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. (OTCMKTS: EGRX) generates a steady flow of corporate, product and governance updates that are relevant to investors following EGRX news. As a fully integrated pharmaceutical company with research and development, clinical, manufacturing and commercial expertise, Eagle regularly issues press releases about its commercial portfolio, pipeline programs and capital structure decisions.
Company announcements describe a portfolio that includes PEMFEXY, RYANODEX, BENDEKA, BELRAPZO, TREAKISYM (Japan), and BYFAVO, as well as BYFAVO and BARHEMSYS historically commercialized through its wholly owned subsidiary Acacia Pharma Inc. News items have covered transactions such as a royalty purchase agreement to monetize BENDEKA royalties and the divestiture of the U.S. marketing authorization for Barhemsys (amisulpride) to LXO Group, with Eagle noting that proceeds would support ongoing operations and debt repayment.
Governance and capital markets developments are also a recurring theme in Eagle’s news flow. The company has reported on the adoption and amendment of a limited duration stockholder rights plan, changes to the plan’s purchase price and duration, and cooperation agreements with significant stockholders involving board appointments. In addition, Eagle issues updates on its annual meeting of stockholders, proxy material availability, and the release of audited and unaudited financial statements.
Investors monitoring EGRX news can use this page to follow Eagle’s disclosures on its oncology and critical care products, CNS/metabolic critical care pipeline, financing transactions, and corporate governance actions. Regularly reviewing these updates can help readers understand how Eagle describes the evolution of its product portfolio, pipeline priorities and capital structure over time.
Eagle Pharmaceuticals (Nasdaq: EGRX) announced FDA approval for an additional indication of PEMFEXY (pemetrexed injection) for treating patients with metastatic, non-squamous, non-small cell lung cancer without EGFR or ALK aberrations. This approval marks the fifth indication for PEMFEXY, a ready-to-use liquid formulation designed to simplify treatment by eliminating reconstitution steps. Additionally, effective October 1, 2022, Eagle amended its agreement, reducing future royalties from 25% to 0%-12.5% in exchange for a $15 million one-time payment.
Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) announced a settlement with Accord Healthcare regarding patents related to BENDEKA®. Accord can market its product starting January 17, 2028, or sooner under specific conditions. This follows a similar settlement with Hospira. Eagle's CEO expressed satisfaction with the settlement and plans to continue enforcing intellectual property rights related to BENDEKA and its bendamustine franchise.
Eagle Pharmaceuticals (EGRX) is set to host an Investor Day on December 6, 2022, at the Lotte New York Palace, featuring key opinion leaders discussing the clinical rationale for its hospital-based products and pipeline programs, including ENA-001, CAL02, BARHEMSYS®, BYFAVO®, and landiolol. The event will start with breakfast at 7:30 am ET, followed by presentations and a Q&A session. Advance registration is required for in-person attendance, with a webcast available on the company's website.
Eagle Pharmaceuticals (EGRX) will showcase its hospital-based products and pipeline at the Investor Day on December 6, 2022, in New York. Featured speakers include CEO Scott Tarriff and other key opinion leaders. The event will provide insights into products like Enalare’s ENA-001, CAL02, BARHEMSYS®, BYFAVO®, and landiolol, focusing on applications such as postoperative respiratory depression, severe pneumonia treatment, and procedural sedation. Attendees can ask questions post-presentation, with availability for a webcast via the company's website.
Eagle Pharmaceuticals has announced that the FDA has accepted its IND application for CAL02, a novel anti-virulence agent intended for adjunct treatment of severe community-acquired pneumonia. The company plans to initiate a Phase 2 study involving approximately 276 patients across 120 sites globally, with enrollment starting as early as early 2023. CAL02 may qualify for ten years of regulatory exclusivity and fast track designations. Eagle also emphasizes its commitment to improving patient outcomes with CAL02 and strengthening its patent portfolio.
Eagle Pharmaceuticals (EGRX) re-issued its Q3 2022 earnings report on November 9, correcting errors in financial statements. Q3 2022 total revenue reached $65.9 million, a significant increase from $39.9 million in Q3 2021. The net loss for the quarter was $(7.1) million, or $(0.54) per share, compared to a loss of $(5.6) million in the same period last year. Adjusted non-GAAP net income for Q3 2022 was $14.9 million, or $1.13 per share, more than double the prior year's earnings. Key developments included an IND application to the FDA for CAL02 and an equity stake in Enalare Therapeutics.
Eagle Pharmaceuticals (EGRX) reported a Q3 2022 net loss of $3.5 million, or $0.27 per share, an improvement from a $5.6 million loss in Q3 2021. Total revenue reached $65.9 million, significantly up from $39.9 million in the prior year, driven by strong sales of vasopressin and PEMFEXY. The company achieved adjusted non-GAAP net income of $14.9 million, doubling from $7.5 million year-over-year. It submitted an IND application for CAL02 to the FDA and strengthened its pipeline by acquiring an equity stake in Enalare Therapeutics. Cash and equivalents stood at $15.4 million as of September 30, 2022.
Eagle Pharmaceuticals, Inc. (EGRX) will release its 2022 third quarter financial results on November 7, 2022, before market opening. A conference call will be hosted by CEO Scott Tarriff and CFO Brian Cahill at 8:30 a.m. ET, with a toll-free number for U.S. participants and an international line provided. The call will be available for replay for two weeks, while the webcast can be accessed for 30 days. Eagle specializes in developing innovative medicines, with products like PEMFEXY®, RYANODEX®, and others aimed at addressing critical therapeutic areas.
Eagle Pharmaceuticals (Nasdaq: EGRX) will host an Investor Day on December 6, 2022, at the Lotte New York Palace Hotel, starting at 8:00 AM ET. The event will feature presentations on the Company’s hospital-based products, including CAL02, BARHEMSYS®, and BYFAVO®, as well as Enalare’s ENA-001. Key speakers will include Scott Tarriff, President and CEO, alongside senior clinical and commercial team members, and notable Key Opinion Leaders discussing each pipeline asset's scientific rationale and potential medical needs. Registration is required, and a webcast will be available on their website.
Eagle Pharmaceuticals has submitted an IND application to the FDA for CAL02, a first-in-class agent aimed at treating severe community-acquired bacterial pneumonia (SCABP). A global Phase 2 study is set to start in early 2023, enrolling around 276 patients across 120 sites. CAL02 is designed to work alongside standard antibiotics, potentially reducing inflammatory markers and critical care duration, thereby lowering mortality risks. Eagle anticipates investing $35 million to achieve interim results by late 2023 or early 2024, while seeking regulatory exclusivity under the GAIN Act.