Shots:
The US FDA has granted clearance to the Magnetic EEG-guided Resonance Therapy (MeRT) System, a personalized, biomarker-guided neuromodulation technology for Post-Traumatic Stress Disorder (PTSD)
Clearance was supported by a trial conducted with investigators from Texas A&M Health Institute of Biosciences & Technology, demonstrating that MeRT significantly reduced PTSD symptom severity with clinically meaningful improvements…
Shots:
The Chinese NMPA has approved Akeso’s gumokimab (AK111; SC, 17 doses per year, incl. loading) to treat mod. to sev. plaque psoriasis in adults based on the P-III (AK111-301) trial & 3 supportive studies, showing rapid improvement in 2wks.
Data showed short-term efficacy, with a PASI 75 response rate approaching 94.6% & PASI 100 reaching…
Shots:
Takeda has reported topline P-III (LATITUDE Atlas) trial data assessing zasocitinib (TAK-279; 30mg, PO, QD) vs deucravacitinib (6mg, QD) in 606 adults with mod. to sev. PsO
Trial showed that zasocitinib was superior to deucravacitinib in the 1EP, with improved PASI 100 response rates at Wk. 16, plus in all key 2EPs, incl. PASI 90…
Shots:
Merck Animal Health has entered into a definitive agreement to acquire TARGAN for an undisclosed purchase price; closing is expected in Q3’26
Upon closing, the acquisition will expand MAH’s poultry portfolio with WingScan, an automated chick sorting platform that uses vision tech & proprietary algorithms to identify & sort chicks by gender in real…
Shots:
The P-II/III (ENERGY) trial assessed 2 different dose schedules of J&J's Imaavy vs PBO in 115 adults living with wAIHA for 24wks. followed by an OLE period, where pts received Imaavy for 144wks. with a follow-up of 6wks. after the last assessment
In the 30mg/kg group, Imaavy showed mean increase of 1g/dL in Hgb…
Shots:
Novartis has reported data from the biomarker cohort of the P-I/II (FORTITUDE) study assessing delpacibart braxlosiran (2mg/kg, Q6W) vs PBO in 90 pts (16-70yrs.) with facioscapulohumeral muscular dystrophy (FSHD)
Trial met its 1 & key 2EPs, showing reductions in KHDC1L (cDUX) & creatine kinase biomarker levels, which indicates potent target engagement & decrease in…
Shots:
The US FDA has accepted sBLA & granted priority review to adj. Tecentriq (atezolizumab) & Tecentriq Hybreza (atezolizumab & hyaluronidase-tqjs) in combination with CT in stage III dMMR or MSI-H colon cancer (PDUFA: Oct 9, 2026)
sBLA was based on the P-III (ATOMIC) trial assessing Tecentriq to FOLFOX6 CT in 712 pts with stage…
Shots:
GlycoNex has reported the P-III trial results assessing SPD8 (SC, Q6M), a biosimilar version of denosumab co-developed with Mitsubishi Gas Chemical, vs Prolia in 266 Japanese subjects with osteoporosis
Trial met its 1EP, with SPD8 demonstrating therapeutic equivalence to Prolia. The between-group difference in the 1EP & its 95% confidence interval fell within the pre-specified…
Shots:
XtalPi has entered into a strategic partnership with a biopharmaceutical company to develop an oral small molecule against G protein-coupled receptor
XtalPi will leverage its structure-based drug design platform, combining quantum physics, generative AI, large-scale automated chemical synthesis orchestrated by a multi-agent system to accelerate Design-Make-Test-Analyze (DMTA) cycles
As per the deal, XtalPi will receive…
Shots:
Orionis Biosciences has entered into a multi-year collaboration with Novartis to discover & design molecular glue drugs for challenging therapeutic targets across multiple disease areas
As per the deal, the companies will leverage Orionis’s Allo-Glue platform & AI-powered discovery engine to accelerate target & ligase profiling, as well as molecular glue optimization, enabling the…

