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Dyne (DYN) Soars 28% on New Data From Muscle Disease Studies
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Dyne Therapeutics (DYN - Free Report) reported new clinical efficacy data from two separate mid to late-stage studies evaluating its two clinical-stage pipeline candidates, DYNE-101 and DYNE-251, in patients with myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD) who are amenable to exon 51 skipping, respectively.
New clinical data from both studies demonstrated a meaningful impact on key biomarkers and functional improvement in multiple clinical endpoints that matter to patients.
We remind the investors that the company had earlier reported positive initial clinical data from both studies evaluating DYNE-101 and DYNE-251 for DM1 and DMD, respectively, in January 2024.
Dyne’s shares rallied 27.8% in the last trading session on May 20 following the encouraging news. Year to date, the stock has skyrocketed 166% against the industry’s 7.2% decline.
Image Source: Zacks Investment Research
Dyne reported efficacy data from 40 adult DM1 patients in the multiple ascending dose (MAD) portion of the phase I/II ACHIEVE study. These patients were randomized to receive either of the three doses of DYNE-101 (1.8 mg/kg, 3.4 mg/kg or 5.4 mg/kg) following different dosing intervals, evaluated over a treatment period of 12, six or three months, respectively.
In the ACHIEVE study, it was observed that treatment with DYNE-101 resulted in robust muscle delivery and dose-dependent, consistent splicing correction, which led to an improvement in muscle strength, multiple functional endpoints and patient-reported outcomes.
Notably, patients treated with the candidate in the high dose cohort (5.4 mg/kg) experienced a 27% mean splicing correction from baseline across a broad, 22-gene panel at three months, with all participants demonstrating splicing correction.
Results also demonstrated that the high-dose cohort of the ACHIEVE study experienced the greatest improvement in myotonia (4.5 seconds on average) at three months, as measured by a video assessment of the time patients needed to uncurl their middle finger after gripping their hand. The lowest-dose cohort (1.8 mg/kg) of DYNE-101, on the other hand, experienced a mean 3.1-second benefit in myotonia at three months that increased to 4.4 seconds at 12 months.
Treatment with the candidate also demonstrated early and sustained potential benefit in the 10-meter Walk/Run Test and five times Sit to Stand Test, demonstrating improvement in muscle strength.
Dyne also reported efficacy data from eight male patients with DMD amenable to exon 51 skipping in the MAD portion of phase I/II DELIVER study, who were randomized to receive either the 10 mg/kg dose of DYNE-251 or placebo once every four weeks for six months.
It was observed that treatment with DYNE-251 resulted in dose-dependent exon skipping and dystrophin expression that exceeded levels reported by Sarepta Therapeutics (SRPT - Free Report) in its clinical study of approved, current standard-of-care DMD drug, Exondys 51 (eteplirsen), at six months.
Treatment with DYNE-251 caused a mean absolute dystrophin level of 3.22% of normal and a 2.97% change (unadjusted for muscle content) from baseline, while Sarepta’s Exondys 51 had achieved a mean absolute unadjusted dystrophin level of 0.30% of normal and a 0.06% change from baseline, both at six months.
It is important to note that DYNE-251 is dosed once every four weeks, while Sarepta’s Exondys 51 is a weekly injection. Thus, DYNE-251, if approved, is expected to significantly reduce the treatment burden for DMD patients, which could ensure higher patient compliance rates.
Adjusting for muscle content, the DYNE-251 treated group reached 7.64% mean absolute dystrophin, which is greater than levels reported by any other similar candidates currently under clinical development.
DYNE-251 also demonstrated encouraging trends in multiple functional endpoints.
Furthermore, both DYNE-101 and DYNE-251 were observed to be safe and, overall, well tolerated in respective patient groups. Treatment-related adverse events with both investigational candidates were generally mild to moderate in severity.
Dyne has already been engaging in dialogues with regulatory bodies across the globe and plans to continue to do so, discussing these encouraging results from the two muscle disease studies. It expects to provide an update on the path to registration for both DYNE-101 and DYNE-251 for their respective indications by the end of 2024.
Dyne also reiterated that both the ongoing ACHIEVE and DELIVER studies are designed to be registrational, and as a result, it is pursuing expedited approval pathways for both programs.
At present, Sarepta is the market leader in the treatment of DMD. Sarepta’s commercial portfolio comprises four drugs, such as Exondys 51, Vyondys 53 (golodirsen), Amondys 45 (casimersen) and Elevidys (SRP-9001), that have received the FDA’s accelerated approval.
In the past 30 days, the Zacks Consensus Estimate for Ligand’s 2024 earnings per share (EPS) has remained constant at $4.56. During the same time frame, the consensus estimate for 2025 EPS has remained constant at $5.27. Year to date, shares of LGND have gained 21.3%.
Ligand beat estimates in each of the trailing four quarters, delivering an average surprise of 56.02%.
In the past 30 days, estimates for ANI Pharmaceuticals’ 2024 EPS have risen from $4.43 to $4.44. During the same period, the consensus estimate for 2025 EPS has remained constant at $5.04. Year to date, shares of ANIP have rallied 12%.
ANI Pharmaceuticals beat estimates in each of the last four quarters, delivering an average surprise of 53.90%.
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Dyne (DYN) Soars 28% on New Data From Muscle Disease Studies
Dyne Therapeutics (DYN - Free Report) reported new clinical efficacy data from two separate mid to late-stage studies evaluating its two clinical-stage pipeline candidates, DYNE-101 and DYNE-251, in patients with myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD) who are amenable to exon 51 skipping, respectively.
