We wanted to walk you through the process of how we update our database and highlight a recent updates that we noticed. First off, we tend to update entries in the database about once a week, sometimes faster or slower depending on the number and importance of clinical/regulatory updates. (We get particularly hammered when the […]
CYTK – Cytokinetics Part 2: the skeletal muscle program
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 […]
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 […]
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 […]
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 […]
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 […]
YMI – A Billion Dollar Company?
Shares of YMI are trading at about $1.96, valuing the company at $309 million; adding in 7.4 million warrants along with 8.2 million options gives a fully diluted value of $339 million. YM Biosciences has several assets: JAK inhibitor CYT387, anti-EGFR antibody Nimotuzumab, and CYT997, a so-called vascular disrupting agent. Investors are focused largely on […]
VVUS – Understanding the Upcoming PDUFA
Vivus’s July 17th PDUFA date is quickly approaching. After the FDA Advisory Committee voted strongly in favor of approving Qnexa, for the treatment of obesity, mostly all pundits and analyst have all but claimed victory for Vivus’s upcoming PDUFA date. We feel that overall, Qnexa has received significantly more positive commentary secondary to a meaningful […]
INCY – An Immunotherapy Play?
At ASCO this past June, Incyte presented early data from its new Indoleamine 2,3-dioxygenase-1 (IDO-1) inhibitor project. Their small molecule inhibitor, INCB024360, was tested primarily to determine safety and tolerability; secondary endpoints included PK, biomarkers, and signs of anti-tumor activity. The compound demonstrated a good safety profile among 38 patients, with the maximum tolerated dose […]
INFI – Pivoting From Hedgehog to PI3K
Failed trials can’t hold this stock down. In recent months, the hedgehog pathway inhibitor saridegib (also known as IPI-926) – once the company’s leading pipeline candidate – has crashed out of pancreatic cancer, chondrosarcoma and myelofibrosis trials, but the stock has since broken out to new 52-week highs. Following these disappointments, Infinity has discontinued all […]
A Look Into Some COPD Plays With Pending Catalysts
A Guest Post by Juan Pedro Rodriguez Serrate Vectura (LSE:VEC; Pink Sheets:VEGPF) British company Vectura is developing two interesting drugs for the treatment of COPD in partnership with pharma giant Novartis and Japanese company Sosei. Vectura sports a market cap of approximately £240M ($375M) at the time of this writing. – NVA237 (Seebri Breezhaler): is […]
ONXX – Upcoming events at Onyx Pharmaceuticals
Onyx Pharmaceuticals(NASDAQ: ONXX) has a pretty long list of upcoming news that will keep the stock’s momentum following the positive FDA ODAC vote for Kyprolis™ (proposed brand name for carfilzomib) in June. As we said in our blog piece, the briefing documents pointed to a very different FDA stance than what actually transpired. With that […]
OGXI – Oncogenex and Teva finally chart a path forward in NSCLC
The collaboration between Teva Pharma $TEVA and Oncogenex $OGXI for the development of custirsen (aka OGX-011, an antisense against clusterin, licensed from Isis Pharma $ISIS) was always envisioned to include three phase 3 trials, two in prostate cancer and one in non-small cell lung cancer. As I have been chronicling, there have been many false starts […]
