Fear

Calls to U.S. poison centers involving psilocybin, or 'magic mushrooms,' among adolescents and young adults rose sharply after several U.S. cities and states began decriminalizing the hallucinogen, researchers have found. Calls to U.S. poison centers involving psilocybin, or "magic mushrooms," among adolescents and young adults rose sharply after several U.S. cities and states began decriminalizing the hallucinogen, University of Virginia School of Medicine researchers have found. Psilocybin-related calls more than tripled among teens ages 13-19 from 152 to 464 and more than doubled among adults ages 20-25 from 125 to 294 between 2018 and 2022, according to anonymized data gathered from the National Poison Data System. Local and state efforts to decriminalize the possession, use and cultivation of psilocybin began in May 2019. Oregon and Colorado have decriminalized psilocybin, as have several cities, including Washington, D.C., Detroit and Seattle. By comparison, the number of psilocybin-related calls to poison centers for patients ages 13-25 was largely unchanged between 2013 and 2018, the researchers found. "It is markedly concerning to me that children are gaining access to these products," said Christopher Holstege, MD, director of UVA Health's Blue Ridge Poison Center and chief of the Division of Medical Toxicology at the UVA School of Medicine. "We have limited data on the potential long-term consequences on the developing brains of children when exposed to such compounds that impact the brain's neurotransmission. We also do not understand fully why some individuals have markedly adverse complications to psilocybin, known as 'bad trips,' that can lead to harm to the individual taking or others who may be victims of violent behavior." Psilocybin's Effects During the 10 years examined in the study, most calls involved intentional consumption of psilocybin (81.1% of calls for ages 13-19 and 78.3% of calls for ages 20-25). Males accounted for about 75% of the calls in both age groups. Approximately 75% of the youths ages 13-19 and 72% of the young adults required some type of medical attention after being exposed solely to psilocybin. The researchers found that the most common effects of the drug were hallucinations or delusions (36.6% of calls), agitation (27.6%), abnormally fast heart rate (20.2%) and confusion (16%). The powerful psychological effects of psilocybin can, even in moderate doses, cause adverse reactions that can include anxiety, disorientation, fear, grief, paranoia and panic attacks. Psilocybin-induced impairments in judgment and perception can contribute to dangerous behavior, accidents, self-harming and even a risk of suicide. There are reports of deaths from falls or jumps from tall buildings attributed to psilocybin use. The researchers note that the increase in psilocybin-related calls among young people from 2018-2022 is "particularly alarming" because the hallucinogen's use is banned for those ages 21 and younger even in cities and states where it has been decriminalized. "As psilocybin may become more widely available, it is important for parents to be aware that psilocybin is also available in edible forms such as chocolate and gummies," said Rita Farah, PharmD, MPH, PhD, the Blue Ridge Poison Center epidemiologist. "And we learned from our experience with edible cannabis that young children can mistake edibles for candy." If someone has an adverse reaction to psilocybin or any other substance, trained healthcare providers at the Blue Ridge Poison Center are available to help around the clock. Call 800.222.1222 for assistance. Calls are free and confidential. Findings Published The researchers have published their findings in the Journal of Adolescent Health. The research team included Farah, Abigail Kerns, Austin Murray, and Holstege.

Study did not meet primary or secondary endpoints Favorable safety and tolerability pro with previous clinical trials Conference call scheduled for today, November 28, 2023 at 8:30am ET (2:30pm CET) Regulated information – Inside information November 28, 2023, 7:00am CET Amsterdam, the Netherlands – argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced topline results from the ADVANCE-SC study evaluating VYVGART Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) in adults with primary immune thrombocytopenia (ITP). The study did not meet the primary endpoint of a sustained platelet count response in chronic ITP patients. Additional analyses of the dataset are ongoing and the full results will be presented at an upcoming medical meeting and in a peer-reviewed publication. “This is not the outcome we had hoped for patients, but setbacks are part of pioneering a new class of medicines and these data will provide insights into the broader understanding of FcRn and ITP,” said Luc Truyen, M.D., Ph.D., Chief Medical Officer of argenx. “We are very grateful to everyone involved in the ADVANCE-SC study, especially the patients and their families, the investigators, and our internal team who worked tirelessly to complete this global study. We remain committed to the ITP patient community who urgently needs additional treatment options to manage this challenging disease, and continue to move forward in our deeper analysis of these results.