Multiple sclerosis (MS) is a chronic immune-mediated disease characterized by the destruction of myelin sheaths, neuroaxonal damage, glial cell activation and formation of demyelinated plaques in the CNS. Since MS is considered a prototypic antigen-specific autoimmune disease, restoring immune tolerance to self-antigens is being explored as a therapeutic strategy.
Reporting sales of its hepatitis B vaccine Heplisav-B pretty much in line with consensus and a phase I/II shingles prospect moving along, Dynavax Technologies Corp. scored a takeover deal with Sanofi SA, which is paying $15.50 per share in cash for a total equity value of about $2.2 billion. The amount is a 39% premium to Dynavax’s closing share price yesterday, Dec. 23.
Formation Bio Inc. acquired ex-China rights to Lynk Pharmaceuticals Co. Ltd.’s oral TYK2-inhibitor, LNK-01006, for up to $605 million. The phase I-ready central nervous system (CNS) candidate will be developed at Formation’s newly formed subsidiary, Bleecker Bio.
Sanofi SA reported more hitches in the development of Bruton’s tyrosine kinase inhibitor tolebrutinib, saying the phase III Perseus study failed to meet its primary endpoint in primary progressive multiple sclerosis (MS) and that the ongoing U.S. regulatory review in non-relapsing secondary progressive MS likely will extend beyond the targeted PDUFA date of Dec. 28.
Formation Bio Inc. acquired ex-China rights to Lynk Pharmaceuticals Co. Ltd.’s oral TYK2-inhibitor, LNK-01006, for up to $605 million. The phase I-ready central nervous system (CNS) candidate will be developed at Formation’s newly formed subsidiary, Bleecker Bio.
Lynk Pharmaceuticals Co. Ltd. has received IND clearance from the FDA for LNK-01006, an allosteric TYK2 inhibitor with potential to treat neurodegenerative diseases.
Biohaven Therapeutics Ltd. has synthesized pyruvate kinase M2 (PKM2) activators reported to be useful for the treatment of age-related macular degeneration, amyotrophic lateral sclerosis, multiple sclerosis, retinitis pigmentosa and fibrosis.
Contineum Therapeutics Inc.’s midstage study of its multiple sclerosis drug, PIPE-307, missed its primary and secondary endpoints, dropping the stock on Nov. 21. Top-line phase II results from the Vista study of the M1 receptor agonist PIPE-307 for treating relapsing-remitting multiple sclerosis saw no significant changes in binocular 2.5% low contrast letter acuity in the treatment arms, a key efficacy measure.
Tr1x Inc. has obtained IND clearance from the FDA for TRX-319, paving the way for initiation of a phase I/IIa study in progressive multiple sclerosis (MS) early next year. TRX-319 is designed to combine targeted B-cell control with active anti-inflammatory signaling and T-cell regulation, with the goal of restoring immune balance.
