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Teva's (TEVA) NDA for Schizophrenia Drug Gets FDA Acceptance

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Teva Pharmaceutical TEVA announced that the FDA has accepted the new drug application (“NDA”) for risperidone (TV-46000/mdc-IRM), an investigational extended-release subcutaneous injectable drug for patients with schizophrenia. The drug is being co-developed in partnership with MedinCell.

The FDA’s acceptance of the NDA is based on data from two pivotal phase III studies, RISE study and SHINE study, which evaluated the drug administered via subcutaneous injection in schizophrenia patients aged between 13 and 65. While the primary endpoint of the RISE study was to time the impending relapse following administration of the drug, the SHINE study’s primary endpoint was the frequency of all adverse events upon administration of the drug, including serious ones. Interim data from the ongoing SHINE study was in conformity with the data from the RISE study.

The company’s shares increased 1.6% in after-market trading on Aug 31, following the above news. In fact, the stock has declined 2.4% so far this year in comparison with the industry’s 8.3% decline.

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It anticipates presenting detailed data from these studies in a future medical meeting or publishing the data in a peer-reviewed publication.

We inform investors that as part of the deal with MedinCell, Teva will lead the clinical development and commercialization for risperidone. MedinCell will be eligible to receive milestones payments and royalties on net sales from the drug, if approved.

Alkermes’ ALKS Aristada has been approved by the FDA for the treatment of schizophrenia. We remind investors that in June, the FDA approved Lybalvi, another drug in Alkermes’ pipeline for the treatment of adults with schizophrenia and those suffering from bipolar I disorder. Alkermes plans to commercially launch Lybalvi in fourth-quarter 2021.

Teva Pharmaceutical Industries Ltd. Price

Teva Pharmaceutical Industries Ltd. Price
Teva Pharmaceutical Industries Ltd. Price

Teva Pharmaceutical Industries Ltd. price | Teva Pharmaceutical Industries Ltd. Quote

Zacks Rank & Stocks to Consider

Teva presently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the biotech/drug sector include Ironwood Pharmaceuticals IRWD and Regeneron Pharmaceuticals REGN, each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Ironwood’s earnings per share estimates for 2021 have increased from $1.00 to $1.18 in the past 30 days. The same for 2022 has risen from $1.20 to $1.72 over the same period. The stock has rallied 15% in the year so far.

Regeneron’s earnings per share estimates for 2021 have increased from $49.96 to $54.15 in the past 30 days. The same for 2022 has risen from $40.91 to $44.11 over the same period. The stock has rallied 39.4% in the year so far.


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