Krystal Biotech

City Therapeutics appoints Andrew Orth, ex-Krystal Biotech chief commercial officer, as CEO and director, leveraging his 25+ years in biopharma to advance RNA medicines.

City Therapeutics appoints Andrew Orth as CEO to lead its RNAi-based medicine advancements. Orth, with over 25 years in biopharmaceuticals, aims to drive the company's clinical and commercial growth, leveraging next-gen RNAi technologies for transformative therapies.

Focke Ziemssen, Michelle Sylvanowicz, Winfried M. Amoaku, Tariq Aslam, Bora Eldem, Robert P. Finger, Richard P. Gale, Laurent Kodjikian, Jean-François Korobelnik, Xiaofeng Lin, Anat Loewenstein, Paul Mitchell, Moira Murphy, David R. Owens, Nick Parker, Ian Pearce, Francisco J. Rodríguez, Jude Stern, S. James Talks, David T. Wong, Tien Yin Wong, and Jane Barratt disclose various financial interests including travel grants, personal fees, advisory board memberships, speaker fees, research sponsorship, and consulting roles with companies such as Allergan, AbbVie, Alimera, Bayer Healthcare, Biogen, Boehringer Ingelheim, Janssen, Novartis, Novo Nordisk, Merck, Regeneron, Roche, Sanofi, and others.

EMA's CHMP to issue opinion on Vyjuvek for DEB in early 2025; Krystal Biotech to address remaining questions. Therapy aims to restore COL7 production in DEB patients, with trials showing significant wound healing benefits. Commercial launch planned in Germany post-CHMP opinion.

EMA's Committee for Medicinal Products for Human Use cancelled the oral explanation for Krystal Biotech's B-VEC marketing authorization application for dystrophic epidermolysis bullosa. The company must submit written responses to outstanding issues before the explanation can proceed.

Krystal Biotech announced EMA's CHMP cancelled the Oral Explanation for B-VEC's MAA, asking for written responses to remaining issues. No Major Objections are outstanding. The company anticipates a CHMP opinion in 1Q 2025 and plans to launch B-VEC in Germany in Q2 2025.