BioSpace News Archive

Consistent with prior two interim analyses, FURI results confirm positive clinical activity of oral ibrexafungerp in patients with difficult-to-treat, severe, mucocutaneous and invasive fungal infections, including those caused by resistant strains 1 st Interim analysis of CARES study shows strong clinical activity of oral ibrexafungerp in patients with Candida auris , a high-mortality infection classified by CDC as an Urgent Threat to public health

Eyenovia, Inc. (NASDAQ: EYEN), a clinical stage ophthalmic biopharmaceutical company developing a pipeline of microdose array print (MAP™) therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has accepted the Company’s New Drug Application (NDA) for MydCombi™, a unique fixed combination mydriatic (pupil dilation) agent for potential use in the over 80 million comprehensive eye exams

Arch Therapeutics, Inc. (OTCQB: ARTH) (“Arch” or the “Company”), innovator of AC5 ® Advanced Wound System and other self-assembling Dermal Sciences and BioSurgery devices, announced today that it will be presenting at the H.C. Wainwright Global Life Sciences Conference, which will be held March 9-10, 2021.

PureTech Health plc (NASDAQ: PRTC, LSE: PRTC) (“PureTech” or the “Company”), a clinical-stage biotherapeutics company dedicated to discovering, developing and commercializing highly differentiated medicines for devastating diseases, is pleased to note that its Founded Entity, Karuna Therapeutics, Inc. (NASDAQ: KRTX) (“Karuna”), announced the pricing of an underwritten public offering of 2,083,334 shares of its common stock

Clearside Biomedical, Inc., a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, announced completion of dosing in the first cohort of OASIS, its ongoing Phase 1/2a clinical trial of CLS-AX in patients with neovascular age-related macular degeneration.

OTL-203 Achieves Proof of Concept (POC) in MPS-I Hurler Syndrome (MPS-IH); Registrational Trial Planned to Initiate by Year End 2021

Placebo-controlled trial anticipated to enroll 60 patients with advanced p53-mutated NSCLC undergoing treatment with first-line carboplatin plus pemetrexed

Freeline Therapeutics Holdings plc, a clinical-stage biotechnology company developing transformative gene therapies for patients suffering from inherited systemic debilitating diseases, announced that Theresa Heggie, Chief Executive Officer, will present a company overview at the following virtual investor conferences in March

BioCryst Pharmaceuticals, Inc. announced that the company has submitted a marketing authorization application to the United Kingdom’s Medicines and Healthcare products Regulatory Agency seeking approval of ORLADEYO™ for the prevention of recurrent hereditary angioedema attacks in HAE patients 12 years and older.

TG Therapeutics, Inc. announced its financial results for the fourth quarter and year ended December 31, 2020 and recent company developments, along with a business outlook for 2021.