Why Protagonist Therapeutics Shares Are Crashing Today

Protagonist Therapeutics Inc PTGX announced topline results from the Phase 2 IDEAL study of PN-943 in moderate-to-severe ulcerative colitis (UC) patients.
159 patients with moderate-to-severe active UC were randomized to either twice daily (BID) with 450 mg or 150 mg PN-943, or placebo, for 12 weeks.
While the 450 mg BID dose did not meet the prespecified primary endpoint, the 150 mg dose achieved 27.5% clinical remission with a delta of 13% versus the placebo (p=0.08) in the modified Intent to Treat (mITT) group and a delta of 16% (p=0.04) in the bio-naïve group.
Also see: FDA Intends To Revoke Protagonist Therapeutics' Rusfertide Breakthrough Tag In Rare Form Of Blood Cancer.
In addition, the 150 mg BID data showed strong concordance across multiple parameters, including statistically significant histological remission and endoscopic improvement.
Safety analysis was similar for the 150 mg BID dose versus the placebo group.
Protagonist plans are underway for a registrational Phase 3 study anchored around twice daily 150 mg dose of PN-943, pending regulatory guidance.
Price Action: PTGX shares are down 46.8% at $10 during the market session on the last check Tuesday.

Overview Rating:

Good

100

0100