AEZS Aeterna Zentaris Inc.

0.62
+0.01  (+1%)
Previous Close 0.61
Open 0.6
52 Week Low 0.29
52 Week High 3.62
Market Cap $75,204,144
Shares 121,297,007
Float 121,293,887
Enterprise Value $2,445,227
Volume 403,163
Av. Daily Volume 1,128,486
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Upcoming Catalysts

Drug Stage Catalyst Date
MACRILEN (Macimorelin Acetate) - DETECT(Study P02)
Paediatric patients with suspected growth hormone deficiency (GHD)
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
MACRILEN (Macimorelin Acetate)
Adult Growth Deficiency
Approved
Approved
CRL issued November 2014. Approval announced following resubmission December 20, 2017.
Zoptrex
Endometrial cancer
Phase 3
Phase 3
Phase 3 trial did not meet primary endpoint - May 1, 2017.

Latest News

  1. CHARLESTON, S.C., Sept. 08, 2021 (GLOBE NEWSWIRE) -- Aeterna Zentaris Inc. (NASDAQ:AEZS) (TSX:AEZS) (the "Company"), a specialty biopharmaceutical company developing and commercializing a diversified portfolio of pharmaceutical and diagnostic products, today announced that Dr. Klaus Paulini, Chief Executive Officer of Aeterna, will present at the virtual H.C. Wainwright 23rd Annual Global Investment Conference taking place September 13-15, 2021.

    In addition to the presentation, management will be available to participate in virtual one-on-one meetings with qualified members of the investor community who are registered to attend the conference. For more information about the conference, please visit the conference website.

    A video webcast

    CHARLESTON, S.C., Sept. 08, 2021 (GLOBE NEWSWIRE) -- Aeterna Zentaris Inc. (NASDAQ:AEZS) (TSX:AEZS) (the "Company"), a specialty biopharmaceutical company developing and commercializing a diversified portfolio of pharmaceutical and diagnostic products, today announced that Dr. Klaus Paulini, Chief Executive Officer of Aeterna, will present at the virtual H.C. Wainwright 23rd Annual Global Investment Conference taking place September 13-15, 2021.

    In addition to the presentation, management will be available to participate in virtual one-on-one meetings with qualified members of the investor community who are registered to attend the conference. For more information about the conference, please visit the conference website.

    A video webcast of the presentation will be available for viewing on-demand beginning Monday, September 13, 2021, at 7:00 AM ET for those registered for the event and will be accessible on the Events page in the Investors section of the Company's website (www.zentaris.com). The webcast replay will be archived for 90 days following the event.

    About Aeterna Zentaris Inc.

    Aeterna Zentaris is a specialty biopharmaceutical company developing and commercializing a diversified portfolio of pharmaceutical and diagnostic products focused on areas of significant unmet medical need. The Company's lead product, macimorelin (Macrilen), is the first and only U.S. FDA and European Commission approved oral test indicated for the diagnosis of adult growth hormone deficiency (AGHD). The Company is leveraging the clinical success and compelling safety profile of macimorelin to develop it for the diagnosis of childhood-onset growth hormone deficiency (CGHD) in collaboration with Novo Nordisk. The Company is also leveraging the clinical success and compelling safety profile of macimorelin to develop it for the diagnosis of childhood-onset growth hormone deficiency (CGHD), an area of significant unmet need.

    Aeterna Zentaris is dedicated to the development of therapeutic assets and has recently taken steps to establish a growing preclinical pipeline to potentially address unmet medical needs across a number of indications, including neuromyelitis optica spectrum disorder (NMOSD), hypoparathyroidism and amyotrophic lateral sclerosis (ALS; Lou Gehrig's disease). Additionally, the Company is developing an oral prophylactic bacterial vaccine against SARS-CoV-2, the virus that causes COVID-19.

    For more information, please visit www.zentaris.com and connect with the Company on TwitterLinkedIn and Facebook.

    Investor Contact:

    Jenene Thomas

    JTC Team

    T (US): +1 (833) 475-8247

    E: aezs@jtcir.com



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  2. CHARLESTON, S.C., July 29, 2021 (GLOBE NEWSWIRE) -- Aeterna Zentaris Inc. (NASDAQ:AEZS) (TSX:AEZS) ("Aeterna" or the "Company"), a specialty biopharmaceutical company developing and commercializing a diversified portfolio of pharmaceutical and diagnostic products, today announced that on July 28, 2021, the Company received notice from the Listing Qualifications Department (the "Staff") of The Nasdaq Stock Market LLC ("Nasdaq") indicating that, based upon a closing bid price of less than $1.00 per share for the Company's common stock for the prior 30 consecutive business day period, the Company no longer satisfies Nasdaq Listing Rule 5550(a)(2) (the "Rule").

