Day: April 18, 2023

Based on large multi-center study with over 1,800 patient samples Primary endpoint for Unyvero UTI for urinary tract infection was successfully met and shows overall weighted average sensitivity of 96.8% and overall weighted average specificity of 97.4% Submission follows FDA’s De Novo pathway for novel medical devicesROCKVILLE, Md., April 18, 2023 (GLOBE NEWSWIRE) — OpGen, Inc. (Nasdaq: OPGN, “OpGen” or “the Company”), a precision medicine company harnessing the power of molecular diagnostics and bioinformatics to help combat infectious disease, today announced that it has submitted a De Novo classification request to the U.S. Food and Drug Administration (FDA) seeking marketing authorization for its Unyvero UTI Urinary Tract Infection (UTI) panel, following successful completion of its clinical trial. OpGen’s Unyvero UTI...

BOCA RATON, Fla., April 18, 2023 (GLOBE NEWSWIRE) — Jushi Holdings Inc. (“Jushi” or the “Company”) (CSE: JUSH) (OTCQX: JUSHF), a vertically integrated, multi-state cannabis operator, announced support and appreciation for the Virginia General Assembly’s passage of medical cannabis and cannabinoid product-related bills amended by Governor Glenn Youngkin. Last week, the Virginia General Assembly gathered to take up seventy-eight (78) bills amended by the Governor, including medical cannabis bills designed to enhance program accessibility for patients, improve operational efficiency for pharmaceutical processors and fully transfer regulatory oversight to the Virginia Cannabis Control Authority (“CCA”). Most patient-focused and operations-based changes will become effective on July 1, 2023, and CCA will take over regulating the program...

TORONTO, April 18, 2023 (GLOBE NEWSWIRE) — Today, Arch Biopartners Inc., (“Arch” or the “Company”) (TSX Venture: ARCH and OTCQB: ACHFF), a clinical stage company focused on the development of novel therapeutics targeting organ inflammation, announced that it has safely increased the maximum daily dose of LSALT peptide to 20 mg per day in healthy, normal volunteers in a recently completed human trial in Australia. LSALT peptide is the Company’s lead drug candidate for treating inflammation in the lungs, liver and kidneys and Arch intends to use the new maximum dose in designing a Phase II trial targeting cardiac surgery-associated acute kidney injury (CS-AKI). The new safety data will be included in an Investigational New Drug Application to the U.S. FDA, to be submitted in relation to the CS-AKI trial in due course. Prior to this...

– Multiple U.S. Clinical Sites to Begin Enrolling ODYSSEY Participants This Quarter – – ODYSSEY Topline Results Expected in Q3 2024 – ALPHARETTA, Ga., April 18, 2023 (GLOBE NEWSWIRE) — Clearside Biomedical, Inc. (Nasdaq: CLSD), a biopharmaceutical company revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS®), announced today plans for ODYSSEY, a randomized, double-masked, parallel-group, active-controlled, multi-center Phase 2b clinical trial of CLS-AX (axitinib injectable suspension) using suprachoroidal delivery in neovascular age-related macular degeneration (wet AMD). The Company plans to open the trial for enrollment this quarter and expects topline results in Q3 2024. George Lasezkay, Pharm.D., J.D., Clearside’s President and Chief Executive Officer,...

FREMONT, Calif., April 18, 2023 (GLOBE NEWSWIRE) — Enovix Corporation (“Enovix”) (NASDAQ: ENVX), an advanced silicon battery company, today announced the pricing of $150.0 million aggregate principal amount of 3.00% Convertible Senior Notes due 2028 (the “Notes”) in a private placement to persons reasonably believed to be qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the “Securities Act”) (the “Offering”) and in a concurrent private placement under Section 4(a)(2) of the Securities Act. An entity affiliated with Thurman J. Rodgers, Chairman of Enovix, has agreed to purchase $10.0 million aggregate principal amount of the Notes in the concurrent private placement. The Notes purchased in the concurrent private placement are referred to as the “Affiliate Notes.” In addition, an...

CHICAGO, April 18, 2023 (GLOBE NEWSWIRE) — LanzaTech Global, Inc. (Nasdaq: LNZA) (“LanzaTech” or the “Company”), the leading Carbon Capture and Transformation (“CCT”) company, today announced that it will issue its first quarter 2023 financial results before the market opens on Monday, May 15, 2023. A conference call will be held that same day at 8:30 A.M. ET to review the Company’s financial results, discuss recent events and conduct a question-and-answer session. The conference call may be accessed via a live webcast on a listen-only basis at https://ir.lanzatech.com/news-events/events-presentations. Please access the site at least 15 minutes prior to the scheduled start time in order to register, download, and install any necessary audio software. To participate in the live teleconference: Domestic callers: 1-877-407-0789 International...

CD3 antibody has emerged as an established and attractive target for Type 1 diabetes after the $2.9 billion acquisition of Provention Bio by Sanofi Mechanism of Action of Tiziana’s first-in-class, only fully human CD3 antibody, intranasal foralumab, makes it an ideal candidate for Type 1 diabetes Tiziana initiates program to study both the treatment and the delay of type 1 diabetes using its convenient self-administered intranasal foralumabNEW YORK, April 18, 2023 (GLOBE NEWSWIRE) — Tiziana Life Sciences Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies via novel routes of drug delivery, today announced that it is initiating a program to develop intranasal foralumab for the treatment or prevention of Type 1 Diabetes. “With the FDA approval of the humanized...