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GILD Scores FDA Win for HDV Drug, CHMP Backs Trodelvy
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Key Takeaways
GILD gained after the FDA approved Hepcludex, the first U.S. treatment for chronic HDV infection.
Trodelvy won CHMP backing in Europe for first-line metastatic TNBC in select patients.
Gilead lowered EPS guidance after deal costs tied to Arcellx, Ouro and Tubulis transactions.
Gilead Sciences, Inc. (GILD - Free Report) announced that the FDA has granted accelerated approval to Hepcludex (bulevirtide-gmod) for adults with chronic hepatitis delta virus (HDV) infection.
The approval makes Hepcludex the first FDA-approved therapy for HDV in the United States.
Shares of GILD inched up 3% on May 22, following the news.
Year to date, shares have gained 9.5% against the industry's decline of 0.3%.
Image Source: Zacks Investment Research
More on FDA Approval of GILD’s HDV Treatment
The approval was supported by data from the phase III MYR301 study, where Hepcludex achieved statistically significant improvements in combined virologic and biochemical response at week 48 compared with delayed treatment. The therapy demonstrated reductions in HDV RNA levels and normalization of alanine aminotransferase, with sustained efficacy and generally favorable tolerability through up to 144 weeks of treatment.
Chronic HDV is considered the most severe form of viral hepatitis due to its rapid progression to liver failure and liver-related death, highlighting the significant unmet need for effective treatments.
HDV affects an estimated 40,000 to 80,000 people in the United States among individuals living with chronic hepatitis B virus.
Hepcludex (bulevirtide-gmod) 8.5 mg is approved for adults with chronic HDV infection without cirrhosis or with compensated cirrhosis under the FDA’s accelerated approval pathway. Continued approval may depend on confirmation of clinical benefit in ongoing studies.
GILD’s Update on Trodelvy
GILD also announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued a positive opinion recommending approval of Trodelvy as a monotherapy for adults with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic treatment for metastatic disease and are not eligible for PD-1 or PD-L1 inhibitor therapy.
A final decision from the European Commission is expected later in 2026.
Metastatic TNBC is an aggressive breast cancer subtype with poor survival outcomes, and many patients receive only one line of therapy in the metastatic setting, underscoring the need for effective first-line treatment options.
The CHMP recommendation was based on results from the phase III ASCENT-03 study, in which Trodelvy significantly improved progression-free survival compared with standard chemotherapy. The study showed a 38% reduction in the risk of disease progression or death among patients ineligible for PD-1/PD-L1 inhibitors.
Gilead Sciences has also filed a supplemental application with the FDA seeking approval of Trodelvy for this indication based on results from the phase III ASCENT-03 study.
Trodelvy is currently approved in over 60 countries for patients with second-line or later metastatic triple-negative breast cancer and in more than 50 countries for certain individuals with previously treated HR-positive/HER2-negative metastatic breast cancer.
Gilead Sciences has also submitted supplemental applications to the European Medicines Agency and the FDA for Trodelvy in combination with Merck’s (MRK - Free Report) Keytruda for patients with PD-L1-positive unresectable locally advanced or metastatic TNBC, supported by data from the phase III ASCENT-04 study. Both regulatory submissions are currently under review. If approved, Trodelvy could become a foundational first-line treatment option for metastatic TNBC regardless of PD-L1 status.
Keytruda is approved for several types of cancer and alone accounts for around 50% of MRK’s pharmaceutical sales. Merck is currently working on different strategies to drive the long-term growth of Keytruda.
GILD’s Efforts to Bolster Portfolio
The FDA approval of Hepcludex bolsters the GILD’s liver disease franchise, which spans treatments for HCV, chronic HBV, and chronic HDV.
The strong uptake of Livdelzi, approved for the treatment of primary biliary cholangitis (PBC), in combination with ursodeoxycholic acid (UDCA), in adults who have had an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA, has fueled liver disease sales.
