PGEN Stock Surges 144% in August on FDA Nod for Rare Lung Disease Drug

Shares of Precigen, Inc. PGEN have skyrocketed 144.4% in August so far, following the company's announcement of the FDA approval for Papzimeos (zopapogene imadenovec-drba) for the treatment of adults with recurrent respiratory papillomatosis (RRP). PGEN considers the approval a landmark achievement for the RRP patient community, representing the first and only FDA-approved treatment option for adults with the condition.

The drug, developed using Precigen’s proprietary AdenoVerse platform, is a non-replicating adenoviral vector immunotherapy engineered to address the primary drivers of RRP. The gene therapy is administered through four subcutaneous injections given over 12 weeks. It also enjoys the FDA’s breakthrough therapy and orphan drug designation for the RRP indication.

More on the FDA Approval of PGEN’s RRP Gene Therapy

In December 2024, Precigen completed submission of the rolling biologics license application (BLA) for Papzimeos to treat RRP, under the FDA’s accelerated approval pathway.

In mid-August, the FDA granted full approval to the gene therapy based on the data from a pivotal phase I/II study that evaluated Papzimeos for the treatment of adult patients with RRP. The study met its primary safety and pre-specified primary efficacy endpoints. In the study, 51% of patients (18 of 35) achieved a complete response, eliminating the need for surgeries in the 12 months following Papzimeos treatment. These responses proved durable beyond one year, with 15 of the 18 patients assessed at 24 months maintaining a complete response. The drug was well-tolerated in the RRP patient population with mild to moderate treatment-related adverse events.

Year to date, the stock has skyrocketed 273.2% compared with the industry’s 4.3% growth.

A full approval means that Precigen will not have to conduct a confirmatory study of Papzimeos for the RRP indication. This has also likely impressed the investors, which contributed to the stock price rally.

A rare disease, RRP causes benign tumors (called papillomas) to grow in the respiratory tract, most commonly in the larynx (voice box). It is caused by two types of human papillomavirus (HPV) – HPV 6 and HPV 11. Per PGEN, approximately 27,000 adult patients in the United States suffer from this condition.

Next Steps for PGEN

Precigen is set to initiate the commercial launch of Papzimeos, underscoring its commitment to driving market uptake and establishing the therapy as the standard of care for adults with RRP. As part of its commercialization strategy, the company has rolled out Papzimeos SUPPORT, a patient services platform designed to streamline insurance processes, reduce financial barriers, and ensure sustained access to treatment — key elements expected to boost adoption and long-term revenue growth.

Other Players in the RRP Space

Another company developing its own RRP medication is Inovio INO, which is on track to begin a rolling BLA submission for INO-3107 soon, to file acceptance by year's end. The submission will be supported by positive data from a pivotal phase I/II study of the candidate for RRP. The Inovio drug is an investigational DNA medicine designed to generate an antigen-specific T-cell response against both HPV-6 and HPV-11 proteins.

Management plans to seek accelerated approval for the drug in the RRP indication. Commercial preparations are currently underway for a potential 2026 launch of INO-3107, pending FDA approval.

Like Papzimeos, the FDA has also granted breakthrough therapy and orphan drug designations to Inovio’s INO-3107 for the RRP indication.

Precigen, Inc. Price and Consensus

Precigen, Inc. price-consensus-chart | Precigen, Inc. Quote

PGEN’s Zacks Rank & Stocks to Consider

Precigen currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the biotech sector are CorMedix CRMD and Kiniksa Pharmaceuticals KNSA, each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

In the past 60 days, estimates for CorMedix’s earnings per share have increased from 93 cents to $1.22 for 2025. During the same time, earnings per share estimates for 2026 have increased from $1.64 to $2.12. Year to date, shares of CRMD have rallied 69%.

CorMedix’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 34.85%.

In the past 60 days, estimates for Kiniksa Pharmaceuticals’ 2025 earnings per share have increased from 74 cents to $1.03. Earnings per share estimates for 2026 have increased from $1.19 to $1.60 during the same period. KNSA stock has soared 70.6% year to date.

Kiniksa Pharmaceuticals’ earnings beat estimates in two of the trailing four reported quarters and missed on the remaining two occasions, delivering an average negative surprise of 330.56%.

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