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LIB Therapeutics
LIB Therapeutics Reports the US FDA’s BLA Acceptance for Lerodalcibep to Reduce LDL-Cholesterol in Cardiovascular Patients
Shots:The US FDA has accepted BLA for lerodalcibep (PCSK9 inhibitor) to lower LDL-C in high-risk or ASCVD pts, HeFH/HoFH pts (≥10 yrs), & primary hyperlipidemia (incl. heterozygous) pts, with no advisory committee meeting planned yet (PDUFA: Dec 12, 2025); EMA’s MAA filing expected in Q2’25 Application was backed by the development program of…
Boehringer Ingelheim
Boehringer Ingelheim Reports Topline Data from P-III (FIBRONEER-ILD) Study of Nerandomilast for Progressive Pulmonary Fibrosis (PPF)
Shots:BI reported topline data from P-III (FIBRONEER-ILD) study assessing nerandomilast (BI 1015550; 9/18mg, BID) vs PBO in PPF pts (n=1178) for ~52wks. with regulatory filings in the US & other regions underway Study met its 1EP of absolute change from baseline in forced vital capacity (FVC; mL) with favorable safety consistent with P-II; full…

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