Faron

Great news for Faron’s lead candidate bexmarilimab!    The USA Food and Drug Administration FDA has granted an Orphan Drug Designation for bexmarilimab in MDS.   The achieved Orphan Drug Designation further strengthens bexmarilimab program by offering clinical development and commercialization benefits. Faron is on track to report frontline and HMA-failed (r/r) MDS top-line efficacy results in April 2025.    “Receiving FDA’s orphan drug designation for bexmarilimab for the treatment of myelodysplastic syndrome marks a significant milestone for Faron Pharmaceuticals as we continue to develop bexmarilimab for MDS and other cancers. This FDA ODD along with the previously granted FDA fast track designation highlights our continued progress and reinforces our belief in the potential of bexmarilimab to address this significant unmet need for treatment of MDS. These designations allow us to receive important regulatory guidance for the development of bexmarilimab and potential additional market exclusivity upon approval” says Dr. Bono, the CMO of Faron.   To read the company announcement, please click on the link in post comments.

Faron Pharmaceuticals Ltd has today published the Annual Report for 2024! HIGHLIGHTS 2024 ↗️ Faron’s financial position improved significantly during 2024 🏛️ In July, Faron announced positive feedback from the FDA regarding the registrational clinical development plan for bexmarilimab for the treatment of higher-risk (HR) MDS and in August the FDA granted Fast Track Designation for bexmarilimab in r/r MDS. 📌 In October, Faron announced the new Scientific Advisory Board bringing further depth and experience to the Company. 📊 In December, Faron presented BEXMAB phase II interim data at ASH annual meeting. The BEXMAB results continued to improve showing a remarkable 80% ORR in r/r MDS patients. To read the full Annual report 2024, visit https://lnkd.in/dpJfhc9T Webcast recording can be found at: https://lnkd.in/eYHYACPq

Next Thursday, February 27, Faron will publish its Financial Statement Release and Annual Report for the year ended December 31 2024.   Our CEO Juho Jalkanen MD, PhD and CFO Yrjö E K Wichmann will host a webcast on the day, at 9am GMT / 11am EET, for analysts, investors and media.  A replay will be made available on Faron’s website shortly afterwards. To register for the webcast visit: https://lnkd.in/eYHYACPq.   #Faron #biotech #drugdevelopment #oncology #healthcare

Results of the Significantly Oversubscribed Placing – Faron   Faron announced on February 05, 2025 a Proposed Issue and Placing of preliminarily approx. EUR 10 million. The results of the placing were announced today, on February 6, 2025. The Placing was oversubscribed 1.8 times and thus the Board decided to upsize the offering and raise gross proceeds of EUR 12 million.    The primary reason for conducting the placing was to strengthen the Company’s financial position ahead of its upcoming BEXMAB Phase II trial topline readout, which is expected in April 2025. The proceeds will be used for the continuation of the BEXMAB Phase II trial, mainly to produce follow-up data (duration of response and survival) and prepare the package for end of Phase II FDA meeting and to enhance the Company’s balance sheet.    The Company will continue to evaluate further business transactions such as licensing agreements as well as other financing alternatives (e.g. equity, convertible or debt instruments) in order to achieve the best commercial outcome to its shareholders. The Placing improves the Company’s negotiation position ahead of the BEXMAB Phase II efficacy and safety readout, while also ensuring compliance with the financial covenants. Read the Company announcement in the post comments.

We are delighted to announce that the final patient has been identified for our BEXMAB Phase II dose optimization study of #bexmarilimab, our wholly owned #immunotherapy candidate, in refractory or relapsed myelodysplastic syndrome (r/r MDS), as well as the BEXMAB Phase I/II study of bexmarilimab in frontline high risk (HR) MDS.    The topline efficacy and safety data from this study is expected to become available in April 2025 and we look forward to presenting detailed data at upcoming medical conferences.     Read the full press release here: https://lnkd.in/espnm88s   #Faron #biotech #drugdevelopment #oncology #heatlhcare 

🛜 We’ve launched our new website today! 🛜 The development of the site has focused on clarity and better serving different stakeholders. The website features dedicated sections for investors, patients, as well as information on Faron’s development pipeline and the company itself. We have gathered all reports and presentations on a dedicated page and provide a separate section in accordance with AIM Rule 26 of the London Stock Exchange under the Investors section. Thank you for the feedback received during the day. To visit the new site, see the link in post comments.

Great to hear our CEO Juho Jalkanen MD, PhD on the latest Citeline In Vivo Podcast with Anabel Costa-Ferreira, discussing the importance of addressing unmet medical needs in cancer by breaking treatment resistance – something we’re working towards with the development of bexmarilimab, our wholly owned #immunotherapy candidate.   To listen to the podcast, please visit: https://lnkd.in/eC7K_Ndk   #Faron #podcast #biotech #drugdevelopment #oncology #heatlhcare  

Greetings from the opening day of J.P. Morgan's 43rd Annual Healthcare Conference in San Francisco, USA. It is a privilege to be invited in this premier conference focusing on health care investment and discussing the major themes of healthcare for 2025. 💡 In the pre words for the event, innovation was mentioned as a guiding principle in the biotech sector and oncology as one of the hot therapeutic areas in 2025 by J.P. Morgan analysts.    We look forward to dozens of super-interesting meetings during the coming days! #Faron #biotech #drugdevelopment #oncology #heatlhcare #conference 

Our CEO Juho Jalkanen MD, PhD CMO Petri Bono and CFO Yrjö E K Wichmann will be attending J.P. Morgan’s 43rd Annual Healthcare Conference taking place in San Francisco from 13-16 January.   This premier conference is the largest and most influential healthcare investment symposium of the year, bringing together global industry leaders, fast-growing emerging companies, innovative technology pioneers and key members of the investment community.   Please reach out if you’d like to meet the Faron team and learn more about the progress in clinical development of #bexmarilimab, our wholly owned #immunotherapy candidate.   #Faron #biotech #drugdevelopment #oncology #heatlhcare #conference  

We were thrilled to present the full phase 2 interim data from BEXMAB trial at the 66th American Society of Hematology (ASH) Annual Meeting earlier today! Key takeaways: ✅ 80% overall response rate in r/r MDS patients  ✅ Deep and durable responses: 70% achieved complete response (CR) / marrow complete remission (mCR) / partial response (PR) ✅ 4 patients advanced to receive a bone marrow transplant ✅ Median overall survival estimated at 13.4 months in r/r MDS population Faron will host a virtual webinar to discuss the full analysis of data today, on December 10, 2024, at 16.00 EET/9am ET/6am PT. To register for the event, please visit https://lnkd.in/dQgiAZ8Z The full poster containing the updated clinical data from the BEXMAB trial is available on Faron ‘s website at https://lnkd.in/ddpM9rCT #Faron #bexmarilimab #biotech #drugdevelopment #CancerResearch #Immunotherapy #ASH