Genfleet Therapeutics Inc. has entered the KRAS G12C inhibitor race in the U.S. as it gears up to begin phase III trials of GFH-925 (IBI-351) in patients with refractory metastatic colorectal cancer (CRC) following FDA clearance. GFH-925 was the first KRAS G12C inhibitor to receive breakthrough therapy designation from China's National Medical Products Administration for previously treated advanced CRC.

Barinthus Biotherapeutics plc’s immunotherapeutic against persistent, high-risk human papillomavirus (HPV) infections, VTP-200, was generally well-tolerated in a phase Ib/II study, but did not demonstrate significant signs of efficacy, pooled top-line data show.

Corner Therapeutics Inc. raised $54 million in a series A financing to create vaccines to protect against cancer and infectious diseases by helping the immune system engineer T cells. The company’s core interest is in advancements in immunotherapy through direct manipulation of T cells, which are the “keys to the kingdom for any cancer therapy,” Nick Seaver, Corner’s chief business officer, told BioWorld.

Cerevel Therapeutics Inc.’s positive results from the long-shot pivotal phase III Tempo-3 trial with tavapadon – the first D1/D5 receptor partial agonist being studied as a once-daily treatment for Parkinson’s disease – added gravy to the $8.7 billion takeover by Abbvie Inc., disclosed late last year. The buyout’s centerpiece was the late-stage asset emraclidine, a positive allosteric modulator of the muscarinic M4 receptor, touted as a potential best-in-class, next-generation antipsychotic for schizophrenia, which strikes more than 5 million people in the G7 (U.S., France, Germany, Italy, Spain, U.K. and Japan).

Eli Lilly and Co. is planning to file for U.S. FDA approval later this year after reporting that tirzepatide met all primary and key secondary endpoints in two phase III trials in obstructive sleep apnea (OSA). Assuming approval, tirzepatide could become the first drug approved specifically for OSA, while providing potential entry access for Medicare Part D coverage, which is denied for the GLP-1 class of drugs approved as obesity medications.

After Sage Therapeutics Inc. reported a phase II failure with oral dalzanemdor, also known as SAGE-718, in mild cognitive impairment related to Parkinson’s disease (PD), Wall Street’s eyes turned to ongoing mid-stage efforts with the same N-methyl-D-aspartate receptor-positive allosteric modulator in Huntington’s disease and Alzheimer’s disease.

Neurotech International Ltd.’s cannabinoid NTI-164 met the primary and secondary endpoints in a phase II/III trial in children with autism spectrum disorder. The company also reported positive top-line data for Rett syndrome in a phase I/II trial.

With no drugs approved by the U.S. FDA for treating Becker muscular dystrophy, Edgewise Therapeutics Inc. reported positive two-year, phase Ib data looking at patients’ ability to physically function, plus biomarker data.