilead received accelerated approval from the U.S. Food and Drug Administration for Hepcludex, marking it as the first and only FDA‑approved treatment for chronic hepatitis delta virus (HDV) infection in adults without cirrhosis or with compensated cirrhosis. At the same time, Trodelvy sales grew 26%, reaching $457 million in the quarter, driven by robust demand. Both of these developments were announced as part of its Q2 2026 earnings release. 

On the flip side, Gilead and Merck decided to discontinue the Phase 3 EVOKE‑03 trial investigating Trodelvy in combination with Keytruda for first‑line metastatic non‑small cell lung cancer (NSCLC) with high PD‑L1 expression. The decision followed a Data Monitoring Committee recommendation after reviewing progression‑free and interim overall survival data from the study. 

Gilead also reported $1.8 billion in R&D expenses during Q2, compared to $1.5 billion in the prior year period, largely due to integration and acquisition‑related costs. Non‑GAAP R&D was $1.4 billion, slightly lower year‑over‑year, reflecting a drop in oncology clinical study activity. Notes to the earnings release also highlighted $11.2 billion in acquired in‑process R&D charges tied to major recent acquisitions, including $7.0 billion for Arcellx, $3.1 billion for Tubulis, and $1.0 billion for Ouro Medicines. 

What This Means for Gilead’s Strategic Trajectory

The FDA nod for Hepcludex fills a critical unmet need in hepatitis treatment and underscores Gilead’s continued strength in viral therapies. Meanwhile, the Trodelvy sales increase reflects strong market uptake in oncology; however, the trial discontinuation signals potential limitations in expanding into certain solid tumor indications, particularly lung cancer.

Meanwhile, elevated R&D and acquisition‑related costs are weighing on Gilead’s reported earnings, though they reflect the company’s pivot toward building a diversified pipeline across oncology, inflammation, and cell therapy.

Investor Watch Points

• Commercial uptake of Trodelvy amid broader oncology ambition
• Integration and early data progress from acquisitions such as Arcellx, Tubulis, and Ouro Medicines
• Future trial readouts and upcoming FDA or European decisions for other pipeline assets

As of the latest available data, Gilead’s stock price stood at $147.10, up 0.25%, as of October 8, 2026. While the price movement may reflect broad earnings reaction, the discontinuation and new approvals are likely to have differentiated impacts on investor sentiment.

Looking ahead, stakeholders will closely watch how Gilead leverages its regulatory wins and manages R&D spending as it seeks to fortify its pipeline across virology and oncology.