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, Apr. 17, 5:36 PM
Thu, Mar. 5, 7:32 AM
- Mallinckrodt (NYSE:MNK) enters into a definitive agreement to acquire privately-held Ikaria for ~$2.3B. The takeover, expected to close by mid-year, will add $150M to Mallinckrodt's top line and at least $0.25 to EPS.
- The Hampton, NJ-based firm develops and commercializes therapies and delivery systems for the treatment of critically ill infants in the hospital neonatal intensive care unit setting. Its lead product is INOmax (inhaled nitric oxide), a vasodilator indicated, in conjunction with ventilatory support and other agents, for the treatment of term and near-term (>34 weeks) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension.
- The transaction will strengthen Mallinckrodt's footprint in hospitals by extending its presence into surgical specialties. It also builds potential diversity in its nephrology rare disease pipeline with terlipressin (injection), currently being investigated for the treatment of Hepato-Renal Syndrome Type 1 (HRS1) , a rare life-threatening condition with no currently available therapies. Terlipressin is approved and recognized as the standard-of-care treatment of HRS1 internationally, including several countries in Europe.
- Mallinckrodt will host a conference call this morning at 8:30 am ET to discuss the deal.
Nov. 13, 2014, 9:14 AM
- Mallinckrodt (NYSE:MNK) is down 8% premarket on average volume in response to the FDA's reclassification of its generic ADHD med.
- Previously: FDA downgrades classification of Mallinckrodt's ADHD med
Nov. 13, 2014, 9:10 AM
Sep. 25, 2014, 5:35 PM
Aug. 20, 2014, 5:35 PM
Aug. 7, 2014, 9:21 AM
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%)
May 8, 2014, 6:38 AM
Apr. 7, 2014, 12:45 PM
Apr. 7, 2014, 9:10 AM
Apr. 1, 2014, 5:38 PM
Feb. 28, 2014, 10:30 AM
- The FDA tells Bloomberg it's reviewing the lab tests of Questcor's (QCOR -8.8%) Acthar gel discussed by Citron Research in a 24-page report published yesterday. Citron claimed the tests showed almost no detectable amounts of the hormone ACTH, which Questcor has said it believes is the primary active ingredient within Acthar.
- Shares are now down 17% from Wednesday's close.
Feb. 27, 2014, 10:28 AM
- Though Questcor (QCOR -6.5%) claims the hormone corticotropin (ACTH) is "believed" to be the primary active ingredient in its Acthar gel, lab tests of at least two separate Acthar batches turned up "almost no detectable ACTH," says Citron Research in a new 24-page report (.pdf).
- Citron, which has published portions of the lab's findings (tests are ongoing), says the test results have been submitted to the FDA. The firm notes Questcor's manufacturing chief/CTO is being transitioned to a "non-executive advisory role," and that the company has been cryptic about Acthar's precise composition (referring to it as a "trade secret").
- The firm argues the findings put Acthar at risk of being pulled by the FDA. Shares are adding to the post-earnings losses they saw yesterday.
- Citron's prior Questcor commentary
Feb. 25, 2014, 4:28 PM
- 8.1K vials of Acthar shipped during quarter vs. 6.33K one year ago. For the full year, shipments of 28.1K vs. 20.7K in 2012.
- New paid prescriptions for Acthar of about 2.45K-2.5K up about 30% Y/Y. Rheumatology prescriptions now account for nearly 30% of Acthar business. In January, company began with a small pilot sales force to educate pulmonologists about Acthar in the treatment of respiratory manifestations of orphan disease symptomatic sarcoidosis.
- 960K shares repurchased during Q for average price of $55.26 each, a total of $53.1M. About 5.3M shares remain under existing authorization. End-of-year float of 62.3M shares.
- "Management is working closely with the Board's newly formed Strategic Advisory Committee to support the Company's investigation and evaluation of potential strategies to use its future potential cash flow to generate long-term growth and value for shareholders."
- CC at 4:30 ET
- Press release, Q4 results
- QCOR -3.4% AH
MNK vs. ETF Alternatives
Mallinckrodt PLC develops, manufactures, markets & distributes generic specialty pharmaceutical products, active pharmaceutical ingredients and diagnostic imaging agents. It operates in two segments; Specialty Pharmaceuticals & Global Medical Imaging.
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