    In accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company has been provided…

    CHARLESTON, S.C., July 29, 2021 (GLOBE NEWSWIRE) -- Aeterna Zentaris Inc. (NASDAQ:AEZS) (TSX:AEZS) ("Aeterna" or the "Company"), a specialty biopharmaceutical company developing and commercializing a diversified portfolio of pharmaceutical and diagnostic products, today announced that on July 28, 2021, the Company received notice from the Listing Qualifications Department (the "Staff") of The Nasdaq Stock Market LLC ("Nasdaq") indicating that, based upon a closing bid price of less than $1.00 per share for the Company's common stock for the prior 30 consecutive business day period, the Company no longer satisfies Nasdaq Listing Rule 5550(a)(2) (the "Rule").

    In accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company has been provided a grace period of 180 calendar days, through January 24, 2022, to evidence compliance with the Rule. To evidence compliance with the Rule, the Company must evidence a closing bid price of at least $1.00 per share for a minimum of 10 consecutive business days on or before January 24, 2022. In the event the Company does not timely evidence compliance with the Rule, the Company may be eligible for an additional 180-day grace period or may face delisting. In the latter case, the Company would be entitled to request a hearing before the Nasdaq Hearings Panel, which request would stay any delisting action by the Staff pending completion of the hearing process.

    The Company's business operations are not affected by the receipt of the Nasdaq notice.

    Nasdaq's notice has no immediate effect on the listing of the Company's common shares on Nasdaq and does not otherwise impact the Company's listing on the Toronto Stock Exchange. The Company is considering the options available to it to evidence compliance with the Rule prior to the expiration of the grace period.

    About Aeterna Zentaris Inc.

    Aeterna Zentaris is a specialty biopharmaceutical company developing and commercializing a diversified portfolio of pharmaceutical and diagnostic products focused on areas of significant unmet medical need. The Company's lead product, macimorelin (Macrilen), is the first and only U.S. FDA and European Commission approved oral test indicated for the diagnosis of adult growth hormone deficiency (AGHD). The Company is leveraging the clinical success and compelling safety profile of macimorelin to develop it for the diagnosis of childhood-onset growth hormone deficiency (CGHD) in collaboration with Novo Nordisk.

    Aeterna Zentaris is dedicated to the development of therapeutic assets and has recently taken steps to establish a growing preclinical pipeline to potentially address unmet medical needs across a number of indications, including neuromyelitis optica spectrum disorder (NMOSD), hypoparathyroidism and amyotrophic lateral sclerosis (ALS; Lou Gehrig's disease). Additionally, the Company is developing an oral prophylactic bacterial vaccine against SARS-CoV-2, the virus that causes COVID-19.

    For more information, please visit www.zentaris.com and connect with the Company on Twitter, LinkedIn and Facebook.

    Forward-Looking Statements

    This press release contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and Private Securities Litigation Reform Act, as amended, including those relating to the Company's ability to regain compliance with the minimum bid price requirement, the impact of Nasdaq's notice on the listing of the Company's common shares on Nasdaq and the Toronto Stock Exchange and the Company's ability to meet the minimum stockholders' equity requirement for continued listing under Nasdaq Listing Rule 5550(b)(3). These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which we operate and management's current beliefs and assumptions.

    These statements may be identified by the use of forward-looking expressions, including, but not limited to, "expect," "anticipate," "intend," "plan," "believe," "estimate," "potential, "predict," "project," "should," "would" and similar expressions and the negatives of those terms. These statements relate to future events or our financial performance and involve known and unknown risks, uncertainties, and other factors which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such factors include those set forth in the Company's filings with the Securities and Exchange Commission. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

    Investor Contact:

    Jenene Thomas

    JTC Team

    T (US): +1 (833) 475-8247

    E: aezs@jtcir.com



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  3. Dr. Levy is a well-established neuroimmunologist with extensive experience and expertise in the area of neuroimmunology, autoimmune and CNS disorders

    Company continues to advance development of its AIM Biologicals pre-clinical program, seeking to develop a potential treatment option for NMOSD, an orphan indication with strong unmet medical need and significant market opportunity

