Edgewise Therapeutics Reports the P-II (CIRRUS-HCM) Trial Data on EDG-7500 for Obstructive and Nonobstructive Hypertrophic Cardiomyopathy

Shots: Edgewise has reported the 12wk. P-II Part D (CIRRUS-HCM) trial data assessing EDG-7500 (PO) in obstructive (oHCM; n=20) and nonobstructive (nHCM; n=33) Hypertrophic Cardiomyopathy, where pts in both groups received doses ranging from 25 to 150mg In oHCM pts, EDG-7500 showed 90% pts had improved LVOT-G, 74% achieved NT-proBNP normalization, or ≥50% reduction, KCCQ-OSS…

ByRidhi RastogiJune 17, 2026

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Akeso Reports First Patient Enrolment in P-Ib/II Trial of AK138D1 ± Ivonescimab for Breast Cancer

Shots: Akeso has enrolled the first patient in the P-Ib/II (AK138D1-202) study assessing its AK138D1 monotx. or in combination with ivonescimab for the treatment of advanced breast cancer The trial is evaluating AK138D1 in 2 breast cancer subtypes: HR+/HER2- & triple-negative breast cancer. The study incl. pts ranging from treatment-naïve to heavily pretreated & enrolls…

ByRidhi RastogiJune 15, 2026

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J&J Reports the P-II/III (ENERGY) Trial Data on Imaavy for Warm Autoimmune Hemolytic Anemia (wAIHA)

Shots: The P-II/III (ENERGY) trial assessed 2 different dose schedules of J&J's Imaavy vs PBO in 115 adults living with wAIHA for 24wks. followed by an OLE period, where pts received Imaavy for 144wks. with a follow-up of 6wks. after the last assessment In the 30mg/kg group, Imaavy showed mean increase of 1g/dL in Hgb…

ByRidhi RastogiJune 11, 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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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

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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

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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

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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

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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

Edgewise Therapeutics Reports the P-II (CIRRUS-HCM) Trial Data on EDG-7500 for Obstructive and Nonobstructive Hypertrophic Cardiomyopathy

Akeso Reports First Patient Enrolment in P-Ib/II Trial of AK138D1 ± Ivonescimab for Breast Cancer

J&J Reports the P-II/III (ENERGY) Trial Data on Imaavy for Warm Autoimmune Hemolytic Anemia (wAIHA)

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

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