Nasdaq First North

Faron Confirms Plans for the Coming Months Under New Leadership

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星期二, 四月 16, 2024
FDA, Science, Nasdaq First North, Myelodysplastic syndrome, Safety, Myelocyte, Food, SOC, Majesty of the Seas, AIM, Fårö, ASCO, Faron Pharmaceuticals, Patient, Society, Standard of care, MDS, Pharmaceutical industry

This data readout will be important for ongoing partnering discussions and the major upcoming industry events that Faron will be attending, including the American Society for Clinical Oncology (ASCO) annual meeting and the Bio International Convention, taking place in June 2024.

Key Points: 
  • This data readout will be important for ongoing partnering discussions and the major upcoming industry events that Faron will be attending, including the American Society for Clinical Oncology (ASCO) annual meeting and the Bio International Convention, taking place in June 2024.
  • “2024 is set to be a pivotal year for Faron in the delivery of key milestones that will be critical to the further development of bexmarilimab,” said Dr. Juho Jalkanen, Faron’s incoming Chief Executive Officer.
  • “In my new role as CEO, I am excited to start executing on some of these key activities and accelerating important discussions with the FDA as we map our future plans for bexmarilimab together.
  • There is a tremendous need for an effective treatment in HMA-failed MDS patients, and so we are very keen to ensure we get this treatment option to patients as soon as we can.”
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Inside Information: Additional Positive Data from the Phase 1 Part of the BEXMAB Study in Both Higher-Risk HMA-Failed MDS and r/r AML

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星期一, 三月 18, 2024
Principal, Nasdaq First North, Survival, ASH, AML, Associate, Webcast, Patient, Acute myeloid leukemia, Doctor of Philosophy, MD, Quality of life, Myelodysplastic syndrome, Faron Pharmaceuticals, HMA, Myelocyte, Society, Helsinki University Central Hospital, Azacitidine, MDS, MCR, FDA, AIM, SAE, Pharmaceutical industry

TURKU, Finland and BOSTON, March 18, 2024 (GLOBE NEWSWIRE) -- Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company pursuing a CLEVER approach to reprogramming myeloid cells to activate anti-tumor immunity in hematological and solid tumor microenvironments, today provided further data from patients treated during the Phase 1 part of the ongoing BEXMAB trial that has moved into Phase 2 for higher-risk (HR) myelodysplastic syndrome (MDS) patients failed on previous hypomethylating agent (HMA).

Key Points: 
  • Latest readout of the BEXMAB study shows more responding patients and good durability of remission amongst HR HMA-failed MDS patients.
  • 4/5 of the initial Phase 1 HR HMA-failed MDS patients were still alive after eight months of follow-up.
  • Faron will be hosting a virtual webinar to discuss the additional data tomorrow, Tuesday, 19 March at 11.00 EET/9am GMT.
  • After the already reported 5 HMA-failed HR MDS patients, 3 new HMA-failed HR MDS patients were enrolled, filling the remaining Phase 1 slots.

Faron to Host Webcast to Discuss latest data from Phase 1 part of the BEXMAB Study of Bexmarilimab

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星期四, 三月 14, 2024
Nasdaq First North, AML, Fårö, Associate, Webcast, Patient, Myeloid leukemia, Standard of care, Acute myeloid leukemia, University, Doctor of Philosophy, MD, Myelodysplastic syndrome, Faron Pharmaceuticals, Myelocyte, MDS, AIM

This interactive event will also include an introduction to myeloid leukemia, insights into bexmarilimab’s unique mode of action and the Company’s latest understanding of the early and long-term efficacy of bexmarilimab treatment.

Key Points: 
  • This interactive event will also include an introduction to myeloid leukemia, insights into bexmarilimab’s unique mode of action and the Company’s latest understanding of the early and long-term efficacy of bexmarilimab treatment.
  • Faron will also provide an update on bexmarilimab’s future development pathway and business opportunity.
  • There will be an opportunity to ask questions during the webcast.
  • To register for the event visit: https://faron.videosync.fi/bexmab-study-update/ or contact the IR team for more information at [email protected] .

