New York, May 26, 2026, 06:01 EDT
- Gilead ended at $134.36, gaining 2.96%, in the last session before Nasdaq closed for Memorial Day.
- The FDA cleared Hepcludex on May 22. It’s the first treatment approved in the U.S. for chronic hepatitis delta virus.
- Investors are tracking Trodelvy’s review in Europe, plus the earnings impact from Gilead’s pipeline push through acquisitions.
Gilead Sciences will get its first U.S. session move on Hepcludex Tuesday, after winning FDA approval as the first chronic hepatitis delta virus treatment. The stock was last at $134.36, with markets shut Monday for Memorial Day.
Timing is key here. Gilead is working to show growth outside its main HIV business as it leans on new liver-disease and cancer drugs to make up for shrinking sales in older drugs and costs from recent acquisitions.
Hepcludex is approved for chronic HDV, a liver infection that happens only in people who already have hepatitis B. The FDA said patients with the disease can develop liver scarring, cancer, failure or die fast, and said Hepcludex fills a gap as there was no approved U.S. therapy before.
The FDA’s acting infectious diseases director Wendy Carter said the approval “fills a critical gap in care.” Gilead Chief Medical Officer Dietmar Berger called it a “historic milestone.” Gilead put the number of U.S. HDV patients at around 40,000 to 80,000. U.S. Food and Drug Administration
The FDA signed off on the drug using its accelerated approval process, which is set up for serious illnesses where markers can help companies get drugs to market faster while longer-term benefit is confirmed. In Gilead’s Phase 3 MYR301 trial, 48% of patients given Hepcludex hit the combined response benchmark at week 48. Only 2% of patients in the delayed group did.
That’s a positive for sentiment, but the earnings story isn’t clear yet. Gilead said improvement in clinical outcomes from the disease hasn’t been proven, and full approval could depend on confirmatory data. The drug has a boxed warning, the FDA’s highest, for severe relapses of hepatitis D and B after stopping therapy.
Gilead could see a lift from the broader market at the open. U.S. stock-index futures pointed higher early Tuesday as investors shook off the long weekend, Reuters said, citing firmer sentiment.
Gilead picked up another late-week oncology trigger as the European Medicines Agency’s CHMP gave a positive opinion for Trodelvy. The committee, which reviews drugs ahead of a European Commission ruling, backed Trodelvy as a first-line monotherapy for some adults with metastatic triple-negative breast cancer, or TNBC, a type that progresses quickly.
Dr. Javier Cortes, who leads the International Breast Cancer Center in Madrid and Barcelona, said metastatic TNBC is “one of the most challenging” forms of breast cancer to treat. Gilead reported that its ASCENT-03 trial found Trodelvy lowered the risk of disease progression or death by 38% compared with chemo in people ineligible for PD-1 or PD-L1 inhibitors. Progression-free survival is the stretch before the cancer worsens or leads to death. Gilead
Competitive setup is a mix. For HDV, Hepcludex doesn’t face any approved U.S. competitors, according to the FDA approval. On the breast cancer side, Gilead is working to move Trodelvy to earlier use. It has also filed to use Trodelvy with Merck & Co.’s Keytruda for first-line metastatic TNBC in PD-L1 positive patients, aiming at a tighter oncology space.
Gilead picked up new approvals after reporting a solid first quarter. Product sales climbed 5% to $6.9 billion, HIV sales rose 10% to $5.0 billion, and Trodelvy brought in $402 million, up 37%. CEO Daniel O’Day called it a “strong quarter,” pointing to up to four possible launches and five Phase 3 readouts on tap for 2026. Gilead
Still, risk isn’t out of the way. Gilead trimmed its 2026 earnings outlook by around $11.5 billion, reflecting expected charges tied to in-process R&D, so costs for drugs it bought but that haven’t proven out yet. Hepcludex sales could come in slower than hoped. Trodelvy timelines could get pushed back. Some deals might disappoint. If that happens, the FDA rally could run out of steam and investors may question whether Gilead is spending too much for potential growth.
Gilead said in its first-quarter update that the FDA has set Aug. 27 as the action date for bictegravir/lenacapavir in virologically suppressed HIV patients. Anito-cel for fourth-line-plus relapsed or refractory multiple myeloma has a Dec. 23 target.
