US/UK/Canada

Share

Pick a time period -
Tags ( Active)

Cessatech enters collaboration with University Hospital of Copenhagen, Rigshospitalet, to advance an intravenous formulation of melatonin for post-anaesthesia delirium (CT004) in children

·CT004 targets post-anaesthetic agitation and emergence delirium, an underserved paediatric condition affecting 25-30% of children, for which no approved treatments are currently available.  ·A phase II study of 676 children at five sites in Denmark has been initiated and funded by University Hospital of Copenhagen, Rigshospitalet.  ·Cessatech retains worldwide commercial rights to CT004.Copenhagen, Denmark – 12 June 2026 - Cessatech A/S, a late-stage paediatric specialty company developing and commercializing hospital medicines for children, today announced a new

First Quarter Report Q1-2026

The Company has advanced well with its planned activities ·Continued progress towards US launch of CT001 ·Regulatory review progressing with EMA following MAA submission for CT001 ·Clinical data from CT001 study 0202 presented at Society for Pediatric Pain Medicine (SPPM) 13th Annual Meeting ·Strengthened intellectual property portfolio with additional patents granted in key marketsCopenhagen, Denmark - 28 May 2026 - Cessatech A/S (“Cessatech” or the “Company”), a late-stage paediatric specialty company developing and commercializing non-invasive hospital

Minutes from the Annual General Meeting in Cessatech A/S

Cessatech A/S, CVR no. 41293055 (“Cessatech” or the “Company”) held its Annual General Meeting on Monday 30 March 2026 at 09:00 (CET) at the Company's address Strandvejen 60, 2900 Hellerup, Denmark.The agenda for the General Meeting was as follows: 1. Election of the Chairman of the meeting 1. Mikkel Rostock-Jensen was elected Chairman of the meeting. The chairman of the meeting ascertained that none of the shareholders objected to the legality of the Annual General Meeting and announced that the Annual General Meeting had been duly convened and was legal and competent in terms of

Cessatech convenes its Annual General Meeting

Notice to convene the Annual General Meeting (the "General Meeting") of Cessatech A/S (CVR no. 41 29 30 55) (“Cessatech” or the “Company”)The Board of Directors hereby convenes the Annual General Meeting of Cessatech to be held on: Monday, 30 March 2026, at 9:00 am (CET) The General Meeting will be held at the Company's address: Strandvejen 60, 2900 Hellerup, Denmark. Agenda 1. Election of Chairman of the meeting 2. Management’s report on the activities of the company in the past financial year 3. Approval of the audited Annual Report 2025 4. Resolution on the covering of

Cessatech A/S Announces Financial Results for the Full Year 2025

Copenhagen, Denmark - 27 February 2026 - Cessatech A/S (“Cessatech” or the “Company”), a late-stage paediatric specialty company developing and commercializing non-invasive hospital medicines for children, today announced financial results for the year ended December 31, 2025, which also includes financial results for the fourth quarter of 2025.Full year 2025 for the period 1 January - 31 December (Q4’2025 results in brackets): · Net revenue: KDKK 5,718 (1,989) · Operating result: KDKK -14,967 (-1,836) · Net result: KDKK -10,904 (-773) · Cash at bank end of the period: KDKK 8,

Welcome to the first quarter of 2026

2025 has been a year of significant progress for Cessatech. Our work is dedicated to improving the treatment of acute pain in children, benefiting patients, families and healthcare professionals. Throughout the year, we have continued to advance our lead paediatric programme, and we enter 2026 positioned for what we expect to be a transformative year for the company.All hands on deck to support the coming US launch In the US, the collaboration with Ventis Pharma (commercial partner) and STAQ Pharma (manufacturing partner) is progressing well, and all efforts are focused on finalizing the

Third Quarter Report Q3-2025

The Company has advanced well with its planned activities · Closing the clinical and regulatory activities related to the CT001 program · Organisational development, search for key competences · Launch and supply planning with commercial partners · US manufacturing technology transfer completed (in October Q4)Cessatech A/S (“Cessatech” or the “Company”) today releases its results for the period 1 July – 30 September 2025. The third quarter report is available as an attached document to this press release and on www.cessatech.com under Investor/Filings & Reports.  Third

CT001 soon available for US hospitals in collaboration with STAQ Pharma, for acute pain management in children

· Successful completion of technology transfer of CT001 with STAQ Pharma supporting near term product availability · CT001 is expected to reach the first hospitals in the US within the coming months · The finalisation of marketing and training material is currently in progressCopenhagen, Denmark – 31 October 2025 – Cessatech A/S (“Cessatech” or “the Company”) today announces the successful completion of the technology transfer of CT001, marking a significant step towards making the product available to the first hospitals in the United States for acute pain management in children.

