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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HanchorBio Out-Licenses HCB101 to Shanghai Henlius Biotech For ~$202M

Shots: HanchorBio entered into an out-licensing agreement with Shanghai Henlius Biotech and granted exclusive rights to develop and commercialize HCB101 in Greater China, Southeast Asia, and MENA Under the terms and agreement, HanchorBio will receive $10M upfront and up to $192M in development and regulatory milestones, plus tiered royalties Henlius will also oversee development, production,…

ByPrince GiriJuly 1, 2025

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Daiichi Sankyo and AstraZeneca Report the US FDA Approval of Datroway for Advanced EGFR-Mutated NSCLC

Shots: The US FDA has approved Datroway (datopotamab deruxtecan-dlnk; 6 mg/kg) for adults with locally advanced or metastatic EGFR-mutated NSCLC previously treated with EGFR therapy & Pt CT Approval was based on the global P-II (TROPION-Lung05) trial results (n=137) and supported by data from the P-III (TROPION-Lung01) trial (n=590), which showed a 45% confirmed ORR…

ByDipanshu DixitJune 26, 2025

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Regeneron and Sanofi Receive the US FDA’s Approval for Dupixent to Treat Bullous Pemphigoid

Shots: The US FDA has approved Dupixent to treat adults with bullous pemphigoid based on P-II/III (ADEPT) trial assessing Dupixent vs PBO for 52wks.; regulatory review is ongoing in the EU, Japan, & China Pts (n=106) received a loading dose of Dupixent (300mg; n=53) or PBO (n=53), followed by Q2W dosing with OCS. OCS tapering began at Wks.…

ByRidhi RastogiJune 20, 2025

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ExCellThera Reports CHMP’s Positive Opinion for Zemcelpro to Treat Haematological Malignancies

Shots: The CHMP has recommended conditional approval of Zemcelpro in 30 EEA states for adults with haematological malignancies requiring allogeneic HSCT after myeloablative conditioning with no suitable donor; EC’s decision is expected within 2mos. Zemcelpro (UM171 Cell Therapy) was evaluated in P-II trials for pts with high & very high-risk acute leukemias & myelodysplasias with…

ByRidhi RastogiJune 20, 2025

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Merck and Daiichi Sankyo Report First Patient Dosing with Ifinatamab DXd in P-III (IDeate-Prostate01) Trial for mCRPC

Shots: Merck & Daiichi Sankyo have dosed first pts with ifinatamab deruxtecan (I-DXd) in its P-III (IDeate-Prostate01) trial for metastatic castration-resistant prostate cancer (mCRPC), which was initiated based on positive P-I/II (IDeate-PanTumor01) trial data The P-III (IDeate-Prostate01) trial will evaluate I-DXd (12mg/kg) vs docetaxel (75mg/m²) plus corticosteroid in ~1440 mCRPC pts, who progressed during or after…

ByRidhi RastogiJune 19, 2025

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Neuspera Medical’s Integrated Sacral Neuromodulation System Secures the US FDA Approval for Urinary Urge Incontinence

Shots: The US FDA has approved integrated sacral neuromodulation (iSNM) system to treat urinary urge incontinence (UUI) iSNM device was evaluated in a P-II trial in 128 pts, which showed 84.2% pts achieved ≥50% reduction in urgent leaks, with 84% & 42% responders experiencing >75% & 100% reduction, respectively in UUI symptoms at 6mos.; 3.5x…

ByRidhi RastogiJune 19, 2025

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Johnson & Johnson Reports P-II (RedirecTT-1) Trial Data on Talvey + Tecvayli for R/R Multiple Myeloma

Shots: J&J has reported P-II (RedirecTT-1) trial data on Talvey (talquetamab-tgvs) + Tecvayli (teclistamab-cqyv) in 90 heavily pretreated r/r MM pts with extramedullary disease, where 84.4% were triple-class refractory, 35.6% penta-drug refractory, 20% had prior BCMA CAR-T, & 8.9% had prior bsAb exposure Trial showed a 78.9% ORR, with 54.4% achieving CR or better, incl.…

ByRidhi RastogiJune 16, 2025

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Celldex Highlights P-II Trial Data of Barzolvolimab for Chronic Spontaneous Urticaria at EAACI Congress 2025

Shots: The P-II trial assessed barzolvolimab (Q4W: 75 or 150mg; Q8W: 300mg) vs PBO for 16wks. in 208 CSU pts unresponsive to antihistamines, followed by 36wks. of active treatment, where 75mg & PBO pts were re-randomized to 150 or 300mg; pts were then followed for 24wks. Enrolment to P-III (EMBARQ-CSU1 & EMBARQ-CSU2) trials is ongoing …

ByRidhi RastogiJune 13, 2025

NEWS

Nuvation Bio Reports the US FDA’s Approval of Ibtrozi to Treat Advanced ROS1+ NSCLC

Shots: The US FDA has approved Ibtrozi (taletrectinib) for treating locally advanced or metastatic ROS1+ NSCLC Approval was based on the P-II [TRUST-I (China) & TRUST-II (global)] studies assessing Ibtrozi monotx. in 173 & 164 pts with ROS1+ NSCLC, respectively TRUST-I showed a cORR of 90% in TKI-naïve pts, with longest DoR of 46.9mos. &…

ByRidhi RastogiJune 12, 2025

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

HanchorBio Out-Licenses HCB101 to Shanghai Henlius Biotech For ~$202M

Daiichi Sankyo and AstraZeneca Report the US FDA Approval of Datroway for Advanced EGFR-Mutated NSCLC

Regeneron and Sanofi Receive the US FDA’s Approval for Dupixent to Treat Bullous Pemphigoid

ExCellThera Reports CHMP’s Positive Opinion for Zemcelpro to Treat Haematological Malignancies

Merck and Daiichi Sankyo Report First Patient Dosing with Ifinatamab DXd in P-III (IDeate-Prostate01) Trial for mCRPC

Neuspera Medical’s Integrated Sacral Neuromodulation System Secures the US FDA Approval for Urinary Urge Incontinence

Johnson & Johnson Reports P-II (RedirecTT-1) Trial Data on Talvey + Tecvayli for R/R Multiple Myeloma

Celldex Highlights P-II Trial Data of Barzolvolimab for Chronic Spontaneous Urticaria at EAACI Congress 2025

Nuvation Bio Reports the US FDA’s Approval of Ibtrozi to Treat Advanced ROS1+ NSCLC

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