10 Hot Biotech Stocks Under $5

4. Precigen, Inc. (NASDAQ:PGEN)

Potential Upside: 311.77%

Number of Hedge Fund Holders: 10.

Precigen, Inc. (NASDAQ:PGEN) develops gene and cell therapies for cancer, autoimmune disorders, and infectious diseases. The clinical-stage biopharma company uses its UltraCAR-T and AdenoVerse platforms to create innovative treatments, with a special emphasis on immuno-oncology.

Precigen, Inc. (NASDAQ:PGEN) ended Q3 2024 with a robust financial standing bolstered by a $30.9 million public offering in August. Research and development expenses rose $5.7 million (16%) in the first nine months of 2024 versus 2023. This was mainly due to investments in PRGN-2012, the company’s leading gene therapy candidate. SG&A costs held steady at $44.8 million, showing effective cost management. Precigen’s cash reserves, enhanced by the capital raise, fund ongoing clinical work and commercialization efforts. Furthermore, revenue dropped 45% year-over-year due to a decline in the Exemplar segment’s performance, but Precigen remains committed to advancing its high-value therapeutic programs.

A major milestone for Precigen, Inc. (NASDAQ:PGEN) is the FDA’s acceptance of its Biologics License Application (BLA) for PRGN-2012, a gene therapy targeting recurrent respiratory papillomatosis (RRP). The FDA granted priority review with an action date set for August 27, 2025. If approved, PRGN-2012 would be the first FDA-approved RRP treatment, offering an alternative to repeated surgeries. The company is gearing up for a potential market launch, including manufacturing and marketing preparations.

Precigen, Inc. (NASDAQ:PGEN) shares have jumped 73.50% over six months, indicating strong investor confidence. The company is also advancing PRGN-3006 for acute myeloid leukemia and PRGN-3008, a next-generation CD19-targeting therapy for cancer and autoimmune conditions. With a potential FDA approval on the horizon and promising pipeline progress, Precigen stands out as a hot biotech stock worth watching.