Anuncio • Jul 08
Nasdaq Stockholm Decides to Delist the Shares of Idogen from Nasdaq First North Growth Market On July 7, 2023, Idogen AB issued a with information that the Lund District Court had declared the company bankrupt. According to item 8.2.6 of the Nasdaq First North Growth Market Rulebook, the exchange may decide to delist the financial instruments of an issuer if the issuer is subject of insolvency. With reference to the above, Nasdaq Stockholm AB has decided to delist the shares of Idogen AB from Nasdaq First North Growth Market with immediate effect. Anuncio • Nov 22
Idogen AB (publ) Appoints Jan Holgersson to Its Board of Directors Idogen AB (publ) announced that Jan Holgersson, who has served for several years as scientific adviser to the company, has agreed to strengthen the company’s Board of Directors in the role as co-opted Board member. Jan Holgersson is a professor of Transplant Immunology at Gothenburg University, the Medical Director of the Tissue Typing and Stem Cell Laboratories at Sahlgrenska University Hospital in Gothenburg, where he was also formerly the Head of Clinical Immunology and Transfusion Medicine. His research focuses on understanding the immunological mechanisms that underlie the rejection of transplanted organs and tissues. Another important initiative has been supporting the development of diagnostics for detection and semiquantification of antibodies against the ABH blood group antigens and other tissue antigens (non-HLA). Jan Holgersson is also Chairman of the Board of VERIGRAFT AB, a Swedish biotech company. Jan has been part of the company’s efforts at a detailed survey of the mechanisms of action for the company’s technology platform. Board Change • Nov 16
High number of new and inexperienced directors There are 7 new directors who have joined the board in the last 3 years. The company's board is composed of: 7 new directors. 4 experienced directors. No highly experienced directors. Founder & Chairman of the Scientific Advisory Board Leif Salford is the most experienced director on the board, commencing their role in 2015. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors. Anuncio • Nov 02
Idogen AB Announces Board Changes Idogen AB announced that Agneta Edberg has been elected as new Chairman of the Board since the current Chairman of the Board, Joakim Söderström, has requested to resign from the Board of Directors at his own request as he has accepted a new position that is incompatible with being active in the Board of Directors of a public company. In addition, Niklas Wallett, who was elected to the Board of Directors at the same time as Joakim Söderström, has also requested to resign from the Board of Directors at his own request. In September 2022, both Joakim Söderström and Niklas Wallett were elected to the Board of Directors of Idogen. Joakim Söderström was elected to be the Chairman of the Board, replacing Agneta Edberg. Joakim Söderström has now requested to resign from the Board of Directors at his own request as he has accepted a new position that is incompatible with being active in the Board of Directors of a public company and he will resume his role as a shareholder. In addition, Niklas Wallett has also requested to resign from the Board of Directors at his own request to resume his role as a shareholder. Due to the above changes, the Board of Directors of Idogen has elected Agneta Edberg as new Chairman of the Board, effective from today. As consequence of these changes, the Board of Directors consists of Agneta Edberg, Chairman, Sharon Longhurst and Christina Herder, meaning that the Board of Directors retains a quorum. Proposal for election of a new Board of Directors will be submitted by the Nomination Committee in connection with the announcement of the notice of the Annual General Meeting 2023, at the latest. Anuncio • Oct 15
Idogen AB (Publ) Announces First Patient Enters Idogen's Hemophilia Study Under the Ido 8 Program Idogen AB (publ) announced that the first patient has been included in the Phase I/IIa clinical trial with ItolDC-028, the company's cell therapy that is part of its IDO 8 program. The patient was included at Oslo University Hospital, where the trial will be carried out under the management of professor and chief physician Pål Andre Holme. The patients that will be included in the study all have hemophilia A and should have developed antibodies to their treatment with factor VIII. They should also have undergone unsuccessful immune tolerance induction (ITI) treatment and still have inhibitors against factor VIII. The patient who has been enrolled in Norway will now undergo planned tests ahead of the apheresis process, the purpose of which is to collect the patient's white blood cells which are then used to manufacture the cell therapy. The white blood cells will be sent to the company's partner, Radboud University Medical Center (RUMC) in the Netherlands, where they will be processed using the company's patented technology. The overall objective of the therapy is toinduce a tolerance to factor VIII, which in turn means the patient can once again undergo factor VIII treatment without any problems. Anuncio • Sep 28
Idogen AB (publ) Announces Board Changes On September 6, 2022, Idogen held an Extraordinary General Meeting to elect Joakim Söderström as new chairman and Niklas Wallett to the board. They are both significant shareholders in Idogen and will now take an active role on the board to take the company to the next level. BioStock had a chat with newly elected Chair Joakim Söderström about his new role and his expectations. Anuncio • Sep 21
