Accomplished regulatory affairs veteran to lead company’s global regulatory strategy and drug product development

NEW YORK, Feb. 26, 2025 (GLOBE NEWSWIRE) -- Aspargo Labs, Inc. (“Aspargo Labs” or the “Company”), a specialty pharmaceutical and MedTech company focused on converting the world’s most meaningful medications into liquid oral suspensions for delivery in digitally connected devices, announced the appointment of Mario Guralnik, Ph.D. as Chief Regulatory Officer. Dr. Guralnik’s extensive experience in regulatory affairs and drug development will be instrumental in advancing Aspargo’s regulatory strategy and product pipeline as the Company expands its oral suspension portfolio and pursues unique and expedited approval pathways with the U.S. FDA and corresponding regulatory agencies worldwide.

“Mario is the person we need to lead us in driving our regulatory strategy, ensuring compliance with FDA and corresponding health authority regulations, and expanding our pipeline,” said Michael Demurjian, Chief Executive Officer & Chairman. “I collaborated with Mario in the past and have seen firsthand his ability to navigate regulatory landscapes. Mario’s deep understanding of the technical requirements for regulatory approval of new and improved drug products, combined with his entrepreneurial spirit, aligns perfectly with our mission to accelerate oral suspension technologies through expedited approval pathways, including the 505(b)(2) approval route, and expand our presence in global markets.”

Dr. Guralnik commented, “Aspargo Labs’ oral suspension technology combined with its proprietary connected device for dose administration under development addresses critical medical needs and improves the standard of patient care and medication adherence. I have navigated numerous first-in-class products through regulatory approval and see the significant therapeutic benefits of Aspargo Labs’ novel oral suspensions and electronic delivery devices. The industry has stagnated regarding developing new ways to deliver and monitor medications, which is where Aspargo Labs will be disruptive. I look forward to leveraging my experience to enable Aspargo to achieve its goals of introducing therapeutic products to market quickly and efficiently, and in full compliance with health authority regulations.”

Dr. Guralnik brings decades of regulatory affairs expertise to Aspargo Labs, including experience at Amgen where he directed the successful Erythropoietin program, leading to the development of the marketed products EPOGEN^® and Aranesp^®. As founder of Synergy Research, Inc., Mario navigated numerous clients through successful drug and device regulatory programs, culminating in product approval. His extensive involvement with FDA advisory boards and industry committees has earned him recognition as a thought leader in regulatory affairs. Dr. Guralnik is a frequent lecturer at the Drug Information Association and Regulatory Affairs Professionals Society and serves as a subcommittee member of the Professional Society for Health Economics and Outcomes Research. He holds advanced degrees from the University of California, Los Angeles (UCLA), including a Ph.D. in Cellular Biophysics, Masters’ degrees in Molecular Biology and Computer Science, and a Bachelor of Science in Biochemistry.

About Aspargo Labs, Inc.

Aspargo Labs, Inc. is a specialty pharmaceutical and MedTech company focused on converting the world’s most meaningful medications into liquid oral suspensions delivered via a proprietary, digitally connected device. Aspargo Labs’ suspension technology offers several key advantages, including improved absorption, ease of administration, flexible dosing, and improved patient adherence. Aspargo is leveraging its unique technology platform to transform a wide range of medications across various therapeutic areas. Aspargo’s initial focus is a liquid oral suspension formulation of sildenafil for the treatment of ED, which the Company markets in Europe and the United Kingdom.

For additional information, please visit our website at www.aspargolabs.com.

FORWARD-LOOKING STATEMENTS
All statements other than statements of historical facts contained in this press release are forward-looking statements, reflecting management’s current knowledge, assumptions, judgment, and expectations regarding future performance or events. Although management believes that the expectations reflected in such forward-looking statements are reasonable, management gives no assurance that such expectations will prove to be correct. You should be aware that actual events or results may differ materially from those contained in the forward-looking statements. Words such as “will,” “expect,” “intend,” “plan,” “potential,” “possible,” “goals,” “accelerate,” “continue,” and similar expressions identify forward-looking statements.

Forward-looking statements are subject to a number of risks and uncertainties, including but not limited to the risks inherent in our lack of profitability and need for additional capital; our dependence on third party vendors to manufacture and advance the development of our drug product candidates and digital drug delivery device; the uncertainties inherent in drug product development, attainment of requisite regulatory approvals and launch of new pharmaceutical products; and the potential for litigation with uncertain outcome.

All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You should not rely upon any forward-looking statements as predictions of future events. We undertake no obligation to revise or update any forward-looking statements made in this press release to reflect new events or circumstances or new information obtained after the date hereof, or to update the reasons why actual results could differ materially from those anticipated in the forward-looking statements, in each case except as required by law.

For more information:
Aspargo Labs, Inc.
(646) 503-1260
information@aspargolabs.com

Investor & media contacts:
Russo Partners
Nic Johnson or Liz Phillips
(347) 956-7697
aspargoIR@russopr.com

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/afd267d3-0479-4a16-b08e-47e2a78659b9

Legal Disclaimer:

EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.