Krystal Biotech, Candel, Edgewise gain after FDA fast track tags [Seeking Alpha]
Edgewise Therapeutics, Inc. (EWTX)
Company Research
Source: Seeking Alpha
FDA issued fast-track designations for some of their product candidates. Krystal ( KRYS ) has won fast-track status for its experimental cancer therapy KB707 as a treatment for solid tumors with pulmonary metastases that are relapsed or refractory to standard of care. A Phase 1 trial for the inhaled therapy is currently underway, with its dosing expected to start in H1 2024. Needham, Massachusetts-based Candel ( CADL ) said that the FDA issued fast-track designation for its gene therapy candidate CAN-3110 to treat patients with high-grade glioma, a cancer affecting the central nervous system. The company expects to report additional data from a Phase 1b trial for CAN-3110 in H2 2024. Meanwhile, Edgewise Therapeutics' ( EWTX ) fast-track designation covers its lead product candidate, EDG-5506, for treating Duchenne muscular dystrophy, a rare neuromuscular disorder. Two mid-stage trials called LYNX and FOX are currently underway for EDG-5506 in Duchenne, with data from the for
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News
- Edgewise Receives European Medicines Agency (EMA) Orphan Drug Designations for Sevasemten (EDG-5506) for the Treatment of Becker and Duchenne Muscular Dystrophies [Yahoo! Finance]Yahoo! Finance
- Edgewise Receives European Medicines Agency (EMA) Orphan Drug Designations for Sevasemten (EDG-5506) for the Treatment of Becker and Duchenne Muscular DystrophiesBusiness Wire
- Edgewise Therapeutics, Inc. (NASDAQ: EWTX) had its price target raised by analysts at Royal Bank of Canada from $28.00 to $32.00. They now have an "outperform" rating on the stock.MarketBeat
- Edgewise Therapeutics, Inc. (NASDAQ: EWTX) had its "outperform" rating re-affirmed by analysts at Wedbush. They now have a $26.00 price target on the stock.MarketBeat
- Edgewise Therapeutics Announces Positive Two-Year Topline Results from the ARCH Open Label Trial of Sevasemten (EDG-5506) in Adults with Becker Muscular Dystrophy (Becker) [Yahoo! Finance]Yahoo! Finance
EWTX
Earnings
- 2/22/24 - Miss
EWTX
Sec Filings
- 4/26/24 - Form DEFA14A
- 4/26/24 - Form DEF
- 4/15/24 - Form PRE
- EWTX's page on the SEC website