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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 (Nasdaq: EGRX) announced that the FDA granted Orphan Drug Designation for ENA-001, a novel respiratory stimulant targeting Apnea of Prematurity (AoP). This designation is pivotal as AoP affects 25% of preterm infants and could lead to market exclusivity and financial incentives. ENA-001 is also being developed for post-operative respiratory depression and drug overdose. Eagle's investment of $12.5 million in Enalare Therapeutics signifies its commitment to advancing this treatment.
Eagle Pharmaceuticals (EGRX) announced a partnership with Enalare Therapeutics to develop ENA-001, a new respiratory stimulant, with funding of up to $50.3 million from BARDA.
The contract will support pre-clinical studies and regulatory submissions for an intramuscular formulation aimed at treating respiratory depression from drug overdoses and other emergencies. Eagle previously invested $12.5 million in Enalare and will continue funding subject to trial milestones. ENA-001 is under development to address urgent medical needs in various settings.
Eagle Pharmaceuticals (Nasdaq: EGRX) announced that CEO Scott Tarriff and CFO Brian Cahill will present at the Morgan Stanley 20th Annual Global Healthcare Conference on September 13, 2022, at 5:15 PM ET. The presentation can be accessed via a webcast on the company's website. Eagle Pharmaceuticals is a fully integrated pharmaceutical company focused on developing innovative medicines, including products like BYFAVO® and BENDEKA®. The company will also engage in one-on-one meetings that day, which must be requested through Morgan Stanley.
Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) announced that the U.S. Court of Appeals upheld a previous ruling confirming that its vasopressin product does not infringe patents held by Par Pharmaceutical, Inc. This ruling follows Par's lawsuit initiated in 2018. Eagle’s Abbreviated New Drug Application (ANDA) for vasopressin received FDA approval in December 2021 and the product was launched in January 2022. This legal victory reinforces Eagle's position in the vasopressin market, where it aims to provide alternatives to existing therapies.
Eagle Pharmaceuticals reported Q2 2022 revenue of $74.1 million, up from $48.1 million in Q2 2021, driven by product sales including vasopressin and PEMFEXY®.
Adjusted non-GAAP net income for Q2 reached $20.3 million, or $1.58 per share, compared to $12.4 million or $0.95 per share in the prior year.
Despite a net loss of $(9.5) million, Eagle's first-half earnings per share doubled compared to full-year 2021, reflecting a strong operational performance.
Eagle Pharmaceuticals (EGRX) has entered a $25 million equity investment agreement with Enalare Therapeutics to enhance its acute care portfolio with ENA-001, a novel respiratory stimulant. This innovative treatment targets post-operative respiratory depression, community drug overdose, and Apnea of Prematurity. The agreement includes additional contingent investments totaling up to $55 million, based on development milestones. ENA-001 is expected to enter Phase 2 trials soon, with potential market entry in 2026 for post-operative respiratory depression. The collaboration aims to address significant medical needs and leverage Eagle's existing expertise.
Eagle Pharmaceuticals (EGRX) will announce its Q2 2022 financial results on August 9, 2022, before market opening. CEO Scott Tarriff and CFO Brian Cahill will discuss the results in a conference call scheduled for the same day at 8:30 a.m. ET. Investors can access the call via toll-free numbers and a live webcast. A replay will be available for two weeks post-call. Eagle's commitment lies in developing innovative medicines, with ongoing projects targeting underserved therapeutic areas.
Eagle Pharmaceuticals, Inc. (EGRX) announced the appointment of Debra M. Hussain as Senior Vice President, Head of Commercial. This comes on the heels of Eagle's acquisition of Acacia Pharma Group Plc, which included commercial products BARHEMSYS® and BYFAVO®. The Company believes both products were underinvested and launched during the challenging COVID period. Hussain, with 25 years of pharmaceutical experience, is tasked with relaunching these products, expected to achieve peak U.S. sales of $275 million. Eagle anticipates that this strengthened leadership will enhance business growth.
Eagle Pharmaceuticals has successfully completed its acquisition of Acacia Pharma, which includes two FDA-approved drugs, BARHEMSYS® and BYFAVO®, expanding its product portfolio significantly. This acquisition could tap into an estimated $3.1 billion addressable market, with projected peak sales of $275 million in the U.S. by 2024. The strategic addition aims to enhance Eagle's presence in the acute care sector and is expected to be earnings accretive. The deal reinforces Eagle's commitment to addressing significant unmet clinical needs in hospital settings.
Eagle Pharmaceuticals (EGRX) announced a new drug application (NDA) submission for landiolol, an intravenous beta-1 blocker intended for short-term reduction of ventricular rates in patients with supraventricular tachycardia. The FDA expects to review the application by mid-2023, following positive feedback from a Type C meeting. If approved, landiolol will establish new chemical entity exclusivity for five years. The company is also diversifying its product offerings, anticipating growth from three to nine products, enhancing its presence in acute care settings.
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