Gilead Sciences Inc

Gilead Sciences expanded the scope of its six royalty-free voluntary licensing agreements for lenacapavir on September 16 to cover an investigational once-yearly formulation for HIV pre-exposure prophylaxis. The expanded framework covers 120 high-incidence, lower-income countries and aims to accelerate manufacturing readiness and technology transfer during the ongoing Phase 3 PURPOSE 365 study. The move follows the efficacy shown by twice-yearly lenacapavir in the PURPOSE 1 and PURPOSE 2 trials, and Gilead is extending its global access strategy while clinical development continues. In the second quarter of 2026, Gilead's HIV product sales rose 12% year over year to $5.7 billion, led by Biktarvy at $3.8 billion, up 7%, and Descovy at $967 million, up 48%, while base product sales excluding Veklury grew 10% to $7.6 billion and quarterly operating cash flow reached $3.6 billion. Those gains were offset by a GAAP diluted loss per share of $(8.45) and a non-GAAP loss per share of $(6.75), reflecting $(9.08) per share in acquired in-process R&D charges totaling $11.2 billion tied mainly to the acquisitions of Arcellx, Tubulis, and Ouro Medicines, which helped cut cash, cash equivalents, and marketable securities to $3.2 billion from $10.6 billion at year-end 2025.

Gilead Sciences raised its 2026 product sales outlook to $30.1 billion-$30.4 billion, while Danaher cut its full-year core revenue growth guidance to 3%-4% from 3%-6%. Gilead's quarterly product sales excluding Veklury rose 10% to $7.6 billion, with HIV sales up 12% to $5.7 billion, Biktarvy generating $3.8 billion, Descovy jumping 48% to $967 million, and the injectable HIV prevention medicine Yeztugo reaching $232 million from $15 million a year earlier. Danaher reported fiscal Q2 revenue up 5.5% to $6.3 billion, core revenue growth of 3%, or 4.5% excluding respiratory testing, and adjusted EPS up 8% to $1.94, and it raised full-year adjusted EPS guidance to $8.45-$8.60 from $8.35-$8.55. Danaher's bioprocessing orders grew at a mid-teens rate even as revenue was held back by customer project timing, and management expects to exit 2026 at a mid-single-digit core revenue growth rate. Gilead's HIV franchise still accounted for $5.69 billion of its $7.63 billion in quarterly product sales, and the company recorded $11.2 billion of acquired in-process R&D expenses tied mainly to Arcellx, Tubulis, and Ouro Medicines, contributing to GAAP and non-GAAP losses per share of $8.45 and $6.75.

Gilead Sciences has raised its 2026 sales outlook and lifted its quarterly dividend by 3.8%. The guidance change lands in a stock that already carries momentum, with a 90 day share price return of 19.46% and a year to date move of 24.12%, while longer-term holders have seen a 37.33% 1 year total shareholder return and triple digit total shareholder returns over 3 and 5 years. The most followed narrative on the company puts fair value at $128.38 against a last close of $150.93, implying the stock is around 18% overvalued even after factoring in the raised sales outlook and the stronger dividend signal. That view frames Gilead as a medium term compounder transitioning from a single-franchise HIV company into a multi-platform biopharma, with lenacapavir and Trodelvy as high-probability growth drivers and cell therapy and immunology as high-upside optionality, but it flags short term volatility tied to an investment phase and recent deal related charges. The same narrative could be knocked off course if key oncology or cell therapy trials disappoint or if acquisition integration drags longer than expected, while a discounted cash flow model points the opposite way, screening the stock as heavily undervalued at an estimated future cash flow value of $309.92.

