Dave Trading – September 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 […]

XENE – Quick note, Positive TMS Data Presented at The European Congress on Epileptology

Today morning, Xenon Pharmaceutical (XENE) reported positive data from its XEN1101 Phase 1b transcranial magnetic stimulation (TMS) study. (LINK) XEN1101 Demonstrates Statistically Significant Reduction in Corticospinal and Cortical Excitability as Measured by TMS-EMG and TMS-EEG XEN1101 Demonstrates Greater Effect on TMS-EMG Resting Motor Threshold at Significantly Lower Dose When Compared to Historical Ezogabine Data XEN1101 […]

Dave Trading – August 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 […]

Bellus – David vs. Goliath Can BLU Deliver A Better Chronic Cough Drug Than Merck?

BELLUS Health (BLU.TO) (BLUSF) is a biopharmaceutical development company based in Quebec, Canada, its pipeline includes several partnered clinical-stage drug development programs, but the company’s lead drug candidate is BLU-5937 which is a highly selective P2X3 antagonist for chronic cough and has the potential to be a best-in-class therapeutic for chronic cough patients who do […]

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 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 […]

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 […]

PSTI – Ahead of IC Phase-2 Top-Line Results

PLURISTEM (PSTI) a cell therapy company, developer of placenta-based cell therapy product candidates for the treatment of multiple ischemic, inflammatory and hematologic conditions, company I’m following for years.  Pluristem trading under the radar and getting even more interesting these days as they already enter late-stage trials in 3 indications, gained the FDA’s Fast Track Designation, EMA’s […]

Dave Trading – May 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 […]

SRPT Was and Still The DMD Gene Therapy Leader

Today after the market close, Solid Biosciences (SLDB) announced it has received notification from the U.S. Food and Drug Administration (FDA) that IGNITE DMD, its Phase I/II clinical trial for SGT-001 microdystrophin gene transfer in Duchenne muscular dystrophy (DMD), has been placed on Clinical Hold. The news sent SLDB share price down to $11.90 or […]

Celldex: Quick Take

Celldex has struggled for a couple years now since its brain cancer drug Rintega failed in 2016. In Q2 this year, results from a pivotal study of the gpNMB antibody drug conjugate, Glembatumumab Vedotin, may change the company’s fate. Glembatumumab is being tested in women with triple negative breast cancer with >25% gpNMB expression. Patients […]

Dr. James Wilson Paper About Safety Concerns, Is Not Sarepta’s Concern!

Today morning, most of the gene-therapy stocks including SLDB, AVXS, ONCE, RGNX, BOLD, ABEO and even SRPT Stumbled following Dr. James Wilson paper published online “Severe toxicity in nonhuman primates and piglets following high-dose intravenous administration of an AAV vector expressing human SMN” (link to the paper) highlighting the toxicity in NHP- non-human primate study. […]