Eagle Pharmaceut Stock Price, News & Analysis

Eagle Pharmaceuticals, Inc. (EGRX) has announced that CEO Scott Tarriff and CFO Brian Cahill will present at two upcoming investor conferences. The first is the Morgan Stanley 19th Annual Global Healthcare Conference on September 14, 2021, at 2:00 p.m. ET, with a live webcast available here. The second conference is the 2021 Cantor Virtual Global Healthcare Conference on September 28, 2021, at 4:40 p.m. ET, with a live webcast available here.

Eagle Pharmaceuticals (NASDAQ: EGRX) has achieved a significant legal victory as the U.S. District Court for the District of Delaware ruled that its proposed vasopressin product does not infringe any patents asserted by Par. The ruling allows Eagle to continue its plans to market a generic version of Vasostrict, which generated $786 million in U.S. sales in 2020. CEO Scott Tarriff expressed optimism about providing a generic alternative, emphasizing its importance for public access. The court's decision does not address Eagle's claims regarding the invalidity of Par's patents.

Eagle Pharmaceuticals (NASDAQ: EGRX) announced the grant of U.S. Patent No. 11,103,483 for formulations of Bendamustine. This patent will be listed in the FDA’s Orange Book for BENDEKA and BELRAPZO. The company had previously asserted patents against Slayback Pharma, Apotex, Mylan, and Fresenius regarding abbreviated new drug applications referencing BENDEKA, with court rulings affirming patent validity. Both the asserted patents and the new patent expire in 2031, strengthening Eagle's IP rights. CEO Scott Tarriff expressed satisfaction with these developments.

Eagle Pharmaceuticals (EGRX) has entered a licensing agreement with Combioxin for CAL02, a novel antitoxin agent targeting severe pneumonia. Results from a first-in-human clinical trial indicate CAL02 demonstrated a favorable safety profile and improved clinical outcomes when used with standard antibiotics. The company plans a robust Phase 2b/3 study in 2022 and anticipates regulatory exclusivity for 10 years. With pneumonia causing 2.4 million deaths annually, CAL02 addresses a significant unmet need and could transform treatment protocols, highlighting its potential impact on patient care.

Eagle Pharmaceuticals announced its financial results for Q2 2021, reporting total revenues of $48.1 million, up from $41.9 million in Q2 2020. The net income was $3.6 million or $0.28 per share, a turnaround from a net loss in the previous year. Significant developments include a licensing agreement for Landiolol and progress in the vasopressin program, anticipating a commercial launch before year-end. The company expects combined royalty and milestone revenue from TREAKISYM in Japan to reach $20-$25 million, marking strong growth potential.

Eagle Pharmaceuticals (Nasdaq: EGRX) announced a licensing agreement with AOP Orphan Pharmaceuticals for the U.S. rights to Landiolol, an ultra-selective beta-1 blocker approved in Europe for tachycardia. Eagle will submit a new drug application (NDA) to the FDA for Landiolol's approval for short-term ventricular rate reduction in supraventricular tachycardia (SVT). The agreement includes a $5 million upfront payment and potential future payments upon regulatory approvals. Landiolol shows promise for critical care management and has the potential for pediatric applications.

Eagle Pharmaceuticals (Nasdaq: EGRX) announced the release of its Q2 2021 financial results on August 9, 2021, prior to market opening. CEO Scott Tarriff and CFO Brian Cahill will lead a conference call at 8:30 a.m. ET to discuss the results. Participation details include toll-free numbers for U.S. and international callers and a webcast available for replay. The company focuses on innovative medicines with products like RYANODEX®, BENDEKA®, and BELRAPZO®. Additional information is available on their website.

Eagle Pharmaceuticals (Nasdaq: EGRX) announced the FDA has maintained Priority Review for its ANDA for vasopressin, with a GDUFA date set for December 15, 2021. The response to the CRL was submitted on June 15, 2021. CEO Scott Tarriff emphasized the importance of this program, highlighting its COVID priority status, and expressed confidence in a commercial launch before the year ends. Eagle is the first to file an ANDA for vasopressin, which had U.S. sales of $786 million in 2020.

Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) announced it has responded to the Complete Response Letter (CRL) concerning its Abbreviated New Drug Application (ANDA) for vasopressin. The company believes it has fully addressed the FDA's concerns and expects final approval soon, highlighting the product as a critical program with significant potential value for shareholders. Eagle is the first to file an ANDA referencing Vasostrict, which earned $786 million in U.S. sales in 2020. The company prioritizes this application as a COVID-related project, aiming for a launch within the year.