    CHARLESTON, S.C., June 07, 2021 (GLOBE NEWSWIRE) -- Aeterna Zentaris Inc. (NASDAQ:AEZS) (TSX:AEZS) ("Aeterna" or the "Company"), a specialty biopharmaceutical company developing and commercializing a diversified portfolio of pharmaceutical and diagnostic products, today announced it has engaged neuroimmunologist, Michael Levy, MD, PhD, Research Director of the…

    Dr. Levy is a well-established neuroimmunologist with extensive experience and expertise in the area of neuroimmunology, autoimmune and CNS disorders

    Company continues to advance development of its AIM Biologicals pre-clinical program, seeking to develop a potential treatment option for NMOSD, an orphan indication with strong unmet medical need and significant market opportunity

    CHARLESTON, S.C., June 07, 2021 (GLOBE NEWSWIRE) -- Aeterna Zentaris Inc. (NASDAQ:AEZS) (TSX:AEZS) ("Aeterna" or the "Company"), a specialty biopharmaceutical company developing and commercializing a diversified portfolio of pharmaceutical and diagnostic products, today announced it has engaged neuroimmunologist, Michael Levy, MD, PhD, Research Director of the Division of Neuroimmunology & Neuroinfectious Disease at Massachusetts General Hospital ("MGH") as a scientific consultant to support the development of the Company's targeted, highly specific immunosuppressive therapeutic proteins ("AIM Biologicals") for the potential treatment of neuromyelitis optica spectrum disorder ("NMOSD"). Dr. Levy will provide scientific support and advice to Aeterna Zentaris in the field of inflammatory CNS disorders, autoimmune diseases of the nervous system, and NMOSD.

    In January 2021, Aeterna Zentaris entered into an exclusive patent license agreement and research agreement with Julius-Maximilians-University of Wuerzburg, Germany (the "University") for worldwide rights to develop, manufacture and commercialize AIM Biologicals for the potential treatment of NMOSD. The Company is currently conducting in-vitro and in-vivo assessments to identify and characterize an AIM Biologicals-based development candidate for the treatment of NMOSD and develop manufacturing process for the selected candidate.

    "We are pleased to welcome Dr. Levy and to have his support as we advance the development of this important program forward," commented Dr. Klaus Paulini, Chief Executive Officer of Aeterna. "We believe that the AIM Biologicals technology has the potential to become a breakthrough in the treatment of NMOSD and we are eager to unlock its full potential. The guidance and leadership that Dr. Levy, a worldwide leading expert on NMOSD, brings will be a critical component as we work with the University to identify development candidates for the AIM Biologicals program."

    Dr. Levy added, "Over the course of my academic and clinical career, I have studied rare neuroimmunological diseases and dedicated my work to understanding how the immune system and the nervous system interact to cause disease. I am excited to support Aeterna Zentaris' development of AIM Biologicals and to potentially offer a new treatment for NMOSD patients, where there remains significant unmet medical need."

    Dr. Levy is also an Associate Professor at Harvard Medical School and Director of the Neuromyelitis Optica Clinic and Research Laboratory at MGH. He completed the MD/PhD program at Baylor College of Medicine (Houston, TX) with a focus on neuroscience. Dr. Levy completed his Johns Hopkins internship in the Osler Medicine program, residency in the Johns Hopkins Neurology program and a fellowship in Neuroimmunology at Johns Hopkins University. In 2009, Dr. Levy was appointed to the faculty as Assistant Professor at Johns Hopkins where he started the Neuromyelitis Optica Clinic and Research Laboratory. In 2019 he moved to the Massachusetts General Hospital and Harvard Medical School to develop the research program in neuroimmunology.



    Clinically, Dr. Levy specializes in taking care of patients with rare neuroimmunological diseases including neuromyelitis optica, transverse myelitis, MOG antibody disease, acute disseminated encephalomyelitis and optic neuritis. In addition to neuroimmunology clinics, Dr. Levy has a special interest in patients with superficial siderosis of the central nervous system. Dr. Levy is the principal investigator on several clinical studies and drug trials for all of these conditions.

    About AIM Biologicals

    AIM Biologicals utilize a novel mechanism which is believed to demonstrate that peptide antigens presented on immunosuppressive MHC class I molecules can selectively and efficiently induce antigen-specific tolerance. Based on this mechanism, the targeted immunosuppressive therapeutics are being designed as optimized soluble molecules with the goal that they may be adapted to selectively induce tolerance to various autoantigens. Pre-clinical studies conducted by the University thus far indicate that tolerance induction appears to be achieved via selective elimination of antigen-specific immune effector cells and via induction of antigen-specific regulatory T cells from naïve T cells. AIM Biologicals thus have the potential to become highly specific and effective yet not personalized treatments of NMOSD.

