STOCK TITAN

Mainz Biomed N.V. Ordinary Shares - MYNZ STOCK NEWS

Welcome to our dedicated page for Mainz Biomed N.V. Ordinary Shares news (Ticker: MYNZ), a resource for investors and traders seeking the latest updates and insights on Mainz Biomed N.V. Ordinary Shares stock.

Mainz Biomed N.V. (symbol: MYNZ) is a pioneering company in the field of molecular genetic diagnostics, dedicated to providing patient-friendly testing solutions for life-threatening conditions. With a mission to improve early detection rates and thereby save lives through science, Mainz Biomed develops market-ready products that are both accurate and easy to use.

One of their key innovations is ColoAlert®, a non-invasive, at-home screening test for colorectal cancer (CRC). Utilizing real-time Polymerase Chain Reaction (PCR) to detect molecular-genetic biomarkers in stool samples, ColoAlert® offers high sensitivity and specificity. This test is available in select European countries and is poised for FDA approval in the United States through the ongoing 'ReconAAsense' clinical trial.

Mainz Biomed aims to expand its market reach by fostering partnerships with laboratories and healthcare providers. The company is also committed to advancing the early detection of other cancers, including pancreatic cancer, through products like PancAlert, which is currently in early stages of development.

Recently, Mainz Biomed showcased ColoAlert® at the UDH Congress, emphasizing its role in enhancing comprehensive health strategies. The company reported a 69% year-over-year revenue increase for ColoAlert® and maintained a stable financial condition with a $7.1 million cash balance at year-end.

In collaboration with healthcare professionals, Mainz Biomed continues to contribute to scientific research and knowledge exchange. This commitment was highlighted by their latest clinical studies, ColoFuture and eAArly DETECT, which demonstrated extraordinary statistical significance in CRC and advanced adenoma detection.

For more details, visit Mainz Biomed's official website at www.mainzbiomed.com.

Rhea-AI Summary

Mainz Biomed (NASDAQ:MYNZ) has appointed Dr. Rainer Metzger to its Strategic Advisory Board, bringing over 25 years of experience in the pharmaceuticals and diagnostics industry. Dr. Metzger's expertise in oncology diagnostics is expected to enhance Mainz's commercial expansion and partnerships. The company emphasizes the early detection capabilities of its ColoAlert test for colorectal cancer, which holds significant market potential, especially with an increasing 50+ population in the U.S. The test is CE-IVD marked and aims for U.S. regulatory approval in 2022.

Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
1.09%
Tags
management
-
Rhea-AI Summary

Mainz Biomed has launched the ColoFuture international clinical study aimed at enhancing ColoAlert, its at-home colorectal cancer screening test. The study will assess the integration of novel mRNA biomarkers to improve diagnostic sensitivity and specificity, particularly for identifying advanced adenomas. Conducted with over 600 patients across Norway and Germany, results are expected in early 2023. The company is also preparing for a regulatory pathway in the U.S., targeting a market opportunity of approximately $3.7 billion annually.

Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
10.3%
Tags
-
Rhea-AI Summary

Mainz Biomed N.V. (NASDAQ:MYNZ) has successfully closed its underwritten public follow-on offering, raising $25.875 million through the sale of 1,725,000 ordinary shares at a price of $15.00 each. This offering included an option exercised by underwriters for an additional 225,000 shares. The funds are earmarked for the development of recently acquired mRNA biomarkers and clinical studies to support the ColoAlert FDA submission. Mainz Biomed, focused on cancer diagnostics, aims to enhance its product portfolio and expedite U.S. market access.

Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
1.09%
Tags
Rhea-AI Summary

Mainz Biomed N.V. (NASDAQ:MYNZ) has appointed Steve Quinn as Vice President of Business Development to spearhead international growth, particularly for its ColoAlert colorectal cancer screening test. With extensive experience in molecular genetics and diagnostics, Quinn aims to enhance market penetration across Europe, the Middle East, Asia, and the U.S. pending FDA approval. The ColoAlert test, with its high sensitivity and specificity, represents a significant opportunity in the colorectal cancer screening market, projected to be worth approximately $3.7 billion annually in the U.S.

Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
5.31%
Tags
management
-
Rhea-AI Summary

Mainz Biomed N.V. (MYNZ) announced a follow-on offering of 1,500,000 ordinary shares at $15.00 per share, aiming for gross proceeds of $22.5 million. The offering is expected to close on January 28, 2022, subject to customary conditions. The underwriter, Boustead Securities, LLC, has an option to purchase an additional 225,000 shares for over-allotments. Mainz Biomed focuses on molecular genetic diagnostic solutions, with its flagship product, ColoAlert, targeting colorectal cancer detection, and plans to seek FDA approval later in 2022.

Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
-28.4%
Tags
none
-
Rhea-AI Summary

Mainz Biomed, a molecular genetics diagnostic company, has engaged DCN Dx to conduct a European clinical study for its ColoAlert test, aimed at detecting colorectal cancer. This partnership focuses on integrating recently acquired mRNA biomarkers to enhance ColoAlert's accuracy in detecting pre-cancerous lesions. The study is set to begin in H1 2022, with potential implications for U.S. FDA approval. With the colorectal cancer market projected at $3.7 billion in the U.S., successful results could establish ColoAlert as a leading at-home screening test.

Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
-7.87%
Tags
Rhea-AI Summary

Mainz Biomed N.V. (NASDAQ:MYNZ) announced the appointment of Dr. Michele Pedrocchi to its Strategic Advisory Board. Dr. Pedrocchi, a seasoned healthcare executive with over 25 years at Roche, brings extensive experience in in vitro diagnostics and international market launches. His expertise is expected to enhance the company’s flagship product, ColoAlert, which is designed for early colorectal cancer detection. The company aims to expand its commercial presence across Europe and beyond. Dr. Pedrocchi will also support strategic partnerships related to product development and distribution.

Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
14.41%
Tags
management
-
Rhea-AI Summary

Mainz Biomed N.V. (NASDAQ:MYNZ) announced its participation in the H.C. Wainwright Bioconnect Virtual Conference from January 10-13, 2022. CEO Guido Baechler will present at the event, which can be accessed online. Mainz Biomed specializes in molecular genetics diagnostics, focusing on early cancer detection, particularly with its ColoAlert test for colorectal cancer, which has a high accuracy and is CE-IVD marked. The U.S. market opportunity for colorectal cancer testing is estimated at $3.7 billion annually, with significant growth expected in the 50+ population.

Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
3.07%
Tags
conferences
-
Rhea-AI Summary

Mainz Biomed (NASDAQ:MYNZ) has secured a Technology Rights Agreement with TTS, gaining access to a portfolio of mRNA biomarkers aimed at enhancing its ColoAlert colorectal cancer screening test. This agreement positions ColoAlert to possibly become the leading at-home screening solution, with previous studies indicating high sensitivity (75% for advanced adenomas and 95% for colorectal cancer). The company plans to initiate a clinical study in Europe to assess these biomarkers, targeting a launch in the first half of 2022. ColoAlert is already CE-IVD marked and aims for U.S. regulatory approval soon.

Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
46.39%
Tags
Rhea-AI Summary

Mainz Biomed (NASDAQ:MYNZ) announced the appointment of Karen Richards as Vice President of Regulatory Affairs. This strategic hire is expected to aid in navigating U.S. regulatory processes for their colorectal cancer detection product, ColoAlert. With over 30 years in the in vitro diagnostics sector, Richards' extensive experience includes spearheading regulatory approvals globally. ColoAlert, already marketed in Europe, detects early-stage colorectal cancer and has a significant market potential in the U.S., estimated at $3.7 billion annually, given the rising population of those eligible for testing.

Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
2.33%
Tags
management fda approval

FAQ

What is the current stock price of Mainz Biomed N.V. Ordinary Shares (MYNZ)?

The current stock price of Mainz Biomed N.V. Ordinary Shares (MYNZ) is $6.68 as of December 20, 2024.

What is the market cap of Mainz Biomed N.V. Ordinary Shares (MYNZ)?

The market cap of Mainz Biomed N.V. Ordinary Shares (MYNZ) is approximately 12.3M.

What does Mainz Biomed specialize in?

Mainz Biomed specializes in developing molecular genetic diagnostic solutions for early detection of life-threatening conditions, such as colorectal and pancreatic cancers.

What is ColoAlert®?

ColoAlert® is Mainz Biomed's flagship product, a non-invasive, at-home test for colorectal cancer that uses PCR technology to detect molecular-genetic biomarkers in stool samples.

Where is ColoAlert® available?

ColoAlert® is currently available in select European countries and is undergoing FDA approval for the U.S. market.

What recent achievements has Mainz Biomed made?

Mainz Biomed recently presented significant clinical study results at the UDH Congress and reported a 69% year-over-year revenue increase for ColoAlert®.

What is the ReconAAsense trial?

The ReconAAsense trial is Mainz Biomed's FDA-registration study designed to evaluate ColoAlert® for U.S. regulatory approval.

What other products does Mainz Biomed have in development?

Apart from ColoAlert®, Mainz Biomed is developing PancAlert, an early-stage screening test for pancreatic cancer.

How does ColoAlert® differ from other CRC screening tests?

ColoAlert® offers higher accuracy and earlier detection rates compared to traditional fecal occult blood tests (FOBT), thanks to its advanced PCR-based technology.

What is Mainz Biomed’s mission?

Mainz Biomed's mission is to save lives through science by providing accurate, easy-to-use diagnostic solutions for early detection of deadly conditions.

How does Mainz Biomed contribute to the healthcare sector?

Mainz Biomed contributes through scientific research, innovative diagnostic solutions, and partnerships with healthcare professionals to improve early detection and patient care.

Where can I find more information about Mainz Biomed’s investor relations?

For more information on investor relations, visit Mainz Biomed’s official website at www.mainzbiomed.com/investors/.

Mainz Biomed N.V. Ordinary Shares

Nasdaq:MYNZ

MYNZ Rankings

MYNZ Stock Data

12.31M
3.26M
5.8%
0.25%
5.57%
Diagnostics & Research
Healthcare
Link
United States of America
Mainz