Genentech Reports P-II (FENopta) Trial Data of Fenebrutinib for Relapsing Multiple Sclerosis (RMS)

Shots:Genentech has reported 96wk. data from P-II (FENopta) trial assessing fenebrutinib vs PBO for 12wks. in 109 RMS pts (18-55yrs.); 99 pts then opted for a 192wk. OLE study, with 93 remaining after 96wks.OLE study showed sustained efficacy over 96wks. with a low ARR of 0.06, no disability progression (per EDSS) & no…

ByRidhi Rastogi11 hours ago

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Eli Lilly to Acquire SiteOne Therapeutics for ~$1B, Strengthening its Pain Pipeline

Shots:Eli Lilly has entered into a definitive agreement to acquire SiteOne Therapeutics incl. its asset, STC-004, expanding its pain pipeline As per the deal, SiteOne shareholders will receive an upfront payment as well as regulatory & commercial milestones for a total consideration of ~$1B in cash STC-004 is a non-opioid Nav1.8 inhibitor, which will advance into…

ByRidhi Rastogi3 days ago

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The US FDA Approves Arcutis Biotherapeutics’ Zoryve Topical Foam for Plaque Psoriasis

Shots:FDA has approved sNDA of Zoryve (0.3% roflumilast) for pts (≥12yrs.) with plaque PsO of scalp & body based on P-III (ARRECTOR) & P-II (Trial 204) trials assessing it vs vehicle in 736 pts for 8wks.ARRECTOR met its co-1EPs, with 66.4% vs 27.8% pts achieving Scalp-IGA success & 45.5% vs 20.1% pts attaining…

ByRidhi RastogiMay 23, 2025

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Merck Reports P-II (WILLOW) Trial Data of Enpatoran for Cutaneous Lupus Erythematosus (CLE) and Systemic Lupus Erythematosus (SLE)

Shots:The P-II (WILLOW) basket trial assessed enpatoran (25, 50 &100mg, BID, PO) vs PBO + SoC in 2 Arms, where Arm 1 has SLE & CLE pts with active lupus rash & Arm 2 has active SLE pts. Discussions with health authorities on a global P-III program are underwayArm 1 met its 1EP,…

ByRidhi RastogiMay 22, 2025

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CRISPR Therapeutics Enters a Multi-Target Collaboration with Sirius Therapeutics to Develop Novel siRNA Therapies

Shots:CRISPR & Sirius have partnered to co-develop & co-market SRSD107, with CRISPR having the option to nominate ~2 siRNA targets, fund related research, & retain opt-in rights for clinical development & marketingAs per the deal, Sirius will receive $25M cash & $70M in equity upfront, with both companies jointly developing SRSD107 under a…

ByRidhi RastogiMay 20, 2025

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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…

ByRidhi RastogiMay 16, 2025

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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 reviewApproval was based on P-III (POD1UM-303/InterAACT2) trial assessing Zynyz + Pt-based CT vs…

ByRidhi RastogiMay 16, 2025

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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 NSCLCApproval was backed by ongoing P-II (LUMINOSITY) study assessing Emrelis as 2L or 3L treatment of c-Met overexpressing NSCLC; showing an ORR of 35% & mDoR of 7.2mos. in pts (n=84)…

ByRidhi RastogiMay 16, 2025

News

Merck’s Welireg Receives the US FDA’s Approval for Pheochromocytoma and Paraganglioma

Shots:The US FDA has approved Welireg for the treatment of pts (≥12yrs.) with advanced, unresectable, or metastatic pheochromocytoma & paraganglioma (PPGL)Approval was based on Cohort A1 data from P-II (LITESPARK-015) trial assessing Welireg monotx. (120mg; QD) in 72 pts with unresectable or non-curable PPGL & stable blood pressure (BP <150/90 mm Hg, <135/85 mm…

ByRidhi RastogiMay 15, 2025

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MavriX Bio Reports the US FDA’s IND Clearance of MVX-220 for Angelman Syndrome

Shots:The US FDA has approved IND application of MVX-220 for the treatment of Angelman Syndrome (AS) to initiate P-I/II (ASCEND-AS) trial, with first pts dosing expected in H2’25The P-I/II trial will evaluate the safety, tolerability, & effectiveness of MVX-220 in both adult & pediatric pts with multiple AS genotypes, incl. rare types like uniparental…

ByRidhi RastogiMay 13, 2025

Genentech Reports P-II (FENopta) Trial Data of Fenebrutinib for Relapsing Multiple Sclerosis (RMS)

Eli Lilly to Acquire SiteOne Therapeutics for ~$1B, Strengthening its Pain Pipeline

The US FDA Approves Arcutis Biotherapeutics’ Zoryve Topical Foam for Plaque Psoriasis

Merck Reports P-II (WILLOW) Trial Data of Enpatoran for Cutaneous Lupus Erythematosus (CLE) and Systemic Lupus Erythematosus (SLE)

CRISPR Therapeutics Enters a Multi-Target Collaboration with Sirius Therapeutics to Develop Novel siRNA Therapies

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

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

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

Merck’s Welireg Receives the US FDA’s Approval for Pheochromocytoma and Paraganglioma

MavriX Bio Reports the US FDA’s IND Clearance of MVX-220 for Angelman Syndrome

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