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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, Inc. (Nasdaq: EGRX) announced Q2 2023 results, with total revenue at $64.6 million, net income of $5.2 million, and adjusted non-GAAP EBITDA of $20.7 million. The company reiterates raised full-year guidance of adjusted non-GAAP EBITDA of $78.0-$84.0 million and adjusted non-GAAP earnings per share of $4.40-$4.70. Recent business highlights include sales growth for Barhemsys and Byfavo, expansion of commercial teams, and upcoming FDA meetings for product candidates.
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