Second Quarter Report Q2-2025

The Company has advanced well with its planned activities · Positive and clinical meaningful top-line results from Study 0202 · New US manufacturing technology transfer nearing completion · CT001 dossier development for EMA submission; filled and validated 14. August · Organisational development, promotion of M. Juhl to Executive Management · Strengthening the financial position with a direct issue of DKK 14.6 millCessatech A/S (“Cessatech” or the “Company”) today releases its results for the period 1 April – 30 June 2025. The second quarter report is available as an

The Marketing Authorisation Application (MAA) for CT001 is submitted to the European Medicines Agency (EMA) for acute pain management in children

· Proveca has submitted a Paediatric Use Marketing Authorisation (PUMA) application for CT001 (ketamine/sufentanil nasal spray) to the EMA · The validation process has been completed · The review process will now be initiated and potential approval expected in 2026This press release is intended for investors only.Copenhagen, Denmark - 14 August 2025 - Cessatech A/S (“Cessatech”) and Proveca Ltd (“Proveca”) today announce that the European Medicines Agency (EMA) has validated the Marketing Authorisation Application (MAA) for CT001 (a prescription only medicine), confirming that the

Cessatech Q&A – June company presentation

Selected top 5 summarized questions from investors focusing on the top-line results of Study 0202 and US launch plans1.Data from Study 0202 – any potential impact for later commercialization or EMA approval process? · We believe the top-line data shared, is really good – and most importantly it fits very well with the predicted data from Study 0208. An overall pain reduction of 75% is considered very good.  · There is not much data in acute pain on children, but two larger studies (+400 children), had a reduction in pain of -64% and -60% (the last being an IV administration study).

Cessatech strengthens Executive Management with the promotion of Martin Juhl

· Welcome to new member of the Executive Management team, Martin Juhl · Acknowledgment of his great contribution and importance for the future development of CessatechOn 19 June – Cessatech A/S (“Cessatech” or “the Company”) and the Board of Directors announces the promotion of Chief Scientific Officers (CSO) Martin Juhl as a member of the Executive Management team, effective today. The appointment is a direct recognition of Martin’s significant impact on the company. This expansion of the leadership team strengthens Cessatech's capacity to execute on its mission to develop vital new

Cessatech announce completion of the directed issue of shares

· As announced on 28 May 2025, the Board of directors in Cessatech exercised an authorization to increase the share capital through a directed issue of shares. · A total of 1,151,343 shares have now been registered at the Danish Business Authority, resulting in an increase in Cessatech’s share capital of nominally DKK 230,268.60.THIS PRESS RELEASE MAY NOT BE ANNOUNCED, PUBLISHED OR DISTRIBUTED, DIRECTLY OR INDIRECTLY, IN OR INTO THE UNITED STATES, AUSTRALIA, HONG KONG, JAPAN, CANADA, NEW ZEALAND, SINGAPORE OR SOUTH AFRICA OR IN ANY OTHER JURISDICTION WHERE SUCH ANNOUNCEMENT, DISTRIBUTION

Cessatech has carried out a directed share issue of approximately DKK 14.8 million to strengthen its financial position ahead of U.S. commercial launch

· As announced on 28 May 2025, Cessatech launched a directed share offering to certain institutional and professional investors through an accelerated bookbuilding process. · The Board of directors in Cessatech has exercised an authorization to increase the share capital by issuing 1,163,123 shares to a limited number of semi-institutional and professional investors.   · Shares will be issued at a subscription price DKK 12.72 per share. · Aggregate gross proceeds from the issue will amount to approximately DKK 14.8 million and Cessatech intends to use the net proceeds for general

Cessatech announces intention to carry out a directed share issue ahead of U.S. commercial launch

·A directed share issue of minimum DKK 10 million to certain institutional and professional investors through an accelerated bookbuilding process will begin immediately.  ·Net proceeds from the directed issue are expected to be used for accelerating U.S. commercialization following finalization of U.S. manufacturing setup during 2025.On 28 of May, Cessatech A/S, CVR no. 41293055 (“Cessatech” or the “Company”) announces its intention to carry out a directed issue of minimum DKK 10 million at market price to institutional and other professional investors with the purpose of

Cessatech announces positive top-line results from its final CT001 Study 0202

·The primary endpoint of responder analysis, of pain relief (pain score ≤4/10), was met and reported by 55% of patients after 15 minutes and by 89% after 30 minutes.  ·Overall pain reduction was 75% after 30 minutes, and 86% after 60 minutes.   ·No drug related unexpected adverse effects, and they were all transient and of mild to moderate intensity.Copenhagen, 28 May - 17.15 On 28 May – Cessatech A/S (“Cessatech” or “the Company”) announces top-line results from its Paediatric Study 0202, an open-label trial in the development program of CT001 an intranasal, needle-free

