Precigen Completes Regulatory Filing For Approval Of Gene Therapy To Treat Respiratory Papillomatosis: Retail Sentiment Surges Amid Stock Rally
By Stocktwits Inc | First Published Dec 31, 2024, 2:21 PM ISTRecurrent respiratory papillomatosis is a rare condition when benign tumors called papillomas grow in the respiratory tract, most commonly in the larynx.
Small-cap, clinical-stage biopharma Precigen, Inc. ($PGEN) rallied on Monday following a regulatory update. The stock ended the session 28.47% higher at $0.9331 on more than six times the average volume.
Germantown, Maryland-based Precigen announced the completion of the rolling submission for a biologic license application (BLA) for PRGN-2012, a gene therapy being investigated as a treatment option for adult patients with recurrent respiratory papillomatosis (RRP).
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RRP is a rare condition when benign tumors called papillomas grow in the respiratory tract, most commonly in the larynx, and it is caused by the human papillomavirus (HPV) 6 or HPV 11. It can prove fatal.
Precigen said the BLA is now in the initial 60-day review period and the FDA will decide whether to accept the application for further review and set the Prescription Drug User Fee Act (PDUFA) date by this period.
The company also noted that the application included a request for priority review, which, if granted, will reduce the review period from 10 months to six months.
PRGN-2012 acts by eliciting immune responses directed against cells infected with HPV 6 or HPV 11. The company noted that there is no cure for the condition currently and the current standard-of-care is repeated surgeries, which do not address the underlying cause of disease.
The regulatory application is supported by pivotal Phase 1/2 study results, which showed more than 50% of patients achieved complete response and more than 85% had a decrease in surgical interventions the year after the treatment.
Helen Sabzevari, President and CEO of Precigen, "We look forward to working closely with the FDA on next steps now that we have completed the BLA submission and we are excited by the potential to bring PRGN-2012 to RRP patients as quickly as possible."'
The executive also said, with the recent $79 million private placement of convertible preferred stock, the company has extended its cash runway into 2026, well beyond the potential commercial launch in the second half of 2025.
On Stocktwits, sentiment toward Precigen flipped from ‘extremely bearish’ a day ago to ‘extremely bullish’ (96/100), the highest in a year. Message volume also spurted from ‘normal’ to ‘extremely high.’
In a message posted on the PGEN stream on Stocktwits, a user said they looked ahead to a good 2025 for the company.
If the company manages to get a priority voucher, it can resell it for $100 million, another noted.
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