Idogen Receives Approval from the Regional Ethics Committee to Conduct Clinical Phase I/IIa Study Idogen AB (publ) announces that the company has received approval from the Norwegian REK (Regionale komiteer for medicinsk og helsefaglig forskningetikk) in Oslo to conduct the clinical phase I/IIa study of their drug candidate within the IDO 8 program for patients suffering from hemophilia who have developed antibodies against their life-saving factor VIII treatment. The approval means that study activities can begin at the clinic and that the first patient can be enrolled in the study within short. Idogen has now received approval from the ethics committee in Oslo to conduct the company's phase I/IIa study in hemophilia with the drug candidate, ItolDC-028. The study is conducted under the leadership of professor and senor physician Pål Andre Holme. Shortly, the first patient will be able to be enrolled, after which the first step in the treatment will be possible to be carried out. Anuncio • Sep 13
Idogen Appoints Christina Herder as Acting CEO Idogen appointed Christina Herder as new acting CEO by the board of directors. Herder has for the past five years been a board member of Idogen and also has more than 30 years of experience in several senior positions in the pharmaceutical industry. Anuncio • Sep 07
Redeye Updates Their Analysis of Idogen as Company Approaches Clinical Phase Redeye updated their analysis of Idogen as company approaches clinical phase Idogen AB (publ) is a company that is developing tolerogenic cell therapies with the aim to treat conditions or diseases caused by an unwanted immune response in the patient. As the company now approaches clinical phase with its most advanced development program IDO 8, Redeye is intensifying their coverage of Idogen and have published an updated analysis of Idogen AB. In summary, Redeye's report describes Idogen as a company developing novel treatments where there are large unmedical needs. In the most advanced program, IDO 8, the company has developed a cell therapy for patients with Hemophilia A, who have developed antibodies, a k a "inhibitors". Against their vital factor VIII treatment. The first clinical study within this program has, as previously communicated, obtained regulatory approval in both Sweden and Norway. The first patient is planned to be included in this phase 1/2a study during autumn. Another example that is highlighted in the analysis of the company's platform is the IDO T-program, where the researchers in the company is working to develop a new cell therapy for patients that are to have a kidney transplant. There is a risk that the patient develops an organ rejection and is currently treated, to minimize the risk, with immunosuppressants for long periods, which may lead to serious side effects. Example of side effects can be e.g. severe infections or cancer. A pre-treatment with Idogen's cell therapy, could counteract the undesired immune reponse that leads to a rejection. There are several more potential uses for cell therapies from the company as the technology platform is adaptable; as the tolerogenic cells may be adapted to several different types of antigens causing problems for the patient. The usage can thus be expanded to other diseases where the immune system attacks tissues or transplants in an unwanted way. Anuncio • Aug 11
Idogen AB (Publ) Announces CEO Executive Changes Idogen AB (publ) announced that Anders Karlsson has decided to leave the company to move on to a CEO role in another Swedish biotechnology company. He will remain in his current position until 1 September 2022; the board is now starting a process to recruit a successor. Christina Herder, who has been a board member of the company for more than five years, has been appointed acting CEO while the recruitment of a new CEO is underway. She will retain her role on the board during this time. Anuncio • Jul 29
Idogen AB (publ) is Preparing to Start Clinical Phase 1/2A Study with IDO 8 in Norway Idogen AB (publ) is working intensively on the preparations for the company's first clinical study with the cell therapy IDO 8 in patients with severe hemophilia A and is meeting a great deal of commitment at participating study centers. In Norway, the company's clinical trial center has come a long way in preparations for the study. Idogen has previously received approval from both the Swedish and the Norwegian Medicines Agency to start the study, and in Norway, patients who are suitable for inclusion have now been identified. Professor Pål Andre Holme, senior physician at Oslo University Hospital and clinical investigator in Idogen's study, says in an interview with BioStock that he expects to soon be able to start the study and hopes to start after the summer. What remains in Norway is an approval from the local ethics committee. The approvals the company received to start the study in Sweden and Norway are now being used to obtain a combined approval that includes all countries in the EU. For the UK, the approval process is based on the work done previously in Sweden and Norway. Board Change • Apr 27
No independent directors There are 6 new directors who have joined the board in the last 3 years. Of these new board members, none were independent directors. The company's board is composed of: 6 new directors. 5 experienced directors. 1 highly experienced director. No independent directors (5 non-independent directors). Founder, Chairman of the Scientific Advisory Board & Director Leif Salford is the most experienced director on the board, commencing their role in 2009. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of independent directors. Lack of board continuity. Lack of experienced directors. Anuncio • Apr 20
