12 Best Biotech Penny Stocks To Invest In Now

6. Mereo BioPharma Group plc (NASDAQ:MREO)

Number of Hedge Fund Investors: 25

Stock Price as of December 26: $3.81

Mereo BioPharma Group plc (NASDAQ:MREO) is a clinical-stage biopharmaceutical company dedicated to the discovery, development, and commercialization of innovative therapies for rare diseases. The company has a robust pipeline of drug candidates, including setrusumab, a monoclonal antibody in late-stage development for the treatment of osteogenesis imperfecta (OI).

Mereo BioPharma Group plc (NASDAQ:MREO) is partnering with Ultragenyx Pharmaceutical on the development of setrusumab for the treatment of osteogenesis imperfecta (OI), a genetic disorder characterized by brittle bones that fracture easily. The companies are conducting two pivotal phase 3 studies, ORBIT and COSMIC. These studies are designed to evaluate the efficacy and safety of setrusumab in reducing fracture rates in patients with OI. The ORBIT study compares setrusumab to a placebo, while the COSMIC study compares setrusumab to intravenous bisphosphonates (IV-BP), a current standard of care. Positive 14-month data from the phase 2/3 ORBIT study has shown a significant and sustained reduction in fracture rates, providing a strong foundation for the ongoing phase 3 trials.

The potential for interim analyses in the phase 3 studies of setrusumab represents a significant opportunity for Mereo BioPharma Group plc (NASDAQ:MREO). If certain p-value thresholds are met, interim analyses could provide early insights into the drug’s efficacy, potentially accelerating the development timeline. Regardless of the interim analysis outcomes, the final data analysis is scheduled for Q4 2025, which will be a critical milestone for the company. A positive final readout could pave the way for regulatory submissions and, ultimately, the approval of setrusumab, addressing a significant unmet need in the OI market, which is projected to reach $873.81 million by 2031.