Mon, Oct. 5, 5:15 PM
- Biopharma Mallinckrodt (NYSE:MNK), down 1.8% after hours, is planning a business and financial guidance update for tomorrow morning.
- The company will give recast historical info showing its reclassification of its contrast media and delivery systems (CMDS) business as discontinued operations after agreeing to sell it to Guerbet for $270M in July. That deal is set to close in fiscal Q1 2016.
- A conference call to discuss the guidance, featuring a Q&A session, is set for 7:30 a.m. ET tomorrow.
- Shares fell 6.8% during market hours today.
Tue, Sep. 22, 1:51 PM
- The market's down day notwithstanding, thinly traded small cap ANI Pharmaceuticals (ANIP -16.2%) gets no help from Leerink analyst Jason Gerberry. Based on discussions with ANI and Mallinckrodt (MNK -1.3%), he says ANI's Acthar-similar won't pose much of a competitive threat to the latter's brand. He says ANI told him that it plans to market its version with a small sales force and offer only a modest discount to Acthar.
- Mr. Gerberry also cites the uncertainty about whether ANI's offering will be cleared for the same indications as Acthar since the package insert for the NDAs it acquired from Merck is not publicly available and the company is not making the documents available to investors. He says more clarity of ANI's development pathway won't be coming until mid-2016, after its meeting with the FDA.
- Previously: ANI Pharma picks up two NDAs from Merck for $75M (Sept. 21)
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.
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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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