TRDA

This story was originally published on BioPharma Dive. To receive daily news and insights, subscribe to our free daily BioPharma Dive newsletter. Entrada Therapeutics lost more than half its value Thursday after the company reported early data for an experimental Duchenne muscular dystrophy treatment that fell short of analyst expectations. The company said results from the Phase 1/2 study were positive, with the RNA-based therapy showing favorable safety and tolerability. Researchers also saw indications that the medicine, dubbed ENTR-601-44, could help patients with the muscle-weakening disease rise off the floor faster than those on placebo. But investors zeroed in on how much the treatment could increase production of dystrophin, a protein that is critical for muscle protection and doesn’t appear at adequate levels in Duchenne patients. The study showed an increase of 2.36%, compared with analyst expectations of 10% or more. Shares of the company have subsequently tumbled 55%. Investors hoping for signs that Entrada’s medicine will be able to rival similar drugs that are further along were likely disappointed by the results released Thursday. Avidity Biosciences, which was scooped up by Novartis in a $12 billion deal that closed in February, reported last year a 25% increase in dystrophin production for its experimental “del-zota” therapy and made plans to seek approval. Entrada will now need to look to higher doses of its drug to compete, and the time needed to conduct the research “will augment first-to-market advantages for del-zota,” assuming Novartis succeeds in the regulatory process, William Blair analyst Myles Minter wrote in a note to clients. Even so, Minter found the time-to-rise data for ENTR-601-44 “intriguing.” Duchenne muscular dystrophy is caused by mutations in a gene that stifle production of the vital dystrophin protein, causing progressive muscle weakening that can eventually affect breathing and weaken the heart. The disease, which affects about 41,000 people in the U.S. and Europe, usually arises in childhood and mostly affects males. Entrada’s drug, like del-zota, is designed to treat a subset of Duchenne patients with mutations involving “exon 44,” a specific part of a defunct gene. The therapy is designed to “skip” this section and help the body produce a shorter, still-functional form of dystrophin. Development of the medicine h...

-- 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 meaningf...

– Company on track to report ELEVATE-44-201 data from Cohort 1 in Q2 2026 and Cohort 2 by year-end 2026 – – Company on track to report ELEVATE-45-201 data from Cohort 1 in mid-2026 – – Independent Data Monitoring Committee recommended initiation of Cohort 2 at the increased dose of 12 mg/kg in the ELEVATE-44-201 study – – Cash runway expected into Q3 2027 with $296 million in cash, cash equivalents and marketable securities as of December 31, 2025 – BOSTON, Feb. 26, 2026 (GLOBE NEWSWIRE) -- Entrada Therapeutics, Inc. (Nasdaq: TRDA) today reported financial results for the fourth quarter and full year ended December 31, 2025, and highlighted recent business updates. “We have started 2026 with strong momentum, including a positive DMC recommendation to initiate the second cohort of ELEVATE-44-201 at the increased dose of 12 mg/kg. In the coming months, we will share multiple clinical readouts, including data from the first patient cohorts of the ELEVATE-44-201 and ELEVATE-45-201 studies, as well as the second patient cohort of the ELEVATE-44-201 study later in the year. We strongly believe these results continue to derisk our entire neuromuscular portfolio,” said Dipal Doshi, Chief Executive Officer at Entrada Therapeutics. “We are also advancing our growing development portfolio of genetic medicines, with the nomination of ENTR-801 for the potential treatment of Usher syndrome type 2A and the planned nomination of a second clinical candidate in inherited retinal diseases expected later this year. With a cash runway into the third quarter of 2027, we believe we are well-positioned to continue expanding our unique pipeline of intracellular therapeutics.” 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. In 2026, the Company expects to have four clinical-stage programs in its DMD franchise (ENTR-601-44, ENTR-601-45, ENTR-601-50 and ENTR-601-51), complementing the ongoing clinical progress of its myotonic dystrophy type 1 (DM1) partnership (VX-670) with Vertex. ELEVATE-44-201: Completed dosing of Cohort 1 of the global Phase 1/2 multiple ascending dose (MAD) portion of the clinical study of ENTR-601-44 in ambulatory patients living with DMD who are amenable to exon 44 skipping. An independent Data Monitoring Commi...

