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Emergent BioSolutions Secures $51.9 Million Contract Modification Award for CNJ-016® [Vaccinia Immune Globulin Intravenous (Human)] (VIGIV) as part of U.S. Biodefense Preparedness Efforts
Globenewswire· 2025-07-08 20:45
Core Viewpoint - Emergent BioSolutions Inc. has secured a contract modification to deliver Vaccinia Immune Globulin Intravenous (Human) (VIGIV) to the U.S. Department of Health and Human Services for smallpox preparedness, highlighting the company's ongoing partnership with the U.S. government [1][2]. Group 1: Contract and Partnership - The contract modification involves additional doses of VIGIV, a treatment for complications arising from smallpox vaccination, under an existing 10-year contract with the Administration for Strategic Preparedness and Response (ASPR) [1]. - This modification follows a recent contract amendment for Botulism Antitoxin Heptavalent (BAT) with ASPR, indicating a broader collaboration between Emergent and the U.S. government in public health preparedness [2]. Group 2: Product Information - VIGIV is indicated for treating complications due to vaccinia vaccination, including severe generalized vaccinia and eczema vaccinatum, but is not indicated for postvaccinial encephalitis [3][4]. - The product has specific contraindications, including isolated vaccinia keratitis and severe allergic reactions to human globulins [4]. Group 3: Safety Information - Important safety information for VIGIV includes potential interactions with glucose monitoring systems, which may lead to falsely elevated blood glucose readings [3]. - Common adverse reactions reported in clinical trials for VIGIV include headache, nausea, rigors, and dizziness, with more than 10% of patients experiencing these effects [6].
Gilead Sciences Rallies 27.2% in Six Months: Buy or Sell the Stock?
ZACKS· 2025-07-08 14:56
Core Viewpoint - Gilead Sciences, Inc. (GILD) has demonstrated strong stock performance, gaining 27.2% over the past six months, significantly outperforming the industry and broader market indices [1][7]. Gilead's HIV Portfolio - The recent FDA approval of lenacapavir, branded as Yeztugo, introduces the first and only twice-yearly injectable option for HIV prevention in the U.S., enhancing Gilead's market-leading HIV treatment portfolio [2][4]. - Gilead's flagship drug, Biktarvy, holds over 51% market share in the U.S. treatment market, while Descovy maintains over 40% market share in the PrEP market [3][4]. - Yeztugo addresses barriers to PrEP adoption, such as adherence and healthcare access, and is expected to increase uptake among underserved populations [5][4]. Financial Performance and Growth - Gilead's stock has outperformed the industry, sector, and S&P 500 index, supported by the FDA approval of Yeztugo and rising earnings estimates [6][7]. - Earnings estimates for Gilead have increased, with the 2025 bottom-line estimate rising to $7.92 from $7.91, and the 2026 estimate improving to $8.48 from $8.39 [15]. Liver Disease Portfolio - Gilead's liver disease portfolio has been strengthened by the FDA approval of seladelpar for primary biliary cholangitis (PBC), which has shown encouraging initial uptake [9][10]. Oncology Business Challenges - Gilead's oncology portfolio faces challenges, particularly in the Cell Therapy franchise due to competitive pressures, but positive results from the ASCENT-03 study on Trodelvy may bolster future growth [11][12]. Strategic Positioning - Gilead's strategic collaborations and acquisitions, including a partnership with Merck for HIV treatment, position the company for continued growth despite competitive pressures from other firms like GSK [17][18]. - The company maintains a strong cash position of $7.9 billion, supporting its attractive dividend yield of 2.83%, which is sustainable [19].
Supplemental new drug application submitted to U.S. FDA for CAPLYTA® (lumateperone) with data demonstrating significant schizophrenia relapse prevention compared to placebo
Prnewswire· 2025-07-08 12:00
Submission is based on long-term Phase 3 data demonstrating 63 percent reduction in risk of relapse in adults with schizophrenia compared to placebo "For people living with schizophrenia, relapses can be devastating as they disrupt lives, undo hard-earned treatment progress toward patients' goals, and increase the risk of hospitalization with each episode," said Christoph U. Correll, M.D., Clinical Professor of Psychiatry at the Zucker School of Medicine at Hofstra/Northwell, New York.a "CAPLYTA® substantia ...
