FDA Accepts Regeneron, Sanofi's Filing For Review In Skin Disease

The U.S. Food and Drug Administration (FDA) has accepted a supplemental Biologics License Application (sBLA) for review submitted by Regeneron Pharmaceuticals 

REGN-4.76%+ Free Alerts

 and Sanofi 

SNY-3.26%+ Free Alerts

 for the lead drug candidate Dupixent (dupilumab) for the treatment of patients with prurigo nodularis.

The regulatory agency has assigned Priority Review for the application and set a PDUFA target action date of Sept. 30, 2022. 

The filing is supported by data readout from PRIME2 and PRIME pivotal Phase 3 trials evaluating the efficacy and safety of Dupixent in patients 18 years and older with prurigo nodularis.Prurigo nodularis is a chronic skin disease that causes extreme itch and inflammatory skin lesions (nodules).

The company said that additional regulatory filings around the world are also planned in 2022.

https://www.benzinga.com/general/biotech/22/05/27475580/fda-accepts-regeneron-sanofis-filing-for-review-in-skin-disease

BofA Securities Highlights PepGen Clinical Trials

PepGen Inc’s 

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 lead asset, PGN-EDO51 for Duchenne muscular dystrophy (DMD), is in phase 1 clinical trials in healthy volunteers with data expected by the end of the year, according to BofA Securities.

The PepGen Analyst: Tazeen Ahmad initiated coverage of PepGen with a Buy rating and a price objective at $16.

The PepGen Thesis: The company expects to initiate the phase IIa trials in DMD in the first half of 2023 with data expected in 2024, Ahmad said in the initiation note.

“PEPG is also developing PGN-EDODM1 for myotonic dystrophy type 1 (DM1) with an expected IND submission in 1H23,” he added.

“We view PEPG’s EDO platform as differentiated with preclinical data suggesting the potential for superior bio-distribution profile compared to unconjugated PMOs and improved clinical efficacy,” the analyst wrote.

He further stated, “While we note that data in DMD patients (pts) will not be available until 2024 and the platform needs further clinical validation, we think that if successful there could be meaningful upside to our estimates given the significant unmet medical need in DMD and DM1.”

https://www.benzinga.com/analyst-ratings/analyst-color/22/05/27473363/pepgen-is-developing-the-next-gen-of-therapeutic-oligos-bofa-says