Mayne says FDA letter on drug risks is not materially price sensitive
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More news: Mayne Pharma has sought to cool a selloff of its shares by addressing claims by the US Food and Drug Administration (FDA) that it had underrepresented risks related to its oral contraceptive product.
The numbers: Mayne Pharma’s share price tumbled 15.61% to end at $5.73 after it emerged from a three hour trading pause.
What they said: “Mayne Pharma takes the views of the FDA seriously and will respond to the letter within the prescribed timeframe. Out of an abundance of caution, and as an initial and immediate action, Mayne Pharma voluntarily withdrew the speaker presentation referenced in the FDA Untitled Letter,” Mayne Pharma said in a statement to the ASX.
“The FDA Untitled Letter does not impact Mayne Pharma’s ability to continue to sell and distribute Nextsellis in the United States. Mayne Pharma does not regard the receipt of the FDA Untitled Letter as materially price sensitive.”
Mayne Pharma in trading pause amid FDA concerns
The news: Mayne Pharma has entered a trading pause following a share price plunge after the US Food and Drug Administration (FDA) made claims that the company underrepresented the risks of its oral birth control pill.
The numbers: Its share price plunged 12.2% to $5.96 before it entered a trading pause.
The context: The South Australia-based pharmaceutical was issued a letter by the US FDA on 28 April stating that a presentation made by the company “makes false or misleading claims and presentations about the risks of [oral birth control pill] Nextstellis”.
Mayne was given 15 working days to respond to the letter.
The letter also states that the FDA previously made advisory comments on draft promotional communications for Nextstellis in January 2022.
The trading pause comes just weeks out from the completion of a $672 million buyout by US pharmaceutical giant Cosette.
