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Representative image: Researchers examine brain imaging and neural cell preparations as Hopstem’s hNPC01 receives FDA clearance for clinical trials targeting chronic motor disability after hemorrhagic stroke and traumatic brain injury.
Pharma & Biotech

FDA clears hNPC01 neural cell therapy trials for hemorrhagic stroke and traumatic brain injury

FDA clears Hopstem’s hNPC01 neural cell therapy for trials in hemorrhagic stroke and traumatic brain injury, with Fast Track status in both.

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Representative image: Clinicians prepare a donor-derived cell therapy infusion as TScan Therapeutics’ $TCRX TSC-101 enters the Phase 3 ALLOHA-2 trial to prevent AML and MDS relapse after stem cell transplantation.
Pharma & Biotech

TSC-101 enters pivotal ALLOHA-2 trial after early donor-chimerism results

TSC-101 enters the Phase 3 ALLOHA-2 trial to test whether donor-derived TCR-T therapy can prevent AML and MDS relapse after transplant.

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Representative image: An ophthalmology team reviews retinal scans as Ocugen’s $OCGN OCU410 one-time gene therapy receives FDA RMAT designation ahead of a Phase 3 geographic atrophy trial.
Pharma & Biotech

FDA grants RMAT designation to OCU410 after Phase 2 geographic atrophy results

OCU410 receives FDA RMAT designation after Phase 2 data showed 31% slower geographic atrophy lesion growth with one gene therapy dose.

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Verastem Oncology has dosed the first patient in the TARGET-D 203 Phase 2 trial evaluating VS-7375 for KRAS G12D-mutated metastatic colorectal cancer, advancing its registration-directed precision oncology programme. Representative image.
Pharma & Biotech

Verastem has opened its KRAS G12D colorectal cancer trial, but the real test is still ahead

Verastem has started TARGET-D 203, testing VS-7375 alone and in combinations for KRAS G12D metastatic colorectal cancer.

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Representative image: Clinicians review muscle imaging and RNA research data as Dyne Therapeutics’ $DYN DYNE-302 receives FDA clearance to enter its first human trial in facioscapulohumeral muscular dystrophy.
Pharma & Biotech

FDA clears DYNE-302 Phase 1 trial targeting DUX4 in facioscapulohumeral muscular dystrophy

FDA clears Dyne’s Phase 1 DYNE-302 trial in FSHD, testing safety, DUX4 suppression and muscle-targeted siRNA delivery.

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Representative image: A researcher reviews alcohol use disorder trial data as Altimmune’s $ALT pemvidutide reduces heavy drinking days and improves lower-risk drinking outcomes in the Phase 2 RECLAIM study.
Pharma & Biotech

Pemvidutide cuts heavy drinking days in Phase 2 alcohol use disorder trial

Pemvidutide reduced heavy drinking days in Altimmune’s Phase 2 RECLAIM trial, but gastrointestinal side effects and limited patient diversity remain.

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Pharma & Biotech

Atea eight-week hepatitis C regimen matches Epclusa in Phase 3 trial

Atea’s eight-week bemnifosbuvir and ruzasvir regimen matched 12-week Epclusa in a 905-patient Phase 3 hepatitis C trial.

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Lantern Pharma is advancing zirdafulven into a European Phase 1b/2 trial evaluating the investigational therapy in biomarker-selected patients with advanced bladder cancer. Representative image.
Pharma & Biotech

Zirdafulven bladder cancer trial to test Lantern Pharma’s PTGR1 biomarker strategy

Lantern Pharma advances zirdafulven into a European Phase 1b/2 bladder cancer trial focused on PTGR1 and DNA repair biomarkers.

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Galmed Pharmaceuticals is developing an oral dispersible film formulation of Aramchol for Parkinson’s disease, aiming to combine brain penetration with easier long-term dosing, although clinical efficacy in patients remains unproven. Representative image.
Pharma & Biotech

Can Galmed’s dissolving Aramchol film turn a former liver drug into a Parkinson’s contender?

Galmed’s Aramchol film may simplify Parkinson’s dosing, but clinical proof and regulatory clearance remain ahead. See what matters next.

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Newleos Therapeutics strengthens its neuroscience leadership by appointing former 89bio chief executive Rohan Palekar as board chairman while advancing its neuropsychiatry clinical pipeline. Representative image.
Pharma & Biotech

What Rohan Palekar’s appointment means for Newleos and its anxiety drug pipeline

Newleos names Rohan Palekar board chairman as three neuropsychiatry programs move through clinical proof-of-concept. Read the analysis.

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