Shots:
JCR & Acumen have entered into a joint collaboration, option, & license agreement to develop a novel therapy to treat Alzheimer’s disease leveraging JCR’s J-Brain Cargo tech
As per the deal, JCR will receive an upfront payment & an option payment if Acumen exercises its exclusive option to develop, manufacture, & commercialize up to…
Shots:
Debiopharm has entered into an exclusive global licensing agreement with Repare Therapeutics for lunresertib (PKMYT1 inhibitor) to treat difficult-to-treat solid tumors
As per the deal, Repare will receive $10M upfront, ~$257M in clinical, regulatory, commercial & sales milestones, incl. $5M in near-term payments & net sales-based single-digit royalties
Debiopharm will assume sponsorship of P-I (MYTHIC)…
Shots:
The US FDA has approved Kirsty (100 units/mL), an interchangeable biosimilar of NovoLog (Insulin Aspart) to improve glycemic control in adults & pediatric pts with diabetes mellitus
Approval was based on comprehensive analytical, non-clinical, & clinical data, which showed similar efficacy, safety, purity & potency of Kirsty vs NovoLog
Kirsty is a rapid-acting human…
Shots:
The UK’s MHRA has approved Ekterly (sebetralstat) to treat hereditary angioedema (HAE) pts (≥12yrs.). Awaits approval in various global markets incl. the EU & Japan
Approval was based on P-III (KONFIDENT) study assessing Ekterly (300mg & 600mg) vs PBO in 136 HAE pts (≥12yrs.) across 20 countries, which showed faster symptom relief, reduced attack severity &…
Shots:
Otsuka Pharmaceutical has entered into an agreement with Cantargia for the acquisition of all assets related to its P-I IL-1RAP antagonist program, CAN10
Otsuka Pharmaceutical will handle global development, regulatory approvals, manufacturing, & commercialization of CAN10. Otsuka has also acquired 3G5 as a backup antibody & holds exclusive negotiation right for next-gen IL-1RAP antibodies…
Shots:
BD to combine its Biosciences & Diagnostic Solutions business with Waters in a Reverse Morris Trust transaction
As per the deal, BD shareholders will receive $4B in cash & a 39.2% stake in the combined company, while Waters will assume $4B in debt & retain 60.8%, with the total deal value of $17.5B reflecting cash,…
Shots:
The US FDA has granted clearance to TAVIPILOT Soft for real-time intra-operative guidance of transcatheter heart valve implantation
TAVIPILOT Soft, set to launch by the end of 2025, is compatible with all cardiac imaging systems & will support all TAVI heart valves available on the market, thereby, allowing seamless integration in clinical settings
TAVIPILOT…
Shots:
LEO Pharma has entered into an exclusive global license & transfer agreement with BI to commercialize & advance the development of Spevigo (spesolimab)
As per the deal, LEO Pharma will handle commercialization & further development of Spevigo in exchange for $105.18M (€90M) upfront, along with milestones & tiered royalties; closing expected in H2’25, subject…
Shots:
Takeda has reported data from 2 P-III (FirstLight & RadiantLight) trials assessing oveporexton over 12wks. in NT1 pts, where FirstLight randomized 168 pts in 3 arms (high dose, low dose & PBO), while RadiantLight randomized 105 pts in 2 arms (high dose & PBO)
Both studies showed improvements across all doses at Wk. 12…
Shots:
AstraZeneca has reported P-III (BaxHTN) trial findings on baxdrostat in pts with uncontrolled hypertension on two antihypertensives & those with resistant hypertension on ≥3 drugs, incl. a diuretic
The P-III (BaxHTN) trial evaluated baxdrostat (1 or 2mg) vs PBO on top of SoCs in 796 pts over 12wks. At Wk. 24, 300 pts on…

