Xenoport, Inc. (XNPT) -Nasdaq Lately, the reals runner were those with pending clinical trial data, where we saw TSRX and ZIOP’s share price move much more than the PDUFA runners. After TSRX and ZIOP(data from both are expected this week), we want to have a look at XNPT, which is expected to release Phase 3 […]
Option Basics (1) – Conceptual Framework
It may surprise you, but an option is very easy to understand. In its most basic form, an option is an exchange-traded contract between two individuals to either buy or sell the stock of a company (the “Underlying” Stock) at a specific price (the “Strike” Price) until the contract expires (the “Expiration” Date). For this […]
ASTX – Astex Is One To Watch
Astex Pharmaceuticals is a promising small cap biotech company with both a marketed drug and pipeline products waiting in the wings. The Dublin, CA based company generates royalty revenue from sales of hypomethylating agent Dacogen (decitabine) for the treatment of AML and MDS. In recent years, the growing revenue stream has helped offset research spending […]
ZIOP – Quick update on Ziopharm
Ziopharm is nearing the top-line data from their Phase 3 study of palifosfamide in first-line soft tissue sarcoma. We have written extensively about them[ref] over the past 6 months in anticipation of this read out. After hours yesterday, CEO Jonathan Lewis gave a presentation at the Barclays Healthcare Conference in Miami[webcast here,transcript]. During this presentation […]
CLDX – A look at a potentially promising orphan drug
With orphan drugs all the rage these days, we wanted to visit an asset owned by a company we follow quite closely. By choosing indications with high unmet need and targetable pathways, companies have commercialized new drugs at lower development cost, shorter clinical studies and streamlined pathways to approval. They’ve also been able to charge […]
PPHM – Peregrine’s Bavituximab future looks bleak
We have previously discussed[1][2] the numerous shortcomings of the overhyped oncology developer, Peregrine Pharmaceuticals (NASDAQ: PPHM). With further details on a botched Phase II trial that still leave many questions, investors still have not woken up to the fact that Bavituximab is worthless. In 2013, we expect to see another failed trial in first-line lung […]
SGMO – Is it The Time For a Correction
Sangamo Biosciences Inc. (SGMO) -Nasdaq Within three months the share price of SGMO doubled, soaring from the $5.50 area and reaching a new 5 years high of $11.24, getting a boost from the hype around the clinical data that investors were anticipating to be presented at CROI 2013. Jason had a thorough report “SGMO: Sangamo […]
ZIOP – Further analysis on PICASSO III study
We previously posted a long look at Ziopharm (NASDAQ: ZIOP) before ESMO 2012. With the pending topline Phase 3 data during the week of March 25th, we wanted to revisit the story before this event. We believe the results from the EORTC 62012 study further validate their belief in the PICASSO 3 study. Upcoming events – […]
SGMO – Sangamo Getting Ahead Of Itself
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 […]
