Mersana Therapeutics Inc. followed grim June news with an even worse headline as the phase Ib/II study called Uplift with upifitamab rilsodotin (upri) did not meet its primary endpoint in platinum-resistant ovarian cancer (prOC). The antibody-drug conjugate (ADC) targets the sodium-dependent phosphate transport protein NaPi2b and was developed via the company’s platform called Dolaflexin. Shares of Mersana (NASDAQ:MRSN) tumbled 73%, or $2.84, to close July 27 at $1.07 on word of the failure of the trial. Read More
Not hitting the primary endpoint of a phase III study caused the U.S. FDA to say it would not review Biohaven Ltd.’s NDA for troriluzole to treat spinocerebellar ataxia (SCA), an ultra-rare disorder. Read More
European biotech investor Medicxi announced the closure of its fourth fund at $400 million, a sum it said is “deliberately sized” for its asset-focused investment model. Read More
Continuing its efforts to reduce prescription drug prices in the U.S., the Senate Finance Committee turned up the heat on pharmacy benefit managers (PBMs), voting overwhelmingly, 26-1, to send the bipartisan Modernizing and Ensuring PBM Accountability (MEPA) Act to the full Senate. Read More
Viage Therapeutics Inc. – formerly Digestome Therapeutics Inc. – on July 26 unveiled positive data from its phase I study on DGX-001 for mild cognitive impairment in Alzheimer’s disease (AD) and Parkinson’s (PD). The randomized, double-blind, placebo-controlled study demonstrated changes in brain activity according to quantitative electroencephalography (qEEG) measurements in 68 healthy volunteers dosed with single ascending and multiple ascending doses. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Abbvie, Alterity, Amytrx, Essex, Humacyte, Karyopharm, Merck & Co., Moderna, Newamsterdam, Nymox, Organicell, Oryzon, Pharmabcine, Viage. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aeglea, Ayala, Biosight, Cellularity, Immedica, Versea, Titan. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amarin, Anova, Denovo, Incannex, Innocare, Inozyme, Myopax, Octapharma, Opthea, Pint. Read More