Egalet Ltd.(EGLT)- NASDAQ
  • Mon, Sep. 19, 8:18 AM
    • Egalet Corporation (NASDAQ:EGLTappoints Patrick Shea as chief commercial officer (CCO). Mr. Shea will be responsible for leading Egalet's commercial activities and will report to Bob Radie, Egalet's CEO.
    • Mr. Shea has over two decades of sales, marketing, market access and commercial operations experience. Previously, Mr. Shea served as CCO at Clarus Therapeutics, VP of sales and marketing for the U.S. operations of CSL Behrin, senior VP of sales and marketing at Astellas Pharmaceuticals, Ligand Pharmaceuticals and Boehringer Ingelheim.
    | Mon, Sep. 19, 8:18 AM
  • Fri, Aug. 5, 9:12 AM
    | Fri, Aug. 5, 9:12 AM
  • Fri, Aug. 5, 8:18 AM
    • Egalet (NASDAQ:EGLT) +17.8% AH following a positive vote from an FDA panel for the company's abuse-deterrent ARYMO ER for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment.
    • Addicts frequently attempt to increase the speed with which opioids get into their bloodstream by chewing or crushing the pills, or by dissolving and injecting them; EGLT's tablets are designed to be extremely hard, making them more difficult to break down to extract the active ingredient.
    • The panel voted 18-1 to recommend approval of ARYMO ER; the FDA's final decision is scheduled for Oct. 14.
    • EGLT also reported a larger than expected Q2 loss.
    | Fri, Aug. 5, 8:18 AM | 4 Comments
  • Fri, Aug. 5, 12:49 AM
    • Egalet (NASDAQ:EGLT): Q2 EPS of -$0.97 misses by $0.15.
    • Revenue of $3.45M (+259.4% Y/Y) misses by $0.38M.
    • Press Release
    | Fri, Aug. 5, 12:49 AM | 2 Comments
  • Tue, Jun. 28, 10:17 AM
    • A joint meeting between the FDA's Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee will take place on August 4 to review Egalet's (EGLT +2.9%) New Drug Application (NDA) seeking approval of ARYMO ER (morphine sulfate) extended-release tablets, an abuse-deterrent formulation of morphine, for the long-term management of pain.
    • ARYMO ER incorporates the company's abuse-deterrent Guardian technology, which utilizes a plastic injection molding process to make the tablets extremely hard, difficult to chew, resistant to particle size reduction and inhibits attempts to chemically extract the active pharmaceutical ingredient. In addition, when exposed to a liquid, the tablet forms a viscous hydrogel which makes it difficult to draw into a syringe.
    • The FDA's action date (PDUFA) is October 14.
    | Tue, Jun. 28, 10:17 AM
  • Fri, Jun. 24, 11:00 AM
    | Fri, Jun. 24, 11:00 AM
  • Mon, May 23, 6:57 AM
    • Purdue Pharma L.P. settles its patent infringement suit against Egalet (NASDAQ:EGLT) and licensor Acura Pharmaceuticals (NASDAQ:ACUR) related to OXAYDO (oxycodone HCl, USP) tablets CII, specifically U.S. Patent Nos. 8,389,007 and 9,308,171. Purdue agreed to dismiss the claims and both parties agreed not to pursue any further action on OXAYDO, an immediate-release oxycodone. There are no financial obligations to either company.
    • Egalet will continue to market the product.
    | Mon, May 23, 6:57 AM
  • Tue, May 10, 6:01 AM
    • Egalet (NASDAQ:EGLT): Q1 EPS of -$0.76 beats by $0.11.
    • Revenue of $2.7M (+237.5% Y/Y) misses by $0.8M.
    • Press Release
    | Tue, May 10, 6:01 AM
  • Tue, Mar. 8, 10:14 AM
    • Egalet (EGLT +6.8%) Q4 results: Revenues: $19.4M (+999%); Operating Expense: $22.7M (+118.3%); Operating Loss: ($6.5M) (+31.6%); Net Loss: ($6.8M) (+20.0%); Loss Per Share: ($0.28) (+46.2%).
    • FY2015 results: Revenues: $22.8M (+999%); Operating Expense: $69.8M (+78.5%); Operating Loss: ($52.2M) (-40.7%); Net Loss: ($57.9M) (-34.0%); Loss Per Share: ($2.94) (+1.0%); Quick Assets: $145.7M (+176.5%).
    • No guidance given.
    | Tue, Mar. 8, 10:14 AM
  • Tue, Mar. 8, 6:07 AM
    • Egalet (NASDAQ:EGLT): Q4 EPS of -$0.28 beats by $0.63.
    • Revenue of $19.38M vs. $0.83M in 4Q14 beats by $16.58M.
    | Tue, Mar. 8, 6:07 AM
  • Mon, Feb. 29, 9:48 AM
    • The FDA accepts for review Egalet's (EGLT -2.6%) New Drug Application (NDA) seeking clearance of ARYMO ER (morphine sulfate) for the management of severe pain. The PDUFA date is October 14. An advisory committee meeting will be held beforehand.
    • ARYMO ER incorporates the company's abuse-deterrent Guardian technology, which utilizes a plastic injection molding process to make the tablets extremely hard, difficult to chew, resistant to particle size reduction and inhibits attempts to chemically extract the active pharmaceutical ingredient. In addition, when exposed to a liquid, the tablet forms a viscous hydrogel which makes it difficult to draw into a syringe.
    • Previously: Egalet submits NDA for abuse-deterrent long-acting opioid (Dec. 15, 2015)
    | Mon, Feb. 29, 9:48 AM
  • Mon, Feb. 8, 1:06 PM
    • Egalet (EGLT -3.9%) inks a collaboration deal with privately held Septodont to promote SPRIX (ketorolac tromethamine) Nasal Spray exclusively to U.S. dentists.
    • Under the terms of the agreement, Egalet will receive an upfront license fee, sales-based milestones and a share of the profits. Specific financial details are not disclosed.
    • SPRIX in a non-steroidal anti-inflammatory (NSAID) drug for the short-term (up to five days) management of moderate-to-severe pain severe enough to require an opioid-level analgesic.
    | Mon, Feb. 8, 1:06 PM | 1 Comment
  • Dec. 17, 2015, 12:00 PM
    • Egalet (EGLT +0.5%) will be added to the Nasdaq Biotechnology Index effective at the open on December 21.
    • The index is calculated under a modified capitalization-weighted scheme and re-ranked once per year.
    | Dec. 17, 2015, 12:00 PM
  • Dec. 15, 2015, 8:14 AM
    • Egalet (NASDAQ:EGLT) submits a New Drug Application (NDA) to the FDA seeking clearance for ARYMO ER (morphine sulfate) extended-release tablets for the management of pain severe enough to require daily, around-the-clock opioid treatment.
    • The data supporting the filing is based on pharmacokinetic studies that showed the bioequivalence of ARYMO ER 15 mg, 30 mg and 60 mg to equivalent doses of MS Contin (morphine sulfate controlled-release). The submission also includes a range of abuse-deterrent studies to support labeling claims against abuse by intravenous injection, snorting or chewing.
    • ARYMO ER incorporates the company's abuse-deterrent Guardian technology, which utilizes a plastic injection molding process to make the tablets extremely hard, difficult to chew, resistant to particle size reduction and inhibits attempts to chemically extract the active pharmaceutical ingredient. In addition, when exposed to a liquid, the tablet forms a viscous hydrogel which makes it difficult to draw into a syringe.
    | Dec. 15, 2015, 8:14 AM
  • Dec. 14, 2015, 8:49 AM
    • Egalet (NASDAQ:EGLT) grants exclusive marketing and commercialization rights for SPRIX (ketorolac tromethamine) Nasal Spray to Teva Pharmaceutical Industries (NYSE:TEVA) for the territory of Israel, Gaza and the West Bank. Under the terms of the agreement, Egalet will receive an undisclosed upfront payment, sales-based milestones and a portion of the profits.
    • SPRIX Nasal Spray is a non-steroidal anti-inflammatory drug indicated for the short term (up to five days) management of moderate-to-severe pain in adult patients.
    | Dec. 14, 2015, 8:49 AM
  • Dec. 3, 2015, 7:29 PM
    • Specialty pharmaceutical firm Egalet (EGLT -2.6%) says it's terminating a collaboration with Shionogi Limited (OTCPK:SGIOY) around an abuse-deterrent, extended-release hydrocodone candidate.
    • The move ends a two-year relationship and means Egalet gains worldwide rights to the Phase 1 product candidate.
    • The deal had means upfront and milestone payments totaling $20M and an investment of $15M in its stock connected to its 2014 IPO. Egalet says it terminated the deal "with the change in [Shinogi's] internal priorities."
    | Dec. 3, 2015, 7:29 PM