Arcutis Biotherapeutics, Inc. (ARQT) came out with quarterly earnings of $0.13 per share, beating the Zacks Consensus Estimate of $0.03 per share. This compares to a loss of $0.09 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +290.39%. A quarter ago, it was expected that this company would post a loss of $0.1 per share when it actually produced earnings of $0.06, delivering a surprise of +160%. Over the last four quarters, the company has surpassed consensus EPS estimates four times. Arcutis Biotherapeutics, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $129.5 million for the quarter ended December 2025, surpassing the Zacks Consensus Estimate by 11.93%. This compares to year-ago revenues of $71.36 million. The company has topped consensus revenue estimates four times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Arcutis Biotherapeutics shares have lost about 7.1% since the beginning of the year versus the S&P 500's gain of 0.7%. While Arcutis Biotherapeutics has underperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Arcutis Biotherapeutics was unfavorable. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #4 (Sell) for the stock. So, the shares are expected to underperform the market in the near fu...

Entrada Therapeutics, Inc. (TRDA) is expected to deliver a year-over-year decline in earnings on lower revenues when it reports results for the quarter ended December 2025. This widely-known consensus outlook gives a good sense of the company's earnings picture, but how the actual results compare to these estimates is a powerful factor that could impact its near-term stock price. The stock might move higher if these key numbers top expectations in the upcoming earnings report. On the other hand, if they miss, the stock may move lower. While the sustainability of the immediate price change and future earnings expectations will mostly depend on management's discussion of business conditions on the earnings call, it's worth handicapping the probability of a positive EPS surprise. This company is expected to post quarterly loss of $1.32 per share in its upcoming report, which represents a year-over-year change of -4500%. Revenues are expected to be $1.29 million, down 96.6% from the year-ago quarter. The consensus EPS estimate for the quarter has been revised 1.52% lower over the last 30 days to the current level. This is essentially a reflection of how the covering analysts have collectively reassessed their initial estimates over this period. Investors should keep in mind that an aggregate change may not always reflect the direction of estimate revisions by each of the covering analysts. Price, Consensus and EPS Surprise Estimate revisions ahead of a company's earnings release offer clues to the business conditions for the period whose results are coming out. Our proprietary surprise prediction model -- the Zacks Earnings ESP (Expected Surprise Prediction) -- has this insight at its core. The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate for the quarter; the Most Accurate Estimate is a more recent version of the Zacks Consensus EPS estimate. The idea here is that analysts revising their estimates right before an earnings release have the latest information, which could potentially be more accurate than what they and others contributing to the consensus had predicted earlier. Thus, a positive or negative Earnings ESP reading theoretically indicates the likely deviation of the actual earnings from the consensus estimate. However, the model's predictive power is significant for positive ESP readings only. A positive Earnin...

-- Company on track to report ELEVATE-44-201 data from first patient cohort in Q2 2026 -- -- First patient dosed in ELEVATE-45-201 and the Company is on track to report data from the first patient cohort in mid-2026 -- -- Filed for regulatory authorization in U.K. to initiate ELEVATE-50-201, a global Phase 1/2 MAD clinical study of ENTR-601-50 -- -- Expected cash runway extended into Q3 2027 with $327 million in cash, cash equivalents and marketable securities as of September 30, 2025 -- BOSTON, Nov. 06, 2025 (GLOBE NEWSWIRE) -- Entrada Therapeutics, Inc. (Nasdaq: TRDA) today reported financial results for the third quarter ended September 30, 2025, and highlighted recent business updates. “This year, we have strategically positioned Entrada to significantly advance what we believe to be best-in-class therapies for people living with Duchenne muscular dystrophy and their families. We expect 2026 to be a data-rich year, with multiple potential value-creating inflection points across our growing Duchenne franchise,” said Dipal Doshi, Chief Executive Officer at Entrada Therapeutics. “The unmet medical need in Duchenne is profound, with the community calling for therapies that are both safe and effective. We look forward to delivering data from the first patient cohort of ELEVATE-44-201 in the second quarter of 2026 and ELEVATE-45-201 in mid-2026. With an expected cash runway extended into the third quarter of 2027, we believe we are well-positioned to advance and expand our unique pipeline of intracellular therapeutics.” Third Quarter and 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. By year-end, the Company expects to have three clinical-stage programs in its DMD franchise (ENTR-601-44, ENTR-601-45 and ENTR-601-50), complementing the ongoing progress of its myotonic dystrophy type 1 (DM1) partnership (VX-670) with Vertex. ELEVATE-44-201: Completed enrollment of Cohort 1 of the global Phase 1/2 multiple ascending dose (MAD) portion of the clinical study of ENTR-601-44 in ambulatory patients living with DMD who are amenable to exon 44 skipping. An independent Data Monitoring Committee (DMC) has reviewed initial data from the eight patients enrolled in Cohort 1 of the blinded, placebo-controlled MAD portion of...

