Gilead Sciences Inc

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.

T-Mobile and Gilead Sciences both received Buy upgrades on Monday, with Bank of America setting a $220 target on T-Mobile and HSBC setting a $155 target on Gilead. Pfizer was downgraded to Hold from Buy at HSBC, which trimmed its target to $28 from $32, while Datadog was cut to Market Perform from Outperform at Bernstein, though its target was raised to $226 from $180. Among other notable calls, Agnico Eagle Mines was upgraded to Buy at Jefferies with a $200 target, Okta was raised to Outperform at Scotiabank with a $165 target, and Delta Air Lines was cut to Outperform from Strong Buy at Raymond James with a target lifted to $104 from $80. New initiations included ERock with Outperform ratings from Evercore ISI and JPMorgan at a $28 target, and Glaukos with a Buy rating at H.C. Wainwright and a $168 target.

Citi has released its stock picks and pans for the second half of 2026, covering real estate, technology and communications, consumer, and healthcare sectors. The bank's year-end S&P 500 target of 8100 is driven by the AI-capex super cycle, according to strategist Scott Chronert. In real estate, most preferred REITs include WELL, PLD, and CPT, while BDN is least preferred. In technology and communications, favored names span sub-sectors such as internet with AMZN, GOOGL, and DASH, and semiconductors with AMD, TXN, and AMAT, while least preferred include OPTU, UNIT, and CCOI in communications infrastructure and QRVO, SWKS, and OLED in semiconductors. Consumer sector top picks feature CL, PG, and KO in beverages, and MCD, CMG, and BROS in restaurants, with KMB and CBRL among the least preferred. In healthcare, most preferred stocks include LLY, VRTX, and GILD in biotech and large cap pharma, and EW, ISRG, and SYK in medical technology, while BAX and XRAY are among the least preferred.

Gilead Sciences received FDA approval for Trodelvy as a first-line treatment for metastatic triple-negative breast cancer. The drug is now authorized as a single agent or in combination with Keytruda, making it the first antibody-drug conjugate approved for this setting regardless of PD-L1 status. The decision follows Phase 3 trials that showed significantly improved progression-free survival and more durable responses compared to standard chemotherapy. The National Comprehensive Cancer Network now lists Trodelvy as a category 1 preferred first-line treatment. This new indication builds on Trodelvy's existing use in later-stage breast cancer and provides a vital standard-of-care option for a disease that has historically lacked diverse first-line therapies.

Merck reported positive Phase 3 results for tulisokibart, an anti-TL1A monoclonal antibody, in moderate-to-severe ulcerative colitis. The company also announced new FDA approvals for KEYTRUDA-based regimens in triple-negative breast cancer and muscle-invasive bladder cancer, while EU regulators cleared additional KEYTRUDA combinations in early-stage oncology settings. These developments reinforce Merck's focus on immunology and oncology, with tulisokibart representing efforts to build franchises beyond oncology and the new KEYTRUDA indications underlining partnerships with Gilead, Pfizer, and Astellas to entrench immunotherapy in earlier treatment lines. Investors will watch how widely tulisokibart is adopted and how new KEYTRUDA regimens fit into evolving treatment pathways, as well as upcoming label details, treatment guidelines, and competitive trial readouts.

Kymera Therapeutics shares have risen 50.9% year to date, driven by rapid advancement of its lead candidate KT-621 for atopic dermatitis. The company completed enrollment in the phase IIb BROADEN2 study roughly six months ahead of schedule, pulling forward pivotal efficacy data to late 2026. Positive phase Ib data presented at the American Academy of Dermatology showed robust STAT6 degradation and a favorable safety profile, supporting KT-621 as a potential oral alternative to injectable biologics. Beyond KT-621, pipeline momentum includes dosing the first participant in a phase I trial of KT-485 under a Sanofi collaboration that triggered a $20 million milestone, new preclinical data for KT-579 in lupus models, and Gilead’s option exercise on KT-200 that brought a $45 million payment. Kymera plans to begin phase III studies in atopic dermatitis by mid-2027 and expects asthma data from the BREADTH trial in late 2027.

This week brought a mix of FDA and EU approvals, layoffs, acquisitions, and clinical trial updates across the biotech sector. Ionis Pharmaceuticals secured FDA approval for TRYNGOLZA as an adjunct therapy for severe hypertriglyceridemia, while Merck received European Commission approval for Keytruda in combination with Padcev as a neoadjuvant treatment for muscle-invasive bladder cancer. Gilead's Trodelvy was cleared by the FDA for first-line metastatic triple-negative breast cancer, and Pfizer's IBRANCE won expanded approval for HR+/HER2+ metastatic breast cancer. Natera gained Japanese approval for its Signatera MRD test in colorectal cancer, and AbbVie's MAVIRET was approved in the EU for both acute and chronic Hepatitis C. Achieve Life Sciences received an FDA Complete Response Letter for its Cytisinicline NDA due to manufacturing deficiencies, though no efficacy or safety issues were raised. ADC Therapeutics announced a 17% workforce reduction as part of a strategic reorganization to focus on its ZYNLONTA lymphoma franchise. In dealmaking, Merck KGaA agreed to acquire Bio-Techne for $73 per share in cash, representing an enterprise value of $11.3 billion, while Ionis inked a licensing deal with Recordati for Zilganersen, an investigational therapy for Alexander disease. Passage Bio and Remix Therapeutics entered an all-stock merger agreement, and Boundless Bio and Serapha Bio also announced an all-stock merger. On the clinical front, IMUNON's Phase 3 OVATION 3 trial passed a safety review, Takeda's Zasocitinib showed superiority over Deucravacitinib in a Phase 3 psoriasis study, and Eledon reported positive long-term kidney transplant data for Tegoprubart. However, Pfizer's Sigvotatug vedotin missed its primary overall survival endpoint in a Phase 3 non-small cell lung cancer study, and MapLight's ML-004 failed to meet its primary endpoint in autism spectrum disorder, though it showed an irritability signal in adolescents. Definium Therapeutics reported positive Phase 3 results for DT120 ODT in major depressive disorder.

The U.S. Food and Drug Administration approved KEYTRUDA and KEYTRUDA QLEX, each in combination with Trodelvy, as a first-line treatment for adults with PD-L1-positive unresectable locally advanced or metastatic triple-negative breast cancer. This marks the first approval of a PD-1 inhibitor combined with a Trop-2-directed antibody-drug conjugate in advanced TNBC. The decision is based on the Phase 3 KEYNOTE-D19/ASCENT-04 trial, which showed the regimen reduced the risk of disease progression or death by 35% compared to KEYTRUDA plus chemotherapy, with a median progression-free survival of 11.2 months versus 7.8 months. The objective response rate was 61% for the combination, including a 12% complete response rate. The approvals represent a potentially practice-changing option for patients who often have limited first-line choices.

Gilead Sciences obtained European Commission approval to expand the label of its breast cancer drug Trodelvy. The authorization covers Trodelvy as a monotherapy for adult patients with unresectable or metastatic triple-negative breast cancer who have not received prior systemic therapy for metastatic disease and are not candidates for PD-1 or PD-L1 inhibitor therapy. The decision makes Trodelvy the first antibody-drug conjugate approved in first-line metastatic TNBC in the European Union and the first new treatment option in 20 years in Europe for these patients. The approval was based on the phase III ASCENT-03 study, which showed a 38% reduction in the risk of disease progression or death compared with standard-of-care chemotherapy. Gilead has also submitted applications to the European Medicines Agency and the U.S. Food and Drug Administration for Trodelvy in combination with Merck's Keytruda for certain patients with PD-L1-positive tumors.