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Here's Why Gilead Sciences Stock Surged 21% in a Month
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Key Takeaways
GILD stock rose 20.8% in a month after NEJM published positive phase III ASCENT-04 results in metastatic TNBC.
GILD's Trodelvy with Keytruda cut progression or death risk by 35% and lifted median PFS to 11.2 months.
GILD data support a new first-line PD-L1 TNBC standard, backing submitted filings to expand Trodelvy's label.
Shares of Gilead Sciences, Inc. (GILD - Free Report) have gained 20.8% in a month compared with the industry’s growth of 4.5%.
Much of this rally followed the Jan. 21 announcement that full results from the late-stage ASCENT-04/KEYNOTE-D19 study were published in The New England Journal of Medicine (“NEJM”).
Image Source: Zacks Investment Research
The phase III ASCENT-04 study is evaluating the combination of Gilead’s oncology drug Trodelvy (sacituzumab govitecan-hziy) with Merck’s (MRK - Free Report) blockbuster immuno-oncology drug Keytruda (pembrolizumab) in patients with previously untreated, inoperable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1. The study enrolled 443 patients across multiple study sites.
This study met its primary endpoint of progression-free survival (PFS) with a 35% reduced risk of disease progression or death for Trodelvy plus Keytruda (n=221) combination as compared to Keytruda plus chemotherapy (n=222). Median PFS with Trodelvy plus Keytruda was 11.2 months versus 7.8 months when Keytruda was given in combination with chemotherapy.
The successful results support Trodelvy plus Keytruda as a potential new standard of care in first-line PD-L1+ metastatic TNBC.
The safety profile of Trodelvy plus Keytruda in ASCENT-04 was consistent with the known safety profile of each agent.
We note that Gilead entered a collaboration with Merck in 2021 to evaluate Trodelvy in combination with Keytruda in the ASCENT-04/KEYNOTE-D19 study.
More on GILD’s Trodelvy
Trodelvy (sacituzumab govitecan-hziy) is a first-in-class Trop-2-directed antibody-drug conjugate.
The drug is currently approved in more than 50 countries for second-line or later metastatic TNBC and in more than 40 countries for certain patients with pre-treated HR+/HER2- metastatic breast cancer (mBC).
Trodelvy continues to gain market share in the second-line setting. GILD has already submitted two supplemental biologics license applications seeking approval of the drug for use in first-line metastatic TNBC patients. A potential approval in the first-line setting (regulatory decisions are expected in 2026) will boost Trodelvy sales.
Management highlighted the significant unmet need in first-line metastatic TNBC, where patients often experience rapid disease progression and poor outcomes with existing therapies, creating a sizable opportunity for differentiated treatments.
The robust efficacy data for the Trodelvy–Keytruda combination therefore strengthen the case for a potential new standard of care, which could materially expand Trodelvy’s addressable market and drive long-term revenue growth.
Importantly, the NEJM publication builds on prior presentations at the 2025 ASCO and ESMO congresses. Primary results from the ASCENT-03 study of Trodelvy monotherapy in patients with first-line metastatic TNBC who are not candidates for PD-1/PD-L1 inhibitors were also published in the NEJM.
Trodelvy is currently being evaluated in multiple ongoing phase III trials across tumor types characterized by high Trop-2 expression, underscoring its potential as a broadly applicable oncology asset. The development program spans both monotherapy and combination regimens with Keytruda, targeting earlier lines of treatment in TNBC and HR+/HER2-negative breast cancer, including curative-intent settings. In addition, Trodelvy is being investigated in lung and gynecologic cancers, indications where prior proof-of-concept data have already demonstrated clinical activity.
A potential label expansion for Trodelvy would strengthen Gilead’s oncology portfolio while reducing its heavy reliance on HIV therapies by meaningfully diversifying the company’s revenue base.
MRK’s Keytruda is approved for several types of cancer and alone accounts for around 50% of the company’s pharmaceutical sales. Merck is currently working on different strategies to drive long-term growth of Keytruda.
Over the past 60 days, estimates for Regeneron Pharmaceuticals’ 2026 EPS have increased from $41.80 to $44.19. Shares of REGN have surged 32.1% over the past six months.
Regeneron Pharmaceuticals’ earnings beat estimates in three of the trailing four quarters and missed the mark on the remaining occasion, delivering an average surprise of 22.91%.
Over the past 90 days, 2026 EPS estimates for Alkermes have increased from $1.95 to $2.02. Shares of ALKS have gained 30.6% over the past six months.
Alkermes’ earnings beat estimates in three of the trailing four quarters and missed on the remaining occasion, with the average surprise being 4.58%.
