cardiovascular

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Allium Medical Solutions

Fast-growing innovative products player

Initiation | Pharmaceutical & healthcare | 02 Nov 2016

Allium Medical Solutions boasts a portfolio of products in diverse clinical areas such as urology and cardiovascular, with the majority of revenues derived from urology stents. Having achieved revenue CAGR of 19% in 2011-15, we expect Allium's growth to accelerate in the medium term, driven by new markets, resulting in 2015-20e revenue CAGR of 41%. We initiate coverage of Allium with a DCF valuation of NIS1.95-2.08/share.

Mesoblast

Teva returns rights to cardiovascular programme

Outlook | Pharmaceutical & healthcare | 08 Jul 2016

Teva has relinquished all rights to cardiovascular applications of Mesoblast's mesenchymal precursor cell (MPC) technology, as it focuses on its core CNS and respiratory interests. Mesoblast will seek a new partner with a cardiovascular focus at the appropriate time. It has entered an A$120m (~US$90m) equity finance facility with Kentgrove Capital to fund the ongoing Phase III CHF trial and a 600-patient confirmatory trial (estimated cost ~US$90m), and has brought forward the interim futility analysis to Q117. We have revised our development timelines and lower our valuation to A$1.8bn from A$2.8bn (A$4.67 from A$7.36 per share).

Capstone Therapeutics

First human lipid biomarker trends

QuickView | Pharmaceutical & healthcare | 15 Sep 2014

Early data in healthy volunteers have demonstrated trends in favour of AEM-28 on a number of lipid biomarkers, even at low doses. These are the first-in-man data, which hint at potential future efficacy. AEM-28 continues to be investigated in a Phase Ib/IIa trial, with data anticipated by YE14/Q115. These could pave the way for future development in an orphan cardiovascular indication, although additional funds will likely be needed if data are positive.

Capstone Therapeutics

A new class of cardiovascular drug

QuickView | Pharmaceutical & healthcare | 15 Jul 2014

First clinical data for AEM-28, an Apo-E mimetic, is expected during H214, which could pave the way for continued development in an orphan cardiovascular (CV) indication, although additional funds will likely be needed if data are positive. Preclinical data suggest AEM-28 can lower cholesterol and protect the artery wall; this profile could have utility in broader CV indications, although development is still at an early stage.

Mesoblast

Little margin for risk

QuickView | Pharmaceutical & healthcare | 22 Mar 2013

Mesoblast is an ASX-listed biotechnology company with a large R&D pipeline built on a proprietary stem cell technology. Mesoblast is developing allogenic cell therapies based on mesenchymal precursor cells in the areas of cardiovascular disease, diabetes, oncology, eye disease and orthopaedic diseases

Nektar Therapeutics

Fear of the unknown

QuickView | Pharmaceutical & healthcare | 08 Feb 2013

Nektar's pipeline features several late-stage assets. Naloxegol for opioid-induced constipation (OIC) currently gets the most attention. Positive Phase III data are already in hand, but long-term cardiovascular (CV) safety concerns persist. Given recent FDA precedence, a long-term CV outcomes study may be required, which by itself should make investors cautious on the stock at these levels.

Orexigen Therapeutics

Investment summary: LIGHT ahead

QuickView | Pharmaceutical & healthcare | 21 Dec 2012

With the screening completed of 13,192 patients for the cardiovascular outcome trial (CVOT), LIGHT, Orexigen is on track to enrol c 10,400 and randomise c 9,000 patients by 1 January and 15 January 2013 respectively. An interim analysis of the trial could occur in between Q2-Q413, making the data available for FDA two to three months thereafter. We believe the LIGHT study has a high probability of generating positive outcome and ultimately leading to an approval in the US.

Sucampo Pharmaceuticals

Easing the strain in 2013

Update | Pharmaceutical & healthcare | 17 Dec 2012

Sucampo is entering a pivotal year in 2013 on the commercial development, alone and through partnerships, of its prostone-based products. Potential FDA approval of Amitiza (lubiprostone) in April 2013 for opioid-induced constipation (OIC) is a significant opportunity, particularly in light of FDA concerns over the cardiovascular safety of mu-opioid antagonists, the main competitive threat in OIC. Amitiza's established safety record is a key differentiating factor for the drug, boosted by the deletion of a pregnancy warning in its label, which also removes a barrier to use. Meanwhile Sucampo plans to commercialise glaucoma drug Rescula (unoprostone) itself in the US, to be launched in Q113 following recent FDA approval of its sNDA.

Resverlogix

A BET on ApoA-I

QuickView | Pharmaceutical & healthcare | 11 Dec 2012

Resverlogix offers investors a potentially geared return based on the outcome o due in Q2 next year o of its ASSURE Phase IIb trial of RVX-208. This study is designed to show regression of atherosclerosis in high-risk cardiovascular disease (CVD), a US$90bn global market. The study result represents a catalyst, magnified by the fact Resverlogix's valuation has recovered little since the steep fall in 2010 on the narrow miss on significance in the ASSERT Phase II trial for the same indication. Edison will take up formal coverage of Resverlogix in 2013.

Amarin

Waiting for the FDA

QuickView | Pharmaceutical & healthcare | 21 Nov 2012

Amarin's potential blockbuster Vascepa (icosapent ethyl) is ostensibly due to be launched into the large US cardiovascular market in Q113, although how this will be achieved remains unresolved. Uncertainty over Vascepa's market exclusivity and commercial strategy has weighed on the shares (-30%) since FDA approval in July 2012. Amarin is considering a trade sale, securing a partner or going it alone as the commercial option for Vascepa. The imminent FDA decision (expected in Dec 12) on Vascepa's NCE status is a major potential catalyst and could set the shares on a new trajectory, although multiple FDA delays to this verdict do not bode well.

LeMaitre Vascular

Waiting for an inflection

QuickView | Pharmaceutical & healthcare | 10 Oct 2012

Maitre is a leader in niche markets serving cardiovascular surgeons and has recovered well after a disastrous foray into non-core areas several years ago. Underlying sales (ex-stent grafts) have provided steady 8-9% revenue growth, but with the overall market for its products now growing 2-5%, it is unclear whether the growth rate is sustainable. New bolt-on acquisitions similar to the XenoSure biocompatible patch (c 60% sales growth a year) could help renew investor interest.

Vivus

Momentous, but...

QuickView | Pharmaceutical & healthcare | 23 Feb 2012

Yesterday's advisory committee's surprisingly strong endorsement of Vivus's Qnexa suggests the imminent US approval of the first obesity drug since Roche's Xenical 13 years ago. Even with controlled distribution and other restrictions Qnexa should eventually generate blockbuster sales. But the key uncertainty remains the need for a cardiovascular outcomes study o which the panel seemed comfortable with as a post-approval commitment o and the shares already price in success.