Wed May 6, 2009 6:14pm EDT
Market News
should help the whole sector on Thursday
* FDA approves schizophrenia drug
* Label to include boxed warning
* Shares jump 8 fold in after-hours trade
May 6 (Reuters) - Embattled drug-maker Vanda Pharmaceuticals Inc (VNDA.O) said U.S. health regulators approved its treatment for schizophrenia, triggering an eight-fold rise in its shares.
The U.S. Food and Drug Administration said label for the drug Fanapta, or iloperidone, will include a boxed warning, just like other atypical antipsychotic class of drugs.
The FDA said the warning will advise doctors and patients about increased risk of death, if the drug is used off-label for behavioral problems in older people with dementia-related psychosis.
The FDA had issued a not-approvable letter in October over concerns of efficacy of the atypical antipsychotic drug in comparison with Johnson & Johnson's (JNJ.N) risperidone in patients suffering from schizophrenia.
Shares of the Rockville, Maryland-based company surged to to $8.00, after the bell. They closed at $1.08 Wednesday, on Nasdaq. (Reporting by Vidya L Nathan in Bangalore; Editing by Anil D'Silva)
Recent VNDA News
- Form 8-K - Current report • Edgar (US Regulatory) • 10/03/2024 09:00:32 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 09/19/2024 12:10:32 PM
- FDA Declines to Approve Vanda's Marketing Application for Tradipitant in Gastroparesis • PR Newswire (US) • 09/19/2024 11:00:00 AM
- Vanda Pharmaceuticals Announces Participation in the 2024 Cantor Global Healthcare Conference • PR Newswire (US) • 09/11/2024 09:00:00 PM
- Vanda Pharmaceuticals Announces Participation in the H.C. Wainwright Global Investment Conference • PR Newswire (US) • 09/04/2024 09:13:00 PM
- Vanda Pharmaceuticals Announces Participation in the Wells Fargo 2024 Healthcare Conference • PR Newswire (US) • 08/29/2024 08:30:00 PM
- Form 8-A12B/A - Registration of securities [Section 12(b)]: [Amend] • Edgar (US Regulatory) • 08/08/2024 11:47:27 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/08/2024 11:29:01 AM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/01/2024 11:01:35 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 07/31/2024 08:05:32 PM
- Vanda Pharmaceuticals Reports Second Quarter 2024 Financial Results • PR Newswire (US) • 07/31/2024 08:01:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 07/29/2024 09:24:41 PM
- Form 144 - Report of proposed sale of securities • Edgar (US Regulatory) • 07/29/2024 09:21:33 PM
- Vanda Pharmaceuticals to Announce Second Quarter 2024 Financial Results on July 31, 2024 • PR Newswire (US) • 07/26/2024 01:19:00 PM
- Federal Court Allows Vanda's HETLIOZ® Patent Lawsuit to Proceed against Teva and Apotex • PR Newswire (US) • 07/01/2024 12:01:00 PM
- Vanda Pharmaceuticals Board of Directors Determines that Recent Unsolicited Takeover Proposals Are Not in the Best Interests of the Company and its Shareholders • PR Newswire (US) • 06/20/2024 12:48:00 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 06/13/2024 08:38:04 PM
- Vanda Pharmaceuticals Confirms Receipt of Revised Unsolicited Takeover Proposal from Future Pak • PR Newswire (US) • 06/13/2024 02:02:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 06/06/2024 08:30:57 PM
- Vanda Pharmaceuticals Confirms Receipt of Unsolicited, Non-Binding Indication of Interest from Cycle Group Holdings Ltd. • PR Newswire (US) • 06/06/2024 01:24:00 PM
- Vanda Pharmaceuticals Announces Participation in the Jefferies 2024 Global Healthcare Conference • PR Newswire (US) • 05/30/2024 09:20:00 PM
- Vanda Pharmaceuticals Announces Completion of Transfer of FDA Marketing Authorization for PONVORY® • PR Newswire (US) • 05/30/2024 08:48:00 PM
- Vanda Pharmaceuticals Announces Presentations at SLEEP 2024 • PR Newswire (US) • 05/29/2024 06:17:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/24/2024 08:49:41 PM
- Vanda Pharmaceuticals Board of Directors Determines that Revised Unsolicited Takeover Proposal is Not in the Best Interests of the Company and its Shareholders • PR Newswire (US) • 05/24/2024 08:46:00 PM
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