Entrada Therapeutics reports clinical-stage biopharmaceutical developments tied to its intracellular genetic-medicine platform and Endosomal Escape Vehicle therapeutics. Company updates center on RNA-based and oligonucleotide programs for neuromuscular and inherited retinal diseases, including Duchenne muscular dystrophy programs for exon 44, 45, 50 and 51 skipping-amenable patients.
Recurring news includes clinical data and study progress for ELEVATE programs, updates on ENTR-601-44 and other DMD candidates, the partnered VX-670 program for myotonic dystrophy type 1, and pipeline expansion into ocular disease such as Usher syndrome. Financial results, cash runway commentary, investor conference participation and Nasdaq inducement equity grants also appear in company communications.
Entrada Therapeutics (Nasdaq: TRDA) announced the granting of equity incentives to seven new non-executive employees under its 2025 Inducement Equity Plan. The grants include 54,360 restricted stock units (RSUs) and options to purchase 38,850 shares at an exercise price of $5.47 per share.
The options will vest over four years, with 25% vesting after one year and the remaining 75% vesting monthly over three years. The RSUs will vest 25% after one year, followed by quarterly vesting of 6.25% on specified dates. All grants are subject to continued employment and were approved as material inducements under Nasdaq Listing Rule 5635(c)(4).
Entrada Therapeutics (Nasdaq: TRDA) reported Q2 2025 financial results and clinical progress. The company achieved significant milestones in its Duchenne muscular dystrophy (DMD) programs, with the first patient dosed in ELEVATE-44-201 and initiation of ELEVATE-45-201. Financial highlights include $354 million in cash providing runway into Q2 2027, though the company reported a net loss of $43.1 million compared to $55.0 million net income in Q2 2024.
The company strengthened its leadership team with key appointments and advanced multiple clinical programs across the UK, EU, and US. Data from the first patient cohort of ELEVATE-44-201 is expected in H1 2026, while ELEVATE-45-201 is set to dose its first patient in Q3 2025. Entrada also plans regulatory submissions for ELEVATE-50 in Q4 2025 and ELEVATE-51 in 2026.
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.