Although Geron Corp.’s imetelstat met its primary and key secondary endpoints in a phase III study, the U.S. FDA is questioning the magnitude and durability of the effect of the first-in-class telomerase inhibitor as a second-line treatment of transfusion-dependent anemia in adults with low- to intermediate-1 risk myelodysplastic syndromes. The agency’s concerns resulted in more than an 12% stock tumble March 12 after the FDA released its briefing document two days ahead of an Oncology Drugs Advisory Committee meeting, in which the panel will be asked to vote on whether imetelstat’s benefits outweigh its risks.
Sosei Group Corp. is getting €25 million (US$27.3 million) up front in a global collaboration and option-to-license deal with Boehringer Ingelheim GmbH aimed at developing GPR52 agonists, a new target for schizophrenia designed to potentially address positive, negative and cognitive symptoms at the same time.
Dimerix Ltd. announced a AU$20 million ($US13.22 million) capital raise following the news that its lead candidate, DMX-200, was successful in a prespecified interim analysis of the efficacy endpoint in its pivotal phase III trial in focal segmental glomerulosclerosis, a rare kidney disease.
Sosei Group Corp. is getting €25 million (US$27.3 million) up front in a global collaboration and option-to-license deal with Boehringer Ingelheim GmbH aimed at developing GPR52 agonists, a new target for schizophrenia designed to potentially address positive, negative and cognitive symptoms at the same time.
Boehringer Ingelheim Pharma GmbH & Co KG and Sosei Group Corp. have entered a global collaboration and exclusive option-to-license agreement in schizophrenia.
The Department of Defense (DoD) office of the Congressionally Directed Medical Research Programs (CDMRP) has awarded funding to Biosplice Therapeutics Inc.’s collaboration with The Roskamp Institute aimed at developing novel therapies for traumatic brain injury (TBI).
Bridgebio Pharma Inc. has obtained FDA clearance for its IND application for BBO-8520, a first-in-class orally bioavailable and potent small-molecule direct inhibitor of KRAS G12C (ON) state. The company expects to begin enrolling patients with KRAS G12C mutant non-small-cell lung cancer (NSCLC) in the first half of this year.
Jiangsu Atom Bioscience and Pharmaceutical Co. Ltd. has received FDA clearance of its IND application for a phase I trial in the U.S. of ABP-745, an anti-inflammatory oral small-molecule drug, for the treatment of acute gout.
Iama Therapeutics Srl has obtained clinical trial application (CTA) clearance from the Italian Medicines Agency (AIFA) to initiate a first-in-human phase I study of IAMA-6, an orally administered small-molecule therapeutic targeting NKCC1 for the treatment of autism and epilepsy.
Hemispherian AS has been granted NOK16 million (US$1.54 million) by the Research Council of Norway, which the company intends to use to support development of its drug candidates aimed at treating platinum-resistant ovarian cancers.
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