Insmed’s Brinsupri (Brensocatib) Receives the CHMP’s Positive Opinion to Treat Non-Cystic Fibrosis Bronchiectasis (NCFB)

Shots:The CHMP has recommended Brinsupri (Brensocatib) for treating NCFB pts (≥12yrs.) with two or more exacerbations in the prior 12 mos.Opinion was based on P-III (ASPEN) trial (n=1721) & P-II (WILLOW) trial (n=256) assessing Brinsupri (10 or 25mg, PO) vs PBO in NCFB pts for 52 & 24wks., respectively, with WILLOW enrolling pts who had…

ByDipanshu DixitOctober 21, 2025

NEWS

Genentech Reports the US FDA’s Approval of Gazyva (Obinutuzumab) to Treat Lupus Nephritis

Shots:The US FDA has approved Gazyva (4 initial dose then Q6M) for the treatment of adults with lupus nephritis who are on SoC & also allowing a shorter 90min. infusion after the first dose for eligible ptsApproval was based on P-II (NOBILITY) & P-III (REGENCY) trials, where in REGENCY (n=271), 46.4% on Gazyva + SoC achieved…

ByRidhi RastogiOctober 21, 2025

NEWS

Corcept Therapeutics Reports the EMA’s MAA Submission of Relacorilant to Treat Platinum-Resistant Ovarian Cancer

Shots:The EMA has received MAA of relacorilant for the treatment of Pt-resistant ovarian cancerMAA was supported by P-III (ROSELLA) & P-II trials, where relacorilant + nab-paclitaxel demonstrated improved PFS & OS compared to nab-paclitaxel monotx., with no need for biomarker selection & showed favorable safetyRelacorilant (PO) is a GR antagonist that is…

ByRidhi RastogiOctober 15, 2025

NEWS

SystImmune Doses First Patient in P-II/III (IZABRIGHT-Breast01) Trial of Iza-Bren to Treat Triple Negative Breast Cancer (TNBC)

Shots:SystImmune has dosed the first patient with izalontamab brengitecan (iza-bren) in the global P-II/III (IZABRIGHT-Breast01) study for previously untreated TNBC ineligible for anti-PD-(L)1 drugsFirst patient dosing triggered $250M milestone payment to SystImmune under its 2023 deal with BMS, where SystImmune is further eligible to receive additional ~$250M in contingent near-term payments & ~$7.1B…

ByRidhi RastogiOctober 14, 2025

NEWS

BeOne Medicines’ Sonrotoclax Receives FDA’s Breakthrough Therapy Designation for R/R Mantle Cell Lymphoma (MCL)

Shots:The US FDA has granted BTD to sonrotoclax for adults with r/r MCL & accepted BeOne’s request for participation in Project Orbis for concurrent global review of the therapyDecision was based on P-I/II (BGB-11417-201) assessing sonrotoclax in r/r MCL pts previously treated with BTKi & anti-CD20 therapy; Part 1 enrolled 22 pts on…

ByRidhi RastogiOctober 13, 2025

NEWS

HUTCHMED Reports the P-II/III (FRUSICA-2) Trial Data of Fruquintinib + Sintilimab for Renal Cell Carcinoma (RCC)

Shots:HUTCHMED has reported the P-II/III (FRUSICA-2) trial data assessing fruquintinib + sintilimab vs axitinib/everolimus as 2L treatment in 234 pts with locally advanced or metastatic RCC As of Feb 17, 2025 (mFU of 16.6mos.), regimen showed a mPFS of 22.2 vs 6.9mos., ORR of 60.5% vs 24.3%, & mDoR 23.7 vs 11.3mos., with benefits observed…

ByRidhi RastogiOctober 13, 2025

NEWS

Arcus Biosciences Reports the P-II (EDGE-Gastric) Trial Data on Domvanalimab + Yutuo (Zimberelimab) for Gastroesophageal Adenocarcinomas

