Cogent Biosciences Reports US FDA’s NDA Acceptance of Bezuclastinib for Advanced Systemic Mastocytosis (AdvSM)

Shots: The US FDA has accepted an NDA for bezuclastinib in pts with AdvSM, plus set a PDUFA target action date of Jun 29, 2027, with no plans to hold an advisory committee, as well as no potential review issues identified NDA was backed by the APEX trial, which showed as of Mar 31, 2026,…

ByRidhi RastogiSeptember 16, 2026

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Apogee Therapeutics Reports Part B P-II (APEX) Data on Zumilokibart in Atopic Dermatitis (AD)

Shots: Part B of P-II (APEX) trial assessed high, medium, or low-dose zumilokibart vs PBO in 346 pts, where mid & high-doses met the 1EP at 16wks., with 61.6% pts on high dose, 65.9% on mid-dose & 50.5% on low dose achieved EASI-75 vs 23.4% on PBO At Wk. 16, mid-dose also met key 2EP…

ByRidhi RastogiMay 28, 2026

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Apogee Therapeutics Reports Part A P-II (APEX) Maintenance Data on Zumilokibart in Atopic Dermatitis

Shots: Apogee has reported maintenance data from Part A of the P-II (APEX) trial assessing zumilokibart (APG777; 360mg at Q3M or Q6M) in pts with mod. to sev. atopic dermatitis Trial showed 75% (Q3M) & 85% (Q6M) of Wk. 16 zumilokibart-responders maintained EASI-75, while 86% (Q3M) & 78% (Q6M) sustained vIGA 0/1, with continued deepening…

ByRidhi RastogiMarch 24, 2026

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Cogent Biosciences Reports US FDA’s NDA Submission of Bezuclastinib for NonAdvanced Systemic Mastocytosis

Shots: The US FDA has received the NDA of bezuclastinib for the treatment of NonAdvanced Systemic Mastocytosis (NonAdvSM) NDA was supported by the SUMMIT trial, which met its 1 & 2EPs, showing clinical benefit across all symptom domains, incl. 11 individual patient-reported symptoms as well as the most severe symptom, along with correlated biomarker reductions…

ByRidhi RastogiDecember 31, 2025

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Cogent Biosciences Reports P-III (PEAK) Trial Data on Bezuclastinib Combination for Gastrointestinal Stromal Tumors (GIST)

Shots: Cogent Biosciences has reported the P-III (PEAK) trial data assessing bezuclastinib + sunitinib vs sunitinib monotx. in pts with imatinib-resistant or intolerant GIST; the US FDA’s NDA filing is planned for H1’26 As of Sep 30, 2025, trial met its 1EP of improved PFS (mPFS: 16.5 vs 9.2mos.) & showed ORR of 46% vs…

ByRidhi RastogiNovember 11, 2025

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Apogee Therapeutics Reports P-II (APEX) Trial Data on APG777 for Atopic Dermatitis (AD)

Shots: Part A of P-II (APEX) trial assessed APG777 vs PBO in 123 mod. to sev. AD pts, which met its 1EP with 71% vs 33.8% EASI reduction as well as highest absolute & PBO-adjusted EASI-75 (66.9% vs 24.6%); results were consistent across disease severity, & EASI-75 at Wk. 16 reached 83.3% & 89.5% in…

ByRidhi RastogiJuly 7, 2025

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Johnson & Johnson Presents P-IIIb (APEX) Trial Findings of Tremfya for Active Psoriatic Arthritis at EULAR 2025

Shots: The P-IIIb (APEX) trial assessed Tremfya (Q4W or Q8W) vs PBO for 24wks. in biologic-naïve PsA pts with inadequate response to SoCs, followed by a 24wk. active treatment period then a 12wk. safety follow-up; pts could enter a 2yr. extension phase prior to the final safety follow-up Trial showed reduced joint damage progression per…

ByRidhi RastogiJune 12, 2025

NEWS

Johnson & Johnson Reports P-IIIb (APEX) Trial Findings of Tremfya for Active Psoriatic Arthritis

Shots: J&J has reported P-IIIb (APEX) trial data assessing Tremfya vs PBO in biologic-naïve PsA pts with inadequate response to standard therapies for 24wks., followed by a 12wk. safety follow-up; eligible pts could enter a 2yr. extension phase prior to the final safety follow-up Trial met its 1EP of improved ACR20 response, showing reduced signs…

ByRidhi RastogiApril 7, 2025

Cogent Biosciences Reports US FDA’s NDA Acceptance of Bezuclastinib for Advanced Systemic Mastocytosis (AdvSM)

Apogee Therapeutics Reports Part B P-II (APEX) Data on Zumilokibart in Atopic Dermatitis (AD)

Apogee Therapeutics Reports Part A P-II (APEX) Maintenance Data on Zumilokibart in Atopic Dermatitis

Cogent Biosciences Reports US FDA’s NDA Submission of Bezuclastinib for NonAdvanced Systemic Mastocytosis

Cogent Biosciences Reports P-III (PEAK) Trial Data on Bezuclastinib Combination for Gastrointestinal Stromal Tumors (GIST)

Apogee Therapeutics Reports P-II (APEX) Trial Data on APG777 for Atopic Dermatitis (AD)

Johnson & Johnson Presents P-IIIb (APEX) Trial Findings of Tremfya for Active Psoriatic Arthritis at EULAR 2025

Johnson & Johnson Reports P-IIIb (APEX) Trial Findings of Tremfya for Active Psoriatic Arthritis

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