Replies to post #224412 on Biotech Values

[DewDiligence]

MOLN.SW—(-36%)—ABBV’s DARPin receives CRL in AMD due to still-high rate of intraocular inflammation:

https://www.prnewswire.com/news-releases/allergan-an-abbvie-company-and-molecular-partners-receive-complete-response-letter-from-fda-on-biologics-license-application-for-abicipar-pegol-301084188.html

Allergan, an AbbVie Company, and Molecular Partners (MOLN.SW)…today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter to the Biologics License Application (BLA) for Abicipar pegol, a novel, investigational DARPin therapy for patients with neovascular (wet) age-related macular degeneration (nAMD).

The letter from the FDA indicates that the rate of intraocular inflammation observed following administration of Abicipar pegol 2mg/0.05 mL results in an unfavorable benefit-risk ratio in the treatment of neovascular (wet) age-related macular degeneration (AMD).

Inasmuch as Abicipar pegol was reformulated to reduce intraocular inflammation from 15% to 9% (#msg-147952065), this CRL probably spells the end of the program.