Shots:
Earendil Labs has granted Sanofi exclusive global rights to develop HXN-1002 & HXN-1003 bispecific antibodies for autoimmune & inflammatory bowel diseases
As per the deal, Earendil Labs will receive $125M upfront, ~$1.72B in development & commercial milestones, incl. a near-term $50M payment, & tiered royalties ranging from high-single to low-double digits
Developed using Earendil…
NEWS
Shots:
China’s NMPA has accepted NDA of zurletrectinib (ICP-723) for the treatment of pts (≥12yrs.) with advanced solid tumors having NTRK gene fusions
In a registrational trial, zurletrectinib demonstrated favorable safety & strong efficacy, with the ability to overcome acquired resistance to the 1st generation TRK inhibitors in mentioned pts
Zurletrectinib is a next-generation pan-TRK inhibitor…
Shots:
BriaCell has reported P-II trial data comparing Bria-IMT + check point inhibitors (CPI) to Trodelvy's historical data in heavily pre-treated pts (n=54) with late-stage metastatic breast cancer
37 HR+ breast cancer pts of P-II trial were treated with the ongoing pivotal P-III (BRIA-ABC) trial formulation of Bria-IMT, showing favorable survival data
Trial showed 25/37…
Shots:
The US FDA has granted 510(k) clearance to Clarity algorithm for the detection of electrographic seizures in pts (≥1yrs.)
Pediatric clearance was backed by extensive electroencephalography (EEG) dataset developed from ~1,700 pts to detect non-convulsive seizures, ensuring rapid diagnosis & prevention of serious brain injury
Clarity algorithm allows seizure detection in both pediatric &…
Shots:
The US FDA has approved Valtoco for short-term treatment of acute repetitive seizures (seizure clusters) in pts (≥2yrs.) with epilepsy
Approval was based on P-I/IIa trial assessing safety & PK of Valtoco, which showed favorable safety & efficacy with easy administration in pts who had episodes of frequent seizures; data was presented at CNS…
Shots:
The IIT P-II (IPAX-Linz) trial assessed TLX101 (IV) in 8 glioblastoma pts with recurrent tumors & PET-confirmed amino acid uptake, who received adaptive dosing with ~4GBq before & ~2GBq after, 2L EBRT; 5/8 had MGMT-unmethylated tumors
Trial showed mOS of 12.4mos. or 32.2mos. from initial diagnosis, complementing P-I (IPAX-1) trial results of 13mos. & 23mos.,…
Shots:
Vivani Medical & Okava Pharmaceuticals have expanded their 2019 collaboration to develop OKV-119 for cardiometabolic conditions in dogs, which initially focused on cats
Financial terms of the expanded agreement remain undisclosed but incl. future milestones & royalty payments to Vivani
OKV-119 (GLP-1 receptor agonists) uses Vivani’s NanoPortal tech for steady drug delivery over time from…
Shots:
RadNet has entered into a definitive merger agreement to acquire iCAD in an all-stock transaction, through which iCAD will become a wholly owned subsidiary of RadNet
As per the deal, iCAD stockholders will receive 0.0677 RadNet shares/ iCAD share, representing transaction value of ~$103M, or ~$3.61/share (~98% premium) on a fully diluted basis; closing…
Shots:
Oak Hill Bio has entered into an exclusive license agreement with Roche to obtain global rights of rugonersen (RO7248824) for the treatment of angelman syndrome
Oak Hill to initiate a pivotal P-III trial of rugonersen for angelman syndrome in early 2026, pending regulatory review of the final trial protocol
TANGELO study led by Roche,…
Shots:
Biocon Biologics & Regeneron have entered into a settlement & license agreement, allowing the US launch of Yesafili, an interchangeable biosimilar version of Eylea (aflibercept) by H2’26
Yesafili’s FDA approval was supported by analytical, nonclinical & clinical data incl. P-III (INSIGHT) trial assessing Yesafili vs Eylea in DME pts, confirming its similarity in PK,…