Revenue: US$1.95m (down 98% from 2Q 2024). Net loss: US$43.1m (down by 178% from US$55.0m profit in 2Q 2024). US$1.04 loss per share (down from US$1.61 profit in 2Q 2024). AI is about to change healthcare. These 20 stocks are working on everything from early diagnostics to drug discovery. The best part - they are all under $10bn in marketcap - there is still time to get in early. All figures shown in the chart above are for the trailing 12 month (TTM) period Revenue missed analyst estimates by 76%. Earnings per share (EPS) also missed analyst estimates by 23%. Looking ahead, revenue is expected to decline by 81% p.a. on average during the next 3 years, while revenues in the Biotechs industry in the US are expected to grow by 18%. Performance of the American Biotechs industry. The company's shares are up 1.2% from a week ago. What about risks? Every company has them, and we've spotted 2 warning signs for Entrada Therapeutics (of which 1 is a bit unpleasant!) you should know about. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) simplywallst.com. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.

-- First patient dosed in ELEVATE-44-201 with data from first patient cohort anticipated in H1 2026 -- -- Initiated ELEVATE-45-201 and on track to dose the first patient in Q3 2025 -- -- Multiple clinical trial sites in U.K. and EU activated for ELEVATE-44-201 and ELEVATE-45-201 -- -- Leadership team expanded with the additions of Navid Khan, PhD, as Senior Vice President of Medical Affairs and Kiran Patki, MD, MSc, FFPM, as Senior Vice President of Clinical Development -- -- Cash runway expected into Q2 2027 with $354 million in cash, cash equivalents and marketable securities as of June 30, 2025 -- BOSTON, Aug. 06, 2025 (GLOBE NEWSWIRE) -- Entrada Therapeutics, Inc. (Nasdaq: TRDA) today reported financial results for the second quarter ended June 30, 2025, and highlighted recent business updates. “Now, more than ever, patients living with Duchenne muscular dystrophy need safer and efficacious therapeutic options. We are pleased that we achieved a key clinical milestone with the dosing of the first patient in our ELEVATE-44-201 clinical study and expect to report data from the first patient cohort during the first half of 2026. ELEVATE-45-201 sites have also been activated, and we remain on track to dose the first patient in the third quarter of this year, making it the most advanced clinical study of a conjugated exon skipping therapy for individuals amenable to exon 45 skipping. These two programs provide the potential for multiple clinical data readouts across our growing Duchenne franchise in 2026,” said Dipal Doshi, Chief Executive Officer at Entrada Therapeutics. Mr. Doshi continued, “This important progress, coupled with the upcoming regulatory submissions to initiate ELEVATE-50 later this year and ELEVATE-51 in 2026, continue to drive clinical momentum for large Duchenne patient populations with profound unmet need. In parallel, we are strategically strengthening our organization with key hires to support our expanding pipeline while remaining committed to financial discipline.” Second Quarter and Recent Corporate Highlights Clinical-Stage Development Pipeline: Since January 2025, Entrada has advanced multiple clinical programs in people living with Duchenne muscular dystrophy (DMD) in the U.K., EU and U.S. These programs include: ELEVATE-44-201: First patient dosed in the global Phase 1/2 multiple ascending dose (MAD) clinical study of ENTR-601-44...

