After much debate from bulls and bears, in late January, Celsion (NASDAQ: CLSN) reported that the Phase 3 HEAT study of ThermoDox failed to meet the primary endpoint of achieving at least a 33% improvement in progression-free survival (PFS). This was not surprising to our group, who had been highlighting the many risks that could potentially […]
SRPT – Preparing For The Next Move
Sarepta Therapeutics, Inc. (SRPT)-Nasdaq Sarepta is a biotech company under the spotlights since early October 2012, after presenting strong Phase IIb results for the compound Eteplirsen in the treatment of Duchenne Muscular Dystrophy. On October 3rd, 2012, SRPT jumped an unbelievable 199.7% by the closing bell, but as with every huge spike, profit taking started […]
The IBB and SPX In The Decision Zone
In my previous report “IBB – A Closer Look at the Market’s Direction” I tried to find out if the markets bottomed out after the technical correction in the indices $IBB and $SPX, as both reached a support area, and the price found a support line around the Fibonacci 61.8% . Is it the bottom ? […]
ALNY – Alnylam falls behind competition
We have previously spoken about Alnylam Pharmaceuticals (NASDAQ: ALNY) legal troubles with Tekmira Pharmaceuticals, and successfully predicted they would settle. Today, we want to talk a bit about their current valuation and where their programs stand relative to competitors. Alnylam has the rights to some important intellectual property for the RNAi space, however, they are […]
FOLD – Amicus approaches inflection point
With Phase 3 data expected from Amicus Therapeutics (NASDAQ : FOLD), we wanted to take the time to do a thorough analysis of the trial and what to expect. Jason Chew has covered Amicus since early 2012, so their story should be familiar for our readers. Now, we would like to review some insightful points […]
CLDX – A Positive Divergence Case
Celldex Therapeutics, Inc. (CLDX)-Nasdaq CLDX’s chart is one of a kind and very easy to understand even by a novice chart technician. It has been repeating the same moves, creating a pattern that makes it easy to predict, using a historical resistance & support lines to find the points of the reversals. Starting in June […]
IBB – A Closer Look at the Market’s Direction
In my previous report “IBB – Nasdaq Biotechnology Index – Reaching a Critical Point ” I tried to find out if the technical correction in the index $IBB reached a support area, and the price found a support line around the Fibonacci 61.8 or the weekly support line at 126.90 points. Today the price reached […]
ALNY – Troubled Legal Battle Ahead For Alnylam
With shares of Alnylam Pharmaceuticals (NASDAQ: ALNY) up well over 150% year-to-date, with 52 week highs at $21.38, we began an investigation into their current valuation and pending catalysts. Alnylam is a biotech company with technology/intellectual property rights on some key patents in the RNAi space, and some early-stage pipeline candidates for several indications. Unfortunately, […]
THLD – More uncertainty ahead for Threshold
As we previously suggested, Threshold Pharmaceuticals (NASDAQ: THLD) had some question marks about their future prospects of TH-302 in two key indications: pancreatic cancer and soft-tissue sarcoma. Recent data readouts have brought these issues into focus again. Although Threshold has a good cash position, we feel their lead (and only) drug, TH-302, will have a […]
ACAD – The Last Run to The Parkinson’s Disease Psychosis Results
ACADIA Pharmaceuticals Inc. (ACAD) -NasdaqGM Catalyst: late Nov. P-III results for Parkinson disease Acadia reported a 100% patient enrollment on Sep 05th: ACADIA Pharmaceuticals Announces Completion of Enrollment in Phase III Pimavanserin Trial in Parkinson’s Disease Psychosis Top-Line Data Expected in November 2012, as I mentioned earlier in my last report and since 09/07 the […]
ISIS and AEGR – Where do they stand after the FDA Advisory Committee meetings?
October 17 and 18, 2012 saw back-to-back meetings of the FDA Endocrine and Metabolic Drugs Advisory Committee (EMDAC) to review pending new drug applications (NDAs) for two drugs for homozygous familial hypercholesterolemia (HoFH): lomitapide from Aegerion Pharma (NASDAQ: AEGR) and mipomersen/Kynamro from Sanofi/Genzyme and Isis Pharma (NASDAQ: ISIS). As Chimera predicted, both drugs received positive […]
EXEL – Looking for Direction Ahead of the PDUFA date
Exelixis (NASDAQ: EXEL) On 5/30/12, Exelixis submitted their NDA for Cabozantinib as a treatment for patients with progressive, unresectable, locally advanced, or metastatic medullary thyroid cancer (MTC). They were subsequently granted priority review with a PDUFA date set for 11/29/12. Recently, the FDA announced they had planned to hold an Advisory Committee to discuss this […]
THLD – What’s left for Threshold
In the first part of the year, Threshold Pharmaceuticals (THLD) delivered considerable returns for investors with a partnership deal for TH-302 and “positive” top-line Phase II data in pancreatic cancer. However, as the year has gone by, Threshold’s future for TH-302 has become less attractive. Even at current valuation, we still see further downside in […]
SRPT – Sarepta Presents 48-Week Data At World Muscle Society Congress
Sarepta Presents 48-Week Data At World Muscle Society Congress Long-term safety and efficacy results were presented this Saturday at the WMS Congress in Persh, Australia. We had already learned from a press release of top-line results October 3rd that results were positive: 50mg/kg treated patients remained stable- perhaps improved on the 6MWT- and treatment delayed […]
PPHM – Little value in Peregrine Pharmaceuticals
For a very brief period of time, Peregrine Pharmaceuticals (NASDAQ: PPHM) had become the phoenix that rose from the ashes. Peregrine recently posted overall survival(OS) data from their randomized Phase II trial in second-line non-small cell lung cancer that excited many. It talked up being approached by over a dozen big pharma companies to partner […]
VNDA – A quick review on Vanda’s tasimelteon
After our first quick take on Vanda Pharmaceuticals (NASDAQ: VNDA), we wanted to provide a deeper insight into the development of tasimelteon, the company’s dual MT1/MT2 melatonin receptors agonist. Vanda is expected to report data from two phase III studies by this year’s end in a condition called Non 24-hour sleep wake disorder (N24). Additionally, […]
EXEL – In A Consolidation Mode
EXEL “Exelixis” had an impressive uptrend starting in June 2012, anticipating the FDA reply for the NDA filling & priority review, starting from the $4.40 area, reaching the $6.95 point on the day of the announcement that the FDA accepted its potential medullary thyroid cancer (MTC) treatment, cabozantinib, for priority review , which is shorter […]
PPHM – More downside expected in Peregrine Pharmaceuticals
We have recently posted on Peregrine Pharmaceuticals (NASDAQ: PPHM) in the forums and decided to further elaborate on the company. There appears to be significant reasons to be cautious with this name. Upcoming catalysts for Peregrine over the next 12 months The following catalysts are expected, which are led by the median OS readouts from […]
Bristol’s HepC Drug Fails – Now Idenix Compound Is On Clinical Hold
Bristol’s nuc, INX189, crashed not long after the compound was acquired through a $2.5 billion buyout of Inhibitex as a result of heart failure in one patient. Now the FDA has called for a partial clinical hold on a similar compound made by Idenix out of caution. IDIX stock has dropped about 30% today. Toxicity […]
SRPT – Sarepta Therapeutics Develops Promising Treatment For DMD
Duchenne’s Muscular Dystrophy (DMD) is a genetic disorder that afflicts approximately 1 out of every 3,600 male infants. The inherited disease is caused by mutations in the gene for dystrophin- a muscle protein- resulting in muscle weakness at an early age that quickly worsens over time. Breathing difficulties and heart disease typically begin in the […]