First Quarter Report Q1-2025

The Company has advanced well with its planned activities · Positive CT001 MDR assessment  · Finalization of Paediatric Safety Study 0202 · US manufacturing and launch finalization still in process · EMA submission planning processCessatech A/S (“Cessatech” or the “Company”) today releases its results for the period 1 January – 31 March 2025. The first quarter report is available as an attached document to this press release and on www.cessatech.com under Investor/Filings & Reports.  First quarter financial results 2025 (1 January – 31 March): · Net Revenue was KDKK 1.

Cessatech announces that recruitment has completed in the Paediatric Study 0202, and now the EMA submission process can be initiated for CT001

· 150 paediatric patients have been recruited in Study 0202 as planned · Study 0202 is the final required clinical study that will evaluate the safety and efficacy profile for CT001 in children · Top-line results are expected within the next 3-6 weeks · The EMA submission process can now be initiated, for submission later this yearOn 30 April – Cessatech A/S (“Cessatech” or “the Company”) announces that it has completed the patient recruitment of its final study Paediatric Study 0202 in the development program of CT001. Study 0202 is the final required clinical study that will

Minutes from the Annual General Meeting in Cessatech A/S

Cessatech A/S, CVR no. 41293055 (“Cessatech” or the “Company”) held its Annual General Meeting on Friday 28 March 2025 at 09:00 (CET) at the Company's address Strandvejen 60, 2900 Hellerup.The agenda for the general meeting was as follows: 1. ELECTION OF CHAIRMAN OF THE MEETING 1. Mikkel Rostock-Jensen was elected chairman of the meeting. The chairman of the meeting ascertained that none of the shareholders objected to the legality of the annual general meeting and announced that the annual general meeting had been duly convened and was legal and competent in terms of all items on

Annual General Meeting - 28 March 2025

Cessatech A/S (“Cessatech” or the “Company”) hereby convenes the annual general meeting to be held on 28 March 2025.The shareholders of Cessatech A/S The board of directors hereby convenes the annual general meeting of Cessatech to be held on Thursday 28 March 2025 at 9.00 (CET) at the Company's address Strandvejen 60, 2900 Hellerup. The agenda for the general meeting is as follows: 1. ELECTION OF CHAIRMAN OF THE MEETING 2. REPORT ON THE ACTIVITIES OF THE COMPANY IN THE PAST FINANCIAL YEAR 3. PRESENTATION OF THE ANNUAL REPORT WITH AUDITORS’ REPORT FOR ADOPTION 4. RESOLUTION

Cessatech A/S publishes Annual Report for the fiscal year 2024

Cessatech A/S (“Cessatech” or the “Company”) hereby publishes its annual report for the fiscal year 2024, which also includes the fourth quarter of 2024 financial reporting. The annual report is attached as a pdf. The report is also available on Cessatech’s website www.cessatech.com under ‘Fillings & Reports’.Full year 2024 for the period 1 January - 31 December (Q4’2024 results in brackets): · Net revenue was KDKK 2.486 (-870) · Operating result was KDKK -19.053 (-8.667) · Net result was KDKK -14.670 (-7.216) · Cash at bank end of the period was KDKK 12.373 (12.373) ·

Cessatech receives positive Notified Body opinion under MDR for CT001

· CT001 receives positive opinion during the Medical Device Regulation (MDR) approval process. · Confirms that CT001 meets the General Safety and Performance Requirements of the MDR. · An important milestone for Cessatech’s EMA filing, planned for later this year – and highlights Cessatech’s commitment to quality and evidence-based treatments.On 4 February (11.30) – Cessatech A/S (“Cessatech” or “the Company”) announces that the Company has received a positive Notified Body Opinion under Article 117 of the Medical Devices Regulation (EU) 2017/745 (MDR) for its lead asset CT001. The

Cessatech updates the milestones for the coming year

· Great progress from the year 2024, including the commercialization agreement for CT001. · The US launch is still pending and our main focus for the coming period. · In 2025 we will work hard for new partnerships, new opportunities and get CT002 moving.On 23 December – Cessatech A/S (“Cessatech” or “the Company”) gives an update on the major milestones for the coming year. We are very pleased with the progress Cessatech has made during 2024, and this is truly the result of an incredible team-effort and partnership collaborations. During 2024 we closed the agreement with Proveca

There are no items matching the current filter
There are no more items matching the current filter
Back to top

Subscribe