Genmab Reports P-III (EPCORE FL-1) Trial Data on Epcoritamab for R/R Follicular Lymphoma

Shots: Genmab has reported P-III (EPCORE FL-1) trial data assessing epcoritamab (SC) + rituximab & lenalidomide (R2) vs R2 alone for the treatment of adult patients with r/r follicular lymphoma The trial met dual primary endpoints with improved ORR and PFS, reducing risk of progression or death by 79%; interim data will be submitted to…

ByRidhi RastogiAugust 8, 2025

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Syndicate of Global Investors to Acquire HistoSonics for $2.25B

Shots: A management-led syndicate, supported by global investors, will acquire a majority stake in HistoSonics for $2.25B The acquisition was led by K5 Global, Bezos Expeditions, Wellington Management, Alpha JWC Ventures, Venture Investors Health Fund, Lumira Ventures, & over 10 other private & public investors HistoSonics aims to expand its Edison histotripsy system beyond liver tumors…

ByRidhi RastogiAugust 8, 2025

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Sebela Pharmaceuticals Reports P-III (TRIUMpH) Program Completion and Data on Tegoprazan for Gastroesophageal Reflux Disease (GERD)

Shots: TRIUMpH program consisted of 2 P-III trials assessing tegoprazan in US GERD pts with erosive esophagitis (EE; n=1250 incl. 463 with LA Grade C/D esophagitis) & non-erosive reflux disease (NERD; n=800); FDA’s NDA filing for both EE & NERD is planned in Q4’25 In EE pts, tegoprazan (100 & 50mg) met the 1EP, showing…

ByRidhi RastogiAugust 8, 2025

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DoveTree Medicines Enters a ~$5.99B Deal with XtalPi to Discover Novel Therapeutics Across Various Indications

Shots: XtalPi has entered into a strategic collaboration with DoveTree Medicines to identify novel therapeutics across oncology, immunology, inflammation, neurology, & metabolic diseases, leveraging XtalPi's de novo drug discovery platform As per the deal, DoveTree will gain exclusive global rights to develop & commercialize multiple therapeutics from the collaboration, in exchange for a $51M upfront,…

ByRidhi RastogiAugust 8, 2025

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Celltrion Secures the US FDA’s Approval for Avtozma IV (Biosimilar, Actemra) to Treat Cytokine Release Syndrome

Shots: The US FDA has approved Avtozma IV, a biosimilar to Actemra (tocilizumab), for treating cytokine release syndrome in pts (≥2yrs.), covering all Actemra IV-approved indications in the US; expected to be available in the US by Aug 31, 2025 In Jan 2025, the US FDA approved Avtozma IV to treat rheumatoid arthritis (RA), giant…

ByRidhi RastogiAugust 8, 2025

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Flare Therapeutics Reports First Patient Dosing in P-Ib Trial of FX-909 for Urothelial Cancer

Shots: Flare Therapeutics has dosed its first patient with FX-909 in P-Ib trial for the treatment of locally-advanced or metastatic urothelial cancer The P-Ib trial will assess FX-909 (30 & 50mg; QD) in 40 pts, incl. a biomarker-defined population, building on clinical PoC achieved in P-Ia, with P-Ia data to be presented in 2025. Efficacy…

ByRidhi RastogiAugust 7, 2025

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Marea Therapeutics Reports First Patient Dosing in P-IIb (TYDAL-TIMI 78) Trial of MAR001 for Atherosclerotic Cardiovascular Disease

Shots: Marea Therapeutics has dosed its first patient with MAR001 in P-IIb (TYDAL-TIMI 78) trial for adults at increased risk of atherosclerotic cardiovascular disease (ASCVD) Trial will evaluate MAR001 (300, 450, 900mg; Q4W) vs PBO in ~216 adults with elevated triglycerides & remnant cholesterol at high ASCVD risk, with the 1EP assessing % change from…

ByRidhi RastogiAugust 7, 2025

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Bracco Imaging Reports the NMPA’s Approval of SonoVue for Assessment of Fallopian Tube Patency

Shots: China’s NMPA has approved SonoVue for use in hysterosalpingo contrast sonography (HyCoSy) to detect tubal issues & uterine problems A meta-analysis of 24 studies in 1358 women with infertility & 2661 fallopian tubes showed superior diagnostic performance of HyCoSy with SonoVue, with pooled sensitivity of 93%, specificity of 90%, & accuracy of 96% vs…

ByRidhi RastogiAugust 7, 2025

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Galapagos Secures the US FDA’s RMAT Designation for GLPG5101 to Treat R/R Mantle Cell Lymphoma

Shots: The US FDA has granted RMAT designation to GLPG5101 for the r/r mantle cell lymphoma (MCL) Designation was supported by P-I/II (ATALANTA-1) trial assessing GLPG5101 [50×106 (DL1), 110×106 (DL2) & 250×106 (DL3)] in r/r B-cell Non-Hodgkin Lymphoma pts, incl. those with MCL Trial demonstrated superior ORR & CR rate as well as favorable safety…

ByRidhi RastogiAugust 6, 2025

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UroGen Pharma Reports P-III (ENVISION) Trial Data on Zusduri to Treat LG-IR-NMIBC

Shots: UroGen Pharma has reported P-III (ENVISION) trial data of Zusduri (mitomycin; QW, intravesical) as a chemoablative therapy for adults (n=240) with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC) Trial showed a 24mos. DoR of 72.2% (Kaplan-Meier) in pts with CR at 3mos., with a mFU of 23.7mos. after 3mos. CR; the mDoR was…

ByRidhi RastogiAugust 6, 2025

Ridhi Rastogi

Genmab Reports P-III (EPCORE FL-1) Trial Data on Epcoritamab for R/R Follicular Lymphoma

Syndicate of Global Investors to Acquire HistoSonics for $2.25B

Sebela Pharmaceuticals Reports P-III (TRIUMpH) Program Completion and Data on Tegoprazan for Gastroesophageal Reflux Disease (GERD)

DoveTree Medicines Enters a ~$5.99B Deal with XtalPi to Discover Novel Therapeutics Across Various Indications

Celltrion Secures the US FDA’s Approval for Avtozma IV (Biosimilar, Actemra) to Treat Cytokine Release Syndrome

Flare Therapeutics Reports First Patient Dosing in P-Ib Trial of FX-909 for Urothelial Cancer

Marea Therapeutics Reports First Patient Dosing in P-IIb (TYDAL-TIMI 78) Trial of MAR001 for Atherosclerotic Cardiovascular Disease

Bracco Imaging Reports the NMPA’s Approval of SonoVue for Assessment of Fallopian Tube Patency

Galapagos Secures the US FDA’s RMAT Designation for GLPG5101 to Treat R/R Mantle Cell Lymphoma

UroGen Pharma Reports P-III (ENVISION) Trial Data on Zusduri to Treat LG-IR-NMIBC

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