Welcome to our dedicated page for Emergent Biosolutions news (Ticker: EBS), a resource for investors and traders seeking the latest updates and insights on Emergent Biosolutions stock.
Emergent BioSolutions, Inc. (NYSE: EBS) is a global life sciences company dedicated to protecting and enhancing life. With a mission to secure public health, Emergent develops, manufactures, and distributes a broad portfolio of medical countermeasures for biological and chemical threats as well as emerging infectious diseases. The company is committed to safeguarding lives and aims to protect and enhance 50 million lives with its products by 2025.
Headquartered in Gaithersburg, Maryland, Emergent operates through three primary segments: Commercial, Products, and Services. The Commercial segment, which generates the majority of the company's revenue, includes key products such as NARCAN® Nasal Spray—a life-saving medication for opioid overdoses. NARCAN® has become widely accessible in pharmacies, grocery stores, and online retailers, significantly increasing public availability since its over-the-counter approval by the FDA in March 2023.
Emergent is also known for its role in developing and manufacturing vaccines and therapeutics, particularly for governments and healthcare providers. The company's Baltimore Bayview manufacturing facility recently received a “No Action Indicated” status from the FDA, confirming its compliance with good manufacturing practices. This recognition underscores Emergent's dedication to quality and compliance in its manufacturing processes.
Financially, Emergent is focused on stabilizing its operations and strengthening its balance sheet. The recent restructuring plan aims to streamline operations, close certain manufacturing facilities, and reduce workforce by 300 employees, resulting in annualized savings of approximately $80 million. Despite these changes, Emergent remains dedicated to its core business areas and continues to offer integrated contract development and manufacturing services to pharmaceutical and biotechnology customers.
Key recent developments include the extension of NARCAN® Nasal Spray's shelf life from 36 to 48 months and its widespread distribution across the U.S. and Canada. Emergent is also actively working with partners like the National Safety Council to educate businesses and the public about opioid overdose prevention and response.
Emergent is committed to its long-term vision of protecting and enhancing 1 billion lives by 2030. The company continues to innovate and expand its product offerings while maintaining a strong focus on public health and safety.
Africa CDC has initiated patient enrollment in the MOSA trial, a pan-African randomized platform adaptive study for Mpox treatment at Mbandaka Hospital in DRC. The study, primarily evaluating brincidofovir, comes as Mpox remains a significant health threat across Africa, particularly affecting vulnerable populations.
The trial follows recent studies (PALM 007 and STOMP) showing tecovirimat's effectiveness in lesion resolution. MOSA will assess different antivirals' safety and efficacy, starting with brincidofovir, an antiviral from Emergent BioSolutions currently available in the US under emergency use IND for Mpox.
The study protocol includes a two-week treatment period with either brincidofovir or placebo in liquid oral form, administered weekly. The first interim analysis is expected by Q1 2025. The trial, sponsored by PANTHER and initially funded by EU's Horizon Europe program, will recruit both children and adults, focusing on those at highest risk of severe outcomes.
Emergent BioSolutions (NYSE: EBS) has secured exclusive commercial rights to KLOXXADO® (naloxone HCl) Nasal Spray in the U.S. and Canada from Hikma Pharmaceuticals through a six-year agreement. This 8 mg naloxone product complements EBS's existing NARCAN® Nasal Spray 4 mg, expanding their portfolio of opioid overdose emergency treatments.
The agreement comes as CDC reports the first meaningful decline in U.S. opioid overdose deaths since 2018. NARCAN® will continue to be available over-the-counter as a 4 mg standard treatment, while KLOXXADO®'s 8 mg dosage will be available by prescription for those requiring higher doses.
Hikma will continue manufacturing KLOXXADO®, which will be integrated into Emergent's NARCANDirect™ online distribution network. This platform serves qualified direct purchasers including emergency services, law enforcement, government agencies, and community-based programs.
Emergent BioSolutions (NYSE: EBS) has received a $16.7 million contract option from BARDA to continue development of Ebanga™, a treatment for Zaire Ebola virus infection. This modification represents the second option period of their existing 10-year contract, which has a maximum value of $704 million.