AbbVie reported second-quarter revenues of $16.99 billion, up 10.2% year on year and 1.2% above analysts' consensus expectations, though the quarter was mixed with only a narrow beat of EPS estimates and a slight miss of full-year EPS guidance estimates. The results came as the 11 therapeutics stocks tracked by the report collectively beat consensus revenue estimates by 8% in Q2, with share prices up 24.8% on average since the latest earnings results. Biogen posted the group's best quarter, with revenues of $2.74 billion, up 3.4% year on year and 12.1% above expectations, while Myriad Genetics delivered the weakest performance, reporting revenues of $190.7 million, down 10.5% year on year and 8.2% below expectations, alongside full-year revenue guidance that missed and a significant EPS miss. Gilead Sciences reported revenues of $7.80 billion, up 10.2% year on year and 6.2% above expectations, and Moderna reported revenues of $145 million, up 2.1% year on year and 35.8% above expectations, the biggest analyst estimate beat of the group. AbbVie's stock is up 2.9% since reporting and currently trades at $264.79.

Lakefront Biotherapeutics said it plans to begin registrational studies next year for its lead T-cell engager, gamgertamig, in immune thrombocytopenia and autoimmune hemolytic anemia, with two additional autoimmune basket studies expected early that year. Speaking at Morgan Stanley's Global Healthcare Conference, Chief Executive Officer Henry Gosebruch said the company, previously known as Galapagos, has shifted focus from its legacy ex vivo CAR-T programs to a portfolio of four T-cell engager candidates following its acquisition of assets from Ouro Medicines in March. Gamgertamig is a BCMA-directed therapy that Gilead Sciences is expected to commercialize, with Lakefront receiving a royalty; Gilead contributed half of the Ouro deal consideration and about $5 billion to the company under a strategic alliance established in 2019 that has roughly three years remaining. Chief Financial Officer Aaron Cox said Lakefront expects to end the year with about €2 billion in cash, supported by Gilead funding, legacy royalties of approximately €15 million to €20 million annually related to Jyseleca, and tax-credit receipts of approximately €20 million to €35 million annually over the next several years. The company has largely completed the wind-down of its legacy cell-therapy operations, which had more than 650 employees and approximately $300 million in annual spending, and announced a €50 million share buyback in June that it expects to complete by year-end. The FDA has granted Orphan Drug Designation for gamgertamig in ITP, AIHA and pemphigus.

Morgan Stanley reaffirmed its Overweight rating on Gilead Sciences after meeting privately with Chairman and CEO Daniel O'Day and Chief Commercial and Corporate Affairs Officer Johanna Mercier at its 2026 Global Healthcare Conference, with the bank singling out the company's HIV prevention franchise as the biggest reason to stay positive. Analyst Terence Flynn, who has held the Overweight rating since January 2025, based his price target on a discounted cash flow model using a 10% weighted average cost of capital and a 3% terminal growth rate, referenced to the September 15 close of $146.30. Gilead guided its first full year of Yeztugo sales at approximately $1 billion, with the total prevention portfolio running at about $4 billion annually; Yeztugo is the twice-yearly HIV prevention shot launched in 2025. Current PrEP users number roughly 550,000, more than double the 2022 level, against CDC estimates that about 2.2 million Americans could benefit, a penetration of about 25% in a market growing 14% to 15% each year, and more than 70% of Yeztugo patients returned for their six-month reinjection. Management described Gilead as being at an important inflection point with no patent expiring until 2036, while Biktarvy still controls more than 50% of the global HIV treatment market and more than two-thirds of patients new to HIV therapy, and the company raised its HIV franchise growth guidance to 9% to 10% for the year from 8%. The near-term catalyst is anito-cel, Gilead's cell therapy for a type of blood cancer, with an FDA decision due in December and an estimated initial opportunity in advanced-stage patients of approximately $3.5 billion, alongside late-stage results expected before year-end for two experimental drugs in immunology and inflammation.

