NEW YORK – Meridian Bioscience's share price declined by as much as 15 percent on Tuesday after it announced the US Food and Drug Administration has requested additional information for its Emergency Use Authorization application for the Revogene SARS-CoV-2 test.
The firm's stock price dropped to a one-day low of $25.32 on Tuesday before rebounding slightly to end the day at $26.12, or down 12 percent compared to Meridian's closing price on Friday. Meridian said earlier in the day that it received a request from the FDA last week for more info about the PCR-based Revogene test, and it plans to submit a response by Tuesday. The test uses nasopharyngeal swabs and returns results in approximately 70 minutes.
Meridian did not provide details about FDA's questions.
Meridian also said in a statement it has placed shipments of its SARS-CoV-2 test kits on hold while it works with the agency. Earlier this month, the firm received $5.5 million from the National Institute of Health to expand production capacity for the test.
In early morning trading on Wednesday, the stock price was up slightly from its closing price to $26.33.