Entrada Therapeutics, Inc. (NASDAQ:TRDA) just released its quarterly report and things are looking bullish. The results were impressive, with revenues of US$21m exceeding analyst forecasts by 102%, and statutory losses of US$0.42 were likewise much smaller than the analysts had forecast. Following the result, the analysts have updated their earnings model, and it would be good to know whether they think there's been a strong change in the company's prospects, or if it's business as usual. Readers will be glad to know we've aggregated the latest statutory forecasts to see whether the analysts have changed their mind on Entrada Therapeutics after the latest results. We've discovered 1 warning sign about Entrada Therapeutics. View them for free. Taking into account the latest results, the five analysts covering Entrada Therapeutics provided consensus estimates of US$39.7m revenue in 2025, which would reflect a substantial 77% decline over the past 12 months. Earnings are expected to tip over into lossmaking territory, with the analysts forecasting statutory losses of -US$2.96 per share in 2025. Before this latest report, the consensus had been expecting revenues of US$36.7m and US$3.50 per share in losses. So it seems there's been a definite increase in optimism about Entrada Therapeutics' future following the latest consensus numbers, with a notable improvement in the loss per share forecasts in particular. View our latest analysis for Entrada Therapeutics The consensus price target fell 7.9%, to US$24.33, suggesting that the analysts remain pessimistic on the company, despite the improved earnings and revenue outlook. It could also be instructive to look at the range of analyst estimates, to evaluate how different the outlier opinions are from the mean. There are some variant perceptions on Entrada Therapeutics, with the most bullish analyst valuing it at US$30.00 and the most bearish at US$20.00 per share. This shows there is still a bit of diversity in estimates, but analysts don't appear to be totally split on the stock as though it might be a success or failure situation. These estimates are interesting, but it can be useful to paint some more broad strokes when seeing how forecasts compare, both to the Entrada Therapeutics' past performance and to peers in the same industry. We would highlight that revenue is expected to reverse, with a forecast 86% annu...

– Receives regulatory authorization in the EU for ELEVATE-44-201, a Phase 1/2 MAD clinical study of ENTR-601-44 in patients living with Duchenne muscular dystrophy who are amenable to exon 44 skipping – – Company remains on track to initiate ELEVATE-44-201 and ELEVATE-45-201 in Q2 and Q3 2025, respectively – – Cash runway expected into Q2 2027 with $383 million in cash, cash equivalents and marketable securities as of March 31, 2025 – BOSTON, May 08, 2025 (GLOBE NEWSWIRE) -- Entrada Therapeutics, Inc. (Nasdaq: TRDA) today reported financial results for the first quarter ended March 31, 2025, and highlighted recent business updates. “We are excited to announce the first European Union regulatory clearance within our Duchenne franchise, with the authorization to initiate the ELEVATE-44-201 patient study across multiple countries. The first quarter of 2025 has been highly productive, with clearances granted for the first two of our novel exon skipping Duchenne programs, ENTR-601-44 and ENTR-601-45,” said Dipal Doshi, Chief Executive Officer at Entrada Therapeutics. “We expect to quickly advance three distinct Duchenne programs – for people who are exon 44, 45 and 50 skip amenable – into global clinical development by the end of this year. In parallel, our partnered program with Vertex for myotonic dystrophy type 1, VX-670, continues to progress in the clinic. This increased clinical momentum, combined with a cash runway expected into Q2 2027 and our ongoing commitment to financial discipline, positions us strongly despite the challenging macroeconomic environment.” Recent Corporate Highlights In May 2025, the ELEVATE-44-201 study received authorization from the Health Authorities and Ethics Committees of multiple countries under the European Union Clinical Trial Regulation (EU-CTR). The recent EU authorization of ELEVATE-44-201 builds upon the Company’s significant clinical momentum. Since January 2025, Entrada has received authorization to initiate clinical studies in people living with Duchenne muscular dystrophy (DMD) in the U.K., EU and U.S. These authorizations include: ELEVATE-44-201: A global Phase 1/2 multiple ascending dose (MAD) clinical study of ENTR-601-44 in ambulatory patients living with DMD who are amenable to exon 44 skipping. The study will run in the U.K. and EU and is on track to initiate in the second quarter of 2025. ELEVATE-44-102: A Phas...