The Pan American Health Organization and Gilead Sciences have reached a new agreement that could expand access to lenacapavir for HIV prevention in 14 countries across Latin America, a deal the AIDS Healthcare Foundation is calling a victory for civil society. AHF, the world's largest HIV care provider, said it was among the first organizations to mobilize after the initial Gilead-WHO agreement excluded Latin American countries, and it joined other civil society groups in calling for that agreement to be expanded. The AHF Global Public Health Institute, in partnership with the National Institute of Public Health of Mexico, conducted a study on lenacapavir's potential impact in the region, finding that greater public health impact will depend on both a significantly reduced price and acceptability among potential users. Dr. Jorge Saavedra, Executive Director of the AHF Global Public Health Institute and former Director General of Mexico's National AIDS Program, said the separate arrangement must aim not simply for a fair price but for a genuinely affordable one, warning that prevention should be less expensive than treatment. Dr. Patricia Campos, AHF Bureau Chief for Latin America and the Caribbean, noted that Argentina, Brazil, Mexico, and Peru helped generate the clinical evidence for lenacapavir through Gilead's pivotal PURPOSE 2 trial yet were excluded from the company's original voluntary licensing arrangement. AHF urged Gilead and PAHO to make pricing, timelines, regulatory requirements, and other key terms transparent, saying access cannot exist only on paper.

A federal appeals court ruled in favor of Gilead Sciences on August 13, upholding a preliminary injunction that bars the defendants from importing or facilitating the sale of foreign-market Gilead-branded medications in the United States. The US Court of Appeals for the Fourth Circuit found that the differences between Gilead's HIV medication for the US market and the foreign versions being imported were material, not theoretical. The dispute dates to December 2024, when Gilead sued third-party administrator Meritain Health, pharmacy benefit manager ProAct, and pharmacies Rx Valet and Advanced Pharmacy over illegal imports of its best-selling HIV drug Biktarvy, a case that arose after a patient in Maryland received the medicine by mail from Turkey with label instructions written in Turkish. A federal district court in Baltimore granted the preliminary injunction after finding Gilead likely to succeed on its Lanham Act trademark violation and unfair competition arguments, and the order was later expanded to include new sellers CanaRx, ElectRx, and ScriptSourcing. The Fourth Circuit rejected the defendants' central argument that the imported and domestic versions of Biktarvy are interchangeable, holding that the two differ materially not only in packaging and labeling but also in the quality-control protocols each version undergoes before reaching a patient. A Gilead representative called the decision a patient-safety victory, and patient advocacy groups that filed amicus briefs supporting the company praised the ruling in similar terms.

Gilead Sciences has secured its third FDA approval in under four months, with the latest being Bixlenvo, a daily pill for virologically suppressed adults with HIV, approved on August 27. The company's shares have risen over 21% this year, nearly doubling the S&P 500's gain, yet it may still be undervalued. More approvals are anticipated, including anito-cel for multiple myeloma with a PDUFA date of December 23, and Yeztugo, a once-weekly oral PrEP, with a target date of February 2. Financially, Gilead reported $7.6 billion in Q2 revenue, up 8% year over year, and raised its dividend by 3.8% to $0.82 per share. For the first time in Q2, the company topped $1 billion in PrEP sales, up 101% year over year, driven by Descovy's $801 million in sales, a 60% increase. Despite concerns about HIV reliance, Gilead's gross margins remain above 80%, and its pipeline positions it for long-term growth.

Gilead Sciences has received FDA approval for Bixlenvo, the smallest once-daily single-tablet regimen for HIV in virologically suppressed adults, making it the first and only option for patients unable to take existing single-tablet regimens. The drug combines bictegravir and lenacapavir, offering a high barrier to resistance and no cross-resistance to current antiretrovirals. This approval strengthens Gilead's HIV portfolio, which already includes Biktarvy, Descovy, and the rapidly growing Yeztugo, and the company has raised its 2026 HIV sales growth outlook to 9-10%, supported by a roughly $4 billion annualized PrEP business. Gilead expects Yeztugo sales to approach $1 billion in 2026, and its pipeline, including a once-weekly oral combination with Merck, offers additional upside. Shares of Gilead have gained 20.3% year to date, and the company currently holds a Zacks Rank #1 (Strong Buy).