Shots:Arcus has reported data from Arm A1 (n=41) of the P-II (EDGE-Gastric) trial assessing domvanalimab (1600mg, IV, Q4W) + Yutuo (480mg, IV, Q4W) & CT in pts with locally advanced unresectable or metastatic G/GEJ or esophageal adenocarcinomaAs of Mar 3, 2025 (mFU of 26.4mos.), pts showed 24mos. OS rate of 50.2% (mOS: 26.7mos.)…

ByRidhi RastogiOctober 13, 2025

NEWS

Adcendo’s ADCE-D01 Receives the US FDA’s Fast Track Designation to Treat Soft Tissue Sarcoma

Shots:The US FDA has granted FTD to ADCE-D01 for the treatment of soft tissue sarcoma (STS)ADCE-D01 is being evaluated in P-I/II (ADCElerate1/EUCT) dose escalation & expansion study as a monotx. for metastatic &/or unresectable STS, with enrolment ongoing in the US & EUADCE-D01 is an ADC targeting uPARAP & conjugated to the…

ByRidhi RastogiOctober 10, 2025

NEWS

Ono Pharmaceutical Reports the P-II (ONO-4578-08) Trial Findings of ONO-4578 in Gastric or Gastroesophageal Junction (G/GEJ) Cancer

Shots:Ono Pharmaceutical has reported the P-II (ONO-4578-08) trial findings of ONO-4578 (EP4 antagonist) regimen for previously untreated, HER2-negative unresectable advanced or recurrent G/GEJ cancerONO-4578-08 assessed ONO-4578 (40mg, QD, PO) + Opdivo (360mg, Q3W) & CT (S-1 + Oxa or CapOx) vs PBO + Opdivo & CT in G/GEJ cancer pts across Japan, South Korea…

ByRidhi RastogiOctober 10, 2025

NEWS

Boehringer Ingelheim Reports the US FDA’s Approval of Jascayd (Nerandomilast) for Idiopathic Pulmonary Fibrosis

Shots:The US FDA has approved Jascayd (nerandomilast) for the treatment of adults with idiopathic pulmonary fibrosis (IPF); regulatory review is ongoing in China, Japan, & the EU, with further filings plannedApproval was based on P-III (FIBRONEER-IPF) & P-II (Trial 2) trials, where FIBRONEER-IPF assessed Jascayd (18 or 9mg, PO, BID) vs PBO in…

ByRidhi RastogiOctober 9, 2025

Insmed’s Brinsupri (Brensocatib) Receives the CHMP’s Positive Opinion to Treat Non-Cystic Fibrosis Bronchiectasis (NCFB)

Genentech Reports the US FDA’s Approval of Gazyva (Obinutuzumab) to Treat Lupus Nephritis

Corcept Therapeutics Reports the EMA’s MAA Submission of Relacorilant to Treat Platinum-Resistant Ovarian Cancer

SystImmune Doses First Patient in P-II/III (IZABRIGHT-Breast01) Trial of Iza-Bren to Treat Triple Negative Breast Cancer (TNBC)

BeOne Medicines’ Sonrotoclax Receives FDA’s Breakthrough Therapy Designation for R/R Mantle Cell Lymphoma (MCL)

HUTCHMED Reports the P-II/III (FRUSICA-2) Trial Data of Fruquintinib + Sintilimab for Renal Cell Carcinoma (RCC)

Arcus Biosciences Reports the P-II (EDGE-Gastric) Trial Data on Domvanalimab + Yutuo (Zimberelimab) for Gastroesophageal Adenocarcinomas

Adcendo’s ADCE-D01 Receives the US FDA’s Fast Track Designation to Treat Soft Tissue Sarcoma

Ono Pharmaceutical Reports the P-II (ONO-4578-08) Trial Findings of ONO-4578 in Gastric or Gastroesophageal Junction (G/GEJ) Cancer

Boehringer Ingelheim Reports the US FDA’s Approval of Jascayd (Nerandomilast) for Idiopathic Pulmonary Fibrosis

Contact US

FOLLOW US