    For the treatment of NMOSD, it is believed that the AIM Biologicals will present a specific antigen derived from the water channel protein aquaporin-4 (AQP4) loaded to soluble immunoregulatory HLA-G protein to selectively induce immunological tolerance in the central nervous system.



    About Neuromyelitis Optica Spectrum Disorder (NMOSD)

    NMOSD is an antibody mediated inflammatory central nervous system ("CNS") disorder that affects about one per million population per year. NMOSD, also known as Devic disease, is a chronic disorder of the brain and spinal cord dominated by inflammation of the optic nerve (optic neuritis) and of the spinal cord (myelitis). Typical symptoms include visual loss, muscle spasms, paraparesis, and incontinence. If left untreated, 50% of individuals with NMOSD will be wheelchair bound and blind, and 30% will have died within five years after the first attack. The water channel protein AQP4 is widely expressed in the brain, spinal cord, and optic nerves. Auto-antibodies directed against the AQP4 channel play an important role in the pathogenesis of NMOSD.

    Currently there are only three approved medications available for the treatment of NMOSD with the risk of the patient contracting even serious infections. Aeterna Zentaris believes there remains a strong medical need to offer additional therapeutic options to NMOSD patients.

    In the U.S. and Europe there are currently approximately 10,000 to 15,000 patients living with NMOSD. Of these the AQP4 antibody seropositive patients who represent about 80% of the NMOSD population are the targeted patients for a potential therapy based on the AIM Biologicals technology.

    About Aeterna Zentaris Inc.

    Aeterna Zentaris is a specialty biopharmaceutical company developing and commercializing a diversified portfolio of pharmaceutical and diagnostic products focused on areas of significant unmet medical need. The Company's lead product, macimorelin (Macrilen), is the first and only U.S. FDA and European Commission approved oral test indicated for the diagnosis of adult growth hormone deficiency (AGHD). The Company is leveraging the clinical success and compelling safety profile of macimorelin to develop it for the diagnosis of childhood-onset growth hormone deficiency (CGHD) in collaboration with Novo Nordisk.



    Aeterna Zentaris is dedicated to the development of therapeutic assets and has recently taken steps to establish a growing preclinical pipeline to potentially address unmet medical needs across a number of indications, including neuromyelitis optica spectrum disorder (NMOSD), hypoparathyroidism and amyotrophic lateral sclerosis (ALS; Lou Gehrig's disease). Additionally, the Company is developing an oral prophylactic bacterial vaccine against SARS-CoV-2, the virus that causes COVID-19.

    For more information, please visit www.zentaris.com and connect with the Company on Twitter, LinkedIn and Facebook.

    Forward-Looking Statements

    This press release contains statements that may constitute forward-looking statements within the meaning of U.S. and Canadian securities legislation and regulations, and such statements are made pursuant to the safe-harbor provision of the U.S. Securities Litigation Reform Act of 1995. Forward-looking statements are frequently, but not always, identified by words such as "expects," "anticipates," "believes," "intends," "potential," "possible," and similar expressions. Such statements, based as they are on current expectations of management, inherently involve numerous risks, uncertainties, and assumptions, known and unknown, many of which are beyond our control. Forward-looking statements in this press release include, but are not limited to, those relating to: Aeterna's expectation with respect to the potential of the AIM Biologicals technology under development by the Company, including the potential to treat NMOSD.

    Forward-looking statements involve known and unknown risks and uncertainties, and other factors which may cause the actual results, performance or achievements stated herein to be materially different from any future results, performance or achievements expressed or implied by the forward-looking information. Such risks and uncertainties include, among others, our our products under development may not be successful or may not support advancing the product to human clinical trials; our ability to raise capital and obtain financing to continue our currently planned operations; our now heavy dependence on the success of Macrilen™ (macimorelin) and related out-licensing arrangements and the continued availability of funds and resources to successfully commercialize the product, including our heavy reliance on the success of the License Agreement with Novo Nordisk; the global instability due to the global pandemic of COVID-19, and its unknown potential effect on our planned operations; our ability to enter into out-licensing, development, manufacturing, marketing and distribution agreements with other pharmaceutical companies and keep such agreements in effect. Investors should consult our quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties, including those risks discussed in our Annual Report on Form 40-F and annual information form, under the caption "Risk Factors". Given the uncertainties and risk factors, readers are cautioned not to place undue reliance on these forward-looking statements. We disclaim any obligation to update any such factors or to publicly announce any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments, unless required to do so by a governmental authority or applicable law.

