Welcome to our dedicated page for Eagle Pharmaceut news (Ticker: EGRX), a resource for investors and traders seeking the latest updates and insights on Eagle Pharmaceut stock.
Eagle Pharmaceuticals, Inc. (OTCMKTS: EGRX) generates a steady flow of corporate, product and governance updates that are relevant to investors following EGRX news. As a fully integrated pharmaceutical company with research and development, clinical, manufacturing and commercial expertise, Eagle regularly issues press releases about its commercial portfolio, pipeline programs and capital structure decisions.
Company announcements describe a portfolio that includes PEMFEXY, RYANODEX, BENDEKA, BELRAPZO, TREAKISYM (Japan), and BYFAVO, as well as BYFAVO and BARHEMSYS historically commercialized through its wholly owned subsidiary Acacia Pharma Inc. News items have covered transactions such as a royalty purchase agreement to monetize BENDEKA royalties and the divestiture of the U.S. marketing authorization for Barhemsys (amisulpride) to LXO Group, with Eagle noting that proceeds would support ongoing operations and debt repayment.
Governance and capital markets developments are also a recurring theme in Eagle’s news flow. The company has reported on the adoption and amendment of a limited duration stockholder rights plan, changes to the plan’s purchase price and duration, and cooperation agreements with significant stockholders involving board appointments. In addition, Eagle issues updates on its annual meeting of stockholders, proxy material availability, and the release of audited and unaudited financial statements.
Investors monitoring EGRX news can use this page to follow Eagle’s disclosures on its oncology and critical care products, CNS/metabolic critical care pipeline, financing transactions, and corporate governance actions. Regularly reviewing these updates can help readers understand how Eagle describes the evolution of its product portfolio, pipeline priorities and capital structure over time.
Eagle Pharmaceuticals (NASDAQ: EGRX) announced the grant of U.S. Patent No. 11,103,483 for formulations of Bendamustine. This patent will be listed in the FDA’s Orange Book for BENDEKA and BELRAPZO. The company had previously asserted patents against Slayback Pharma, Apotex, Mylan, and Fresenius regarding abbreviated new drug applications referencing BENDEKA, with court rulings affirming patent validity. Both the asserted patents and the new patent expire in 2031, strengthening Eagle's IP rights. CEO Scott Tarriff expressed satisfaction with these developments.
Eagle Pharmaceuticals (EGRX) has entered a licensing agreement with Combioxin for CAL02, a novel antitoxin agent targeting severe pneumonia. Results from a first-in-human clinical trial indicate CAL02 demonstrated a favorable safety profile and improved clinical outcomes when used with standard antibiotics. The company plans a robust Phase 2b/3 study in 2022 and anticipates regulatory exclusivity for 10 years. With pneumonia causing 2.4 million deaths annually, CAL02 addresses a significant unmet need and could transform treatment protocols, highlighting its potential impact on patient care.
Eagle Pharmaceuticals announced its financial results for Q2 2021, reporting total revenues of $48.1 million, up from $41.9 million in Q2 2020. The net income was $3.6 million or $0.28 per share, a turnaround from a net loss in the previous year. Significant developments include a licensing agreement for Landiolol and progress in the vasopressin program, anticipating a commercial launch before year-end. The company expects combined royalty and milestone revenue from TREAKISYM in Japan to reach $20-$25 million, marking strong growth potential.
Eagle Pharmaceuticals (Nasdaq: EGRX) announced a licensing agreement with AOP Orphan Pharmaceuticals for the U.S. rights to Landiolol, an ultra-selective beta-1 blocker approved in Europe for tachycardia. Eagle will submit a new drug application (NDA) to the FDA for Landiolol's approval for short-term ventricular rate reduction in supraventricular tachycardia (SVT). The agreement includes a $5 million upfront payment and potential future payments upon regulatory approvals. Landiolol shows promise for critical care management and has the potential for pediatric applications.
Eagle Pharmaceuticals (Nasdaq: EGRX) announced the release of its Q2 2021 financial results on August 9, 2021, prior to market opening. CEO Scott Tarriff and CFO Brian Cahill will lead a conference call at 8:30 a.m. ET to discuss the results. Participation details include toll-free numbers for U.S. and international callers and a webcast available for replay. The company focuses on innovative medicines with products like RYANODEX®, BENDEKA®, and BELRAPZO®. Additional information is available on their website.
Eagle Pharmaceuticals (Nasdaq: EGRX) announced the FDA has maintained Priority Review for its ANDA for vasopressin, with a GDUFA date set for December 15, 2021. The response to the CRL was submitted on June 15, 2021. CEO Scott Tarriff emphasized the importance of this program, highlighting its COVID priority status, and expressed confidence in a commercial launch before the year ends. Eagle is the first to file an ANDA for vasopressin, which had U.S. sales of $786 million in 2020.
Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) announced it has responded to the Complete Response Letter (CRL) concerning its Abbreviated New Drug Application (ANDA) for vasopressin. The company believes it has fully addressed the FDA's concerns and expects final approval soon, highlighting the product as a critical program with significant potential value for shareholders. Eagle is the first to file an ANDA referencing Vasostrict, which earned $786 million in U.S. sales in 2020. The company prioritizes this application as a COVID-related project, aiming for a launch within the year.
Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) announced that CEO Scott Tarriff and CFO Brian Cahill will present at the Jefferies Virtual Healthcare Conference on June 2, 2021, at 1:30 p.m. Eastern Time. The presentation will be available for live webcast and archived for 30 days on Eagle's website. Eagle is a fully integrated pharmaceutical company focusing on innovative medicines that significantly improve patient outcomes, with products like RYANODEX®, BENDEKA®, and BELRAPZO®. More details can be found at www.eagleus.com.
Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) will present at the 2021 RBC Capital Markets Global Healthcare Conference on May 18, 2021, at 1:20 p.m. Eastern Time. CEO Scott Tarriff and CFO Brian Cahill will lead the presentation, which will be available via a live webcast and archived for 30 days on the company’s website under the Investors Section. Eagle is dedicated to developing innovative medicines, with commercialized products including RYANODEX®, BENDEKA®, and BELRAPZO®. For more information, visit www.eagleus.com.
Eagle Pharmaceuticals announced its Q1 2021 financial results, reporting total revenues of $41.2 million, down from $46.0 million in Q1 2020, attributed to decreased sales of RYANODEX and lower royalties from BENDEKA. The net loss narrowed to $0.4 million, compared to $2.9 million a year prior. Significant business highlights include FDA study completion for vasopressin, TREAKISYM approval in Japan, and active discussions for new in-licensing opportunities. Eagle anticipates $20-$25 million from TREAKISYM in 2022.