Aytu BioScience (NASDAQ: AYTU), a specialty pharmaceutical Company engaged in developing solutions for unmet needs in areas such as virility, reproductive health, severe cough and insomnia, has entered into a definitive agreement with Innovus Pharmaceuticals (OTCQB: INNV) for acquisition of the company. The deal is...
Nonalcoholic Steatohepatitis (NASH) is a form of Non-Alcoholic Fatty Liver Disease (NAFLD) and is characterized by the buildup of FAT in the liver. This condition is marked by hepatitis, inflammation, cell damage and fat deposits in the liver. These fat deposits can cause fibrosis of...
Neurotrope Inc, (NASDAQ: NTRP) announced a setback, with Bryostatin, its lead candidate for the treatment of Alzheimer’s, failing to meet its clinical endpoints of its mid-stage study. The Topline results from the confirmatory Phase 2 study of Bryostatin-1, in moderate to severe Alzheimer’s, failed to achieve...
CRISPR, which is an acronym for Clustered Regularly Interspaced Short Palindromic Repeats, is a revolutionary genome editing approach that helps change an individual’s DNA, by altering it at a specific location. The Crisper-Cas9, short for clustered regularly interspaced short palindromic repeats and CRISPR-associated protein 9,...
CytoDyn Inc (OTCQB: CYDY), a clinical stage biotechnology company, announced the filing of an Investigational Drug License (IND) for treatment of NASH with Leronlimab. The drug candidate is a humanized IgG4 mAb CCR5 antagonist that has been granted the Fast Track designation by the FDA...
KemPharm (NASDAQ: KMPH), a specialty pharmaceutical company, has entered into a collaboration and licensing agreement with an affiliate of Gurnet Point Capital (GPC) in exchange for an upfront payment of $10 million, in addition to receiving pre-approval cost reimbursements, regulatory milestone and sales milestone amounting...
Mucopolysaccharidosis type III (MPS III), also known as Sanfilippo syndrome, is caused by the mutations in the glucosamine (N-acetyl)-6-sulfatase (GNS), heparan-alpha-glucosaminide N-acetyltransferase (HGSNAT), N-acetyl-alpha-glucosaminidase (NAGLU) and N-sulfoglucosamine sulfohydrolase (SGSH) genes, which are responsible for the synthesis of large sugar molecules called glycosaminoglycans (GAGs). The dysfunction...
Kala Pharmaceuticals (NASDAQ: KALA) received a Complete Response Letter (CRL) from the FDA, asking for efficacy data from an additional trial, in response to its NDA for KPI-121 0.25%, its lead candidate for the treatment of dry eye disease. The company had filed a New...
Seelos Therapeutics (NASDAQ: SEEL), a clinical-stage biotechnology Company, announced the acceptance of its Investigation New Drug (IND) application for SLS-005 (trehalose) by the FDA. The company is planning to initiate a combined Phase IIb/III, multicenter study to assess the safety, tolerability and efficacy of trehalose...
Sarepta Therapeutics (NASDAQ: SRPT) faced a setback recently with the FDA rejecting Vyondys 53 (Golodirsen), an experimental drug for Duchenne muscular dystrophy, which targets over 8% of the DMD patients with a rare genetic mutation. The company was issued a Complete Response Letter (CRL), which...
