Welcome to our dedicated page for Entrada Therapeutics news (Ticker: TRDA), a resource for investors and traders seeking the latest updates and insights on Entrada Therapeutics stock.
Entrada Therapeutics, Inc. (Nasdaq: TRDA) is a clinical-stage biopharmaceutical company developing RNA- and protein-based medicines using its Endosomal Escape Vehicle (EEV™) technology. The news flow around Entrada centers on its neuromuscular and ocular pipelines, corporate updates and collaboration activities.
Investors following TRDA news can track detailed updates on the company’s Duchenne muscular dystrophy (DMD) franchise, including the ELEVATE-44-201 and ELEVATE-45-201 global Phase 1/2 multiple ascending dose studies of ENTR-601-44 and ENTR-601-45, and the planned development of ENTR-601-50 and ENTR-601-51. Company announcements describe milestones such as first patient dosing, cohort completion, regulatory authorizations in the U.K. and EU, and expectations for future data readouts.
News releases also highlight Entrada’s expansion into ocular and metabolic diseases, including preclinical progress and the nomination of ENTR-801 as the first ocular clinical candidate for Usher syndrome type 2A. Additional coverage includes updates on the VX-670 collaboration for myotonic dystrophy type 1, quarterly financial results furnished via Form 8-K, inducement equity grants under Nasdaq Listing Rule 5635(c)(4), leadership appointments and participation in healthcare and investor conferences.
By reviewing Entrada Therapeutics news, readers can follow how the company reports on its clinical-stage programs, regulatory interactions, financial position and patient-focused initiatives such as the DREAMS Grant Program. This page aggregates press releases and related disclosures so that followers of TRDA can see how the pipeline and corporate activities evolve over time.
Entrada Therapeutics (NASDAQ: TRDA) has received authorization from the UK's MHRA to initiate ELEVATE-45-201, a Phase 1/2 multiple ascending dose clinical study for ENTR-601-45 in Duchenne muscular dystrophy (DMD) patients amenable to exon 45 skipping.
The study is structured in two parts: Part A will evaluate safety, pharmacokinetics, and pharmacodynamics in approximately 24 patients across three cohorts, with doses ranging from 5 mg/kg to 15 mg/kg administered every six weeks. Part B will further assess the optimal dose established in Part A. Study participants may be eligible for an open-label extension study.
The company plans to initiate the study in Q3 2025. ELEVATE-45 represents the second of three Duchenne programs Entrada expects to advance into global clinical development in 2025, with regulatory filings already submitted in the EU.
Entrada Therapeutics (NASDAQ: TRDA) reported strong Q4 and full year 2024 results, marking significant progress in their DMD therapeutic programs. The company secured FDA authorization for ELEVATE-44-102 in the US and MHRA authorization for ELEVATE-44-201 in the UK, while submitting regulatory filings for ENTR-601-44 in the EU and ENTR-601-45 in the UK and EU.
Financial highlights include $420 million in cash and equivalents as of December 31, 2024, extending runway into Q2 2027. The company reported collaboration revenue of $210.8 million for 2024, up from $129.0 million in 2023. R&D expenses increased to $125.3 million for 2024, while net income reached $65.6 million, compared to a net loss of $6.7 million in 2023.
Entrada Therapeutics (NASDAQ: TRDA) announced that the FDA has lifted the clinical hold on ENTR-601-44 and authorized the initiation of ELEVATE-44-102, a Phase 1b multiple ascending dose clinical study for treating Duchenne muscular dystrophy (DMD) in adult patients.
The global ELEVATE-44 program, which includes ELEVATE-44-102 in the U.S. and ELEVATE-44-201 outside the U.S., will evaluate patients with both early and advanced disease. The Phase 1b study will involve approximately 32 non-ambulatory and ambulatory adult patients with DMD amenable to exon 44 skipping.
The study will assess safety, tolerability, target engagement, and pharmacokinetics. Dosing will be administered every six weeks across four cohorts, ranging from 0.16 mg/kg to 1.28 mg/kg. Study participants may qualify for an open label extension study. Enrollment is planned to begin in the first half of 2026.
Entrada Therapeutics (TRDA) has received authorization from the UK's MHRA to initiate ELEVATE-44-201, a Phase 1/2 multiple ascending dose clinical study for ENTR-601-44, targeting Duchenne muscular dystrophy (DMD) patients with exon 44 skipping mutations.
The study will be conducted in two parts: Part A will evaluate safety, pharmacokinetics, and pharmacodynamics in approximately 24 patients, with doses ranging from 6 mg/kg to 18 mg/kg administered every six weeks. Part B will further assess the optimal dose established in Part A. The company plans to initiate the study in Q2 2025.
This authorization follows a successful Phase 1 study where ENTR-601-44 showed favorable safety profiles in healthy volunteers, with no serious adverse events and demonstrated significant plasma concentration, muscle concentration, and exon skipping. The company has also submitted regulatory filings in the U.S. and EU.
Azenta (NASDAQ: AZTA) announced the election of Dipal Doshi to its Board of Directors at its Annual Meeting of Stockholders. Doshi, who currently serves as the Chief Executive Officer of Entrada Therapeutics (NASDAQ: TRDA), brings extensive experience in the biotechnology and pharmaceutical industries.
John Marotta, President and CEO of Azenta, highlighted Doshi's exceptional leadership qualities and valuable experience in strategy, operational and commercial growth, along with his perspective as a current public company CEO. Doshi expressed enthusiasm about joining Azenta during a important period in its development, emphasizing the company's strong market leadership position and commitment to growth and innovation.
Entrada Therapeutics (Nasdaq: TRDA), a clinical-stage biopharmaceutical company focused on developing medicines for intracellular targets, has announced its participation in the 43rd Annual J.P. Morgan Healthcare Conference. CEO Dipal Doshi will deliver a presentation on Wednesday, January 15, 2025, at 11:15 a.m. PT (2:15 p.m. ET).
The presentation will be accessible via live webcast on the company's Investor Relations website, with a replay available for 30 days following the event. Entrada's mission centers on transforming patient lives by creating innovative treatments that can reach previously inaccessible intracellular targets.
Entrada Therapeutics (NASDAQ: TRDA) reported Q3 2024 financial results with a net loss of $14.0 million, compared to net income of $35.5 million in Q3 2023. The company reported $449.3 million in cash, cash equivalents and marketable securities, extending runway into 2027. Collaboration revenue decreased to $19.6 million from $43.7 million year-over-year. R&D expenses increased to $31.3 million from $22.2 million, while G&A expenses rose to $10.0 million from $7.5 million.
The company presented additional Phase 1 clinical trial data for ENTR-601-44 and new preclinical data for ENTR-601-45 at the World Muscle Society Congress. Global regulatory filings for Phase 2 trials of both compounds are planned for Q4 2024.
FAQ
What is the current stock price of Entrada Therapeutics (TRDA)?
What is the market cap of Entrada Therapeutics (TRDA)?
