Karen Carey

4 days ago | bioworld.com | Karen Carey

Next IgAN contenders line up; Vera preps a BLA for ataciceptWith a 42% placebo-adjusted reduction in proteinuria at week 36, Vera Therapeutics Inc. met its primary endpoint in the Origin phase III trial with BAFF and APRIL dual inhibitor atacicept in treating immunoglobulin A nephropathy (IgAN) in adults. BioWorld Clinical Immune Nephrology Protein U.S. BLA

1 week ago | bioworld.com | Karen Carey

CRL blocks Barth syndrome drug; Stealth aims to try againDeveloping a therapy for an ultra-rare condition has its challenges, including finding enough patients for clinical enrollment and convincing regulatory authorities that limited data prove the candidate is safe and effective. For that reason, Stealth Biotherapeutics Inc.

1 week ago | bioworld.com | Karen Carey

Home » Grin’s radiprodil heads to phase III with $570M deal, $140M series DGrin’s radiprodil heads to phase III with $570M deal, $140M series DA new version of a drug candidate that failed in a phase II for neuropathic pain 15 years ago has attracted $140 million in series D funds, plus an ex-North American deal worth up to $570 million, for Grin Therapeutics Inc. BioWorld Clinical Deals and M&A Financings Neurology/psychiatric Small molecule Series D

2 weeks ago | bioworld.com | Karen Carey

Imunon ovarian cancer prospect impresses with survival benefitsImunon Inc. soared by 179% on the heels of phase II Ovation 2 data showing that its IMNN-001 immunotherapy led to a 13-month increase in overall survival among women with ovarian cancer. Patients in the intent-to-treat population, receiving the drug plus standard-of-care neoadjuvant and adjuvant chemotherapy (N/ACT), achieved median overall survival (OS) at 46 months vs. 33 months with N/ACT alone.

3 weeks ago | bioworld.com | Karen Carey

Inozyme’s INZ-701 shows promise for rare disease ENPP1 deficiencyJust two months after Inozyme Pharma Inc. cut its workforce by 25% and prioritized activities to focus on a BLA filing for INZ-701 for ENPP1 deficiency, interim phase III data from its Energy 3 trial showed consistent safety and immunogenicity and increased phosphate levels in patients treated with the rare disease enzyme replacement therapy. BioWorld Clinical Musculoskeletal Enzyme U.S. FDA