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Representative image: Retina specialists review OCT scans as EyePoint’s $EYPT DURAVYU completes enrollment in two Phase 3 diabetic macular edema trials testing six-month dosing against aflibercept.
Pharma & Biotech

DURAVYU pivotal trials move closer to testing a longer-lasting diabetic eye treatment

DURAVYU completes enrollment in two Phase 3 DME trials testing six-month dosing against aflibercept, with results expected in late 2027.

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Representative image: A cardiologist reviews heart imaging as Cytokinetics’ $CYTK aficamten gains UK approval and NICE backing for approximately 6,600 adults with symptomatic obstructive hypertrophic cardiomyopathy.
Pharma & Biotech

Aficamten wins UK approval and NICE backing for 6,600 adults with obstructive HCM

Aficamten gains UK authorisation and NICE backing for symptomatic obstructive HCM after Phase 3 improvements in exercise capacity.

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Representative image: Clinicians review heart imaging and Duchenne muscular dystrophy trial data as Capricor Therapeutics’ $CAPR deramiocel faces heightened FDA uncertainty following a 9 to 3 advisory committee vote against its cardiomyopathy evidence.
Pharma & Biotech

Conflicting HOPE-3 analyses divide FDA panel over deramiocel in Duchenne muscular dystrophy

FDA advisers voted 9 to 3 against deramiocel’s Duchenne cardiomyopathy evidence after challenging the Phase 3 analysis and trial population.

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Johnson & Johnson’s $1 billion Firefly Bio acquisition adds the preclinical Firelink degrader antibody conjugate platform to its oncology pipeline, strengthening its research into KRAS-driven cancers and other difficult-to-treat solid tumors. Representative image.
Pharma & Biotech

Johnson & Johnson just spent $1bn on a preclinical cancer platform: What must Firefly Bio prove next?

Johnson & Johnson closes its $1 billion Firefly Bio deal, adding a preclinical degrader antibody conjugate platform for KRAS-driven cancers.

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ImmunityBio’s ANKTIVA has received United Arab Emirates marketing authorization for BCG-unresponsive bladder cancer and previously treated metastatic non-small cell lung cancer, expanding the immunotherapy’s international regulatory footprint. Representative image.
Pharma & Biotech

Why ImmunityBio’s UAE authorization gives ANKTIVA a broader cancer label than it has in the United States

ImmunityBio gains UAE authorization for ANKTIVA in broader bladder cancer and metastatic lung cancer uses, widening its Gulf commercial opportunity.

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Sail Biomedicines’ in vivo CAR-T collaboration with Johnson & Johnson highlights growing investment in RNA-based immune-cell therapies for autoimmune diseases. Representative image.
Pharma & Biotech

Why Johnson & Johnson is staking $785m on Sail’s in vivo CAR-T platform before human trials

Johnson & Johnson backs Sail Biomedicines’ in vivo CAR-T platform with $785 million in initial payments and a $2.58 billion buyout option.

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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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