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FDA Approves J&J's Akeega for Expanded Use in Prostate Cancer
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Key Takeaways
JNJ won FDA approval to expand Akeega for BRCA2-mutated metastatic castration-sensitive prostate cancer.
The phase III AMPLITUDE study showed the Akeega-prednisone combo cut progression or death risk by 54%.
The label expansion moves Akeega into earlier treatment, building on its 2023 approval in resistant disease.
Johnson & Johnson (JNJ - Free Report) announced that the FDA approved its precision therapy, Akeega (niraparib and abiraterone acetate dual-action tablet), for a second indication in prostate cancer. The agency has cleared this drug, in combination with prednisone, to treat patients with BRCA2-mutated (BRCA2m) metastatic castration-sensitive prostate cancer (mCSPC).
Per J&J, this label expansion marks the first FDA-approved precision medicine combination of a PARP inhibitor with an androgen receptor pathway inhibitor for BRCA2m mCSPC. The approval is supported by data from the phase III AMPLITUDE study, which showed that treatment with the Akeega-prednisone combo reduced the risk of radiographic progression or death by 54%.
With this new indication, the drug’s use has been expanded to an earlier stage of the disease. The FDA approved the combination of Akeega and prednisone in 2023 to treat BRCA-mutated metastatic castration-resistant prostate cancer (mCRPC).
Akeega combines the PARP inhibitor niraparib and the CYP17 inhibitor abiraterone acetate. While niraparib is an active ingredient used in GSK plc’s (GSK - Free Report) cancer drug Zejula, abiraterone acetate is marketed by J&J under the brand name Zytiga for prostate cancer. The company has an exclusive agreement with GSK for the rights to niraparib in prostate cancer.
JNJ Stock Performance
Shares of J&J have risen 46% this year so far compared with the industry’s 16% growth.
Image Source: Zacks Investment Research
J&J Chases $50B Goal in Oncology Sales
The company has a strong presence in oncology, with extensive expertise in blood cancers and solid tumors. This segment now comprises around 27% of its total revenues. Its oncology sales rose nearly 21% year over year in the first nine months to $18.52 billion, driven by strong market growth and share gains from key products such as multiple myeloma treatment Darzalex and prostate cancer drug Erleada.
New cancer drugs, such as Carvykti, Tecvayli, Talvey and Rybrevant, plus Lazcluze, contributed significantly to growth as they witnessed strong launches.
Based on this momentum, J&J has set an ambitious target to reach $50 billion in oncology sales by the end of this decade. While this goal may seem overly optimistic, it does not appear unachievable. In the five years from 2019 to 2024, J&J’s oncology sales doubled from $10.7 billion to $20.8 billion. To attain the $50-billion target over the next five to six years, the company needs to more than double its sales from the 2024 reported levels.
J&J seems quite confident of the target, citing strong growth in its marketed cancer drugs and launches like Inlexzoh (TAR-200) in high-risk non-muscle invasive bladder cancer and the subcutaneous formulation of Rybrevant plus Lazcluze for advanced EGFR-mutated non-small cell lung cancer.
The company is also building its oncology pipeline through inorganic growth strategies. Last month, it announced a definitive agreement to acquire the clinical-stage biotech Halda Therapeutics for $3.05 billion in cash. This deal aims to strengthen J&J’s broader oncology pipeline, mainly in prostate cancer, where it already has a strong presence with drugs like Zytiga, Erleada and Akeega.
In the past 60 days, estimates for ANI Pharmaceuticals’ 2025 earnings per share (EPS) have risen from $7.29 to $7.54. EPS estimates for 2026 have increased from $7.79 to $8.15 during the same period. Year to date, shares of ANIP have rallied more than 45%.
ANIP’s earnings beat estimates in the trailing four quarters, delivering an average surprise of 21.24%.
Estimates for CorMedix’s 2025 EPS have increased from $1.85 to $2.87 over the past 60 days, while the same for 2026 has increased from $2.49 to $2.88. CRMD shares have risen 42% year to date.
CorMedix’s earnings beat estimates in the trailing four quarters, delivering an average surprise of 27.04%.
