FDA clears Papzimeos to treat adult respiratory papillomatosis - UPI.com

B. Riley rates Precigen Buy on Papzimeos, the first FDA-approved adult RRP therapy, plus Q2 profit and management’s year-end cash break-even goal.

FDA has Granted Full Market Approval for Papzimeos - NIH / cancer, Headlines, NIH, OncoDaily, Oncology, RRP, The National Institutes of Health

Precigen has received FDA platform technology designation for its AdenoVerse platform, enabling faster development of innovative therapies targeting HPV-related cancers.

Precigen’s PAPZIMEOS therapy is transforming the lives of adults with recurrent respiratory papillomatosis, eliminating endless surgeries.

What PRECIGEN, INC. changed in their own words, quarter over quarter.

In the second quarter of 2026, Precigen reported remarkable growth driven by PAPZIMEOS, showcasing the company's strong commercial momentum and expanding reach.

Precigen meldet überraschenden Quartalsgewinn dank starkem PAPZIMEOS-Absatz. Die Gentherapie etabliert sich als Standard und treibt das Wachstum.

Precigen (Nasdaq: PGEN) reported second quarter 2026 net product revenue of $53.1 million from PAPZIMEOS, more than double the prior quarter, driving total revenue to $55.0 million and net income of $20.1 million ($0.05 diluted EPS) versus a prior-year net loss of $26.6 million.For the first six months of 2026, total revenue reached $78.2 million, including $74.7 million from PAPZIMEOS, generating net income of $12.1 million compared with a $80.8 million loss a year earlier. Cash, cash equivalents and investments totaled $38.7 million at June 30, 2026, and, according to Precigen, together with anticipated PAPZIMEOS revenue are expected to fund operations through cash flow break-even by year-end 2026.PAPZIMEOS adoption includes well over 500 patient hub enrollments, payer coverage across about 315 million US lives, a permanent J-code (J3404), and seven-year FDA market exclusivity. An EMA marketing application is under review and a redosing study is enrolling.

The Food and Drug Administration approved Papzimeos (zopapogene imadenovec-drba) for the treatment of adults with recurrent respiratory papillomatosis (RRP).

Precigen, Inc. (Nasdaq: PGEN), a commercial-stage biopharmaceutical company specializing in the advancement of innovative precision medicines to improve the lives of patients, today announced updated long-term follow-up data from the pivotal study of PAPZIMEOS™ (zopapogene imadenovec-drba) for the treatment of adults with recurrent respiratory papillomatosis (RRP).

Precigen, Inc. (Nasdaq: PGEN), a commercial-stage biopharmaceutical company specializing in the advancement of innovative precision medicines to improve the lives of patients, today announced the publication of a new expert consensus paper sponsored by the Recurrent Respiratory Papillomatosis Foundation (RRPF) and authored by 16 leading physicians in the field of recurrent respiratory papillomatosis (RRP) has been published in The Laryngoscope, one of the field's most respected peer-reviewed jou

Precigen, Inc. (Nasdaq: PGEN), a biopharmaceutical company specializing in the advancement of innovative precision medicines to improve the lives of patients, today announced that the US Food and Drug Administration (FDA) has approved PAPZIMEOS™ (zopapogene imadenovec-drba) for the treatment of adults with recurrent respiratory papillomatosis (RRP).

The U.S. Food and Drug Administration has approved Papzimeos (zopapogene imadenovec-drba) for the treatment of adults with recurrent respiratory papillomatosis (RRP).

Precigen has won approval in the US for a first-in-class immunotherapy for recurrent respiratory papillomatosis, Papzimeos, its first product.

Papzimeos is the first FDA-approved therapy for recurrent respiratory papillomatosis, a rare HPV-driven disease that has long forced patients into repeated surgeries.