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

NEWS

D&D Pharmatech Reports P-II Trial Results on Zabopegdutide for Metabolic Dysfunction-Associated Steatohepatitis (MASH)

Shots: D&D Pharmatech has reported the topline P-II (DD01-DN-02) trial data assessing zabopegdutide (DD01) vs PBO in 67 overweight/obese pts with MASH & significant liver fat across the US, which met its all 3 key histological EPs Pts received a 2wk. 20mg titration followed by maintenance dosing of DD01 (40mg, QW) or PBO; the Wk.…

ByRidhi RastogiMay 27, 2026

NEWS

OSE Immunotherapeutics Reports P-II (TEDOVA) Trial Data on Tedopi Combination in Recurrent Ovarian Cancer

Shots: OSE Immunotherapeutics has reported the topline P-II (TEDOVA/GINECO-OV244b/ENGOT-ov58) trial results evaluating Tedopi (OSE2101) ± Keytruda as a maintenance treatment in pts with Pt-sensitive recurrent ovarian cancer (PSOC) Trial enrolled 185 pts with PSOC who progressed after or were ineligible for PARP inhibitors & Avastin. Pts achieving CR, PR, or stable disease after Pt-based therapy…

ByRidhi RastogiMay 25, 2026

NEWS

Pfizer Reports the P-II Trial Data on PF-07872412 to Prevent Pneumococcal Disease at ISPPD 2026

Shots: Pfizer has reported its P-II trial data assessing the safety, tolerability & immunogenicity of a 4 dose series of PF-07872412 (25vPnC) vs 4 doses of PREVNAR 20 at mos. 2, 4, 6 & 12-15 in infants 25vPnC vaccine generated higher immune responses against serotype 3 vs Prevnar 20, with geometric mean titers 8.8-fold higher…

ByRidhi RastogiMay 20, 2026

NEWS

Bayer’s Hyrnuo (Sevabertinib) Gains the US FDA Priority Review for 1L Treatment of HER2-Mutated NSCLC

Shots: The US FDA has granted Priority Review to Bayer’s Hyrnuo (sevabertinib) for the 1L treatment of adults with locally advanced or metastatic NSCLC harboring HER2 (ERBB2) TKD-activating mutations & no prior systemic therapy sNDA was supported by preliminary data from Cohort F of the P-I/II (SOHO-01) trial evaluating the efficacy & safety of Hyrnuo…

ByRidhi RastogiMay 19, 2026

NEWS

Sanofi Reports P-II (ElevAATe) Trial Data on Efdoralprin alfa for Alpha-1 Antitrypsin Deficiency (AATD)-Related Emphysema

Shots: Sanofi has reported the P-II (ElevAATe) study data assessing efdoralprin alfa (Q3W or Q4W) vs SoC plasma-derived augmentation therapy (pdAAT; QW) in 97 pts with AATD-related emphysema Efdoralprin alfa achieved a mean increase in fAAT trough levels of 24.1μM (Q3W) & 16.8μM (Q4W) vs 7.6μM at Wk. 32, with Q3W meeting the 1EP, while…

ByRidhi RastogiMay 19, 2026

NEWS

Biogen Reports P-II (CELIA) Trial Results on Diranersen in Early Alzheimer’s Disease

Shots: Biogen has reported the global P-II (CELIA) trial data assessing diranersen [60mg (Q24W), 115mg (Q24W), or 115mg (Q12W); intrathecal) vs PBO over 76wks. in 416 pts with mild cognitive impairment due to Alzheimer’s disease (AD) or mild AD dementia Although CELIA did not meet its 1EP of dose response on CDR-SB change from baseline…

ByRidhi RastogiMay 15, 2026

NEWS

BeOne Medicines Receives US FDA Accelerated Approval for Beqalzi (Sonrotoclax) to Treat R/R Mantle Cell Lymphoma

Shots: The US FDA has granted accelerated approval to BeOne's Beqalzi for the treatment of adults with r/r mantle cell lymphoma, after ≥2L of systemic therapy, incl. a BTK inhibitor; regulatory review is ongoing in the EU Approval was supported by the global P-I/II (BGB-11417-201) assessing Beqalzi in r/r MCL pts (n=125), which showed 52%…

ByRidhi RastogiMay 14, 2026

NEWS

ALX Oncology Presents P-I/II Trial Data on Evorpacept Combination in Metastatic Breast Cancer (mBC) at ESMO Breast Cancer’26

Shots: ALX Oncology presented data from exploratory analyses of P-Ib/II trial assessing evorpacept + Ziihera in pts with heavily pre-treated HER2+ mBC, all of whom had received prior Enhertu therapy, at ESMO Breast Cancer 2026 Exploratory analyses in 24 pts treated with evorpacept + Ziihera at dosages of 20mg/kg (n=3) or 30mg/kg (n=21), showed a…

ByRidhi RastogiMay 8, 2026

NEWS

Beacon Therapeutics Reports P-II (DAWN) Trial Data on Laru-zova in X-Linked Retinitis Pigmentosa (XLRP)

Shots: Beacon has reported the 12mos. data from P-II (DAWN) trial assessing laruparetigene zovaparvovec (laru-zova) in pts with XLRP who have previously been treated with an AAV vector-based gene therapy delivering the full-length RPGR protein Data showed sustained improvements in low luminance visual acuity (LLVA) & microperimetry mean sensitivity through Mos. 12, with 50% of…

ByRidhi RastogiMay 8, 2026

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

D&D Pharmatech Reports P-II Trial Results on Zabopegdutide for Metabolic Dysfunction-Associated Steatohepatitis (MASH)

OSE Immunotherapeutics Reports P-II (TEDOVA) Trial Data on Tedopi Combination in Recurrent Ovarian Cancer

Pfizer Reports the P-II Trial Data on PF-07872412 to Prevent Pneumococcal Disease at ISPPD 2026

Bayer’s Hyrnuo (Sevabertinib) Gains the US FDA Priority Review for 1L Treatment of HER2-Mutated NSCLC

Sanofi Reports P-II (ElevAATe) Trial Data on Efdoralprin alfa for Alpha-1 Antitrypsin Deficiency (AATD)-Related Emphysema

Biogen Reports P-II (CELIA) Trial Results on Diranersen in Early Alzheimer’s Disease

BeOne Medicines Receives US FDA Accelerated Approval for Beqalzi (Sonrotoclax) to Treat R/R Mantle Cell Lymphoma

ALX Oncology Presents P-I/II Trial Data on Evorpacept Combination in Metastatic Breast Cancer (mBC) at ESMO Breast Cancer’26

Beacon Therapeutics Reports P-II (DAWN) Trial Data on Laru-zova in X-Linked Retinitis Pigmentosa (XLRP)

Contact US

FOLLOW US