Precigen Stock Up 280% in a Year — Is FDA Approval Behind This Big New Investor Bet?

On November 14, San Diego-based Tang Capital Management disclosed a new position in Precigen (NASDAQ:PGEN), adding approximately $40.8 million, or 12.4 million shares, per SEC filings.

What Happened

According to a filing with the U.S. Securities and Exchange Commission dated November 14, Tang Capital Management established a new position in Precigen (NASDAQ:PGEN), acquiring 12.4 million shares valued at about $40.8 million as of September 30. This new holding accounts for 1.6% of the fund’s approximately $2.6 billion in reportable U.S. equity assets.

What Else to Know

Top five fund holdings after the filing:

• NASDAQ: TARS: $145.9 million (5.6% of AUM)
• NASDAQ: GLPG: $143.8 million (5.5% of AUM)
• NASDAQ: AUPH: $125.2 million (4.8% of AUM)
• NASDAQ: PTCT: $92.1 million (3.5% of AUM)
• NASDAQ: MIRM: $90.6 million (3.5% of AUM)

As of Tuesday, PGEN shares were priced at $3.48, up a staggering 282% over the past year and well outperforming the S&P 500, which is up 13% in the same period.

Company Overview

Company Snapshot

• Precigen develops gene and cellular therapies, disease-modifying therapeutics, and biotechnological platforms such as UltraVector, Sleeping Beauty, and UltraCAR-T.
• The company generates revenue through the development and licensing of proprietary genetic engineering technologies, as well as collaboration and license agreements with industry partners.
• It targets pharmaceutical and biotechnology companies, healthcare providers, and research institutions seeking advanced genetic and cell therapy solutions.

Precigen operates at the forefront of biotechnology, leveraging proprietary platforms to develop next-generation gene and cell therapies. The company’s strategy centers on innovation in genetic engineering, supported by a portfolio of advanced tools and collaborative agreements with key industry players. With a focus on disease-modifying therapeutics and engineered solutions, Precigen aims to address unmet medical needs and establish a competitive edge in the evolving healthcare landscape.

Foolish Take

A move into a company as volatile as Precigen signals a high-conviction bet on a true inflection point—and the FDA approval of PAPZIMEOS in August looks exactly like that. The gene-therapy developer has spent years rebuilding after a 95% collapse from its 2015 peak, but its first commercial product is now rolling out with unusually strong early demand. More than 100 patients have already enrolled in the PAPZIMEOS Patient Hub, and Precigen says its cash position should fund operations to breakeven.

According to the latest SEC filing, Tang Capital Management opened a new position in Precigen, purchasing 12.4 million shares worth roughly $40.8 million as of September 30. The position represents 1.6% of Tang’s $2.6 billion in U.S. equity assets—notable for a fund already heavily concentrated in commercial-stage biotech names like Tarsus, Galapagos, and Aurinia.

Financially, Precigen remains deep in the red—reporting a third-quarter net loss attributable to common shareholders of $325 million, driven largely by non-cash items connected to warrant liabilities and preferred share conversion. But operational momentum is real: PAPZIMEOS is the first FDA-approved therapy for recurrent respiratory papillomatosis, launched with a broad label and no confirmatory-trial requirement, and long-term data show durable responses through 36 months. Ultimately, Precigen is still risky, but commercial execution and regulatory tailwinds may finally be shifting the trajectory of a stock that has spent nearly a decade trying to recover.

Glossary

Assets under management (AUM): The total market value of investments managed on behalf of clients by a fund or firm.

13F assets: U.S. equity securities that institutional investment managers must report quarterly to the U.S. Securities and Exchange Commission on Form 13F.

Alpha: A measure of an investment's performance compared to a benchmark, representing excess return above the benchmark.

Trailing twelve months (TTM): The 12-month period ending with the most recent quarterly report.

Net loss: When a company's total expenses exceed its total revenues over a specific period.

Reportable assets: Investments that must be disclosed to regulators, typically those included in regulatory filings like Form 13F.

Gene and cellular therapies: Medical treatments that modify genes or use living cells to treat or prevent diseases.

Biotechnological platforms: Proprietary systems or technologies used to develop advanced biological products or therapies.

Collaboration and license agreements: Contracts allowing companies to jointly develop, use, or sell proprietary technologies or products.

Market capitalization: The total value of a company's outstanding shares, calculated as share price times number of shares.

Proprietary platforms: Unique, company-owned technologies or systems not available to competitors.

Disease-modifying therapeutics: Treatments designed to alter the course or progression of a disease, not just its symptoms.

Jonathan Ponciano has no position in any of the stocks mentioned. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy.