Shots:
Dyno Therapeutics has reported that Astellas has exercised its option to license an AI-engineered AAV capsid for skeletal muscle delivery, marking the first licensed asset from their 2021 collaboration
The capsid, designed using Dyno’s AI models trained on large-scale in vivo data, demonstrates improved muscle targeting at lower doses, addressing key safety & manufacturing…
NEWS
Shots:
Garda Therapeutics has entered into a definitive agreement to acquire Assertio, delisting it from Nasdaq
As per the deal, Garda will acquire Assertio for $18/share in cash (~$125.1M) plus a non-tradeable CVR related to potential future milestones for Sprix, with the deal expected to close in Q2’26 & remaining shares acquired later via a…
Shots:
The US FDA has granted clearance to ECG-AI algorithm, a software-as-a-medical-device designed for cardiac amyloidosis (CA), cleared for use with standard 12-lead ECGs
ECG-AI algorithm analyzes ECG waveforms to detect CA-related patterns not visible to clinicians, integrating into existing workflows using routine ECGs without additional testing to help identify at-risk pts & guide next…
Shots:
Halozyme Therapeutics, via its subsidiary Halozyme Hypercon, has entered a global exclusive collaboration & license agreement with Vertex to utilize its Hypercon technology across up to three drug targets
As per the deal, Halozyme will receive $15M upfront, with additional milestone payments & royalties tied to products developed using the technology
Hypercon is a…
Shots:
The US FDA has received the NDA of neladalkib for the treatment of TKI pre-treated pts with advanced ALK-positive NSCLC
NDA was supported by global P-I/II (ALKOVE-1) trial of neladalkib in TKI-pretreated advanced ALK-positive NSCLC, showing favorable activity incl. intracranial responses, targeting key progression drivers, & a generally well-tolerated safety profile; data to be…
Shots:
The NMPA has approved Exdensur as an add-on therapy for adults with CRSwNP for whom therapy with systemic corticosteroids & /or surgery do not provide adequate disease control, based on P-III (ANCHOR 1 & 2) trials
The ANCHOR-1 & ANCHOR-2 trial assessed Exdensur(Q6M)+ intranasal corticosteroids (SoC) vs PBO + SoC in 271 & 257 pts,…
Shots:
Biocon has reported the commercial launch of Bosaya & Aukelso, an interchangeable biosimilar version of Prolia & Xgeva (Denosumab) in the US, following FDA approval in Sep 2025
Bosaya will be available in the 60mg/mL PFS format, while Aukelso will be available as 120mg/1.7 mL (70mg/mL) single-dose vial, both for subcutaneous use
Denosumab is a…
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The US FDA has approved the Nexus Aortic Arch Stent Graft for the treatment of aortic arch disease
Approval was supported by the 1yr. results from the TRIOMPHE IDE trial assessing Nexus in aortic arch disease, incl. chronic aortic dissections, in pts at high risk for open surgical repair, which showed safe & effective treatment in…
Shots:
Gilead has entered into a definitive agreement to acquire Tubulis, making it an ADC research organization within Gilead, with the Munich site serving as a hub for ADC innovation
As per the deal, Gilead will acquire Tubulis for $3.15B upfront & ~$1.85B in contingent milestone payments; closing is expected in Q2’26
Acquisition will expand…
Shots:
Alloy Therapeutics has entered into a collaboration & license agreement with Biogen to advance antisense therapeutics against multiple undisclosed targets using Alloy’s AntiClastic ASO Platform
As per the deal, Alloy will receive an upfront payment, along with additional milestone payments & tiered royalties on any products resulting from the collaboration
The AntiClastic ASO platform…

