Precigen Stock Shot Through The Roof On Friday Morning – Here’s Why

Precigen, Inc. (PGEN) said on Friday that the US Food and Drug Administration (FDA) has approved its immunotherapy Papzimeos for the treatment of adults with recurrent respiratory papillomatosis (RRP).

Recurrent respiratory papillomatosis (RRP) is a rare condition where benign, wart-like tumors, called papillomas, grow in the respiratory tract, most commonly the larynx or the voice box. The disease can lead to severe voice disturbance, a compromised airway, and recurrent post-obstructive pneumonias. According to Precigen, there are about 27,000 adult RRP patients in the U.S.

Papzimeos is now the first and only FDA-approved therapy for the treatment of adults with RRP, the company said.

On Stocktwits, retail sentiment around Precigen jumped from ‘neutral’ to ‘extremely bullish’ over the past 24 hours, while message volume rose from ‘high’ to ‘extremely high’ levels. Shares of the company traded 50% higher in the pre-market session at the time of writing.

“With the landmark FDA approval of Papzimeos and broad label, all adult RRP patients are now eligible for access to the first and only approved therapy that targets the root cause of the disease," said CEO Helen Sabzevari. Management of RRP, the company said, previously primarily consisted of repeated surgeries that did not address its root cause.

The FDA approval was supported by data from an open-label, single-arm study in adult patients with RRP in which 51% of study patients required no surgeries in the 12 months after treatment with Papzimeos. Further, the therapy was well-tolerated in the trial with no serious treatment-related adverse events.

Precigen noted that no confirmatory clinical trial is required for the therapy, which is delivered via four subcutaneous injections over a 12-week interval. The company added that it will begin promoting Pazimeos immediately.

H.C. Wainwright subsequently raised its price target on Precigen to $8.50 from $6 while keeping a 'Buy' rating on the shares. The firm expects the drug to generate sales of $1.1 billion in 2033 from $138 million in 2026.

PGEN stock is up by 65% this year and by about 73% over the past 12 months. 

Read also: Apple Stock Climbs Premarket Even After Warren Buffett’s Berkshire Trims Stake

For updates and corrections, email newsroom[at]stocktwits[dot]com.