First quarter earnings for 2013 are on the horizon. We want to outline some of the main events for some of the larger biotech companies we follow. It can be hard to track the progress of such large companies, but there are meaningful updates still expected in the next 6 months. Alexion Pharmaceuticals (NASDAQ: ALXN) […]
Three bloated valuations with approaching exclusivity and patent expirations
With the strong performance of pharmaceutical and biotechnology stocks over the past few years, some have even outperformed expectations. Specialty pharmaceutical companies have filled various niches recently with reformulated products for various indications. However, at some point, their valuations exceed the fair value of their respective opportunities and do not account for the risks they […]
ACHN – Sell Achillion, Buy Idenix
A lot has happened since we last discussed HCV stocks back in October ahead of AASLD. One thing that remains unchanged is Gilead’s dominant lead in the development of next-generation HCV drugs. Beating expectations, Gilead is set to submit its regulatory filing of an all-oral combo consisting of sofosbuvir and GS-5885 by mid-2014 with potential […]
AVEO – An analysis of Aveo’s upcoming advisory committee
(in collaboration with Juan Pedro Rodriguez Serrate) The FDA’s Oncologic Drugs Advisory Committee (ODAC) is slated to review AVEO Oncology (NASDAQ: AVEO) / Astellas Pharmaceuticals’ Tivozanib for the treatment of patients with advanced renal cell carcinoma (RCC) during the morning session of its meeting on May 2, 2013. An FDA decision is expected by Jul […]
ECYT – Update on Endocyte
It’s been awhile, but we wanted to update our coverage on Endocyte (NASDAQ: ECYT). Endocyte has a novel small molecule drug conjugates or SMDCs, and companion imaging diagnostics; think Seattle Genetics(NASDAQ: SGEN), but given orally. Endocyte expects that its cash will be between $145-160 million at the end of this year. Following the strong move […]
DCTH – Our take on Delcath’s upcoming advisory committee
The FDA’s Oncologic Drugs Advisory Committee (ODAC) is slated to review Melblez (previously known as Chemosat) on May 2nd. An FDA decision is expected on June 15th. Melblez is a chemosaturation system that isolates the liver in order to allow the administration of high doses of melphalan for the treatment of liver metastases from other […]
CRIS – Curis Pipeline May Propel Shares
Curis is best known for its hedgehog (Hh) pathway inhibitor Erivedge, which has been licensed to Genentech (Roche). Erivedge was approved for the treatment of inoperable basal cell carcinoma (BCC) in January 2012. The launch has been slow; sales reached only $30.6 million last year. Partnered early, Curis receives only 5% royalties, escalating to high […]
Recent Biotech IPOs
We want to highlight some biotech companies that have recently come public. The end of 2012 and continuing into the spring of 2013 brought forward a number of companies in search of new funding across various stages of development(Phase 1-3). Initially, shares in these companies will be rather illiquid, so expect to see some volatility. […]
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 […]
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 […]