Meanwhile, breast cancer drug Trodelvy continues to gain market share in the second-line setting. A potential approval in the first-line setting will boost sales.
Earlier this month, Gilead reported better-than-expected first-quarter results as its HIV business continued to maintain momentum, driven by strong performance from Biktarvy and Descovy, along with incremental contributions from Yeztugo.
Gilead Sciences, Inc. Price, Consensus and EPS Surprise
However, GILD lowered its full-year earnings outlook due to expected acquired IPR&D charges of $11.5 billion and financing expenses associated with the Arcellx, Ouro Medicines, and Tubulis GmbH deals.
Gilead’s aggressive dealmaking strategy — including the acquisition of Arcellx and agreements with Ouro and Tubulis — highlights the company’s commitment to diversifying beyond its core HIV franchise into higher-growth oncology and immunology markets. While these transactions strengthen Gilead’s long-term pipeline and growth potential, the sizable upfront payments and integration-related costs are pressuring near-term profitability.
This, in turn, has prompted Gilead to lower its EPS guidance, raising investor concerns about margin pressure and the timeline required for these acquisitions to generate meaningful returns.
GILD’s Zacks Rank
Gilead currently has a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector are Liquidia Corporation (LQDA - Free Report) and Immunocore (IMCR - Free Report) . While LQDA currently sports a Zacks Rank #1 (Strong Buy), IMCR carries a Zacks Rank #2 (Buy).
Over the past 60 days, estimates for Liquidia’s 2026 earnings per share have risen from $1.50 to $2.97, while those for 2027 have increased from $2.91 to $4.81. LQDA’s shares have surged 76.8% year to date.
Liquidia’s earnings beat estimates in three of the trailing four quarters and missed in one, with the average surprise being 54.40%.
Over the past 60 days, 2026 loss per share estimates for Immunocore have narrowed from 97 cents to 16 cents, while 2027 estimates have improved from a loss of 39 cents to earnings of 11 cents per share. IMCR stock has lost 13.5% year to date.
Immunocore’s earnings beat estimates in three of the trailing four quarters and missed in one, with the average surprise being 46.66%.
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GILD Scores FDA Win for HDV Drug, CHMP Backs Trodelvy
Key Takeaways
Gilead Sciences, Inc. (GILD - Free Report) announced that the FDA has granted accelerated approval to Hepcludex (bulevirtide-gmod) for adults with chronic hepatitis delta virus (HDV) infection.
The approval makes Hepcludex the first FDA-approved therapy for HDV in the United States.
Shares of GILD inched up 3% on May 22, following the news.
Year to date, shares have gained 9.5% against the industry's decline of 0.3%.
Image Source: Zacks Investment Research
More on FDA Approval of GILD’s HDV Treatment
The approval was supported by data from the phase III MYR301 study, where Hepcludex achieved statistically significant improvements in combined virologic and biochemical response at week 48 compared with delayed treatment. The therapy demonstrated reductions in HDV RNA levels and normalization of alanine aminotransferase, with sustained efficacy and generally favorable tolerability through up to 144 weeks of treatment.
Chronic HDV is considered the most severe form of viral hepatitis due to its rapid progression to liver failure and liver-related death, highlighting the significant unmet need for effective treatments.
HDV affects an estimated 40,000 to 80,000 people in the United States among individuals living with chronic hepatitis B virus.
Hepcludex (bulevirtide-gmod) 8.5 mg is approved for adults with chronic HDV infection without cirrhosis or with compensated cirrhosis under the FDA’s accelerated approval pathway. Continued approval may depend on confirmation of clinical benefit in ongoing studies.
GILD’s Update on Trodelvy
GILD also announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued a positive opinion recommending approval of Trodelvy as a monotherapy for adults with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic treatment for metastatic disease and are not eligible for PD-1 or PD-L1 inhibitor therapy.
A final decision from the European Commission is expected later in 2026.
