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JNJ Gets EU Nod for Expanded Use of Akeega in Prostate Cancer
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Key Takeaways
J&J won EU approval to expand Akeega use to BRCA1/2-mutated metastatic hormone-sensitive prostate cancer.
JNJ's phase III AMPLITUDE study showed the combo nearly halved the risk of disease progression or death.
Akeega was approved in the EU in 2023 for BRCA-mutated metastatic castration-resistant prostate cancer.
J&J (JNJ - Free Report) announced that the European Commission has approved its precision therapy, Akeega (niraparib and abiraterone acetate dual action tablet), for expanded use in prostate cancer. The regulatory body in Europe has now approved an indication extension for Akeega with prednisone or prednisolone (AAP) in combination with androgen deprivation therapy (ADT) to treat patients with BRCA1/2-mutated metastatic hormone-sensitive prostate cancer (mHSPC).
The EU approval was based on results from the phase III AMPLITUDE study, which showed that the Akeega-prednisone combination led to a clinically meaningful delay in disease progression, nearly halving the risk of progression or death and showing an early trend toward improved overall survival compared with the standard of care.
In January 2026, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency issued a positive opinion recommending an indication extension for Akeega to treat patients with BRCA1/2-mutated mHSPC.
The combination of Akeega and prednisone was approved in the EU to treat patients with BRCA-mutated metastatic castration-resistant prostate cancer (mCRPC) in 2023.
JNJ’s Price Performance
In the past six months, shares of J&J have rallied 35.9% compared with the industry’s increase of 19.7%.
Image Source: Zacks Investment Research
More on JNJ’s Akeega & Oncology Goal
Akeega combines the PARP inhibitor niraparib and the CYP17 inhibitor abiraterone acetate. While niraparib is an active ingredient used in GSKplc’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.
In December 2025, the FDA approved Akeega 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.
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 to treat BRCA-mutated mCRPC in 2023.
J&J has a strong presence in oncology, with extensive expertise in blood cancers and solid tumors. The company’s Oncology segment comprises around 27% of total revenues. J&J expects its oncology sales to reach $50 billion by 2030. Though quite bullish, J&J seems quite confident that it can meet the target, citing strong growth in its marketed cancer drugs and new product launches.
Over the past 60 days, estimates for ANI Pharmaceuticals’ 2026 earnings per share have increased from $8.20 to $9.00, while the same for 2027 have increased from $9.25 to $10.10. ANIP’s shares have fallen 24.2% in the past six months.
ANI Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 22.21%.
Over the past 60 days, Replimune’s 2026 loss per share estimates have narrowed from $3.59 to $3.41, while the same for 2027 have narrowed from $2.42 to $2.33. REPL’s shares have rallied 43.6% in the past six months.
Replimune’s earnings beat estimates in one of the trailing four quarters and missed on the remaining three occasions, with the average negative surprise being 4.46%.
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JNJ Gets EU Nod for Expanded Use of Akeega in Prostate Cancer
Key Takeaways
J&J (JNJ - Free Report) announced that the European Commission has approved its precision therapy, Akeega (niraparib and abiraterone acetate dual action tablet), for expanded use in prostate cancer. The regulatory body in Europe has now approved an indication extension for Akeega with prednisone or prednisolone (AAP) in combination with androgen deprivation therapy (ADT) to treat patients with BRCA1/2-mutated metastatic hormone-sensitive prostate cancer (mHSPC).
The EU approval was based on results from the phase III AMPLITUDE study, which showed that the Akeega-prednisone combination led to a clinically meaningful delay in disease progression, nearly halving the risk of progression or death and showing an early trend toward improved overall survival compared with the standard of care.
In January 2026, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency issued a positive opinion recommending an indication extension for Akeega to treat patients with BRCA1/2-mutated mHSPC.
The combination of Akeega and prednisone was approved in the EU to treat patients with BRCA-mutated metastatic castration-resistant prostate cancer (mCRPC) in 2023.
JNJ’s Price Performance
In the past six months, shares of J&J have rallied 35.9% compared with the industry’s increase of 19.7%.
Image Source: Zacks Investment Research
More on JNJ’s Akeega & Oncology Goal
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.
In December 2025, the FDA approved Akeega 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.
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 to treat BRCA-mutated mCRPC in 2023.
J&J has a strong presence in oncology, with extensive expertise in blood cancers and solid tumors. The company’s Oncology segment comprises around 27% of total revenues. J&J expects its oncology sales to reach $50 billion by 2030. Though quite bullish, J&J seems quite confident that it can meet the target, citing strong growth in its marketed cancer drugs and new product launches.
JNJ's Zacks Rank & Stocks to Consider
J&J currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are ANI Pharmaceuticals (ANIP - Free Report) and Replimune Group (REPL - Free Report) , each carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Over the past 60 days, estimates for ANI Pharmaceuticals’ 2026 earnings per share have increased from $8.20 to $9.00, while the same for 2027 have increased from $9.25 to $10.10. ANIP’s shares have fallen 24.2% in the past six months.
ANI Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 22.21%.
Over the past 60 days, Replimune’s 2026 loss per share estimates have narrowed from $3.59 to $3.41, while the same for 2027 have narrowed from $2.42 to $2.33. REPL’s shares have rallied 43.6% in the past six months.
Replimune’s earnings beat estimates in one of the trailing four quarters and missed on the remaining three occasions, with the average negative surprise being 4.46%.