Entrada Therapeutics reported positive ELEVATE-44-201 results in Duchenne muscular dystrophy, with upcoming data and strong financial position.
Quiver AI Summary
Entrada Therapeutics has announced positive topline results from Cohort 1 of its ELEVATE-44-201 clinical study in Duchenne muscular dystrophy (DMD), highlighting favorable safety and tolerability of the investigational product ENTR-601-44, along with early functional benefits observed in treated participants. With a current cash position of approximately $255 million, positioned to sustain operations into Q3 2027, the company plans to report further data from multiple cohorts of the ELEVATE studies by the end of 2026. Upcoming clinical trials are being carefully evaluated as Entrada continues to advance its neuromuscular disease pipeline, alongside its partnership with Vertex for myotonic dystrophy type 1. The company will host an investor webcast to discuss its recent business updates and financial results for Q1 2026.
Potential Positives
- Announced positive topline results from Cohort 1 of the ELEVATE-44-201 study, demonstrating favorable safety, tolerability, and early functional benefits for the treatment of Duchenne muscular dystrophy (DMD).
- Cash runway expected to extend into Q3 2027, providing financial stability for ongoing and future clinical programs.
- Company on track to report additional data from its clinical studies by the end of 2026, indicating continued progress in its development pipeline.
Potential Negatives
- Collaboration revenue significantly decreased from $20.6 million in Q1 2025 to $0.9 million in Q1 2026, indicating potential difficulties in monetizing partnerships and dependency on successful product outcomes.
- Net loss increased to $39.7 million in Q1 2026 compared to $17.3 million in Q1 2025, raising concerns about the company's financial sustainability and operational efficiency.
- Cash position declined from $295.7 million at year-end 2025 to $254.9 million by March 31, 2026, suggesting increased operational expenditures that could challenge future funding initiatives.
FAQ
What are the recent ELEVATE-44-201 study results?
Recent results show ENTR-601-44 has favorable safety and tolerability, with promising early functional benefits in patients with Duchenne muscular dystrophy.
When will ELEVATE-45-201 data be reported?
Data from the ELEVATE-45-201 Cohort 1 is expected to be reported in mid-2026.
How is Entrada Therapeutics financially positioned?
Entrada has a cash runway projected into Q3 2027, with $255 million in cash and equivalents as of March 31, 2026.
What does Entrada's pipeline include?
Entrada’s pipeline includes clinical programs for Duchenne muscular dystrophy and inherited retinal diseases, among other conditions.
When is the investor webcast scheduled?
The investor webcast is set for May 7, 2026, at 8:30 a.m. ET to discuss the quarterly results and ELEVATE-44-201 data.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
$TRDA Insider Trading Activity
$TRDA insiders have traded $TRDA stock on the open market 27 times in the past 6 months. Of those trades, 16 have been purchases and 11 have been sales.
Here’s a breakdown of recent trading of $TRDA stock by insiders over the last 6 months:
- KUSH PARMAR sold 200,000 shares for an estimated $1,760,000
- VENTURES V, L.P. 5AM sold 200,000 shares for an estimated $1,760,000
- BROS. ADVISORS LP BAKER has made 16 purchases buying 206,911 shares for an estimated $1,614,432 and 0 sales.
- KORY JAMES WENTWORTH (Chief Financial Officer) has made 0 purchases and 5 sales selling 35,875 shares for an estimated $433,577.
- NATHAN J DOWDEN (President & COO) has made 0 purchases and 3 sales selling 30,010 shares for an estimated $425,723.
- NATARAJAN SETHURAMAN (President, Research & Develop.) sold 25,907 shares for an estimated $398,809
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$TRDA Hedge Fund Activity
We have seen 56 institutional investors add shares of $TRDA stock to their portfolio, and 52 decrease their positions in their most recent quarter.
Here are some of the largest recent moves:
- TCG CROSSOVER MANAGEMENT, LLC added 1,503,437 shares (+257.0%) to their portfolio in Q4 2025, for an estimated $15,455,332
- RENAISSANCE TECHNOLOGIES LLC removed 341,665 shares (-57.5%) from their portfolio in Q4 2025, for an estimated $3,512,316
- MILLENNIUM MANAGEMENT LLC removed 338,914 shares (-40.5%) from their portfolio in Q4 2025, for an estimated $3,484,035
- BAKER BROS. ADVISORS LP added 206,911 shares (+4.3%) to their portfolio in Q4 2025, for an estimated $2,127,045
- 5AM VENTURE MANAGEMENT, LLC removed 200,000 shares (-4.7%) from their portfolio in Q4 2025, for an estimated $2,055,999
- JANE STREET GROUP, LLC removed 161,854 shares (-65.4%) from their portfolio in Q4 2025, for an estimated $1,663,859
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$TRDA Analyst Ratings
Wall Street analysts have issued reports on $TRDA in the last several months. We have seen 1 firms issue buy ratings on the stock, and 0 firms issue sell ratings.
