ReNu Advances Toward FDA Approval: Organogenesis Charts Path for Rolling BLA Submission

Organogenesis Holdings Inc. (ORGO) has cleared a critical regulatory milestone with the U.S. FDA, paving the way for a rolling Biologics License Application (BLA) submission for ReNu, its regenerative therapy targeting symptomatic knee osteoarthritis. The stock market has taken notice—ORGO surged to $5.37 in after-hours trading, reflecting an 11.18% gain following the announcement, up from yesterday’s close of $4.83.

The Market Opportunity Behind ReNu

Knee osteoarthritis represents one of the most pressing orthopedic challenges in the United States, affecting approximately 31.1 million people today with projections suggesting this number could climb to 34.4 million by 2027. The condition ranks among leading causes of disability and diminished quality of life, often culminating in total knee replacement when conventional interventions prove insufficient. This massive patient population underscores the commercial potential for an effective regenerative medicine solution.

ReNu’s Clinical Foundation

ReNu is engineered as a cryopreserved amniotic suspension allograft, derived from amniotic fluid cells combined with micronized amniotic membrane components. This composition delivers a rich blend of cellular material, growth factors, and extracellular matrix elements designed to address the degenerative mechanisms underlying osteoarthritis. The therapy’s development program is grounded in substantial clinical evidence: three large randomized controlled trials involving over 1,300 patients, complemented by two Phase 3 RCTs, a dedicated 200-patient investigation, and considerable real-world commercial history.

FDA’s Regulatory Stamp of Approval

The FDA’s Type-B meeting confirmed that Organogenesis’s comprehensive ReNu development portfolio meets the standards necessary for BLA submission. Notably, ReNu received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA back in 2021, acknowledging its potential to address significant unmet medical needs. The company has signaled its intention to file the rolling BLA before year-end 2025, a timeline that could accelerate the path to formal approval.

Transition to Full FDA Licensure

Previously, ReNu operated under the regulatory framework of Section 361 of the Public Health Service Act, which permitted limited commercial distribution without complete FDA licensure. As regulatory guidance has evolved, Organogenesis is now pursuing formal BLA approval to establish a durable market authorization and strengthen reimbursement prospects for broader patient access.

What Lies Ahead

If approved, ReNu would introduce a genuinely novel regenerative medicine option to the market, potentially benefiting millions of osteoarthritis patients seeking alternatives to invasive surgical interventions. For ORGO, which has traded between $2.61 and $7.07 over the past twelve months, regulatory success could represent a transformative inflection point in the company’s trajectory and investor outlook.