Tag

Phase Iii

All articles tagged with #phase iii

investing2 days ago•20 min saved

Moderna Stock Rises on Platform Validation as GSK Pushes Rival Flu mRNA to Phase III

Moderna stock jumped about 6% midday after GSK moved its rival mRNA influenza vaccine to Phase III, a development investors view as platform validation for mRNA tech rather than direct competition to Moderna's mFlusvia, which recently received FDA approval. The move underscores the market’s focus on the broader potential of mRNA platforms (including Moderna’s melanoma program with MRK) rather than near-term vaccine revenue, with analysts cautioning that sustained upside hinges on broad solid-tumor success and continued adoption amid a backdrop of policy and financing developments for the modality.

via 247wallst.com|

#flu-vaccine #gsk #investing

healthcare2 years ago•0 min saved

"FDA-Approved ALS Drug Relyvrio Withdrawal Looms After Amylyx's AMX0035 Fails Global Phase 3 Trial"

Despite the FDA's reluctance to pull fully-approved drugs from the market, the significant failure of Amylyx's Phase III data in ALS, with a failed primary endpoint and missed secondary endpoints, may leave the company with few options, especially considering past promises to consider withdrawing the drug if the final-stage study didn't succeed.

via Endpoints News|

#als #amylyx #drug-withdrawal

healthcare3 years ago•0 min saved

Roche Advances Hemophilia Gene Therapy in Phase III, Terminates Another

Roche has announced the removal of RG6358, or SPK-8016, from its gene therapy pipeline for hemophilia A, while initiating a Phase III trial for RG6357, or SPK-8011. The company plans to open enrollment for the study, named Keystone1, later this year.

via Endpoints News|

#clinical-trial #gene-therapy #healthcare

healthcare3 years ago•0 min saved

FibroGen's Lead Drug Fails Again, Stock Crashes.

FibroGen's pamrevlumab failed in a Phase III study for idiopathic pulmonary fibrosis, marking the company's third late-stage miss in two months. The drug was not better than placebo at a lung function test and did not delay disease progression. However, it was generally safe and well-tolerated.

via Endpoints News|

#clinical-trials #fibrogen #healthcare

pharmaceuticals3 years ago•6 min saved

AstraZeneca and Ionis report Phase III success with eplontersen, a potential $3B drug.

AstraZeneca and Ionis have announced positive Phase III results for eplontersen, a drug for hereditary transthyretin-mediated amyloid polyneuropathy (ATTRv-PN), a fatal neurodegenerative disease. Patients taking eplontersen recorded a 0.28-point average increase from baseline compared to a 25.06-point average increase in the placebo group. The drug is expected to generate over $3 billion in sales.

via Endpoints News|

#astrazeneca #clinical-trial #ionis