NEWS

Novo Nordisk Enters a ~$2.2B Deal with Septerna to Develop Oral Small Molecules for Cardiometabolic Diseases

Shots: Septerna & Novo Nordisk to identify, develop & market oral small molecules for obesity, T2D & other cardiometabolic diseases under an exclusive global collaboration & license agreement As per the deal, Septerna will receive ~$2.2B, incl. over $200M in upfront & near-term milestones, plus research, development, & commercial milestones, along with net sales-based tiered…

May 15, 2025

Merck’s Welireg Receives the US FDA’s Approval for Pheochromocytoma and Paraganglioma

Shots: The US FDA has approved Welireg for the treatment of pts (≥12yrs.) with advanced, unresectable, or metastatic pheochromocytoma & paraganglioma (PPGL) Approval was based on Cohort A1 data from P-II (LITESPARK-015) trial assessing Welireg monotx. (120mg; QD) in 72 pts with unresectable or non-curable PPGL & stable blood pressure (BP <150/90 mm Hg, <135/85 mm…

May 15, 2025

Herantis Pharma Reports First Patient Dosing in P-Ib Trial of HER-096 for Parkinson’s Disease

Shots: Herantis has dosed first pts with HER-096, a synthetic peptidomimetic in final arm of its P-Ib trial for Parkinson’s disease The P-Ib trial consists of 2 parts, with the 1st assessing the safety & PK properties of 300mg HER-096 (SC) & Part 2 evaluating HER-096 vs PBO in 2 Arms along with selected biomarkers…

May 14, 2025

Median Technologies Seeks the US FDA’s 510(k) Clearance of eyonis LCS for Lung Cancer Detection

Shots: The US FDA has received application for 510(k) clearance of eyonis Lung Cancer Screening (LCS) to detect & diagnose lung cancer, with clearance expected in Q3'25 Submission is backed by 2 studies, REALITY & RELIVE, both of which met their 1EP; REALITY depicted an AUC of 0.904 (vs 0.80 threshold), accurately detecting early lung…

May 14, 2025

Cytokinetics Reports P-III (MAPLE-HCM) Trial Data of Aficamten for Obstructive Hypertrophic Cardiomyopathy

Shots: Cytokinetics has reported P-III (MAPLE-HCM) trial data assessing aficamten vs SoC metoprolol in pts (n=175) with symptomatic obstructive hypertrophic cardiomyopathy (HCM); regulatory review is ongoing in the US FDA (PDUFA: Dec 26, 2025) & EMA, with its NDA also under NMPA's priority review The trial met its 1EP, showing superior improvement in peak oxygen…

May 14, 2025

GSK to Acquire Efimosfermin Alfa from Boston Pharmaceuticals for ~$2B, Strengthening its Hepatology Pipeline

Shots: GSK to acquire Boston’s lead asset, efimosfermin alfa, a P-III candidate for steatotic liver disease (SLD) As per the deal, GSK will acquire BP Asset IX (Boston’s subsidiary) for ~$2B to access efimosfermin, incl. $1.2B upfront & $800M in milestones, plus GSK will also be responsible for royalties & milestone payments owed to Novartis…

May 14, 2025

REGENXBIO Reports the US FDA’s BLA Acceptance and Priority Review of RGX-121 for Treating Mucopolysaccharidosis II

Shots: The US FDA has accepted BLA & granted priority review to RGX-121 (clemidsogene lanparvovec) for the treatment of Mucopolysaccharidosis II (MPS II or Hunter syndrome), with PDUFA action date of Nov 09, 2025 As per Jan 2025 partnership, NS Pharma (Nippon Shinyaku’s subsidiary) will commercialize RGX-121 in the US post approval while REGENXBIO will handle…

May 14, 2025

Sarepta Therapeutics Reports the MHLW’s Conditional & Time-Limited Approval of Elevidys for Duchenne Muscular Dystrophy (DMD)

Shots: Japan's MHLW has granted conditional & time-limited approval to Elevidys for DMD pts (3–8yrs.) with no exon 8/9 deletions in the DMD gene & who are negative for anti-AAVrh74 Abs Approval was based on extensive clinical data, incl. 2yr. global P-III (EMBARK) trial showing motor function benefits vs external controls; Part 2 data was…

May 14, 2025

Mentice Reports US Launch of Ankyras 4.0 to Advance Patient-Specific Aneurysm Planning for Neuro Interventions

Shots: Following FDA 510(k) clearance, Mentice has launched Ankyras 4.0 for pts-specific flow diverter planning to treat intracranial aneurysms in the US Ankyras 4.0 introduces DICOM node integration, a redesigned user interface & broader accessibility via online platform & mobile apps, plus its integration with VIST simulation allows virtual case rehearsal to accelerate decision-making &…

May 13, 2025

Spice Biotechnologies Partners with AbTherx to Discover Antibodies in Immuno-Oncology

Shots: AbTherx has entered into a multi-program antibody discovery partnership with Spice Biotechnologies to identify antibodies against targets selected by Spice Bio, using AbTherx’s Atlas Mouse technologies As per the deal, Spice Bio will obtain rights to develop & commercialize antibodies from the collaboration in exchange for research payments, potential clinical & commercial milestones, plus…

May 13, 2025

NEWS

Novo Nordisk Enters a ~$2.2B Deal with Septerna to Develop Oral Small Molecules for Cardiometabolic Diseases

Merck’s Welireg Receives the US FDA’s Approval for Pheochromocytoma and Paraganglioma

Herantis Pharma Reports First Patient Dosing in P-Ib Trial of HER-096 for Parkinson’s Disease

Median Technologies Seeks the US FDA’s 510(k) Clearance of eyonis LCS for Lung Cancer Detection

Cytokinetics Reports P-III (MAPLE-HCM) Trial Data of Aficamten for Obstructive Hypertrophic Cardiomyopathy

GSK to Acquire Efimosfermin Alfa from Boston Pharmaceuticals for ~$2B, Strengthening its Hepatology Pipeline

REGENXBIO Reports the US FDA’s BLA Acceptance and Priority Review of RGX-121 for Treating Mucopolysaccharidosis II

Sarepta Therapeutics Reports the MHLW’s Conditional & Time-Limited Approval of Elevidys for Duchenne Muscular Dystrophy (DMD)

Mentice Reports US Launch of Ankyras 4.0 to Advance Patient-Specific Aneurysm Planning for Neuro Interventions

Spice Biotechnologies Partners with AbTherx to Discover Antibodies in Immuno-Oncology

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