Gilead Sciences Inc NASDAQ:GILD Price, Chart, News & Insight

Gilead’s Twice-Yearly Lenacapavir Shows Nearly Double the PrEP Persistence of Daily Oral Therapy

Gilead Sciences (NASDAQ: GILD) reported new Phase 2 data showing that twice-yearly injectable lenacapavir achieved substantially higher one-year persistence than daily oral F/TDF for HIV prevention.

At Week 52, 85.6% of participants receiving lenacapavir remained persistent on PrEP, compared with 46.3% of those taking daily oral F/TDF. The 39.3 percentage-point difference was statistically significant.

No HIV acquisitions occurred among participants receiving lenacapavir during the 52-week study, while one case was reported in the F/TDF group, where drug-level testing indicated very limited adherence.

Safety results were generally consistent with prior lenacapavir studies. Serious adverse events were uncommon, and no participant discontinued lenacapavir because of adverse events, although injection-site reactions were frequent.

The results strengthen Gilead’s case that long-acting HIV prevention could address one of the biggest limitations of daily PrEP: maintaining consistent use over time. The company is also evaluating once-yearly lenacapavir as part of its broader long-acting HIV prevention strategy.

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Global Finance News 11-07-26

Gilead Expands Access Plans for Once-Yearly HIV Prevention Drug

Gilead Sciences (NASDAQ: GILD) is expanding its global access strategy for investigational once-yearly lenacapavir, potentially offering HIV prevention with just one injection per year if the treatment succeeds in clinical trials and receives regulatory approval.

The company expanded six royalty-free voluntary licensing agreements to cover the once-yearly formulation, supporting manufacturing readiness and future supply across 120 high-incidence, primarily low- and lower-middle-income countries. Partners include Dr. Reddy’s, Emcure, Eva Pharma, Ferozsons, Hetero and Viatris subsidiary Mylan.

The drug is currently being evaluated in the Phase 3 PURPOSE 365 study, which is testing whether a single intramuscular dose can maintain HIV-preventive drug concentrations for a full 52 weeks. The once-yearly formulation remains investigational and has not been approved by any regulatory authority.

Lenacapavir is already approved in multiple countries in a twice-yearly formulation for HIV prevention. Extending the dosing interval to once a year could strengthen Gilead’s HIV franchise by reducing the frequency of treatment and potentially addressing adherence and access barriers associated with more frequent PrEP regimens.

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WS Investor 09-16-26

Gilead and PAHO Partner to Expand Twice-Yearly HIV Prevention Across Latin America

Gilead Sciences (NASDAQ: GILD) and the Pan American Health Organization announced a partnership aimed at expanding access to twice-yearly lenacapavir for HIV prevention across Latin America and the Caribbean. The agreement will use PAHO’s Regional Revolving Funds to support country-led adoption and implementation of the long-acting PrEP treatment.

The agreement creates a new access pathway for 14 countries currently outside Gilead’s voluntary licensing agreements, including Brazil, Mexico, Argentina, Colombia and Chile. It complements existing generic-access programs and could significantly broaden the drug’s regional availability.

Lenacapavir requires only two doses per year and is already approved for HIV prevention in multiple countries. Gilead is also evaluating a once-yearly injectable version as part of its longer-term HIV prevention program.

The partnership represents another step in Gilead’s global commercialization and access strategy for lenacapavir. The company recently expanded its no-profit supply program with PEPFAR and the Global Fund by 50%, targeting access for as many as 3 million people through 2028.

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The Investor 09-15-26

Gilead Wins FDA Approval for Bixlenvo, Expanding Its HIV Treatment Portfolio

Gilead Sciences (NASDAQ: GILD) received U.S. FDA approval for Bixlenvo, a new once-daily single-tablet HIV treatment for virologically suppressed adults, including patients currently requiring complex treatment regimens.

Bixlenvo combines bictegravir, an integrase inhibitor with a high barrier to resistance, with lenacapavir, Gilead’s first-in-class capsid inhibitor. Importantly, it becomes the first and only single-tablet regimen for virologically suppressed patients on complex HIV regimens who cannot use currently available single-tablet options.

Approval was supported by the Phase 3 ARTISTRY-1 and ARTISTRY-2 trials. In both studies, Bixlenvo demonstrated comparable efficacy in maintaining viral suppression through Week 48 and was generally well tolerated, with no significant new safety concerns identified.

The approval is strategically important for Gilead because HIV remains one of its core franchises. Bixlenvo adds a differentiated treatment option for patients with resistance, tolerability issues or complicated multi-pill regimens, while extending the commercial potential of lenacapavir beyond its existing uses. It also strengthens Gilead’s broader strategy of developing daily, weekly and longer-acting HIV treatment and prevention options.

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European Investor 08-28-26

Gilead Stock Slips Despite Strong Core Business Growth as Acquisition Charges Weigh on Earnings

Gilead Sciences (NASDAQ: GILD) shares slipped about 1% on Tuesday despite reporting solid second-quarter revenue growth, as large acquisition-related charges resulted in a quarterly loss.

Second-quarter revenue increased 10% year over year to $7.8 billion, while product sales excluding COVID-19 treatment Veklury rose 10% to $7.6 billion, highlighting continued strength across Gilead's core business. However, the company reported a GAAP loss of $8.45 per share and a non-GAAP loss of $6.75 per share, largely reflecting approximately $9.08 per share of acquired in-process R&D and related tax expenses tied to the acquisitions of Arcellx, Tubulis, and Ouro Medicines.

The HIV franchise remained the company's primary growth engine. HIV product sales increased 12% to $5.7 billion, led by Biktarvy, whose sales rose 7% to $3.8 billion, while Descovy surged 48% as demand and pricing improved. Oncology drug Trodelvy also delivered strong momentum, with sales climbing 26%, and liver disease treatment Livdelzi continued to contribute to growth.

