Month: August 2024

– On Track to Submit OLC New Drug Application (NDA) by End of August 2024 – LOS ALTOS, Calif., Aug. 14, 2024 (GLOBE NEWSWIRE) — Unicycive Therapeutics, Inc. (Nasdaq: UNCY) (the “Company” or “Unicycive”), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced its financial results for the three months ended June 30, 2024, and provided a business update. “Achieving successful results from our oxylanthanum carbonate (OLC) pivotal trial was a significant milestone for the company and brings us one step closer to becoming a commercial organization,” said Shalabh Gupta, M.D., Chief Executive Officer of Unicycive. “Importantly, the trial confirmed tolerability of OLC in patients with hyperphosphatemia on dialysis which is the final data component needed to support submission of a...

Received European Union (EU) and United Kingdom (UK) Marketing Authorization for LYTENAVA™ (bevacizumab gamma) for the treatment of wet AMD NORSE EIGHT current enrollment pace supports topline readout target of Q4 CY2024 Resubmission of the ONS-5010 Biologics License Application (BLA) on track for Q1 CY2025 Quarterly update conference call and webcast today, Wednesday, August 14th at 8:30 AM ETISELIN, N.J., Aug. 14, 2024 (GLOBE NEWSWIRE) — Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company that has achieved regulatory approval in the EU and UK for the first authorized use of an ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration (wet AMD), today announced financial results for the third quarter of fiscal year 2024 and provided a corporate update. As previously...

– Reported combined Stage 1 and Stage 2 results from the relapsed or refractory EBV-positive peripheral T-cell lymphoma (PTCL) cohort of the Phase 2 NAVAL-1 trial demonstrating Nana-val’s substantial antitumor activity and generally well-tolerated safety profile – – New positive data and productive feedback from the FDA support updated Nana-val clinical development plan in EBV-positive PTCL patients; randomized controlled trial planned to begin in the second half of 2025 to support potential registration – – Appointed Michael Faerm as Chief Financial Officer – SAN DIEGO, Aug. 14, 2024 (GLOBE NEWSWIRE) — Viracta Therapeutics, Inc. (Nasdaq: VIRX), a clinical-stage precision oncology company focused on the treatment and prevention of virus-associated cancers that impact patients worldwide, today...

43% Year-over-Year Top Line Growth; Refinancing Complete LOUISVILLE, Ky., Aug. 14, 2024 (GLOBE NEWSWIRE) — Creative Realities, Inc. (“Creative Realities,” “CRI,” or the “Company”) (NASDAQ: CREX), a leading provider of digital signage and media solutions, today announced its financial results for the fiscal second quarter ended June 30, 2024. Highlights:Record second quarter revenue of $13.1 million, up 43% from $9.2 million in the prior-year period Gross profit of $6.8 million for the three months ended June 30, 2024 versus $4.3 million in the second quarter of fiscal 2023 Adjusted EBITDA* of $1.5 million for the second quarter of 2024 versus $0.3 million in the prior-year period Annual recurring revenue (“ARR”) of approximately $18.0 million at the end of the second quarter versus $17.7 million as of March 31, 2024 On May 28,...

Company reports second quarter 2024 financial results MALVERN, Pa., Aug. 14, 2024 (GLOBE NEWSWIRE) — Galera Therapeutics, Inc. (Nasdaq: GRTX), a clinical-stage biopharmaceutical company historically focused on developing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, today announced that its Board of Directors has approved a Plan of Liquidation and Dissolution (Plan of Dissolution), which provides for the dissolution of the Company under Delaware law, and plans to seek stockholder approval of the Plan of Dissolution at a special meeting of stockholders to be held on or around October 17, 2024. If the Plan of Dissolution is approved by the Company’s stockholders, the Company intends to file a certificate of dissolution with the Delaware Secretary of State and distribute...

–– FDA PDUFA Action Date of October 25, 2024; Advisory Committee Meeting on September 9, 2024— –-Cash Runway into 2025, including through PDUFA Action Date– –Company to Host Conference Call Today at 8:30 a.m. EDT– DUBLIN and CHICAGO, Aug. 14, 2024 (GLOBE NEWSWIRE) — Iterum Therapeutics plc (Nasdaq: ITRM), (Iterum) a clinical-stage pharmaceutical company focused on developing next generation oral and IV antibiotics to treat infections caused by multi-drug resistant pathogens in both community and hospital settings, today reported financial results for the second quarter ended June 30, 2024. “We are pleased to have recently closed our rights offering, the proceeds of which allows us to continue to pursue our business plan and strategy, including funding our ongoing strategic process to maximize...

Company to host investor call and webcast today, August 14th, at 8:30am EDT PITTSBURGH, Aug. 14, 2024 (GLOBE NEWSWIRE) — Predictive Oncology (Nasdaq: POAI), a science driven company leveraging its proprietary artificial intelligence and machine learning capabilities, extensive biorepository of tumor samples, and CLIA laboratory, to accelerate oncologic drug discovery and enable drug development, today reported financial and operating results for the quarter ended June 30, 2024, and provided a corporate update. The Company reported a net loss of approximately $3.2 million on total revenue of approximately $0.3 million for the quarter. Q2 2024 and Recent Highlights:Entered biomarker discovery market following compelling results from retrospective ovarian cancer study with UPMC Magee-Womens Hospital:Predictive Oncology successfully...

– Announced research collaboration with Arcturus Therapeutics to explore second-generation mRNA cancer vaccines using Achilles’ AI-powered, tumor-targeting technology – – Provided interim Phase I/IIa update on the use of cNeT in Advanced NSCLC and Melanoma including first patients with enhanced host conditioning (EHC), with the first three EHC patients showing improved cNeT persistence and engraftment – – Cash position of $95.1 million supports operations through 2025 – LONDON, Aug. 14, 2024 (GLOBE NEWSWIRE) — Achilles Therapeutics plc (NASDAQ: ACHL), a clinical-stage biopharmaceutical company developing AI-powered precision T cell therapies targeting clonal neoantigens to treat solid tumors, today announced its financial results for the second quarter ended June 30, 2024, and recent business highlights. “During the second quarter...