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Pelthos to buy Castle Creek, adding Phase 3 gene therapy D-Fi for dystrophic EB

🇺🇸 Pelthos Therapeutics Inc. (PTHS) · Fri 30 Oct 2026

Pelthos Therapeutics has signed a merger agreement with Castle Creek Biosciences, offering shares and milestone payments tied to FDA approval of the orphan-designated cell therapy D-Fi.

Pelthos Therapeutics and Castle Creek Biosciences signed a definitive merger agreement on 30 October 2026. The deal gives Pelthos D-Fi (dabocemagene autoficel), a gene-modified cell therapy for dystrophic epidermolysis bullosa (DEB) that has orphan designation and is in Phase 3.

At closing, Castle Creek holders will receive 5.2 million Pelthos shares, equal to about 32.5% of the company on a fully diluted basis. They may also receive contingent shares.

The agreement also provides for milestone payments of up to $300 million. Castle Creek holders would also receive most of any proceeds from a priority review voucher linked to FDA approval of D-Fi. As background, a priority review voucher can shorten the FDA review clock for a later application, and it can sometimes be sold.

Pelthos expects the transaction to close by the end of the first quarter of 2027. Closing is subject to conditions, including approval by Castle Creek stockholders. The summary available does not give further detail on the Phase 3 programme or its timelines.

What it means for your team

  • Regulatory teams tracking DEB should note that D-Fi's US development and any FDA filing would move under Pelthos if the deal closes.
  • The milestone and voucher terms are tied to FDA approval, so the regulatory outcome directly affects the deal's value to Castle Creek holders.
  • Market-access teams should watch for post-closing information on Phase 3 timing and commercial plans, which the current announcement does not provide.

Company's press release (SEC filing): Pelthos Therapeutics Inc. ↗

Article written by VigiEye from the official source (Pelthos Therapeutics Inc.). Claims are the company's own. AI-assisted; check the source before acting.

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