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

NEWS

Cyllene Therapeutics Secures US FDA RMAT Designation for EG110A in Neurogenic Detrusor Overactivity

Shots: The US FDA has granted Regenerative Medicine Advanced Therapy (RMAT) designation to EG110A to treat neurogenic detrusor overactivity (NDO) with urinary incontinence The designation was based on the initial P-Ib/IIa trial data, ongoing in the US, in pts with NDO associated with spinal cord injury, with interim results to be presented at the ICS…

ByRidhi RastogiSeptember 14, 2026

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Teva Reports Topline P-IIa Trial Results on TEV ‘408 in Celiac Disease

Shots: Teva has reported topline P-IIa trial results assessing TEV ‘408 in adults with celiac disease on a gluten-free diet (GFD) with minimal intestinal damage; additional analyses are underway The trial met its 1EP, showing prevention of gluten-induced intestinal damage at Wk. 8 following a single SC dose & improving Vh:Cd ratio, with least squares (LS)…

ByRidhi RastogiSeptember 3, 2026

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Telix Reports the First Patient Dosing in P-III (LUTEON) Trial of TLX250-Tx for Renal Cancer

Shots: Telix has dosed the first patient with TLX250-Tx (lutetium-177 (177Lu) girentuximab tetraxetan) in the P-III (LUTEON) study to identify eligible pts with CAIX-positive tumors in r/r clear cell renal cell carcinoma (ccRCC) LUTEON trial in Australia is part of Telix’s global development program for TLX250-Tx, alongside the P-IIa (LUTEON ATLAS) study in the US…

ByRidhi RastogiJuly 21, 2026

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CervoMed Completes Patient Enrollment in P-IIa Study of Neflamapimod for Nonfluent Variant Primary Progressive Aphasia

Shots: CervoMed has completed enrollment in the P-IIa study of neflamapimod for the treatment of nonfluent variant primary progressive aphasia (nfvPPA), a type of frontotemporal dementia, with interim results to be presented at CTAD 2026 The study will evaluate the safety, PK, & clinical effects of neflamapimod (40mg, PO, TID; n=19 and 80mg, BID; n=6)…

ByRidhi RastogiJuly 9, 2026

NEWS

PulseSight Therapeutics Reports P-I (PST-611-CT1) Trial Data on PST-611 in Dry AMD/Geographic Atrophy

Shots: PulseSight has presented the P-I (PST-611-CT1) trial data assessing two dose levels (low and high) of PST-611 in two successive dose groups involving 6 pts with late-stage dry AMD/Geographic Atrophy, with a 16wk. follow-up, at ARVO 2026 Trial met its 1 & 2EPs, showing favorable safety & tolerability, along with stable BCVA, no SAEs/SUSARs…

ByRidhi RastogiMay 11, 2026

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Earendil Labs Doses First Patient with HXN-1001 in P-IIa Trial in Ulcerative Colitis

Shots: Earendil Labs has dosed the first patient with HXN-1001 in the P-IIa trial, & completed enrolment of healthy subjects in the P-I trial across Australia The P-IIa trial will assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of HXN-1001 vs PBO in ulcerative colitis patients HXN-1001 is a half-life extended anti-TL1A antibody…

ByRidhi RastogiApril 3, 2026

NEWS

Aplagon Doses First Patient in P-IIa (HEALING) Trial of APAC for Peripheral Arterial Occlusive Disease/Chronic Limb Threatening Ischemia

Shots: Aplagon has dosed the first patient with APAC (IV) in its P-IIa (HEALING) trial in Finland for peripheral arterial occlusive disease (PAOD), leading to chronic limb-threatening ischemia (CLTI) Trial will evaluate APAC in ~42 CTLI pts across 4 cohorts to assess safety, efficacy, & effects on thrombo-inflammatory biomarkers. Additionally, an associated PET imaging study with…

ByRidhi RastogiMarch 12, 2026

NEWS

OrsoBio Reports P-IIa Trial Data on TLC-2716 in Severe Hypertriglyceridemia and Metabolic Liver Disease

Shots: OrsoBio has reported topline P-IIa PoC trial data assessing TLC-2716 (6 or 12mg, QD, PO) vs PBO in 30 overweight pts with severe hypertriglyceridemia & metabolic dysfunction–associated steatotic liver disease (MASLD) The study met its 1EP, showing statistically significant reductions in fasting triglycerides & remnant cholesterol, plus improved liver fat by MRI-PDFF, with stronger lipid…

ByRidhi RastogiFebruary 11, 2026

NEWS

Teva and Royalty Pharma Enter Funding Agreement to Accelerate TEV-’408 Development in Vitilgo

Shots: Teva has entered into a funding agreement with Royalty Pharma to accelerate the clinical development of Teva’s TEV-’408 for the treatment of vitiligo As per the deal, Teva will receive ~$500M to support TEV-‘408 development costs, incl. $75M in R&D co-funding for a P-IIb study planned for 2026. Royalty will have an option to…

ByRidhi RastogiJanuary 12, 2026

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

Cyllene Therapeutics Secures US FDA RMAT Designation for EG110A in Neurogenic Detrusor Overactivity

Teva Reports Topline P-IIa Trial Results on TEV ‘408 in Celiac Disease

Telix Reports the First Patient Dosing in P-III (LUTEON) Trial of TLX250-Tx for Renal Cancer

CervoMed Completes Patient Enrollment in P-IIa Study of Neflamapimod for Nonfluent Variant Primary Progressive Aphasia

PulseSight Therapeutics Reports P-I (PST-611-CT1) Trial Data on PST-611 in Dry AMD/Geographic Atrophy

Earendil Labs Doses First Patient with HXN-1001 in P-IIa Trial in Ulcerative Colitis

Aplagon Doses First Patient in P-IIa (HEALING) Trial of APAC for Peripheral Arterial Occlusive Disease/Chronic Limb Threatening Ischemia

OrsoBio Reports P-IIa Trial Data on TLC-2716 in Severe Hypertriglyceridemia and Metabolic Liver Disease

Teva and Royalty Pharma Enter Funding Agreement to Accelerate TEV-’408 Development in Vitilgo

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