NEW YORK, Nov. 05, 2026 (GLOBE NEWSWIRE) -- The federal government's October 30, 2026, decision could be a big deal for the peptide industry. HHS has signaled that it does not intend to pursue enforcement action against qualifying state-licensed pharmacies, federal facilities, and licensed physicians compounding six peptides that had previously faced significant restrictions: BPC-157, TB-500, KPV, MOTS-c, Epitalon, and Semax. That's an important development for an industry that has been waiting for clearer federal direction. While this does not mean these peptides are FDA-approved or that restrictions have disappeared, it could make it easier for qualified providers to offer certain compounded peptides under specific conditions. Just as important, it could bring more business into regulated pharmacy channels and create new opportunities for companies involved in peptide manufacturing, research, and distribution.   Watch These Biotech and Wellness Companies Positioned for Growth in Today’s Expanding Markets: The Precision Peptide Company Inc. (OTCQB: PNGAF) (CSE: BPC), MBX Biosciences, Inc. (NASDAQ: MBX), Kailera Therapeutics, Inc. (NASDAQ: KLRA), Altimmune, Inc. (NASDAQ: ALT), Hims & Hers Health, Inc. (NYSE: HIMS).

The market opportunity is hard to ignore. Grand View Research estimates that the global peptide therapeutics market was worth approximately $140.9 billion in 2025 and could grow to roughly $294.6 billion by 2033. That's a substantial market, and the latest federal policy could add another layer of momentum. The immediate question is how quickly the industry responds. Pharmacies may look to expand their offerings, manufacturers could see new demand, and investors may begin paying closer attention to companies already working in the peptide space. There is still plenty of regulatory uncertainty, but the direction of federal policy has given the industry something it has been looking for: a potential path forward. Companies involved in peptide development, manufacturing, and supply could be well positioned to benefit if this momentum continues.

Four Major Investment Drivers to Watch:

• Greater Market Access: The policy could create new opportunities for qualifying pharmacies and healthcare providers to offer certain compounded peptides.
• Growing Manufacturing Demand: More activity could mean increased demand for peptide production, raw materials, research, and distribution.
• More Regulatory Clarity: Future FDA decisions could determine how much further the industry can expand.
• Potential Investor Momentum: Peptide-focused biotechnology and healthcare companies could attract greater attention as the market develops.

Important: This policy is not FDA approval of these peptides or blanket authorization to sell or compound them. Specific federal and state requirements still apply.

The Precision Peptide Company Inc. (CSE: BPC) (OTCQB: PNGAF) Moves Early on New Federal Peptide Policy, Adding All Six Covered Peptides to Its Prescription Platform - The Precision Peptide Company (the "Company" or "BPC"), a publicly traded wellness company focused on advanced peptide formulations and delivery systems, today announced that it is adding all six peptides covered by the U.S. Department of Health and Human Services' (“HHS”) interim enforcement policy, titled “Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances” (the “Policy”) to its prescription platform, a process it began within a week of the Policy's publication in the Federal Register. The six peptides are expected to be available to patients in November 2026.   The six peptides are BPC-157, Epitalon, KPV, MOTS-c, Semax and TB-500.

Highlights:

• All six peptides covered by the new HHS policy being added: BPC-157, Epitalon, KPV, MOTS-c, Semax and TB-500 are being added to the Company's prescription platform, with availability to patients expected in November 2026
• Underway within a week of publication: the Company began adding all six peptides within a week of the policy's publication in the Federal Register on October 30, 2026
• Built to the policy's standards: each peptide will be prescribed as a single-ingredient compounded product, prepared from bulk drug substance supplied with a lot-specific certificate of analysis, in the dosage forms set out in the policy
• Clinician-prescribed and U.S.-compounded: every prescription is issued by a U.S.-licensed clinician following a clinical review and compounded in the United States by a licensed 503A pharmacy
• Builds on a growing prescription platform: follows the Company's expansion of its U.S. telehealth formulary to 16 prescription therapies across seven therapy areas, announced October 29, 2026
  

Moving early on a new federal Policy - HHS published the Policy in the Federal Register on October 30, 2026 under Docket No. HHS-OASH-2026-0496. While the U.S. Food and Drug Administration (“FDA”) develops, through rulemaking, the list of bulk drug substances that may be used in compounding under section 503A of the Federal Food, Drug, and Cosmetic Act (the “503A bulks list”), HHS has stated that it does not intend to take enforcement action against State-licensed pharmacies, Federal facilities or licensed physicians compounding products from these six peptides, provided the conditions outlined in the Policy are met. The Policy follows the July 2026 meeting of FDA's Pharmacy Compounding Advisory Committee, which voted to recommend the same six peptides for the 503A bulks list.

The Company commented on the Policy and its relevance to the Company's U.S. prescription platform on November 3, 2026. Two days later, all six peptides are being added to that platform, with availability to patients expected in November 2026.

How it works - Patients complete a secure online health assessment, which is reviewed by a U.S.-licensed clinician to determine whether a therapy is clinically appropriate. Approved prescriptions are compounded in the United States by a licensed 503A pharmacy through the Company's prescription and compounding partners, and shipped directly to patients.

