The US FDA Grants Priority Review to Takeda’s Zasocitinib in Plaque Psoriasis

Shots: The US FDA has accepted the NDA & granted priority review to zasocitinib (TAK-279) for the treatment of adults with mod. to sev. plaque psoriasis (PsO), with the PDUFA target action date in Q1’27. MAA is under EMA’s review, with further global filings planned NDA was supported by extensive data incl. global P-III (Latitude…

ByRidhi RastogiSeptember 14, 2026

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Taiho Oncology, Taiho Pharmaceutical and Cullinan Report P-III (REZILIENT3) Trial Data on Zipalertinib for 1L EGFRm NSCLC at WCLC’26

Shots: The global P-III (REZILIENT3) trial data assessed zipalertinib + CT vs CT in the 1L treatment of 285 adults with previously untreated, locally advanced or metastatic NSCLC harboring EGFR ex20ins mutations After a 6-patient safety lead-in, 279 pts were randomized to zipalertinib (100mg, BID) + CT (n=140) or CT alone (n=139); as previously reported, the trial met…

ByRidhi RastogiSeptember 14, 2026

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Daiichi Sankyo and AstraZeneca Report the P-III (DESTINY-Lung04) Trial Data on Enhertu for HER2-Mutant Non-Squamous NSCLC

Shots: Daiichi Sankyo & AZ have reported P-III (DESTINY-Lung04) trial data assessing Enhertu (5.4mg/kg) vs Pt-pemetrexed doublet CT + Keytruda as the 1L treatment in 454 pts with unresectable, locally advanced or metastatic, nsq-NSCLC harboring a HER2 exon 19 or 20 mutation Enhertu improved PFS by 37% (mPFS: 14.3 vs 8.3mos.) & showed ORR of 70%…

ByRidhi RastogiSeptember 14, 2026

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Pharming Reports the US FDA Approval of Joenja (Leniolisib) for Activated Phosphoinositide 3-Kinase Delta Syndrome

Shots: The US FDA has approved Joenja (leniolisib; 40 & 50mg, BID, PO) for the treatment of children (4-11yrs.; ≥27kg) with activated phosphoinositide 3-kinase delta (APKD) syndrome Approval was backed by a P-III trial in APKD pediatric pts (4-11yrs.), which showed reduced lymphadenopathy & increased naïve B cells over 12wks. with a favorable safety profile…

ByRidhi RastogiSeptember 14, 2026

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Scholar Rock Reports the US FDA Approval of Isembyld (Apitegromab-mstn) to Treat Spinal Muscular Atrophy

Shots: The US FDA has approved Isembyld for the treatment of spinal muscular atrophy (SMA) in pts (≥2yrs.) who are currently receiving a SMN2-targeted treatment Approval was backed by the P-III (SAPPHIRE), which met its 1EP of 2.2-point improvement in HFMSE with Isembyld + SMN2-targeted therapy vs PBO at 1yr. in main efficacy population (n=103);…

ByRidhi RastogiSeptember 14, 2026

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Lundbeck’s Asedebart Receives the US FDA Orphan Drug Designation for Endogenous Cushing’s Syndrome

Shots: The US FDA has granted Orphan Drug Designation (ODD) to asedebart (Lu AG13909) for the treatment of endogenous Cushing's syndrome Lundbeck is evaluating efficacy and safety of asedebart in proof-of-concept trials for Cushing's disease & classic congenital adrenal hyperplasia (CAH) Asedebart is a humanized anti-ACTH monoclonal antibody that blocks ACTH signaling at the adrenal…

ByRidhi RastogiSeptember 11, 2026

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Resolution Therapeutics Reports Enrollment Completion in P-I/II (EMERALD) Trial of RTX001 in ESLD

Shots: Resolution Therapeutics has reported that the final patient has been treated in P-I/II (EMERALD) trial assessing RTX001 in patients with end-stage liver disease (ESLD) & a history of decompensated liver cirrhosis; Interim data are expected in the Q4’26 RTX001 is engineered with IL-10 & MMP-9 to enhance anti-inflammatory & anti-fibrotic effects of RMT, delivered…

ByRidhi RastogiSeptember 11, 2026

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Nutromics Receives FDA Breakthrough Device Designation for Vancomycin TDM Patch

Shots: The US FDA has granted Breakthrough Device Designation to a wearable Vancomycin therapeutic drug monitoring (TDM) Patch, designed to continuously monitor vancomycin levels & support faster, more personalized dosing decisions In Feb 2026, Nutromics published first-in-human data on its molecular monitoring platform in Nature Biotechnology, plus the company has conducted ICU clinical studies in…

ByRidhi RastogiSeptember 11, 2026

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Prelude Therapeutics Receives FDA IND Clearance for PRT13722

Shots: The US FDA has granted IND clearance to initiate P-I trial of PRT13722 in HR+/HER2− breast cancer, with patient enrollment expected to begin in Q4’26 The P-I study will assess PRT13722’s safety, tolerability, PK, PD & antitumor activity as monotx. & in combination with endocrine or targeted therapies in adults with locally advanced/metastatic HR+/HER2−…

ByRidhi RastogiSeptember 11, 2026

NEWS

Ocumension Therapeutics Reports NMPA NDA Acceptance of OT-301 to Lower Intraocular Pressure

Shots: The NMPA has accepted NDA for OT-301(bimatoprost grenod; NCX 470) to lower intraocular pressure in patients with open-angle glaucoma or ocular hypertension The NDA was backed by the P-III (Mont Blanc & Denali) trial data, where Mont Blanc’s 1EP showed robust efficacy & safety, plus Denali met its 1EP of non-inferiority of OT-301 as…

ByRidhi RastogiSeptember 11, 2026

Ridhi Rastogi

The US FDA Grants Priority Review to Takeda’s Zasocitinib in Plaque Psoriasis

Taiho Oncology, Taiho Pharmaceutical and Cullinan Report P-III (REZILIENT3) Trial Data on Zipalertinib for 1L EGFRm NSCLC at WCLC’26

Daiichi Sankyo and AstraZeneca Report the P-III (DESTINY-Lung04) Trial Data on Enhertu for HER2-Mutant Non-Squamous NSCLC

Pharming Reports the US FDA Approval of Joenja (Leniolisib) for Activated Phosphoinositide 3-Kinase Delta Syndrome

Scholar Rock Reports the US FDA Approval of Isembyld (Apitegromab-mstn) to Treat Spinal Muscular Atrophy

Lundbeck’s Asedebart Receives the US FDA Orphan Drug Designation for Endogenous Cushing’s Syndrome

Resolution Therapeutics Reports Enrollment Completion in P-I/II (EMERALD) Trial of RTX001 in ESLD

Nutromics Receives FDA Breakthrough Device Designation for Vancomycin TDM Patch

Prelude Therapeutics Receives FDA IND Clearance for PRT13722

Ocumension Therapeutics Reports NMPA NDA Acceptance of OT-301 to Lower Intraocular Pressure

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