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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 (EGRX) has announced its intention to file Form 25 with the SEC to complete its delisting from the Nasdaq Global Market. The company's common stock was suspended from Nasdaq trading on October 3, 2024, due to non-compliance with listing requirements, and has been trading on the OTC Expert Market since October 4, 2024. The Form 25 filing, expected on or after November 25, 2024, will finalize the delisting process and deregister the stock under Section 12(b) of the Securities Exchange Act, reducing SEC reporting obligations.
Eagle Pharmaceuticals (OTCMKTS: EGRX) has appointed Christopher Krawtschuk as Chief Financial Officer, effective November 11, 2024. Krawtschuk replaces Steven Ratoff, who steps down as interim CFO but remains on the company's board. Krawtschuk brings extensive pharmaceutical sector experience, having previously served as CFO at bluebird bio and Jubilant Pharma. His background includes roles at Morphosys, where he helped build U.S. commercial operations, and Pfizer, where he provided financial leadership. He began his career at PricewaterhouseCoopers, holds a B.S. in Accounting, and is a licensed CPA.
Eagle Pharmaceuticals has implemented a duration stockholder rights plan in response to significant stock price dislocation and unsolicited third-party accumulation attempts. The plan grants stockholders one preferred share purchase right for each common stock share as of November 11, 2024. These rights become exercisable if any entity acquires or attempts to acquire 10% or more of outstanding common stock (15% for passive institutional investors). When exercisable, each right allows holders to purchase additional shares at $10.00, with a market value of twice the exercise price. The plan expires on October 30, 2025, unless redeemed earlier.
Eagle Pharmaceuticals (Nasdaq: EGRX) received a delisting notification from Nasdaq on August 21, 2024, due to its failure to timely file the Q2 2024 Form 10-Q. This follows a previous notice on August 1, 2024, where Nasdaq granted the company continued listing subject to specific conditions. Eagle must file its 2023 Annual Report by September 30, 2024, and both Q1 and Q2 2024 Form 10-Qs by October 31, 2024. The company plans to file a comprehensive Form 10-K, including restated financial information, and separate Form 10-Q filings to meet these deadlines. However, there's no guarantee that Eagle will meet the compliance dates or maintain its Nasdaq listing.
Eagle Pharmaceuticals received a delisting notification from Nasdaq on May 20, 2024, due to its failure to file key financial forms, including the Q3 2023 Form 10-Q, the 2023 Form 10-K, and the Q1 2024 Form 10-Q. The delisting process will commence if Eagle does not request a hearing by May 28, 2024, which will result in the suspension of their stock trading on May 30, 2024. Eagle plans to request a hearing to potentially extend their compliance period. However, there is no guarantee that such an extension will be granted or that they will regain compliance.
Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) announced a Trial in Progress presentation for their ongoing Phase 2/3 study of intravenous amisulpride as a prevention of postoperative nausea and vomiting in pediatric patients at the SAMBA 2024 Annual Meeting. Preliminary results are expected in the first half of 2025. The study aims to evaluate the potential benefits of amisulpride therapy in pediatric patients.
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