Sanofi | November 17, 2020
When a new drug goes in front of the FDA for consideration, a lot of moving pieces must be in place for a successful review—manufacturing standards included. That didn't happen for Sanofi, which is pressing pause on a rare disease candidate after the FDA found issues at a contract manufacturer's plant.
The FDA blasted a third-party manufacturer of Sanofi's rare blood disease drug sutimlimab in a complete response letter, citing "certain deficiencies" at the contractor's site, the French drugmaker said Friday.
A Sanofi spokeswoman declined to specify who the manufacturer cited in the FDA's letter was or what the nature of the deficiencies were.
With its application on hold, Sanofi said it would work with its manufacturer and the FDA to resolve the issues in a "timely manner." The drugmaker didn't say how quickly it expected to turn around a new application.
The untimely feedback from the FDA dims C1 inhibitor sutimlimab's chances in cold agglutinin disease (CAD), a rare blood disease characterized by anemia, fatigue and other symptoms.
Acurx Pharmaceuticals, Inc. | September 06, 2021
Acurx Pharmaceuticals, Inc, a clinical stage biopharmaceutical company developing a new class of antibiotics for difficult-to-treat bacterial infections, announced today that the Company is set to join the Russell Microcap® Index when the market opens on September 20, 2021, according to a preliminary list of additions posted on September 1, 2021.
Membership in the Russell Microcap Index, which remains in place for one year, means automatic inclusion in the appropriate growth and value style indexes. FTSE Russell determines membership for its Russell indexes primarily by objective, market-capitalization rankings, and style attributes.
"Inclusion in the Russell Microcap Index reflects the ongoing achievement of our previously stated drug development objectives for our pipeline of DNA polymerase IIIC inhibitors, and the fact that, if approved, we would bring to market the first of a new class of antibiotics in over 30 years," said David P. Luci, President and CEO of Acurx. "Inclusion in the Index benefits our Company and stockholders by elevating our visibility within the global investment community. We look forward to continuing our progress towards completing the clinical development program for ibezapolstat, our lead antibiotic candidate targeting the treatment of C. difficile Infection and delivering on several key milestone catalysts through 2021 and 2022," concluded Luci.
Russell indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for active investment strategies. Approximately $10.6 trillion in assets are benchmarked against Russell's US indexes. Russell indexes are part of FTSE Russell, a leading global index provider.
About FTSE Russell
FTSE Russell is a global index leader that provides innovative benchmarking, analytics, and data solutions for investors worldwide. FTSE Russell calculates thousands of indexes that measure and benchmark markets and asset classes in more than 70 countries, covering 98% of the investable market globally. FTSE Russell index expertise and products are used extensively by institutional and retail investors globally. Approximately $17.9 trillion is currently benchmarked to FTSE Russell indexes. For over 30 years, leading asset owners, asset managers, ETF providers and investment banks have chosen FTSE Russell indexes to benchmark their investment performance and create ETFs, structured products, and index-based derivatives. A core set of universal principles guides FTSE Russell index design and management: a transparent rules-based methodology is informed by independent committees of leading market participants. FTSE Russell is focused on applying the highest industry standards in index design and governance and embraces the IOSCO Principles. FTSE Russell is also focused on index innovation and customer partnerships as it seeks to enhance the breadth, depth and reach of its offering. FTSE Russell is wholly owned by London Stock Exchange Group.
About Acurx Pharmaceuticals, Inc.
Acurx Pharmaceuticals is a clinical stage biopharmaceutical company focused on developing new antibiotics for difficult to treat infections. The Company's approach is to develop antibiotic candidates that target the DNA polymerase IIIC enzyme and its R&D pipeline includes antibiotic product candidates that target Gram-positive bacteria, including Clostridioides difficile, methicillin-resistant Staphylococcus aureus (MRSA), vancomycin resistant Enterococcus (VRE) and drug-resistant Streptococcus pneumoniae (DRSP).
prnewswire | August 26, 2020
ForwardVue Pharma has secured initial seed round funding in order to advance pre-clinical development of potent long acting anti-angiogenic molecules directed against diabetic eye disease and neovascular age related macular degeneration. As the Founder of ForwardVue Pharma, Alan has performed 40,000+ intravitreal injections as a practicing retina specialist with over 20 years of experience. He has served as principle investigator in a number of diabetic retinopathy and AMD trials, presents his work internationally and published multiple manuscripts on candidate molecules to treat these diseases.