#HVO hVIVO PLC – MSD to acquire Cidara November 27, 2025 – Posted in: hVIVO (HVO)

hVIVO plc (AIM: HVO), a full-service early phase Contract Research Organisation (CRO) and the world leader in human challenge clinical trials, congratulates its client Cidara Therapeutics, Inc (“Cidara” or the “partner”) which has entered into a definitive agreement under which Merck Sharp & Dohme LLC (“MSD”), through a subsidiary, will acquire Cidara for a total transaction value of approximately $9.2 billion. This transaction underscores the value of hVIVO’s unique capabilities in accelerating drug development and validates the…

#POLB Poolbeg Pharma PLC – FDA Orphan Drug Designation granted for POLB 001 & AGM May 27, 2025 – Posted in: Poolbeg Pharma (POLB)

27 May 2025 – Poolbeg Pharma (AIM: POLB, ‘Poolbeg’ or the ‘Company’), a clinical-stage biopharmaceutical company focussed on the development of innovative medicines to address unmet medical needs, announces that the US Food and Drug Administration (“FDA”) has granted Orphan Drug Designation (“ODD”) to POLB 001 as an oral preventative therapy for T-cell engager bispecific antibody-induced Cytokine Release Syndrome (“CRS”). The FDA grants orphan status to support the development of medicines for rare disorders affecting less than…

#TSP TruSpine Technologies – FDA Update February 19, 2024 – Posted in: TruSpine Plc (TSP)

TruSpine Technologies Plc, the medical device company focused on the spinal (vertebral) stabilisation market, announces an update on its U.S. Food and Drug Administration (“FDA”) process in relation to its FDA 510(k) application for its Cervi-LOK product. Further to the announcement on 5 January 2024, the Company confirms it has submitted additional documentation to the FDA in respect of the additional clarifications that the FDA were seeking. In the weeks leading up to the…

#TSP Truspine Technologies PLC – Convertible Loan, Loan Update, AGM Update and RPT February 14, 2024 – Posted in: TruSpine Plc (TSP)

TruSpine Technologies Plc, the medical device company focused on the spinal (vertebral) stabilisation market, announces that it has entered into a £50,000 convertible loan note agreement with Martin Armstrong (the “CLN Agreement”), the former Non-Executive Chairman of the Company. The Company also provides an update on the loan agreement announced on 5 January 2024 and on its 2022 annual general meeting (“2022 AGM”) which is due to be convened. CLN Agreement Pursuant to the…

#TSP Truspine Technologies PLC – Loan, Related Party Transaction and FDA Update January 5, 2024 – Posted in: TruSpine Plc (TSP)

TruSpine Technologies Plc, the medical device company focused on the spinal (vertebral) stabilisation market, announces that it has entered into a £30,000 loan agreement with Annabel Schild (the “Loan Agreement”), a former Non-Executive Director of the Company within 12 months of the Loan Agreement being entered into and therefore is considered a related party pursuant to the AQSE Growth Market Access Rulebook. The Company also provides an update on its U.S. Food and Drug Administration…

#TSP TruSpine Technologies PLC – Half-year Report December 28, 2023 – Posted in: Blog, TruSpine Plc (TSP)

CHIEF EXECUTIVE’S REPORT During the period under review and the period to date the Company is pleased to have made progress on three fronts namely :- – the FDA submission is progressing and has now reached the substantive phase which it is currently undergoing and the Company is hoping for more positive news in the New Year. – Following the registration of its IP title, the Company anticipates signing a distribution agreement in 2024. – …

#TSP TruSpine Technologies – Further re: FDA Update October 30, 2023 – Posted in: Blog, TruSpine Plc (TSP)

TruSpine Technologies plc, (AQSE: TSP) the medical device company focused on the development of its pioneering “screwless,” spinal (vertebral) stabilisation systems announces that, further to the announcement on 12 October 2023, the Company has received communication from the U.S. Food and Drug Administration (“FDA”) that its FDA 510(k) application has been progressed to the substantive review stage. CEO Laurence Strauss commented: “I am delighted that after the prompt response of the Company in providing clarification and…

#TSP TruSpine PLC – Further re: FDA Update October 12, 2023 – Posted in: TruSpine Plc (TSP)

TruSpine Technologies plc, (AQSE: TSP) the medical device company focused on the development of its pioneering “screwless,” spinal (vertebral) stabilisation systems announces that, further to the announcement on 3 October 2023, the Company has submitted additional documentation and provided further clarification in regard to the questions raised by the U.S. Food and Drug Administration (“FDA”) relating to the Company’s FDA 510(k) application. TruSpine CEO Laurence Strauss commented: “We are pleased the US FDA have responded…

#HVO hVIVO PLC – FDA Breakthrough and Fast Track for US biotech April 26, 2023 – Posted in: Uncategorized

hVIVO plc (AIM & Euronext: HVO), (formerly Open Orphan plc) a rapidly growing specialist contract research organisation (CRO) and world leader in testing infectious and respiratory disease products using human challenge clinical trials, notes the announcements dated 13 April 2023 and 18 April 2023 from SAB Biotherapeutics (NASDAQ: SABS) (“SAB”), reporting that the US Food and Drug Administration (“FDA”) has granted Breakthrough Therapy and Fast Track designations for its investigational therapeutic for the treatment of…

#VELA Vela Technologies PLC investee co. #TSP TruSpine Technologies PLC – Half-year Report January 3, 2023 – Posted in: Vela Technologies Plc (VELA)

CHIEF EXECUTIVE’S REPORT Despite the challenges presented by Covid-19 globally, TruSpine has managed to overcome many of the obstacles presented, and we believe the Company will be in a position in 2023 to submit the FDA 510k application for the Cervi-LOK. Post period end, the Company has secured a £200,000 bridge debt facility (“Bridge Loan”) and a Letter of Intent (“LOI”) for a £2.4m staged equity funding over three tranches (“Investment Agreement”), a separate announcement…