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) is now covered by analysts at HC Wainwright. They set a "buy" rating and a $72.00 price target on the stock.MarketBeat
- Avidity Biosciences to Participate in Upcoming Investor ConferencePR Newswire
- Avidity Biosciences, Inc. (NASDAQ: RNA) is now covered by analysts at Royal Bank of Canada. They set an "outperform" rating and a $67.00 price target on the stock.MarketBeat
- Avidity Biosciences Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)PR Newswire
RNA
Earnings
- 8/9/24 - Beat
RNA
Sec Filings
- 12/19/24 - Form 4
- 12/19/24 - Form 4
- 12/19/24 - Form 4
- RNA's page on the SEC website