New clinical data from both studies demonstrated a meaningful impact on key biomarkers and functional improvement in multiple clinical endpoints that matter to patients.
We remind the investors that the company had earlier reported positive initial clinical data from both studies evaluating DYNE-101 and DYNE-251 for DM1 and DMD, respectively, in January 2024.
Dyne’s shares rallied 27.8% in the last trading session on May 20 following the encouraging news. Year to date, the stock has skyrocketed 166% against the industry’s 7.2% decline.
Image Source: Zacks Investment Research
Dyne reported efficacy data from 40 adult DM1 patients in the multiple ascending dose (MAD) portion of the phase I/II ACHIEVE study. These patients were randomized to receive either of the three doses of DYNE-101 (1.8 mg/kg, 3.4 mg/kg or 5.4 mg/kg) following different dosing intervals, evaluated over a treatment period of 12, six or three months, respectively.
In the ACHIEVE study, it was observed that treatment with DYNE-101 resulted in robust muscle delivery and dose-dependent, consistent splicing correction, which led to an improvement in muscle strength, multiple functional endpoints and patient-reported outcomes.
Notably, patients treated with the candidate in the high dose cohort (5.4 mg/kg) experienced a 27% mean splicing correction from baseline across a broad, 22-gene panel at three months, with all participants demonstrating splicing correction.
Results also demonstrated that the high-dose cohort of the ACHIEVE study experienced the greatest improvement in myotonia (4.5 seconds on average) at three months, as measured by a video assessment of the time patients needed to uncurl their middle finger after gripping their hand. The lowest-dose cohort (1.8 mg/kg) of DYNE-101, on the other hand, experienced a mean 3.1-second benefit in myotonia at three months that increased to 4.4 seconds at 12 months.
Treatment with the candidate also demonstrated early and sustained potential benefit in the 10-meter Walk/Run Test and five times Sit to Stand Test, demonstrating improvement in muscle strength.
Dyne also reported efficacy data from eight male patients with DMD amenable to exon 51 skipping in the MAD portion of phase I/II DELIVER study, who were randomized to receive either the 10 mg/kg dose of DYNE-251 or placebo once every four weeks for six months.
It was observed that treatment with DYNE-251 resulted in dose-dependent exon skipping and dystrophin expression that exceeded levels reported by Sarepta Therapeutics (SRPT - Free Report) in its clinical study of approved, current standard-of-care DMD drug, Exondys 51 (eteplirsen), at six months.
Treatment with DYNE-251 caused a mean absolute dystrophin level of 3.22% of normal and a 2.97% change (unadjusted for muscle content) from baseline, while Sarepta’s Exondys 51 had achieved a mean absolute unadjusted dystrophin level of 0.30% of normal and a 0.06% change from baseline, both at six months.
It is important to note that DYNE-251 is dosed once every four weeks, while Sarepta’s Exondys 51 is a weekly injection. Thus, DYNE-251, if approved, is expected to significantly reduce the treatment burden for DMD patients, which could ensure higher patient compliance rates.
Adjusting for muscle content, the DYNE-251 treated group reached 7.64% mean absolute dystrophin, which is greater than levels reported by any other similar candidates currently under clinical development.
Dyne Therapeutics, Inc. Price and Consensus
Dyne Therapeutics, Inc. price-consensus-chart | Dyne Therapeutics, Inc. Quote
DYNE-251 also demonstrated encouraging trends in multiple functional endpoints.
Furthermore, both DYNE-101 and DYNE-251 were observed to be safe and, overall, well tolerated in respective patient groups. Treatment-related adverse events with both investigational candidates were generally mild to moderate in severity.
Dyne has already been engaging in dialogues with regulatory bodies across the globe and plans to continue to do so, discussing these encouraging results from the two muscle disease studies. It expects to provide an update on the path to registration for both DYNE-101 and DYNE-251 for their respective indications by the end of 2024.
Dyne also reiterated that both the ongoing ACHIEVE and DELIVER studies are designed to be registrational, and as a result, it is pursuing expedited approval pathways for both programs.
At present, Sarepta is the market leader in the treatment of DMD. Sarepta’s commercial portfolio comprises four drugs, such as Exondys 51, Vyondys 53 (golodirsen), Amondys 45 (casimersen) and Elevidys (SRP-9001), that have received the FDA’s accelerated approval.
Zacks Rank and Stocks to Consider
Dyne currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks from the drug/biotech industry are Ligand Pharmaceuticals (LGND - Free Report) and ANI Pharmaceuticals (ANIP - Free Report) . Each stock presently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 30 days, the Zacks Consensus Estimate for Ligand’s 2024 earnings per share (EPS) has remained constant at $4.56. During the same time frame, the consensus estimate for 2025 EPS has remained constant at $5.27. Year to date, shares of LGND have gained 21.3%.
Ligand beat estimates in each of the trailing four quarters, delivering an average surprise of 56.02%.
In the past 30 days, estimates for ANI Pharmaceuticals’ 2024 EPS have risen from $4.43 to $4.44. During the same period, the consensus estimate for 2025 EPS has remained constant at $5.04. Year to date, shares of ANIP have rallied 12%.
ANI Pharmaceuticals beat estimates in each of the last four quarters, delivering an average surprise of 53.90%.