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Novartis (NVS - Free Report) recently announced that the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency has adopted a positive opinion for Pluvicto.
Pluvicto is a radioligand therapy combining a targeting compound with a therapeutic radioisotope.
The CHMP recommended granting marketing authorization to Pluvicto in combination with androgen deprivation therapy (ADT) with or without androgen receptor (AR) pathway inhibition for the treatment of adult patients with progressive prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with AR pathway inhibition and taxane-based chemotherapy.
The positive CHMP opinion is based on data from the phase III VISION study wherein Pluvicto plus best standard of care (BSoC) demonstrated significantly improved overall survival in PSMA-positive mCRPC patients previously treated with AR pathway inhibition and taxane-based chemotherapy compared to BSoC alone.
A final decision from the European Commission is expected in approximately two months.
Please note that Pluvicto was already approved by the FDA in March 2022.
The drug is also being evaluated in two additional phase III studies in earlier lines of treatment for metastatic prostate cancer. These are evaluating potential clinical utility in the mCRPC pre-taxane setting (PSMAfore) and the metastatic hormone-sensitive setting (PSMAddition).
Novartis is also evaluating opportunities to investigate Pluvicto radioligand therapy in earlier stages of prostate cancer.
Approval in additional geographies will boost the growth potential of the drug.
Shares of Novartis have lost 11.6% so far this year compared with the industry’s decline of 4%.
Image Source: Zacks Investment Research
We remind investors that Novartis recently outlined a new strategy with a primary focus on gaining market share in the U.S. markets.
The company is looking to focus on strengthening its solid position in five core therapeutic areas (Hematology, Solid Tumors, Immunology, Neuroscience and Cardiovascular).
Backed by eight current in-market brands, Cosentyx, Entresto, Zolgensma, Kisqali, Kesimpta, Leqvio, Pluvicto and Scemblix, Novartis aims to improve competitive positioning and organically build its business in the United States to become a top-five player in the country by 2027. The company believes that each drug holds multi-billion dollar peak sales potential.
Concurrently, NVS is looking to shift its portfolio of medicines toward biologics and technology platforms. Novartis will prioritize three newer platforms – gene & cell therapy, radioligand therapy and ‘xRNA’ – for continued investment in new R&D capabilities and manufacturing scale, in addition to two established platforms in chemistry and biotherapeutics.
Puma’s loss estimates have narrowed to 6 cents from 16 cents over the past 60 days. Puma surpassed estimates in three of the trailing four quarters and missing in the other one, the average being 201.37%.
Dynavax’s earnings estimates have increased to $1.73 from $1.14 for 2022 over the past 90 days. Earnings of Dynavax surpassed estimates in two of the trailing four quarters.
Loss estimates for BOLT have narrowed to $2.25 from $2.87 in the past 30 days. BOLT surpassed earnings in three of the trailing four quarters, the average being 2.39%.
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Novartis' (NVS) Pluvicto Secures Positive CHMP Opinion
Novartis (NVS - Free Report) recently announced that the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency has adopted a positive opinion for Pluvicto.
Pluvicto is a radioligand therapy combining a targeting compound with a therapeutic radioisotope.
The CHMP recommended granting marketing authorization to Pluvicto in combination with androgen deprivation therapy (ADT) with or without androgen receptor (AR) pathway inhibition for the treatment of adult patients with progressive prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with AR pathway inhibition and taxane-based chemotherapy.
The positive CHMP opinion is based on data from the phase III VISION study wherein Pluvicto plus best standard of care (BSoC) demonstrated significantly improved overall survival in PSMA-positive mCRPC patients previously treated with AR pathway inhibition and taxane-based chemotherapy compared to BSoC alone.
A final decision from the European Commission is expected in approximately two months.
Please note that Pluvicto was already approved by the FDA in March 2022.
The drug is also being evaluated in two additional phase III studies in earlier lines of treatment for metastatic prostate cancer. These are evaluating potential clinical utility in the mCRPC pre-taxane setting (PSMAfore) and the metastatic hormone-sensitive setting (PSMAddition).
Novartis is also evaluating opportunities to investigate Pluvicto radioligand therapy in earlier stages of prostate cancer.
Approval in additional geographies will boost the growth potential of the drug.
Shares of Novartis have lost 11.6% so far this year compared with the industry’s decline of 4%.
Image Source: Zacks Investment Research
We remind investors that Novartis recently outlined a new strategy with a primary focus on gaining market share in the U.S. markets.
The company is looking to focus on strengthening its solid position in five core therapeutic areas (Hematology, Solid Tumors, Immunology, Neuroscience and Cardiovascular).
Backed by eight current in-market brands, Cosentyx, Entresto, Zolgensma, Kisqali, Kesimpta, Leqvio, Pluvicto and Scemblix, Novartis aims to improve competitive positioning and organically build its business in the United States to become a top-five player in the country by 2027. The company believes that each drug holds multi-billion dollar peak sales potential.
Concurrently, NVS is looking to shift its portfolio of medicines toward biologics and technology platforms. Novartis will prioritize three newer platforms – gene & cell therapy, radioligand therapy and ‘xRNA’ – for continued investment in new R&D capabilities and manufacturing scale, in addition to two established platforms in chemistry and biotherapeutics.
Zacks Rank & Stocks to Consider
Novartis currently carries a Zacks Rank #3 (Hold). Few better-ranked stocks in the sector are Puma Biotechnology (PBYI - Free Report) , Bolt Pharmaceuticals (BOLT - Free Report) and Dynavax (DVAX - Free Report) . While Puma sports a Zacks Rank #1 (Strong Buy), the other two carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Puma’s loss estimates have narrowed to 6 cents from 16 cents over the past 60 days. Puma surpassed estimates in three of the trailing four quarters and missing in the other one, the average being 201.37%.
Dynavax’s earnings estimates have increased to $1.73 from $1.14 for 2022 over the past 90 days. Earnings of Dynavax surpassed estimates in two of the trailing four quarters.
Loss estimates for BOLT have narrowed to $2.25 from $2.87 in the past 30 days. BOLT surpassed earnings in three of the trailing four quarters, the average being 2.39%.