FDA approval
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SeaStar Medical Announces $4 Million Registered Direct Offering Priced at the Market Under NASDAQ Rules
SeaStar Medical raised $4M through a registered direct offering of 5.24 million shares priced at $0.763 each, with five-year warrants exercisable at $0.638. The capital infusion supports commercialization of its FDA-approved pediatric AKI device and adult trials, but triggers 33% equity dilution. Analysts note the structure creates potential stock price pressure, as warrants priced 16% below offering prices might constrain valuations. While addressing immediate liquidity needs, the conventional equity approach suggests urgency in funding operations rather than strategic growth initiatives, with funds allocated vaguely for corporate purposes.
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AbbVie Partnered with Enanta Pharmaceuticals, Receives FDA Approval for Expanded MAVYRET® Use: First and Only Acute Hepatitis C Treatment
Enanta Pharmaceuticals (ENTA) announced FDA approval for MAVYRET (glecaprevir/pibrentasvir), now the only eight-week oral treatment for acute HCV in adults and children (3+ years). The approval allows providers to immediately treat diagnosed HCV patients with a 96% cure rate. This breakthrough aims to prevent chronic disease progression and supports the global public health goal of HCV elimination by 2030.
