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Novartis (NVS) Anti-PD-1 Drug Validated by EMA for Lung Cancer
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Novartis (NVS - Free Report) recently announced that the European Medicines Agency (“EMA”) validated Marketing Authorization Applications (MAAs) for the immune checkpoint inhibitor tislelizumab.
We note that Novartis has the right to develop, manufacture and commercialize tislelizumab in North America, Europe and Japan through a collaboration and license agreement with BeiGene (BGNE - Free Report) .
The MAA is seeking approval of tislelizumab for locally advanced or metastatic, squamous or non-squamous non-small cell lung cancer (NSCLC) as first-line treatment in combination with chemotherapy, locally advanced or metastatic NSCLC as monotherapy after prior chemotherapy, and unresectable, recurrent, locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) as monotherapy after prior chemotherapy.
The candidate is a humanized IgG4 anti-PD-1 monoclonal antibody being developed both as a monotherapy and in combination with other therapies.
The MAA was submitted based on data from phase III RATIONALE 302, 303, 304 and 307 trials, in which tislelizumab monotherapy and in combination with chemotherapy demonstrated significant clinical benefits versus chemotherapy in multiple cancer types and lines of therapy.
In September 2021, the FDA also accepted the biologics license application (BLA) for tislelizumab to treat unresectable recurrent locally advanced or metastatic ESCC in patients who had received prior systemic therapy.
Novartis is currently evaluating tislelizumab in 14 pivotal clinical trials in a broad array of solid tumors, with more than 8,800 patients enrolled to date in 35 countries.
Novartis recently signed an option, collaboration and license agreement with BeiGene for ociperlimab (BGB-A1217).
During the option period, Novartis and BeiGene will collaborate on the clinical development of ociperlimab in combination with tislelizumab, with Novartis designing, sponsoring, conducting and funding global combination clinical studies.
Shares of Novartis have gained 3.6% so far this year compared with the industry’s growth of 7.4%.
Image Source: Zacks Investment Research
Approval of new drugs bodes well for Novartis.
The FDA recently approved Novartis’ targeted radioligand therapy, Pluvicto, for the treatment of progressive, PSMA positive metastatic castration-resistant prostate cancer.
The FDA has approved its kinase inhibitor, Vijoice (alpelisib), for the treatment of patients aged two years and above with severe manifestations of PIK3CA-Related Overgrowth Spectrum (PROS), requiring systemic therapy.
Novartis has a strong and diverse portfolio. Solid momentum in key brands like psoriasis drug Cosentyx, cardiovascular drug Entresto, gene therapy Zolgensma, the oncology portfolio and the launch of Kesimpta continue to boost performance.
Novartis has streamlined its business significantly and is looking forward to focusing on its core business. NVS is still evaluating whether to retain or sell its generic business and expects to provide an update on the same by the end of this year.
Novartis currently carries a Zacks Rank #4 (Sell).
Loss estimates for VYGR have narrowed to $1.35 from $2.20 for 2022 in the past 60 days. Earnings of Voyager surpassed estimates in three of the trailing four quarters and missed the same once.
Loss estimates for VTGN have narrowed to 22 cents from 27 cents for 2022 in the past 60 days. Earnings of VistaGen surpassed estimates in two of the trailing four quarters and missed the same twice.
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Novartis (NVS) Anti-PD-1 Drug Validated by EMA for Lung Cancer
Novartis (NVS - Free Report) recently announced that the European Medicines Agency (“EMA”) validated Marketing Authorization Applications (MAAs) for the immune checkpoint inhibitor tislelizumab.
We note that Novartis has the right to develop, manufacture and commercialize tislelizumab in North America, Europe and Japan through a collaboration and license agreement with BeiGene (BGNE - Free Report) .
The MAA is seeking approval of tislelizumab for locally advanced or metastatic, squamous or non-squamous non-small cell lung cancer (NSCLC) as first-line treatment in combination with chemotherapy, locally advanced or metastatic NSCLC as monotherapy after prior chemotherapy, and unresectable, recurrent, locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) as monotherapy after prior chemotherapy.
The candidate is a humanized IgG4 anti-PD-1 monoclonal antibody being developed both as a monotherapy and in combination with other therapies.
The MAA was submitted based on data from phase III RATIONALE 302, 303, 304 and 307 trials, in which tislelizumab monotherapy and in combination with chemotherapy demonstrated significant clinical benefits versus chemotherapy in multiple cancer types and lines of therapy.
In September 2021, the FDA also accepted the biologics license application (BLA) for tislelizumab to treat unresectable recurrent locally advanced or metastatic ESCC in patients who had received prior systemic therapy.
Novartis is currently evaluating tislelizumab in 14 pivotal clinical trials in a broad array of solid tumors, with more than 8,800 patients enrolled to date in 35 countries.
Novartis recently signed an option, collaboration and license agreement with BeiGene for ociperlimab (BGB-A1217).
During the option period, Novartis and BeiGene will collaborate on the clinical development of ociperlimab in combination with tislelizumab, with Novartis designing, sponsoring, conducting and funding global combination clinical studies.
Shares of Novartis have gained 3.6% so far this year compared with the industry’s growth of 7.4%.
Image Source: Zacks Investment Research
Approval of new drugs bodes well for Novartis.
The FDA recently approved Novartis’ targeted radioligand therapy, Pluvicto, for the treatment of progressive, PSMA positive metastatic castration-resistant prostate cancer.
The FDA has approved its kinase inhibitor, Vijoice (alpelisib), for the treatment of patients aged two years and above with severe manifestations of PIK3CA-Related Overgrowth Spectrum (PROS), requiring systemic therapy.
Novartis has a strong and diverse portfolio. Solid momentum in key brands like psoriasis drug Cosentyx, cardiovascular drug Entresto, gene therapy Zolgensma, the oncology portfolio and the launch of Kesimpta continue to boost performance.
Novartis has streamlined its business significantly and is looking forward to focusing on its core business. NVS is still evaluating whether to retain or sell its generic business and expects to provide an update on the same by the end of this year.
Novartis currently carries a Zacks Rank #4 (Sell).
A few better-ranked stocks in the healthcare space are Voyager Therapeutics (VYGR - Free Report) and VistaGen Therapeutics (VTGN - Free Report) , both carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Loss estimates for VYGR have narrowed to $1.35 from $2.20 for 2022 in the past 60 days. Earnings of Voyager surpassed estimates in three of the trailing four quarters and missed the same once.
Loss estimates for VTGN have narrowed to 22 cents from 27 cents for 2022 in the past 60 days. Earnings of VistaGen surpassed estimates in two of the trailing four quarters and missed the same twice.