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Here's Why Gilead Sciences Stock Surged 21% in a Month
Key Takeaways
Shares of Gilead Sciences, Inc. (GILD - Free Report) have gained 20.8% in a month compared with the industry’s growth of 4.5%.
Much of this rally followed the Jan. 21 announcement that full results from the late-stage ASCENT-04/KEYNOTE-D19 study were published in The New England Journal of Medicine (“NEJM”).
Image Source: Zacks Investment Research
The phase III ASCENT-04 study is evaluating the combination of Gilead’s oncology drug Trodelvy (sacituzumab govitecan-hziy) with Merck’s (MRK - Free Report) blockbuster immuno-oncology drug Keytruda (pembrolizumab) in patients with previously untreated, inoperable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1. The study enrolled 443 patients across multiple study sites.
This study met its primary endpoint of progression-free survival (PFS) with a 35% reduced risk of disease progression or death for Trodelvy plus Keytruda (n=221) combination as compared to Keytruda plus chemotherapy (n=222). Median PFS with Trodelvy plus Keytruda was 11.2 months versus 7.8 months when Keytruda was given in combination with chemotherapy.
The successful results support Trodelvy plus Keytruda as a potential new standard of care in first-line PD-L1+ metastatic TNBC.
The safety profile of Trodelvy plus Keytruda in ASCENT-04 was consistent with the known safety profile of each agent.
We note that Gilead entered a collaboration with Merck in 2021 to evaluate Trodelvy in combination with Keytruda in the ASCENT-04/KEYNOTE-D19 study.
More on GILD’s Trodelvy
Trodelvy (sacituzumab govitecan-hziy) is a first-in-class Trop-2-directed antibody-drug conjugate.
The drug is currently approved in more than 50 countries for second-line or later metastatic TNBC and in more than 40 countries for certain patients with pre-treated HR+/HER2- metastatic breast cancer (mBC).
Trodelvy continues to gain market share in the second-line setting. GILD has already submitted two supplemental biologics license applications seeking approval of the drug for use in first-line metastatic TNBC patients. A potential approval in the first-line setting (regulatory decisions are expected in 2026) will boost Trodelvy sales.
Management highlighted the significant unmet need in first-line metastatic TNBC, where patients often experience rapid disease progression and poor outcomes with existing therapies, creating a sizable opportunity for differentiated treatments.
The robust efficacy data for the Trodelvy–Keytruda combination therefore strengthen the case for a potential new standard of care, which could materially expand Trodelvy’s addressable market and drive long-term revenue growth.
Importantly, the NEJM publication builds on prior presentations at the 2025 ASCO and ESMO congresses. Primary results from the ASCENT-03 study of Trodelvy monotherapy in patients with first-line metastatic TNBC who are not candidates for PD-1/PD-L1 inhibitors were also published in the NEJM.
Trodelvy is currently being evaluated in multiple ongoing phase III trials across tumor types characterized by high Trop-2 expression, underscoring its potential as a broadly applicable oncology asset. The development program spans both monotherapy and combination regimens with Keytruda, targeting earlier lines of treatment in TNBC and HR+/HER2-negative breast cancer, including curative-intent settings. In addition, Trodelvy is being investigated in lung and gynecologic cancers, indications where prior proof-of-concept data have already demonstrated clinical activity.
A potential label expansion for Trodelvy would strengthen Gilead’s oncology portfolio while reducing its heavy reliance on HIV therapies by meaningfully diversifying the company’s revenue base.
MRK’s Keytruda is approved for several types of cancer and alone accounts for around 50% of the company’s pharmaceutical sales. Merck is currently working on different strategies to drive long-term growth of Keytruda.
GILD’s Zacks Rank and Stocks to Consider
Gilead currently has a Zacks Rank #3 (Hold). A couple of better-ranked biotech stocks are Regeneron Pharmaceuticals (REGN - Free Report) and Alkermes (ALKS - Free Report) . You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Over the past 60 days, estimates for Regeneron Pharmaceuticals’ 2026 EPS have increased from $41.80 to $44.19. Shares of REGN have surged 32.1% over the past six months.
Regeneron Pharmaceuticals’ earnings beat estimates in three of the trailing four quarters and missed the mark on the remaining occasion, delivering an average surprise of 22.91%.
Over the past 90 days, 2026 EPS estimates for Alkermes have increased from $1.95 to $2.02. Shares of ALKS have gained 30.6% over the past six months.
Alkermes’ earnings beat estimates in three of the trailing four quarters and missed on the remaining occasion, with the average surprise being 4.58%.