Shots:
NMPA has accepted the supplemental application of toripalimab + Pt-containing CT as perioperative treatment & subsequent monotx. as adj. therapy for the treatment of adult pts with resectable stage II-III NSCLC
Filing was based on P-III (NEOTORCH) trial (n=501), which showed perioperative toripalimab + CT met 1EP of improved EFS by 60% (mEFS: not reached…
Shots:
Akari has entered into a strategic research collaboration with Whitehawk to evaluate Akari’s PH1 spliceosome-modulating payload tech in combination with Whitehawk’s TOP1i ADC platform
As per the deal, Akari will lead the design, execution, & evaluation of the research program, which will incl. multiple preclinical workstreams assessing dual-payload compatibility & potential synergies
Collaboration begins…
Shots:
Telix has dosed the first patient with TLX250-Tx (lutetium-177 (177Lu) girentuximab tetraxetan) in the P-III (LUTEON) study to identify eligible pts with CAIX-positive tumors in r/r clear cell renal cell carcinoma (ccRCC)
LUTEON trial in Australia is part of Telix’s global development program for TLX250-Tx, alongside the P-IIa (LUTEON ATLAS) study in the US…
Shots:
Samsung Bioepis & Harrow have reported interim data from a P-IV post-marketing surveillance study on SB11, a biosimilar version of Lucentis (ranibizumab), conducted in South Korea from May 2022 to May 2026
The interim analysis incl. 298 of 305 enrolled pts (182 treatment-naïve & 116 switched), with investigator-determined dosing intervals & follow-up through 24wks.…
Shots:
The EC has approved an expansion of the indication for Crysvita (burosumab) for the treatment of X-linked hypophosphataemia (XLH), to incl. infants from 1mos. to 1yr. of age
Approval was supported by data from P-I/II (BUR-CL207) study assessing safety, tolerability, PK & efficacy of burosumab in pts with XLH from birth to 1yr. Trial showed…
Shots:
Incyte has entered into a global collaboration & license agreement with Halozyme to evaluate additional SC formulations of INCA033989 for pts with mutCALR-expressing myeloproliferative neoplasms, using Halozyme's Enhanze tech
As per the deal, Halozyme will receive an upfront payment, as well as milestone payments, plus royalties, with Incyte having an option to nominate up…
Shots:
Tempus AI has entered into a definitive agreement to acquire Personalis, expanding Tempus' capabilities in minimal residual disease (MRD)
As per the deal, Personalis shareholders will receive $16.25 per share, valuing the company at an enterprise value of $1.5B, net of Tempus AI’s existing ownership interest; closing expected in late 2026 or early 2027…
Shots:
Organon & Samsung Bioepis have expanded their development and commercialisation agreement to commercialise a new biosimilar in Australia
As per the deal, Organon will receive exclusive commercial rights to the biosimilar in Australia while Samsung Bioepis will be responsible for full development, manufacturing & regulatory responsibilities
The amended agreement expands their collaboration to 4…
Shots:
The EMA has accepted a submission to extend marketing authorization of Ebglyss (lebrikizumab) to pts (6mos. to <18yrs., weighing <40kg) with mod. to sev. atopic dermatitis
Application was supported by interim data from the pediatric clinical program, incl. the ADorable-1 evaluating Ebglyss in pts (6mos. to <18yrs.), & the ADorable-2 LTE study assessing safety…
Shots:
4DMT reported 2yr. data from the P-IIb (PRISM) trial evaluating intravitreal 4D-150 at 3E10 vg/eye (n=30) & 1E10 vg/eye (n=15) in 45 pts with wet age-related macular degeneration
P-IIb subgroup incl. 15 recently diagnosed pts treated with 3E10 vg/eye, which was also selected for the P-III (4FRONT) trials, with the 2-year Phase 2b data…

