SGMO: Sangamo Getting Ahead Of Itself Sangamo BioSciences has received a great deal of attention in recent weeks with the unveiling of a broad orphan drug therapy initiative at JPMorgan. This has overshadowed what appears to be weak data in its leading HIV drug candidate SB-728-T. Background: SB-728-T is an autologous zinc finger nuclease (ZFN) […]
THRX – Insight into Relovair’s upcoming FDA Advisory Committee
On April 17th, Theravance (NASDAQ: THRX) and partner GlaxoSmithKline (LSE: GSK; NYSE: GSK) will sit in front of the FDA’s Pulmonary-Allergy Drugs Advisory Committee that will decide on whether to recommend Breo (formerly known as relovair) for approval. The FDA has set a PDUFA goal date of May 12, 2013. Breo is a combination of […]
ARIA – Ariad: Overvalued
Investors have high expectations for Ariad’s recently approved drug Iclusig. The tyrosine kinase inhibitor performed well in a pivotal Phase II of resistant/intolerant CML and Ph+ ALL patients. The successful PACE trial allowed for accelerated approval in mid-December 2012, with the launch beginning a few weeks later. Briefly, there are currently five approved targeted therapies […]
NLNK – 2013 Outlook for Newlink Genetics
Earlier this year, we mentioned our interest in NewLink Genetics (NASDAQ: NLNK) throughout 2013 with a keen eye toward their upcoming interim Phase III data. Currently, Newlink’s main asset is novel immunotherapy called HyperAcute Pancreas, or Algenpantucel-L. With the recent $49 million cash raise and upcoming interim look, we wanted to take a deeper look. […]
ZIOP – Preparing for an Explosive Move
ZIOPHARM Oncology, Inc. (ZIOP)-Nasdaq Since November 11, 2012 ZIOP was trading in a horizontal channel, the upper resistance line at $4.81 and the lower support line at $4.01, till February 12, 2013, the day ZIOP announced that the Phase 3 (PICASSO 3) trial of palifosfamide (ZIO-201) in first-line metastatic soft tissue sarcoma has reached its […]
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 […]
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 […]
