Amicus Therapeutics released updated data Thursday for its chaperone molecule Amigal (migalastat) for Fabry disease at the American Society of Human Genetics (ASHG) Annual Meeting. Results looked good, continuing to build on positive data presented earlier this year. This study looks at the ability of Amigal to increase the activity of Enzyme Replacement Therapies (ERTs) […]
DCTH – Commercial prospects and valuation
In our previous note, we discussed why we thought that a drug with orphan status, fast-track that tackles metastatic disease would receive a 6-month priority review. However, the FDA didn’t think Chemosat was elegible to get it and granted a 10 month review with a PDUFA date on June 15, 2013. The agency will convene […]
IBB – Nasdaq Biotechnology Index – Reaching a Critical Point
iShares Nasdaq Biotechnology (IBB)-NasdaqGM Typically, the best indicator of the action in our biotech portfolio is the $IBB. By looking at it we get the whole picture of the pressure that we as investors or traders in the biotech sector have felt in the past 4 trading weeks after the euphoria and the hype that […]
PBYI – Quick look at Puma Biotechnology
We wanted to take a moment to take a quick look at Puma Biotechnology (NYSE: PBYI). They recently raised $130M in cash from a public offering. The company has some notoriety due to the co-founder’s, Alan Auerbach, presence at the helm of the company(CEO and President). Prior to founding Puma, Mr. Auerbach served as founder, […]
Upcoming medical conferences – Q4 2012
With the beginning of November, we enter the home stretch for some of the major medical meetings that will serve as pivotal events for some companies. We have attempted to list some of the higher profile conferences, but it’s entirely possible that some will slip by us. November American Heart Association(AHA) Scientific Sessions – 11/3 […]
What we’re looking for at ASH 2012
On Monday, November 5th, abstracts submitted to 2012 Annual Meeting of the American Society of Hematology (ASH) Annual Meeting will be published online. A time has not been released, but we have heard they will be released at 10AM Eastern time. Below are some comments on companies we expect to have a present at the […]
CPRX – Catalyst Pharmaceutical Partners – Promising But Still Early
Catalyst Pharmaceutical Partners Inc. (CPRX) -NasdaqCM Catalyst: Phase IIb trial results Sentiment : Bullish Tiny Catalyst Pharmaceutical Partners is expected to disclose top-line results from its pivotal Phase IIb study of CPP-109 for the alleviation of cocaine addiction in mid-November. CPP-109 is a very promising drug in a field otherwise littered with failure. Should it […]
ZIOP – Ziopharm is undervalued
We have previously posted a long look at Ziopharm Oncology here. We feel the story is worth reiterating given near-term events and our view that the company is undervalued. Recent volatility due to a bearish, yet misleading article have opened up an opportunity. Upcoming events — Update overall survival data from their Phase 2 study […]
Biotech and Pharma earnings preview
Starting after-hours on Tuesday, we’ll see a lot of biotech and pharmaceuticals earnings, guidance, and outlook on their current programs. With the market cooling off, companies will be under pressure to meet investor expectations. Next week a number of sector leaders will kick things off. We’ve listed the updates in chronological order. Amgen (Nasdaq: AMGN) […]
ISIS and AEGR – Where do they stand after the FDA Advisory Committee meetings?
October 17 and 18, 2012 saw back-to-back meetings of the FDA Endocrine and Metabolic Drugs Advisory Committee (EMDAC) to review pending new drug applications (NDAs) for two drugs for homozygous familial hypercholesterolemia (HoFH): lomitapide from Aegerion Pharma (NASDAQ: AEGR) and mipomersen/Kynamro from Sanofi/Genzyme and Isis Pharma (NASDAQ: ISIS). As Chimera predicted, both drugs received positive […]
Upcoming events for ALXN, BIIB, CELG, and VRTX
This is the fifth installment in our series about upcoming events across the biotech sector(see our 1st piece, 2nd piece, 3rd piece, 4th piece). This time around we want to take a look at some upcoming events at some larger biotech companies and what will be drivers for them going forward. Alexion Pharmaceuticals (NASDAQ: ALXN) […]
SRPT – Sarepta Presents 48-Week Data At World Muscle Society Congress
Sarepta Presents 48-Week Data At World Muscle Society Congress Long-term safety and efficacy results were presented this Saturday at the WMS Congress in Persh, Australia. We had already learned from a press release of top-line results October 3rd that results were positive: 50mg/kg treated patients remained stable- perhaps improved on the 6MWT- and treatment delayed […]
Upcoming events for ARRY, ACHN, and OMER
This is the fourth installment in our series about upcoming events across the biotech sector(see our 1st piece, 2nd piece, 3rd piece). We continue our look at some upcoming events at smaller biotech companies and what we will be drivers for them going forward. If there are any companies that subscribers would like covered, please […]
ALNY IDIX ISIS LXRX – Dispatches from the Morgan Stanley and UBS conferences
The annual Morgan Stanley Global Healthcare conference and the UBS Global Life Sciences conference were held September 10-12 and 19-20, 2012, respectively. The MS presentations were moderated by the analyst host, while the UBS presentations were webcast without a Q&A session. We will highlight timeline projections and other notes for a few biotech companies. Isis […]
AASLD 2012 – An HCV Primer
It seems EASL has just ended, but AASLD is fast approaching, coming mid November. For HepC watchers, here is an overview of some companies that will be presenting at the Liver Meeting. Despite the tremendous progress made to-date, new advances keep it exciting. Gilead: Acknowledged leader in the race to bring an all-oral drug combination […]
DCTH – Flash note on Delcath’s NDA acceptance
Delcath (NASDAQ: DCTH) is approaching a key catalyst related to its technology Chemosat. The company is slated to hear from the FDA with regards to the acceptance of its NDA for the Chemosat technology and we’ll know whether it’s granted priority review (expected announcement on October 14), or standard review (expected Oct 28). Depending on the […]
VRTX – Vertex: Kalydeco Is The Key
Catalyst: North American Cystic Fibrosis Conference, October 11 Outlook: Neutral Ten abstracts from Vertex have been accepted at the North American Cystic Fibrosis Conference (NACFC). Investors will be keenly focused on the October 11 presentation titled, “The Investigational CFTR Corrector, VX-809 (Lumacaftor) Co-Administered with the Oral Potentiator Ivacaftor Improved CFTR and Lung Function in F508DEL […]
Updates out of ESMO12
The European Society for Medical Oncology (ESMO) Congress 2012 kicked off this weekend and goes until October 2nd(Tuesday). Abstracts with data for those presentations that have already occurred can be viewed and searched here(link). We did get several updates from companies that we would like to review. First up is Threshold Pharmaceuticals (NASDAQ: THLD). On Saturday, they presented […]
ZIOP – Analysis of Ziopharma
Biotech investors are currently looking for Ziopharm Oncology (NASDAQ: ZIOP) to announce top-line results of their Phase 3 trial of Palifosfamide. Ziopharm appears close to an inflection point and everyone is awaiting these results. Below we map out the next few months at the company and what to expect. Upcoming events ESMO Presidential Symposium presentation on […]
INFI – Infinity Pharmaceuticals – Is It Overvalued
Catalyst: ASH 2012, December 8-11 Sentiment: Bullish The bulk of Infinity’s value lies in the early stage asset, dual PI3K delta/gamma inhibitor IPI-145. Based on near-term clinical results, Infinity may be deemed vastly overvalued, or the next must-own biotech stock. The company is also developing an HSP90 inhibitor retaspamycin, but we ascribe nominal value to […]
