XENE – Epilepsy and Advocacy Under the New FDA

Xenon Pharmaceuticals (XENE) is a clinical stage biopharmaceutical company focusing on discovering and developing innovative therapeutics for neurological disorders. XENE has an extensive knowledge of human genetics and diseases caused by mutations in ion channels, known as channelopathies, focusing their efforts on novel product pipeline of CNS-central nervous system therapies, to address areas of high […]

August 6 Biotech Update

A slow start to the week in which there are a lot of earnings calls but likely nothing to change the course of the sector. That has already been set by the large caps and we still need them to stay within striking distance of news highs if not break through them this week. It […]

August 3 Biotech Update

I will quickly finish up the week as there are a couple of interesting tidbits and the broader trading is more or less the same. There are some areas of strength but its relatively isolated but there is also not a ton of broad weakness either. Barring an awful day today the sector should end […]

August 2 Biotech Update

The sector continues to hold up in terms of price action relative to the broader market. If the market can at least stabilize, the sector has a good chance to eventually regain and perhaps break through recent highs. Obviously, all bets are off if the broader market collapses. My inclination is that the tech and […]

August 1 Biotech Update

The sector recovered a little yesterday from last week’s sell-off but ideally we would need to see the sector break into new highs. It seems highly likely that the sector tests the recent highs and the price action at that point is likely to be a strong signal of underlying strength. Given the fundamentals and […]

July 31 Biotech Update

I am still trying to catch up on all the earnings and happenings last week but I wanted to talk about two broad observations. In some ways, I benefited from not being able to watch the price action last week and only really looked at the news. In general, the price action does not reflect […]

Dave Trading July 2018

*** David Sobek is a disciplined value investor.  Using models, research, and fundamental data, David devises a value for biotech stocks, buys when significantly undervalued, and sells when significantly overvalued.*** As a reminder, this is my personal guide.  You can alter it in accordance with your risk tolerance. >3 Standard deviations – No position 2-3 […]

July 20 Biotech Update

Not a ton of news to end the week as the sector continues to drift around. This is not completely surprising given the earnings coming next week. I will be out of town on vacation all of next week, so there will be no updates. I will catch up the week after next but on […]

July 19 Biotech Update

The sector has hit a rough patch as we get into earnings season. The market itself has not been stellar, so I would not read this as some early take on the big set of earnings next week. In fact, large biotech has tended to do relatively well on these sell offs so despite the […]

July 17 Biotech Update

The lack of news continues as well as a generally weak market. While it certainly was not strong yesterday (and to start today), it feels more like indifference than a strong push by the bears. This does not mean it could not morph into something more meaningful but at this point it seems more like […]

July 16 Biotech Update

Not a lot of news this morning so I will keep it quick. We will have some earnings but large pharma tends to not be a leading indicator for biotech earnings but we will certainly watch to see if there is anything meaningful in the earnings or how the respective stocks react to the earnings. […]

July 13 Biotech Update

While we are talking about small numbers and small difference, I would argue that it looks like large caps are finally starting to show some relative strength to SMID. I would argue that this is a better case to build a new breakout than one led by SMID as those moves are likely more driven […]

July 12 Biotech Update

I think we are entering a lull in the sector as we are approaching earnings seasons. In general, this tends to be a better season than the first but that also means expectations are a little higher. A good earning season would see no major misses and at least a couple beat and raises from […]

FDA GT Draft Guidance is Bullish for Sarepta's DMD Pivotal Trial

Yesterday July 11, 2018 the FDA FDA issues 6 new draft guidance documents for gene therapy, clinical development and manufacturing guidance. Human Gene Therapy for Rare Diseases – FDA Draft Guidance for Industry https://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/CellularandGeneTherapy/UCM610802.pdf   The FDA guidance noting the pre-existing antibody to GT, this is the strongest SRPT’s & Dr. Mendell point, choosing the AAVrh74 which […]

July 11 Biotech Update

Apparently my effect is now hitting the broader markets as they are pretty weak today. It could be more trade tensions with the Trump administration amping up the trade war rhetoric with China but I would not discount my impact. That being said I would not be looking for the sector to trade green in […]

July 10 Biotech Update

So I stay away and the sector does well and now that I am back, let us see how it does. I apologize for any weakness that my return causes but the sector has been demonstrating some decent strength in the past days. On the positive side, it seems related to positive fundamental news and […]

July 2 Biotech Update

Apparently I am the problem with the sector. I miss one day and the sector moves higher and now that I am back it is back to going lower. I would argue that today seems to be driven more by the broader market but it is still going down. On the positive, I will be […]

June 28 Biotech Update

I tried to hold out as much hope for the sector as possible but the selling has been non-stop since the false breakout. The first bit of selling made sense against a weaker market and a natural retest of the breakout but it has not stopped and one could possible argue that it accelerated. It […]