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

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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

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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

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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

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Mabwell Receives the US FDA IND Clearance to Initiate P-IIa Trial of 9MW1911 in COPD

Shots: The US FDA has granted IND clearance to initiate a P-IIa trial of 9MW1911 for the treatment of patients with mod. to sev. chronic obstructive pulmonary disease (COPD) In the China P-IIa trial (n=80) vs PBO, 9MW1911 showed dose-proportional exposure & dose-dependent efficacy, with the RP2D (n=30) reducing mod. to sev. COPD exacerbations by…

ByRidhi RastogiDecember 26, 2025

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Sanofi Reports P-IIa (HS-OBTAIN) Trial Data of Brivekimig for Hidradenitis Suppurativa

Shots: Sanofi has reported the P-IIa (HS-OBTAIN) trial data assessing brivekimig (150mg, SC, Q2W) vs PBO in pts with mod. to sev. hidradenitis suppurativa, incl. biologic-naïve pts for 16 wks., followed by a 12wk. open-label period & an 8wk. safety follow-up At 16wks., brivekimig achieved higher HiSCR50 median response rates of 67% vs 37%, with 54%…

ByRidhi RastogiSeptember 17, 2025

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Ethris Reports First Patient Dosing in P-IIa Trial of ETH47 for Asthma

Shots: Ethris has dosed the first pts in a P-IIa trial of ETH47 for asthma symptom reduction after rhinovirus challenge, building on P-I trial data, which showed strong respiratory tract activity, local IFNλ induction, antiviral gene activation, & no systemic exposure The P-IIa trial will evaluate ETH47 vs PBO in ~50 adults with asthma who…

ByRidhi RastogiAugust 5, 2025

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Ascletis Pharma Reports First Patient Dosing with ASC30 in P-IIa Trial for Obese or Overweight Patients

Shots: Ascletis Pharma has dosed first participants with ASC30 (PO, QD) in its US P-IIa trial for obesity (BMI ≥30kg/m^2) or overweight pts (BMI ≥27kg/m^2 but <30kg/m^2) with ≥1 weight-related comorbidity Trial will assess 2 ASC30 formulations (tablets & tablets A1), with pts starting at 1mg & undergoing weekly titrations to maintenance doses of 20 or 40mg…

ByRidhi RastogiJuly 3, 2025

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Processa Pharmaceuticals and Intact Therapeutics Enter Binding Term Sheet for PCS12852 Licensing Deal

Shots: Processa & Intact have entered into a binding term sheet for granting Intact an exclusive option to license PCS12852 for gastroparesis & other GI motility disorders As per the deal, Processa will receive a 3.5% equity in Intact at closing, $2.5M option fee, ~$20M in development & regulatory milestones, ~$432.5M in commercial milestones, &…

ByRidhi RastogiJune 18, 2025

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

Mabwell Receives the US FDA IND Clearance to Initiate P-IIa Trial of 9MW1911 in COPD

Sanofi Reports P-IIa (HS-OBTAIN) Trial Data of Brivekimig for Hidradenitis Suppurativa

Ethris Reports First Patient Dosing in P-IIa Trial of ETH47 for Asthma

Ascletis Pharma Reports First Patient Dosing with ASC30 in P-IIa Trial for Obese or Overweight Patients

Processa Pharmaceuticals and Intact Therapeutics Enter Binding Term Sheet for PCS12852 Licensing Deal

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