Zenas BioPharma Enters a ~$300M Funding Agreement with Royalty Pharma to Support Obexelimab Development

Shots: Zenas BioPharma has entered into an agreement with Royalty Pharma granting it royalty rights on the future sales of obexelimab As per the deal, Zenas will receive ~$300M, consisting of a $75M upfront & 3 additional $75M each in milestones tied to P-III (INDIGO) trial achievement & FDA approvals in IgG4-RD & SLE, while Royalty Pharma…

ByRidhi RastogiSeptember 4, 2025

NEWS

Ionis Reveals Topline P-III (CORE & CORE2) Trial Data of Olezarsen for Severe Hypertriglyceridemia

Shots: Ionis has reported P-III (CORE: n=617 & CORE2: n=446) trials data assessing olezarsen (50 or 80mg, SC, Q4W) vs PBO for 12mos. in adults with severe hypertriglyceridemia (sHTG); the US FDA’s sNDA submission expected by year end Both studies met their 1EP, with CORE showing reduction in fasting triglycerides by 72% (80mg) & 63%…

ByRidhi RastogiSeptember 4, 2025

NEWS

AbbVie’s Elahere (Mirvetuximab Soravtansine) Receives the Health Canada’s Approval to Treat Platinum-Resistant Ovarian Cancer

Shots: Health Canada has approved Elahere under priority review to treat FRα+, Pt-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer after 1-3 prior treatments Approval was based on P-III (MIRASOL) trial assessing Elahere vs investigator's choice of CT in pts (n=453) to treat PROC expressing high levels of FRα, as determined using the Ventana…

ByRidhi RastogiSeptember 4, 2025

NEWS

Shionogi Reports the US FDA’s Acceptance of Ensitrelvir Post-Exposure COVID-19 Prevention

Shots: The US FDA has accepted NDA of ensitrelvir fumaric acid for the prevention of COVID-19 following exposure to an infected individual (PDUFA: Jun 16, 2026); regulatory review is ongoing in Taiwan, Japan (for both PEP & paediatric pts), & the EU NDA was supported by global P-III (SCORPIO-PEP) trial assessing ensitrelvir vs PBO as post-exposure…

ByRidhi RastogiSeptember 3, 2025

NEWS

Merck Reports Topline P-III (CORALreef Lipids) Trial Data of Enlicitide Decanoate to Treat Hypercholesterolemia

Shots: Merck has reported topline P-III (CORALreef Lipids) trial data assessing enlicitide decanoate vs PBO for the treatment of adults with hypercholesterolemia receiving mod. to high-intensity statins or are intolerant to statins Trial met its 1EP with significant LDL-C reduction at Wk. 24 & achieved 2EPs, showing reduced non-HDL-C, apolipoprotein B, & lipoprotein(a) levels; data…

ByRidhi RastogiSeptember 3, 2025

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IDEAYA Biosciences Partners with Servier to Develop and Commercialize Darovasertib for Uveal Melanoma (UM)

Shots: IDEAYA has entered an exclusive licensing agreement granting Servier global regulatory and commercial rights to darovasertib, while retaining all the US rights IDEAYA & Servier will co-develop darovasertib & share costs, with Servier leading regulatory & commercial efforts worldwide excl. the US, in exchange for $210M upfront, ~$100M on approval, ~$220M in commercial milestones,…

ByRidhi RastogiSeptember 2, 2025

NEWS

AstraZeneca Reports P-III (BaxHTN) Trial Data on Baxdrostat for Uncontrolled or Treatment Resistant Hypertension

Shots: The P-III (BaxHTN) trial assessed baxdrostat (1 or 2mg) vs PBO on top of SoCs in 796 pts with uncontrolled or treatment resistant hypertension over 12wks.; P-III (Bax24) trial readout is expected in late 2025 Trial met its 1EP, reducing mean seated SBP at 12wks. by 15.7 (2mg) & 14.5 mmHg (1mg), with PBO-adjusted…

ByRidhi RastogiSeptember 1, 2025

NEWS

Merck Reports P-III (VICTOR) Trial Data of Verquvo (Vericiguat) for Chronic Heart Failure and Reduced Ejection Fraction (HFrEF)

Shots: Merck has reported P-III (VICTOR) trial data assessing Verquvo (n=3,053) vs PBO (n=3,052) in pts with stable chronic heart failure & reduced ejection fraction Trial did not meet its 1EPs of reducing CV death or HF hospitalization (18% vs 19.1%); however, 2EPs showed numerically lower rates of CV death (9.6% vs 11.3%) & HF…

ByRidhi RastogiSeptember 1, 2025

NEWS

Zydus Reports Topline P-IIb/III (EPICS-III) Trial Data of Saroglitazar for Primary Biliary Cholangitis (PBC)

Shots: Zydus has reported topline P-IIb/III (EPICS-III) trial results in PBC pts resistant or intolerant to ursodeoxycholic acid (UDCA), where pts were randomized to Saroglitazar (1mg) or PBO, following optimal dose selection Trial met its composite 1EP, showing a 48.5% treatment difference in biochemical response, & also achieved its key 2EP with a higher proportion…

ByRidhi RastogiSeptember 1, 2025

NEWS

Sanofi’s Wayrilz (Rilzabrutinib) Receives the US FDA’s Approval for Immune Thrombocytopenia (ITP)

Shots: FDA has approved Wayrilz for adults with persistent or chronic ITP who did not respond adequately to prior therapy following approval in UAE in Jun 2025; Application under the EMA & NMPA's review Approval was based on P-III (LUNA 3) trial assessing Wayrilz (400mg, BID, PO) vs PBO in adults (n=202) with ITP over…

ByRidhi RastogiSeptember 1, 2025

Zenas BioPharma Enters a ~$300M Funding Agreement with Royalty Pharma to Support Obexelimab Development

Ionis Reveals Topline P-III (CORE & CORE2) Trial Data of Olezarsen for Severe Hypertriglyceridemia

AbbVie’s Elahere (Mirvetuximab Soravtansine) Receives the Health Canada’s Approval to Treat Platinum-Resistant Ovarian Cancer

Shionogi Reports the US FDA’s Acceptance of Ensitrelvir Post-Exposure COVID-19 Prevention

Merck Reports Topline P-III (CORALreef Lipids) Trial Data of Enlicitide Decanoate to Treat Hypercholesterolemia

IDEAYA Biosciences Partners with Servier to Develop and Commercialize Darovasertib for Uveal Melanoma (UM)

AstraZeneca Reports P-III (BaxHTN) Trial Data on Baxdrostat for Uncontrolled or Treatment Resistant Hypertension

Merck Reports P-III (VICTOR) Trial Data of Verquvo (Vericiguat) for Chronic Heart Failure and Reduced Ejection Fraction (HFrEF)

Zydus Reports Topline P-IIb/III (EPICS-III) Trial Data of Saroglitazar for Primary Biliary Cholangitis (PBC)

Sanofi’s Wayrilz (Rilzabrutinib) Receives the US FDA’s Approval for Immune Thrombocytopenia (ITP)

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