Tue, Feb. 17, 8:40 AM
- The FDA accepts for review the New Drug Application (NDA) from privately-held Canton, MA-based Collegium Pharmaceuticals for Xtampza ER, its abuse-deterrent extended-release oxycodone formulation for the treatment of chronic pain.
- Its abuse-deterrent technology is called DETERx, which preserves the extended-release properties following common methods of tampering. It also avoids the use of antagonists (Pfizer's (NYSE:PFE) ALO-02 and Embeda) and aversive agents (Acura's (NASDAQ:ACUR) AVERSION), thereby minimizing the risks to legitimate patients.
- Related tickers: (NASDAQ:ZGNX) (NYSE:MNK) (NYSE:ACT) (NYSE:TEVA) (NYSE:ABBV) (NYSE:LCI) (NASDAQ:ALKS) (NASDAQ:EGLT)
Fri, Feb. 13, 11:22 AM
- The FDA accepts for review Pfizer's (PFE -0.1%) New Drug Application (NDA) for ALO-02 (oxycodone hydrochloride and naltrexone hydrochloride) extended-release capsules for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
- ALO-02 incorporates abuse-deterrent technology. The capsules contain pellets consisting of the opioid, oxycodone, surrounding sequestered naltrexone hydrochloride, an opioid receptor antagonist. When used as directed, patients receive oxycodone in an extended release manner with no effect from the naltrexone. If the pellets are crushed in an attempt to misuse or abuse ALO-02, naltrexone is released, counteracting the effects of oxycodone.
- Related tickers: (ZGNX +1.8%)(MNK +1.8%)(ACT +1.1%)(TEVA -0.6%)(ABBV +1%)(LCI -1%)(ALKS -3.7%)
Wed, Feb. 11, 3:42 PM
- Anika Therapeutics (ANIK +0.9%) files a premarket approval application (PMA) with the FDA and an application seeking CE Mark clearance in the E.U. for approval to commercialize Cingal (sodium hyaluronate with triamcinolone hexatonide) for the single-injection treatment of osteoarthritis of the knee. The product utilizes the same hyaluronic acid as Monovisc plus a commonly used steroid.
- Related tickers: (FLXN -0.4%)(HZNP +0.8%)(OTCPK:NRIFF +4.6%)(AMPE +6.7%)(MNK -1.3%)(XENE -0.9%) (NASDAQ:CBYL)
Mon, Feb. 9, 12:21 PM
- The following are healthcare companies whose after-tax margins have expanded the past three quarters and trade at least 500K shares per day:
- (ACOR -0.7%)(BCR -1.5%)(BIIB -0.2%)(CAH -1.2%)(CPHD +1.3%)(EVHC -1.6%)(ILMN +0.7%)(JAZZ -1.7%)(LCI +7.3%)(MNK -0.5%)(SHPG -2.9%)(SYK -0.2%)(TMO -0.7%)(UTHR +1.4%)(VRX).
- This is not a list of "Buy" recommendations, but rather a targeted list of firms that may be suitable for more in-depth research.
Wed, Feb. 4, 1:13 PM
- Yesterday's earnings announcement from Mallinckrodt (MNK +1.6%) reinforced bullish calls from several analysts.
- Piper Jaffray's team has a price target of $114 supported by targets for revenues of $3.7B and EPS of $7.01 after the company beat their fiscal Q1 earnings target of $1.51 with $1.84, although revenues came in slightly below expectations ($866M vs. $890M). They project Acthar revenues of $1.165B.
- Oppenheimer's team has a price target of $122 based on EPS of $7.21 on revenues of $3.6B, including $1.146B for Acthar.
- The company's current 2015 guidance is EPS of $6.70 - 7.20 on revenues of $3.65B - 3.75B, including $2.87B - 2.93B for Specialty Pharmaceuticals and $760M - 800M for Global Medical Imaging.
- MNK has given longs plenty of reasons to love it. Shares have climbed 125% since the $48 breakout 15 months ago.
