Shots:
Solid Biosciences has entered into a non-exclusive global license & collaboration agreement with Kinea Bio to develop & commercialize KNA-155 for treating dysferlin-related limb-girdle muscular dystrophy, using Solid’s AAV-SLB101 capsid
As per the deal, Kinea Bio will receive a non-exclusive global license to utilize AAV-SLB101 for the delivery of KNA-155, which will enter IND-enabling studies…
NEWS
Shots:
The CHMP has recommended Gobivaz (50mg/0.5mL & 100mg/mL in PFS & autoinjector), a biosimilar version of Simponi (golimumab) for the treatment of rheumatoid arthritis, PsA, ankylosing spondylitis & ulcerative colitis in adult pts & juvenile idiopathic arthritis across 30 EEA states
In trials, Gobivaz demonstrated comparable efficacy, safety, & immunogenicity to Simponi in pts…
Shots:
The US FDA has accepted sBLA & granted priority review to Enhertu + Perjeta for the 1L treatment of adults with unresectable or metastatic HER2+ breast cancer, which will be reviewed under RTOR pathway (PDUFA: Jan 23, 2026)
sBLA was supported by P-III (DESTINY-Breast09) trial data on Enhertu (5.4mg/kg) ± Perjeta vs taxane, trastuzumab & Perjeta…
Shots:
BMS has reported the P-III (EXCALIBER-RRMM) trial data assessing iberdomide + daratumumab + dexamethasone (IberDd) vs daratumumab + bortezomib + dexamethasone (DVd) in pts with r/r multiple myeloma
The trial has 2 stages: Stage 1 randomized ~200 pts to iberdomide (1, 1.3, or 1.6mg) plus daratumumab & dexamethasone, identifying 1mg as the selected dose; Stage…
Shots:
Variational AI has entered into a collaboration with Merck to design and optimize novel small molecule candidates against two undisclosed targets using Variational AI’s Enki platform
As per the deal, Variational AI will leverage its fine-tuned Enki platform trained on Merck’s proprietary data to generate & optimize small-molecule candidates for Merck’s targets, with Merck…
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The CHMP has recommended Tezspire for the treatment of Chronic Rhinosinusitis with Nasal Polyps (CRSwNP); regulatory review is ongoing in the US, China, Japan & other countries
Opinion was based on the P-III (WAYPOINT) study assessing Tezspire (SC) vs PBO to treat adults with severe CRSwNP for 52wks., followed by a post-treatment follow-up duration…
Shots:
Angelini Pharma has entered into an exclusive global option agreement with Sovargen to develop & commercialize SVG105 for the treatment of brain health disorders
As per the deal, Angelini & Sovargen will co-lead preclinical development of SVG105, with Angelini having the option to advance it clinically & commercially outside Korea, China, Hong Kong, Macau,…
Shots:
Starpharma has entered into a collaboration & license agreement with Genentech to develop dendrimer-drug conjugates incorporating Genentech’s drugs for oncology targets, leveraging Starpharma’s DEP drug delivery tech
As per the deal, Genentech will receive an exclusive global license under Starpharma’s IP to develop & commercialize collaboration-derived products, potentially multiple per target, in exchange for…
Shots:
The EC has approved Tryngolza (olezarsen) as an adjunct to diet in adult patients for the treatment of genetically confirmed familial chylomicronemia syndrome
Approval was based on P-III (Balance) trial assessing Tryngolza (Q4W) vs PBO, which showed reduced triglyceride levels at 6mos., sustained through 12mos., with decrease in acute pancreatitis events over 12mos.; data…
Shots:
The CHMP has recommended AVT03, a biosimilar version of Amgen’s Prolia & Xgeva (denosumab) for the treatment of bone & skeletal disorders
STADA & Dr. Reddy’s have semi-exclusive commercial rights to AVT03 in the EU, incl. Switzerland & the UK, leading to STADA marketing it as Kefdensis (Prolia; 60mg/mL PFS) & Zvogra (Xgeva; 70mg/mL single-use…

