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Avid Bioservices - CDMOP STOCK NEWS

Welcome to our dedicated page for Avid Bioservices news (Ticker: CDMOP), a resource for investors and traders seeking the latest updates and insights on Avid Bioservices stock.

Overview of Avid Bioservices

Avid Bioservices (CDMO) is a dedicated contract development and manufacturing organization specializing in the development and CGMP manufacturing of biologics. With over three decades of experience, the company offers a comprehensive suite of services that include process development, clinical and commercial drug substance manufacturing, and a broad range of testing and regulatory compliance services. Key industry terms such as CGMP manufacturing, process development, and biologics production are central to its operations, positioning Avid as an essential partner for biotechnology and pharmaceutical companies.

Core Business Areas

Avid Bioservices provides extensive services tailored to meet the evolving needs of life sciences companies. Its operations are divided into several critical segments:

  • Process Development: Encompassing cell line development, upstream and downstream process optimization, analytical methods development, and comprehensive testing and characterization, this segment focuses on building a robust foundation for biologic production.
  • CGMP Manufacturing: Operating state-of-the-art, fully compliant facilities, the company handles both clinical and commercial-scale production of drug substances. It covers bulk packaging, release and stability testing, and supports regulatory submissions.
  • Comprehensive Support Services: In addition to production, Avid offers support in regulatory strategy, assay development, and data analysis, allowing clients to navigate the complex landscape of biologic development with confidence.

Market Position and Industry Significance

Avid Bioservices has established itself as a reliable partner in the highly specialized field of biologics development. Its longstanding track record of consistent regulatory compliance and commitment to quality has earned it trust among leading pharmaceutical and biotech innovators. The company’s ability to manage end-to-end services — from early-stage development to final commercialization — highlights its expertise and deep industry knowledge, making it a significant player in the global CDMO landscape.

Expertise and Operational Excellence

The company prioritizes technological innovation and process optimization to meet the rigorous demands of its clients. Its investments in state-of-the-art facilities and a skilled team proficient in analytical testing and regulatory affairs underline its commitment to operational excellence. Avid Bioservices continuously adapts its service offerings to address the evolving challenges in biologics manufacturing, ensuring high-quality and efficient treatment production.

Competitive Landscape

Avid competes in a dynamic and challenging marketplace alongside other renowned CDMOs. What sets it apart is its specialized focus on biologics, its comprehensive suite of services, and its dedication to maintaining robust regulatory standards. These factors enable the company to offer customized solutions that are not only technically advanced but also meticulously aligned with industry best practices.

Customer Focus and Value Proposition

The core value proposition of Avid Bioservices lies in its ability to support the sustainable innovation of biopharmaceutical products. By integrating advanced process development with scalable manufacturing solutions, the company helps clients bring complex biologics to market efficiently. Its customer-centric approach, underscored by tailored solutions and a deep understanding of regulatory frameworks, enhances overall client value across the product lifecycle.

Conclusion

With a rich history in biologics production, Avid Bioservices stands out for its unwavering commitment to quality, comprehensive service offerings, and precise, regulatory-compliant manufacturing practices. The company remains a crucial partner for biotechnology and pharmaceutical innovators looking for dependable, full lifecycle development and manufacturing solutions, underpinned by a deep well of industry expertise and operational excellence.

Rhea-AI Summary

Avid Bioservices reported a robust third-quarter revenue surge of 61% to $21.8 million, compared to $13.6 million in Q3 FY2020. The company secured $74 million in new orders, resulting in a historic backlog of $120 million. Gross margins significantly improved to 28%, up from 6% year-over-year. Avid raised its fiscal 2021 revenue guidance to $88-$91 million. The ongoing Myford facility expansion will enhance annual revenue capacity to $270 million. Cash on hand as of January 31, 2021, stands at $70.9 million.

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Avid Bioservices, Inc. (NASDAQ:CDMO, CDMOP) has announced a quarterly cash dividend of $0.65625 per share on its 10.50% Series E Convertible Preferred Stock. The dividend will be payable on April 1, 2021, to holders of record by March 15, 2021. This payment reflects an annualized rate of 10.50%, based on a liquidation preference of $25.00 per share. Avid Bioservices specializes in biologics contract development and manufacturing with extensive experience in the biotechnology sector.

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Avid Bioservices, Inc. (NASDAQ:CDMO, CDMOP) announced it will report its third-quarter fiscal year 2021 financial results on March 8, 2021, after market close. A conference call will be held at 1:30 PM PT (4:30 PM ET) to discuss these results and recent corporate developments. The company specializes in biologics contract development and manufacturing, focusing on high-quality services in the biotechnology and pharmaceutical sectors. With 28 years of experience, Avid offers comprehensive drug substance manufacturing and process development services.

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Avid Bioservices has commenced Phase 2 of its Myford facility expansion to meet increasing customer demand.

This phase will introduce a second manufacturing train expected to cost between $45 million and $55 million and take 18 to 24 months to complete.

