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Entrada (TRDA) Down on FDA Maintaining Clinical Hold on DMD Drug

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Shares of Entrada Therapeutics (TRDA - Free Report) lost 31.9% on Nov 22 after management announced that the FDA continues to maintain the clinical hold on ENTR-601-44, the lead product candidate in the company’s Duchenne muscular dystrophy (“DMD”) franchise. This hold has been in place since last December.

Despite the submission of additional information to the FDA – which Entrada claims supported the study initiation for the DMD drug in the United Kingdom – the agency refused to lift the clinical hold. Entrada intends to re-engage with the FDA to determine the next steps in due course.

Management had submitted this information with the intent to start a phase I study on ENTR-601-44 in the United States. In September, management started an early-stage study in the United Kingdom to evaluate the safety and tolerability of a single dose of ENTR-601-44 in healthy male volunteers. Data from this study is expected in second-half 2024.

Year to date, shares of Entrada have lost 10.6% compared to the industry’s 23.2% decline.

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Currently, ENTR-601-44 is the only candidate in Entrada’s pipeline undergoing clinical development. The company intends to develop the drug as a potential treatment for DMD patients who are exon 44 skipping amenable.

Entrada is also evaluating multiple other DMD candidates in preclinical studies and intends to advance them toward clinical development in the coming years. These include ENTR-601-45 (for patients who are exon 45 skipping amenable) and ENTR-601-50 (for those who are exon 50 skipping amenable).

Currently, the DMD market is dominated by Sarepta Therapeutics (SRPT - Free Report) , which has four approved therapies in its marketed portfolio, all targeting DMD indications. Sarepta markets three PMO-based exon-skipping treatments in DMD, namely Exondys 51, Vyondys 53 and Amondys 45.

For the fourth therapy, Sarepta markets the only approved one-shot gene therapy in the United States. In June, the FDA granted accelerated approval to Sarepta’s Elevidys (SRP-9001), an adeno-associated virus-based gene therapy, to treat ambulatory pediatric patients aged between four and five years with DMD.

Another company marketing DMD drugs is PTC Therapeutics (PTCT - Free Report) . PTCT markets Emflaza (deflazacort) in the United States, which received FDA approval in 2017. The PTC Therapeutics drug is approved to treat DMD in individuals aged two years and older.

Entrada is developing a new class of medicines, Endosomal Escape Vehicle (EEV) therapeutics, to engage intracellular targets that have long been considered inaccessible and undruggable. Through its proprietary EEV platform, management intends to build a robust development portfolio of RNA-, antibody- and enzyme-based programs for the potential treatment of neuromuscular diseases, immunology, oncology and diseases.


Zacks Rank & A Key Pick

Entrada currently carries a Zacks Rank #1 (Strong Buy). Another top-ranked stock in the overall healthcare sector is AnaptysBio (ANAB - Free Report) , which carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

AnaptysBio’s loss estimate has narrowed from $6.57 to $6.08 per share in the past 60 days. During the same period, the loss estimates per share for 2024 have narrowed from $6.93 to $6.38. Shares of ANAB have lost 54.2% in the year-to-date period.

The earnings of AnaptysBio beat estimates in two of the last four quarters while missing the mark on the other two occasions, posting a negative average earnings surprise of 6.48%. AnaptysBio’s earnings beat estimates by 18.02%.

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