“ ADVANCE-SC Study Data ADVANCE-SC is the second of two registrational trials conducted as part of the ongoing ITP development program for VYVGART and enrolled 207 adult patients with chronic and persistent ITP. Patients were heavily pre-treated and 75% of patients had received three or more prior ITP therapies. Primary endpoint was not met (p=0.5081); 13.7% (17/124) of treated patients demonstrated a sustained platelet count response compared to 16.2% (11/68) of placebo patients Secondary endpoints were not met, including additional endpoints on International Working Group (IWG) responder status and mean platelet count change from baseline VYVGART Hytrulo was well-tolerated in ADVANCE-SC; the observed safety and tolerability pro consistent with ADVANCE-IV and the confirmed safety pro VYVGART and VYVGART Hytrulo Results from the first study in the ITP registrational program, ADVANCE-IV, were reported in May 2022. The study met its primary and key platelet-derived secondary endpoints. ADVANCE-IV formed the basis of the regulatory submission for approval of VYVGART IV for ITP in Japan, where a decision is expected in the first quarter of 2024. VYVGART is currently being evaluated in 13 severe autoimmune diseases, including the registrational ADDRESS study for pemphigus from which topline results are expected around year-end 2023. Conference Call Details argenx will host a conference call today at 2:30 pm CET (8:30am ET) to discuss the ADVANCE-SC results. A webcast of the live call and replay may be accessed on the Investors section of the argenx website. Dial-in numbers: Please dial in 15 minutes prior to the live call. Belgium 32 800 50 201 France 33 800 943355 Netherlands 31 20 795 1090 United Kingdom 44 800 358 0970 United States 1 888 415 4250 Japan 81 3 4578 9081 Switzerland 41 43 210 11 32 About the ADVANCE-SC Study The ADVANCE-SC trial was a randomized, double-blind, placebo-controlled, multicenter, global trial evaluating the efficacy and safety of VYVGART Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) in adult patients with chronic or persistent primary ITP. ​ Enrolled patients had a confirmed ITP diagnosis and a mean entry platelet count of less than 30x109/L. Patients were on a stable dose of at least one ITP treatment prior to randomization and had received at least one prior therapy. Concomitant medications permitted included corticosteroids, nonsteroidal immunosuppressive drugs, fostamatinib or TPO-RAs. The study patients who were on 'watch and wait' at baseline were required to have received at least 2 prior treatments for ITP. ​ Patients were randomized in a 2:1 ratio to receive VYVGART Hytrulo or placebo for a total of 24 weeks as part of the primary trial. The primary endpoint was measured by the proportion of patients with chronic ITP with a sustained platelet count response defined as achieving platelet counts of greater than or equal to 50x109/L for at least four of the last six scheduled visits between weeks 19 and 24. Patients who received rescue therapy at week 12 or later, or for whom dose and/or frequency of concurrent ITP therapies increased at week 12 or later, were considered non-responders. ​Key secondary endpoints included extent of disease control over 24-week treatment period, proportion of overall population with sustained platelet count response, an extended primary endpoint analysis between weeks 17 and 24, and the incidence and severity of WHO-classified bleeding events. About Immune Thrombocytopenia (ITP) Immune thrombocytopenia (ITP) is an autoimmune disorder where immunoglobulin G (IgG) autoantibodies destroy platelets and reduce platelet production, which can lead to an increased risk of excessive bleeding and bruising. In rare cases, ITP can lead to severe anemia and life threatening gastrointestinal or intracranial hemorrhages. ITP is also associated with debilitating fatigue and significant impacts on mental health, including anxiety, fear and depression. Many ITP patients are inadequately controlled on current therapies so a significant unmet need exists for additional treatment options. About VYVGART Hytrulo VYVGART Hytrulo is a subcutaneous combination of efgartigimod alfa, a human IgG1 antibody fragment marketed for intravenous use as VYVGART®, and recombinant human hyaluronidase PH20 (rHuPH20), Halozyme’s ENHANZE® drug delivery technology to facilitate subcutaneous injection delivery of biologics. In binding to the neonatal Fc receptor (FcRn), VYVGART Hytrulo results in the reduction of circulating IgG. VYVGART Hytrulo is the proprietary name in the U.S. for subcutaneous efgartigimod alfa and recombinant human hyaluronidase PH20. It is marketed in Europe as VYVGART and may be marketed under different proprietary names following approval in other regions. About argenx argenx is a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases. Partnering with leading academic researchers through its Immunology Innovation Program (IIP), argenx aims to translate immunology breakthroughs into a world-class portfolio of novel antibody-based medicines. argenx developed and is commercializing the first approved neonatal Fc receptor (FcRn) blocker in the U.S., Japan, Israel, the EU, the UK, China and Canada. The Company is evaluating efgartigimod in multiple serious autoimmune diseases and advancing several earlier stage experimental medicines within its therapeutic franchises. For more information, visit and follow us on LinkedIn, Twitter, and Instagram. Media: Ben Petok bpetok@argenx.com Investors: Alexandra Roy (US) aroy@argenx.com Lynn Elton (EU) lelton@argenx.com This press release contains inside information within the meaning of Article 7(1) of the EU Market Abuse Regulation (Regulation 596/2014). Forward-looking Statements The contents of this announcement include statements that are, or may be deemed to be, “forward-looking statements.” These forward-looking statements can be identified by the use of forward-looking terminology, including the terms “aims,” “believes,” “hope,” “estimates,” “anticipates,” “expects,” “intends,” “may,” “will,” “should,” or “commitment” and include statements argenx makes concerning argenx’ topline results from the ADVANCE-SC study of VYVGART Hytrulo in ITP, its commitment to the ITP patient community, its commitment to bringing VYVGART IV to ITP patients in Japan, where the regulatory