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Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) is a leading specialty pharmaceutical company committed to the development and commercialization of innovative injectable products targeted at critical care, orphan diseases, and oncology. The company’s robust portfolio includes four FDA-approved products: Argatroban, Ryanodex, Belrapzo, and Bendeka. Eagle is also advancing multiple product candidates through late-stage development, with several under review by the Food and Drug Administration (FDA).
Recently, Eagle achieved a significant regulatory milestone with its product Barhemsys® (amisulpride) injection. On January 1, 2024, Barhemsys will receive a unique, product-specific billing code (J-0184) from the Centers for Medicare & Medicaid Services (CMS), facilitating better access and separate reimbursement for the drug outside of surgical bundled payments. Barhemsys is the only FDA-approved medication for treating postoperative nausea and vomiting (PONV) in patients who have failed PONV prophylaxis, addressing a critical unmet medical need.
In addition to its marketed products, Eagle Pharmaceuticals boasts an extensive pipeline focusing on oncology and CNS/metabolic critical care. Noteworthy among these is the ready-to-dilute formulation of Pemfexy, used in treating non-small cell lung cancer and malignant pleural mesothelioma. Pemfexy's unique J-Code from CMS has earned it a 24% share in the non-340B pemetrexed market, reflecting its commercial success and innovation.
Financially, Eagle remains strong, with steady revenues from its commercialized products and a commitment to reporting accurate financial results. While the company has revised its 2023 guidance downward, it remains confident in the outlook for 2024, backed by ongoing development and new initiatives.
This strategic focus is further reinforced by Eagle’s robust intellectual property protections and recent litigation successes. The company is actively defending its patents against generic competitors, ensuring the continued commercial viability of its flagship products, Bendeka and Belrapzo.
With a team of dedicated professionals in research, development, clinical, and commercial operations, Eagle Pharmaceuticals is poised to make significant strides in the pharmaceutical industry. For the latest news and updates, visit their official website at 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.
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.
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