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Regeneron has entered into an in-licensing agreement with Hansoh for exclusive global clinical development & commercialization rights of HS-20094, excl. Mainland China, Hong Kong & Macau
As per the deal, Hansoh will receive $80M upfront & ~$1.93B in development, regulatory & sales milestones, with low double digits royalties on sales in Regeneron-licensed areas
HS-20094…
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Skye Bioscience has partnered with Arecor Therapeutics to develop a higher concentration formulation of Skye’s nimacimab, leveraging Arecor’s Arestat formulation platform
As per the deal, Skye will fund Arecor's development efforts, with the option to license rights of the new proprietary formulation & its intellectual property for further development & commercialization
Nimacimab (CB1 inhibitor,…
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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…
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The US FDA has accepted NDA of oral Wegovy for chronic weight management & major adverse CV events risk reduction in adults with obesity or overweight & comorbidities (PDUFA: Q4’25)
Submission was based on the P-III (OASIS 4) trial assessing oral Wegovy (25mg; OD) vs PBO over 64wks. (incl. 12wk. dose escalation & 7wk.…
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Pfizer has discontinued the development of danuglipron (PF-06882961) as a potential therapy for chronic weight management
Danuglipron was evaluated in 2 P-I trials (NCT06567327 & NCT06568731), meeting key PK objectives & confirming formulation & dose with potential for strong efficacy & tolerability in P-III. However, a case of drug-induced liver injury & recent regulatory input led…
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Zealand Pharma & Roche will develop & market petrelintide & its products incl. petrelintide + CT-388 (Roche’s asset) in the US & EU for weight loss, with Roche obtaining exclusive marketing rights in the rest of the world
Zealand will handle ~50% marketing in the US & EU with opt-in/out rights under specific…
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Novo Nordisk has reported P-III (REDEFINE 2) trial data assessing CagriSema (cagrilintide 2.4mg + semaglutide 2.4mg, QW, SC) vs PBO in 1,206 obese/overweight pts (~102Kg) and type 2 diabetes for 68wks., and followed flexible dosing protocol with 61.9% pts reaching highest dose after 68wks.
Trial met its co-1EPs demonstrated 15.7% superior weight loss…
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The P-Ib/IIa trial assessed amycretin (Q1W) vs PBO in overweight or obese patients (n=125) in 5 parts
Part A (single ascending dose) assessed PK & determined the initial dose for Part B (multiple dose arm), which evaluated safety/tolerability over 36wks. Parts C, D, & E (PoC) evaluated weight loss with 3 doses (1.25mg,…
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The P-IIIb (STEP UP) study assessed semaglutide (7.2mg) vs semaglutide (2.4mg) & PBO as an adjunct to lifestyle intervention in obese adults (n=1,407; BMI ≥30kg/m^2) without diabetes for 72wks. STEP program also includes STEP UP T2D study of semaglutide (7.2mg) in obese adults (n=512) with T2D for 72wks.
Study met its 1EP, depicting…
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