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Skye Bioscience & Arecor Therapeutics
News

Skye Bioscience Enters a Formulation Development Agreement with Arecor Therapeutics for Nimacimab

Shots: 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,…
May 19, 20250Comments

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Inozyme Pharma
News

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…
May 19, 20250Comments

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GSK
News

GSK Receives the MHLW’s Approval for Blenrep (Belantamab Mafodotin) Regimens to Treat R/R Multiple Myeloma

Shots: MHLW has approved Blenrep + BorDex & PomDex in MM pts with ≥1 prior therapy; review ongoing in the US (PDUFA: Jul 23, 2025), EU, Canada, China (PR for DREAMM-7), & Switzerland (with PR for DREAMM-8) Approval was based on P-III (DREAMM-7 & DREAMM-8) trials assessing Blenrep (2.5mg/kg, IV, Q3W) + BorDex vs Darzalex + BorDex in 494…
May 19, 20250Comments

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Weekly Snapshot

PharmaShots Weekly Snapshots (May 12, 2025 – May 16, 2025)  

PharmaShots Weekly Snapshots (May 12, 2025 – May 16, 2025)   This week PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A & Animal Health. Check out our full report below:       Johnson & Johnson Reveals P-III (ICONIC-TOTAL) Trial Data of Icotrokinra for Plaque Psoriasis  Read More: J&J  AstraZeneca Reports…
May 16, 20250Comments

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BioCryst
News

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…
May 16, 20250Comments

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Travere Therapeutics
News

Travere Therapeutics Reports the US FDA’s sNDA Acceptance of Filspari for Focal Segmental Glomerulosclerosis (FSGS)

Shots: The US FDA has accepted sNDA of Filspari for the treatment of FSGS, plus FDA has planned to hold advisory committee meeting to discuss the application (PDUFA: Jan 13, 2026) sNDA was supported by P-III (DUPLEX) trial & P-II (DUET) trial assessing Filspari vs irbesartan in FSGS pts; Pts completing the DUPLEX & DUET double-blind…
May 16, 20250Comments

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Incyte
News

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…
May 16, 20250Comments

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Rznomics and Eli Lilly
News

Rznomics Partners with Eli Lilly for RNA Editing Therapeutics

Shots: Rznomics has signed a strategic global license agreement with Eli Lillyto develop & commercialize RNA-editing therapies for inherited hearing loss using Rznomics' trans-splicing ribozyme platform As per the deal, if Lilly avail all its options then total deal value could surpass $1.3B with undisclosed upfront payment, in addition to separate royalties from product sales The…
May 16, 20250Comments

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