Independent Data Monitoring Committee Recommends Initiation of Cohort 2 at the Increased Dose of 12 mg/kg in Entrada Therapeutics’ ELEVATE-44-201 Study

Rhea-AI Summary

Entrada Therapeutics (Nasdaq: TRDA) reported that an independent Data Monitoring Committee recommended initiating Cohort 2 at 12 mg/kg in the ELEVATE-44-201 Phase 1/2 study, up from 6 mg/kg in Cohort 1.

Cohort 1 participants have moved into the open-label Phase 2 portion. The company expects Cohort 1 data in Q2 2026, Cohort 2 data by year-end, and Cohort 3 (up to 18 mg/kg) to follow. In December 2025, the FDA granted Rare Pediatric Disease Designation to ENTR-601-44.

Positive

• DMC recommended Cohort 2 initiation at 12 mg/kg
• Cohort 1 participants progressed to open-label Phase 2
• Company targets Cohort 1 data in Q2 2026
• FDA granted Rare Pediatric Disease Designation in December 2025

Negative

• Cohort 1 safety/PK review based on only 8 patients
• Key efficacy readouts remain pending (Cohort 1 Q2 2026)

Key Figures

Cohort 2 dose: 12 mg/kg Cohort 1 dose: 6 mg/kg Cohort 1 patients: 8 patients +5 more

8 metrics

Cohort 2 dose 12 mg/kg Dose level for ELEVATE-44-201 Cohort 2

Cohort 1 dose 6 mg/kg Dose level for ELEVATE-44-201 Cohort 1

Cohort 1 patients 8 patients Patients completing dosing in Cohort 1 MAD portion

Cohort 3 max dose up to 18 mg/kg Planned maximum dose for ELEVATE-44-201 Cohort 3

Open-label doses 6 doses Open-label Phase 2 portion dosing schedule

Cohort 1 data timing Q2 2026 Planned disclosure of Cohort 1 (6 mg/kg) data

Cohort 2 data timing By end of 2026 Planned disclosure of Cohort 2 (12 mg/kg) data

Rare Pediatric Disease Designation December 2025 FDA designation granted to ENTR-601-44

Market Reality Check

Price: $10.88 Vol: Volume 183,478 is below t...

normal vol

$10.88 Last Close

Volume Volume 183,478 is below the 243,748 20-day average (relative volume 0.75). normal

Technical Trading above its 200-day MA of 7.86, with price at 10.88.

Peers on Argus

TRDA is up 0.74% while only one tracked biotech peer (CGTX) appears in momentum ...

1 Up

TRDA is up 0.74% while only one tracked biotech peer (CGTX) appears in momentum scanners, up 1.79%. Other peers show mixed moves, suggesting today’s action leans stock-specific rather than a coordinated sector move.

Historical Context

5 past events · Latest: Feb 04 (Neutral)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Feb 04	Investor conferences	Neutral	-8.2%	Announced CEO presentations at two upcoming investor conferences with webcasts.
Jan 08	Pipeline progress	Positive	-2.1%	Outlined progress across neuromuscular and ocular RNA programs and 2026 milestones.
Dec 17	Conference appearance	Neutral	-1.3%	Planned presentation at the 44th Annual J.P. Morgan Healthcare Conference.
Dec 04	Inducement grants	Neutral	+1.6%	Granted RSUs and stock options to new hires under inducement equity plan.
Nov 06	Q3 2025 earnings	Neutral	+0.1%	Reported Q3 2025 financials and DMD pipeline updates with cash runway into Q3 2027.

Pattern Detected

Recent TRDA headlines, including portfolio progress and conference appearances, often saw negative or muted price reactions, with only two of the last five events modestly aligning positively with the news.

Recent Company History

Over the last several months, Entrada highlighted cash runway into Q3 2027, advanced multiple DMD programs, and maintained an active presence at major investor conferences. A Q3 10‑Q detailed higher R&D spending and a larger net loss as clinical activity expanded. Today’s ELEVATE‑44‑201 dose-escalation update follows prior disclosures that Cohort 1 dosing was completed and that first data from this study are expected in Q2 2026, reinforcing the same clinical trajectory.

