Tillkännagivande • Aug 15
IntelGenx Technologies Corp. announced delayed 10-Q filing On 08/14/2024, IntelGenx Technologies Corp. announced that they will be unable to file their next 10-Q by the deadline required by the SEC. Tillkännagivande • May 29
ATAI Life Sciences AG entered into an agreement of purchase and sale to acquire the Assets of IntelGenx Technologies Corp. (OTCPK:IGXT). ATAI Life Sciences AG entered into an agreement of purchase and sale to acquire the Assets of IntelGenx Technologies Corp. (OTCPK:IGXT) on May 28, 2024. The transaction is a stalking horse bid. The Court approved the agreement of purchase and sale. Tillkännagivande • May 18
IntelGenx Technologies Corp. Announces Board Resignations IntelGenx Technologies Corp. has announced changes to its board of directors as Clemens Mayr, Sahil Kirpekar and Ryan Barrett have resigned from the Board of Directors of the Company, effective immediately. Tillkännagivande • Apr 10
Intelgenx Announces First Parkinson’S Disease Patients Dosed with Montelukast Versafilm® in Phase 2 ‘Montpark’ Clinical Trial IntelGenx Technologies Corp. announced that Montelukast VersaFilm® has been administered to the first Parkinson’s Disease (“PD”) patients in the Phase 2 (‘MONTPARK’) clinical trial. MONTPARK (EudraCT number 2023-504278-39-00) is a Phase 2, randomized, double-blind, placebo-controlled, parallel arm, multicentre trial that will investigate the efficacy of oral high-dose Montelukast on the progression of early-to-moderate PD. The study will enroll up to 90 patients who will receive 30 mg Montelukast VersaFilm® or placebo twice daily for 18-months, followed by a 3-month washout period. Eligible candidates must be on levodopa treatment at the time of enrolment and may also be on other dopaminergic symptomatic agents. MONTPARK is being conducted at the Karolinska University Hospital and at three other Swedish University affiliated institutions under IntelGenx’s previously announced research collaboration with Per Svenningsson, MD, PhD, who is serving as the study’s Lead Principal Investigator. Tillkännagivande • Apr 05
IntelGenx Corp. Updates Status of Buprenorphine Buccal Film ANDA IntelGenx Corp. announced that its co-developer, Chemo Research SL, through its agent and affiliate, Xiromed LLC has received a Complete Response Letter from the U.S. Food and Drug Administration regarding its resubmitted abbreviated new drug application for Buprenorphine Buccal Film. The CRL includes a request for additional Pharmaceutical Quality information. The FDA confirmed that no additional inspection of IntelGenx’s facility is required at this time. Buprenorphine Buccal Film, which incorporates IntelGenx’s VersaFilm technology in a novel formulation, is a generic version of Belbuca, an opioid that is used to manage chronic pain severe enough to require daily, around-the-clock, long-term treatment with an opioid, when other pain treatments are inadequate. Approved by the FDA in 2015, Belbuca is applied to the oral or buccal mucosa every 12 hours and comes in seven strengths ranging from 0.075 mg to 0.9 mg. Tillkännagivande • Mar 22
IntelGenx Technologies Corp., Annual General Meeting, May 07, 2024 IntelGenx Technologies Corp., Annual General Meeting, May 07, 2024, at 11:00 US Eastern Standard Time. Agenda: To elect eight directors to the Company's Board of Directors to serve until the next Annual Meeting of Shareholders of the Company or until their successors are duly elected and qualified; to ratify the appointment of Richter LLP as the Company's Independent Registered Public Accountants for the 2024 fiscal year; to vote on a non-binding, advisory proposal to approve the compensation of the named executive officers and consider and, if deemed advisable, pass an ordinary resolution, approving all unallocated restricted share units and performance share units under the Company's Performance and Restricted Share Unit Plan; and to consider other business matters. Tillkännagivande • Mar 15
IntelGenx Technologies Corp. to Report Q4, 2023 Results on Mar 21, 2024 IntelGenx Technologies Corp. announced that they will report Q4, 2023 results Pre-Market on Mar 21, 2024 Tillkännagivande • Feb 06