Here are some recent analyst ratings:
- HC Wainwright & Co. issued a "Buy" rating on 02/18/2026
To track analyst ratings and price targets for $TRDA, check out Quiver Quantitative's $TRDA forecast page.
$TRDA Price Targets
Multiple analysts have issued price targets for $TRDA recently. We have seen 3 analysts offer price targets for $TRDA in the last 6 months, with a median target of $20.0.
Here are some recent targets:
- Francois Brisebois from Oppenheimer set a target price of $23.0 on 04/06/2026
- Raghuram Selvaraju from HC Wainwright & Co. set a target price of $20.0 on 02/18/2026
- Debjit Chattopadhyay from Guggenheim set a target price of $20.0 on 02/11/2026
Full Release
-- Announced positive ELEVATE-44-201 Cohort 1 topline results in Duchenne muscular dystrophy showing favorable safety, tolerability and early functional benefit --
-- Company on track to report ELEVATE-45-201 Cohort 1 data in mid-2026, as well as ELEVATE-44-201 open-label period and Cohort 2 data by year-end 2026 --
-- Cash runway expected into Q3 2027 with $255 million in cash, cash equivalents and marketable securities as of March 31, 2026 --
-- Entrada to host investor webcast and conference call today, Thursday, May 7, at 8:30 a.m. ET --
BOSTON, May 07, 2026 (GLOBE NEWSWIRE) -- Entrada Therapeutics, Inc. (Nasdaq: TRDA) today reported financial results for the first quarter ended March 31, 2026, and highlighted recent business updates.
“With the recently announced positive data from Cohort 1 of our ELEVATE-44-201 clinical study, this year has already delivered a significant clinical inflection point. Establishing that ENTR-601-44 demonstrated not only favorable safety and tolerability, but early and differentiated functional benefits at 6 mg/kg, is a clear milestone for the program as well as Entrada’s neuromuscular pipeline,” said Dipal Doshi, Chief Executive Officer at Entrada Therapeutics. “With cash runway into the third quarter of 2027, we are well positioned to achieve additional clinical inflection points throughout the year, including data from the first participant cohort of the ELEVATE-45-201 study, as well as the open-label and second cohort of the ELEVATE-44-201 study. The Company is also carefully evaluating the optimal timing for initiating the planned clinical studies of ENTR-601-50 and ENTR-601-51.”
Recent Corporate Highlights
Clinical-Stage Development Pipeline: Entrada continues to advance multiple clinical programs in people living with Duchenne muscular dystrophy (DMD) in the U.K., EU and U.S., complementing the ongoing clinical progress of its myotonic dystrophy type 1 (DM1) partnership (VX-670) with Vertex.
- ELEVATE-44-201: Announced positive topline results from Cohort 1 in the global Phase 1/2 multiple ascending dose (MAD) portion of the clinical study of ENTR-601-44 in ambulatory participants living with DMD who are amenable to exon 44 skipping. Study participants in Cohort 1 received three doses of 6 mg/kg of ENTR-601-44, the lead investigational product in Entrada’s DMD franchise, or placebo. Topline results demonstrated meaningful and potentially differentiated early functional benefits including statistically significant improvement in Time to Rise (TTR) velocity in the majority of participants treated with ENTR-601-44. Results also demonstrated a favorable safety and tolerability profile, all adverse events (AEs) were mild or moderate, there were no reported serious adverse events (SAEs), and no AEs leading to discontinuation from the study. Plasma markers for kidney function were normal. The Company is on track to report data from the Cohort 1 open-label period and Cohort 2 (12 mg/kg) MAD by year-end 2026, with data from Cohort 3 MAD (up to 18 mg/kg) to follow.
- ELEVATE-44-102: The Company believes this clinical study, in the underserved adult patient population with advanced disease, would be best to initiate at the highest advisable starting dose. Following a review of safety, pharmacokinetic and pharmacodynamic data from Cohort 1 of the ELEVATE-44-201 study in the U.K. and EU, the Company plans to re-engage with the FDA to discuss increasing the planned doses in this clinical study. As such, the Company will provide an update on clinical study design and timing following interactions with the FDA.
