Insmed (NASDAQ: INSM) is expected to report top-line data from a Phase II trial of Arikace in non-tuberculosis mycobacteria (NTM) infection tomorrow morning. This is a double-blind placebo-controlled study that has recruited 90 patients and is comparing the change in semi-quantitative mycobacterial culture density on a seven-point scale from baseline to the end of treatment […]
Corcept – Fourth time a charm?
Corcept Therapeutics (CORT) is currently awaiting topline Phase III data for Korlym(mifepristone) in psychotic depression in the second quarter. Currently, Corcept projects Korlym will do net revenue between $24-$28 million under it’s limited label for endogenous Cushing’s syndrome, a rare condition in which the adrenal glands overproduce cortisol. Below you will find an assessment of […]
Quick Take on GERN Clinical Hold
Geron announced this morning the FDA had placed a clinical hold on its lead drug Imetelstat. While the agency cited only trials in ET, PV, and MM, the company also expects a delay in its key Phase II MF study- originally set to begin mid-year. Shares plunged from $4.40 to as low as $1.39, but […]
Upcoming events for Merck
Members of Chimera Research Group have successfully been trading Merck for the past few months, especially Joe Gantos(@GantosJ). Merck has been one of the strongest big pharmas over the past few month on the heels of pipeline developments. With a new year, we want to provide a road map for what’s to come in the […]
Upcoming events for Pfizer
Pfizer (PFE) isn’t traditionally on my watchlist as a name to follow, however, this may be an exception. Palbocicib is likely the most exciting pipeline product in development at Pfizer right now. It received Breakthrough Therapy designation from the FDA in April 2013 for the treatment of breast cancer, following very encouraging Phase 2 results […]
A look at Auspex Pharma
Lately, it seems like there is a new biotech IPO being filed every other day. Today, we want to take a look at a recent IPO, Auspex Pharmaceuticals (ASPX). Auspex recently raised 7 million shares at $12 per share and has roughly 22.5 million shares outstanding. It is currently valued around $550 million in market […]
High Risk, High Reward With GW Therapeutics (GWPH)
In just a year’s time, GW has morphed from a company focused on the marketing of an approved product to one dedicated to the development of an early stage orphan drug candidate. A majority of the company’s valuation is now derived from this Phase I anti-epilepsy treatment. Crucial data from an ongoing Investigator Sponsored Trial […]
Update on Protalix
On Wednesday, Protalix (PLX) will present data from their phase I clinical trial of oral glucocerebrosidase (GCD), or Oral GCD (PRX-112), in patients with Gaucher disease. The presentation will be at 1:15pm PST at the Lysosomal Storage Disease Network WORLD Symposium (LDN WORLD). While Sanofi/Genzyme are nearing potential approval of Cerdelga (eliglustat), the data should […]
Arrowhead Research (ARWR)– Great Technology, But is the Company Over-Promising on ARC-520?
Two billion people globally have been infected with hepatitis B (HBV), and approximately 350 million are chronic carriers, including approximately 750,000 persons in the US. Among the chronically infected, 15% – 40% will develop cirrhosis and/or hepatocellular carcinoma. Each year approximately 5000 people in the US and 1 million worldwide die from cirrhosis, liver failure […]
CYTK – Will tirasemtiv BENEFIT ALS patients?
As Cytokinetics confirmed in its Q4 2013 conference call, it will report top-line data from the BENEFIT-ALS study in the second quarter of this year, precisely, at the American Academy of Neurology annual meeting in Philadelphia April 26-May 3. If the company can’t have the whole data ready for that meeting, they’ll present a […]
Prospects for Prana's PBT2
On the wildly speculative front, Prana Biotechnology (PRAN) is a developer of metal protein attenuating compounds(MPAC) for neurodegenerative disorders. Shares are up over 350% in the past year as the company has neared readouts from 2 Phase 2 studies of their lead product, PBT2. The first is a small, 12-month study in 40 patients with […]
Upcoming Phase 3 trials
With a fresh start to 2014 and the biotech market still very strong, we wanted to examine some upcoming Phase 3 results that will be in focus in the first quarter. Expectations for some of these trials varies widely. We have a blend of small biotech to big pharma. Company: Merck (MRK) and Amgen (AMGN) […]
GERN- A Speculative Trade
To be clear, I’m not a big fan of Geron. However, upcoming events provide an interesting, although somewhat risky trading opportunity. The telomerase inhibitor imetelstat has demonstrated activity in the myeloproliferative disorders essential thrombosis and myelofibrosis. Geron is now planning a company sponsored P2 in MF set to begin around June; data may become available […]
A look at Innate Pharma
Immuno-oncology was one of the hottest themes of 2013 and its been almost entirely a big pharma story. We saw Bristol-Myers Squibb, Merck and Roche reveal more data and future plans for their PD-1 and PD-L1 inhibitors. It’s going to be the hottest theme for awhile, so we want to highlight one company that has […]
GenVec: hearing a comeback
On the verge of shutting down just a few months ago, Genvec (NASDAQ: GNVC) has recently had a comeback that might last for a few more years if its partnered hearing loss program yields good results in the clinic. As some background, in early 2010, Genvec was running higher in hopes that its gene therapy […]
Quick Take On NBIX
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), […]
