PaxMedica Files Nasdaq Delisting Appeal Notice and Prepares for Upcoming FDA Meeting on PAX-101
PaxMedica has filed an appeal against Nasdaq's decision to delist the company. The appeal follows recent achievements, including the completion of pivotal batches of PAX-101, an urgent request from Malawi for emergency access to the treatment, and the submission of a briefing book for an upcoming FDA Type C meeting.
PaxMedica is optimistic that these developments will support its case to remain listed on Nasdaq. The company stresses its commitment to addressing global health challenges and advancing treatments for neurological disorders. However, PaxMedica acknowledges the uncertainty surrounding the appeal outcome.
- Completion of three pivotal registration/validation batches of PAX-101 (April 11th).
- Urgent request from Malawi’s Ministry of Health for PAX-101 to address TBr HAT (April 16th).
- Agreement to supply Malawi with PAX-101 (April 23rd).
- Submission of FDA Briefing Book for Type C meeting (May 10th).
- Plans for NDA submission for PAX-101 later this year.
- Strong commitment to addressing global health challenges and advancing neurological disorder treatments.
- Nasdaq decision to delist the company.
- Uncertainty about the outcome of the Nasdaq appeal.
- Potential risk of Nasdaq delisting impacting stock valuation and investor confidence.
The announcement of PaxMedica's appeal against the Nasdaq delisting is a significant event for investors. The company is facing a critical financial challenge, which could impact its stock performance. If the appeal is unsuccessful, it might lose access to a major stock exchange, limiting liquidity and potentially reducing investor confidence. The appeal hinges on recent milestones, including the completion of registration lots of PAX-101 and emergency supply agreements. Investors should monitor the situation closely, as the outcome of the appeal and upcoming FDA meeting will likely have a profound impact on the stock price. A successful appeal could restore confidence, while a failure might lead to further stock depreciation.
The engagement of Jacob Frenkel, a noted lawyer from Dickinson Wright, PLLC, for the appeal process adds a layer of credibility to PaxMedica's efforts. The legal expert's role is critical in navigating the complexities of Nasdaq's regulatory framework and presenting a compelling case. The company's argument hinges on new developments and recent achievements, which they believe were not sufficiently considered by the Hearings Panel. While the outcome is uncertain, the involvement of experienced legal counsel could improve the chances of a favorable decision. However, investors should be aware that legal proceedings can be unpredictable and the delisting appeal's success is not guaranteed.
PaxMedica's recent progress with PAX-101, particularly the completion of pivotal registration batches and the submission of an FDA briefing book, underscores its operational capabilities. These steps are essential for the eventual NDA submission and potential market approval. Additionally, the agreement to supply suramin to Malawi for a humanitarian crisis highlights the company's commitment to addressing urgent public health needs. These developments could positively influence regulatory perspectives. Nevertheless, investors should consider that the drug approval process is lengthy and uncertain and the company's financial stability is important during this period.
TARRYTOWN, New York, May 15, 2024 (GLOBE NEWSWIRE) -- via IBN -- PaxMedica, Inc. (the “Company” or “PaxMedica”) (OTC:PXMD), a biopharmaceutical company dedicated to advancing treatments for neurological disorders, today announced it has timely filed a formal notice of appeal with the Nasdaq Office of Appeals and Review to reverse the decision of a Nasdaq Hearings Panel to delist the Company from Nasdaq. Following receipt of notification from Nasdaq on April 30th, PaxMedica determined to appeal the decision and intends to maintain that the Hearings Panel did not consider sufficiently or appropriately crucial aspects of PaxMedica’s recent achievements and ongoing actions to regain compliance with all applicable requirements for continued listing. PaxMedica has retained Jacob Frenkel, Dickinson Wright, PLLC as its lead counsel in the appeal, working with the consulting firm that interacted previously with the Hearings Panel.
Howard Weisman, CEO of PaxMedica, commented, "We are seeking a reevaluation of Nasdaq’s recent action based on new developments that underscore our ongoing progress and commitment to addressing global health challenges. Notably, following our announcements on the completion of registration lots of PAX-101 in mid-April, the Company just submitted a briefing book for an important FDA Type C meeting scheduled for June 27th, during which we will present key updates on our plans for NDA submission later this year. We believe this, as well as our financing plans, which we made known to the Hearings Panel, support persuasively our arguments to appeal and restore trading on Nasdaq."