Pratap Sandhu, CEO of The Precision Peptide Company, commented:   “When HHS published this policy, we did not wait. We spent the past year building a U.S. prescription platform, with licensed clinicians, U.S. compounding and the infrastructure to serve patients nationwide, so that when the framework arrived we could move. Within a week of publication, we are adding all six covered peptides to our platform, prepared to the standards HHS has set out, and we expect patients to have access this month. This is what being ready looks like.”   Continued… Read this full release and additional news for Precision Peptide Company by visiting: https://ir.precisionpeptidecompany.com/

Active Biotech, Peptide, and GLP-1 Companies Positioned to Capitalize on Growing Healthcare and Wellness Markets:

MBX Biosciences, Inc. (Nasdaq: MBX), a clinical-stage biopharmaceutical company focused on the discovery and development of novel precision peptide therapies for the treatment of endocrine and metabolic disorders, recently announced that the first patient has been dosed in its pivotal Phase 3 oPTimize clinical trial evaluating once-weekly canvuparatide for the treatment of chronic hypoparathyroidism (HP).

“The initiation of our pivotal Phase 3 program marks an important milestone for MBX as we advance once-weekly canvuparatide toward potential registration,” said Steve Hoerter, Chairman and Chief Executive Officer of MBX Biosciences. “The promising efficacy observed in the Phase 2 Avail™ trial and the sustained clinical effect demonstrated through one year of treatment reinforce our confidence in canvuparatide’s potential to become a new standard of care in the treatment of HP. We look forward to advancing the Phase 3 oPTimize trial and bringing once-weekly canvuparatide one step closer to patients living with chronic HP."

Kailera Therapeutics, Inc. (Nasdaq: KLRA), a clinical-stage biotechnology company focused on elevating the next era of obesity care, recently announced Phase 1 data for ribupatide injection, a GLP-1/GIP receptor dual agonist currently advancing through global Phase 3 clinical trials, presented at the 62nd Annual Meeting of the European Association for the Study of Diabetes (EASD). In addition, partner Hengrui Pharma delivered four oral presentations highlighting clinical data from programs now in global development by Kailera, including ribupatide injection, oral small molecule GLP-1 receptor agonist safiglipron, also known as KAI-7535 (HRS-7535), and injectable GLP-1/GIP/glucagon receptor tri-agonist KAI-4729 (HRS-4729).

Ribupatide Phase 1 Injection Site Clinical Trial - Kailera's Phase 1 single-dose, crossover trial investigated the effect of injection site on the relative bioavailability and safety of ribupatide injection administered subcutaneously in adults living with obesity or overweight. The trial enrolled 51 participants and consisted of three treatment periods, each with a different injection site (abdomen, upper arm, thigh) administered according to a randomized sequence (n=17 per sequence). Participants received a single 2 mg dose of ribupatide injection on Day 1 of each 29-day period. Plasma drug exposure following subcutaneous ribupatide injection to the upper arm or thigh was similar to that observed following abdominal injection, supporting these sites as alternative injection locations. Ribupatide injection was generally well tolerated irrespective of injection site, with no new safety signals identified; most treatment-emergent adverse events (TEAEs) were mild and gastrointestinal in nature.

Altimmune, Inc. (Nasdaq: ALT), a late clinical-stage biopharmaceutical company developing pemvidutide to address serious liver diseases, recently announced that new clinical and preclinical data on pemvidutide will be presented at the American Association for the Study of Liver Diseases’ (AASLD) The Liver Meeting® 2026, taking place November 5-9, 2026, in Denver, Colorado.

Data being presented will include results from 48-week IMPACT Phase 2b analyses in metabolic dysfunction-associated steatohepatitis (MASH) which showed that treatment with pemvidutide achieved concurrent reductions in two non-invasive markers of fibrosis, liver stiffness and ELF score, as well as liver fat and alanine aminotransferase (ALT) compared to placebo. These concordant changes across multiple non-invasive tests provide a more robust picture of treatment response than an individual measure. Separate IMPACT data showed that gastrointestinal adverse events were mild to moderate, with no severe gastrointestinal treatment-emergent adverse events reported. Treatment discontinuations due to adverse events were lower with pemvidutide than placebo, with a greater proportion of pemvidutide-treated patients completing study treatment despite no dose titration.

Hims & Hers Health, Inc. (NYSE: HIMS), the leading global health and wellness platform, recently announced the launch of new injectable and oral testosterone replacement therapies (TRT) for eligible men. It’s the largest expansion of the company’s men’s health program since first introducing the category last September, giving eligible men more options to treat low testosterone in partnership with licensed providers through Hims.

An estimated 20 million men in the U.S. are affected by low testosterone, which, when left untreated, can lead to feelings of lower energy, reduced muscle mass, lower sex drive, and erectile dysfunction. For years, stigma kept many men quiet about these symptoms, but new research suggests men are starting to open up. A new survey commissioned by Hims of 2,000 U.S. men ages 18 and older found that men are speaking more openly about testosterone, and the hormonal shifts that come with age. When asked about what they actually want, 79% of men surveyed say more energy is a higher priority than more muscle, so they can show up more fully at work, in their hobbies and with the people who matter most. Despite this progress, awareness of treatment hasn’t caught up: the same study shows fewer than half of men surveyed (45%) say they're familiar with specific low T treatments.

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