review is ongoing based on the success of its first trial, and the expected timing of such regulatory review decision, the expected timing of the topline results for the registrational ADDRESS study, and its goal of translating immunology breakthroughs into a world-class portfolio of novel antibody-based medicines. By their nature, forward-looking statements involve risks and uncertainties and readers are cautioned that any such forward-looking statements are not guarantees of future performance. argenx’s actual results may differ materially from those predicted by the forward-looking statements as a result of various important factors, including but not limited to argenx’s additional analyses of the dataset from the ADVANCE-SC study of VYVGART Hytrulo in ITP, expectations regarding the inherent uncertainties associated with development of novel drug therapies, preclinical and clinical trial and product development activities and regulatory approval requirements, including the approval of VYVGART IV for ITP patients in Japan and the topline results of the registrational ADDRESS study for pemphigus, the acceptance of our products and product candidates by our patients as safe, effective and cost-effective, and the impact of governmental laws and regulations on our business. A further list and description of these risks, uncertainties and other risks can be found in argenx’s U.S. Securities and Exchange Commission (SEC) filings and reports, including in argenx’s most recent annual report on Form 20-F filed with the SEC as well as subsequent filings and reports filed by argenx with the SEC. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. argenx undertakes no obligation to publicly update or revise the information in this press release, including any forward-looking statements, except as may be required by law

Utilizing Advice from the UK’s Medicines and Healthcare Regulatory Agency, PharmAla to move forward on Clinical TrialsVANCOUVER, British Columbia, July 20, 2023 (GLOBE NEWSWIRE) -- PharmAla Biotech Holdings Inc. (“PharmAla” or the “Company”) (CSE: MDMA) (OTC:PMBHF), a biotechnology company focused on the research, development, and manufacturing of novel MDXX class molecules (including MDMA), is thrilled that – following pre-submission meetings held in Q1 of 2023 – it has received written guidance from the UK’s Medicines and Healthcare products Regulatory Agency’s (MHRA). The guidance constitutes, in part, advice that ALA-002 does not require further preclinical data in order for clinical trials to proceed. “While this result took a bit longer to receive than we anticipated, it did conform with our expectations,” said Dr. Harpreet Kaur, Vice President of Research, PharmAla Biotech. “We are now prepared to move into the clinical phase of ALA-002’s development with full confidence that we have a range of competent and well-regulated jurisdictions to choose from. Our intent is to move rapidly, with the expectation of moving into a Phase 2 trial.” Following receipt of this guidance, PharmAla is further pleased to announce that it has entered into a clinical development agreement with the University of Sydney, under the leadership of Dr. Adam Guastella, the Michael Crouch Chair in Child and Youth Mental Health at the University. “Dr. Guastella is highly expert in the specific area of research in which we wish to engage, and we are very pleased to formalize our relationship with him – and to continue deepening our ties to Australia,” said Nick Kadysh, CEO, PharmAla Biotech. “We believe that ALA-002 represents one of PharmAla’s most promising IP assets. Not only is it viable as a treatment for fear disorders – much like generic MDMA – but with its improved toxicology, we are hopeful that clinical trials will bear out its viability for treating another orphan indication. PharmAla intends to treat the symptoms of social anxiety in Autism patients – we couldn’t imagine a better partner than Dr. Guastella to move forward on this exciting research.” About PharmAla PharmAla is a biotechnology company focused on the research, development, and manufacturing of MDXX class molecules, including MDMA. PharmAla was founded with a dual focus: alleviating the global backlog of generic, clinical-grade MDMA to enable clinical trials, and to develop novel drugs in the same class. PharmAla is the first publicly-traded company to manufacture clinical-grade MDMA. PharmAla’s research and development unit has completed proof-of-concept research into ALA-002, PharmAla’s lead drug candidate. PharmAla is a “regulatory first” organization, formed under the principle that true success in the psychedelics industry will only be achieved through excellent relationships with regulators. For more information, please contact: Nicholas KadyshChief Executive OfficerPharmAla Biotech Holdings Inc.Email: press@PharmAla.caPhone: 1-855-444-6362Website: www.PharmAla.ca Neither the Canadian Securities Exchange ("CSE") nor the Market Regulator (as that term is defined in the policies of the CSE accepts responsibility for the adequacy or accuracy of this news release. Cautionary Note Regarding Forward-Looking Statements This news release contains forward-looking statements and forward-looking information (collectively, "forward-looking statements") within the meaning of applicable Canadian securities legislation. These statements relate to matters that identify future events or future performance. Often, but not always, forward looking information can be identified by words such as "could", "pro forma", "plans", "expects", "may", "will", "should", "budget", "scheduled", "estimates", "forecasts", "intends", "anticipates", "believes", "potential" or variations of such words including negative variations thereof, and phrases that refer to certain actions, events or results that