Regeneron and Tessera Announce 50/50 Gene‑Editing Partnership for Alpha‑1 Antitrypsin Deficiency

REGN
December 01, 2025

Regeneron Pharmaceuticals and Tessera Therapeutics have entered into a global collaboration that will develop and commercialize TSRA‑196, Tessera’s lead in‑vivo gene‑writing program for alpha‑1 antitrypsin deficiency (AATD). The deal provides Regeneron with a $150 million upfront payment—comprising cash and equity—and gives Tessera the right to receive up to $125 million in milestone payments. Both companies will share worldwide development costs and future profits on a 50/50 basis, with Tessera leading the first‑in‑human trial and Regeneron taking charge of subsequent global development and commercialization.

Regeneron’s move expands its gene‑editing pipeline into a rare monogenic disease, complementing its existing VelocImmune‑based biologics and other gene‑editing collaborations with Mammoth Biosciences and Intellia Therapeutics. Tessera’s “Gene Writing” platform delivers permanent genomic edits without viral vectors, a technology that could offer a durable, one‑time treatment for the estimated 200,000 patients in the United States and Europe who suffer from AATD. The partnership positions Regeneron to tap a sizable unmet medical need while leveraging its global development and commercialization infrastructure.

Regeneron’s recent financial performance underpins the partnership. In Q3 2025, the company reported revenue of $3.75 billion—up 2.5 % from the prior quarter—and a non‑GAAP EPS of $11.83, beating analyst expectations of $9.78 by $2.05, or 21 %. The earnings beat was driven by strong sales of Dupixent and disciplined cost management, which allowed Regeneron to maintain healthy margins despite a modest increase in operating expenses. The robust cash position and earnings momentum give Regeneron the financial flexibility to fund the $150 million upfront payment and support the joint development program.

Preclinical data for TSRA‑196 show robust editing efficiency and a favorable safety profile in relevant animal models, with editing rates exceeding 70 % in target tissues and no off‑target activity detected in deep sequencing assays. The data suggest that the therapy could correct the underlying genetic defect in AATD patients, potentially eliminating the need for lifelong protein replacement infusions. In the competitive landscape, only a handful of gene‑editing candidates are in early clinical stages, and none have a non‑viral delivery platform comparable to Tessera’s. Regeneron’s partnership therefore gives it a first‑mover advantage in a niche but high‑impact therapeutic area.

George D. Yancopoulos, President and Chief Scientific Officer of Regeneron, said the collaboration “offers a unique opportunity to pioneer a durable, one‑time treatment for a serious disease with limited options.” Michael Severino, CEO of Tessera, added that the partnership “accelerates the clinical development of TSRA‑196 and expands its potential impact to patients in need.” Together, the companies aim to bring a transformative therapy to market, leveraging Regeneron's global reach and Tessera’s innovative gene‑writing technology.

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