Idogen AB (publ) Announces Study Approval in Norway and Sweden Idogen AB (publ) has received the go-ahead from both the Swedish and Norwegian Medical Products Agencies to initiate a clinical phase I/IIa study with the cell therapy IDO 8 in hemophilia A. The study's primary purpose is to show that the treatment is safe and to obtain preliminary data on the potential treatment effect. Anuncio • Apr 11
Idogen AB (Publ) Receives Approval from the Norwegian Medicines Agency, Noma, for the Start of Clinical Phase 1/2A Study with IDO 8 Idogen AB (publ) received approval from the Norwegian Medicines Agency, NoMA, to ben recruitment for its clininical phase 1/2a study with IDO 8, a completely new type of cell therapy for patients with severe hemophilia A who have developed antibodies to their treatment with coagulation factor VIII. The Swedish Medical Product Agency has already previously approved the phase 1/2a study and patient recruitment in Sweden will begin as soon as the authority has formally approved the local trial center where the study is to be carried out. The approval from NoMA now gives the go -ahead to start patient recruitment in Norway as well. The plan is for the study to be carried out in several European countries. Idogen's cell therapy IDO 8 is tailored for each individual patient in a GMP-certified facility at the company's Dutch manufacturing partner Radboud University Medical Center (RUMC). The study has been designed in dialogue with the regulatory authorities in the Nordic countries and the goal is to evaluate the safety of IDO 8 and to follow signals of treatment effect in patients. Anuncio • Mar 29
Idogen Receives Approval from the Swedish Medical Products Agency for the Clinical Phase I/IIa Study with IDO 8 Idogen recently announced that they have received approval from the Swedish Medical Products Agency for the clinical phase I/IIa study with IDO 8. The cell therapy is aimed at patients with severe haemophilia A who have developed antibodies to their substitution therapy with coagulation factor VIII. BioStock contacted Professor Jan Astermark, Principal Investigator in the clinical study, to find out more about the unmet medical need of these patients. Anuncio • Feb 15
Idogen AB (publ) has completed a Composite Units Offering in the amount of SEK 50.425465 million. Idogen AB (publ) has completed a Composite Units Offering in the amount of SEK 50.425465 million.
Security Name: Units
Security Type: Equity/Derivative Unit
Securities Offered: 16,478,910
Price\Range: SEK 3.06
Transaction Features: Rights Offering Anuncio • Jan 12
Idogen AB (Publ) Submits Application to Norwegian Medicines Agency to Begin Clinical Phase 1/2A Study of the Advanced Cell Therapy Treatment IDO 8 in Norway Idogen AB announced that in addition to its Swedish application, it has also sub-mitted an application to the Norwegian Medicines Agency, NoMA, to be able to begin its clinical phase 1/2a study of the company's most advanced cell therapy treatment IDO 8 in Norway. IDO 8 aims to create tolerance for factor VIII and thus enable ongoing substitu-tion treatment with coagulation factor VIII - a life-saving drug treatment for hemophilia A against which many patients develop antibodies. The aim of the planned phase 1/2a study, which was designed in close dialogue with clinical experts and regulatory authorities in the Nordic region, is to evaluate the safety of IDO 8 and follow signals of treatment effect in patients. Given that the application is approved by NoMA without adjustments, the study is planned to start during the second quarter of 2022. Idogen's cell therapy is tailored for each individual patient in a GMP-certified facility at the company's manufacturing partner Radboud University Medical Center (RUMC) in the Netherlands. The therapy is based on the patient's own cells and is expected to have a favorable safety profile and the opportunity to create a long-term treatment effect. Anuncio • Dec 22
Idogen Submits Clinical Trial Application Idogen submitted a clinical trial application to the Swedish Medical Products Agency to initiate a clinical phase I/IIa study with the cell therapy IDO 8 in patients with haemophilia A who have developed antibodies to their treatment. Once the application has been reviewed and approved, the study can be initiated, which is expected to be in the second quarter of 2022. Anuncio • Dec 18
Idogen AB Submits an Application to the Swedish Medical Products Agency to Initiate A Clinical Phase 1/2A Study of the Cell Therapy Treatment IDO 8 Idogen AB announced that it has submitted a clinical trial application to the Swedish Medical Products Agency (MPA) to begin its clinical phase 1/2a study of the company's most advanced cell therapy treatment, IDO 8. IDO 8 aims to create tolerance to factor VIII, thereby enabling ongoing substitution treatment withcoagulation factor VIII a vital treatment in hemophilia (hemophilia A) against which many patients develop antibodies. The aim of the planned phase 1/2a study, which has been designed in close dialogue with the regulatory authorities in the Nordic countries, is to evaluate the safety of IDO 8 and to monitor patients forsignals of a clinical treatment effect. The planned start date of the trial is dependent on the MPA review process, but it is anticipated the study, once approved, will be initiated in the second quarter of 2022. Idogen's cell therapy is tailored for each individual patient in a GMP-certified laboratory at the company'smanufacturing partner Radboud University Medical Center in the Netherlands. The therapy is based on the patient's own cells and is therefore expected to have a favorable safety profile and to create a long-term treatment effect. The company is now initially submitting the application to start the phase 1/2a study to theMPA. Anuncio • Dec 08
