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. reports developments tied to its specialty pharmaceutical portfolio, research and development programs, and public-company governance. The company combines research and development, clinical, manufacturing, and commercial capabilities, with commercialized products including PEMFEXY®, RYANODEX®, BENDEKA®, BELRAPZO®, TREAKISYM® in Japan, and BYFAVO® through Acacia Pharma Inc. Its pipeline is described around oncology and CNS/metabolic critical care product candidates.
Recurring Eagle news includes portfolio actions such as the U.S. Barhemsys marketing-authorization divestiture, availability of audited and unaudited financial statements, annual meeting materials and voting results, board and stockholder matters, and amendments to its limited-duration stockholder rights plan.
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.
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.