Arrowhead Reports Topline P-I/IIa Trial Data on ARO-DIMER-PA for Mixed Hyperlipidemia

Shots: Arrowhead has reported P-I/IIa (ARO-DIMER-PA-1001) study data assessing the safety, tolerability, PK, PD, & effects on LDL-C and TGs of single-dose (part 1) & multiple doses (part 2) of ARO-DIMER-PA in ~78 adults with mixed hyperlipidemia ARO-DIMER-PA single doses produced dose-dependent mean maximal reductions in serum PCSK9 of 72% & APOC3 of 88%, along with…

ByRidhi RastogiSeptember 17, 2026

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Resolution Therapeutics Reports Enrollment Completion in P-I/II (EMERALD) Trial of RTX001 in ESLD

Shots: Resolution Therapeutics has reported that the final patient has been treated in P-I/II (EMERALD) trial assessing RTX001 in patients with end-stage liver disease (ESLD) & a history of decompensated liver cirrhosis; Interim data are expected in the Q4’26 RTX001 is engineered with IL-10 & MMP-9 to enhance anti-inflammatory & anti-fibrotic effects of RMT, delivered…

ByRidhi RastogiSeptember 11, 2026

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Prelude Therapeutics Receives FDA IND Clearance for PRT13722

Shots: The US FDA has granted IND clearance to initiate P-I trial of PRT13722 in HR+/HER2− breast cancer, with patient enrollment expected to begin in Q4’26 The P-I study will assess PRT13722’s safety, tolerability, PK, PD & antitumor activity as monotx. & in combination with endocrine or targeted therapies in adults with locally advanced/metastatic HR+/HER2−…

ByRidhi RastogiSeptember 11, 2026

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Acepodia Reports the US FDA IND Clearance to Initiate P-I Trial of ACE723 in HCC

Shots: The US FDA has granted IND clearance to ACE723 for the initiation of P-I trial to treat patients with unresectable or metastatic hepatocellular carcinoma (HCC) The P-I study will assess ACE723’s safety, tolerability, dose-limiting toxicities, PK & preliminary antitumor activity in above-mentioned pts, with dose-escalation portion of establishing recommended dose for further development &…

ByRidhi RastogiSeptember 7, 2026

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uniQure Reports the US FDA BLA Submission for Ifezuntirgene Inilparvovec to Treat Huntington’s Disease

Shots: The US FDA has received a BLA for the accelerated approval of ifezuntirgene inilparvovec (AMT-130) for the treatment of Huntington’s disease, plus a request for Priority Review BLA was supported by the 3yr. data analysis from the P-I/II trial of AMT-130 vs a propensity score-matched external control derived from the Enroll-HD natural history database;…

ByRidhi RastogiSeptember 2, 2026

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Daiichi Sankyo Doses First Patient in the P-I Trial with DS1025 for Advanced Solid Tumors

Shots: Daiichi Sankyo has dosed the first patient in the P-I trial with DS1025 for the treatment of advanced or metastatic solid tumors with disease progression on or after ≥1 prior line of standard therapy The P-I trial of DS1025 will evaluate safety, tolerability, PK & preliminary efficacy above-mentioned pts (n=~45), assessing safety & tolerability,…

ByRidhi RastogiAugust 28, 2026

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Dyne Therapeutics Reports IND Clearance to Initiate P-I Trial of DYNE-302 for FSHD

Shots: The US FDA has granted IND clearance to initiate a P-I multiple ascending dose trial assessing DYNE-302 against PBO in ambulatory adults with facioscapulohumeral muscular dystrophy (FSHD) In the first cohort, 9 pts will receive DYNE-302 (1.5 mg/kg, Q4W) or PBO, with higher doses & less frequent dosing planned. Pts completing the PBO-controlled phase…

ByRidhi RastogiJuly 28, 2026

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Kyowa Kirin Reports the EC Approval for Crysvita for X-Linked Hypophosphataemia

Shots: The EC has approved an expansion of the indication for Crysvita (burosumab) for the treatment of X-linked hypophosphataemia (XLH), to incl. infants from 1mos. to 1yr. of age Approval was supported by data from P-I/II (BUR-CL207) study assessing safety, tolerability, PK & efficacy of burosumab in pts with XLH from birth to 1yr. Trial showed…

ByRidhi RastogiJuly 21, 2026

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Diagonal Therapeutics Reports First Patient Dosed in P-I/II (DIAMOND) Trial of DIAG723 for HHT

Shots: Diagonal has dosed the first patient with DIAG723, a clustering agonist antibody, in P-I/II (DIAMOND) trial (n=~93) for people living with hereditary hemorrhagic telangiectasia (HHT) Trial will evaluate DIAG723 (SC) vs PBO in 3 parts: Part A (P-I) will assess single ascending doses; Part B (P-II) will evaluate multiple doses over 14wks. for safety…

ByRidhi RastogiJuly 16, 2026

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Samsung Bioepis Reports Clinical Data on SB27 (Biosimilar, Keytruda)

Shots: Samsung Bioepis has reported the P-I & P-III trial results on SB27, a proposed biosimilar to Keytruda (pembrolizumab), which met their 1EP, with trial completion expected within 2026 The P-I trial (n=163) evaluated PK, efficacy, safety, & immunogenicity of SB27 vs EU & US-sourced Keytruda in resected stage II/IIIA NSCLC pts after adjuvant Pt-based CT,…

ByRidhi RastogiJune 29, 2026

Arrowhead Reports Topline P-I/IIa Trial Data on ARO-DIMER-PA for Mixed Hyperlipidemia

Resolution Therapeutics Reports Enrollment Completion in P-I/II (EMERALD) Trial of RTX001 in ESLD

Prelude Therapeutics Receives FDA IND Clearance for PRT13722

Acepodia Reports the US FDA IND Clearance to Initiate P-I Trial of ACE723 in HCC

uniQure Reports the US FDA BLA Submission for Ifezuntirgene Inilparvovec to Treat Huntington’s Disease

Daiichi Sankyo Doses First Patient in the P-I Trial with DS1025 for Advanced Solid Tumors

Dyne Therapeutics Reports IND Clearance to Initiate P-I Trial of DYNE-302 for FSHD

Kyowa Kirin Reports the EC Approval for Crysvita for X-Linked Hypophosphataemia

Diagonal Therapeutics Reports First Patient Dosed in P-I/II (DIAMOND) Trial of DIAG723 for HHT

Samsung Bioepis Reports Clinical Data on SB27 (Biosimilar, Keytruda)

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