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 […]
ACAD – The Last Run to The Parkinson’s Disease Psychosis Results
ACADIA Pharmaceuticals Inc. (ACAD) -NasdaqGM Catalyst: late Nov. P-III results for Parkinson disease Acadia reported a 100% patient enrollment on Sep 05th: ACADIA Pharmaceuticals Announces Completion of Enrollment in Phase III Pimavanserin Trial in Parkinson’s Disease Psychosis Top-Line Data Expected in November 2012, as I mentioned earlier in my last report and since 09/07 the […]
CPRX – Volatility Squeeze Ahead of The Tope-Line Results
Catalyst Pharmaceutical Partners Inc. (CPRX) -NasdaqCM Catalyst: Phase IIb trial results Sentiment : Bullish This report is supplement to the thorough report by Jason Chew, release earlier this week. In that report, he outlined the history of CPRX & it’s upcoming catalyst: Tiny Catalyst Pharmaceutical Partners (CPRX) is expected to disclose top-line results from its […]
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) […]
EXEL – Looking for Direction Ahead of the PDUFA date
Exelixis (NASDAQ: EXEL) On 5/30/12, Exelixis submitted their NDA for Cabozantinib as a treatment for patients with progressive, unresectable, locally advanced, or metastatic medullary thyroid cancer (MTC). They were subsequently granted priority review with a PDUFA date set for 11/29/12. Recently, the FDA announced they had planned to hold an Advisory Committee to discuss this […]
THLD – What’s left for Threshold
In the first part of the year, Threshold Pharmaceuticals (THLD) delivered considerable returns for investors with a partnership deal for TH-302 and “positive” top-line Phase II data in pancreatic cancer. However, as the year has gone by, Threshold’s future for TH-302 has become less attractive. Even at current valuation, we still see further downside in […]
