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Exelixis (EXEL) Reports Positive EU Patent Ruling for Cabometyx
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Exelixis, Inc. (EXEL - Free Report) announced that it has successfully defended an EU patent for Cabometyx (cabozantinib) tablets against three opponents in a hearing before the Opposition Division of the European Patent Office (EPO). The three opponents were STADA Arzneimittel AG, Teva Pharmaceuticals (TEVA - Free Report) and Generics (U.K.) Ltd.
Exelixis’ Cabometyx is approved for several oncology indications in the United States and EU.
The Opposition Division panel (comprising three members) rejected all grounds of conflict, thus upholding EXEL’s patent for Cabometyx as granted.
The patent in question protects the tablet formulations of cabozantinib, including Cabometyx tablets approved by the European Medicines Agency. The patent has an expiration date of Jul 18, 2031.
Per Exelixis, the EPO’s ruling is specific to the European patent at issue and is subject to appeal.
Over the past year, shares of Exelixis have gained 33.1% against the industry’s 13.8% decline.
Image Source: Zacks Investment Research
In the United States, Exelixis has already entered into a settlement and license agreement with Teva Pharmaceuticals, which resolves patent litigation brought by EXEL in response to TEVA’s abbreviated new drug application seeking approval to market a generic version of Cabometyx before the expiration of the applicable patents.
Per the settlement terms, Exelixis will grant Teva Pharmaceuticals a license to market its generic version of the drug in the United States beginning Jan 1, 2031, upon the FDA’s approval.
EXEL’s Cabometyx is approved as a monotherapy for patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy. The drug has become a standard of care for the treatment of patients suffering from advanced RCC.
The drug’s label was further expanded to include first-line treatment of advanced RCC in the United States. In the EU, Cabometyx is approved for the first-line treatment of adults with intermediate or low-risk advanced RCC.
Cabometyx is also currently approved in the United States and EU as a monotherapy forhepatocellular carcinoma.
In the past 30 days, the Zacks Consensus Estimate for Puma Biotech’s 2023 earnings per share (EPS) has increased from 72 cents to 73 cents. During the same time frame, the consensus estimate for Puma Biotech’s 2024 EPS has increased from 64 cents to 69 cents. Over the past year, shares of PBYI have gained 16.7%.
PBYI beat estimates in three of the last four quarters while missing on one occasion, delivering a four-quarter average earnings surprise of 76.55%.
In the past 30 days, the Zacks Consensus Estimate for ADMA Biologics’ 2023 loss per share has narrowed from 3 cents to 2 cents. The consensus estimate for ADMA Biologics’ 2024 EPS is pegged at 22 cents. Over the past year, shares of ADMA have risen 43.4%.
ADMA beat estimates in three of the trailing four quarters and matched in one, delivering an average earnings surprise of 63.57%.
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Exelixis (EXEL) Reports Positive EU Patent Ruling for Cabometyx
Exelixis, Inc. (EXEL - Free Report) announced that it has successfully defended an EU patent for Cabometyx (cabozantinib) tablets against three opponents in a hearing before the Opposition Division of the European Patent Office (EPO). The three opponents were STADA Arzneimittel AG, Teva Pharmaceuticals (TEVA - Free Report) and Generics (U.K.) Ltd.
Exelixis’ Cabometyx is approved for several oncology indications in the United States and EU.
The Opposition Division panel (comprising three members) rejected all grounds of conflict, thus upholding EXEL’s patent for Cabometyx as granted.
The patent in question protects the tablet formulations of cabozantinib, including Cabometyx tablets approved by the European Medicines Agency. The patent has an expiration date of Jul 18, 2031.
Per Exelixis, the EPO’s ruling is specific to the European patent at issue and is subject to appeal.
Over the past year, shares of Exelixis have gained 33.1% against the industry’s 13.8% decline.
Image Source: Zacks Investment Research
In the United States, Exelixis has already entered into a settlement and license agreement with Teva Pharmaceuticals, which resolves patent litigation brought by EXEL in response to TEVA’s abbreviated new drug application seeking approval to market a generic version of Cabometyx before the expiration of the applicable patents.
Per the settlement terms, Exelixis will grant Teva Pharmaceuticals a license to market its generic version of the drug in the United States beginning Jan 1, 2031, upon the FDA’s approval.
EXEL’s Cabometyx is approved as a monotherapy for patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy. The drug has become a standard of care for the treatment of patients suffering from advanced RCC.
The drug’s label was further expanded to include first-line treatment of advanced RCC in the United States. In the EU, Cabometyx is approved for the first-line treatment of adults with intermediate or low-risk advanced RCC.
Cabometyx is also currently approved in the United States and EU as a monotherapy forhepatocellular carcinoma.
Exelixis, Inc. Price and Consensus
Exelixis, Inc. price-consensus-chart | Exelixis, Inc. Quote
Zacks Rank and Stocks to Consider
Exelixis currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks from the same industry worth mentioning are Puma Biotechnology, Inc. (PBYI - Free Report) and ADMA Biologics (ADMA - Free Report) , sporting a Zacks Rank #1 (Strong Buy) each at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 30 days, the Zacks Consensus Estimate for Puma Biotech’s 2023 earnings per share (EPS) has increased from 72 cents to 73 cents. During the same time frame, the consensus estimate for Puma Biotech’s 2024 EPS has increased from 64 cents to 69 cents. Over the past year, shares of PBYI have gained 16.7%.
PBYI beat estimates in three of the last four quarters while missing on one occasion, delivering a four-quarter average earnings surprise of 76.55%.
In the past 30 days, the Zacks Consensus Estimate for ADMA Biologics’ 2023 loss per share has narrowed from 3 cents to 2 cents. The consensus estimate for ADMA Biologics’ 2024 EPS is pegged at 22 cents. Over the past year, shares of ADMA have risen 43.4%.
ADMA beat estimates in three of the trailing four quarters and matched in one, delivering an average earnings surprise of 63.57%.