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.
Arcus Biosciences Inc. and partner Gilead Sciences Inc. are scrapping phase III work with anti-TIGIT antibody domvanalimab after an independent data monitoring committee said the drug will fail in gastric and esophageal cancers.
AC Immune SA plans talks with regulators based on positive interim safety and efficacy results from the phase II Vacsyn trial of its wholly owned anti-alpha-synuclein (a-syn) active immunotherapy ACI-7104.056 in early Parkinson’s disease (PD). The firm said that for the first time, data support targeting a-syn pathology via such a strategy. Disease-related biomarker results that suggest PD slowing include a-syn cerebrospinal fluid (CSF) levels and neurofilament light (NfL).
Exicure Inc.’s buyout early this year of GPCR Therapeutics Inc. is paying off in a big way with data from the finished phase II trial testing burixafor (GPC-100). The agent is used with propranolol and granulocyte colony-stimulating factor to mobilize hematopoietic progenitor cells in patients with multiple myeloma (MM) undergoing autologous hematopoietic cell transplant.
GSK plc said in paperwork filed with the U.S. SEC that the potentially whopping deal inked in the summer of 2020 with Ideaya Biosciences Inc. has gone down the tubes. The two firms were collaborating on three of Ideaya’s synthetic lethality programs, MAT2A (methionine adenosyltransferase 2a), Pol Theta (polymerase theta) and Werner Helicase.
GSK plc said in paperwork filed with the U.S. SEC that the potentially whopping deal inked in the summer of 2020 with Ideaya Biosciences Inc. has gone down the tubes.
On the heels of mixed phase III data from Agios Pharmaceuticals Inc. with mitapivat to treat sickle cell disease (SCD), Fulcrum Therapeutics Inc. wowed investors by way of initial results from the ongoing 20-mg dose cohort in the phase Ib Pioneer trial testing oral, once-daily fetal hemoglobin inducer pociredir.
Individual liberty and choice vs. wider public health became one predictable hinge upon which swung the often-acerbic debates at the CDC’s Advisory Committee for Immunization Practices (ACIP) meeting, which took up – again – the matter of hepatitis B virus (HBV) vaccine scheduling, a day after the panel voted not to vote on such guidance.
Drug developers big and small are pursuing a solution for the curse of psychosis that occurs along with the already tragic diagnosis of Alzheimer’s disease, an affliction known as ADP.
Shares of San Diego-based Capricor Therapeutics Inc. (NASDAQ: CAPR) closed Dec. 3 at $29.96, up $23.60, or 371%, as investors cheered top-line data from the pivotal phase III Hope-3 trial testing cell therapy deramiocel in Duchenne muscular dystrophy.
