FDA lifts clinical hold on Avidity's lead antibody conjugate therapy trial [Yahoo! Finance]
Avidity Biosciences, Inc. (RNA)
Company Research
Source: Yahoo! Finance
on Avidity Biosciences' investigational drug, delpacibart etedesiran (del-desiran). In 2022, the US regulatory agency placed a partial hold after a report of a serious adverse event in a newly enrolled patient in the Phase I/II MARINA trial (NCT05027269), which evaluated del-desiran in patients myotonic dystrophy type 1 (DM1). The company did not disclose the details of the adverse event and the US FDA eased the partial clinical hold the following year, allowing the company to recruit new patients. The clinical hold has not slowed down Avidity's efforts to advance the clinical development of del-desiran in DM1. Earlier this year, Avidity started a pivotal placebo-controlled Phase III HARBOR trial (NCT06411288). The study is expected to enrol 150 participants with DM1 who will be assessed over 54 weeks. The trial's primary endpoint is the improvement of myotonia over 30 weeks, measured using video Hand Opening Time (vHOT), the average time to extend the right third and first digits
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News
- Avidity Biosciences Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)PR Newswire
- Avidity Biosciences, Inc. (NASDAQ: RNA) had its "buy" rating re-affirmed by analysts at Chardan Capital. They now have a $65.00 price target on the stock.MarketBeat
- Avidity Biosciences, Inc. (NASDAQ: RNA) had its "buy" rating re-affirmed by analysts at Needham & Company LLC. They now have a $60.00 price target on the stock.MarketBeat
- Avidity Biosciences Announces New Precision Cardiology Development Candidates to Treat Rare Genetic Cardiomyopathies and Provides First Look at Next-Generation Technology InnovationsPR Newswire
- Avidity Biosciences Third Quarter 2024 Earnings: EPS Beats Expectations, Revenues Lag [Yahoo! Finance]Yahoo! Finance
RNA
Earnings
- 8/9/24 - Beat
RNA
Sec Filings
- 11/20/24 - Form 4
- 11/20/24 - Form 4
- 11/14/24 - Form SC
- RNA's page on the SEC website