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NEWS

Janux Therapeutics and BMS Forge ~$850M Deal to Develop Therapies in Oncology

Shots: Janux has entered into a collaboration & exclusive global license agreement with BMS to develop a novel, undisclosed tumor-activated therapy targeting a validated solid-tumor antigen expressed across multiple cancer types Janux will advance the program through preclinical development & IND submission, after which BMS will hold the IND, lead global development & commercialization, with…
January 23, 2026

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NEWS

IntraBio Reports Topline P-III (IB1001-303) Trial Data on Aqneursa for Ataxia-Telangiectasia

Shots: IntraBio has reported the topline P-III (IB1001-303) trial data on Aqneursa (levacetylleucine) vs PBO in pediatric & adult pts with Ataxia-Telangiectasia (A-T) Trial met the 1EP with a significant –1.88 SARA improvement vs PBO (–1.92 vs –0.14) after 12wks.& achieved 2EPs, showing meaningful gains on ICARS (–4.22 vs –1.69) & CGI-I (–0.6 vs –0.2)…
January 22, 2026

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CereVasc Completes Patient Enrolment in ETCHES 1 Study of eShunt System for Communicating Hydrocephalus

Shots: CereVasc completed enrollment in the ETCHES-1 Study evaluating its eShunt System in adults with communicating hydrocephalus resulting from elevated intracranial pressure following post-aneurysmal subarachnoid hemorrhage Study will assess changes in intracranial pressure, device performance & safety, with pts monitored for safety outcomes for up to 24mos. following the procedure eShunt System is designed to…
January 22, 2026

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Celcuity
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The US FDA Accepts Celcuity’s Gedatolisib NDA under Priority Review to Treat HR+/HER2- Breast Cancer

Shots: The US FDA has accepted NDA under priority review of gedatolisib in HR+/ HER2-, PIK3CA wild-type advanced breast cancer, which will be reviewed under RTOR pathway (PDUFA: Jul 17, 2026) NDA was supported by data from the PIK3CA wild-type cohort of the P-III (VIKTORIA-1) study assessing gedatolisib + fulvestrant ± palbociclib vs SoC in HR+/HER2-…
January 22, 2026

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NEWS

Trisol Medical Reports US Early Feasibility Study Results on Transcatheter Tricuspid Valve Replacement (TTVR) System

Shots: The US Early Feasibility Study assessed TTVR system in 22 pts with severe to torrential tricuspid regurgitation; enrollment in the trans-jugular cohort is complete, with the study continuing via Trisol’s newly developed trans-femoral access route Safety outcomes showed <5% permanent pacemaker need at 30 days, with considerable reduction in tricuspid regurgitation following implantation At 30 days…
January 22, 2026

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NEWS

IntraBio’s Aqneursa Receives the EC Approval for Treating Niemann-Pick Disease Type C (NPC)

Shots: The EC has approved Aqneursa (levacetylleucine), available as 1g granules for oral suspension, with or without miglustat for treating adults & pediatric pts (≥6yrs.; ≥20kg) with NPC Approval was backed by P-III (IB1001-301) crossover study assessing Aqneursa vs PBO in NPC pts, which showed improved neurological symptoms & function after 12wks. as measured by…
January 22, 2026

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Ionis and Otsuka
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The EC Approves Ionis and Otsuka’s Dawnzera (Donidalorsen) as a Prophylactic Treatment of Hereditary Angioedema (HAE)

Shots: The EC has approved Dawnzera (SC autoinjector; Q4W/Q8W) for the routine prevention of HAE attacks in pts (≥12yrs.) Approval was based on P-III (OASIS-HAE) trial & OASISplus study, showing improvements across multiple domains, incl. sustained reduction in mean monthly HAE attack rate, with 94% overall mean monthly reduction at 1yr. in the OASISplus OLE study Approval…
January 22, 2026

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NEWS

Insilico Medicine and Hygtia Therapeutics Partner to Advance ISM8969 for CNS Disorders

Shots: Insilico Medicine & Hygtia Therapeutics have entered into a co-development global collaboration agreement for Insilico's ISM8969 program for CNS disorders As per the deal, Hygtia will receive 50% worldwide rights to research, develop, register, manufacture, & commercialize ISM8969 in exchange for ~$66M, incl. milestone payments & $10M initial upfront payment Under the agreement, Insilico…
January 21, 2026

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NEWS

SurGenTec Receives the US FDA Clearance for ION-C Facet Fixation System

Shots: The US FDA has granted clearance to ION-C Facet Fixation System, part of SurGenTec’s posterior cervical platform, for the treatment of cervical pseudoarthrosis Clearance was supported by IRB-approved long-term study data showing bridging bone across facet joints with no reported AEs, implant migration, or revision surgeries, & postoperative imaging confirming preserved cervical alignment &…
January 21, 2026

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