The contract includes a base period and two option periods for advanced development valued at $118 million, plus additional option periods for Ebanga™ procurement worth up to $583 million. Under the contract terms, Emergent will focus on drug product process validation, analytical testing validation, and long-term stability studies. The company will also work on manufacturing scale-up, technology transfer, and completing stability studies, culminating in a supplemental Biologics License Application to the FDA.
Emergent BioSolutions (NYSE: EBS), a public health company focused on protective and life-saving solutions, has announced its participation in the 43rd Annual J.P. Morgan Healthcare Conference. Joe C. Papa, the company's president and CEO, will deliver a presentation on Wednesday, January 15, 2025, at 1:30 PM PST.
The presentation will be accessible through an audio link, which will remain available for 30 days following the event. Additionally, the presentation slides will be published in the Investors section of Emergent's website coinciding with the presentation time.
Emergent BioSolutions (NYSE: EBS) announced a $20 million contract option exercise from the U.S. Department of Defense (DoD) for supplying BioThrax® (Anthrax Vaccine Adsorbed). The first delivery, valued at approximately $7 million, began in December 2024, with remaining deliveries scheduled for 2025.
The option is part of an existing indefinite-delivery, indefinite-quantity (IDIQ) procurement contract with the DoD, providing BioThrax® for pre-exposure prophylaxis across all U.S. military branches. This follows a recent $50 million contract option from BARDA for CYFENDUS® procurement announced on December 16, 2024.
The company's anthrax franchise includes four products: BioThrax®, CYFENDUS®, and two treatments - Anthrasil® and raxibacumab.
Emergent BioSolutions (NYSE: EBS) has received a $50 million contract option from BARDA for its CYFENDUS® anthrax vaccine. The deliveries are scheduled between now and April 2025. This follows a previous $30 million contract modification for the same vaccine. CYFENDUS®, FDA-approved in July 2023, is a two-dose anthrax vaccine for post-exposure prophylaxis in individuals aged 18-65.
The contract strengthens national anthrax preparedness against potential bioterrorist incidents, as anthrax is classified as a Tier 1 biological select agent. Emergent's anthrax portfolio also includes BioThrax® vaccine and two treatments: Anthrasil® and raxibacumab.
Emergent BioSolutions (NYSE: EBS) announced that its antiviral drug brincidofovir (TEMBEXA®) will be included in a clinical trial led by Africa CDC as part of the 'MpOx Study in Africa' (MOSA). The randomized double-blind placebo-controlled trial will evaluate the safety and efficacy of brincidofovir in treating mpox virus. Currently, there are no FDA-approved therapeutics for treating patients with mpox who are at risk of severe complications. While brincidofovir can be used for mpox in the U.S. under emergency Investigational New Drug protocol, this will be its first randomized controlled study for mpox treatment.
Emergent BioSolutions (EBS) reported strong Q3 2024 financial results with total revenues of $293.8 million, up 9% year-over-year. Net income reached $114.8 million, a 144% increase, while Adjusted EBITDA grew 432% to $105.3 million. The company secured significant financing through a $250 million Term Loan and $100 million asset-backed facility. Notable transactions included the $75 million sale of RSDL®, $35 million from Baltimore-Camden site sale, and receipt of $50 million from Janssen dispute resolution. Based on strong performance, EBS raised its FY 2024 guidance, projecting revenues of $1,065-$1,125 million.
Emergent BioSolutions (NYSE: EBS) has appointed Dr. Simon Lowry as Chief Medical Officer and Head of Research and Development, effective November 18. Dr. Lowry brings over 25 years of experience in healthcare and pharmaceuticals, most recently serving as CEO of Mysthera Therapeutics AG. He will oversee research and development, regulatory affairs, medical affairs, clinical and biostatistics, and patient safety. Additionally, Jessica Perl has been promoted to General Counsel and Corporate Secretary after serving in the interim role since August.
Emergent BioSolutions (NYSE: EBS) has scheduled its third quarter 2024 financial results conference call for November 6, 2024, at 5:00 pm eastern time. The call will cover Q3 financial performance, recent business developments, and the company's financial outlook for full year 2024. Participants can join via webcast or telephone, with dial-in numbers provided for both U.S./New York (+1-646-968-2525) and U.S. & Canada toll-free (+1-888-596-4144). A replay will be available on the company's Investors webpage.
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