- ELEVATE-45-201: Completed enrollment and initiated dosing in Cohort 1 of the global Phase 1/2 MAD clinical study of ENTR-601-45 in ambulatory participants living with DMD who are amenable to exon 45 skipping. The Company is on track to report data from Cohort 1 (5 mg/kg) in mid-2026, with data from Cohort 2 and Cohort 3 (up to 10 mg/kg and 15 mg/kg, respectively) to follow.
- ELEVATE-50-201 : The Company received regulatory authorization from the U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA) and Research Ethics Committee to initiate a Phase 1/2 MAD clinical study of ENTR-601-50 in ambulatory participants living with DMD who are amenable to exon 50 skipping. The Company expects to submit additional regulatory applications and obtain authorization in the EU following a review of data from the ongoing studies of its lead programs.
- ENTR-601-51: The Company has completed Clinical Trial Authorization (CTA)-enabling studies for people living with DMD who are amenable to exon 51 skipping, which is applicable to the largest sub-population of exon skipping amenable patients. The Company expects to submit regulatory applications and obtain authorization following a review of data from the ongoing studies of its lead programs.
-
VX-670:
Vertex continues to enroll and dose the MAD portion of the GALILEO global Phase 1/2 clinical study of VX-670 in people with DM1. The study assesses both safety and efficacy and Vertex is on track to share results during the second half of 2026.
Expanding Preclinical Pipeline: The Company has generated compelling preclinical data from programs focused on ocular and metabolic diseases. The pipeline includes the advancement of two novel oligonucleotide-based programs for the potential treatment of inherited retinal diseases, where there exists high unmet need. The first ocular candidate, ENTR-801, for the potential treatment of Usher syndrome type 2A (USH2A) was announced in December 2025. The Company plans to announce a second clinical candidate in ocular disease in the second half of 2026 and will provide additional details on its clinical development strategy at that time.
Upcoming Investor Conferences
- H.C. Wainwright 4 th Annual BioConnect Investor Conference, New York, NY on May 19, 2026
- 2026 Jefferies Global Healthcare Conference, New York, NY on June 3, 2026
- Goldman Sachs 47 th Annual Global Healthcare Conference 2026, Miami Beach, FL on June 8, 2026
Investor Webcast and Conference Call Information
Entrada Therapeutics will host an investor webcast and conference call today, Thursday, May 7, 2026, at 8:30 a.m. ET to discuss financial results for the first quarter ended March 31, 2026, recent business updates and topline results from Cohort 1 of the Phase 1/2 ELEVATE-44-201 study. The webcast can be accessed by visiting the Investor Relations section of the Company’s website at
www.entradatx.com
. Analysts planning to participate during the Q&A portion of the live call can join the conference call at the audio-conferencing link
here
. The webcast will be archived and available for replay on the Entrada Therapeutics website for 90 days following the call.
Patients and Their Care Partners
Patients and their care partners are a critical part of our community, and we are committed to keeping them informed and connected. To receive community updates in real time and read today’s update, please visit
Community Updates
on our corporate website.
First Quarter 2026 Financial Results
Cash Position: Cash, cash equivalents and marketable securities were $254.9 million as of March 31, 2026, compared to $295.7 million as of December 31, 2025. The decrease was primarily driven by cash used to fund operations. Based on current operating plans, the Company believes that its cash, cash equivalents and marketable securities as of March 31, 2026 will be sufficient to fund its operations into the third quarter of 2027.
Collaboration Revenue: Collaboration revenue was $0.9 million for the first quarter of 2026, compared to $20.6 million for the same period in 2025. This decrease is primarily attributable to the substantial completion of the collaboration research plan activities associated with VX-670 during the first quarter of 2025.
Research & Development (R&D) Expenses: R&D expenses were $33.1 million for the first quarter of 2026, compared to $32.1 million for the same period in 2025. The increase was primarily driven by additional costs incurred related to the Company’s DMD programs.
General & Administrative (G&A) Expenses: G&A expenses were $10.1 million for the first quarter of 2026, compared to $10.3 million for the same period in 2025. The decrease was primarily driven by fewer professional services costs incurred.
Net Loss: Net loss was $39.7 million for the first quarter of 2026, compared to $17.3 million for the same period in 2025.