Regulatory & Risk Context

Active S-3 Shelf · $400,000,000

Shelf Active

Active S-3 Shelf Registration 2025-11-06

$400,000,000 registered capacity

An effective Form S-3 shelf filed on Nov 06, 2025 allows Entrada to offer up to $400,000,000 in various securities, including a $150,000,000 ATM program, for general corporate purposes such as R&D and working capital. No usage of this shelf or ATM has been recorded yet in the provided context.

Market Pulse Summary

This announcement details a favorable safety review enabling dose escalation of ENTR-601-44 from 6 m...

Analysis

This announcement details a favorable safety review enabling dose escalation of ENTR-601-44 from 6 mg/kg to 12 mg/kg and progression of ELEVATE‑44‑201 into Phase 2. It reinforces earlier disclosures about Cohort 1 completion and upcoming data in Q2 2026 and year-end. Investors may track execution against these timelines, monitor future cohort results, and consider the existing $400,000,000 shelf and $150,000,000 ATM when assessing funding flexibility.

Key Terms

independent data monitoring committee, multiple ascending dose, double-blinded, placebo-controlled, +4 more

8 terms

independent data monitoring committee medical

"an independent Data Monitoring Committee (DMC), per study protocol, has reviewed"

A panel of independent medical, statistical and ethical experts who review ongoing clinical trial data to judge participant safety, study integrity and whether the trial should continue, change or stop. Like impartial referees or safety inspectors, their decisions can speed, delay or halt a drug’s development and therefore materially affect a company’s timelines, regulatory chances and investment risk.

multiple ascending dose medical

"double-blinded, placebo-controlled, multiple ascending dose (MAD) portion of"

A multiple ascending dose is a method used in testing new medicines where small groups of people receive gradually larger amounts of the drug over time. This approach helps researchers find the safest and most effective dose without causing too many side effects. For investors, it signals ongoing steps in drug development that can impact a company's potential success or approval prospects.

double-blinded technical

"double-blinded, placebo-controlled, multiple ascending dose (MAD) portion"

A double-blinded study is a test where neither the participants nor the people administering the treatments know who is getting which version, so expectations can't influence the results. For investors, that fairness check makes clinical or product test results more reliable—think of it like a blind taste test where both the taster and server are kept unaware—so positive outcomes from double-blinded studies carry more weight for valuation and regulatory confidence.

placebo-controlled technical

"double-blinded, placebo-controlled, multiple ascending dose (MAD) portion"

"Placebo-controlled" describes a testing method where one group receives the actual treatment or intervention, while another group receives a harmless, inactive version called a placebo. This approach helps determine whether the real treatment has genuine effects beyond psychological expectations. For investors, understanding this ensures confidence that reported benefits are real and not influenced by bias or false perceptions.

open label technical

"progressed to the open label, Phase 2 portion of ELEVATE-44-201"

Open label is a clinical trial design in which both the participants and the researchers know which treatment or intervention is being given. For investors, this matters because knowledge of the treatment can influence reported effects and side effects—like how seeing a product label can change a shopper’s opinion—so open-label results are useful for safety and real-world experience but are generally viewed as less rigorous evidence of effectiveness than blinded studies.

phase 1/2 medical

"ELEVATE-44-201 is a Phase 1/2 MAD clinical study of ENTR-601-44"

Phase 1/2 is a combined early-stage clinical trial that first tests a new drug or treatment for safety and the right dose, then quickly expands to check if it shows any signs of working in patients. For investors, results from a Phase 1/2 study offer an early read on both risk and potential reward—like a prototype test that both confirms a product won’t harm users and suggests whether it could sell—helping guide valuation and development decisions.

duchenne muscular dystrophy medical

"for the potential treatment of Duchenne muscular dystrophy (DMD) in patients"

A rare, inherited condition that progressively weakens muscles, Duchenne muscular dystrophy causes the body’s muscle fibers to break down over time, often leading to severe disability. For investors, it matters because the small, well-defined patient population, high unmet medical need and complex regulatory and pricing dynamics mean successes or failures in clinical trials, approvals, or therapies can have outsized effects on a company’s valuation and future revenue prospects.

rare pediatric disease designation regulatory

"In December 2025, the U.S. Food and Drug Administration (FDA) granted Rare Pediatric Disease Designation"

A rare pediatric disease designation is an official regulatory status given to a drug or therapy that targets a serious or life‑threatening condition primarily affecting children and is uncommon in the population. It matters to investors because the status often brings financial and development perks — such as tax credits, reduced fees, faster review and periods of market protection — which can lower costs, speed approval and improve the commercial outlook; think of it as a VIP pass that makes bringing a scarce, child‑focused treatment to market easier and potentially more profitable.

