South San Francisco-based Septerna Inc. filed an S-1 with the U.S. SEC to conduct an IPO on Nasdaq about two years and eight months after launching operations with a $100 million series A led by Third Rock Ventures. The company is focused on G protein-coupled receptor oral small molecules derived from its Native Complex Platform, aimed at treating diseases within the endocrinology, immunology and inflammation, and metabolic diseases realms.
Loqus23 Therapeutics Ltd. has raised £35 million (US$46.6 million) in a series A to take forward small molecules it has discovered for the treatment of Huntington’s disease and other conditions that are driven by DNA mismatch repair (MMR). MMR fixes DNA insertions, deletions and misincorporation errors that occur during transcription and/or cellular replication. Smaller repairs are directed by MutSalpha, a protein that binds single base mismatches, while MutSbeta handles larger insertion/deletion loops. Huntington’s and other triplet repeat diseases are caused when trinucleotide repeats accumulate in somatic DNA to the extent that they interfere with protein expression.
In one of the top series A financings in biopharma history, new company Kailera Therapeutics Inc. emerged with $400 million raised and a pipeline of next-generation assets to treat obesity and type 2 diabetes.
South San Francisco-based Kezar Life Sciences Inc. voluntarily stopped its phase IIb Palizade trial of zetomipzomib in active lupus nephritis, following four fatal, or grade 5, serious adverse events of patients enrolled in the Philippines and Argentina.
China’s National Medical Products Administration has approved Sino Biopharmaceutical Ltd.’s rivastigmine transdermal patch to treat mild to moderate Alzheimer’s disease. Developed by Sino Biopharm, the patch is the first domestically produced rivastigmine transdermal patch approved for marketing. Rivastigmine is a cholinesterase inhibitor used for the treatment of Alzheimer’s disease.
South San Francisco-based Kezar Life Sciences Inc. voluntarily stopped its phase IIb Palizade trial of zetomipzomib in active lupus nephritis, following four fatal, or grade 5, serious adverse events of patients enrolled in the Philippines and Argentina.
Cereno Scientific AB’s positive top-line results from the phase IIa trial of histone deacetylase inhibitor CS1 in pulmonary arterial hypertension provide a “clear path forward” in the debilitating, fatal disease, the company said.
The FDA has approved Cobenfy, a dual M1/M4 muscarinic agonist that offers a fundamentally different approach to treating schizophrenia. The fixed dose combination of xanomeline-trospium is the first to act via a novel mechanism for the serious psychiatric disorder in over 50 years, finally expanding the treatment options beyond dopamine-targeted therapies. Bristol Myers Squibb Co., which acquired Cobenfy developer Karuna Therapeutics Inc. for $14 billion in a deal that closed in March 2024, said the drug will be available in the U.S. from late October.
The risk and benefit of Pfizer Inc.’s oral sickle cell disease drug Oxbryta (voxelotor) has flipped, prompted by what the company called new clinical data indicating “an imbalance in vaso-occlusive crises and fatal events” that need more study. Based on an EMA recommendation, Pfizer said it is voluntarily recalling all lots of Oxbryta from wherever it’s approved worldwide. Pfizer also is shuttering its Oxbryta clinical studies and expanded access programs.
Nine years on from securing $3.84 million for a phase I clinical trial to test the formulation, with results showing it overcame side effects that had confounded its forerunner, the schizophrenia treatment Karxt met its PDUFA date Sept. 26 with no decision by midday. If approved, the fixed combination of xanomeline-trospium will be the first in a new drug class, and as a dual M1/M4 muscarinic agonist, the first new therapy to act via a novel mechanism for the serious psychiatric disorder in over 50 years.
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