The quarter also included three FDA approvals and three positive Phase 3 clinical updates, further strengthening Gilead's development pipeline. Meanwhile, COVID-19 antiviral Veklury sales fell 81% as pandemic-related hospitalizations continued to normalize, while the cell therapy business faced ongoing competitive pressure.

Looking ahead, Gilead raised its full-year 2026 guidance for product sales excluding Veklury to $29.8 billion-$30.1 billion, reflecting confidence in continued momentum across its HIV and oncology portfolios. The company also expects Veklury sales to decline further to approximately $300 million for the year.

While investors welcomed the strong underlying revenue growth and improving outlook for Gilead's core business, the stock came under modest pressure as the headline earnings figures were heavily impacted by substantial acquisition-related charges associated with expanding the company's long-term pipeline.

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WS Investor 08-04-26

Gilead Sciences (GILD) Shares Climb After HSBC Sets $155 Price Target

Gilead Sciences (NASDAQ: GILD) gained 4.2% on Thursday and added another 1.3% in premarket trading on Monday after HSBC initiated coverage on the biopharmaceutical company with a *$155 price target*.

The new price target came as Gilead shares extended their recent rally, reflecting continued investor optimism toward the company's growth prospects across its HIV, oncology, and liver disease portfolios.

The $155 target implies additional upside from Thursday's closing price, suggesting HSBC sees room for further appreciation despite the stock's recent gains. While the rating summary did not disclose the firm's detailed investment thesis, the initiation highlights growing institutional interest in Gilead.

Investor sentiment has also been supported by the company's diversified portfolio, strong cash generation, and continued investment in innovative therapies. Gilead remains focused on expanding its oncology business while maintaining its leadership position in HIV treatments, two areas viewed as key long-term growth drivers.

The combination of Thursday's strong rally and HSBC's new price target kept Gilead in focus as investors continued to favor large-cap pharmaceutical companies with stable earnings and attractive growth opportunities.

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European Investor 07-06-26

# Gilead Edges Lower After Hours as Acquisition Charges Swamp Strong Operating Quarter

Foster City, May 7, 2026 — Shares in Gilead Sciences slipped roughly 1% in after-hours trading yesterday after the biopharmaceutical company reported a solid first quarter operationally but issued full-year EPS guidance that alarmed investors at first glance — a dramatic reduction driven almost entirely by the accounting cost of three major acquisitions rather than any deterioration in the underlying business.

The operating results were genuinely strong. Total revenues grew 4% to $7.0 billion, with base business product sales excluding Veklury up 8% to $6.8 billion. HIV remains the engine, with HIV product sales growing 10% to $5.0 billion. Biktarvy, the company's flagship HIV treatment, rose 7% to $3.4 billion, and Descovy surged 38% to $807 million. Trodelvy, the oncology antibody-drug conjugate, grew 37% to $402 million, reflecting strengthening demand. Non-GAAP diluted EPS improved to $2.03 from $1.81 a year ago, and product gross margin expanded to 87.5% on a non-GAAP basis. Full-year product sales guidance was raised to $30.0 to $30.4 billion from the prior range.

The jolt came from the updated EPS guidance. Full-year non-GAAP diluted EPS was cut to a loss of $0.65 to $1.05, compared to prior guidance of $8.45 to $8.85 — a swing of roughly $9.50 per share. The reason is entirely attributable to $11.5 billion in anticipated acquired in-process R&D charges from the company's acquisition spree: the completed $7.8 billion purchase of Arcellx, the pending acquisition of Ouro Medicines for autoimmune treatments, and the pending Tubulis deal for next-generation antibody-drug conjugates. These are non-cash accounting charges that hit the income statement at closing but represent strategic investments in future pipeline assets rather than operational losses.

Investors familiar with biotech acquisition accounting will recognize the pattern, but the headline EPS reversal is jarring enough to explain the modest after-hours dip as others digest what is actually a strong underlying quarter.

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WS Investor 05-08-26

Gilead Sciences announced it has completed its acquisition of Arcellx Inc. in a deal valued at approximately $7.8 billion, strengthening its oncology portfolio.

The transaction gives Gilead full control of anitocabtagene autoleucel (anito-cel), an investigational CAR T-cell therapy for multiple myeloma, allowing the company to streamline development and maximize long-term value by eliminating profit-sharing and royalty obligations.

Gilead said the deal is expected to be dilutive to earnings in 2026 and 2027 but accretive from 2028 onward, subject to regulatory approval of the therapy. Arcellx will now operate as a wholly owned subsidiary of Gilead.

Source: Gilead Sciences press release, Business Wire

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The Investor 04-28-26

Gilead Sciences to Release First Quarter 2026 Financial Results on Thursday, May 7, 2026

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The Investor 04-24-26

Gilead Sciences announced that it has secured all required regulatory approvals for its acquisition of Arcellx, clearing a key hurdle toward completing the transaction.

The approval process concluded after clearance from the Australian Competition and Consumer Commission, with the final waiting period set to expire on April 27, 2026. The company also confirmed that other international regulatory reviews have been completed, meaning all approval conditions will be satisfied once the waiting period ends.

Gilead has extended its tender offer for Arcellx shares to April 27, maintaining the offer at $115 per share in cash plus a contingent value right tied to future sales milestones of its lead therapy. As of mid-April, approximately 17.5% of shares had been tendered.

The deal remains subject to customary closing conditions, including majority shareholder participation, but positions Gilead to strengthen its oncology pipeline and expand its capabilities in cell therapy as it moves closer to completing the acquisition.
Business Wire

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European Investor 04-18-26

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