With the first quarter behind us, we look to updates across the biotech industry on new product launches and guidance for the year. We are also coming upon the summer medical conference series. Additionally, we briefly discuss 2 upcoming FDA approvals. Upcoming earnings releases and updates Monday, April 22nd After-Hours: ILMN Tuesday, April 23rd Pre-Market: […]
Q2 outlook for ARIA, AEGR, CLDX, GHDX, ISIS, MNTA, RPRX, XNPT
First quarter updates for 2013 are on the horizon. Below we outline some of the main events for some biotech companies we’re tracking closely. Aegerion Pharmaceuticals (NASDAQ: AEGR) Most investors will be focused on the how the US launch of Juxtapid(Lomitapide) is tracking. JUXTAPID was approved by the FDA in December 2012. They anticipate a […]
Whats next for ALXN, BMRN, INCY, MDVN, ONXX, REGN, VRTX
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 […]
EDAP – A look at microcap device maker, EDAP TMS
Last year, we had projected that EDAP TMS (NASDAQ:EDAP) would report data from their Phase 2/3 trial(ENLIGHT) trial for the indication of low risk, localized prostate cancer. However, we have seen no statement on the results of the trial thus far. Ablatherm HIFU has been approved in the EU for quite some time, but their […]
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 […]
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. […]
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 […]
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 – […]
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. […]
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 […]
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. […]
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 […]
