I have not followed this story before today, but I’ll throw my hat into the ring anyways It looks like Phase 2b results turned out positive in this second study due to some key differences. The first being a dose titration, lower average AIM score, and central raters. I think this bodes well for eventual […]
Analysis of TGR-1202, a PI3K Delta Inhibitor From TGTX
This is a quick take on the TGTX efficacy data presented at ASH this past weekend. TG Therapeutics reported PK data as well as results from the higher 800 mg cohort. It appears this step up from 400 mg has finally resulted in some activity and the company continues to dose escalate; an 1800 mg […]
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 […]
TSRO – A look at Tesaro
Following additional information released at ASCO 2013 and their recent quarterly updated, we wanted to take a moment to talk about Tesaro (TSRO). Since their IPO, Tesaro’s stock is up roughly 186% at a fully diluted marketcap of $1.22 billion (@ $35 per share) based on roughly 35 million shares outstanding. Tesaro’s pipeline consists of […]
ASH 2013 Preview on ALL/CML/MDS/AML
This year’s annual meeting of the American Society of Hematology (ASH13) is highly anticipated for a number of reasons. The first series in our preview covered what to expect in multiple myeloma. Today’s preview will focus on some of the moves going in acute lymphoblastic leukemia (ALL), acute myeloid leukemia (AML), chronic myeloid leukemia (CML), […]
ASH 2013 Preview on Myelofibrosis
This year’s annual meeting of the American Society of Hematology (ASH13) is highly anticipated for a number of reasons. With the general market for the healthcare/biotech sector at all-time highs on the backs of Pharmacyclic’s Ibrutinib (stock is up 1000% since ASH11), Celgene’s Revlimid (~67% of their $6.3B 2013 revenue) and Amgen’s $10.6B deal for […]
ASH 2013 Preview on Lymphoid Malignancies
This year’s annual meeting of the American Society of Hematology(ASH13) is highly anticipated for a number of reasons. Pharmacyclic’s Ibrutinib could be viewed as one of the several catalysts sparking the biotech sector’s run the past 2 years. They are now within months of receiving approval for 2 indications where they could benefit patient lives […]
ASH 2013 Preview on rare blood disorders
This year’s annual meeting of the American Society of Hematology (ASH13) is highly anticipated for a number of reasons. Orphan diseases has been a key element in the bull market in biotech over the past 2-3 years. Consider that the market for hemophilia A treatments in 2011 was over $5 billion alone. Today’s preview will […]
ASH 2013 Preview on Multiple Myeloma
This year’s annual meeting of the American Society of Hematology (ASH13) is highly anticipated for a number of reasons. With the general market for the healthcare/biotech sector at all-time highs on the backs of Pharmacyclic’s Ibrutinib (stock is up 1000% since ASH11), Celgene’s Revlimid (~67% of their $6.3B 2013 revenue) and Amgen’s $10.6B deal for […]
CLDX – A look at CDX-1127
Celldex Therapeutics (CLDX) has one of the most anticipated data releases amongst small biotech companies this fall. They are scheduled to present data from their Phase 1 dose-escalation trial of a CDX-1127 (CD27, a T-cell stimulator) at the annual meeting of the Society for ImmunoTherapy of Cancer(SITC), November 7-10th. We will also likely see some […]
Ariad- Where Do They Go From Here
Following the FDA’s clinical hold, then discontinuation of the Phase III trial in front line CML for Ariad’s only marketed drug, Iclusig, the most pressing issue comes down to are finances. Ariad is a big spender, burning through $69 million in the second quarter of this year with $83 million in operating expenses. It will […]
Datasets in focus at IASLC this weekend
This weekend is the 15th annual World Conference on Lung Cancer, sponsored by tge International Assoc. for The Study Of Lung Cancer (IASLC). It takes place Sunday October 27th through Wednesday 30th (Site). Abstracts can be found here. In particular, we want to speak briefly about 7 presentations. PD1 inhibitors Bristol-Myers (BMY), Merck (MRK) and Roche (RHHBY) […]
Biocryst up on hope(hype) for HAE prophylaxis
In a previous post, Jason Chew provided some background and analysis on Biocryst (BCRX) BCX4161, an oral drug candidate for the treatment of hereditary angioedema (HAE). Biocryst’s stock is up 300%+ since July of this year on the back’s of Phase 1 trial of BCX4161 in healthy volunteers. With that said, we do question some […]
MDVN – Confusion over PREVAIL data explained in a single graph
On Tuesday, the market was rather confused on what to make of the PREVAIL news. To be clear, this wasn’t entirely the market’s fault: Medivation released a poorly worded press release that did not convey the whole story. A little extra detail would have gone a long way. From the press release, we know that […]
October 17- EOD
A mixed day in the market which was nice to see a day in which not all stocks were moving in the same direction. Obviously had some stock specific news with AMRN and the PSDV PDUFA and some more general biotech news. 1. AMRN was the stock of the day with about a 67% haircut […]
PSDV ALIM – Analysis of Iluvien for DME
On Thursday, Alimera (ALIM) and Psivida (PSDV) are expected to hear from the FDA on the status of their new drug application(NDA) for Iluvien(fluocinolone acetonide intravitreal implant) to treat chronic diabetic macular edema. With it’s third attempt, one could say Iluvien has taken the long and winding road to approval. The PDUFA date is October […]
ISIS Huntington’s Disease Program: A good start on an ambitious target
Huntington’s Disease (HD) is a neurodegenerative disease characterized by motor, cognitive and psychiatric symptoms. The most typical symptom, but by far not the only, is the occurrence of incontrollable, random and sudden movements (chorea). Symptoms appear around 30 and 40, and the life expectancy after the first manifestations is two decades. Huntington’s is caused by […]
Quick comments on Achillion and TG Therapeutics
(with Jason Chew) In biotech, all too often are investors given news on Friday that is not so good. With many updates expected by the end of the quarter, someone was bound to have the honors of being one of those companies. Today we had quite bad news out of Achillion and an update from […]
What to look for at AASLD 2013
We wanted to take a moment to highlight some of the presentations at the 2013 Annual Meeting of the American Association for the Study of Liver Diseases. This conference takes place Friday, November 1st thru Tuesday, November 5th and covers . Research interest in new therapies against the hepatitis C virus(HCV) still remain high, although […]
What to look for at ESMO 2013
Apropos to our post yesterday on upcoming medical conferences, we wanted to begin with some coverage of the European Cancer Congress 2013 (ECCO-ESMO). This conference takes place Friday, September 27th thru Tuesday, October 1st. Below we have some of the datasets and updates we are looking forward to seeing. ESMO planners also put out their, […]
