April 4 Biotech Update

As often happens when you have small children the best laid plans are often disrupted. So I am taking care of a child with a suspected strep throat infection (the irony is certainly not lost on me given how much time I spend researching antibiotics and the companies that are developing new treatments) and this […]

April 2nd Biotech Update

The sector was a little manic today in that the large caps continue to find a good bid but as you move down the market cap food chain the price action is more mixed. This makes perfect sense as investors are slowly coming back into the sector and are going after value and the security […]

Catalyst Watch – Vol. 2, Edition 9 (3/28/14)

Below are current tactical and strategic thoughts on approaching FDA and clinical trial catalysts for select names. Estimates, values and views are as of the date published (or are noted), are subject to potential future, pre-catalyst revision and are not intended as investment recommendations. Please read our Disclaimer: (1) Catalyst Watch List – Update: CYTK: […]

A Follow Up

Just a really quick update. I had a good email exchange with one of the lead ACLF trial investigators and he basically confirmed what CNAT noted in their CC. The exclusion/inclusion criteria were so restrictive that it was virtually impossible for anyone to qualify. The investigator was confident that the issues were corrected with the […]

March 26- Biotechs are Not Dead Yet

This is a better day but sellers still seem there but buying seems more concerted today. It appears that yesterday was the buyers dipping their toes in the water to make sure the coast was clear and today they seemed much more willing to put cash to work. As we saw with yesterday, however, the […]

INSM – Quick take on Insmed

 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 […]

March 21 Biotech Update

[This was written Friday but the site was down and I was unable to post it. I am publishing it as it was Friday and will write another column later today for more recent news] Well, it was a manic day with a very nice win followed by the broader morning bloodbath in the sector. […]

Quick Confirmation

I just talked to CNAT and confirmed that they have not seen any lipid abnormalities either at the pre-clinical or clinical stages. In addition, they noted that there is no reason to expect the emricisan mechanism of action to generate any lipid abnormalities. Obviously, this does not completely rule anything out but simply confirms my […]

Catalyst Watch – Vol. 2, Edition 8 (3/18/14)

Below are current tactical and strategic thoughts on approaching FDA and clinical trial catalysts for select names. Estimates, values and views are as of the date published (or are noted), are subject to potential future, pre-catalyst revision and are not intended as investment recommendations. Please read our Disclaimer: (1) Catalyst Watch List – Update: CYTK: […]

March 18 Biotech Update- Cause for Optimism?

This morning was much more encouraging than yesterday with the sector finally seeming to outperform the broader market. Obviously one day does not make a trend and even despite the price action; most of it seemed on fairly light volume so this could still be the pause that refreshes for the next move down. In […]

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 […]