Metastatic TNBC is an aggressive breast cancer subtype with poor survival outcomes, and many patients receive only one line of therapy in the metastatic setting, underscoring the need for effective first-line treatment options.
The CHMP recommendation was based on results from the phase III ASCENT-03 study, in which Trodelvy significantly improved progression-free survival compared with standard chemotherapy. The study showed a 38% reduction in the risk of disease progression or death among patients ineligible for PD-1/PD-L1 inhibitors.
Gilead Sciences has also filed a supplemental application with the FDA seeking approval of Trodelvy for this indication based on results from the phase III ASCENT-03 study.
Trodelvy is currently approved in over 60 countries for patients with second-line or later metastatic triple-negative breast cancer and in more than 50 countries for certain individuals with previously treated HR-positive/HER2-negative metastatic breast cancer.
Gilead Sciences has also submitted supplemental applications to the European Medicines Agency and the FDA for Trodelvy in combination with Merck’s (MRK - Free Report) Keytruda for patients with PD-L1-positive unresectable locally advanced or metastatic TNBC, supported by data from the phase III ASCENT-04 study. Both regulatory submissions are currently under review. If approved, Trodelvy could become a foundational first-line treatment option for metastatic TNBC regardless of PD-L1 status.
Keytruda is approved for several types of cancer and alone accounts for around 50% of MRK’s pharmaceutical sales. Merck is currently working on different strategies to drive the long-term growth of Keytruda.
GILD’s Efforts to Bolster Portfolio
The FDA approval of Hepcludex bolsters the GILD’s liver disease franchise, which spans treatments for HCV, chronic HBV, and chronic HDV.
The strong uptake of Livdelzi, approved for the treatment of primary biliary cholangitis (PBC), in combination with ursodeoxycholic acid (UDCA), in adults who have had an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA, has fueled liver disease sales.
Meanwhile, breast cancer drug Trodelvy continues to gain market share in the second-line setting. A potential approval in the first-line setting will boost sales.
Earlier this month, Gilead reported better-than-expected first-quarter results as its HIV business continued to maintain momentum, driven by strong performance from Biktarvy and Descovy, along with incremental contributions from Yeztugo.
Gilead Sciences, Inc. Price, Consensus and EPS Surprise
Gilead Sciences, Inc. price-consensus-eps-surprise-chart | Gilead Sciences, Inc. Quote
However, GILD lowered its full-year earnings outlook due to expected acquired IPR&D charges of $11.5 billion and financing expenses associated with the Arcellx, Ouro Medicines, and Tubulis GmbH deals.
Gilead’s aggressive dealmaking strategy — including the acquisition of Arcellx and agreements with Ouro and Tubulis — highlights the company’s commitment to diversifying beyond its core HIV franchise into higher-growth oncology and immunology markets. While these transactions strengthen Gilead’s long-term pipeline and growth potential, the sizable upfront payments and integration-related costs are pressuring near-term profitability.
This, in turn, has prompted Gilead to lower its EPS guidance, raising investor concerns about margin pressure and the timeline required for these acquisitions to generate meaningful returns.
GILD’s Zacks Rank
Gilead currently has a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector are Liquidia Corporation (LQDA - Free Report) and Immunocore (IMCR - Free Report) . While LQDA currently sports a Zacks Rank #1 (Strong Buy), IMCR carries a Zacks Rank #2 (Buy).
You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Liquidia’s 2026 earnings per share have risen from $1.50 to $2.97, while those for 2027 have increased from $2.91 to $4.81. LQDA’s shares have surged 76.8% year to date.
Liquidia’s earnings beat estimates in three of the trailing four quarters and missed in one, with the average surprise being 54.40%.
Over the past 60 days, 2026 loss per share estimates for Immunocore have narrowed from 97 cents to 16 cents, while 2027 estimates have improved from a loss of 39 cents to earnings of 11 cents per share. IMCR stock has lost 13.5% year to date.
Immunocore’s earnings beat estimates in three of the trailing four quarters and missed in one, with the average surprise being 46.66%.