Item 8.01 Other Events



Press Releases

Principia Biopharma Inc. (the "Company") issued a press release on January 7, 2020 announcing an expansion in the development of its lead drug candidate, PRN1008 (now known by the generic name rilzabrutinib) into IgG4-Related Disease (RD). The Company anticipates initiating a Phase 2 clinical trial in IgG4-RD in the first half of 2020. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

In addition, the Company issued a press release on January 9, 2020 announcing an expansion of its Bruton tyrosine kinase (BTK) franchise with an additional BTK inhibitor, PRN473 Topical. PRN473 Topical is entering into a Phase 1, randomized, double blind, placebo-controlled, single and multiple dose clinical trial to evaluate its safety, tolerability and pharmacokinetics. The trial will be conducted in Australia and is expected to be completed in 2020.

The Company also summarized certain anticipated key milestones for the Company's clinical development programs, and announced suspension of its development of PRN1371, an FGFR inhibitor for bladder cancer, to focus the Company's portfolio on immune-mediated diseases. A copy of the press release is attached hereto as Exhibit 99.2 and is incorporated herein by reference.

Item 9.01 Financial Statements and Exhibits.




(d) Exhibits




Exhibit
  No.       Description

99.1          Press Release issued by Principia Biopharma Inc. dated January 7, 2020.

99.2          Press Release issued by Principia Biopharma Inc. dated January 9, 2020.

--------------------------------------------------------------------------------

© Edgar Online, source Glimpses