Wed, Mar. 11, 10:01 AM
- Based on feedback from the FDA, Egalet (EGLT) now plans to submit a New Drug Application (NDA) for its abuse-deterrent, extended-release oral morphine product, Egalet-001, by the end of the year.
- The company will initiate a pivotal bioequivalence study comparing the 60 mg dose to Purdue's MS Contin later this month. Bioequivalence to MS Contin has already been demonstrated at the 15 mg and 30 mg doses.
- Egalet-001 incorporates the company's Guardian Technology to deter abuse. It utilizes injection molding to create a hard matrix and shell that is designed to be difficult to crush, grind, chew or dissolve. It also turns to gel when exposed to water.
- Related tickers: (ZGNX -23.4%)(ACUR)(ALKS +0.5%)(PFE +0.6%)(ABBV +0.7%)(LCI +1.6%)(ACT +1.7%)(MNK +1.6%)(TEVA +2.6%)
Tue, Mar. 10, 8:01 AM
- Privately-held Collegium Pharmaceutical raises $50M from institutional investors to fund the advancement of its abuse-deterrent product candidate, Xtampa ER (oxycodone extended-release capsules) through FDA clearance and commercial launch as well as fund operational growth and other pipeline programs.
- The FDA accepted the company's New Drug Application (NDA) for Xtampa ER in February. Its abuse-deterrent technology is called DETERx, which combines oxycodone with fatty acid and waxes to form small spherical beads which resist particle size reduction and dose dumping when subjected to breaking, crushing, chewing and dissolving.
- Previously: FDA accepts Collegium's NDA for abuse-deterrent opioid (Feb. 17)
- Related tickers: (NASDAQ:ZGNX) (NYSE:MNK) (NYSE:ACT) (NYSE:TEVA) (NYSE:ABBV) (NYSE:LCI) (NASDAQ:ALKS) (NASDAQ:EGLT) (NYSE:PFE) (NASDAQ:ACUR)
Thu, Mar. 5, 1:23 PM
- Analysts at Deutsche Bank and Oppenheimer both like the strategic fit of Ikaria with Manllinckrodt's (MNK +4.8%) blended business.
- Deutsche maintains its "Buy" recommendations and raises its 2015 EPS estimate to $7.74 from $7.46 and price target to $130 (+7.4% upside) based on a P/E of 15.7.
- Oppenheimer maintains its "Outperform" rating and raises its price target to $140 based on a P/E of 16.1.
- Previously: Mallinckrodt buys critical care firm for $2.3B (March 5)
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.
Wed, Feb. 25, 9:42 AM
- The FDA accepts for review the New Drug Application (NDA) from Teva Pharmaceutical Industries (TEVA -0.6%) for CEP-33237, its hydrocodone bitartrate extended release tablets for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment.
- The product is formulated with its proprietary abuse-deterrent technology, although it does not specify the nature of the technology or how it works. In an oral human abuse liability study (HAL) in nondependent recreational opioid users, the abuse potential of finely crushed CEP-33237 powder was significantly lower based on peak at-the-moment drug liking. An intranasal HAL study produced the same result.
- Related tickers: (ZGNX -0.6%)(EGLT)(OTCQB:ELTP)(PFE -0.7%)(ACUR)(MNK -0.6%)(ACT +0.7%)(ABBV -0.6%)(LCI +1%)(ALKS -1.7%)
Tue, Feb. 17, 10:06 PM
- Elite Pharmaceuticals (OTCQB:ELTP) plans to commence a Phase 3 study in late March evaluating its abuse-deterrent opioid product candidate, ELI-200. The company has submitted a study protocol to the FDA and expects to receive its comments by mid-March. Patient dosing should start shortly thereafter.
- The multi-center, randomized, double-blind, placebo-controlled, parallel group clinical trial will assess the safety and efficacy of abuse-deterrent ELI-200 for the treatment of adult patients with moderate-to-severe pain following surgery. The study will enroll ~150 patients and will take ~eight weeks to complete.
- Elite projects submitting a New Drug Application (NDA) in Q3 and achieving regulatory clearance by early 2016.
- The company's abuse-deterrent technology is a multi-particulate capsule that contains an opioid agonist in addition to the opioid antagonist, naltrexone. If the multi-particulate beads are crushed or dissolved, the naltrexone is released which blocks the effects of the opioid. The technology is the firm's top priority, expected to add considerably to its modest revenues to date. Fiscal Q3's top line was only $1.4M.
- Related tickers: (NYSE:PFE) (NASDAQ:ACUR) (NASDAQ:ZGNX) (NYSE:MNK) (NYSE:ACT) (NYSE:TEVA) (NYSE:ABBV) (NYSE:LCI) (NASDAQ:ALKS) (NASDAQ:EGLT)
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)
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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