Stock index futures were mixed on Friday as traders awaited Federal Reserve Chair Kevin Warsh's speech at the Jackson Hole Symposium, with several individual stocks moving on regulatory and corporate news. JetBlue Airways rose 0.82% in premarket trade after activist investor Carl Icahn lowered his stake below the level required to maintain board representation, prompting Icahn Enterprises representatives Jesse Lynn and Steven Miller to step away from the board, leaving it with 11 members, 10 of whom are independent. Gilead Sciences gained 0.64% after the U.S. Food and Drug Administration approved its once-daily oral antiviral Bixlenvo as the smallest single-tablet regimen for treating HIV in adults, combining its once-daily HIV pill bictegravir with its twice-yearly pre-exposure prophylaxis option lenacapavir. Eli Lilly rose 0.76% after the FDA approved a label expansion for its blockbuster GLP-1 drug Mounjaro to lower the risk of major adverse cardiovascular events, including stroke, in adults with type 2 diabetes. Moderna fell 1.93% after pricing $2.6 billion of 0.00% convertible senior notes due 2032 in a private placement, upsized from the previously announced $2 billion, with an option for initial purchasers to buy up to an additional $400 million of the notes.

Gilead Sciences has snapped out of its slump, with shares surging from around $130 to $146 following its Q2 2026 earnings release on Aug. 4. The biotech reported $7.8 billion in sales, up 10% year over year and ahead of forecasts, but recorded a net loss of $8.45 per share due to in-process R&D charges from acquisitions including Arcellx. Investors focused on the HIV drug portfolio, where PrEP medicines hit over $1 billion in quarterly sales for the first time, with Descovy sales rising 48% and Yeztugo jumping from $15 million to $232 million. Management expects continued growth, with Yeztugo potentially reaching blockbuster status, and forecasts call for 2027 earnings between $9.19 and $11.10 per share, putting Gilead at 13 to 16 times forward earnings versus Amgen's nearly 20 times.

Lakefront Biotherapeutics announced that the U.S. Food and Drug Administration has granted Orphan Drug Designation to gamgertamig for the treatment of pemphigus. Gamgertamig was previously granted both Fast Track and Orphan Drug Designation by the U.S. FDA for the treatment of autoimmune hemolytic anemia and immune thrombocytopenia. The drug is being developed by Lakefront in collaboration with Gilead Sciences, with ongoing clinical trials in autoimmune diseases actively enrolling and expansion of the clinical trials program anticipated in 2027. Gamgertamig is an investigational BCMAxCD3 bispecific T cell engager currently in Phase 2 studies and is expected to enter registrational studies in 2027.

The European Commission has granted marketing authorization for Gilead Sciences' Trodelvy in combination with Keytruda for first-line treatment of PD-L1-positive metastatic triple-negative breast cancer. The approval covers adult patients with unresectable, locally advanced or metastatic TNBC who have not received prior systemic therapy for metastatic disease and whose tumors express PD-L1 with a combined positive score of at least 10. This makes Trodelvy plus Keytruda the first and only antibody-drug conjugate plus immunotherapy combination approved in first-line metastatic TNBC across the European Union's 27 member states, as well as Norway, Iceland and Liechtenstein. The decision follows a recent EC approval of Trodelvy as monotherapy for first-line metastatic TNBC patients who are not candidates for PD-1 or PD-L1 inhibitor therapy, together establishing Trodelvy as a backbone therapy across PD-L1 status. The approval is based on the Phase 3 ASCENT-04/KEYNOTE-D19 study, which showed a 35% reduced risk of disease progression or death versus standard chemotherapy plus Keytruda.

Gilead Sciences has entered an ongoing translational research collaboration with Nucleai to apply AI-powered tissue analytics across its global antibody-drug conjugate clinical development programs in multiple oncology indications. The partnership, announced in August 2026, aims to standardize biomarker assessment and refine precision medicine efforts within Gilead's oncology portfolio. It follows an extended collaboration with Arcus Biosciences in April 2026, underscoring how much of Gilead's medium-term upside now depends on converting its growing network of oncology alliances into approved products. The key near-term catalyst remains regulatory and commercial progress for Trodelvy in first-line breast cancer, while execution on oncology and cell therapy returns remains a major risk after recent net losses.

