Tue, Jun. 16, 12:51 PM
Thu, May 21, 10:58 AM
- Thinly traded nano cap Intellipharmaceutics (IPCI +17.3%) heads north on a 10x surge in volume in response to its announcement that the FDA may not require a Phase 3 study for its abuse-deterrent opioid candidate, Rexista Oxycodone XR, if bioequivalence to Purdue Pharma's Oxycontin is demonstrated. The company believes that its previously completed Phase 1 trials fulfill this criterion.
- The firm intends to file its New Drug Application (NDA) within the next 6 - 12 months. Approval is not guaranteed, however. After reviewing the data, the FDA may still require further studies.
- Rexista Oxycodone XR's formulation deters abuse by instantaneously coagulating and entrapping the drug in a viscous hydrogel when pulverized and hydrated. It is also designed to prevent dose dumping if taken with alcohol.
- Related tickers: (PTIE -1.9%)(DRRX)(COLL +1.9%)(ZGNX)(MNK -0.3%)(ACT +1.1%)(TEVA +1.6%)(ABBV -0.7%)(LCI -0.7%)(ALKS -1%)(EGLT -0.1%)(PFE -0.2%)(ACUR -2.4%)
Fri, Jan. 23, 11:38 AM
- Thinly-traded nano cap Egalet (EGLT +32.7%) has jumped almost 60% since yesterday in response to its announcement of positive results from a Category 3 human abuse liability (HAL) study of Egalet-001 (abuse deterrent extended release oral morphine). The study showed that the abuse potential of Egalet-101 taken orally was significantly lower than that for manipulated MS Contin (morphine sulfate controlled-release).
- Egalet-001's abuse deterrent characteristics are based on the company's Guardian technology which makes the pill extremely hard, difficult to chew and resists common methods of physical and chemical manipulation. For example, it turns to gel when exposed to water.
- The company will disclose the results from additional abuse-deterrent studies later this year.
- Related tickers: (ZGNX +2.3%)(ACUR -1.6%)(ALKS +0.4%)
Fri, Jan. 16, 5:36 PM
Jul. 18, 2014, 5:37 PM
Jul. 8, 2014, 3:59 PM
- Shares of Zogenix (ZGNX -12.9%) tumble today on more than a 2x surge in volume in response to the competitive threat from Purdue. The FDA granted its tamper-resistant hydrocodone product Priority Review which means that it could debut in the U.S. by the end of 2014.
- Zogenix is working on its own abuse deterrent version of Zohydro. It plans to submit an sNDA in October. The time frame for regulatory review may delay its U.S. launch until the mid-2015, however.
- Related tickers: (ABBV -3%) (TEVA -1.7%) (ALKS -2.4%) (MNK -2.2%) (PFE -1.1%)
Apr. 8, 2014, 9:16 AM
Oct. 17, 2013, 9:47 AM
- Citi is out reiterating a Buy on Alkermes (ALKS +2.6%).
- Analyst Jonathan Eckard raises his price target to $43 (from $38) representing a 32% upside from Wednesday's close.
- Eckard cites "increased estimates for late-stage programs, introduction of estimates for earlier stage programs, and a lower outyear tax rate."
- Pipeline is here
Oct. 10, 2013, 2:29 PM
- Alkermes (ALKS +3.8%) powers higher after the biotech company's investigational treatment for major depressive disorder received fast-track designation from the FDA.
- The ALKS-5461 once daily treatment is earmarked for use for hard-to-treat cases.
- Chief Medical Officer Elliot Ehrich says the FDA's move "supports our position that there is a clear and compelling need for a novel mechanism for the treatment of depression."
Aug. 5, 2013, 1:00 PM
- Perrigo's (PRGO) recent deal for Elan has investors all jazzed up about Irish-domiciled healthcare companies.
- The allure of a 12.5% corporate tax rate could mean more M&A activity in the not-so-distant future for "anything with an Irish corporate tax structure," one analyst tells Bloomberg.
- Some of the names being tossed about: Jazz Pharmaceuticals (JAZZ +3.2%) and Alkermes (ALKS +3.8%).
Jul. 25, 2013, 12:25 PMMore on Alkermes (ALKS +5.6%) Q2: Shares rise as results comfortably beat estimates. Revenues from ALKS' "five key products" increase 22% Y/Y. Risperdal, Consta, Invega Sustenna/ Xeplion manufacturing and royalty revenues rise 16% Y/Y. Ampyra/ Fampyra manufacturing and royalty revenues jump 16% from Q2 2012. Vivitrol net sales are up 40%. (PR) | Jul. 25, 2013, 12:25 PM | Comment!
Jul. 17, 2013, 2:49 PM
Apr. 26, 2013, 10:47 AMAnalysts continue to sound a cautious tone regarding Alkermes' (ALKS -2.1%) MDD drug candidate ALKS5461 after positive Phase II trial data generated quite a buzz last week. "We appreciate the significant market opportunity for this drug [but] challenges could lie ahead for this product," notes BofA analyst Steve Byrne who downgrades the stock to Underperform (price target raised to $29). "We value 5461 at $2.50 per share," he adds. Both Lazard and Mizuho also seem tentative on the stock (I, II). | Apr. 26, 2013, 10:47 AM | Comment!
Apr. 17, 2013, 12:59 PM
Apr. 17, 2013, 9:12 AM
Feb. 1, 2013, 9:10 AM
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Alkermes PLC is a biotechnology company. It is engaged in developing, manufacturing and commercializing medicines designed to yield therapeutic outcomes and improve the lives of patients with serious diseases.
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