- Previously: Mallinckrodt ups revenues 60% in FQ1 (Feb. 3)
Wed, Feb. 4, 10:34 AM
- In Mallinckrodt's (MNK +1.7%) 10-Q filed yesterday, under the section "Governmental Proceedings" (page 21), the company discloses that it received a Civil Investigative Demand (CID) in late November from the Medicaid Fraud Division of the Texas Attorney General's Office. The AD is investigating potential false reporting by the company regarding the prices of certain of its drugs used by Texas Medicaid to establish reimbursement rates for pharmacies dispensing the company's drugs to Texas Medicaid patients. The company is in the process of responding to the CID and intends to cooperate fully.
Tue, Feb. 3, 9:25 AM
- Mallinckrodt (MNK +0.7%) FQ1 results: Revenues: $866.3M (+60.4%), Specialty Brands: $373.6M (+526.8%), Specialty Generics: $284.2M (+13.7%), Global Medical Imaging: $199.3M (-8.8%), Other: $9.2M (-24.0%); COGS: $427.6M (+50.2%); R&D Expense: $42.4M (+8.7%); SG&A: $262.5M (+79.5%); Operating Income: $127.4M (+74.3%); Net Income: $92.1M (+98.5%); EPS: $0.78 (-1.3%); Quick Assets: $899M (+27.0%); CF Ops: $216.8M (+881.0%).
- No guidance given.
Tue, Feb. 3, 7:03 AM
Mon, Feb. 2, 5:30 PM
Mon, Feb. 2, 4:27 PM
- The first patient has been dosed in a 450-patient Phase 3 clinical trial assessing Flexion Therapeutics' (NASDAQ:FLXN) lead product candidate, FX006, for the treatment of moderate-to-severe pain associated with osteoarthritis of the knee.
- FX006 is a novel, non-opioid, sustained release, intra-articular formulation of triamcinolone acetonide. The company expects top line data in 2016.
- The FDA lifted its clinical hold on the company's Phase 2b trial in early December after it concluded its investigation of a case of septic shock in one patient.
- Previously: Clinical hold lifted for Flexion's lead product (Dec. 1, 2014)
- OA-related tickers: (NASDAQ:HZNP) (OTCPK:NRIFF) (NASDAQ:XENE) (NYSEMKT:AMPE) (NASDAQ:ANIK) (NYSE:MNK) (NASDAQ:CBYL)
Sat, Jan. 31, 12:35 PM
- The FDA approves Zogenix's (NASDAQ:ZGNX) Zohydro ER (hydrocodone bitartrate) Extended-Release Capsules, CII, with BeadTek, a formulation technology that provides abuse-deterrent features without changing the release properties of hydrocodone.
- BeadTek incorporates pharmaceutical excipients that immediately form a viscous gel when crushed and dissolved in liquids or solvents.
- The company intends to transition all Zohydro strengths to the BeadTek version in Q2. In H2, it expects to submit the results from its ongoing Human Abuse Liability Studies, which will further characterized the abuse-deterrent properties of the BeadTek formulation, to the FDA.
- Related tickers: (NYSE:MNK) (NYSE:ACT) (NYSE:TEVA) (NYSE:ABBV) (NYSE:LCI) (NASDAQ:ALKS) (NYSE:PFE)
Tue, Jan. 27, 1:13 PM
- Palo Alto, CA-based Carbylan Therapeutics (Pending:CBYL) is set for its IPO of 5.8M shares of common stock at $12 - 14. Underwriters over-allotment is an additional 870K shares.
- The clinical stage specialty pharmaceutical firm develops novel and combination therapies that address significant unmet medical needs. The technological basis for its products is a methodology that cross-links hyaluronic acid to form hydrogels. Alterations in the formula enable the formation of hydrogels in a wide range of textures, from soft to hard. Biologically-active agents can be directly incorporated into the gels, which can be applied topically or parenterally.
- Its lead product candidate is Hydros-TA, currently in Phase 3 development, an injectable therapy to treat the pain associated with osteoarthritis of the knee. The company expects to submit a New Drug Application (NDA) to the FDA for this indication in early 2017.