Gilead Sciences raised its full-year HIV sales growth guidance to 9-10% from 8%, driven by a $4-billion annualized PrEP business and continued strong performance of Biktarvy. The company expects Yeztugo sales to reach approximately $1 billion in 2026, signaling blockbuster potential in its first full year on the market. The FDA accepted Gilead's new drug application for bictegravir/lenacapavir under priority review with a target action date of Aug. 27, 2026. Gilead and Merck announced positive phase III results from the ISLEND-1 and ISLEND-2 studies for a once-weekly oral combination of islatravir and lenacapavir, which will form the basis of regulatory submissions. Gilead's shares have gained 13.2% year to date, and the stock currently carries a Zacks Rank #3 (Hold).

Gilead Sciences has shifted from stagnant growth to a turnaround led by new HIV and oncology drugs, with the stock up more than 12% this year. The company reported second-quarter sales of $7.8 billion, up 10% year over year, including HIV-related sales of $5.7 billion, up 12% year over year. PrEP sales exceeded $1 billion for the first time, led by $801 million in Descovy sales, up 60% from the same quarter a year ago. Oncology revenue is growing, with Trodelvy sales of $457 million, up 26% year over year, and the company expects to launch anito-cel for multiple myeloma after its December 23 PDUFA date. Gilead raised its quarterly dividend by 3.8% to $0.82, the 11th consecutive annual increase, and is on track to exceed $12 billion in free cash flow this year.

Gilead Sciences has exercised its option to exclusively license a preclinical bispecific program targeting solid tumors using MacroGenics' proprietary TRIDENT platform, triggering a $10 million milestone payment to MacroGenics. The decision builds on the companies' 2022 collaboration, which spans three programs including the clinical-stage CD123 x CD3 bispecific MGD024, and keeps MacroGenics eligible for up to $1.6 billion in milestone payments plus sales royalties. MacroGenics reported Q1 2026 revenue of $20.8 million and a net loss of $36.8 million, with $154.2 million in cash, and has extended its cash runway through 2028 after monetizing ZYNYZ royalties and selling its manufacturing operations to Bora Pharmaceuticals. Gilead's Q2 2026 revenue rose 10% year-over-year to $7.8 billion, but it posted a net loss per share of $8.45 due to $11.2 billion in acquired in-process R&D expenses from acquisitions of Arcellx, Tubulis, and Ouro Medicines, while raising its full-year product sales guidance to $29.8 billion to $30.1 billion.

Merck and Gilead Sciences reported first-quarter 2026 earnings and announced two joint clinical milestones. Merck posted $16.3 billion in total sales, up 5% year-over-year, while Gilead reported $7.0 billion in total revenue, up 5% year-over-year. The European Medicines Agency's CHMP recommended Gilead's Trodelvy in combination with Merck's Keytruda for first-line PD-L1-positive triple-negative breast cancer. Phase 3 results from the ISLEND-1 and ISLEND-2 trials showed a once-weekly oral combination of Gilead's lenacapavir and Merck's islatravir achieved noninferior virologic suppression compared to daily regimens. Both companies raised full-year guidance, with Merck targeting $65.8 billion to $67.0 billion in sales and Gilead targeting $30.0 billion to $30.4 billion in product sales.

Assembly Biosciences reported second quarter 2026 financial results and announced expansion of ABI-6250 into cholestatic liver diseases including primary biliary cholangitis and primary sclerosing cholangitis. The company completed a $115 million gross financing and projects cash runway into 2029, including the first $75 million Gilead collaboration extension payment due in the fourth quarter of 2026. Gilead selected GS-1179, formerly ABI-1179, to advance in the HSV helicase primase inhibitor program with Phase 2 initiation expected by year-end 2026. Net loss attributable to common stockholders was $3.9 million, or $0.20 per share, compared to $10.2 million, or $1.33 per share, in the same period last year. Cash, cash equivalents and marketable securities totaled $320.4 million as of June 30, 2026.

