We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Teva's (TEVA) Schizophrenia Drug Gets CRL From the FDA
Read MoreHide Full Article
Teva Pharmaceutical (TEVA - Free Report) announced that the FDA has issued a complete response letter (CRL) to its new drug application (NDA) for its investigational extended-release subcutaneous injectable drug, risperidone (TV-46000/mdc-IRM), to treat schizophrenia. Teva is co-developing the drug in partnership with MedinCell.
However, neither TEVA nor MedinCell provided any reasons for receiving the CRL nor revealed if there were any safety concerns raised by the FDA. In fact, neither of the companies disclosed any recommendations or points in the CRL.
TEVA is reviewing the CRL to determine the next steps to quickly address the regulatory agency’s recommendations. The FDA had accepted this NDA in August 2021.
Teva Pharmaceutical’s shares declined 3.7% in aftermarket trading on Apr 19 following the announcement. The stock has risen 27.1% so far this year against the industry’s 6.7% decline.
Image Source: Zacks Investment Research
The NDA filing with the FDA was based on positive data from two pivotal phase III studies, RISE study and SHINE study, which evaluated risperidone administered via subcutaneous injection to 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.
Per the terms of the agreement between TEVA and MedinCell, the former is responsible for leading the clinical development and commercialization of risperidone. MedinCellwill be eligible to receive milestones payments and royalties on net sales from the drug once it receives the FDA’s approval.
If approved, risperidone will face stiff competition from Alkermes (ALKS - Free Report) , which is currently marketing two drugs for treating schizophrenia. Aristada, one of the proprietary products in Alkermes’ portfolio, received FDA approval in 2015 to treat schizophrenia in adults. Last year in June, the FDA approved another one of Alkermes’ drugs, Lybalvi, to treat adults with schizophrenia and bipolar I disorder. Lybalvi was commercially launched by ALKS in the United States in October 2021. For full-year 2021, Alkermes recorded $275.4 million and $8.2 million from Aristada and Lybalvi product sales, respectively.
Teva Pharmaceutical presently carries a Zacks Rank #3 (Hold). A few better-ranked stocks in the overall sector are Angion Biomedica and Vertex Pharmaceuticals (VRTX - Free Report) . While Angion Biomedica sports a Zacks Rank #1 (Strong Buy) at present, Vertex Pharmaceuticals carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Angion Biomedica’s loss per share estimates for 2022 have narrowed from $2.59 to $1.79 in the past 60 days. The same for 2023 has narrowed from $3.11 to $2.19 in the past 60 days.
Earnings of Angion Biomedica beat estimates in three of the last four quarters and missed the mark once, the average surprise being 47.5%.
Vertex Pharmaceuticals’ earnings per share estimates for 2022 have increased from $14.52 to $14.58 in the past 30 days. The same for 2023 has increased from $15.31 to $15.37 in the past 30 days. Shares of VRTX have risen 28.7% year to date.
Earnings of Vertex Pharmaceuticals beat estimates in each of the last four quarters, the average being 10%.
Unique Zacks Analysis of Your Chosen Ticker
Pick one free report - opportunity may be withdrawn at any time
Image: Bigstock
Teva's (TEVA) Schizophrenia Drug Gets CRL From the FDA
Teva Pharmaceutical (TEVA - Free Report) announced that the FDA has issued a complete response letter (CRL) to its new drug application (NDA) for its investigational extended-release subcutaneous injectable drug, risperidone (TV-46000/mdc-IRM), to treat schizophrenia. Teva is co-developing the drug in partnership with MedinCell.
However, neither TEVA nor MedinCell provided any reasons for receiving the CRL nor revealed if there were any safety concerns raised by the FDA. In fact, neither of the companies disclosed any recommendations or points in the CRL.
TEVA is reviewing the CRL to determine the next steps to quickly address the regulatory agency’s recommendations. The FDA had accepted this NDA in August 2021.
Teva Pharmaceutical’s shares declined 3.7% in aftermarket trading on Apr 19 following the announcement. The stock has risen 27.1% so far this year against the industry’s 6.7% decline.
Image Source: Zacks Investment Research
The NDA filing with the FDA was based on positive data from two pivotal phase III studies, RISE study and SHINE study, which evaluated risperidone administered via subcutaneous injection to 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.
Per the terms of the agreement between TEVA and MedinCell, the former is responsible for leading the clinical development and commercialization of risperidone. MedinCellwill be eligible to receive milestones payments and royalties on net sales from the drug once it receives the FDA’s approval.
If approved, risperidone will face stiff competition from Alkermes (ALKS - Free Report) , which is currently marketing two drugs for treating schizophrenia. Aristada, one of the proprietary products in Alkermes’ portfolio, received FDA approval in 2015 to treat schizophrenia in adults. Last year in June, the FDA approved another one of Alkermes’ drugs, Lybalvi, to treat adults with schizophrenia and bipolar I disorder. Lybalvi was commercially launched by ALKS in the United States in October 2021. For full-year 2021, Alkermes recorded $275.4 million and $8.2 million from Aristada and Lybalvi product sales, respectively.
Teva Pharmaceutical Industries Ltd. Price
Teva Pharmaceutical Industries Ltd. price | Teva Pharmaceutical Industries Ltd. Quote
Zacks Rank & Stocks to Consider
Teva Pharmaceutical presently carries a Zacks Rank #3 (Hold). A few better-ranked stocks in the overall sector are Angion Biomedica and Vertex Pharmaceuticals (VRTX - Free Report) . While Angion Biomedica sports a Zacks Rank #1 (Strong Buy) at present, Vertex Pharmaceuticals carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Angion Biomedica’s loss per share estimates for 2022 have narrowed from $2.59 to $1.79 in the past 60 days. The same for 2023 has narrowed from $3.11 to $2.19 in the past 60 days.
Earnings of Angion Biomedica beat estimates in three of the last four quarters and missed the mark once, the average surprise being 47.5%.
Vertex Pharmaceuticals’ earnings per share estimates for 2022 have increased from $14.52 to $14.58 in the past 30 days. The same for 2023 has increased from $15.31 to $15.37 in the past 30 days. Shares of VRTX have risen 28.7% year to date.
Earnings of Vertex Pharmaceuticals beat estimates in each of the last four quarters, the average being 10%.