This expansion could increase annual revenue capacity by an additional $100 million, alongside the ongoing Phase 1, potentially raising total capacity to $270 million.

The company is optimistic about its growth trajectory and the successful integration of new clients.

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Avid Bioservices (NASDAQ:CDMO, CDMOP) has entered a manufacturing services agreement with Humanigen to enhance production of lenzilumab, a monoclonal antibody for treating COVID-19. This partnership aims to deliver cGMP drug substance batches to support Humanigen's regulatory filings for emergency use authorization (EUA) and a future Biologics License Application (BLA). The collaboration focuses on scalable manufacturing to ensure patient access as Humanigen completes its Phase 3 clinical trial with 520 patients enrolled.

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Avid Bioservices (NASDAQ:CDMO, CDMOP) and Humanigen (NASDAQ:HGEN) have entered a manufacturing services agreement to boost production for lenzilumab, aimed at treating COVID-19. This collaboration will involve cGMP drug substance batches essential for Humanigen’s upcoming regulatory filings, including emergency use authorization (EUA) and a Biologics License Application (BLA). Humanigen has successfully completed enrollment in a 520-patient Phase 3 clinical trial. Both companies emphasize their commitment to enhancing therapeutic access amid the ongoing pandemic.

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Avid Bioservices, Inc. (NASDAQ:CDMO, CDMOP) has completed its public offering of 3,833,335 shares at $9.00 per share, yielding approximately $34.5 million in gross proceeds. The offering included 500,000 shares sold via the underwriters’ option. Funds will primarily enhance manufacturing capabilities and support general corporate activities. RBC Capital Markets led the offering, with Craig-Hallum and Stephens acting as co-managers. The shares were registered under an effective SEC Form S-3, with a final prospectus supplement filed. This is a strategic move aimed at bolstering operational growth.

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Avid Bioservices, Inc. (NASDAQ:CDMO, CDMOP) announced a public offering of 3,333,335 shares at $9.00 each, potentially raising approximately $30 million. The offering, expected to close around December 14, 2020, allows underwriters a 30-day option for an additional 500,000 shares. Proceeds will primarily expand manufacturing capabilities and cover general corporate purposes. RBC Capital Markets is the sole book-running manager. The offering is made under an effective shelf registration statement with the SEC.

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Avid Bioservices, Inc. (NASDAQ:CDMO, CDMOP) announced an underwritten public offering of its common stock, including a 30-day option for underwriters to purchase an additional 15% of shares. The net proceeds will primarily fund the expansion of manufacturing capabilities, with any remainder allocated to general corporate purposes. RBC Capital Markets is the sole book-running manager, and the offering is made under a previously filed shelf registration statement. This move is aimed at bolstering the company's growth within the biotechnology sector.

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Avid Bioservices (NASDAQ:CDMO, CDMOP) has appointed Jeanne Thoma as an independent director, enhancing its board with over 30 years of pharmaceutical experience. Thoma's background includes leadership roles at SPI Pharma and Lonza, focusing on product development and operations. The board welcomes her expertise to aid in expanding Avid's client base and revenue. Avid, a dedicated biologics CDMO, specializes in CGMP manufacturing of biopharmaceuticals, boasting 27 years in producing monoclonal antibodies and recombinant proteins.

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FAQ

What core services does Avid Bioservices provide?

Avid Bioservices offers a comprehensive range of services that include process development, CGMP clinical and commercial manufacturing, analytical testing, and regulatory submissions support for biologics.

How does Avid Bioservices serve the biotech and pharmaceutical industries?

The company provides end-to-end development and manufacturing services, from early-stage process development to full-scale commercial production, ensuring high quality and regulatory compliance.

What distinguishes Avid Bioservices in the competitive CDMO market?

Avid Bioservices stands out due to its extensive experience, specialized focus on biologics, state-of-the-art facilities, and a strong commitment to operational excellence and regulatory adherence.

How does Avid ensure quality and compliance in its manufacturing processes?

By adhering to stringent CGMP standards, investing in advanced technological capabilities, and employing a skilled team focused on process optimization and regulatory requirements, Avid ensures high quality and consistent compliance.

What is the significance of process development in Avid Bioservices' operations?

Process development is crucial as it forms the foundation for effective biologics production, involving activities such as cell line development, upstream and downstream optimization, and analytical testing to ensure scalable and compliant manufacturing.

How does Avid Bioservices support its clients throughout the product lifecycle?

Avid offers a full spectrum of services from initial development through to commercialization, providing technical expertise, customized solutions, and continuous support to meet the evolving needs of its clients.

Who are the typical customers of Avid Bioservices?

The company primarily serves biotechnology and pharmaceutical companies that require specialized contract development and manufacturing services for complex biologics.

How does Avid Bioservices maintain its industry expertise?

With over 30 years in the industry, Avid continuously invests in new technologies, staff training, and process innovation, ensuring that its services remain at the forefront of regulatory standards and manufacturing techniques.
Avid Bioservices

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