Entrada Therapeutics, Inc. - TRDA STOCK NEWS

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.

Entrada Therapeutics (Nasdaq: TRDA) presented new data supporting its Duchenne franchise at the 29th Annual Congress of the World Muscle Society. The company shared additional positive data from its completed Phase 1 trial of ENTR-601-44, reinforcing its safety profile and supporting planned Q4 2024 global regulatory filings for a Phase 2 trial. Preclinical data for ENTR-601-45 showed exon skipping and dystrophin production, supporting planned Q4 2024 regulatory filings for a global direct-to-patient Phase 2 trial.

Key highlights include:

• No adverse findings or clinically relevant changes to renal toxicity biomarkers at the highest dose tested for ENTR-601-44
• Statistically significant differences in exon skipping between 6 mg/kg and placebo administrations
• ENTR-601-45 produced robust dose-dependent exon skipping and dystrophin restoration in preclinical models
• Improved skeletal muscle function in an exon 45 skip-amenable DMD mouse model

Entrada Therapeutics, Inc. (Nasdaq: TRDA), a clinical-stage biopharmaceutical company, has promoted Natarajan Sethuraman, PhD, to President of Research and Development. Dr. Sethuraman, previously the Chief Scientific Officer, has been with Entrada since its inception and has played a important role in advancing the company's ENTR-601-44 program into clinical trials. His leadership has been instrumental in building Entrada's pipeline of proprietary intracellular therapeutics.

CEO Dipal Doshi praised Dr. Sethuraman's contributions, highlighting his experience in end-to-end therapeutics development. Dr. Sethuraman expressed excitement about Entrada's approach to intracellular therapeutics and the potential to reach previously inaccessible targets. He joined Entrada in 2017 and has since led global research and clinical development, building an R&D team advancing a portfolio of programs from discovery through clinical development.

āshibio, a clinical-stage biotech company, has appointed Dipal Doshi to its Board of Directors. Doshi, currently CEO of Entrada Therapeutics (NASDAQ: TRDA), brings extensive experience in biopharmaceutical strategy and growth. āshibio, which emerged from stealth mode in June 2024 with $40 million in seed and Series A funding, is developing therapies for bone and connective tissue disorders, including a potential treatment for fibrodysplasia ossificans progressiva (FOP).

Doshi's appointment is expected to contribute significantly to āshibio's next growth phase, leveraging his operational and fundraising expertise. His track record includes advancing Entrada's pipeline, completing private financings, leading its IPO, and executing a major business development collaboration.

Entrada Therapeutics (NASDAQ: TRDA) reported positive Q2 2024 financial results and clinical progress. Key highlights include:

1. Positive Phase 1 data for ENTR-601-44 in DMD, showing dose-dependent plasma and muscle concentration, and exon skipping.

2. Planning for global Phase 2 trials for ENTR-601-44 and ENTR-601-45, with regulatory filings expected in Q4 2024.

3. Completed a $100 million registered direct offering, extending cash runway into 2027.

4. Strong financial position with $470 million in cash and equivalents as of June 30, 2024.

5. Q2 collaboration revenue of $94.7 million, up from $18.2 million in Q2 2023.

6. Net income of $55.0 million for Q2 2024, compared to a net loss of $25.9 million in Q2 2023.