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Novartis (NVS) Gets FDA Nod for Vijoice in Rare Disorder

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Novartis AG NVS announced that 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.

Per the company, following the nod, Vijoice became the first FDA-approved therapy to treat PROS, which includes rare conditions where overgrowths and blood vessel anomalies occur.

The approval was made on an accelerated basis, with continued approval contingent on verification of clinical benefit from confirmatory evidence.

The FDA approval was based on real-world data from the EPIK-P1 study, which evaluated Vijoice in select patients with severe manifestations of PROS. Data from the same showed that treatment with Vijoice led to reduction in the size of PROS lesions and improvement of PROS-related signs and symptoms in the given patient population.

Shares of Novartis have gained 0.8% so far this year compared with the industry’s growth of 3.7%.

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Per the company, approximately 14 people per million are diagnosed with PROS. Until now, the only treatment options available for such patients were surgical or interventional radiology procedures. Hence, the approval of Vijoice is likely to offer a better treatment trajectory and outcomes for the given patient population.

Alpelisib is also approved under the brand name Piqray in the United States, the European Union and other countries. Piqray, in combination with fulvestrant, is approved to treat men and postmenopausal women with PIK3CA-mutated, HR+/HER2- locally advanced or metastatic breast cancer.

The FDA recently approved Novartis’ targeted radioligand therapy, Pluvicto, for the treatment of progressive PSMA-positive metastatic castration-resistant prostate cancer.

Novartis has a strong and diverse portfolio. Solid momentum in key brands like psoriasis drug, Cosentyx; cardiovascular drug, Entresto; gene therapy, Zolgensma; its oncology portfolio and the launch of Kesimpta continue to boost performance.

Zacks Rank & Stocks to Consider

Novartis currently carries a Zacks Rank of #3 (Hold).

Better-ranked stocks in the healthcare sector include Innoviva, Inc. INVA, Collegium Pharmaceutical, Inc. COLL and Voyager Therapeutics, Inc. VYGR. While Innoviva and Collegium Pharmaceutical sport a Zacks Rank #1 (Strong Buy), Voyager Therapeutics carries a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

The Zacks Consensus Estimate for Innoviva’s earnings has been revised 20.5% upward for 2022 and 27.9% upward for 2023 over the past 60 days. The INVA stock has rallied 13.7% year to date.

Earnings of Innoviva surpassed estimates in each of the trailing four quarters.

Collegium Pharmaceutical’s earnings estimates have been revised 51.9% upward for 2022 and 66.2% for 2023 over the past 60 days. The COLL stock has gained 7.5% year to date.

Earnings of Collegium Pharmaceutical surpassed estimates in one of the trailing four quarters and missed the same on the other three occasions.

Voyager Therapeutics’ loss per share estimates have narrowed 38.6% for 2022 and 29% for 2023 over the past 60 days. The VYGR stock has skyrocketed 231.7% year to date.

Earnings of Voyager Therapeutics surpassed estimates in three of the trailing four quarters and missed the same on the other occasion.


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Novartis AG (NVS) : Free Stock Analysis Report

Collegium Pharmaceutical, Inc. (COLL) : Free Stock Analysis Report

Voyager Therapeutics, Inc. (VYGR) : Free Stock Analysis Report

Innoviva, Inc. (INVA) : Free Stock Analysis Report

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