Eton Pharmaceuticals, Inc. (ETON) is expected to deliver a year-over-year increase in earnings on higher revenues when it reports results for the quarter ended March 2025. This widely-known consensus outlook gives a good sense of the company's earnings picture, but how the actual results compare to these estimates is a powerful factor that could impact its near-term stock price. The stock might move higher if these key numbers top expectations in the upcoming earnings report. On the other hand, if they miss, the stock may move lower. While the sustainability of the immediate price change and future earnings expectations will mostly depend on management's discussion of business conditions on the earnings call, it's worth handicapping the probability of a positive EPS surprise. This company is expected to post quarterly earnings of $0.09 per share in its upcoming report, which represents a year-over-year change of +400%. Revenues are expected to be $16.2 million, up 103.3% from the year-ago quarter. The consensus EPS estimate for the quarter has been revised 75% higher over the last 30 days to the current level. This is essentially a reflection of how the covering analysts have collectively reassessed their initial estimates over this period. Investors should keep in mind that an aggregate change may not always reflect the direction of estimate revisions by each of the covering analysts. Estimate revisions ahead of a company's earnings release offer clues to the business conditions for the period whose results are coming out. This insight is at the core of our proprietary surprise prediction model -- the Zacks Earnings ESP (Expected Surprise Prediction). The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate for the quarter; the Most Accurate Estimate is a more recent version of the Zacks Consensus EPS estimate. The idea here is that analysts revising their estimates right before an earnings release have the latest information, which could potentially be more accurate than what they and others contributing to the consensus had predicted earlier. Thus, a positive or negative Earnings ESP reading theoretically indicates the likely deviation of the actual earnings from the consensus estimate. However, the model's predictive power is significant for positive ESP readings only. A positive Earnings ESP is a strong predictor of an...

The market expects Entrada Therapeutics, Inc. (TRDA) to deliver a year-over-year decline in earnings on lower revenues when it reports results for the quarter ended March 2025. This widely-known consensus outlook is important in assessing the company's earnings picture, but a powerful factor that might influence its near-term stock price is how the actual results compare to these estimates. The stock might move higher if these key numbers top expectations in the upcoming earnings report. On the other hand, if they miss, the stock may move lower. While the sustainability of the immediate price change and future earnings expectations will mostly depend on management's discussion of business conditions on the earnings call, it's worth handicapping the probability of a positive EPS surprise. This company is expected to post quarterly loss of $0.78 per share in its upcoming report, which represents a year-over-year change of -214.7%. Revenues are expected to be $9.72 million, down 83.6% from the year-ago quarter. The consensus EPS estimate for the quarter has been revised 2.86% lower over the last 30 days to the current level. This is essentially a reflection of how the covering analysts have collectively reassessed their initial estimates over this period. Investors should keep in mind that the direction of estimate revisions by each of the covering analysts may not always get reflected in the aggregate change. Estimate revisions ahead of a company's earnings release offer clues to the business conditions for the period whose results are coming out. Our proprietary surprise prediction model -- the Zacks Earnings ESP (Expected Surprise Prediction) -- has this insight at its core. The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate for the quarter; the Most Accurate Estimate is a more recent version of the Zacks Consensus EPS estimate. The idea here is that analysts revising their estimates right before an earnings release have the latest information, which could potentially be more accurate than what they and others contributing to the consensus had predicted earlier. Thus, a positive or negative Earnings ESP reading theoretically indicates the likely deviation of the actual earnings from the consensus estimate. However, the model's predictive power is significant for positive ESP readings only. A positive Earnings ESP is a...