Dynavax (NASDAQ: DVAX) has an upcoming FDA decision on Hepislav with a PDUFA date of Sunday, February 24th. On November 15th Vaccines and Related Biological Products Advisory Committee(VRBPAC) delivered a surprising 8 to 5 with one abstention that there was insufficient data to adequately support the safety of HEPLISAV. The stock cratered over 50% on […]
DVAX – Dynavax’s upcoming dance with the FDA
Dynavax (NASDAQ: DVAX) has an upcoming FDA decision on Hepislav with a PDUFA date of Sunday, February 24th. On November 15th Vaccines and Related Biological Products Advisory Committee(VRBPAC) delivered a surprising 8 to 5 with one abstention that there was insufficient data to adequately support the safety of HEPLISAV. The stock cratered over 50% on […]
Upcoming WORLD symposium meeting
(with Jason Chew) Lysosomal Disease Network WORLD Symposium meeting The Lysosomal Disease Network (LDN) WORLD Symposium provides an interdisciplinary forum to explore and discuss specific areas of research and clinical interest related to lysosomal diseases. With regards to clinical data presentations, all of the important clinical data will be released on Friday, February 15th. Amicus […]
DEPO – Making sense of the AdCom Noise
Summary of our recent coverage/positions: October 26, 2011: We reiterated a BUY, see report April 21, 2012: We reiterated a BUY, see report October 17, 2012: We reiterated a BUY, see report January 31, 2012: I tweeted that I sold my shares, see tweet Respective Outcomes: Gains from coverage initiation in October 2011: +52% Gains from […]
Preview of the 2013 ASCO GU Symposium
The 2013 ASCO Genitourinary Cancers Symposium provides an interdisciplinary forum to explore and discuss specific areas of research and clinical interest related to lysosomal diseases. With regards to clinical data presentations, all of the important clinical data will be released on Friday, February 15th. Abstracts can be searched with this link. The embargoes on abstract […]
After Phase III failure, Celsion is still worthless
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 […]
A look at TG Therapeutics
with Jason Chew TG Therapeutics (OTC: TGTX, formerly Manhattan Therapeutics), has caught a bit of attention recently with the rise of PI3K inhibitors. TG Therapeutics has 2 main assets: Ublituximab(TG-1101), an anti-CD20 mAb, and TGR-1202, a PI3K delta inhibitor. Both programs are currently behind competitors, but there could still exist an opportunity for both drugs. […]
DEPO – Action Ahead Of The AdCom
DepoMed Inc. (DEPO) -Nasdaq Serada is an investigational formulation of gabapentin, an FDA-approved immediate release pharmaceutical for the treatment of partial epilepsy and management of postherpetic neuralgia (PHN). Recently published studies suggest the potential application of gabapentin for the treatment of menopausal hot flashes. Based on these findings, Depomed has secured exclusive rights to develop […]
STML – Initiating coverage on new public company Stemline Therapeutics
The IPO window was almost closed in 2008 when the financial crisis hit the markets worldwide. Companies looking to raise funds from the capital markets had to think it twice or lower their proposed price ranges considerably. Fortunately, in 2011 and 2012 the situation seems to have improved substantially and more companies are using the […]
ISIS – A Promising Treatment For SMA
Outlook: Bullish Catalyst: American Academy of Neurology Meeting, Mid-March Isis Pharmaceuticals recently received approval for Kynamro, a drug to treat Homozygous Familial Hypercholesterolemia (HoFH); but it is the development of an early stage treatment for Spinal Muscular Atrophy (SMA) that is currently generating the most interest. It is the leading inherited cause of infant mortality […]
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 […]
INFI – Infinity Pharmaceuticals Still Going Strong
Sentiment: Bullish Catalyst: ASCO, Early June 2013 Following a nice presentation at ASH 2012, Infinity Pharmaceuticals impressed once again at the annual JP Morgan Healthcare conference earlier this month. The company is developing the dual PI3K delta/gamma inhibitor IPI-145 in multiple hematological malignancies and inflammatory diseases, and HSP90 inhibitor Retaspimycin for lung cancer. Results were […]
ARRY – Is It Ready For The Next Move
Array BioPharma, Inc. (ARRY)-Nasdaq As a technical analyst I’m looking for patterns and throughout the years I’ve found that stock patterns show that more often than not history repeats itself. Looking at the one year ARRY chart, we can see the uptrend started January 2012, stopped for a while after the February 10th, 2012 price […]
CLDX – 2013 Outlook for Celldex
Honestly, we have been one of the very few to stand by Celldex Therapeutics (NASDAQ: CLDX) over the past year and a half. The opportunity for CDX-011 marks a major inflection point in the company and the market is still not giving them much credit. Off the heels of strong data in December, we continue […]
ARRY – 2013 Outlook for Array
With the 2013 JP Morgan Healthcare conference wrapped up and time to marinate on some of the presentations, we are ready to share our view on the year ahead for many companies. Today, we want to revisit Array BioPharma Inc. (Nasdaq: ARRY). They currently have around $139 million in cash and could have 5 Phase […]
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 ? […]