Gilead Sciences announced a partnership with Nucleai to use AI-powered tissue analytics in its global antibody drug conjugate programs. The collaboration focuses on translational research to speed up biomarker discovery and support precision oncology development. The AI tools are intended to help standardize and accelerate analysis of tumor samples across Gilead's oncology pipeline. Gilead Sciences is a US biopharmaceutical company with a reported market value of about $165.0b, focused on medicines for areas of unmet medical need.

Bank of America reiterated its Buy rating and $162 price target on Gilead Sciences after the company reported second-quarter product sales of $7.6 billion and raised its full-year product sales guidance to $29.8 billion to $30.1 billion. The bank highlighted that more than 70% of patients remained on Gilead's twice-yearly HIV prevention shot Yeztugo roughly a year after launch, the highest persistence rate across available PrEP options. Yeztugo posted quarterly sales of $232 million, up 40% from the prior quarter, helping Gilead's total PrEP franchise top $1 billion in quarterly sales for the first time. Gilead also raised its HIV franchise growth forecast to 9% to 10% for the year and pointed to momentum in liver and oncology drugs, including a 26% year-over-year increase in Trodelvy sales to $457 million. The stock trades near $135, up more than 6% year to date but below its 52-week high of $157.27.

Gilead Sciences reported a 10% increase in base business sales for the second quarter, driven by growth in its HIV and oncology segments, which offset a decline in Veklury revenue. The company also raised its full-year HIV growth outlook to a range of 9% to 10% and projected total base business sales of $29.8 billion to $30.1 billion for 2026.

Gilead Sciences announced second quarter 2026 financial results, with total revenues increasing 10% year-over-year to $7.8 billion. Product sales excluding Veklury grew 10% to $7.6 billion, driven by a 12% increase in HIV product sales to $5.7 billion, including Biktarvy sales up 7% to $3.8 billion. The company reported a diluted loss per share of $8.45, compared to earnings of $1.56 in the prior-year period, primarily due to $11.2 billion in acquired IPR&D expenses from the acquisitions of Arcellx, Tubulis, and Ouro Medicines, net of the Lakefront collaboration impact. Non-GAAP diluted loss per share was $6.75, also reflecting the $9.08 per share impact of those charges. Gilead raised its full-year 2026 product sales guidance excluding Veklury to a range of $29.8 billion to $30.1 billion, while lowering Veklury expectations to approximately $300 million.

Baron Health Care Fund stated in its second-quarter 2026 investor letter that Gilead Sciences' new HIV prevention therapy Yeztugo remains a promising long-term growth engine despite management's conservative 2026 sales guidance of approximately $800 million, which fell below investor expectations and weighed on the stock during the quarter. The fund noted that Yeztugo, a twice-yearly injectable, could significantly improve patient compliance compared to Gilead's daily oral preventive treatment Descovy. Baron also highlighted Gilead's next-generation pipeline, including a weekly oral lenacapavir and islatravir combination being developed with Merck, and a wholly-owned weekly regimen with a novel integrase inhibitor. Gilead shares closed at $131.15 on August 3, 2026, with a market capitalization of $162.83 billion, and the stock gained 16.62% over the past 52 weeks.

Merck & Co., Inc., Rahway, N.J., USA announced second-quarter 2026 worldwide sales of $16.6 billion, a 5% increase from the prior year, and narrowed its full-year 2026 sales outlook to between $66.3 billion and $67.3 billion. KEYTRUDA and KEYTRUDA QLEX sales reached $8.4 billion, including $463 million from the newly launched KEYTRUDA QLEX, while WINREVAIR sales grew 75% to $588 million and Animal Health sales rose 8% to $1.8 billion. The company reported a GAAP loss per share of $0.54 and a non-GAAP loss per share of $0.13, both reflecting a $2.31 per share charge for the acquisition of Terns Pharmaceuticals. Key regulatory milestones included U.S. FDA approval of LIPFENDRA, the first once-daily oral PCSK9 inhibitor, and positive Phase 3 results for the investigational sacituzumab tirumotecan in endometrial cancer and for a once-weekly oral HIV regimen of islatravir and lenacapavir in collaboration with Gilead. Merck now expects full-year non-GAAP EPS between $2.66 and $2.76, which includes charges of $2.43 per share related to the Terns acquisition.