IntelGenx Technologies Corp. Announces Positive Results from Proof-Of-Concept Study to Assess the Palatability, Owner-Perceived Acceptability, and Ease of Repeated Administration of Intelgenx’s VetaFilm® Platform in Healthy Dogs and Cats IntelGenx Corp. announced positive results from a proof-of-concept (“POC”) study to assess the palatability, owner-perceived acceptability, and ease of repeated administration of IntelGenx’s VetaFilm® platform in healthy dogs and cats. The POC study was conducted through a research collaboration with the University Prince Edward Island (“UPEI”). The reliable administration of medications to dogs and cats is a concern for many owners and veterinarians. There are few prescribed medications that dogs and cats will eagerly accept. Forced administration of capsules, tablets and liquids may be stressful for both the pet and its owner(s). Additionally, many owners report that medicating their pet becomes more difficult with each dose, often leading to decreased owner compliance, missed doses and potentially treatment failures. IntelGenx’s VetaFilm®-based fast dissolving oral films (“VetaFilm® FDOFs”) present a new and potentially superior way to medicate companion animals. The research collaboration with UPEI evaluated: (1) the acceptance rate of various VetaFilm® placebo formulations in dogs and cats at first exposure; (2) preference between flavours of VetaFilm® placebo formulations in dogs and cats; (3) changes in acceptance rates over longer periods; and (4), owner perception of ease of administration, acceptance and other behaviors associated with VetaFilm® placebo formulations. Tillkännagivande • Dec 04
IntelGenx Technologies Corp. Announces Changes to its Board of Directors IntelGenx Technologies Corp. announced the resignation of Frank Stegert and Srinivas Rao from the Board of Directors of the Company (the “Board”) effective December 2, 2023. Mr. Stegert and Dr. Rao were the Board designees for atai Life Sciences AG (“atai”) pursuant to the purchaser rights agreement by and between the Company and atai (the “Rights Agreement”). On December 2, 2023, the Board appointed Sahil Kirpekar, M.D. and Ryan Barrett as the new atai Board designees pursuant to the Rights Agreement, to serve until the 2024 annual meeting of the Company’s stockholders, or until their respective successors are duly elected and qualified. Dr. Kirpekar has served as atai’s Chief Business Officer since 2022 and Mr. Barrett has served as atai’s Senior Vice President and General Counsel since August 2020. Tillkännagivande • Nov 15
IntelGenx Corp. Receives Approval to Conduct 'Montpark' Montelukast Versafilm Phase 2 Clinical Trial in Patients with Parkinson's Disease IntelGenx Corp. announced that the Swedish Medical Products Agency, the Swedish Ethical Review Authority, and the Regional Biobank Centre have approved the planned clinical study to investigate the use of IntelGenx's Montelukast VersaFilm for the treatment of Parkinson's Disease. PD is the second most common neurodegenerative disease after Alzheimer's disease, with an estimated 9 million patients globally and 1 million patients in the United States. In the United States it is estimated that 90,000 new patients will be diagnosed with PD every year. No neuroprotective or disease-modifying treatments are currently available. The current standard treatment of PD motor dysfunction is based on the enhancement of dopaminergic transmission and involves the administration of L-dopa. Evidence from multiple patient studies and animal models has shown a significant immune component during the course of the disease, highlighting immunomodulation as a potential treatment strategy. Montelukast is a CysLT1 antagonist which decreases neuroinflammation by inhibiting CysLT1. Early results have indicated its potential usefulness for the treatment of various neurodegenerative disorders like PD and Alzheimer's Disease. The Phase 2 MONTPARK study (CT number 2023-504278-39-00) is a randomized, double-blind, placebo-controlled, parallel arm, multicentre trial that will investigate the efficacy of oral high-dose Montelukast on the progression of early-to-moderate PD. The study will enroll up to 90 patients who will receive 30 mg Montelukast Versa film®? or placebo twice daily for 18-months, followed by a 3-month washout period. Eligible candidates must be on levodopa treatment at the time of enrolment and may also be on other dopaminergic symptomatic agents. Tillkännagivande • Nov 03
IntelGenx Technologies Corp. to Report Q3, 2023 Results on Nov 09, 2023 IntelGenx Technologies Corp. announced that they will report Q3, 2023 results After-Market on Nov 09, 2023 Tillkännagivande • Sep 27