Faron’s Financial Statement Release January 1 to December 31, 2023

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星期三, 三月 13, 2024
Head, Q&A, Survival, Immunotherapy, Patient, Medicine, Standard of care, CMML, Macrophage, Faron Pharmaceuticals, Neoplasm, EET, Rheumatology, PD-1, TME, PR, ASH, AML, Cancer, Johnson & Johnson, Safety, Azacitidine, MDS, BLA, Decitabine, Food, ODD, Nasdaq First North, PD, Tumor microenvironment, Manuscript, CRS, SICAV, MD, Interferon beta-1a, Haematopoietic system, GMT, FDA, AIM, Neurotoxicity, Infection, EUR, Sanofi, SOC, Metabolism, European Hematology Association, EDT, MBA, IPF, Facility, Treasury, Society, Cytokine release syndrome, CPA, Pharmaceutical industry

As at March 13, 2024, the Company is in compliance with all IPF financial covenants as agreed with the waiver letter.

Key Points: 
  • As at March 13, 2024, the Company is in compliance with all IPF financial covenants as agreed with the waiver letter.
  • Loss for the period for the financial year ended December 31, 2023, was EUR 30,9 million (2022: EUR 28,7 million).
  • In June 2023, Faron conducted a placement of 2,601,510 newly issued treasury shares to investors to raise EUR 6,6 million gross.
  • In October 2023, the Company successfully raised EUR 7,1 million gross through the issuance of 2,491,998 ordinary shares to investors.

Proposed Fundraising

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星期一, 二月 12, 2024
SRK, Engineering, EIA, Copper, Nickel, Nanoq, Weather, Mining, Mineral, Social impact assessment, Resource, ESG, Titanium, AIM, GCAM, Nasdaq First North, Halyard, Growth, Metal, Gold, National instrument, Acceleration, Graphite, Environmental impact assessment, Feasibility study, KT, Cryptocurrency

The Dolerite Dyke Model: Amaroq has worked with SRK Consulting to develop a robust Mineral Resource estimation technique for Nalunaq.

Key Points: 
  • The Dolerite Dyke Model: Amaroq has worked with SRK Consulting to develop a robust Mineral Resource estimation technique for Nalunaq.
  • Preparation for a phased ramp-up to 300 tonnes per day process plant design capacity will continue throughout the year.
  • The main initiative is accelerating development of the Target Block which will undergo trial mining in conjunction with the Mountain Block.
  • The net use of proceeds from the Fundraising will be used to fund the accelerated development of the Target Block, infrastructure investment to allow for the mining of two blocks simultaneously, preparatory works at the South & Valley Blocks, installation of the flotation circuit and DSTF, and accelerated exploration at Vagar/Nanoq and the Gardaq joint venture.

Detailed Analysis of BEXMAB Data Provides Insights into Patient Profiles of Responding HMA-Failed MDS Population

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星期四, 一月 25, 2024
AIM, Patient, SOC, MDS, Decitabine, Standard of care, Survival, Faron Pharmaceuticals, PD, Quality of life, Azacitidine, Nasdaq First North, Safety, Majesty of the Seas, Myelodysplastic syndrome, Myelocyte, Pharmaceutical industry

The new analysis of data from the Phase 1 part of the trial explores the 100% overall response rate (ORR) achieved among both the higher-risk frontline and HMA-failed MDS patients treated with a bexmarilimab/azacitidine combination – 5 out of 5 patients in each population – and examines previous therapies in the patients’ treatment pathways.

Key Points: 
  • The new analysis of data from the Phase 1 part of the trial explores the 100% overall response rate (ORR) achieved among both the higher-risk frontline and HMA-failed MDS patients treated with a bexmarilimab/azacitidine combination – 5 out of 5 patients in each population – and examines previous therapies in the patients’ treatment pathways.
  • “Patients with high-risk MDS who have failed HMA therapy face a poor prognosis and median overall survival in refractory MDS is just 4-6 months with no viable treatment options.
  • Yet here we have data showing that patients are surpassing anticipated survival rates and maintaining remission.
  • It is remarkable to see patients going into remission with bexmarilimab/azacitidine after showing disease progression on all the leading azacitidine combinations such as venetoclax, sabatolimab and magrolimab.

