The company’s most promising pipeline program can continue unabated.
Clinical-stage biotech Avidity Biosciences (RNA 0.53%) had some good news to report toward the end of this week, and investors rewarded it by piling into the company’s stock. By the close of trading Friday, said equity had risen almost 12% in value across the week, according to data compiled by S&P Global Market Intelligence.
Partial clinical hold released
On Thursday, Avidity announced that the U.S. Food and Drug Administration (FDA) has released its partial clinical hold on one of the biotech company’s investigational drugs. This is delpacibart etedesiran (del-desiran), also known as AOC 1001, a medication aimed at combating a form of muscular dystrophy called myotonic dystrophy type 1.
The drug is being tested in a phase 3 clinical trial. In 2022, the FDA placed its hold following news of a patient experiencing a serious adverse event. Avidity did not disclose the nature of that event, banning the recruitment of new patients. The regulator relaxed that hold, allowing the company to restart recruitment. The current phase 3 trial of del-desiran began earlier this year.
Now that the hold has been entirely lifted, the drug’s prospects are significantly brighter. It already holds breakthrough therapy, orphan drug, and fast track designations from the FDA.
Goldman analyst reiterates her bullish view
Investors and pundits alike were cheered by this news. Analyst Corinne Johnson of influential investment bank Goldman Sachs reiterated her buy recommendation on Avidity’s stock, and her price target of $59 per share. She wrote that the FDA’s move “is incrementally reassuring of the agent’s safety profile which has been the primary source of investor pushback.”
Eric Volkman has no position in any of the stocks mentioned. The Motley Fool has positions in and recommends Goldman Sachs Group. The Motley Fool has a disclosure policy.