may, could, would, might or will occur or be taken or achieved. The forward-looking statements contained herein include, but are not limited to statements regarding: the Company’s objectives and goals; the shipment of MDMA to the University of Sydney and the Company's contract with the University of Sydney; the Company refiling an amended and restated offering document and corresponding news release to relaunch the LIFE Offering; and the results of the Sydney trial and further research into MDMA based on these results. These forward-looking statements are based on certain assumptions and estimates of management of the Company at the time such statements were made, including: the Company’s ability to attract and retain qualified members of management to grow the Company’s business and its operations; the Company’s ability to raise any necessary additional capital on reasonable terms to advance the development of the Company’s products; the Company’s ability to effectively manage unanticipated costs and expenses; the Company retaining and supplementing its board of directors and management, or otherwise engaging consultants and advisors having knowledge of the industries (or segments thereof) within which the Company may from time to time participate; current and future members of management abiding by the Company’s business objectives and strategies from time to time established by the Company; the Company’s ability to generate cash flow from operations; future prices and demand for MDXX class molecules and MDMA; the Company’s ability to procure equipment and operating supplies in sufficient quantities and on a timely basis; future currency exchange rates and interest rates; operating conditions being favourable such that the Company is able to operate in a safe, efficient and effective manner; the Company’s ability to attract and retain skilled personnel; political and regulatory stability; the receipt of governmental, regulatory and third-party approvals, licenses and permits on favourable terms; obtaining required renewals for existing approvals, licenses and permits on favourable terms; requirements under applicable laws; sustained labour stability; stability in financial and capital goods markets; results of operations and performance; industry trends; the market for MDXX class molecules and MDMA will continue to strengthen; the Company having sufficient funds to meet its administrative overhead expenses for the next twelve months; the Authorized Prescriber Program in Australia coming into effect on July 1, 2023; the Company's ability to fulfil the shipment to the University of Sydney; the Company's ability to refile an amended and restated offering document and news release to relaunch the LIFE Offering; and the Company's ability to view the results of the Sydney trial. While the Company considers these assumptions to be reasonable, based on information currently available, they may prove to be incorrect. Readers are cautioned not to place undue reliance on forward-looking statements. Actual future results may differ materially as forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements expressed or implied by such forward-looking statements. Such factors include, without limitation: risks associated with general economic conditions; adverse industry events; income tax and regulatory matters; the Company not utilizing the use of proceeds to expand its operations and products; additional financing may not be available to the Company when required or, if available, the terms of such financing may not be favourable to the Company; fluctuations in demand of MDXX class molecules and MDMA; the Company may not be able to identify, negotiate or finance any future acquisitions successfully, or to integrate such acquisitions with its current business; the Company’s research and development activities are dependent upon the grant of appropriate licenses, concessions, leases, permits and regulatory consents, which may be withdrawn or not granted; the Company’s operations could be adversely affected by possible future government legislation, policies and controls or by changes in applicable laws and regulations; the Company and/or its directors and officers may be subject to a variety of legal proceedings, the results of which may have a material adverse effect on the Company’s business; the Company may be adversely affected if potential conflicts of interests involving its directors and officers are not resolved in favour of the Company; dilution from future equity financing could negatively impact holders of the Company’s securities; employee relations; ongoing uncertainties relating to the COVID-19 pandemic; the Authorized Prescriber Program in Australia not coming into effect on July 1, 2022; the Company's inability to fulfil the shipment to the University of Sydney; the Company's inability to access the results of the University of Sydney trials; the Company's inability to refile an amended and restated offering document and news release to relaunch the LIFE Offering; and those factors described under the heading "Risks and Uncertainties" in the Company's management’s discussion and analysis for the fiscal year ended August 31, 2022, available under the Company’s profile on SEDAR. Readers are cautioned that the foregoing list is not exhaustive. Readers are further cautioned not to place undue reliance on forward-looking statements as there can be no assurance that the plans, intentions or expectations upon which they are placed will occur. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement and reflect our expectations as of the date hereof, and thus are subject to change thereafter. The Company does not undertake to release publicly any revisions for updating any voluntary forward-looking statements, except as required by law.