Prestige Biopharma Reports Topline P-III (SAMSON-II) Study Results for HD204 (Biosimilar, Avastin)

Shots: Prestige has reported the topline P-III (SAMSON-II) trial results evaluating HD204, a biosimilar version of Avastin (bevacizumab), vs Avastin in 625 adults with advanced non-squamous NSCLC Trial showed an ORR of 48.7% vs 46.5% at 18wks., meeting its 1EP & showing clinical equivalence between HD204 & Avastin; 2EPs supported the primary analysis, with similar Wk.…

ByRidhi RastogiMarch 24, 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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Pfizer and Valneva Report Topline P-III (VALOR) Trial Data on PF-07307405 for Lyme Disease Prevention

Shots: Pfizer & Valneva have reported the P-III (VALOR) trial data in pts (≥5yrs.) at high risk of Lyme disease randomized to either PF-07307405 vs saline PBO, with one dose administered at mos. 0, 2, 5-9 followed by a fourth dose 1yr. late In pre-specified analyses, efficacy reached 73.2% at 28 days post-dose 4 &…

ByRidhi RastogiMarch 24, 2026

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HUTCHMED Initiates P-III Trial of HMPL-760 + R-GemOx for R/R Diffuse Large B-cell Lymphoma in China

Shots: HUTCHMED has initiated a P-III trial of HMPL-760 + R-GemOx (rituximab, gemcitabine and oxaliplatin) in r/r DLBCL Chinese pts, with first patient dosing achieved on Mar 20, 2026 Trial will evaluate efficacy, safety, & PK of HMPL-760 vs PBO, both in combination with R-GemOx in r/r DLBCL pts (n=~240) who are who are relapsed or…

ByRidhi RastogiMarch 23, 2026

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Dizal Reports the P-III (WU-KONG28) Trial Results on Zegfrovy (Sunvozertinib) in EGFRm NSCLC

Shots: Dizal has reported the topline P-III (WU-KONG28) trial data assessing Zegfrovy monotx. (QD, PO) vs Pt-based CT as the 1L treatment of pts with advanced NSCLC harboring EGFR exon 20 insertion mutations across Asia, EU, North America & South America The trial met its 1EP of improved PFS, assessed by BICR, plus showed superiority across…

ByRidhi RastogiMarch 23, 2026

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Eli Lilly Reports P-III (TRANSCEND-T2D-1) Trial Data on Retatrutide for Type 2 Diabetes (T2D)

Shots: Trial assessed retatrutide vs PBO, alongside lifestyle intervention in T2D adults (n=537) inadequately controlled with diet & exercise alone & mean disease duration of 2.5yrs.; pts started at 2mg QW, with dose escalation at Q4W till assigned doses of 4mg, 9mg, or 12mg are reached Trial met its 1EP, showing superior A1C reduction at…

ByRidhi RastogiMarch 20, 2026

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Pfizer Reports P-III (TALAPRO-3) Trial Data on Talzenna Combination in HRR-Gene Mutated Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

Shots: Pfizer has reported P-III (TALAPRO-3) trial data assessing Talzenna (talazoparib; 0.5mg/day) + Xtandi (160mg/day) vs PBO + Xtandi in 599 pts with HRR gene-mutated mHSPC Trial met its 1EP, showing improved rPFS with a hazard ratio surpassing the pre-specified target of 0.63, as most pts remained progression-free; consistent benefit was observed across tumors with both…

ByRidhi RastogiMarch 19, 2026

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AL-S Pharma Reports the P-II (AP-101-02) Trial Data on AP-101 for Amyotrophic Lateral Sclerosis (ALS)

Shots: AL-S Pharma has reported the global P-II (AP-101-02) trial data assessing AP-101 (IV, Q3W) vs PBO in 73 pts with sporadic ALS (n=52) & SOD1 mutations (n=21) for 24wks., followed by 24wk. OLE phase, where all pts received AP-101, & 16wk. safety follow-up Trial met its 1EP for safety & tolerability, with AP-101 showing…

ByRidhi RastogiMarch 19, 2026

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Ascendis Pharma Reports Topline P-II (New InsiGHTS) Trial Data on TransCon hGH in Turner Syndrome

Shots: Ascendis Pharma has reported the P-II (New InsiGHTS) trial data assessing TransCon hGH (lonapegsomatropin, QW) vs somatropin (QD) in 49 prepubertal children (1-10yrs.) with Turner syndrome At Wk. 52, TransCon hGH showed improved annualized height velocity (AHV) with LS mean AHV of 9.05 vs 9.04 cm/year, irrespective of starting dose, with mean dose of…

ByRidhi RastogiMarch 18, 2026

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Pfizer Reports P-II (FOURLIGHT-1) Trial Data on Atirmociclib Combination for 2L Metastatic Breast Cancer

Shots: Pfizer has reported P-II (FOURLIGHT-1) trial data assessing atirmociclib + fulvestrant vs fulvestrant or everolimus plus exemestane in 264 pts with HR+, HER2- advanced or metastatic breast cancer who had received prior CDK 4/6 inhibitor-based treatment Trial met its 1EP, showing improved PFS as assessed by the investigator, with benefit consistent across all subgroups. OS…

ByRidhi RastogiMarch 17, 2026

Prestige Biopharma Reports Topline P-III (SAMSON-II) Study Results for HD204 (Biosimilar, Avastin)

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

Pfizer and Valneva Report Topline P-III (VALOR) Trial Data on PF-07307405 for Lyme Disease Prevention

HUTCHMED Initiates P-III Trial of HMPL-760 + R-GemOx for R/R Diffuse Large B-cell Lymphoma in China

Dizal Reports the P-III (WU-KONG28) Trial Results on Zegfrovy (Sunvozertinib) in EGFRm NSCLC

Eli Lilly Reports P-III (TRANSCEND-T2D-1) Trial Data on Retatrutide for Type 2 Diabetes (T2D)

Pfizer Reports P-III (TALAPRO-3) Trial Data on Talzenna Combination in HRR-Gene Mutated Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

AL-S Pharma Reports the P-II (AP-101-02) Trial Data on AP-101 for Amyotrophic Lateral Sclerosis (ALS)

Ascendis Pharma Reports Topline P-II (New InsiGHTS) Trial Data on TransCon hGH in Turner Syndrome

Pfizer Reports P-II (FOURLIGHT-1) Trial Data on Atirmociclib Combination for 2L Metastatic Breast Cancer

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