Alkermes Looks To FDA For Approval Of Schizophrenia Drug [Seeking Alpha]
Alkermes plc - Ordinary Shares (ALKS)
Last alkermes plc - ordinary shares earnings: 4/29 07:00 am
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Source: Seeking Alpha
Summary Alkermes achieved positive results from its second phase 3 study known as ENLIGHTEN-2, where those who took ALKS 3831 saw a reduction in weight gain compared to current SOC olanzapine. The company expects to file an NDA for FDA approval of ALKS 3831 treating patients with schizophrenia by mid-2019. The first phase 3 efficacy study for ALKS 3831, known as ENLIGHTEN-1, already had achieved the primary efficacy endpoint based on the PANSS compared to placebo. Recently, Alkermes Plc ( ALKS ) announced results from its second phase 3 study treating patients with schizophrenia. These next set of results will allow the company to file a New Drug Application (NDA) for FDA approval by mid 2019. The reduced amount of weight gain for those taking ALKS 3831 over olanzapine is very intriguing. Alkermes may face some challenges moving forward, but the drug has a good shot at being approved regardless. Pushing The Envelope The phase 3 trial is known as ENLIGHTEN-2 a
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News
- Alkermes to Report First Quarter Financial Results on May 1, 2024PR Newswire
- Alkermes to Report First Quarter Financial Results on May 1, 2024PR Newswire
- Are You a Value Investor? This 1 Stock Could Be the Perfect Pick [Yahoo! Finance]Yahoo! Finance
- Alkermes' (ALKS) ALKS 2680 Betters Wakefulness in Phase Ib Study [Yahoo! Finance]Yahoo! Finance
- Alkermes plc (NASDAQ: ALKS) had its price target raised by analysts at Jefferies Financial Group Inc. from $42.00 to $50.00. They now have a "buy" rating on the stock.MarketBeat
ALKS
Earnings
- 2/15/24 - Miss
ALKS
Sec Filings
- 4/15/24 - Form ARS
- 4/15/24 - Form DEFA14A
- 4/15/24 - Form DEF
- ALKS's page on the SEC website