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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.
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.
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.
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.
# 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.
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
Gilead Sciences to Release First Quarter 2026 Financial Results on Thursday, May 7, 2026
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
Gilead Sciences Inc. announced expanded global investment in its HIV prevention drug lenacapavir, with support from PEPFAR and The Global Fund to increase access in high-risk, low-resource regions.

The additional commitment aims to provide lenacapavir to up to 1 million more people over the next three years, bringing the total target to 3 million individuals by 2028. The twice-yearly injectable treatment is considered a major breakthrough in HIV prevention and is already being distributed in regions such as sub-Saharan Africa.

Gilead stated it will supply the drug at no profit to these global health programs in the near term, while preparing for a broader rollout through generic manufacturing starting in 2027. The initiative is supported by partnerships with multiple generic drug producers to expand long-term affordability and accessibility.

The move comes as global health organizations continue efforts to reduce the approximately 1.3 million new HIV infections each year, with long-acting prevention therapies seen as a key tool in combating the epidemic.
Business Wire
Gilead Sciences, Inc. announced it will acquire Tubulis GmbH in a deal valued at up to $5 billion, strengthening its oncology pipeline.

The transaction includes $3.15 billion in upfront cash and up to $1.85 billion in milestone payments. Tubulis brings a next-generation antibody-drug conjugate (ADC) platform and clinical-stage assets, including TUB-040, currently in development for ovarian and lung cancers.

Gilead said the acquisition will enhance its capabilities in targeted cancer therapies by adding advanced ADC technologies designed to improve drug delivery and treatment outcomes.

The deal is expected to close in the second quarter of 2026, subject to regulatory approvals, with Tubulis to operate as a dedicated research unit within Gilead.
Business Wire