Mayne Pharma has clarified why it did not disclose an FDA Untitled Letter to the market despite sharing it with its scheme bidder, reaffirming compliance with ASX rules amid recent share price volatility.
- FDA Untitled Letter related to NEXTSTELLIS shared confidentially with scheme bidder
- Mayne Pharma deems letter not materially price sensitive, no market disclosure required
- Company confirms compliance with ASX Listing Rule 3.1 and continuous disclosure policy
- Share price volatility followed public release of FDA letter
- Scheme of Arrangement with Cosette Pharmaceuticals remains on track
Context of the FDA Untitled Letter
Mayne Pharma Group Limited (ASX: MYX) recently found itself under the spotlight following the US Food and Drug Administration’s publication of an 'untitled letter' concerning promotional claims made during a speaker presentation for its contraceptive product NEXTSTELLIS. The letter, received by Mayne Pharma on 28 April 2025 and made public on 12 May 2025, sparked market speculation and a notable dip in MYX’s share price.
Despite the market reaction, Mayne Pharma maintained that the letter was not materially price sensitive and therefore did not warrant immediate disclosure to the broader market. Instead, the company shared the letter confidentially with Cosette Pharmaceuticals Inc, the bidder in the ongoing Scheme of Arrangement to acquire Mayne Pharma.
Rationale Behind Non-Disclosure
In response to an ASX Aware Letter seeking clarity, Mayne Pharma explained that under the Scheme Implementation Deed signed with Cosette in February 2025, it is obligated to provide the bidder with reasonable access to information, including regulatory correspondence. The FDA Untitled Letter was shared with Cosette on 5 May 2025 in compliance with these terms.
However, Mayne Pharma emphasized that the volume of information shared with Cosette includes many items not deemed materially price sensitive and thus not disclosed to the market. The company reiterated its position that the FDA letter relates solely to promotional claims and does not affect its ability to sell or distribute NEXTSTELLIS in the US.
Compliance and Market Implications
Mayne Pharma confirmed full compliance with ASX Listing Rule 3.1, which mandates immediate disclosure of information likely to impact the price or value of securities. The company also affirmed that its responses to the ASX were authorized by its board or delegated officers, underscoring adherence to its continuous disclosure policy.
The ASX’s inquiry and subsequent market volatility highlight the delicate balance companies must maintain between regulatory obligations and strategic confidentiality during takeover processes. While Mayne Pharma’s stance is that the letter is not price sensitive, the market’s reaction suggests investors remain cautious about potential regulatory scrutiny.
Looking Ahead
With the Scheme of Arrangement proceeding as planned, attention now turns to Mayne Pharma’s forthcoming response to the FDA and how this might influence both regulatory outcomes and investor sentiment. The company’s ability to manage this regulatory challenge without disrupting the acquisition timeline will be closely watched.
Bottom Line?
Mayne Pharma’s handling of the FDA letter underscores the fine line between regulatory transparency and strategic discretion in a high-stakes acquisition.
Questions in the middle?
- How will the FDA respond to Mayne Pharma’s forthcoming reply to the Untitled Letter?
- Could further regulatory scrutiny impact the timing or terms of the Scheme of Arrangement?
- Will market confidence stabilize as more information emerges or remain volatile?