Halveron Therapeutics Announces FDA Approval of LUMEVRA™ (velaglipron), a Once-Daily Oral GLP-1 Receptor Agonist for Chronic Weight Management in Adults
Halveron plans to make LUMEVRA available beginning September 22, 2026 through HalveronDirect home delivery, retail pharmacies and telehealth partners, with the terms of each route stated separately.
SAN DIEGO, Sept. 15, 2026 — Halveron Therapeutics (Nasdaq: HLVN) today announced that the U.S. Food and Drug Administration (FDA) has approved LUMEVRA™ (velaglipron), a once-daily oral small-molecule GLP-1 receptor agonist, as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with obesity (body mass index of 30 kg/m² or greater), or overweight (BMI of 27 kg/m² or greater) with at least one weight-related comorbidity. LUMEVRA is the first FDA-approved medicine and first commercial product for Halveron, a San Diego company moving from clinical-stage development into commercial operations.
LUMEVRA is taken as one maintenance strength — 12 mg once daily, following a single four-week 6 mg initiation period. It may be taken at any time of day, with or without food or water.
What the KESTREL program showed
In KESTREL-OB1 (NCT06481140), a 72-week trial in 3,044 adults without diabetes, LUMEVRA reduced mean body weight by 10.9% compared with 2.2% for placebo (efficacy estimand). In that trial, 58% of adults treated with LUMEVRA achieved a body-weight reduction of at least 10%, compared with 16% on placebo, and 34% achieved a reduction of at least 15%, compared with 6% on placebo.
In KESTREL-OB2 (NCT06592230), a 72-week trial in 1,512 adults with type 2 diabetes, LUMEVRA reduced mean body weight by 8.4% compared with 1.9% for placebo, with an A1C reduction of 1.6% compared with 0.3%.
Across the pooled safety population, the most common adverse events were nausea (24%), constipation (17%), diarrhea (14%) and vomiting (9%). These events were predominantly mild-to-moderate and occurred primarily during the four-week initiation period. Discontinuation due to adverse events occurred in 4.6% of adults treated with LUMEVRA, compared with 2.9% on placebo. No hepatic safety signal was observed, and no new safety findings beyond the GLP-1 class profile were identified. LUMEVRA carries a boxed warning for the risk of thyroid C-cell tumors and is contraindicated in people with a personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). No head-to-head trials of LUMEVRA versus any other GLP-1 medicine have been conducted.
"This approval is the first for our company, and it changes what we are accountable for," said Mara Ellison, Chief Executive Officer of Halveron Therapeutics. "When LUMEVRA becomes available, our job is to make the path plain — each route with its own visible terms, so an adult who is considering treatment walks into the clinician conversation with a real question instead of a guess." [proposed quote — pending approval]
"The KESTREL program studied more than 4,500 adults across two 72-week trials, and it tells clinicians two things at once," said Dr. Tomas Ferreira, Chief Medical Officer of Halveron Therapeutics. "There is a meaningful weight reduction to weigh, and there is a tolerability profile concentrated in the first four weeks that patients should be prepared for, alongside a boxed warning for the risk of thyroid C-cell tumors. Which patients are appropriate is a judgment only the treating clinician can make." [proposed quote — pending approval]
[fact needed — no advocacy partner is confirmed; a named organization and speaker must exist before any third-party quote is drafted]
Planned availability and access routes
Halveron plans to make LUMEVRA available beginning September 22, 2026 through HalveronDirect home delivery, retail pharmacies and telehealth partners. [anticipated event — not yet occurred]
As planned, HalveronDirect will offer a self-pay price of $99 per month for every strength — the same price for the 6 mg starting month and the 12 mg maintenance dose — as one transparent cash price with free home delivery. That price is current pricing through HalveronDirect self-pay only. It is not a commitment for future years, it is not the price at every pharmacy, and it covers the medicine only.
Eligible commercially insured adults filling at retail pharmacies may pay as little as $0 for the first fill and $25 per month ongoing with the LUMEVRA savings card; terms apply. The applicable plan and pharmacy determine actual costs.
Telehealth partners set their own consultation fees. Those fees are separate from the cost of the medicine and are not included in the $99 HalveronDirect self-pay price.
Treatment decisions are made by independent healthcare providers; availability and terms subject to eligibility.
The next step
Adults with obesity, or overweight with at least one weight-related health condition, who are considering treatment should talk with their clinician, who can determine whether LUMEVRA is appropriate for them and help them choose the access route — HalveronDirect, a retail pharmacy or a telehealth visit — that fits their coverage and circumstances. LUMEVRA is a prescription medicine.
Patient information: [fact needed — patient information URL]
ABBREVIATED IMPORTANT SAFETY INFORMATION
[regulatory language — pending review]
WARNING: RISK OF THYROID C-CELL TUMORS
LUMEVRA carries a boxed warning for the risk of thyroid C-cell tumors.
Contraindications: LUMEVRA is contraindicated in people with a personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
Most common adverse events: nausea (24%), constipation (17%), diarrhea (14%) and vomiting (9%), predominantly mild-to-moderate and occurring primarily during the four-week initiation period. Discontinuation due to adverse events occurred in 4.6% of adults treated with LUMEVRA versus 2.9% on placebo.
Please see full Prescribing Information, including Boxed Warning: [fact needed — Prescribing Information URL]
About LUMEVRA™ (velaglipron)
LUMEVRA is a once-daily oral small-molecule GLP-1 receptor agonist approved by the FDA as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with obesity (BMI ≥30 kg/m²), or overweight (BMI ≥27 kg/m²) with at least one weight-related comorbidity. LUMEVRA has one maintenance strength: 12 mg once daily following a single four-week 6 mg initiation period, taken at any time of day, with or without food or water.
About Halveron Therapeutics
Halveron Therapeutics (Nasdaq: HLVN) is a biopharmaceutical company headquartered in San Diego. LUMEVRA is the company's first FDA-approved medicine and first commercial product.
Media Contact
Corinne Vasquez Corporate Communications, Halveron Therapeutics media@halveron.example