Announcement • May 29
Mountain Valley Md Holdings Inc Advances Quicksome Sublingual Delivery Platform for Compounded Peptide Applications and Reports on Initial Formulation Work Across Multiple Peptides Including BPC-157
Mountain Valley MD Holdings Inc. has expanded its internal formulation capabilities following investments in laboratory equipment and capabilities to support direct work with sensitive molecules, including peptides and bioactive compounds requiring controlled environment handling and stability-focused formulation work. Through this program, the company has completed initial Quicksome sublingual formulation work across several peptides currently drawing noteworthy attention within the compounded pharmacy channel, including BPC-157, GHK-Cu, KPV, SNAP-8, and retatrutide. Dosing finalization is being conducted across several of these programs in preparation for anticipated compounded pharmacy commercialization opportunities. The company’s current programs are focused on evaluating sublingual delivery applicability, formulation stability characteristics, and commercial potential within the compounded pharmacy network. The company is not developing proprietary peptide drugs and does not hold ownership rights to any of the underlying peptide molecules referenced in this release. A fundamental challenge in peptide administration is bioavailability. Peptide chains are highly susceptible to degradation by the harsh acidic environment of the stomach and the proteolytic enzymes of the gastrointestinal tract, which break down peptide bonds before the active molecule can reach systemic circulation. The result is that conventional oral peptide formulations typically achieve negligible systemic bioavailability, making injection the dominant delivery method across most clinically active peptides in use today. Sublingual delivery bypasses the gastrointestinal tract entirely, allowing molecules to be absorbed directly through the highly vascularized tissue beneath the tongue and enter systemic circulation without first-pass degradation. Quicksome is the company’s patented sublingual rapid-dissolve delivery technology. Active molecules are formulated into a tablet that dissolves under the tongue, designed to provide systemic delivery without injection. For peptides currently requiring refrigeration and needle-based administration, the company believes this format may offer several potential advantages: needle-free administration and improved patient convenience, potential elimination or reduction of refrigerated handling requirements, expanded distribution flexibility and commercial accessibility, improved regimen compliance for needle-adverse patients. The company’s cold chain credentialing is grounded in validation work conducted under a formal two-year collaborative research agreement with the FDA, announced in June 2021. In the company’s initial cold chain evaluation, Quicksome technology achieved 100% preservation and stability of IPV serotype two of a Trivalent Inactivated Poliovirus Vaccine after five days of exposure to 40 degrees Celsius, meeting the World Health Organization’s requirements across all three defined vaccine cold chain management categories, including the Controlled Temperature Chain standard which requires tolerance of 40 degrees Celsius for a minimum of three days. IPV serotypes one and three achieved 50% preservation in the same evaluation. The company believes these results demonstrate the platform’s capability to preserve and stabilize heat-sensitive biological molecules outside of a refrigerated environment — a characteristic it considers directly beneficial to the compounded peptide category. Peptides are naturally occurring chains of amino acids that function as biological signaling molecules involved in tissue repair, hormonal regulation, metabolic function, immune response, and other physiological processes. Peptide therapeutics have been used clinically for decades across oncology, endocrinology, metabolic disease, and regenerative medicine, with the FDA having authorized approximately 100 peptide-based medicines to date. The global peptide therapeutics market was valued at approximately USD 141 billion in 2025 and is projected to reach approximately USD 295 billion by 2033, growing at an approximately 8.7% compound annual growth rate. A recent development within the category has been with regard to the GLP-1 receptor agonist class. Therapies anchored by semaglutide and tirzepatide generated combined global reported revenues of approximately USD 46 billion in 2024. The next-generation GLP-3 class, anchored by retatrutide — Eli Lilly’s triple agonist currently in Phase III clinical trials — is projected by leading industry analysts to generate revenues in the range of USD 15 billion to USD 30 billion by 2031 for Lilly alone. The company does not own, develop, or hold any rights to GLP-class molecules. The company’s work in this area is limited to evaluating the applicability of its Quicksome delivery platform to such molecules within the compounded pharmacy channel. The company’s formulation and commercialization activities are not dependent solely on the potential expansion of categories currently under regulatory review. Several GLP-class therapies and other peptide molecules are already commercially established within approved pharmaceutical and compounded pharmacy channels. The company notes, however, that the United States regulatory framework surrounding compounded peptides continues to evolve in a direction that may materially expand the addressable market for differentiated delivery technologies. On February 27, 2026, United States Secretary of Health and Human Services Robert F. Kennedy Jr. publicly stated that approximately 14 peptides currently classified on the FDA’s Category 2 Bulk Drug Substances List — a designation that has restricted their use by compounding pharmacies — are expected to be considered for potential return to Category 1 status, which would permit licensed compounding pharmacies to prepare them under physician prescription. On April 16, 2026, the FDA confirmed a Pharmacy Compounding Advisory Committee meeting scheduled for July 23 and 24, 2026, at which seven peptides will be reviewed for potential inclusion on the 503A Bulk Drug Substances List: BPC-157, TB-500, KPV, MOTS-c, Emideltide, Semax, and Epitalon. A second meeting anticipated before February 2027 will review five additional peptides including GHK-Cu, Melanotan II, Cathelicidin, Dihexa acetate, and PEG-MGF. The company notes that a positive Committee recommendation initiates a formal rulemaking process and that the timing of any reclassification remains subject to that process.
