Top 5 NASDAQ Biotech Stocks of 2023

Year-to-date gain: 321.76 percent; market cap: US$296.13 million; share price: US$6.80

TScan Therapeutics is developing T-cell receptor-engineered therapies (TCR-T) for the treatment of patients with cancer. Its lead TCR-T therapy candidates are TSC-100 and TSC-101, which are intended for patients with hematologic malignancies. Multiplexed TCR-T therapy candidates for the treatment of various solid tumors are also in TScan’s development pipeline.

In May, TScan and biopharma giant Amgen (NASDAQ:AMGN) announced a multi-year collaboration agreement under which they will use TScan’s proprietary target discovery platform, TargetScan, to identify the antigens recognized by T-cells in patients with Crohn’s disease. At various points this past year, the clinical-stage biotech company also announced US Food and Drug Administration (FDA) clearance for five investigational new drug (IND) applications: T-Plex, TSC-204-A0201 and TSC-204-C0702 for solid tumors; TSC-200-A0201, which is targeting HPV16 to treat solid tumors; and TSC-203-A0201, which is geared at PRAME, or preferentially expressed antigen in melanoma.

Before the year is out, the company plans to complete two more IND applications and report interim clinical data for its TSC-100 and TSC-101 program. TScan’s share price reached its highest point in 2023 on November 30, hitting US$7.15.

Year-to-date gain: 229.17 percent; market cap: US$338.42 million; share price: US$7.92

Immunome has a proprietary platform for identifying novel therapeutic antibodies and their targets by leveraging components of the immune system — known as human memory B cells — from patients who have learned to fight off their disease. The company has a collaboration agreement with AbbVie (NYSE:ABBV) to identify up to 10 novel target-antibody pairs using Immunome’s proprietary Discovery Engine human memory B cell technology platform.

In October, Immunome completed a merger with Morphimmune, a private biotech firm developing targeted oncology therapeutics, along with a US$125 million private placement with leading institutional investors.

“This merger is an essential step in establishing a preeminent oncology company,” said Dr. Clay B. Siegall, Immunome’s chairman and CEO. “We believe that we are well positioned to advance our current oncology pipeline into the clinic, build upon the pipeline through our technology platform and proprietary toolbox, and expand our portfolio through strategic transactions focused on clinical and preclinical assets.”

This NASDAQ biotech stock hit a yearly high of US$9.52 on October 17.

Year-to-date gain: 215.09 percent; market cap: US$218.77 million; share price: US$3.28

Mereo BioPharma is a clinical-stage biopharmaceutical company focused on rare diseases and cancer.

The most advanced product candidate in the company’s pipeline is setrusumab for the treatment of osteogenesis imperfecta (OI). The FDA has granted setrusumab an orphan drug designation and a pediatric disease designation for OI. The European Medicines Agency has also granted setrusumab an orphan drug designation, as well as a PRIME designation that supports the development of medicines that target an unmet medical need.

Part of Mereo’s focus this year has been late-stage clinical trials of setrusumab in pediatric and young adult OI patients. They are being completed through the company’s partnership with Ultragenyx Pharmaceutical (NASDAQ:RARE).

The first patients for both trials were dosed in July, and in October Mereo and Ultragenyx announced that interim data from the Phase 2 portion of the Phase 2/3 Orbit study on young adults showed that treatment with setrusumab significantly reduced fractures in patients with at least six months of follow up. The patients also showed improvements in lumbar spine bone mineral density. Mereo’s share price hit its highest point in 2023 on November 7, reaching US$2.39.

Year-to-date gain: 118.77 percent; market cap: US$100.33 million; share price: US$5.05

Immix Biopharma is developing personalized therapies for oncology and immunology. The lead cell therapy in its pipeline is CAR-T NXC-201 for relapsed/refractory AL Amyloidosis and relapsed/refractory multiple myeloma. Currently in an ongoing Phase 1b/2a clinical trial, NXC-201 has an orphan drug designation from the FDA for both these indications.

In late November, the clinical-stage biotech company announced FDA clearance for its IND application for NXC-201; this will allow for expanded studies of NXC-201 for the treatment of relapsed/refractory AL Amyloidosis.

“Building on encouraging NXC-201 clinical data to-date, we are thrilled that multiple leading U.S. sites are currently planning to enroll patients in the coming months,” said Ilya Rachman, CEO of Immix Biopharma. “No approved treatment options currently exist for relapsed/refractory AL Amyloidosis patients.”

Immix Biopharma’s share price reached a 2023 high of US$5.47 on November 28.

Year-to-date gain: 109.83 percent; market cap: US$204.58 million; share price: US$2.46

Last on this NASDAQ biotech stocks list is Standard BioTools, a leading supplier of biomedical research technologies, including its proprietary mass cytometry and microfluidics technologies. The company’s clients represent a variety of sectors, including academia, government, pharma, biotech, plant and animal research and clinical laboratories.

Standard BioTools is set to soon complete a strategic all-stock merger with proteomics technology firm SomaLogic (NASDAQ:SLGC), a leader in data-driven proteomics technology. In its third quarter financials, Standard BioTools reported instrument sales growth of 47 percent year-to-date and 14 percent over the previous quarter, with total revenue increasing by 10 percent year-to-date despite a 1 percent decline for the quarter.

Shares of Standard BioTools traded at a 2023 peak of US$3.16 on September 1.