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Inozyme Pharma

BioMarin Pharmaceutical to Acquire Inozyme Pharma for ~$270M, Strengthening its Enzyme Therapies Portfolio

Shots: BioMarin has entered into a definitive agreement to acquire Inozyme, strengthening its enzyme therapies portfolio with the addition of INZ-701, an enzyme replacement therapy As per the deal, Inozyme’s shareholders will receive $4.00 per share in an all-cash transaction for a total consideration of ~$270M; closing is expected in Q3’25 INZ-701 (SC) is being evaluated…

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BioCryst

BioCryst Reports the US FDA’s NDA Acceptance and Priority Review of Orladeyo for Hereditary Angioedema (HAE)

Shots: The US FDA has accepted NDA & granted priority review to Orladeyo (berotralstat) for the treatment of HAE pts (2-11yrs.), with PDUFA action date of Sep 12, 2025. Line extension application has been filed with the EMA; further filings are planned globally incl. Japan & Canada NDA was supported by P-III (APeX-P) trial assessing Orladeyo…

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Incyte

The US FDA Approves Incyte’s Zynyz to Treat Adults with Squamous Cell Anal Carcinoma (SCAC)

Shots: FDA has approved Zynyz (retifanlimab-dlwr) + Pt-based CT as 1L treatment of inoperable locally recurrent or metastatic SCAC, & as monotx. for locally recurrent or metastatic SCAC progressing on or intolerant to Pt-based CT; EMA & PMDA’s application are under review Approval was based on P-III (POD1UM-303/InterAACT2) trial assessing Zynyz + Pt-based CT vs…

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Abbvie

AbbVie’s Emrelis Receives the US FDA’s Accelerated Approval for NSCLC With High c-Met Protein Overexpression

Shots: The US FDA has granted accelerated approval to Emrelis (telisotuzumab vedotin-tllv) for treatment-experienced pts with locally advanced or metastatic, c-Met overexpressing, non-squamous NSCLC  Approval was backed by an ongoing P-II (LUMINOSITY) study assessing Emrelis as 2L/3L treatment of c-Met overexpressing NSCLC; showing an ORR of 35% & mDoR of 7.2mos. in pts (n=84) with…

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Pet Pace

TelmyVet and PetPace Launch Quality-of-Life Consultation to Support Pets and Families in End-of-Life Care

Shots: TelmyVet & PetPace have launched the Quality-of-Life Consultation, a virtual care service to support pets & their families during end-of-life stages Service combines TelmyVet’s telemedicine platform with PetPace’s AI-powered smart collar, which tracks HRV, vital signs, mobility, & behavior to assess pain & stress. It offers a supportive space for pet parent guidance &…

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