About Entrada Therapeutics
Entrada Therapeutics is a clinical-stage biopharmaceutical company aiming to transform the lives of patients by establishing a new class of genetic medicines that engage intracellular targets that have long been considered inaccessible. Through proprietary, versatile and modular approaches, Entrada is advancing a robust development portfolio of genetic medicines for the potential treatment of neuromuscular and inherited retinal diseases, among others. 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 Entrada’s Phase 1/2 MAD clinical study of ENTR-601-44, including the timing of data from the Cohort 1 open-label period and Cohort 2 by year-end 2026 with data from Cohort 3 to follow, expectations regarding the initiation of the planned ELEVATE-44-102 study in the U.S., including plans to re-engage with the FDA to discuss increasing planned doses, the ability to recruit for and complete the global Phase 2 clinical studies of ENTR-601-44, ENTR-601-45, ENTR-601-50 and ENTR-601-51, the potential therapeutic benefits of Entrada’s EEV product candidates, including the potential for ENTR-601-44 to be a transformative treatment option, the potential of TTR velocity data observed in Cohort 1 to predict early functional benefit, the potential for a deepening of functional responses, continued functional benefit and higher dystrophin levels with increase in plasma exposure during the Cohort 1 open-label Phase 2 portion of the study, the potential for further enhanced muscle function and a meaningful increase in dystrophin in Cohort 2, expectations regarding Entrada's Phase 1/2 MAD clinical study of ENTR-601-45, including the timing of data from Cohort 1 in mid-2026, with data from Cohort 2 and Cohort 3 to follow, expectations regarding regulatory filings in the EU for the planned Phase 1/2 MAD clinical study of ENTR-601-50, expectations regarding regulatory filings for the ENTR-601-51 program, the potential therapeutic benefits of Entrada’s EEV product candidates and the ability to advance therapeutic candidates in indications beyond neuromuscular disease, including but not limited to ocular disease, expectations regarding the timing of nomination of a second clinical candidate for ocular disease in the second half of 2026, and the continued development and advancement of ENTR-601-44, ENTR-601-45, ENTR-601-50, and ENTR-601-51 for the treatment of DMD and ENTR-801 for the potential treatment of Usher syndrome type 2A and the partnered product candidate VX-670 for the potential treatment of DM1, expectations regarding the progress and success of Entrada’s collaboration with Vertex, including the timing of results from the MAD portion of the global Phase 1/2 study of the VX-670 program in the second half of 2026, the ability to continue to expand and develop additional therapeutic programs and modalities, including further exon skipping programs, and the sufficiency of its cash resources into the third quarter of 2027, 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.
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ENTRADA THERAPEUTICS, INC.
Condensed Consolidated Statements of Operations (Unaudited) (In thousands, except share and per share amounts) |
|||||||
| Three Months Ended March 31, | |||||||
| 2026 | 2025 | ||||||
| Collaboration revenue | $ | 875 | $ | 20,558 | |||
| Operating expenses: | |||||||
| Research and development | 33,054 | 32,074 | |||||
| General and administrative | 10,124 | 10,274 | |||||
| Total operating expenses | 43,178 | 42,348 | |||||
| Loss from operations | (42,303 | ) | (21,790 | ) | |||
| Other income: | |||||||
| Interest and other income | 2,624 | 4,441 | |||||
| Total other income | 2,624 | 4,441 | |||||
| Loss before provision for income taxes | (39,679 | ) | (17,349 | ) | |||
| Provision for income taxes | 38 | — | |||||
| Net loss | $ | (39,717 | ) | $ | (17,349 | ) | |
| Net loss per share, basic and diluted | $ | (0.95 | ) | $ | (0.42 | ) | |
| Weighted‑average common shares outstanding, basic and diluted | 41,836,275 | 41,073,732 | |||||
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ENTRADA THERAPEUTICS, INC.
Condensed Consolidated Balance Sheet Data (Unaudited) (In thousands) |
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| March 31, | December 31, | ||||
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2026
|
2025
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| Cash, cash equivalents and marketable securities | $ | 254,859 | $ | 295,698 | |
| Total assets | $ | 335,518 | $ | 377,378 | |
| Total liabilities | $ | 64,664 | $ | 71,245 | |
| Total stockholders’ equity | $ | 270,854 | $ | 306,133 | |
Investor Contact
Karla MacDonald
Chief Corporate Affairs Officer
[email protected]
Patient Advocacy Contact
Sarah Friedhoff
Head of Patient Advocacy
[email protected]
Media Contact
Megan Prock McGrath
CTD Comms, LLC
[email protected]