ORGO Stock Rallies After Hours On Clearing Regulatory Pathway For Pain Relief Treatment

• ReNu is a cryopreserved, amniotic suspension allograft.
• The company decided to initiate a rolling application for ReNu following the completion of a meeting with the FDA.
• The treatment received FDA’s Regenerative Medicine Advanced Therapy (RMAT)-designation in 2021.

Shares of Organogenesis Holdings Inc. (ORGO) jumped 22% in Monday’s extended trading hours after the company said that it met with the U.S. Food and Drug Administration (FDA), and now plans to initiate seeking approval for its experimental treatment ReNu before the end of December.

The company is seeking approval for ReNu in the treatment of knee osteoarthritis pain, a degenerative joint disease that is estimated to affect nearly 31.1 million Americans.

ReNu is a cryopreserved, amniotic suspension allograft. It provides anti-inflammatory, growth factor, and cellular components, offering a non-surgical alternative to reduce inflammation, alleviate pain, and enhance joint function. The treatment received FDA’s Regenerative Medicine Advanced Therapy (RMAT)-designation in 2021.

ReNu Application

The company decided to initiate a rolling application for ReNu following the completion of a meeting with the FDA.

“We are excited about the outcome of our FDA meeting and reaching this important milestone in the ReNu program. We are pleased the ReNu clinical development program consisting of two large Phase 3 randomized controlled trials (RCT), extensive commercial history and Regenerative Medicine Advanced Therapy (RMAT)-designation is appropriate for BLA submission,” said Patrick Bilbo, Chief Operating Officer of Organogenesis.

How Did Retail Traders React?

On Stocktwits, retail sentiment around ORGO stock stayed within the ‘neutral’ territory while message volume remained at ‘normal’ levels.

According to data from Koyfin, the sole analyst covering ORGO rated it ‘Buy’ with a $8 price target that implies a potential upside of about 257% from current trading levels.

ORGO stock has fallen 42% over the past 12 months. 

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