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FDA Approves J&J's Akeega for Expanded Use in Prostate Cancer
Key Takeaways
Johnson & Johnson (JNJ - Free Report) announced that the FDA approved its precision therapy, Akeega (niraparib and abiraterone acetate dual-action tablet), for a second indication in prostate cancer. The agency has cleared this drug, in combination with prednisone, to treat patients with BRCA2-mutated (BRCA2m) metastatic castration-sensitive prostate cancer (mCSPC).
Per J&J, this label expansion marks the first FDA-approved precision medicine combination of a PARP inhibitor with an androgen receptor pathway inhibitor for BRCA2m mCSPC. The approval is supported by data from the phase III AMPLITUDE study, which showed that treatment with the Akeega-prednisone combo reduced the risk of radiographic progression or death by 54%.
With this new indication, the drug’s use has been expanded to an earlier stage of the disease. The FDA approved the combination of Akeega and prednisone in 2023 to treat BRCA-mutated metastatic castration-resistant prostate cancer (mCRPC).
Akeega combines the PARP inhibitor niraparib and the CYP17 inhibitor abiraterone acetate. While niraparib is an active ingredient used in GSK plc’s (GSK - Free Report) cancer drug Zejula, abiraterone acetate is marketed by J&J under the brand name Zytiga for prostate cancer. The company has an exclusive agreement with GSK for the rights to niraparib in prostate cancer.
JNJ Stock Performance
Shares of J&J have risen 46% this year so far compared with the industry’s 16% growth.
Image Source: Zacks Investment Research
J&J Chases $50B Goal in Oncology Sales
The company has a strong presence in oncology, with extensive expertise in blood cancers and solid tumors. This segment now comprises around 27% of its total revenues. Its oncology sales rose nearly 21% year over year in the first nine months to $18.52 billion, driven by strong market growth and share gains from key products such as multiple myeloma treatment Darzalex and prostate cancer drug Erleada.
New cancer drugs, such as Carvykti, Tecvayli, Talvey and Rybrevant, plus Lazcluze, contributed significantly to growth as they witnessed strong launches.
Based on this momentum, J&J has set an ambitious target to reach $50 billion in oncology sales by the end of this decade. While this goal may seem overly optimistic, it does not appear unachievable. In the five years from 2019 to 2024, J&J’s oncology sales doubled from $10.7 billion to $20.8 billion. To attain the $50-billion target over the next five to six years, the company needs to more than double its sales from the 2024 reported levels.
J&J seems quite confident of the target, citing strong growth in its marketed cancer drugs and launches like Inlexzoh (TAR-200) in high-risk non-muscle invasive bladder cancer and the subcutaneous formulation of Rybrevant plus Lazcluze for advanced EGFR-mutated non-small cell lung cancer.
The company is also building its oncology pipeline through inorganic growth strategies. Last month, it announced a definitive agreement to acquire the clinical-stage biotech Halda Therapeutics for $3.05 billion in cash. This deal aims to strengthen J&J’s broader oncology pipeline, mainly in prostate cancer, where it already has a strong presence with drugs like Zytiga, Erleada and Akeega.
JNJ’s Zacks Rank
J&J currently carries a Zacks Rank #3 (Hold).
Johnson & Johnson Price
Johnson & Johnson price | Johnson & Johnson Quote
Key Picks Among Biotech Stocks
Some better-ranked stocks from the sector are ANI Pharmaceuticals (ANIP - Free Report) and CorMedix (CRMD - Free Report) , each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for ANI Pharmaceuticals’ 2025 earnings per share (EPS) have risen from $7.29 to $7.54. EPS estimates for 2026 have increased from $7.79 to $8.15 during the same period. Year to date, shares of ANIP have rallied more than 45%.
ANIP’s earnings beat estimates in the trailing four quarters, delivering an average surprise of 21.24%.
Estimates for CorMedix’s 2025 EPS have increased from $1.85 to $2.87 over the past 60 days, while the same for 2026 has increased from $2.49 to $2.88. CRMD shares have risen 42% year to date.
CorMedix’s earnings beat estimates in the trailing four quarters, delivering an average surprise of 27.04%.