Idogen AB (publ) Completes the Optimization of the GMP Manufacturing Process for the First Clinical Study with Its Tolerogenic Cell Therapy IDO 8 Idogen AB announces that it has successfully maximized the antigen levels in the cell therapy IDO 8 that the body should learn to recognize and tolerate. This is considered to be an important feature in order to obtain a good treatment effect. The IDO 8 treatment is aiming to create tolerance for ongoing substitution treatment with coagulation factor VIII, a vital drug for hemophilia (hemophilia A) which in many patients is inactivated as a result of undesired immune reactions. The company will shortly submit a clinical trial application to start the first study in patients. Subject to required regulatory approvals, the study is planned to start during the second quarter of 2022. A successful tech transfer and scale-up of the manufacturing process for Idogen's cell therapy has been followed by extensive work aimed at optimizing, documenting and qualifying the manufacturing process for the planned first clinical study. The company's manufacturing partner, Radboud University Medical Center (RUMC) in the Netherlands, a manufacturer of cell therapies, has now optimized and qualified the manufacturing process, achieving product properties equivalent to those generated when IDO 8 was manufactured in Idogen's own research laboratory. This has been achieved through an effective collaboration between RUMC and Idogen. Idogen's cell therapy will now be tailored for each individual patient in a GMP-certified laboratory at the company's partner Radboud University Medical Center in the Netherlands. The proprietary treatment is based on patients own cells, differentiated into dendritic cells using Idogen's unique tolerance inducers and the specific antigen that the body's immune system must learn to tolerate. Recent Insider Transactions • Oct 06
CEO & MD recently bought kr144k worth of stock On the 5th of October, Anders Karlsson bought around 70k shares on-market at roughly kr2.06 per share. This was the largest purchase by an insider in the last 3 months. This was Anders' only on-market trade for the last 12 months. Anuncio • Feb 26
Idogen AB Receives Confirmation the European Patent Office Intends to Grant A Patent Application Idogen AB has received confirmation that the European Patent Office (EPO) intends to grant a patent application which supports and covers the company's tolerogenic cell therapy's application to the severe bleeding disorder, hemophilia A. This patent application was submitted in 2016 and will provide additional protection to the broader patent application for Idogen's technology which in December 2020 was extended via an International (PCT) application. When the patent (Patent Application No. EP16710978.4) is granted, it will protect this technical space until 2036. The final grant of this patent by the EPO is expected to occur within two to three months following the completion of routine formalities by Idogen. A similar application is pending in the US. The granted patent will provide important complementary protection to that sought via the International (PCT) application for Idogen's new, innovative method for cell therapy that was filed in December 2020. That patent application will, following grant, provide the company with a patent protection and market exclusivity until 2040. Is New 90 Day High Low • Feb 23
New 90-day low: kr2.99 The company is down 16% from its price of kr3.55 on 25 November 2020. The Swedish market is up 9.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is up 4.0% over the same period. Anuncio • Feb 09
Idogen AB (publ) Announces Executive Changes Idogen AB (publ) announced that Åsa Schiött was appointed new Chief Scientific Officer (CSO), Christina Brattström new Chief Medical Officer (CMO) and Vicky Venizelos Chief Regulatory Officer (CRO). Is New 90 Day High Low • Dec 28
New 90-day low: kr3.08 The company is down 41% from its price of kr5.18 on 29 September 2020. The Swedish market is up 4.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is down 12% over the same period. Is New 90 Day High Low • Dec 08
New 90-day low: kr3.27 The company is down 42% from its price of kr5.68 on 09 September 2020. The Swedish market is up 8.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is down 3.0% over the same period. Is New 90 Day High Low • Nov 19
New 90-day low: kr3.63 The company is down 42% from its price of kr6.24 on 20 August 2020. The Swedish market is up 8.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is down 10.0% over the same period. Is New 90 Day High Low • Oct 16
New 90-day low: kr3.98 The company is down 43% from its price of kr6.98 on 17 July 2020. The Swedish market is up 7.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is down 1.0% over the same period. Is New 90 Day High Low • Sep 28
New 90-day low: kr5.06 The company is down 5.0% from its price of kr5.30 on 30 June 2020. The Swedish market is up 12% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is up 15% over the same period.