AI-generated analysis. Not financial advice.

-- Patients in Cohort 1 have progressed to the open label, Phase 2 portion of ELEVATE-44-201 --

-- Company on track to report ELEVATE-44-201 Cohort 1 data in Q2 2026, with Cohort 2 data by end of year --

BOSTON, Feb. 17, 2026 (GLOBE NEWSWIRE) -- Entrada Therapeutics, Inc. (Nasdaq: TRDA) today announced that an independent Data Monitoring Committee (DMC), per study protocol, has reviewed all available safety and PK data from the eight patients who completed dosing in Cohort 1 of the double-blinded, placebo-controlled, multiple ascending dose (MAD) portion of ELEVATE-44-201. The DMC recommended initiation of Cohort 2 at 12 mg/kg, a dose escalation from 6 mg/kg in Cohort 1. ELEVATE-44-201 is a Phase 1/2 MAD clinical study of ENTR-601-44 for the potential treatment of Duchenne muscular dystrophy (DMD) in patients with a confirmed mutation in the DMD gene amenable to exon 44 skipping.

“We are pleased that after reviewing the Cohort 1 data from our ELEVATE-44-201 study, the independent Data Monitoring Committee supports the initiation of Cohort 2 dosing at an increased dose of 12 mg/kg,” said Natarajan Sethuraman, PhD, President of Research and Development at Entrada Therapeutics. “Because Entrada’s neuromuscular programs all leverage the same Endosomal Escape Vehicle, we are confident that this study progression substantially de-risks our clinical programs and marks a significant clinical inflection point for our company. Establishing that ENTR-601-44 is safe at 6 mg/kg is a clear milestone for the program. We expect our Cohort 1 data at 6 mg/kg to show double-digit dystrophin production when we disclose the data in the second quarter. As we dose escalate to 12 mg/kg, we believe we will achieve best-in-class dystrophin restoration with the readout of our Cohort 2 data later this year.”

ELEVATE-44-201 is a global, two-part, randomized, double-blind, placebo-controlled Phase 1/2 study evaluating the safety, tolerability and effectiveness of ENTR-601-44 in ambulatory patients with DMD who are exon 44 skipping amenable. The Company completed dosing of the MAD portion of the study for Cohort 1, and participants have transitioned to the 6-dose open label, Phase 2 portion of the study. The Company is on track to report data from Cohort 1 (6 mg/kg) in the second quarter of 2026, data from Cohort 2 (12 mg/kg) by year-end, and data from Cohort 3 (up to 18 mg/kg) to follow. The Company also intends to open an expansion cohort later in the year to increase the number of participants treated in the ELEVATE-44-201 study, as this study has been designed to support an accelerated approval in the U.S. In December 2025, the U.S. Food and Drug Administration (FDA) granted Rare Pediatric Disease Designation to ENTR-601-44.

About Entrada Therapeutics
Entrada Therapeutics is a clinical-stage biopharmaceutical company aiming to transform the lives of patients by establishing a new class of medicines that engage intracellular targets that have long been considered inaccessible. The Company’s Endosomal Escape Vehicle (EEV™)-therapeutics are designed to enable the efficient intracellular delivery of a wide range of therapeutics into a variety of organs and tissues, resulting in an improved therapeutic index. Entrada is advancing a robust development portfolio of RNA- and protein-based programs for the potential treatment of neuromuscular, ocular and other diseases, leveraging next-generation EEVs, novel oligonucleotide sequences and an advanced protein engineering platform. The Company’s lead oligonucleotide programs are in development for the potential treatment of people living with Duchenne muscular dystrophy who are exon 44, 45, 50 and 51 skipping amenable. Entrada has partnered to develop a clinical-stage program, VX-670, for myotonic dystrophy type 1.