    No securities regulatory authority has either approved or disapproved of the contents of this news release. The Toronto Stock Exchange accepts no responsibility for the adequacy or accuracy of this release.

    Investor Contact:

    Jenene Thomas

    JTC Team

    T (US): +1 (833) 475-8247

    E: aezs@jtcir.com



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  4. - Aeterna Zentaris granted exclusive option to negotiate a license of any resulting intellectual property and know-how developed by the University related to the therapeutic use of macimorelin for the treatment of ALS

    CHARLESTON, S.C., May 17, 2021 (GLOBE NEWSWIRE) -- Aeterna Zentaris Inc. (NASDAQ:AEZS) (TSX:AEZS) (the "Company" or "Aeterna Zentaris"), a specialty biopharmaceutical company developing and commercializing a diversified portfolio of pharmaceutical and diagnostic products, today announced the commencement of the previously announced preclinical program to qualify macimorelin for clinical development as a potential treatment option for amyotrophic lateral sclerosis (ALS; Lou Gehrig's disease). The preclinical development…

    - Aeterna Zentaris granted exclusive option to negotiate a license of any resulting intellectual property and know-how developed by the University related to the therapeutic use of macimorelin for the treatment of ALS

    CHARLESTON, S.C., May 17, 2021 (GLOBE NEWSWIRE) -- Aeterna Zentaris Inc. (NASDAQ:AEZS) (TSX:AEZS) (the "Company" or "Aeterna Zentaris"), a specialty biopharmaceutical company developing and commercializing a diversified portfolio of pharmaceutical and diagnostic products, today announced the commencement of the previously announced preclinical program to qualify macimorelin for clinical development as a potential treatment option for amyotrophic lateral sclerosis (ALS; Lou Gehrig's disease). The preclinical development program is part of the recently executed Material Transfer Agreement (MTA) with The University of Queensland ("The University").

    The University researchers, led by Frederik Steyn, MSc, PhD, will conduct preclinical studies in disease-related in-vitro and in-vivo models of ALS to demonstrate the therapeutic potential of macimorelin on disease progression and ALS-specific pathology. Recently, The University researchers have filed funding applications to dedicated organizations in Australia to finance parts of the abbreviated preclinical development program and to conduct a subsequent investigator-initiated clinical trial to evaluate the safety, tolerability and efficacy of macimorelin as a potential new treatment option for ALS patients.

    Dr. Klaus Paulini, Chief Executive Officer of Aeterna Zentaris, commented, "The start of the preclinical phase represents a significant milestone in the development of a potential new treatment option for ALS to help patients with this terrible, incurable disease and to improve their quality of life. We look forward to supporting Dr. Steyn's research team in addressing this significant unmet medical need."

    In the event of positive preclinical results, the Company has the exclusive right to acquire a license from The University on the therapeutic use of macimorelin for the treatment of ALS.

    Aeterna Zentaris' lead product, macimorelin, is the only United States Food and Drug Administration ("FDA") approved oral drug indicated for the diagnosis of adult growth hormone deficiency (AGHD) and is currently marketed in the United States under the tradename Macrilen™, by Novo Nordisk. It is also licensed to Consilient Health Ltd. for the European Economic Area and United Kingdom, and Megapharm Ltd. for Israel and the Palestinian Authority. Aeterna Zentaris is currently developing macimorelin for the diagnosis of childhood-onset growth hormone deficiency (CGHD), an area of significant unmet need, in collaboration with Novo Nordisk.

    Ghrelin is a natural hormone stimulating release of growth hormone. Its level is often reduced in ALS patients and stimulation of GH excretion improves survival in ALS mouse models. Ghrelin and ghrelin mimetics have already demonstrated in preclinical models stimulation of growth factors to protect motor neurons and enhance muscle building, stimulate appetite, slow metabolism to promote positive energy balance and dampen neuroinflammatory processes. Dr. Steyn's research team at The University have confirmed these positive effects of ghrelin mimetics in several experiments. Ghrelin itself is not qualified as medicine because of rapid clearance from circulation. However, macimorelin is an orally active ghrelin agonist and could mimic the biological effect of the hormone via mechanisms similar to ghrelin.

