Precigen (PGEN) Stock News

Precigen (Nasdaq: PGEN) reported rapid commercialization and growing adoption of PAPZIMEOS, the first-and-only FDA-approved therapy for adults with recurrent respiratory papillomatosis (RRP). Key highlights include FDA full approval in August 2025 with a broad label and no confirmatory trial requirement, patient-hub enrollment >200 (doubling since November), private health plan coverage for ~170 million US lives, Medicare and Medicaid coverage, and EMA validation of the Marketing Authorization Application following a November 2025 submission. The company says manufacturing, cold-chain logistics, and field engagement (>96% of target centers) are in place and expects current capital resources to fund operations through anticipated cash-flow break-even.

Precigen (Nasdaq: PGEN) announced that Helen Sabzevari, PhD, President and CEO, will present at the 44th Annual J.P. Morgan Healthcare Conference in San Francisco on January 15, 2026 at 7:30 AM PT. Dr. Sabzevari will also join a fireside chat hosted by commercialization partner Eversana on January 12, 2026 at 10:30 AM PT during the Biotech Showcase (January 12–14, 2026).

Investors and other participants may view event details in the company’s Events & Presentations section at the investor website.

Precigen (Nasdaq: PGEN) reported Q3 2025 results and business updates after FDA full approval of PAPZIMEOS in August 2025 for adults with recurrent respiratory papillomatosis (RRP). PAPZIMEOS is commercially available and shipping in the US with >100 patients registered in the PAPZIMEOS Patient Hub and >90% of target institutions engaged since sales deployment in September 2025.

Long-term follow-up (data cutoff Sept 19, 2025) showed durable complete responses in 15 of 18 patients (83%) with median follow-up of 36 months. Cash, cash equivalents, and investments were $123.6M as of Sept 30, 2025; company also accessed a credit facility providing up to $125M and received a $100M tranche.

Precigen (Nasdaq: PGEN) will release third quarter 2025 financial results and provide business updates on November 13, 2025. The company will host a conference call at 4:30 PM ET the same day; dial-in numbers are 1-800-836-8184 (North America) and 1-646-357-8785 (International). Participants are asked to call 10–15 minutes early. Event details and a webcast are available in the Events & Presentations section at investors.precigen.com/events-presentations. The release includes a standard cautionary statement about forward-looking statements, including references to PAPZIMEOS and regulatory and clinical risks.

Precigen (Nasdaq: PGEN) reported long-term follow-up showing durable clinical benefit after treatment with PAPZIMEOS for adults with recurrent respiratory papillomatosis (RRP). PAPZIMEOS received full FDA approval in August 2025 as the first and only approved therapy for adults with RRP. In the pivotal study 51% (18/35) of patients achieved complete response in the first 12 months (95% CI: 34-69%). As of the September 19, 2025 cutoff, 15 of 18 complete responders (83%) remained in ongoing complete response with a median follow-up of 36 months (range 27–37); median duration of complete response not yet reached. Surgical interventions decreased versus the year prior in 86% (Year 1), 91% (Year 2) and 95% (Year 3). No new safety events observed during long-term follow-up.

Precigen (Nasdaq: PGEN) has secured a significant non-dilutive credit facility of up to $125 million through Pharmakon Advisors, LP. The financing includes $100 million funded at closing and an additional $25 million available through March 31, 2027. The credit facility matures in five years and carries an interest rate of 6.50% plus three-month SOFR with a 3.75% floor.

The funding will support the US commercialization of PAPZIMEOS, Precigen's novel immunotherapy for recurrent respiratory papillomatosis (RRP) in adults. The company plans to use the proceeds for international market expansion and pursuing pediatric and other HPV-related indications. This strategic financing positions Precigen for its transition into a commercial-stage biopharmaceutical company.

Precigen (NASDAQ: PGEN) announced its participation in two upcoming virtual fireside chats to discuss their recently FDA-approved therapy for adult recurrent respiratory papillomatosis. The first event, hosted by Jennifer Kim of Cantor, is scheduled for August 27, 2025, while the second chat, moderated by Dr. Swayampakula Ramakanth of H.C. Wainwright, will take place on September 2, 2025.

Both events will feature presentations from Helen Sabzevari, PhD, President and CEO, and Phil Tennant, Chief Commercial Officer. Investors can access the live webcasts through Precigen's investor relations website.

Precigen (NASDAQ: PGEN) has achieved a historic milestone with the FDA's full approval of PAPZIMEOS (zopapogene imadenovec-drba), the first and only approved therapy for adults with Recurrent Respiratory Papillomatosis (RRP). This groundbreaking treatment targets the root cause of RRP, a rare disease affecting approximately 27,000 adult patients in the US.

The therapy demonstrated remarkable efficacy in clinical trials, with 51% of patients (18 out of 35) achieving Complete Response, requiring no surgeries for 12 months post-treatment. Of these, 15 patients maintained Complete Response at 24 months. PAPZIMEOS is administered via four subcutaneous injections over 12 weeks and showed excellent tolerability with no treatment-related adverse events above Grade 2.

Precigen (PGEN) reported Q1 2025 financial results and significant progress with its lead candidate PRGN-2012. The company's BLA for PRGN-2012, a potential first-in-class treatment for Recurrent Respiratory Papillomatosis (RRP), is under FDA priority review with a PDUFA date of August 27, 2025. Clinical results showed 51% of patients achieved Complete Response, with durable responses beyond 12 months. The company ended Q1 with $81.0 million in cash and investments, expected to fund operations into 2026. Q1 net loss was $54.2 million ($0.18 per share), compared to $23.7 million ($0.10 per share) in Q1 2024. The US market opportunity includes approximately 27,000 adult RRP patients, with over 125,000 patients outside the US. Precigen has partnered with EVERSANA for commercialization and is advancing launch preparations.