Gilead Sciences shares have moved higher after European regulators issued a positive opinion on expanding the use of Trodelvy alongside Keytruda for certain advanced triple negative breast cancer patients. The stock has returned 5.07% over the past 30 days and 9.15% year to date, with a five-year total shareholder return of 130.07%. A widely followed narrative on the company estimates a fair value of $128.38 per share, suggesting the stock is about 3.4% overvalued at its last close of $132.73, while a separate earnings-ratio view notes the stock trades at a price-to-earnings multiple of 17.9 times compared with a fair ratio of 32.8 times and a peer average of 50.1 times.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended marketing authorization for Gilead Sciences’ Trodelvy in combination with Merck’s Keytruda for adults with previously untreated, unresectable locally advanced or metastatic triple-negative breast cancer whose tumors express PD-L1 with a combined positive score of at least 10. The positive opinion is based on the Phase 3 ASCENT-04/KEYNOTE-D19 study, which showed a 35% reduction in the risk of disease progression or death versus standard chemotherapy plus Keytruda. If approved by the European Commission later in 2026, the combination would build on the recent EU approval of Trodelvy monotherapy in the same setting, establishing a Trodelvy-based backbone across PD-L1 status. Metastatic triple-negative breast cancer is an aggressive disease with poor prognosis, and about 40% of tumors are PD-L1 positive. Gilead noted that Trodelvy is the only Trop-2-directed antibody-drug conjugate to show a meaningful overall survival benefit in two distinct types of metastatic breast cancer.

Gilead Sciences has raised its 2026 HIV sales growth forecast to approximately 8% year over year, up from a prior guidance of 6%, driven by increased expectations for its twice-yearly injectable lenacapavir, branded Yeztugo. The approval of injectable lenacapavir, a first-in-class capsid inhibitor, has solidified Gilead's HIV portfolio, offering meaningful adherence advantages over daily oral regimens and targeting a broad patient population. Biktarvy continues to hold more than 52% market share as the most prescribed HIV treatment, while Descovy demand remains strong. Gilead and Merck also reported positive phase III results for a once-weekly oral regimen of islatravir plus lenacapavir, which was non-inferior to daily standard-of-care treatments including Biktarvy at week 48. With no significant loss-of-exclusivity events expected until 2036 and up to seven new HIV therapies potentially launching by 2033, Gilead's HIV franchise is positioned for sustained long-term growth.

Gilead Sciences and Merck announced that the investigational once-weekly oral single-tablet HIV treatment regimen of islatravir 2 mg and lenacapavir 300 mg maintained virological suppression in adults with HIV who switched from daily antiretroviral therapy, according to Week 48 results from the Phase 3 ISLEND-1 and ISLEND-2 trials. In ISLEND-1, no participants who switched to the once-weekly regimen had HIV-1 RNA of 50 copies per milliliter or more at Week 48, compared to 0.3 percent of those who remained on BIKTARVY, while in ISLEND-2 the rates were 0.3 percent for the once-weekly regimen versus 1.3 percent for standard-of-care daily treatments. The safety profile of the once-weekly combination was generally similar to the comparator regimens, with no new safety concerns identified, and participants who switched reported higher treatment satisfaction and lower treatment burden. The data will be presented at the 26th International AIDS Conference and will form the basis of regulatory submissions, with the potential to make this the first once-weekly oral HIV treatment option.

The global cell and gene therapy market reached $15.92 billion in 2025 and is forecast to grow to $114.87 billion by 2035, according to a new report from ResearchAndMarkets.com. The market expanded at a compound annual growth rate of 23.4% from 2020 to 2025 and is projected to grow at 22.6% through 2030, reaching $44.19 billion, before advancing at 21.1% to 2035. Cell therapy was the largest product segment in 2025, accounting for 69% of the market or $10.99 billion, while gene therapy is expected to be the fastest-growing segment with a CAGR of 26.1% through 2030. Oncology remained the leading application, generating $8.69 billion and representing 54.6% of the market in 2025, and hospitals accounted for 60.3% of the market, equivalent to $9.61 billion. North America led with a 47.5% share valued at $7.57 billion, but Asia-Pacific is forecast to be the fastest-growing region with a CAGR of 27.5% through 2030, and the market remains highly concentrated with the top 10 competitors holding 66.6% of the market in 2024, led by Gilead Sciences at 15.3%.

