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…
Shots:
The NMPA has accepted IND application for HBM7004 for the treatment of advanced solid tumors
HBM7004, developed using Harbour’s HBICE platform, is a novel B7H4×CD3 bispecific antibody that is designed to enhance cancer immunotherapy, aiming to improve both efficacy & safety through targeted immune activation
In preclinical studies, HBM7004 induced B7H4-dependent T-cell activation within…
Shots:
The Japanese MHLW has granted full marketing approval to Telomelysin Injection (suratadenoturev/OBP-301) for the treatment of esophageal cancer pts ineligible for curative resection or CT, based on a Japanese pivotal trial conducted at 17 sites
Approval triggered a milestone payment to Oncolys under its deal with FUJIFILM Toyama Chemical, which granted FUJIFILM commercialization rights…