Soligenix Corporate Update Letter - Key Highlights and Upcoming Milestones
Prnewswire· 2025-07-08 11:30
PRINCETON, N.J., July 8, 2025 /PRNewswire/ -- Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, today issued an update letter from its President and Chief Executive Officer, Dr. Christopher J. Schaber. The content of this letter is provided below.Dear Friends and Shareholders,I would like to start by thanking you for your continued support, and hope ...
Agios Appoints Dr. Jay Backstrom to Board of Directors
GlobeNewswire News Room· 2025-07-08 11:00
CAMBRIDGE, Mass., July 08, 2025 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a leader in cellular metabolism and pyruvate kinase (PK) activation pioneering therapies for rare diseases, today announced the appointment of Jay Backstrom, M.D., M.P.H., to its Board of Directors, effective immediately. Dr. Backstrom is an accomplished healthcare executive with a proven track record of advancing clinical programs across a range of therapeutic areas, including rare diseases, to regulatory approv ...
CervoMed Announces Late-Breaking Presentations at Alzheimer’s Association® International Congress 2025
GlobeNewswire· 2025-07-08 11:00
BOSTON, July 08, 2025 (GLOBE NEWSWIRE) -- CervoMed Inc. (NASDAQ: CRVO), a clinical stage company focused on developing treatments for age-related neurologic disorders, today announced it will deliver Developing Topics (late-breaking) virtual and in-person poster presentations at Alzheimer's Association International Congress (AAIC) 2025, being held on July 27 – 31, 2025 in Toronto, Canada. The Company will be presenting the results, including new results, from the RewinD-LB Phase 2b study of neflamapimod in ...
Arcus Biosciences(RCUS) - 2024 Q4 - Earnings Call Presentation
2025-07-08 05:48
COMBINING TO CURE ® Forward-Looking Statements/Safe Harbor Arcus is at the forefront of designing combination therapies, with best-in-class potential, in the relentless pursuit of cures for cancer. Forward Looking Statements Safe Harbor: This presentation contains forward-looking statements about Arcus Biosciences, Inc. ("we," "Arcus" or the "Company") made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All statements regarding events or results to occur in t ...
NANOBIOTIX Announces Regulatory Harmonization and New Composition of Matter Patent Filed for JNJ-1900 (NBTXR3)
Globenewswire· 2025-07-07 20:15
Health authorities in major European countries have accepted the reclassification of JNJ-1900 (NBTXR3) from a medical device to a medicinal product, aligning with regulatory status in the US and other major marketsMedicinal product classification supports unified global regulatory classification, facilitating future global strategies and filingsNew composition of matter patent for JNJ-1900 (NBTXR3) filed by Nanobitotix PARIS and CAMBRIDGE, Mass., July 07, 2025 (GLOBE NEWSWIRE) -- NANOBIOTIX (Euronext: NANO ...
Generation Bio Announces Inducement Grant under Nasdaq Listing Rule 5635(c)(4)
Globenewswire· 2025-07-07 20:05
CAMBRIDGE, Mass., July 07, 2025 (GLOBE NEWSWIRE) -- Generation Bio Co. (Nasdaq:GBIO), a biotechnology company working to change what’s possible for people living with T cell-driven autoimmune diseases, today announced that, on July 1, 2025, the company granted equity awards to one new employee, pursuant to the company’s 2025 Inducement Stock Incentive Plan, as an inducement material to such new employee’s entering into employment with the company in accordance with Nasdaq Listing Rule 5635(c)(4). The employ ...
Ibogaine: Can an African Root Help Solve the U.S. Opioid Crisis?
For decades, the opioid crisis has defied standard treatments. But deep in the shadows of modern medicine lies a radical but effective alternative. Ibeine is a powerful psychedelic often described as miraculous by those who've tried it because of its remarkable ability to erase years of addiction and the agony of withdrawal in just one harrowing session.But ibeane remains illegal in the US in part because it can be deadly. Despite the risks, thousands of desperate Americans addicted to opioids are crossing ...