Shots:
The P-III (BRUIN CLL-322) trial assessed Jaypirca + venetoclax & rituximab vs venetoclax & rituximab in r/r chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL), with both arms treated ~2yrs. followed by therapy-free period until disease progression
The trial met its 1EP, demonstrating improved PFS per IRC, with consistent results across clinically relevant subgroups…
Shots:
DeepCyte, a techbio startup focused on advancing AI-powered toxicology for drug development, has officially launched with $1.5 million in seed funding, introducing two solutions to help biopharma teams detect, predict, and understand drug toxicity in human cells at single-cell resolution
DeepCyte's MetaCore, a high-throughput single-cell metabolomics platform, leverages laser-based sampling and mass spectrometry to…
Shots:
C4 has entered into a new collaboration with Roche to develop degrader-antibody conjugates (DACs), combining targeted protein degradation with ADCs for cancer treatment
Partnership will focus on two oncology programs against undisclosed targets, leveraging C4’ Torpedo platform for degrader payloads, while Roche will select & design the antibodies, conjugate them to payloads, & lead…
Shots:
The US FDA has granted clearance to the Onclarity HPV Self-Collection Kit & approved the BD Onclarity HPV Assay for at-home use, expanding access to cervical cancer screening
The kit is tested with the BD Onclarity HPV Assay, detecting all high-risk HPV genotypes with individual & pooled results, & processed on the automated BD…
Shots:
Vanda Pharmaceuticals has initiated the Thetis study assessing Nereus (tradipitant) vs PBO for the prevention of vomiting in pts receiving GLP-1 receptor agonist therapies
The Thetis study will assess the proportion of pts free from vomiting episodes as the 1EP, with Vanda expecting topline results by Q4’26 & noting that additional data may be…
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…
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…