- Net losses for 2014 (9 mo.) and 2013 were $8.6M and $5.7M, respectively.
- OA-related tickers: (NASDAQ:HZNP) (OTCPK:NRIFF) (NASDAQ:XENE) (NYSEMKT:AMPE) (NASDAQ:FLXN) (NASDAQ:ANIK) (NYSE:MNK)
Fri, Jan. 23, 1:42 PM
- The Board of Directors of Mallinckrodt (MNK +1.5%) approves an open-ended $300M share repurchase program.
- CEO Mark Trudeau says, "Funding additional initiatives and seeking attractive business development opportunities remain top priorities as we continue to pursue a range of focused growth strategies. This authorization reflects our strong financial position and commitment to a disciplined capital allocation strategy while reaffirming our confidence in the company's outlook and long-term potential. It also gives us the flexibility to execute share repurchases in a measured and opportunistic manner over time."
Dec. 25, 2014, 12:41 PM
- Endo International plc (NASDAQ:ENDP) subsidiary Endo Pharmaceuticals and BioDelivery Sciences (NASDAQ:BDSI) submit a New Drug Application (NDA) to the FDA for Buprenorphine HCl Buccal Film for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
- The product uses BioDelivery's BioErodible MucoAdhesive (BEMA) technology to deliver buprenorphine across the buccal mucosa (inside lining of the cheek) via a thin film that adheres to the cheek lining in less than five seconds and then completely dissolves.
- Buprenorphine is a partial mu-opioid receptor agonist and a kappa antagonist which is different than full mu-opioid agonists like morphine. It is a Schedule III controlled substance which has a lower abuse potential than Schedule II drugs.
- Opioid-related tickers: (NASDAQ:ZGNX) (NYSE:PFE) (NASDAQ:EGLT) (NASDAQ:ACUR) (NYSE:MNK) (NYSE:ABBV) (NYSE:TEVA) (NASDAQ:ALKS)
Nov. 20, 2014, 1:36 PM
- The FDA approves Purdue Pharma's Hysingla ER (hydrocodone bitartrate) for pain severe enough to require daily, around-the-clock, long-term opioid treatment for which alternative treatment options are inadequate.
- Hysingla ER incorporates abuse-deterrent properties that make the tablet difficult to crush, break or dissolve and it forms a viscous hydrogel that makes it difficult to prepare for injection.
- The agency is requiring postmarketing studies of Hysingla ER to assess the effects of its abuse-deterrent properties on the risk of abuse and the consequences of that abuse in the community. Purdue is also required to make educational programs available to healthcare professionals on now to safely prescribe ER/LA opioid analgesics in addition to medication guides and patient counseling documents.
- Opioid-related tickers: (ZGNX -0.8%)(PFE +0.2%)(EGLT +4.5%)(ACUR)(MNK +0.9%)(ABBV)(TEVA -0.1%)(ALKS +1.5%)
Nov. 19, 2014, 9:09 AM
- Mallinckrodt (MNK +0.4%) FQ4 results: Revenues: $789.3M (+44.8%); Specialty Pharmaceuticals revenue: $564.8M (+85.5%); Global Medical Imaging revenue: $213.4M (-6.8%); COGS: $388.7M (+32.6%); R&D Expense: $43.8M (+1.2%); SG&A: $280.5M (+107.0%); Operating Loss: ($356.5M) (-747.0%); Net Loss: ($352.4M) (-999%); Loss Per Share: ($4.14) (-813.8%).
- FY2014 results: Revenues: $2,540.4M (+15.2%); Specialty Pharmaceuticals revenue: $1,612.9M (+32.5%); Global Medical Imaging revenue: $881.5M (-5.8%); COGS: $1,337.3M (+13.4%); R&D Expense: $166.9M (+0.7%); SG&A: $842.1M (+38.1%); Operating Loss: ($284.1M) (-296.2%); Net Loss: ($319.3M) (-643.0%); Loss Per Share: ($4.92) (-582.4%); Quick Assets: $707.8M (+156.9%); CF Ops: $373.5M (+174.8%).
- No guidance given.
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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