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DURHAM, N.C. - Precision BioSciences, Inc. (NASDAQ:DTIL), a gene editing company currently trading at $5.04 and showing a 32% year-to-date gain, has received U.S. Food and Drug Administration (FDA) clearance for its Investigational New Drug (IND) application for PBGENE-HBV. According to InvestingPro analysis, the company appears undervalued, making it a potentially interesting watch for investors following undervalued biotech opportunities. This IND clearance allows the company to expand its Phase 1 ELIMINATE-B study to the United States, adding to the clinical sites already active in Moldova, Hong Kong, and New Zealand.
PBGENE-HBV is the first in vivo gene editing therapy designed to potentially cure chronic hepatitis B by targeting cccDNA, the persistent form of the virus in liver cells, and inactivating integrated HBV DNA. The company has reported promising initial safety and efficacy data from the lowest dose level in the ongoing ELIMINATE-B trial.
The trial’s expansion into the U.S. is significant, as over one million Americans live with chronic hepatitis B, a disease that has not seen a substantial decrease in prevalence over the past 15 years. With a solid current ratio of 9.22 and more cash than debt on its balance sheet, Precision BioSciences appears well-positioned to fund this expansion. InvestingPro data reveals 8 additional key financial metrics and insights available to subscribers. The ELIMINATE-B study is set to begin patient enrollment at the Liver Center at Massachusetts General Hospital, as part of the company’s global development strategy.
Precision BioSciences plans to escalate the dosage in upcoming trial cohorts to determine the optimal dose for effectively targeting the virus without causing undue harm. The company also intends to extend the study to the United Kingdom and continue to recruit a genetically diverse patient population.
The significance of this regulatory milestone is underscored by the global burden of hepatitis B, which affects an estimated 300 million people worldwide. Current treatments primarily manage the symptoms and reduce viral replication but do not offer a cure, often requiring lifelong administration. PBGENE-HBV represents a potentially transformative approach to treating a disease that can lead to serious complications, including liver cancer and cirrhosis.
Chronic hepatitis B is a major cause of morbidity and mortality, and the development of PBGENE-HBV aligns with Precision BioSciences’ mission to address diseases with high unmet needs using its ARCUS genome editing platform. The company’s approach has been characterized by its ability to perform sophisticated gene edits, which may lead to more defined therapeutic outcomes compared to other technologies.
This announcement is based on a press release statement from Precision BioSciences. Further clinical data from the ELIMINATE-B trial is expected to be shared throughout 2025. With analysts forecasting profitability this year and a strong revenue growth of 43.6% in the last twelve months, investors seeking detailed analysis can access comprehensive financial health scores and forecasts through InvestingPro, which currently rates the company’s overall financial health as "GOOD" with a score of 2.71 out of 5.
In other recent news, Precision BioSciences has reported promising results from its gene editing trials, with significant attention on its ARCUS platform. The company announced initial findings from the ELIMINATE-B study, which evaluates PBGENE-HBV, a therapy for chronic hepatitis B, revealing notable antiviral activity and a favorable safety profile. Additionally, a successful clinical response was observed in a Phase 1/2 trial for Ornithine Transcarbamylase deficiency, conducted by partner iECURE, further boosting confidence in the ARCUS technology. Following these developments, H.C. Wainwright maintained a Buy rating with a $60 price target, while BMO Capital upgraded the stock from Market Perform to Outperform, setting a $34 price target. Precision BioSciences also projects a strong cash position, with approximately $108.5 million reported as of December 31, 2024, and an expected operational runway into the second half of 2026. The company received $2.5 million from TG Therapeutics and anticipates further cash inflows, supporting the advancement of its programs. In governance news, Dr. Sam Wadsworth announced his retirement from the Board of Directors, effective January 23, 2025. Precision BioSciences’ recent developments reflect a positive trajectory in its financial and clinical endeavors.
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