Jim Cramer has named biotechnology the hottest group in the market right now, a call he says he has not made in years. He argues that a friendlier regulatory backdrop is reopening the door to takeovers, with his sources expecting a flood of deals. The iShares Nasdaq Biotechnology ETF is up roughly 51% over the past year, while the equal-weighted SPDR S&P Biotech ETF has returned about 70%, driven by smaller drugmakers. Big pharma is spending aggressively, with Eli Lilly closing four acquisitions in the first quarter of 2026 alone and Gilead Sciences completing a $7.8 billion purchase of Arcellx. Analysts see a survival-of-the-fittest market favoring late-stage companies with real clinical data, but warn that a lot of good news is already priced in after the rally.

Gilead Sciences is preparing four drug launches this year as it works to diversify beyond its core HIV franchise. The company reported first-quarter revenue of $7 billion, up 4% year over year, driven by a 10% increase in HIV product sales to $5 billion, while earnings per share rose 54.8% to $1.61. Key launches include bulevirtide, which received accelerated FDA approval on May 22 as the first treatment for chronic hepatitis delta virus infection in certain adults, and a once-daily single-tablet regimen of bictegravir plus lenacapavir for suppressed HIV, with a PDUFA date of August 27. Gilead also expects a decision by December on anito-cel, a multiple myeloma therapy gained through its acquisition of Arcellx, and is expanding use of its breast cancer drug Trodelvy into first-line metastatic triple-negative breast cancer following a June 24 FDA approval. The company’s twice-yearly injectable HIV prevention drug Yeztugo is entering a multimarket launch and is projected to generate $1 billion in 2026 sales. Gilead trades at about 15 times forward earnings and offers a 2.39% dividend yield, having raised its dividend for 11 consecutive years.

Investors seeking shelter from a potential recession may consider CVS Health and Gilead Sciences, two healthcare dividend stocks with defensive business models. CVS Health operates a diversified healthcare business spanning pharmacy, insurance, and pharmacy benefits management, which tends to see steady demand even during economic downturns; it offers a forward dividend yield of 2.6% and has raised payouts by 56.5% over the past decade. Gilead Sciences is a leading drugmaker with a dominant HIV franchise and a growing oncology portfolio, ensuring consistent demand for its therapies; it provides a forward yield of 2.4% and has increased dividends by 74.5% over the past 10 years. Both companies have competitive advantages and long-term growth prospects tied to aging populations and rising healthcare spending.

Morgan Stanley maintained its Buy rating on Gilead Sciences and kept its price target at $168. The firm cited the company's growth outlook and the launch trajectory of Yeztugo as key factors, viewing Yeztugo as a medium-term growth driver. Gilead has raised its 2026 sales guidance for Yeztugo. Separately, the FDA accepted a supplemental New Drug Application for a 300 mg tablet version of Yeztugo for once-weekly oral HIV prevention, with a decision date of February 2, 2027. If approved, it would become the first long-acting oral PrEP treatment.

The World Health Organization has launched an experimental Ebola trial in the Democratic Republic of Congo, where the Bundibugyo strain has killed more than 500 people. The study is evaluating Mapp Biopharmaceutical's monoclonal antibody cocktail MBP134 and Gilead Sciences' antiviral remdesivir alongside optimized supportive care in Ituri province. It is structured as an adaptive platform trial that can continue through future outbreaks if the current epidemic ends before enough patients are enrolled. The primary endpoint is all-cause mortality 28 days after enrollment, with secondary endpoints including viral clearance and pregnancy outcomes. Researchers plan to enroll several hundred patients, who may receive MBP134, remdesivir, a combination, or supportive care alone.