    About ALS

    Amyotrophic lateral sclerosis (ALS) is the most common motor neuron disease (MND). Most patients with ALS present with random, asymmetric symptoms, consisting of cramps, weakness, and muscle atrophy of the hands (most commonly) or feet. Weakness progresses to the forearms, shoulders, and lower limbs. Fasciculations, spasticity, hyperactive deep tendon reflexes, extensor plantar reflexes, clumsiness, stiffness of movement, weight loss, fatigue, and difficulty controlling facial expression and tongue movements soon follow. Death is usually caused by failure of the respiratory muscles; 50% of patients die within 3 years of onset, 20% live 5 years, and 10% live 10 years. Survival for > 30 years is rare.

    The mainstay of care for patients with amyotrophic lateral sclerosis is timely intervention to manage symptoms.

    About Macimorelin



    Macimorelin, a ghrelin agonist, is an orally active small molecule that stimulates the secretion of growth hormone from the pituitary gland. Stimulated growth hormone levels are measured in blood samples after oral administration of macimorelin for the assessment of growth hormone deficiency (GHD).



    Macimorelin is the only U.S. FDA and European Commission approved oral test indicated for the diagnosis of AGHD. Macimorelin is currently marketed in the United States under the tradename Macrilen, through a license agreement with Novo Nordisk. Through a license agreement with Consilient Health Ltd, macimorelin will be commercialized in Europe and the United Kingdom upon receipt of pricing and reimbursement approvals in the particular country. Additionally, the Company has entered into a distribution agreement with MegaPharm Ltd. under which MegaPharm will seek regulatory approval and then commercialize macimorelin in Israel and the Palestinian Authority.



    Additionally, the Company is leveraging the clinical success and compelling safety profile of macimorelin to develop it for the diagnosis of childhood-onset growth hormone deficiency (CGHD), an area of significant unmet need, in collaboration with Novo Nordisk.

    About Aeterna Zentaris Inc.

    Aeterna Zentaris is a specialty biopharmaceutical company developing and commercializing a diversified portfolio of pharmaceutical and diagnostic products focused on areas of significant unmet medical need. The Company's lead product, macimorelin, is the first and only U.S. FDA and European Commission approved oral test indicated for the diagnosis of adult growth hormone deficiency (AGHD). The Company is leveraging the clinical success and compelling safety profile of macimorelin to develop it for the diagnosis of childhood-onset growth hormone deficiency (CGHD) in collaboration with Novo Nordisk.

    Aeterna Zentaris is dedicated to the development of therapeutic assets and has recently taken steps to establish a growing pipeline to address unmet medical needs across a number of indications, including neuromyelitis optica spectrum disorder (NMOSD), hypoparathyroidism and ALS (Lou Gehrig's disease). Additionally, the Company is developing an oral prophylactic bacterial vaccine against SARS-CoV-2, the virus that causes COVID-19.

    For more information, please visit www.zentaris.com and connect with the Company on Twitter, LinkedIn and Facebook

    Forward-Looking Statements

    This press release contains statements that may constitute forward-looking statements within the meaning of U.S. and Canadian securities legislation and regulations and such statements are made pursuant to the safe-harbor provision of the U.S. Securities Litigation Reform Act of 1995. Forward-looking statements are frequently, but not always, identified by words such as "expects," "anticipates," "believes," "intends," "potential," "possible," and similar expressions. Such statements, based as they are on current expectations of management, inherently involve numerous risks, uncertainties and assumptions, known and unknown, many of which are beyond our control. Forward-looking statements in this press release include, but are not limited to, those relating to: the Company's exclusive right to acquire a license from The University on the therapeutic use of macimorelin for the treatment of ALS; the development of macimorelin for the diagnosis of CGHD in collaboration with Novo Nordisk; the ability of macimorelin to mimic the biological effect of the hormone via mechanisms similar to ghrelin; Aeterna's expectation that, upon receipt of pricing and reimbursement approvals, macimorelin will be marketed in Europe and the United Kingdom;