For more information about Entrada, please visit our website, www.entradatx.com, and follow us on LinkedIn.

Forward-Looking Statements
This press release contains express and implied forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this press release, including statements regarding Entrada’s strategy, future operations, prospects and plans, objectives of management, the validation and differentiation of Entrada’s approach and EEV platform and its ability to provide a potential treatment for patients, expectations regarding planned Cohort 2 and Cohort 3 of Entrada’s ELEVATE-44-201 study, the timing of data from Entrada’s 1/2 MAD clinical study of ENTR-601-44 including Cohort 1 in the second quarter of 2026, Cohort 2 by year-end, and Cohort 3 to follow, the ability of Entrada to open an expansion cohort for ELEVATE-44-201 in 2026, the ability to recruit for and complete the global Phase 2 clinical study for ENTR-601-44, the ability of Entrada’s ELEVATE-44-201 study to support an accelerated approval in the U.S., the potential therapeutic benefits of Entrada’s EEV product candidates, including the potential for ENTR-601-44 to be a transformative treatment option, for Cohort 1 data at 6 mg/kg to show double-digit dystrophin and to achieve best-in-class dystrophin restoration with the dose escalation to 12 mg/kg for Cohort 2 with the data readout for Cohort 2 later this year, the ability for the ELEVATE-44-201 study progression to substantially de-risk our clinical programs, and the continued development and advancement of ENTR-601-44 for the treatment of DMD, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “objective,” “ongoing,” “plan,” “predict,” “project,” “potential,” “should,” or “would,” or the negative of these terms, or other comparable terminology are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Entrada may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various important factors, including: uncertainties inherent in the identification and development of product candidates, including the conduct of research activities and the initiation and completion of preclinical studies and clinical studies; uncertainties as to the availability and timing of results from preclinical and clinical studies; the timing of and Entrada’s ability to submit and obtain regulatory clearance and initiate clinical studies; whether results from preclinical studies or clinical studies will be predictive of the results of later preclinical studies and clinical studies; whether Entrada’s cash resources will be sufficient to fund the Company’s foreseeable and unforeseeable operating expenses and capital expenditure requirements; as well as the risks and uncertainties identified in Entrada’s filings with the Securities and Exchange Commission (SEC), including the Company’s most recent Form 10-K and in subsequent filings Entrada may make with the SEC. In addition, the forward-looking statements included in this press release represent Entrada’s views as of the date of this press release. Entrada anticipates that subsequent events and developments will cause its views to change. However, while Entrada may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Entrada’s views as of any date subsequent to the date of this press release.

Investor Contact
Karla MacDonald
Chief Corporate Affairs Officer
kmacdonald@entradatx.com

Patient Advocacy Contact
Sarah Friedhoff
Head of Patient Advocacy
patientadvocacy@entradatx.com

Media Contact
Megan Prock McGrath
CTD Comms, LLC
megan@ctdcomms.com

FAQ

What did Entrada (TRDA) announce about ELEVATE-44-201 dosing on Feb 17, 2026?

The DMC recommended starting Cohort 2 at 12 mg/kg, escalating from 6 mg/kg. According to Entrada, this decision followed review of safety and PK data from eight patients who completed Cohort 1 dosing.

When will Entrada (TRDA) report ELEVATE-44-201 Cohort 1 data?

Entrada expects to report Cohort 1 data in Q2 2026, per the company. This readout covers safety, tolerability and dystrophin production for the 6 mg/kg cohort.

What timeline did Entrada (TRDA) give for Cohort 2 and Cohort 3 data in ELEVATE-44-201?

Entrada aims to report Cohort 2 (12 mg/kg) data by year-end 2026 and Cohort 3 (up to 18 mg/kg) thereafter. According to Entrada, these are target timelines contingent on study progress.

How many patients completed dosing in ELEVATE-44-201 Cohort 1 for Entrada (TRDA)?

Eight patients completed dosing in Cohort 1 of the MAD portion. According to Entrada, the DMC reviewed safety and PK data from those eight patients prior to recommending dose escalation.

What regulatory designation does ENTR-601-44 have for Entrada (TRDA)?

ENTR-601-44 received Rare Pediatric Disease Designation from the FDA in December 2025. According to Entrada, this designation may support expedited development pathways.