Stealth Granted Pre-NDA Meeting For Elamipretide To Treat Barth Syndrome

RTTNews | vor 1207 Tagen
Stealth Granted Pre-NDA Meeting For Elamipretide To Treat Barth Syndrome

(RTTNews) - Biotechnology company Stealth BioTherapeutics Corp (MITO) announced Tuesday its plan to meet with the U.S. Food & Drug Administration (FDA) Division of Cardiology and Nephrology (DCN) to discuss new clinical data that may inform a potential new drug application (NDA) submission for the treatment of Barth Syndrome.

The Company recently requested a Type B pre-NDA meeting to discuss new clinical data on patients treated with elamipretide for over 3.5 years in the open-label extension period of the Phase 2 TAZPOWER study.

In October 2021, the FDA had refused to file the Company's NDA for the treatment of Barth Syndrome.

The Company believes that the new data may support an NDA filing and approval of elamipretide as a treatment for Barth Syndrome.

read more
Stealth BioTherapeutics To Be Taken Private In All-cash Deal

Stealth BioTherapeutics To Be Taken Private In All-cash Deal

Biotechnology company Stealth BioTherapeutics Corp (MITO) announced Monday that it has entered into a definitive Agreement and Plan of Merger with Stealth Parent Limited,, and Stealth Merger Sub Limited, a wholly-owned subsidiary of Parent, to be acquired by a consortium of investors led by Morningside Venture (I) Investments Ltd. and J. Wood Capital Advisors LLC in an all-cash transaction.
RTTNews | vor 1159 Tagen
CAC 40 Roughly Flat As Investors Focus On Economic Data

CAC 40 Roughly Flat As Investors Focus On Economic Data

The French stock market is roughly flat Friday afternoon with stocks turning in a mixed performance as investors react to the latest batch of regional economic data, and continuing to assess the impact of the government shutdown in the U.S.
RTTNews | vor 1Std 12 Minuten
DAX Down Marginally, But Stays On Course For Strong Weekly Gain

DAX Down Marginally, But Stays On Course For Strong Weekly Gain

German stocks are turning in a mixed performance on Friday, but remain well on course to record their strongest week in over five months. Optimism surrounding artificial intelligence and expectations of a rate cut by the Federal Reserve help underpin sentiment.
RTTNews | vor 1Std 38 Minuten
Sensex, Nifty End Modestly Higher On Firm Global Cues

Sensex, Nifty End Modestly Higher On Firm Global Cues

Indian shares ended modestly higher on Friday, tracking firm cues from global markets amid renewed optimism around artificial intelligence and hopes for more Federal Reserve interest-rate cuts.
RTTNews | vor 2Std 40 Minuten
European Shares Inch Higher In Cautious Trade

European Shares Inch Higher In Cautious Trade

European stocks edged higher on Friday and were on track for their strongest week since May, driven by investor optimism over artificial intelligence and Fed rate cut hopes.
RTTNews | vor 3Std 41 Minuten
Asian Shares Mixed; Hong Kong Stocks Slip On Profit Booking

Asian Shares Mixed; Hong Kong Stocks Slip On Profit Booking

Asian stocks ended mixed in cautious trade on Friday as concerns about a U.S. government shutdown and potential federal job cuts offset excitement around AI as well as expectations of further interest-rate cuts by the U.S. Federal Reserve.
RTTNews | vor 3Std 59 Minuten
European Shares Seen Higher At Open

European Shares Seen Higher At Open

European stocks are likely to open higher on Friday, with renewed optimism around artificial intelligence and Fed rate cut hopes likely to underpin investor sentiment, heading into the weekend.
RTTNews | vor 7Std 31 Minuten