Entrada Therapeutics, Inc. Stock Price, News & Analysis

Entrada Therapeutics (NASDAQ: TRDA) has granted 23,820 restricted stock units (RSUs) to six new non-executive employees under its 2025 Inducement Equity Plan, effective June 1, 2025. The grants were approved by the Board's Compensation Committee as a material inducement for employment, complying with Nasdaq Rule 5635(c)(4). The vesting schedule includes 25% vesting after one year, followed by quarterly vesting of 6.25% on March 1, June 1, September 1, and December 1 of subsequent years, contingent on continued employment. The RSUs are governed by the Inducement Plan terms approved in March 2025 and individual award agreements.

Entrada Therapeutics (NASDAQ: TRDA) has received EU authorization to begin ELEVATE-45-201, a Phase 1/2 multiple ascending dose clinical study for ENTR-601-45 in patients with Duchenne muscular dystrophy (DMD) amenable to exon 45 skipping. The study, set to begin in Q3 2025, follows recent UK authorization and will be conducted in two parts. Part A will evaluate safety 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 assess the optimal dose for safety and efficacy. The study represents the most advanced clinical trial of a conjugated exon skipping therapy for exon 45 skipping-amenable patients.

Entrada Therapeutics (TRDA) reported Q1 2025 financial results and key business updates. The company received EU regulatory authorization for ELEVATE-44-201, a Phase 1/2 MAD clinical study for ENTR-601-44 in Duchenne muscular dystrophy patients. Entrada maintains a strong financial position with $382.5 million in cash as of March 31, 2025, expecting runway into Q2 2027. Q1 financial results showed collaboration revenue of $20.6M (vs $59.1M in Q1 2024), R&D expenses of $32.1M (vs $28.6M), and a net loss of $17.3M (vs $23.5M net income). The company implemented a strategic plan focusing on DMD clinical candidates, reducing workforce by 20%. Three DMD programs (exon 44, 45, and 50 skip) are expected to enter clinical development by year-end, while partner Vertex continues progressing VX-670 for myotonic dystrophy type 1.

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.