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Dyne Therapeutics (DYN) Submits IND to FDA for DMD Candidate

Dyne Therapeutics, Inc. DYN announced that it has submitted an investigational new drug (IND) application to the FDA to start a clinical study on its investigational candidate DYNE-251 for Duchenne Muscular Dystrophy (DMD) patients with mutations amenable to skipping exon 51.

If the IND is accepted by the regulatory agency, Dyne Therapeutics will initiate a phase I/II study. The study will enroll approximately 30-40 ambulant and non-ambulant male patients aged between 4 years and 16 years with symptomatic DMD and mutations amenable to exon 51 skipping therapy. DYN plans to begin dosing patients by mid-2022.

The stock has declined 40.7% in the year so far compared with the industry’s 19.8% fall.

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Dyne Therapeutics also plans to build a DMD franchise with programs for patients with mutations amenable to skipping exons 53, 45 and 44.

Apart from DYNE-251, the company has two pre-clinical candidates in its pipeline, namely DYNE-101 for myotonic dystrophy type 1 (DM1) and DM-301 for facioscapulohumeral muscular dystrophy (FSHD). The company is planning to submit an IND to the FDA in first-quarter 2022 for DYNE-101 while an IND for DYNE-301 is anticipated to be filed with the regulatory body in second-half 2022.

The DMD market is highly competitive as many companies are evaluating their candidates for DMD. Among those, Sarepta Therapeutics SRPT is a leading player in the market.

Sarepta currently has three approved therapies for DMD in its commercial portfolio. SRPT is also evaluating other candidates in its pipeline for DMD indication. In October, SRPT initiated a global pivotal study called EMBARK on SRP-9001, a gene therapy to treat DMD. SRPT expects to complete enrollment in the study in first-half 2022.

REGENXBIO RGNX is also evaluating its own pipeline candidate for DMD in pre-clinical studies.

Last month, REGENXBIO announced that the FDA granted an orphan-drug designation to its pre-clinical stage, one-time gene therapy RGX-202 as a potential treatment of DMD.  RGNX plans to submit an IND to the FDA to support commencing a clinical study on the candidate by 2021 end.

Zacks Rank & Stock to Consider

Dyne Therapeutics currently carries a Zacks Rank #4 (Sell).

A better-ranked stock in the same sector is Endo International ENDP, which sports a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

Endo International’s earnings per share estimates for 2021 have increased from $2.32 to $2.84 in the past 30 days. The same for 2022 has increased from $2.25 to $2.47 in the past 30 days.

Earnings of Endo International beat estimates in all the last four quarters, the average being 57.7%.

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Dyne Therapeutics, Inc. (DYN): Free Stock Analysis Report
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REGENXBIO Inc. (RGNX): Free Stock Analysis Report
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