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Aeterna Zentaris Inc. (NASDAQ: AEZS, TSX: AEZS) is a global biopharmaceutical company specializing in endocrine therapy and oncology. With a robust track record in drug discovery, development, and commercialization, the company focuses on addressing significant unmet medical needs. Aeterna Zentaris' flagship product, macimorelin (marketed as Macrilen® in the U.S. and Ghryvelin™ in Europe), is the first and only FDA and European Commission-approved oral test for diagnosing adult growth hormone deficiency (AGHD). The company is actively pursuing the extension of macimorelin’s application for diagnosing childhood-onset growth hormone deficiency (CGHD), with the Phase 3 DETECT trial nearing completion.
Recently, Aeterna Zentaris announced a definitive agreement to merge with Ceapro Inc. The merger, expected to close in the second quarter of 2024, aims to leverage Ceapro's revenue-generating cosmeceutical and nutraceutical products, such as oat beta glucan and avenanthramides. The combined entity is poised to generate stable cash flow, diversify its product pipeline, enhance research and development capabilities, and strengthen its market presence in both North America and Europe.
The company remains committed to developing an array of therapeutic assets, including treatments for neuromyelitis optica spectrum disorder (NMOSD), Parkinson's disease (PD), hypoparathyroidism, and amyotrophic lateral sclerosis (ALS). Aeterna Zentaris is well-capitalized, with a strategic plan to advance innovative products and deliver sustained value to its shareholders.
Aeterna Zentaris Inc. (NASDAQ: AEZS) announced the temporary discontinuation of Macrilen® (macimorelin) sales for adult use in the U.S., effective May 23, 2023, as it seeks a new commercialization partner. This decision follows the termination of a licensing agreement with Novo Nordisk. However, sales efforts in the UK and European Economic Area continue under Pharmanovia's management. The U.S. Patent and Trademark Office issued a Notice of Allowance for a patent related to macimorelin's use in assessing growth hormone deficiency in children. The ongoing DETECT trial aims for potential approval for childhood onset growth hormone deficiency.
Aeterna Zentaris (NASDAQ: AEZS) reported its financial results for the year ending December 31, 2022, showing a consolidated net loss of $22.7 million, or $4.68 per share. This marks an increase from a $8.4 million loss in 2021. The company's total revenue slightly rose to $5.6 million from $5.3 million, primarily due to development services associated with its DETECT trial. Aeterna ended the year with $50.6 million in cash, projected to sustain operations through 2024 and into 2025. The company aims to streamline its development programs and enhance recruitment for the DETECT trial, along with securing Macrilen's partnering rights in the U.S. and Canada.
Aeterna Zentaris (NASDAQ: AEZS) has announced that Pharmanovia will acquire the license for GHRYVELIN (macimorelin) from its existing partner, Consilient Health, effective immediately. This acquisition allows Pharmanovia exclusive rights to commercialize GHRYVELIN in Europe for diagnosing Adult and Childhood Onset Growth Hormone Deficiency. Aeterna's CEO, Dr. Klaus Paulini, expressed confidence in Pharmanovia's expertise in endocrinology, viewing this as a strategic partnership to enhance patient outcomes. Additionally, Aeterna aims to regain rights for Macrilen in the U.S. and Canada by May 2023, seeking a new partner for further commercialization.
Aeterna Zentaris Inc. (NASDAQ: AEZS) provides a business update highlighting significant progress in its development pipeline. The company is focusing on enhancing recruitment for its DETECT trial and seeking a commercialization partner for Macrilen™ in the U.S. and Canada. Aeterna has decided to streamline operations by discontinuing its early-stage vaccine programs, which is expected to extend its cash runway into 2025. Recent achievements include bolstered patient enrollment and regulatory approvals for Macrilen™ as a diagnostic tool in multiple regions. Upcoming milestones involve completing the DETECT trial enrollment by the end of 2023.
Aeterna Zentaris Inc. (NASDAQ: AEZS) will host a live video webcast presentation on January 19, 2023, at 3:00 PM ET during the Virtual Investor 2023 Companies to Watch Event. The presentation will be led by Dr. Klaus Paulini, CEO, and will be available on the Company’s website, with a replay accessible for 90 days. Aeterna focuses on developing pharmaceutical and diagnostic products for unmet medical needs, notably through its lead product, macimorelin, an FDA-approved oral test for diagnosing adult growth hormone deficiency.
Aeterna Zentaris reported its Q3 2022 financial results, highlighting a net loss of $3.4 million ($0.70 per share), up from $1.9 million ($0.40 per share) a year earlier. Revenue rose to $1.9 million, driven by licensing and development revenue. Operating expenses increased to $5.6 million due to higher R&D costs. The company maintains $53.8 million in cash. Aeterna will regain full rights to Macrilen after Novo's termination of their agreement, effective May 2023, while pursuing options for its asset. Additionally, a research agreement with Massachusetts General Hospital was established.
Aeterna Zentaris (NASDAQ: AEZS) announced the termination of its development agreement with Novo Nordisk for Macrilen (macimorelin), effective after a 270-day notice period. This transition allows Aeterna to regain full control over Macrilen in the U.S. and Canada, with plans to continue its pivotal DETECT-trial for childhood-onset growth hormone deficiency (CGHD). The company intends to seek a strategic partner for Macrilen's commercialization. Aeterna's strong balance sheet, with $58.2 million in cash, supports ongoing trials and pipeline investments.
Aeterna Zentaris Inc. (AEZS) reported a net loss of $4.2 million for Q2 2022, compared to a $2.1 million loss in Q2 2021. Revenue plummeted to -$0.2 million, down from $1.6 million a year earlier, primarily due to revenue reversals linked to the DETECT project affected by the Ukraine/Russia conflict. Operating expenses rose to $4.5 million. The company ended the quarter with $58.2 million in cash. Aeterna recently received Nasdaq compliance notice, confirming its continued listing despite previous delisting risks.
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