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Filed: 2026-07-30 AccNo: 0001193125-26-326337 Size: 20 MB Item 1.01: Entry into a Material Definitive Agreement Item 9.01: Financial Statements and Exhibits
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Vertex Pharmaceuticals reported positive results from its phase IIb AMPLIFIED study, showing that inaxaplin reduced UACR by 42.7% in AMKD patients with modest proteinuria and 17.3% in those with AMKD and type II diabetes. The company has completed enrollment in the phase II/III AMPLITUDE pivotal study, with interim data expected in early 2027. Inaxaplin was well-tolerated with no serious adverse events reported.
Xenon Pharmaceuticals submitted an FDA application for azetukalner to treat focal onset seizures, supported by positive phase IIb and phase III epilepsy studies showing significant seizure reductions. However, the company temporarily paused enrollment in depression studies due to neuropsychiatric adverse events, causing a 27% stock decline in premarket trading. The X-NOVA2 depression study is 80% enrolled with top-line data expected in Q1 2027.
Definium Therapeutics announced positive Phase III results for DT120 ODT in generalized anxiety disorder, with the Panorama study meeting primary and key secondary endpoints. The treatment showed a 5.1-point placebo-adjusted benefit in HAM-A scores at Week 12 with rapid effects by day 2. The company plans an FDA pre-NDA meeting in Q4 2026 and NDA filing in H1 2027, with DT120 also advancing in major depressive disorder and posttraumatic stress disorder trials.
Verastem (VSTM) shares have surged 121% over three months, driven by accelerating sales of ovarian cancer drug Avmapki Fakzynja Co-Pack, which generated $25.1 million in Q2 2026 revenues (up 1,095% YoY), and growing optimism around VS-7375, a KRAS G12D inhibitor in phase II trials across pancreatic, lung, and colorectal cancers. The company expects VS-7375 data in October 2026 and plans FDA meetings before year-end to discuss phase III pivotal trial designs.