Thomson Reuters Corporation acquires majority interest in Pagero - a World Leader in E-Invoicing

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星期一, 一月 15, 2024
Thomson Reuters, Linklaters, Partnership, Indirect tax, Nasdaq First North, Acquisition, CTC, Growth, News

On January 11, 2024 Thomson Reuters announced a recommended public tender offer to acquire 100 per cent of the shares of Pagero (the "Offer").

Key Points: 
  • On January 11, 2024 Thomson Reuters announced a recommended public tender offer to acquire 100 per cent of the shares of Pagero (the "Offer").
  • The independent bid committee of Pagero's board of directors unanimously recommends all shareholders of Pagero accept the Revised Offer.
  • Pagero is a global leader in e-invoicing and indirect tax solutions, which it delivers through its Smart Business Network.
  • To ensure continuity for its community of Indirect Tax customers, Thomson Reuters is committed to maintaining Pagero as a market solution.

Thomson Reuters Corporation Announces a Recommended Public Offer to Acquire Pagero - a World Leader in E-Invoicing

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星期四, 一月 11, 2024
Thomson Reuters, Linklaters, Partnership, Nasdaq First North, Acquisition, CTC, Vertex, Growth, Online shopping

Pagero is a global leader in e-invoicing and indirect tax solutions, which it delivers through its Smart Business Network.

Key Points: 
  • Pagero is a global leader in e-invoicing and indirect tax solutions, which it delivers through its Smart Business Network.
  • An offer document regarding the Offer is expected to be made public on this day, January 11, 2024.
  • This press release shall not constitute an offer to buy or a solicitation of an offer to sell any Pagero securities.
  • Thomson Reuters has engaged Morgan Stanley & Co. LLC as financial adviser and Linklaters as legal adviser in connection with the Offer.

Inside information: Faron Announces First HMA-failed MDS Patient Dosed with Bexmarilimab as part of Phase 2 of BEXMAB Trial

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星期二, 一月 9, 2024
Patient, Azacitidine, Risk, FDA, Nasdaq First North, HMA, Disease, Myelodysplastic syndrome, CMML, AIM, MDS, Standard of care, ASH, Myelocyte, Faron Pharmaceuticals, SOC, Safety, Phase II, Majesty of the Seas, Pharmaceutical industry

TURKU, Finland and BOSTON, Jan. 09, 2024 (GLOBE NEWSWIRE) -- Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company pursuing a CLEVER approach to reprogramming myeloid cells to activate anti-tumor immunity in hematological and solid tumor microenvironments, today announced that the first patient has been dosed in Phase 2 of the BEXMAB trial that evaluates the safety and efficacy of bexmarilimab, in combination with standard of care (SoC) in patients with hypomethylating agents (HMAs)-refractory or relapsed myelodysplastic syndrome (MDS), an aggressive myeloid leukemia with very few treatment options.

Key Points: 
  • The ongoing, randomized parallel-assigned Phase 2 part is enrolling 32 HMA-failed MDS patients at 3 mg/kg and 6 mg/kg dose levels of bexmarilimab.
  • Patients are being randomized 1:1 between the doses before moving into a Phase 2/3 study expansion.
  • Post selection of final dosing, Faron intends to discuss a potential registrational study plan with the FDA.
  • The Company’s key focus is to pursue an accelerated path to approval in refractory higher risk MDS, where no treatment option exists.

Nasdaq European Markets sustains its strong position in the SME listings and sustainable debt market in 2023

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星期一, 一月 8, 2024
SME, Forward, Nasdaq First North, Uncertainty, NDAQ, Vasakronan, Initial public offering, Nasdaq Stockholm, Growth, EUR

Despite the uncertainties in the wider global economy, the Nordic and Baltic regions maintained their position in capital markets in several key areas, including Sustainable Debt Market and SME listings.

Key Points: 
  • Despite the uncertainties in the wider global economy, the Nordic and Baltic regions maintained their position in capital markets in several key areas, including Sustainable Debt Market and SME listings.
  • With 19 listings, Nasdaq Stockholm also remained one of the most successful listings venues in Europe in 2023.
  • Nasdaq continues to perform a crucial role as a vibrant growth engine for northern European capital markets,” said Roland Chai, President of European Market Services, Nasdaq.
  • Since the founding of Nasdaq First North in 2006, Nasdaq had its 130th company to transfer from Nasdaq First North Growth Market to Main Market in December 2023.