5 Top NASDAQ Biotech Stocks of 2024

Year-to-date gain: 465.93 percent
Market cap: US$315.37 million
Share price: US$48.49

Clinical-stage biopharmaceutical company Instil Bio is developing a pipeline of oncology therapies. The company’s primary asset is IMM2510, a differentiated PD-L1xVEGF bispecific antibody aimed at the treatment of multiple solid tumor cancers.

Instil Bio has a definitive agreement for the in-licensing, ex-China development and commercial rights to IMM2510 from China-based ImmuneOnco Biopharmaceuticals (HKEX:1541). The agreement also covers another drug candidate in its pipeline, IMM27M, a next-generation anti-CTLA-4 antibody targeting multiple solid tumors.

In July, the company secured a 15-year lease agreement with AstraZeneca Pharmaceuticals (LSE:AZN) for a cell therapy manufacturing facility based in the United States.

“By executing a 15-year lease of our Tarzana cell therapy manufacturing facility, we have strengthened our financial foundation to support Instil’s near-term clinical development of these assets,” said Instil Bio CEO Bronson Crouch.

In mid-September, Instil Bio and ImmuneOnco announced a global registrational strategy for IMM2510 in combination with chemotherapy in treating non-small cell lung cancer and triple-negative breast cancer. The strategy includes a series of clinical trials to be launched both in the US and China in late 2024 and early 2025.

Instil Bio’s stock surged in September to reach a year-to-date high of US$92.00 on the 13th of the month.

Year-to-date gain: 408.25 percent
Market cap: US$273.53 million
Share price: US$4.94

Late-stage biopharma company Rezolute is developing novel therapies targeting rare and chronic metabolic diseases. At the top of the company’s drug pipeline is RZ358, which is being studied for the treatment of congenital hyperinsulinism and tumor hyperinsulinism. The company also has RZ402, which is targeted for patients with diabetic macular edema.

RZ358 is currently in global Phase 3 clinical studies for congenital hyperinsulinism, with topline data expected in mid-2025. It opened to US participation in September after the US Food and Drug Administration (FDA) removed partial clinical holds.

In March, Rezolute shared results from a preclinical study that validated RZ358’s potential to treat patients with non-islet cell tumors that have uncontrolled hypoglycemia. Rezolute announced positive topline results for its Phase 2 study of RZ402 in May.

The company closed on a public offering with net proceeds of about US$56.4 million in June, which will help to fund post-phase 3 planning for its RZ358 program in congenital hyperinsulinism as well as a potential late-stage, registrational, clinical study of RZ358 in patients with tumor hyperinsulinism associated with islet cell and non-islet cell tumors.

In August, the FDA granted clearance for Rezolute’s investigational new drug application for a Phase 3 study of RZ358 in tumor hyperinsulinism. Patient enrollment is slated to begin in the first half of 2025.

This NASDAQ biotech stock had a great run up in the second quarter this year, posting a year-to-date high of US$6.09 on June 5.

Year-to-date gain: 346.31 percent
Market cap: US$213.52 million
Share price: US$6.66

Candel Therapeutics is another NASDAQ biotech company focused on developing oncology treatments. The company’s pipeline includes two clinical stage multimodal biological immunotherapy platforms.

Candel’s lead product candidate CAN-2409 is in a Phase 2 clinical trial in non-small cell lung cancer and borderline resectable pancreatic cancer, as well as Phase 2 and 3 trials for localized, non-metastatic prostate cancer. Positive interim data for the trial on pancreatic cancer, released on April 4, sent the company's share price spiking upwards.

Its second lead product candidate is CAN-3110, which is in an ongoing Phase 1 clinical trial in recurrent high-grade glioma (HGG).

The company has had a number wins with the FDA this year. In February, Candel’s CAN-3110 received regulatory approval for a fast-track designation for the treatment of recurrent HGG. The agency also granted Candel orphan drug designation for CAN-2409 for the treatment of pancreatic cancer in April and CAN-3110 for HGG in May.

Candel is another NASDAQ biotech stock that had an excellent second quarter this year. After spiking on positive interim trial data for CAN-2409 in April, it continued climbing to hit a year-to-date high of US$14.30 on May 16.

Year-to-date gain: 195.33 percent
Market cap: US$100.7 million
Share price: US$9.48

California-based Benitec Biopharma is advancing novel genetic medicines via its proprietary “Silence and Replace” DNA-directed RNA interference platform. The company is currently focused on developing therapeutics for chronic and life-threatening conditions including oculopharyngeal muscular dystrophy (OPMD). Its drug candidate BB-301 was granted orphan drug designation by the FDA and the European Medicines Agency.

In April, Benitec reported positive interim clinical trial data for its first OPMD subject treated with BB-301 in its Phase 1b/2a study. Following the report, Benitec's share price began trending upward, and reached its then highest point in 2024 on May 20 at US$10.47 before falling back to US6.30 in late June. The company reported additional positive interim safety and efficacy data in mid-July, which boosted its share price once again to US$10.41 on July 16.

Benitec is well-funded to advance its BB-301 clinical development program through the end of 2025. The company's share price hit its highest year-to-date value on October 1 at US$12.89.

Year-to-date gain: 141.01 percent
Market cap: US$137.67 million
Share price: US$1.97

Biopharma company Cardiol Therapeutics is developing novel treatments for inflammation and fibrosis in cardiovascular conditions, including pericarditis, myocarditis, and heart failure.

The company has two drug candidates in its pipeline: CardiolRX, an orally administered cannabidiol under clinically studied for use in rare heart diseases, including recurrent pericarditis and acute myocarditis; and CRD-38, a drug formulation of cannabidiol that is administered subcutaneously for treating heart failure.

The FDA granted CardiolRx orphan drug designation in February. Cardiol released positive top-line results in mid-June for its Phase 2 open-label pilot study investigating the safety, tolerability and efficacy of CardiolRx in patients with recurrent pericarditis. The company believes the results will support moving the drug to Phase 3 clinical trials.

The positive news flow contributed to the strong momentum the stock has enjoyed this year, leading to a year-to-date share price high of US$3.12 on June 12.

An upcoming catalyst for Cardiol is the expected mid-November presentation of full clinical data for its aforementioned Phase 2 open-label study of CardiolRx for recurrent pericarditis.