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 […]
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 […]
An October full of data and decisions
With October underway, we felt the need to highlight some of the most important upcoming data readouts and regulatory decisions. This month is particularly busy on the regulatory side of things with 5 PDUFAs, 4 Advisory Committees, 6 FDA actions, and multiple potential European Medicines Agency(EMA) decisions. The events are listed in chronological order. Eli […]
BMRN – A Busy Quarter Ahead.
BioMarin (NASDAQ:BMRN) $BMRN is a ticker that every biotech investor or trader would like to see it in his portfolio. Just look at the weekly chart to understand the huge & steady uptrend, $BMRN had a huge run since Mar 2009 starting at $10 and running to $41 these days, it’s more than 400% in […]
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 […]
INCY – Is It A Good Time To Start A Position?
Incyte Corporation (INCY) The chart of INCY pop up in my chart screener, as a chart with a bullish reversal pattern called “Tripple Bottom” . The Triple Bottom Reversal is a bullish reversal pattern, Once the first bottom is created, the price reaches a peak and retraces back toward the prior support. This is when […]
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 […]
Option traders making moves
Today, we detected some large moves in the option markets for multiple names we follow. As we enter the fourth quarter, we suspect this increase in frequency. ARIAD Pharmaceuticals (NASDAQ: ARIA) The February $16 puts were very active today, with over 9,000 in volume (vs open interest of only 76 contracts). One trader sold two […]
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 […]
