Shots:
The US FDA has approved Utebzi (tebipenem pivoxil; 600mg, PO, Q6H) for the treatment of cUTIs incl. pyelonephritis, in adults who have limited or no alternative oral treatment options, with launch expected by the end of 2026
Approval was supported by the P-III (PIVOT-PO) trial demonstrating that Utebzi was non-inferior to IV imipenem-cilastatin in…
NEWS
Shots:
Biogen has entered into a definitive agreement to acquire RayThera, expanding its immunology pipeline
As per the deal, Biogen will acquire RayThera for ~$1B, incl. an upfront payment & clinical and regulatory milestone payments; closing is expected in Q3’26
Following closing, Biogen will lead development, manufacturing & global commercialization of RayThera’s assets, incl. the…
Shots:
Jazz has entered into a preclinical research collaboration, option & license agreement with AbCellera to discover & develop next-generation T-cell engaging (TCE) multispecific antibodies for GI cancer & other solid tumors, leveraging AbCellera’s antibody discovery engine
AbCellera will lead discovery & early-stage research for 2 initial programs, with a third to start within…
Shots:
The US FDA has accepted BLA of ozekibart (INBRX-109) for the treatment of patients with unresectable or metastatic conventional chondrosarcoma, with no filing review issues identified yet (PDUFA: Apr 14, 2027)
BLA was backed by the ChonDRAgon study assessing ozekibart vs PBO in pts with metastatic or unresectable conventional chondrosarcoma, which met its 1EP…
Shots:
FiberSense has received the CE Marking for its CGM System as a Class IIb medical device, with the company planning to launch in select markets, with initial orders confirmed & first deliveries expected in late 2026
The company is preparing manufacturing scale-up, logistics, customer support, & market access activities for launch, while advancing its…
Shots:
Edgewise has reported the 12wk. P-II Part D (CIRRUS-HCM) trial data assessing EDG-7500 (PO) in obstructive (oHCM; n=20) and nonobstructive (nHCM; n=33) Hypertrophic Cardiomyopathy, where pts in both groups received doses ranging from 25 to 150mg
In oHCM pts, EDG-7500 showed 90% pts had improved LVOT-G, 74% achieved NT-proBNP normalization, or ≥50% reduction, KCCQ-OSS…
Shots:
Altaris has entered into a definitive agreement to acquire Simulations Plus, making it a privately held subsidiary of Altaris & delisting it from NASDAQ
As per the deal, Altaris will acquire Simulations Plus in an all-cash transaction valued at $18.50/share, representing the total deal value of ~$375M; closing is expected in Q4’26
At or…
Shots:
Protillion has entered into a multi-target discovery collaboration & license agreement with Merck, integrating Protillion’s Prot-MaP technology with Merck’s global expertise in the discovery of novel therapeutic candidates
As per the deal, Protillion will receive an undisclosed upfront payment & ~$510M in research, development, & commercial milestone payments for the successful development of multiple…
Shots:
Dimerix has granted Everest exclusive rights to commercialize DMX-200 for all indications incl. FSGS, in Greater China, South Korea, Singapore, Malaysia, Thailand, Indonesia, Vietnam & Philippines; Dimerix will retain rights outside the licensed regions
Dimerix will continue funding & conducting the P-III (ACTION3) study, while Everest will manage regulatory filings, maintenance of the regulatory…
Shots:
The EC has granted centralized marketing authorization to Zandoriah, a biosimilar version of Forsteo (teriparatide) for the treatment of osteoporosis in adults, across all 30 EEA states
Zandoriah has demonstrated biosimilarity in line with EMA guidelines, with comprehensive comparability studies confirming similar quality, safety, and efficacy to the reference product
Teriparatide is a synthetic…