Gensco® Pharma and Intelgenx Announces Rizafilm Commercialization Update in the United States Gensco® Pharma, in partnership with IntelGenx announced the anticipated launch of RizaFilm® for Q1-2024. RizaFilm® is based on IntelGenx's proprietary VersaFilm® technology and is patent protected until 2034. As the NDA holder, Gensco® will begin commercialization of the 10mg Film and will continue to fund the expanded indications for the 5mg Pediatric dose. RizaFilm® is a film formulation of rizatriptan and the only oral dissolvable film available for the treatment of acute migraines. RizaFilm® has ease of convenience and does not require a drink for swallowing, thus allowing for rapid administration and relief from migraine related pain and nausea. The switch to RizaFilm® is seamless, as it is prescribed the same way as current rizatriptan, but in a Film form. A patient survey indicated that 69% of respondents said they would discuss switching their current migraine therapy to RizaFilm® with their doctor. Patients are encouraged to discuss the benefits of switching to RizaFilm with their healthcare provider. Tillkännagivande • Sep 21
IntelGenx Corp. Provides Regulatory Update for Xiromed-Partnered Development Candidate, Buprenorphine Buccal Film IntelGenx Corp. provided a regulatory update on Buprenorphine Buccal Film, for which an abbreviated new drug application ("ANDA") has been filed with the U.S. Food and Drug Administration ("FDA" or the "Agency") by its co-developer, Chemo Research SL, through its agent and affiliate, Xiromed LLC ("Xiromed"). As previously announced, Xiromed received a Complete Response Letter ("CRL") from the FDA in April 2023. In response to the CRL, Xiromed submitted to the FDA an Amendment to the ANDA, requesting priority review. In an Amendment Acknowledgement received from the FDA by Xiromed, the FDA granted priority review with a generic Drug User Fee Act ("GDUFA") goal date for review of the Amendment of March 8, 2024, unless the Agency determines that an inspection is required. Alternatively, if the FDA determines that an inspection is required, the GDUFA goal date is July 8, 2024. Tillkännagivande • Sep 02
IntelGenx Technologies Corp. announced that it expects to receive CAD 9.43492 million in funding from ATAI Life Sciences AG IntelGenx Technologies Corp. announced that the company issued 2,220 US units at a price of CAD 1,352.68 ($1,000) per unit for the gross proceeds of CAD 3,002,950 on August 31, 2023. The company may issue additional US units for the gross proceeds of CAD 7,020,410 and Canadian units for the gross proceeds of CAD 1,400,000. The tranche included participation from returning investor, ATAI Life Sciences AG. In addition, the investor committed to subscribe for an additional 750 US Units for additional aggregate proceeds of CAD 1,014,510 ($750,000), on the same terms, subject to the company obtaining the shareholder approvals. The transaction is expected to close on or before October 13, 2023. All securities issued in connection with the offering, including shares issuable pursuant to the conversion of the notes or exercise of the warrants, are subject to a 6-month hold period, during which time trading in the securities is restricted in accordance with applicable securities laws. Tillkännagivande • Aug 23
Intelgenx Technologies Corp. Completes Enrollment for `Buena' Montelukast Versafilm® Phase 2A Clinical Trial in Patients with Mild to Moderate Alzheimer's Disease IntelGenx Corp. announced that it has completed patient enrollment in the ongoing Montelukast VersaFilm Phase 2a clinical trial in patients with mild to moderate Alzheimer's Disease. The Company successfully enrolled 52 patients in the study, 18 fewer than initially planned, in a study design modification that received a No Objection Letter from Health Canada. The NOL provided authorization to proceed with the study changes. IntelGenx, in consultation with its statistical consultant, Cogstate Ltd., determined that adjusting the p-value to p<0.1 will provide a basis for determining the extent to which effect sizes of 0.6 or greater are statistically significant. GlobalData recently reported that the AD market is expected to reach $13.7 billion in 2030 across the eight major markets (U.S., France, Germany, Italy, Spain, U.K., Japan, and China), representing a compound annual growth rate of 20.0% from $2.2 billion in 2020. The expansion is primarily attributed to the significant unmet needs posed by AD, combined with the introduction of