The main disease the program aims to treat is Amyotrophic Lateral Sclerosis (ALS). Despite being tested in other muscle wasting and debilitating diseases such as myasthenia gravis and claudication, we consider that the main value generator at present for the company’s skeletal program rests on the ALS indication. This is an unpartnered program that features […]
INCY – Q2 Earnings Call
For the first time since the launch of recently approved myelofibrosis drug Jakafi, Incyte provided revenue guidance for the year – and investors were disappointed. Overview: While Q2 product sales were slightly above expectations at $32.7 million, projected 2012 revenue of between $120 and $135 million were below some analyst estimates of as high as […]
ONCY – Phase III Trade Strategy
Some comments from Patrick on this name: When to expect the data: Oncolytics Biotech is running a two-stage Phase III clinical trial examining REOLYSIN® in combination with paclitaxel and carboplatin in patients with platinum-refractory head and neck cancers (REO 018). From the company’s June 20th DMC safety review, “The study design stipulates that the study […]
GILD – Gilead’s battle plans for Hepatitis C
During their quarterly conference call on Jul. 26th, Gilead essentially showed their hand in HCV. With such swift plans in place and competitors much further behind, Gilead should have a commanding lead and marketshare for the foreseeable future in HCV. Their results presented at EASL12 in April have even been convincing some in the medical […]
INFI – A Summer of Transition at Infinity Pharma
So much for July and August being dead months in the biopharma sector. Infinity Pharma (NASDAQ: INFI) has released a string of updates that promise to completely alter the trajectory of the company compared to just a couple quarters ago. Entering 2012, Infinity’s lead program was the hedgehog inhibitor saridegib (IPI-926, background info here). Unfortunately the company […]
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 […]
VNDA – Flash take on Vanda Pharmaceuticals
Vanda Pharmaceuticals (NASDAQ: VNDA) is a pharmaceutical company that carries a certain amount of folklore around it amongst traders. As legend has it, they fell upon hard times following the FDA’s rejection of their Fanapt for schizophrenia in 2008 and faced bankruptcy in 2009. They later re-emerged from bankruptcy, gained FDA approval of Fanapt in […]
A few recent biotech IPO’s
There have been a few recent IPOs from biotech companies that we want to briefly highlight. Some have upcoming data or regulatory decisions that we will be adding to the database shortly. (1) Hyperion Therapeutics (NASDAQ: HPTX), a biotech focused on the treatment of urea cycle disorders and hepatic encephalopathy. Hyperion plans to raise $50 […]
AMRN HZNP – Amarin’s VASCEPA and Horizon’s RAYOS receive FDA approval
Late Thursday afternoon, we learned that both Amarin (NASDAQ: AMRN) and Horizon Pharmaceuticals (NASDAQ: HZNP) separate new drug applications had been approved by the FDA. We have some insight to share on both names. With respect to Horizon, unfortunately, their future is not looking so bright. Rayos is a delayed-release formulation of low-dose prednisone. Prednisone […]
ECYT – Holds Promise
Endocyte was looking good during ASCO 2011 when it released results from its Phase II PRECEDENT study of women with platinum-resistant ovarian cancer (PROC). Data presented showed the company’s lead compound, EC145, in combination with pegylated liposomal doxorubicin (PLD) improved median progression free survival (PFS) over PLD alone. A pivotal Phase III trial was initiated […]
FOLD – Quick Take – Amigal P3 Monotherapy
Amicus Therapeutics is expected to unveil results from its Phase III registration trial for migalastat (Amigal) as monotherapy for the treatment of Fabry disease in the third quarter of this year. The study, if successful, will allow Amicus to file for marketing approval in the U.S. A separate global Phase III is also in progress. […]
Upcoming FDA Decisions
We will have several regulatory decisions expected this week, some more important than others. This coming week got slightly tamer with the FDA’s approval decision for Carfilzomib on Friday for Onyx and Ligand. Horizon Pharmaceuticals (NASDAQ: HZNP) has a PDUFA date of Thursday, July 26, 2012 for LODOTRA(delayed-release low-dose prednisone), for the treatment of rheumatoid […]
CYTK – Cytokinetics Part 1: Omecamtiv mecarbil a promising drug that faces a tough road ahead.
This is the first of a two part series on Cytokinetics Inc (NASDAQ: CYTK). For the first article, we’ll discuss its cardiac program and in the second part, we’ll focus on the skeletal muscle program. Over the last few quarters, Cytokinetics has continued its downtrend amidst no relevant catalysts in the very short term, a […]
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. […]
SNTA SPPI – Updates from JMP Securities Healthcare Conference
Next up in our dispatches from the JMP Securities Healthcare conference is a pair of oncology companies, Spectrum Pharma SPPI and Synta Pharma SNTA, that always seem to generate strong opinions among biotech investors. Spectrum Pharma $SPPI presentation by Shiv Kapoor, VP of Strategic Planning and Investor Relations This year we have already made […]
LGND – Updates from the JMP Securities
The JMP Securities Healthcare Conference was held July 12-13, a rare biotech investor event during the summer doldrums [webcast link and check back at BiotechDueDiligence where I will archive select slides]. We will follow up with reports on Synta Pharma SNTA, Biosante Pharma BPAX, Spectrum Pharma SPPI, Alnylam ALNY and Isis Pharma ISIS, but for now […]
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 […]