    Forward-looking statements involve known and unknown risks and uncertainties, and other factors which may cause the actual results, performance or achievements stated herein to be materially different from any future results, performance or achievements expressed or implied by the forward-looking information. Such risks and uncertainties include, among others, our reliance on the success of the pediatric clinical trial in the European Union and U.S. for Macrilen (macimorelin); the commencement of Study P02 may be delayed or we may not obtain regulatory approval to initiate that study, we may be unable to enroll the expected number of subjects in Study P02 and the result of Study P02 may not support receipt of regulatory approval in CGHD, we may be delayed or unsuccessful in obtaining pricing and reimbursement approvals in Europe and the UK to market macimorelin; results from ongoing or planned pre-clinical studies of macimorelin by The University of Queensland or for our other products under development may not be successful or may not support advancing the product to human clinical trials; our ability to raise capital and obtain financing to continue our currently planned operations; our now heavy dependence on the success of Macrilen (macimorelin) and related out-licensing arrangements and the continued availability of funds and resources to successfully commercialize the product, including our heavy reliance on the success of the license agreement with Novo Nordisk; the global instability due to the global pandemic of COVID-19, and its unknown potential effect on our planned operations; our ability to enter into out-licensing, development, manufacturing, marketing and distribution agreements with other pharmaceutical companies and keep such agreements in effect. Investors should consult our quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties, including those risks discussed in our Annual Report on Form 40-F and annual information form, under the caption "Risk Factors". Given the uncertainties and risk factors, readers are cautioned not to place undue reliance on these forward-looking statements. We disclaim any obligation to update any such factors or to publicly announce any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments, unless required to do so by a governmental authority or applicable law.

    No securities regulatory authority has either approved or disapproved of the contents of this news release. The Toronto Stock Exchange accepts no responsibility for the adequacy or accuracy of this release.

    Investor Contact:



    Jenene Thomas

    JTC Team

    T (US): +1 (833) 475-8247

    E: aezs@jtcir.com



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  5. Safety and efficacy study for macimorelin initiated as agreed with U.S. FDA and the European Medicines Agency ("EMA") in the Company's Pediatric Investigation Plan ("PIP")

    – Patient enrollment on track to start this quarter

    – Planned completion of pivotal Phase 3 study expected in Q3 2022

    CHARLESTON, S.C., May 13, 2021 (GLOBE NEWSWIRE) -- Aeterna Zentaris Inc. (NASDAQ:AEZS) (TSX:AEZS) ("Aeterna" or the "Company"), a specialty biopharmaceutical company developing and commercializing a diversified portfolio of pharmaceutical and diagnostic products, today announced the commencement of its pivotal Phase 3 safety and efficacy study AEZS-130-P02 ("the DETECT-trial") evaluating macimorelin for the diagnosis of childhood-onset growth hormone…

    Safety and efficacy study for macimorelin initiated as agreed with U.S. FDA and the European Medicines Agency ("EMA") in the Company's Pediatric Investigation Plan ("PIP")

    – Patient enrollment on track to start this quarter

    – Planned completion of pivotal Phase 3 study expected in Q3 2022

    CHARLESTON, S.C., May 13, 2021 (GLOBE NEWSWIRE) -- Aeterna Zentaris Inc. (NASDAQ:AEZS) (TSX:AEZS) ("Aeterna" or the "Company"), a specialty biopharmaceutical company developing and commercializing a diversified portfolio of pharmaceutical and diagnostic products, today announced the commencement of its pivotal Phase 3 safety and efficacy study AEZS-130-P02 ("the DETECT-trial") evaluating macimorelin for the diagnosis of childhood-onset growth hormone deficiency ("CGHD").

    The investigational new drug application ("IND"), "Multicenter, open-label trial to investigate the efficacy and safety of a single oral dose of 1.0 mg/kg macimorelin acetate as growth hormone stimulation test ("GHST") in pediatric patients with suspected growth hormone deficiency ("GHD")," for the study is active and the first clinical site in the U.S. is open for patient recruitment.

    Children and adolescents from two to less than 18 years of age with suspected growth hormone deficiency are planned to be included. The study is expected to enroll approximately 100 participants worldwide, with at least 40 participants in pre-pubertal and 40 participants in pubertal status. A macimorelin GHST will be performed twice to ensure the repeatability of the data. Two standard GHSTs will be used as controls: arginine (i.v.) and clonidine (p.o.). The study design is expected to be suitable to support a claim for potential stand-alone testing with macimorelin, if successful.

    "The initiation of the pivotal Phase 3 DETECT-trial is a key milestone for the Company," commented Dr. Klaus Paulini, Chief Executive Officer of Aeterna. "While we continue to make progress on multiple fronts across our development pipeline, the launch of this pivotal trial for the diagnosis of CGHD remains an integral piece of our product portfolio and an area of key focus. As sponsors of the trial, we look forward to getting the remainder of the clinical sites active and patient enrollment underway as quickly and efficiently as possible."

    The Company announced positive results in April 2020 from AEZS-130-P01 ("Study P01"), the first of two studies as agreed with FDA and EMA. The goal of Study P01 was to establish a dose that could both be safely administered to pediatric participants and causes a clear rise in growth hormone concentration in participants ultimately diagnosed as not having GHD. Results from the study demonstrated that the pharmacokinetic and pharmacodynamic profile of macimorelin proved to be in the expected range and in general comparable to data in adults.

