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. reports developments tied to its specialty pharmaceutical portfolio, research and development programs, and public-company governance. The company combines research and development, clinical, manufacturing, and commercial capabilities, with commercialized products including PEMFEXY®, RYANODEX®, BENDEKA®, BELRAPZO®, TREAKISYM® in Japan, and BYFAVO® through Acacia Pharma Inc. Its pipeline is described around oncology and CNS/metabolic critical care product candidates.
Recurring Eagle news includes portfolio actions such as the U.S. Barhemsys marketing-authorization divestiture, availability of audited and unaudited financial statements, annual meeting materials and voting results, board and stockholder matters, and amendments to its limited-duration stockholder rights plan.
Eagle Pharmaceuticals announced the filing of TREAKISYM RI (50ml) with Japan's Pharmaceuticals and Medical Devices Agency (PMDA). This application is based on clinical studies confirming the safety and pharmacokinetics of the 10-minute intravenous infusion. CEO Scott Tarriff expressed optimism about reaching peak income of $20-$25 million next year from TREAKISYM products. The RI formulation notably reduces infusion time from 60 to 10 minutes, enhancing patient and healthcare provider experience. Eagle's partnership with SymBio supports the commercialization of these products in Japan.
Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) has appointed Dr. Luciana Borio to its Board of Directors. Dr. Borio's extensive experience includes significant roles at the FDA and the National Security Council, focusing on public health and infectious diseases. Eagle's CEO Scott Tarriff expressed optimism about her contributions to the company's growth and advancement of its product pipeline. Dr. Borio's background includes leadership in biodefense policy and medical countermeasures, which aligns with Eagle's strategic goals. This appointment reflects Eagle's commitment to enhancing its expertise in addressing unmet medical needs.
Eagle Pharmaceuticals (NASDAQ: EGRX) announced the approval of TREAKISYM ready-to-dilute (RTD) liquid formulation for a new indication in combination with rituximab for relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL) by Japan's Pharmaceuticals and Medical Devices Agency (PMDA). This approval is expected to enhance the TREAKISYM market opportunity in Japan, with a potential peak revenue of $25 million from combined royalties and milestones. The RTD formulation offers benefits such as reduced preparation time compared to the lyophilized version.
Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) will release its 2021 first quarter financial results on May 10, 2021, before market opens. The CEO Scott Tarriff and CFO Brian Cahill will host a conference call at 8:30 a.m. ET to discuss the results. Investors can participate by calling 877-876-9173 (U.S.) or 785-424-1667 (International). A replay will be available for one week, and a webcast will be archived for 30 days at www.eagleus.com.
Eagle Pharmaceuticals (Nasdaq: EGRX) reported strong financial results for Q4 2020 and the full year, highlighting a 36% increase in adjusted non-GAAP earnings year-over-year. Q4 revenue reached $49.9 million, driven by product sales growth of Ryanodex and Belrapzo. The company received a complete response letter from the FDA regarding its ANDA for vasopressin, but plans to resubmit by mid-2021. Full-year revenue was $187.8 million, down from $195.9 million in 2019, with net income of $12.0 million. Eagle intends to launch Pemfexy in February 2022 and remains focused on growth opportunities.
Eagle Pharmaceuticals (EGRX) will announce its Q4 and full-year 2020 financial results on March 2, 2021, before market opening. The event will feature a 90-minute conference call hosted by CEO Scott Tarriff and CFO Brian Cahill, starting at 8:30 a.m. ET. Investors can participate by calling toll-free or internationally. A replay will be available for a week post-call. Eagle focuses on developing innovative treatments, including RYANODEX®, BENDEKA®, and BELRAPZO®, aiming to address unmet medical needs across various conditions.
Eagle Pharmaceuticals (Nasdaq: EGRX) announced that the FDA has issued a complete response letter (CRL) for its ANDA for vasopressin. The Company has engaged in discussions with the FDA and plans an additional meeting within 30 days. Eagle intends to address the CRL's concerns and will conduct a short-duration study by mid-March, anticipating satisfactory results.
Additionally, litigation against Endo Par Innovation regarding vasopressin is set for July 7, 2021. Eagle remains optimistic about both the ANDA approval process and the patent litigation.
Eagle Pharmaceuticals, Inc. (EGRX) announced that the U.S. District Court for Delaware postponed the vasopressin trial with Endo Par Innovation, initially scheduled for February 1, 2021. A new trial date will be discussed in a court call. CEO Scott Tarriff expressed optimism, noting that Eagle's proposed product formulation differs from the patent claims, and they expect to gain 180 days of exclusivity post-trial. This litigation outcome may influence Eagle's market position and future product availability.
Eagle Pharmaceuticals (Nasdaq: EGRX) has announced a postponement of its vasopressin trial originally set for January 11, 2021, due to COVID-19 concerns. The trial will now begin remotely on February 1, 2021, and is expected to conclude by February 5, 2021. Eagle, a fully integrated pharmaceutical company, focuses on developing innovative medicines to improve patient lives, with products such as RYANODEX®, BENDEKA®, and BELRAPZO®. The company is engaged in research, clinical trials, and commercial activities aimed at addressing unmet medical needs.
Eagle Pharmaceuticals (Nasdaq: EGRX) announced that CEO Scott Tarriff and CFO Brian Cahill will present at the 39th Annual J.P. Morgan Healthcare Conference on January 13, 2021, at 4:30 p.m. EST. The presentation will be webcast live and archived for 30 days on the Company’s website under the Investors Section. Eagle is committed to developing innovative medicines, with commercialized products including RYANODEX®, BENDEKA®, and BELRAPZO®. For more information, visit www.eagleus.com.