Recent milestones for PaxMedica include:
- April 11th: Completion of three pivotal registration/validation batches of PAX-101, an IV formulation of suramin, crucial for ongoing regulatory submissions.
- April 16th: Receipt of an urgent request from Malawi’s Ministry of Health for emergency access to suramin to address a looming humanitarian crisis due to the scarcity of treatment for TBr HAT, a fatal form of African Sleeping Sickness.
- April 23rd: Agreement to supply Malawi with PAX-101 from our stock, reinforcing our role in combating global health emergencies.
- May 10th: PaxMedica submits FDA Briefing Book for June 27, 2024, Type C meeting.
Weisman stated "these actions not only demonstrate our operational effectiveness, but also our vital role in the global healthcare landscape. We are encouraged that the upcoming FDA meeting, and our continuous efforts to supply life-saving treatments, will result in favorable consideration by Nasdaq in our appeal." Nevertheless, PaxMedica acknowledges that it cannot predict the outcome of the appeal. Weisman added that “we are committed to advancing expeditiously our efforts to maximize shareholder opportunities and value and pursue approval of our solutions for neurological disorders.”
PaxMedica remains resolute in its mission to develop and provide innovative treatments for neurological disorders, ensuring significant contributions to public health worldwide. For more information on PaxMedica’s ongoing initiatives and developments, please visit www.paxmedica.com.
About PaxMedica
PaxMedica, Inc. is a forward-looking clinical-stage biopharmaceutical firm specializing in cutting-edge anti-purinergic drug therapies (APT) aimed at addressing a range of challenging neurologic disorders. Our comprehensive portfolio encompasses a spectrum of conditions, including neurodevelopmental disorders such as Autism Spectrum Disorder (ASD), as well as other critical areas within the neurology field. Additionally, we intend to provide the rest of the world with an additional, reliable source of suramin, the accepted standard of care for Stage 1, Trypanosoma Brucei Rhodesiense.
We are dedicated to the continuous development and evaluation of our pioneering program, PAX-101, an intravenous suramin formulation that lies at the heart of our efforts, particularly focused on innovative ASD treatment solutions. Our ongoing research initiatives not only prioritize the needs of ASD patients, but also extend to exploring potential therapeutic applications for related conditions. To learn more about our transformative work, please visit www.paxmedica.com.
Interested investors and shareholders are encouraged to sign up for press releases and industry updates by registering for Email Alerts at https://www.paxmedica.com/email-alerts and by following PaxMedica on Twitter and LinkedIn.
Forward-Looking Statements
This press release contains “forward-looking statements.” Forward-looking statements reflect our current view about future events. Investors can identify these forward-looking statements by words or phrases such as “may,” “will,” “could,” “expect,” “anticipate,” “aim,” “estimate,” “intend,” “plan,” “believe,” “is/are likely to,” “propose,” “potential,” “continue” or similar expressions. These forward-looking statements include our anticipated clinical program, the timing and success of our anticipated data announcements, pre-clinical and clinical trials and regulatory filings, and distribution and demand for our product candidates. These forward-looking statements involve known and unknown risks and uncertainties and are based on the Company’s current expectations and projections about future events that the Company believes may affect its financial condition, results of operations, business strategy and financial needs. Such risks and uncertainties include, but are not limited to, risks associated with the Company’s development work, including any delays or changes to the timing, cost and success of the Company’s product development and clinical trials, risk of insufficient capital resources, cash funding and cash burn, regulatory approvals and risks associated with intellectual property and infringement claims. The Company undertakes no obligation to update or revise publicly any forward-looking statements to reflect subsequent occurring events or circumstances, or changes in its expectations, except as may be required by law. Although the Company believes that the expectations expressed in these forward-looking statements are reasonable, it cannot assure you that such expectations will turn out to be correct, and the Company cautions investors that actual results may differ materially from the anticipated results and encourages investors to review other factors that may affect its future results described in the Company’s “Risk Factors” section and other sections in its most recent Annual Report on Form 10-K, and subsequent quarterly and other filings with the U.S. Securities and Exchange Commission.
Contacts
PaxMedica, Inc.
303 S Broadway,
Suite 125.
Tarrytown, NY 10591
www.paxmedica.com
Media Contact
media@paxmedica.com
Investor Contact
Scott McGowan
InvestorBrandNetwork (IBN)
Phone: 310.299.1717
ir@paxmedica.com
www.paxmedica.com/investors
SOURCE: PaxMedica, Inc.
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