Drugs

Drug Co. Charged with Unfairly Disclosing FDA Info

Selectively sharing information with stock analysts and not through open public disclosures after meeting with FDA on a product development issue is a “no-no.” So learns TherapeuticsMD, a pharmaceutical company headquartered in Boca Raton, FL, after being charged by the Securities and Exchange Commission (SEC) 8/20.

According to the SEC, TherapeuticsMD selectively shared on two separate occasions in 2017 material information with analysts about the company’s interactions with FDA. In one instance, the company sent private messages to analysts describing a meeting as “very positive and productive.” The SEC said that this caused the company’s stock price to jump 19.4% on heavy trading volume. “At that time, the company had not issued a press release or made any other market-wide disclosure about the meeting,” SEC says.

On a separate occasion, TherapeuticsMD issued a press release announcing that it had submitted additional information to FDA, but did not yet have a clear path forward regarding its NDA. The SEC says that the firm told analysts in a call and email “undisclosed details” about an FDA meeting and the information it had subsequently submitted to the agency.

“Information about a pharmaceutical company’s interactions with the FDA can be critical to investors,” SEC says. “It is essential that when companies disseminate material, nonpublic information, they do so fairly and appropriately to all investors and not just a select few analysts.”

TherapeuticsMD consented to an SEC order without admitting or denying the findings and was ordered to cease and desist from future disclosure violations. It also agreed to pay a $200,000 penalty.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome