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BOSTON - Entrada Therapeutics, Inc. (NASDAQ:TRDA), a biotechnology company with a market capitalization of $271 million, has obtained the green light from health authorities in multiple European Union countries to commence a clinical study for a Duchenne muscular dystrophy (DMD) treatment, the company announced today. The news comes as the company’s stock has experienced a significant decline, falling over 61% in the past six months.According to InvestingPro data, analysts maintain a bullish outlook with price targets ranging from $20 to $30, suggesting substantial upside potential from current levels. The authorization, under the European Union Clinical Trial Regulation (EU-CTR), paves the way for the Phase 1/2 multiple ascending dose (MAD) clinical study, named ELEVATE-45-201, to begin in the third quarter of 2025.
ELEVATE-45-201 will investigate the safety, tolerability, and effectiveness of ENTR-601-45, a drug designed for DMD patients who are amenable to exon 45 skipping. The study is set to enroll approximately 24 ambulatory patients and will be conducted in two parts. The first part will focus on determining the safety and optimal dosing, while the second part will assess the efficacy of the drug, including its impact on patients’ functional outcomes and quality of life.
DMD is a rare genetic disorder characterized by progressive muscle degeneration and weakness due to the absence of dystrophin, a protein that helps keep muscle cells intact. ENTR-601-45, an investigational therapy, is aimed at restoring the mRNA reading frame, potentially allowing for the production of a functional, albeit slightly shortened, dystrophin protein.
ENTR-601-45 is part of Entrada’s broader DMD franchise which includes other exon-skipping drug candidates. The company’s approach involves the use of its proprietary Endosomal Escape Vehicle (EEV™) technology to deliver therapeutics into cells, targeting diseases that have traditionally been challenging to treat.
The upcoming trial is a significant step for Entrada, following the recent Medicines and Healthcare Products Regulatory Agency authorization in the United Kingdom. With a focus on addressing a substantial unmet medical need within the DMD community, the company is poised to potentially expand its treatment offerings for the disease.
The press release makes clear that these developments are part of Entrada’s strategic plan to advance its pipeline of EEV-therapeutics, with the goal of providing new treatment options for patients with neuromuscular and ocular diseases, among others. The company maintains a strong financial position with more cash than debt and a remarkably high current ratio of 21.88, though InvestingPro analysis indicates the company is quickly burning through its cash reserves.Want deeper insights? InvestingPro subscribers have access to over 10 additional key metrics and ProTips that could help evaluate Entrada’s investment potential.
This article is based on a press release statement and aims to present the key facts regarding Entrada Therapeutics’ upcoming clinical trial and the potential implications for DMD treatment. Based on InvestingPro’s Fair Value analysis, the stock currently appears to be trading near its fair value, with analysts anticipating a sales decline in the current year.
In other recent news, Entrada Therapeutics has received clearance from the U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA) to initiate a Phase 1/2 study for its investigational drug ENTR-601-45. This study, known as ELEVATE-45-201, is designed to assess the safety and efficacy of the treatment in patients with Duchenne muscular dystrophy (DMD) who have a specific mutation. The trial will be conducted in two parts, evaluating multiple ascending doses and optimizing dosing based on functional outcomes. This development comes as William Blair maintains an Outperform rating for Entrada, highlighting the significance of ENTR-601-45’s entry into clinical studies.
Meanwhile, Oppenheimer has reiterated its Outperform rating and a $30 price target for Entrada Therapeutics. This follows the company’s recent regulatory progress, including the MHRA’s approval for the ELEVATE-45-201 study and the lifting of a clinical hold by the U.S. FDA for related studies. Roth/MKM also maintained a Buy rating with a $23 price target, citing strong preclinical data and positive Phase 1 human volunteer study outcomes for Entrada’s DMD programs. The firm’s confidence is reflected in the potential market success of Entrada’s exon-skipping therapies.
H.C. Wainwright continues to express a positive outlook on Entrada Therapeutics, maintaining a Buy rating and a $20 price target. The analyst emphasized the safety concerns associated with gene therapies, following a patient fatality linked to a competitor’s treatment, and noted the potential of Entrada’s exon-skipping therapies as safer alternatives. These recent developments underscore the company’s progress in advancing its DMD-focused pipeline and its strategic plans to conduct studies in the U.K. and EU, with the aim of supporting future U.S. registrational studies.
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