    Under new terms and conditions of the license agreement revised in November 2020, Aeterna is closely coordinating the activities related to the development of macimorelin in CGHD through a joint steering committee with Novo Nordisk, Aeterna's licensee for the U.S. and Canada.

    For more information about Study P01 and the DETECT-trial, please visit EU Clinical Trials Register and reference EudraCT #2018-001988-23 and clinicaltrials.gov identifier NCT04786873.

    About Aeterna Zentaris Inc.

    Aeterna Zentaris is a specialty biopharmaceutical company developing and commercializing a diversified portfolio of pharmaceutical and diagnostic products focused on areas of significant unmet medical need. The Company's lead product, macimorelin (Macrilen), is the first and only U.S. FDA and European Commission approved oral test indicated for the diagnosis of adult growth hormone deficiency (AGHD). The Company is leveraging the clinical success and compelling safety profile of macimorelin to develop it for the diagnosis of childhood-onset growth hormone deficiency (CGHD) in collaboration with Novo Nordisk.

    Aeterna Zentaris is dedicated to the development of therapeutic assets and has recently taken steps to establish a growing preclinical pipeline to potentially address unmet medical needs across a number of indications, including neuromyelitis optica spectrum disorder (NMOSD), hypoparathyroidism and an undisclosed neurodegenerative disease. Additionally, the Company is developing an oral prophylactic bacterial vaccine against SARS-CoV-2, the virus that causes COVID-19.

    For more information, please visit www.zentaris.com and connect with the Company on Twitter, LinkedIn and Facebook.

    Forward-Looking Statements

    This press release contains statements that may constitute forward-looking statements within the meaning of U.S. and Canadian securities legislation and regulations, and such statements are made pursuant to the safe-harbor provision of the U.S. Securities Litigation Reform Act of 1995. Forward-looking statements are frequently, but not always, identified by words such as "expects," "anticipates," "believes," "intends," "potential," "possible," and similar expressions. Such statements, based as they are on current expectations of management, inherently involve numerous risks, uncertainties, and assumptions, known and unknown, many of which are beyond our control. Forward-looking statements in this press release include, but are not limited to, those relating to: Aeterna's expectation with respect to Study P02 (including the ability to initiate the remainder of the clinical sites, to enroll subjects in the USA or elsewhere in Study P02, and expectations that Study P02 are suitable to support a claim (regulatory approval) for potential stand-alone testing with macimorelin), and Aeterna's intentions with respect to growth opportunities and its business focus, including its development pipeline.

    Forward-looking statements involve known and unknown risks and uncertainties, and other factors which may cause the actual results, performance or achievements stated herein to be materially different from any future results, performance or achievements expressed or implied by the forward-looking information. Such risks and uncertainties include, among others, our reliance on the success of the pediatric clinical trial in the European Union and U.S. for Macrilen (macimorelin); we may be unable to enroll the expected number of subjects in Study P02 and the result of Study P02 may not support receipt of regulatory approval in CGHD, we may be delayed or unsuccessful in obtaining pricing and reimbursement approvals in Europe and the UK to market macimorelin; our other products under development may not be successful or may not support advancing the product to human clinical trials; our ability to raise capital and obtain financing to continue our currently planned operations; our now heavy dependence on the success of Macrilen (macimorelin) and related out-licensing arrangements and the continued availability of funds and resources to successfully commercialize the product, including our heavy reliance on the success of the License Agreement with Novo Nordisk; the global instability due to the global pandemic of COVID-19, and its unknown potential effect on our planned operations; our ability to enter into out-licensing, development, manufacturing, marketing and distribution agreements with other pharmaceutical companies and keep such agreements in effect. Investors should consult our quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties, including those risks discussed in our Annual Report on Form 40-F and annual information form, under the caption "Risk Factors". Given the uncertainties and risk factors, readers are cautioned not to place undue reliance on these forward-looking statements. We disclaim any obligation to update any such factors or to publicly announce any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments, unless required to do so by a governmental authority or applicable law.

    No securities regulatory authority has either approved or disapproved of the contents of this news release. The Toronto Stock Exchange accepts no responsibility for the adequacy or accuracy of this release.

    Investor Contact:

    Jenene Thomas

    JTC Team

    T (US): +1 (833) 475-8247

    E: aezs@jtcir.com



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