new therapies, including the recently approved Leqembi and donanemab, which is expected to be approved by year-end. Montelukast is a leukotriene receptor antagonist that was approved by the U.S. Food and Drug Administration in 1997 for the treatment of asthma and seasonal allergic rhinitis. IntelGenx is working to repurpose Montelukast as a therapeutic to treat neurodegenerative diseases by re-formulating the drug into an oral film-based product. IntelGenx's proprietary VersaFilm® technology is especially suited for special needs patient populations, and the Montelukast VersaFilm product offers many distinct advantages over tablets for AD and Parkinson's Disease patients, including the avoidance and minimization of first- pass-effects, ease of administration, improved API bioavailability, lower dosing and toxicity, better acceptability and improved compliance. In Phase 1 studies, IntelGenx demonstrated that an oral film formulation of Montelukast is safe and tolerable in healthy subjects, reduces the first-pass-effect and has a 52% higher bioavailability compared to the regular Montelukast tablet, demonstrating a clear advantage of delivering Montelukast via film. IntelGenx's oral film also crossed the blood-brain barrier, an essential feature for treating degenerative brain diseases. Tillkännagivande • Aug 08
IntelGenx Technologies Corp. to Report Q2, 2023 Results on Aug 14, 2023 IntelGenx Technologies Corp. announced that they will report Q2, 2023 results After-Market on Aug 14, 2023 Tillkännagivande • Aug 02
Intelgenx Corp. Completes Enrollment for 'Buena' Montelukast Versafilm®? Phase 2A Clinical Trial in Patients with Mild to Moderate Alzheimer's Disease IntelGenx Corp. announced that it has completed patient enrollment in the ongoing Montelukast VersaFilm® Phase 2a ("BUENA") clinical trial in patients with mild to moderate Alzheimer's Disease ("AD"). The Company successfully enrolled 52 patients in the study, 18 fewer than initially planned, in a study design modification that received a No Objection Letter ("NOL") from Health Canada. The NOL provided authorization to proceed with the study changes. IntelGenx, in consultation with its statistical consultant, Cogstate Ltd., determined that adjusting the p-value (which determines whether a drug effect exists) to p $13.7 billion in 2030 across the eight major markets (U.S., France, Germany, Italy, Spain, U.K., Japan, and China), representing a compound annual growth rate of 20.0% from $2.2 billion in 2020. The expansion is primarily attributed to the significant unmet needs posed by AD, combined with the introduction of new therapies, including the recently approved Leqembi and donanemab, which is expected to be approved by year-end. Tillkännagivande • Jul 26
Intelgenx Corp. Provides Update on Research Collaboration Evaluating Montelukast Versafilm for the Treatment of Parkinson's Disease IntelGenx Corp. announced the execution of a Research Grant Agreement with Karolinska University Hospital and that the manufacturing of both active and placebo films are underway in preparation for a planned multicentre, randomized, double-blind, placebo-controlled clinical study (the "Study") to investigate the use of IntelGenx's Montelukast VersaFilm®? for the treatment of Parkinson's Disease ("PD"). The Study will be conducted at the Karolinska University Hospital under IntelGenx's previously announced research collaboration with Per Svenningsson, MD, PhD, who will serve as the Study's Principal Investigator. Dr. Svenningsson - a Professor of Clinical Neuroscience who investigates the pathogenic mechanisms of PD - previously conducted a clinical study utilizing the tablet form of Montelukast for the treatment of PD, where 2 tablets of 10 mg Montelukast were administered twice daily, for a total daily dose of 40 mg. Tillkännagivande • Jul 23
IntelGenx Technologies Corp. Announces the Resignation of J. Bernard (Bernie) Boudreau from the Board of Directors IntelGenx Technologies Corp. announced the resignation of Mr. J. Bernard (Bernie) Boudreau from the Board of Directors of the Company effective July 21, 2023. Mr. Boudreau was a Director of the Company since 2006 and the Vice Chairman since 2014. He was also the Chair of the Corporate Governance and Nomination Committee. Tillkännagivande • May 05
IntelGenx Technologies Corp. to Report Q1, 2023 Results on May 11, 2023 IntelGenx Technologies Corp. announced that they will report Q1, 2023 results on May 11, 2023