The sector seems to be getting its feet but unevenly and in fits and starts. It looks like the large caps are probably the most consistent outperformers with some strong SMID names but as a group it is much more mixed. We continue to be in earnings seasons and likely explains the outperformance of the […]
July 28 Biotech Update
The sector looked like it would be off to a good start but it faded quickly. I would still argue that any movement before the GILD earnings can be quickly changed, so the trading action tomorrow is much more important than anything today. Not a ton of major news but a decent amount of tidbits, […]
May 22 Biotech Update
Yesterday sort of followed the potential new pattern of gaining strength throughout the day but volumes were a little low as we approach the holiday weekend. I suspect today will be even worse, so I will refrain from making any real interpretations of the moves given the lack of volume. 1. There is a lot […]
July 10 Biotech Update
It was clearly a bad day in the market and the sector. It is looking more and more likely that the long anticipated correction is here and the question now is how deep of a correction and how long will it last? I would not be surprised to see at least a 5% correction in […]
April 22- Building Some Momentum
Everyone loves biotechs again. Has the bottom been put in? Perhaps but there was a lot of damage done to the sector, so I would remain selective on buys and not chase any of these early moves. That being said the coast is likely clear for the near term assuming that the large cap biotechs […]
January 7 Biotech Update: Good News for PCYC, EPZM, and FMI
I thought yesterday was going to start a run in biotechs but I was a day early. We had the broad market rally helping but the sector was pushed today by some positive news. Of course, every move higher in the sector is bemoaned as being too much making this one of the most hated […]
December 18 Biotech Update- Rigorsertib Fail Pancreatic Trial (no surprise) and MRK Collaborates
We are getting into the doldrums so to speak and not much is going on. The market really seemed listless in the morning as I guess traders were waiting for the taper decision. I still see a negative bias in biotech, especially in this year’s big winners. It could very well be that funds are […]
SRPT – FDA Says No To Sarepta AA
On Tuesday morning, Sarepta informed investors that in what appeared to be a change from its previous stance, the FDA was not supportive of the company’s planned Accelerated Approval filing for the DMD drug eteplirsen. Even more damaging, the agency not only called into question the legitimacy of dystrophin as a biomarker, but cast doubt […]
SRPT – Sarepta Quick Commentary
It Has Everything And Nothing To Do With Dystrophin Investors have been intensely focused on Sarepta CEO Chris Garabedian’s July 24 “Regulatory Update”, parsing each sentence as if it were one of Bernanke’s speeches. The call went generally as expected: following discussions with the FDA, Sarepta announced plans around an NDA filing based on Phase […]
June 26- EOD
Generally it was a good bounce back day for a lot of biotechs, although there were some pockets of underperformance. That being said, this is a positive day but the real test will be when these stock get to their 50-day moving average and whether they can decisively move back above them. Until then I […]
ASCO2013 Take Three: PD1 antibodies will have significant presence
This is our third piece in a series of articles on developments expected at ASCO 2013[1,2]. Currently, we think the majority of the exciting presentations at ASCO 2013 will be from clinical candidates at big pharma. In particular, anti-programmed death-1 monoclonal antibodies(anti-PD-1) like Bristol Myers’ Nivolumab(BMS-936558), Merck’s Lambrolizumab (MK-3475), GSK’s AMP-224, Teva/CureTech’s CT-011 and Roche/Genentech’s […]
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 […]
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 […]
LGND – Updates from the JMP Securities
The JMP Securities Healthcare Conference was held July 12-13, a rare biotech investor event during the summer doldrums [webcast link and check back at BiotechDueDiligence where I will archive select slides]. We will follow up with reports on Synta Pharma SNTA, Biosante Pharma BPAX, Spectrum Pharma SPPI, Alnylam ALNY and Isis Pharma ISIS, but for now […]
A Look Into Some COPD Plays With Pending Catalysts
A Guest Post by Juan Pedro Rodriguez Serrate Vectura (LSE:VEC; Pink Sheets:VEGPF) British company Vectura is developing two interesting drugs for the treatment of COPD in partnership with pharma giant Novartis and Japanese company Sosei. Vectura sports a market cap of approximately £240M ($375M) at the time of this writing. – NVA237 (Seebri Breezhaler): is […]
DEPO, SNTS, XNPT, PFE – Update on Q1 Earnings
DEPO – Reaffirming Buy Yesterday, Depomed reported better-than-expected earnings for the first quarter. Gralise revenue was $1.75 million, Glumetza revenue was $9.2 million, Janumet XR was $0.2 million. We are reaffirming our BUY recommendation for this company. We feel that increases in total sales for Glumetza, price increases, and an increase in the percentage revenue […]
DEPO – Quick Update – Paragraph IV – DM1992 Phase 2
Depomed released a statement that Actavis Group, a generic drug manufacturer filed a paragraph IV challenge against Gralise, Depomed’s once-daily gabapentin formulation. NEUTRAL on Paragraph IV We view this event as having no net impact. Patent challenges are not unexpected in this pharmaceutical environment, especially in the drug delivery space. The current generic drug legislation rewards early […]
PFE & BMY – The anticoagulant market & the Apixaban Catalyst
Background: The market for anti-thrombosis agents is set for dramatic changes. A thrombus is an aggregation of platelets which plays a key part in several life-threatening diseases, such as myocardial infarction, stroke, deep-vein thrombosis, pulmonary embolism, stent thrombosis, as well as other medical conditions. The market for therapies against thrombosis can be broken down simply […]
DEPO, XNPT, PFE – Managed-care to stunt Lyrica, Horizant and Gralise with step-edits
The Neurology and Pain sectors have been very interesting for biotech investors focused over the past year. Xenoport (NASDAQ:XNPT), Depomed (NASDAQ:DEPO), GlaxoSmithKline (NYSE:GSK) and Pfizer (NYSE:PFE) have all had regulatory successes over the past several months. The problem is the regulatory successes haven’t necessarily resulted in financial success for companies and their shareholders. At a […]
GSK: What To Do With ViiV
Great story came out May 6 from Reuters, reporting that Morgan Stanley analysts recently told investors a ViiV IPO or spinoff could be beneficial for GSK and the Pfizer/GSK joint venture. ViiV was formed in 2009 to wrap together GSK and Pfizer’s HIV drug assets under the premise that a separate entity would allow for […]
