Horizon Pharma (NASDAQ: HZNP) currently has 2 FDA approved products, one of which is also approved in select EU countries. I view this company as significantly overvalued given their products have no data suggestion superiority claims over cheap generics. Products Duexis is a combination of ibuprofen 800 mg and famotidine 26.6 mg, indicated for rheumatoid […]
CRTX – Analysis on Cornerstone Therapeutics
Cornerstone Therapeutics (NASDAQ:CRTX) recently caught our attention following the announcement of an FDA Cardiovascular and Renal Drugs Advisory Committee (CRDAC) to review their NDA for lixivaptan (CRTX 080) for the proposed indication of the treatment of symptomatic hypervolemic and euvolemic hyponatremia associated with heart failure and syndrome of inappropriate antidiuretic hormone (SIADH), respectively. The meeting […]
ALNY ISIS – Updates from the JMP Healthcare Conference
If you aren’t a long-time BiotechDueDiligence blog reader or Chimera Research Group subscriber, you may wonder what one of our updates from biotech investor conferences and quarterly earnings conference calls looks like. These reports are not a detailed thesis about the company, nor do they purport to summarize everything the company said on the webcast. […]
VVUS – PDUFA approaching, company revving Branding & Marketing
Vivus’s (VVUS), a specialty pharmaceutical company, had faced many setbacks with it’s drug candidate, Qnexa, an investigational treatment for obesity, obstructive sleep apnea and diabetes. In October 2010, Vivus received a Complete Response Letter from the FDA. In March of 2011, several studies were published demonstrating teratogenicity with one of Qnexa’s main ingredients, topiramate. Despite […]
CELG ONXX – Lessons in humility courtesy of Celgene and Onyx
First, Onyx Pharmaceuticals (NASDAQ:ONXX) received an unanimous recommendation for approval of Kyprolis™ (proposed brand name for carfilzomib) by the FDA’s Oncologic Drugs Advisory Committee (ODAC) by a vote of 11-0 [with 1 abstention]. This indication will be for patients with relapsed and refractory multiple myeloma who have received at least 2 prior lines of therapy […]
A Deliberate Walk Down Wall Street – Opinion
The Random Walk Hypothesis first emerged in the 1800s and was popularized in 1973 by Burton Malkiel in his book titled, “A Random Walk Down Wall Street”. This theory asserts that stock prices move randomly and can not be predicted by market participants; any observed cycles are purely due to chance. It is closely linked […]
ASCO 2012 presentations on my schedule
With the 2012 Annual Meeting of the American Society of Clinical Oncology(ASCO 2012) set to kickoff on Friday, June 1st (thru the 5th), I thought I would share my list of must-see presentations(the bolded ones with links). Abstracts for all others can be found here[link]. There are so many presentations but so little time, it […]
Heat Shock Protein 90 (HSP90) inhibitors: Back in the spotlight – Part 1
Heat Shock Protein 90 (HSP90) was originally proposed as a cancer drug target in the 1990s, though no drug in this class have ever successfully completed a randomized clinical trial, let alone achieve regulatory approval. Despite repeated setbacks, HSP90 inhibitors are poised to find a significant niche in the evolving cancer treatment landscape. We will […]
AMRN – Update on Amarin’s AMR101 as PDUFA date draws closer
Amarin Corp (NASDAQ: AMRN) released first quarter 2012 financial results and held a conference call on May 8, 2012. It is often hard to distinguish the signal from the noise when it comes to chatter about AMRN on Twitter and other venues, so we will try to objectively update where things stand as the July […]
VRTX – Vertex Sweat Chloride to FEV1 Correlation in Cystic Fibrosis
Vertex released interim data May 7th of an ongoing combination study of VX-809 and KALYDECO in Cystic Fibrosis patients with two copies of the F508del mutation. Results were very good- VX809 plus Kalydeco led to significant improvements in lung function (as measured by absolute change in percent predicted FEV1). Treatment Group Absolute Improvement from Baseline in Lung Function (FEV1) […]
IDIX – Interview With CEO Ron Renaud
Idenix CEO Ron Renaud Q&A April 11, 2012 Idenix has been the subject of considerable attention with EASL (The European Association for the Study of the Liver) approaching and embargoed abstracts flying around the web. The company’s shares have been battered, dropping nearly 50% from January highs as questions have arisen over the potency of […]
VVUS, OREX, ARNA – Understanding the Advisory Committee
Playing VVUS, OREX, ARNA through FDA Adcomm and Qnexa PDUFA Over the past several months, these three companies, with their respective late-stage anti-obesity drug candidates, have experienced a considerable increase in volatility and share price, due in part to new regulatory revelations regarding clinical pathways to regulatory approval. We believe there will continued volatility leading […]
Galapagos JAK1 Inhibitor Is One To Contend With
Galapagos’ JAK1 Inhibitor Is One To Contend With Just today, Galapagos announced a major partnership with Abbott to develop its JAK1 specific inhibitor for the treatment of rheumatoid arthritis. This Belgium based biotech snagged a lucrative deal with $150 million in upfront payments. Upon the completion of Phase II studies, Abbott has the option to […]
DEPO – Quick Update – Paragraph IV – DM1992 Phase 2
Depomed released a statement that Actavis Group, a generic drug manufacturer filed a paragraph IV challenge against Gralise, Depomed’s once-daily gabapentin formulation. NEUTRAL on Paragraph IV We view this event as having no net impact. Patent challenges are not unexpected in this pharmaceutical environment, especially in the drug delivery space. The current generic drug legislation rewards early […]
INCY – Initiate Coverage on Incyte
Incyte Pharmaceuticals (INCY) Initiating Coverage: Incyte Pharmaceuticals is a small biotech company focused on developing treatments for cancer and inflammatory disorders. Lead compound Ruxolitinib (INCB18424) is awaiting FDA approval for the treatment of Myelofibrosis (MF) with an expected decision date on December 3rd. Ruxolitinib is also recruiting patients in a global Phase III study for […]
