Shares in Pharming Group NV were up after the company announced detailed data from its phase II/III trial of leniolisib for the rare disease activated phosphoinositide 3-kinase delta (PI3K-delta) syndrome (APDS). 

While clinical trial updates in 2022 started off slow, the gap with last year appears to be closing, even as pandemic activity diminishes.

The amount of clinical data reported in January so far is currently 30% below the amount reported during the same month last year, which was the slowest month of 2021.

PERTH, Australia – Stem cell therapy company Mesoblast Ltd. provided new subgroup analyses from its phase III advanced chronic heart failure trial showing a greater treatment benefit from rexlemestrocel-L in high-risk patients with chronic heart failure and low ejection fraction (HFrEF) with diabetes or ischemia.

Beyondspring Pharmaceuticals Inc. said it received a complete response letter from the FDA regarding the NDA for plinabulin, the company’s lead asset. The FDA said results of a phase III registrational trial were strong enough to show benefit but a second trial is needed to satisfy the agency.

Efforts to find new treatments for cancer and infectious diseases account for nearly half of the phase I, II and III clinical data recorded in 2021.

A phase III trial testing the oral antiviral favipiravir for the treatment of mild to moderate COVID-19 failed to hit statistical significance on the primary endpoint of time to sustained clinical recovery, sponsor Appili Therapeutics Inc. said. Company shares (TSX:APLI) plummeted Nov. 11, falling 53.6% to CA26 cents (US21 cents). Originally approved for the treatment of pandemic flu, favipiravir has since gained marketing authorizations for the treatment of COVID-19 in several markets.

Marking September as the second busiest month, 2021 is more than 6% ahead of last year in terms of reported clinical data, although the gap between the two years has narrowed significantly from 26% in April.