Home / Gilead News: U.S. Expansion, Drug Research Progress, Q1 Sales & Legal Affairs

Gilead News: U.S. Expansion, Drug Research Progress, Q1 Sales & Legal Affairs

By: Jasmin Espinas
May 8, 2025

Gilead Sciences is a global biopharmaceutical company best known for its treatments in areas like HIV, cancer, and viral infections. In recent Gilead news, the company plans to add more investments in U.S. manufacturing and research.

As Gilead Sciences pushes forward on several fronts, this update breaks down its growing presence in the U.S., new steps in drug development, first-quarter sales performance, and recent legal challenges.

Latest Gilead News: Additional $11 Billion Investments In U.S. Manufacturing and Research

Gilead Sciences plans to invest another $11 billion to grow its manufacturing and research work in the U.S. The company shared this update on May 7, adding to its earlier plan of spending $21 billion through 2030.

This money will go toward new technology, building three new facilities, and improving three existing ones. Gilead’s decision comes as the government continues to push drugmakers to shift more of their production to the U.S. The administration has also started looking into drug imports, which could lead to new trade limits.

Gilead says the added investment will help create at least 800 direct jobs and support over 2,200 other jobs by 2028. Over the next five years, the company estimates its spending will add $43 billion in value to the U.S. economy.

Gilead News: Q1 Earnings Slight Beat Expectations, Mixed Analyst Opinions On Stock Performance

On April 25, Gilead shared its results for the first quarter of 2025. The company said it started the year strong thanks to solid performance in sales and research and careful cost control.

Revenue stayed flat overall. However, higher sales of HIV and liver disease treatments helped make up for weaker cancer drug sales. Gilead also kept spending in check, which helped balance out the slower areas.

Still, the company’s stock slipped about 3% in after-hours trading, landing at $102.75. Adjusted earnings per share reached $1.81, just above the $1.79 average that analysts expected. Then, revenue came in at $6.7 billion, slightly below the $6.8 billion forecast.

Some analysts saw promising signs in the steady sales, strong earnings, and lower costs. But others say future growth may depend on whether the FDA gives the green light to Gilead’s HIV prevention drug, lenacapavir, without delays.

FDA Accepts Gilead’s HIV Prevention Drug Applications for Twice-Yearly Lenacapavir

On February 18, 2025, the U.S. Food and Drug Administration (FDA) accepted Gilead’s application to review lenacapavir, a long-acting injection given twice a year to help prevent HIV. The drug is being reviewed as a form of pre-exposure protection, also known as PrEP.

The FDA plans to make a decision by June 19 on whether to approve the drug.

“We are one step closer to introducing the first-ever twice-yearly HIV prevention choice that could, if approved, help transform the landscape for individuals who need or want additional prevention options that better fit into their lives,” said Dietmar Berger, MD, PhD, Chief Medical Officer at Gilead.

Berger added, “We’re excited about the potential of lenacapavir to make a real difference in HIV prevention in the U.S. and around the world, supporting the broader goal of ending the HIV epidemic for everyone, everywhere.”

Gilead News: Progress In Phase 3 Trial of Trodelvy-Keytruda Combo

Gilead shared new results from a late-stage study of its cancer drug Trodelvy on April 21. When combined with Merck’s Keytruda, the treatment helped slow the growth of an aggressive form of breast cancer.

The Phase 3 trial looked at 443 patients with advanced triple-negative breast cancer whose tumors showed PD-L1, a protein targeted by drugs like Keytruda. The study compared the Trodelvy-Keytruda mix to the usual treatment of chemotherapy plus Keytruda.

Gilead said the combination showed signs of improving overall survival, though more time and follow-up with patients are needed to confirm that benefit.

“The findings are statistically significant and clinically meaningful. This is a study that could potentially change the standard of care,” said Dietmar Berger.

Gilead Legal Affairs: $202 Million Settlement & Ongoing Litigation

Gilead Sciences has agreed to pay $202 million to settle a whistleblower case that accused the company of giving illegal payments to doctors who prescribed its HIV medicines.

The U.S. Attorney in Manhattan, Jay Clayton, said Gilead broke the law by causing Medicare, Medicaid, and other programs to cover prescriptions tied to its speaker events. These programs involved paying doctors to attend or speak at events that promoted the company’s drugs.

From 2011 to 2017, Gilead reportedly spent over $23 million on speaker fees, expensive dinners, and trips to places like Hawaii and New Orleans for hundreds of healthcare providers. In some cases, doctors repeatedly attended talks on the same topic. One group of ten doctors from Manhattan showed up together at around 384 dinners, according to court documents.

The drugs involved include Biktarvy, Complera, Descovy, Genvoya, Odefsey, and Stribild.

“With this settlement, Gilead has taken responsibility for its conduct. The message is clear: Companies that illegally drain taxpayer dollars from federal healthcare programs will be held accountable,” Clayton said

Gilead said it agreed to settle to avoid a lengthy and costly legal fight. The company had already put aside funds for the settlement last year.

At the same time, Gilead is dealing with a separate legal case involving patients who claim the company’s HIV treatments caused bone and kidney problems. After some of the plaintiffs’ lawyers stepped away from the case, Gilead asked the court to dismiss those who hadn’t found new legal representation or filed to represent themselves. A California judge partly agreed and set a meeting to go over the next steps.

What Gilead’s Latest Moves Mean for Biotech, Patients, and Investors

Gilead’s work could lead to new treatments and better care for patients, while investors are watching how drug approvals and legal issues might affect the company’s future.

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