PepGen (PEPG) Down on Clinical Hold for DM1 Candidate
PepGen’s PEPG shares were down almost 16.3% on May 30, after market hours. This happened soon after the company announced that it received a clinical hold notice from the FDA regarding PEPG’s investigational new drug application for PGN-EDODM1, a potential treatment for myotonic dystrophy type 1 (DM1).
This news came as a disappointment to the company, as it was planning to initiate a phase I study of PGN-EDODM1 in patients with DM1. The FDA has expressed its intention to provide an official clinical hold letter to PepGen within the next 30 days, stating the reasons for the same.
Despite this setback, PepGen remains determined to advance the development of PGN-EDODM1 outside the Unites States. It is also actively working with the FDA to remove the clinical hold shortly.
PepGen’s shares have risen 18% year to date against the industry’s 9.2% decline.
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On a positive note, its lead product candidate PGN-EDO51 completed a first-in-human phase I clinical study in the third quarter of 2022. PGN-EDO51 is being developed to treat individuals with Duchenne muscular dystrophy (DMD). The phase I study indicated that the candidate was generally well tolerated at pharmacologically active dose levels.
PepGen is advancing the development of two parallel phase II studies of PGN-EDO51 — CONNECT1-EDO51 and CONNECT2-EDO51.
The company recently received a no objection letter from Health Canada for its Clinical Trial Application to initiate a phase II CONNECT1-EDO51 clinical study. This investigation will evaluate the efficacy of PGN-EDO51 in DMD patients, who have agreed to undertake an exon 51 skipping approach.
The clinical hold on PGN-EDODM1 in the United States does not impact the progress of the CONNECT1-EDO51 study, as the latter has been cleared to proceed in Canada.
PEPG plans to increase its research and development (R&D) expenses for 2023, as it continues to advance its clinical and preclinical programs. For the first quarter, the company incurred R&D expenses of almost $14.4 million, up 3.4% year over year.
PepGen, Inc. Price and Consensus
PepGen, Inc. price-consensus-chart | PepGen, Inc. Quote
Zacks Rank and Stocks to Consider
Currently, PepGen carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Allogene Therapeutics ALLO, Akero Therapeutics AKRO and ADMA Biologics, Inc. ADMA, each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Loss per share estimate for Allogene Therapeutics has narrowed from $2.83 to $2.31 for 2023 in the past 90 days. In the year so far, shares of the company have nosedived 17.5%.
ALLO’s earnings beat estimates in three of the trailing four quarters and missed the mark in one, delivering an average surprise of 5.08%.
Loss per share estimate for Akero Therapeutics has narrowed from $3.46 to $2.78 for 2023 in the past 90 days. In the year so far, shares of Akero Therapeutics have fallen 19.9%.
AKRO’s earnings beat estimates in three of the trailing four quarters and missed the mark in one, delivering an average surprise of 7.96%.
Loss per share estimate for ADMA Biologics has narrowed from 19 cents to 9 cents for 2023 in the past 90 days. In the year so far, shares of ADMA Biologics have risen 4.1%.
ADMA’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 19.13%.
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