• Regenerative medicine company with late-stage studies in 3 indications • Ready to use GMP-certified manufacturing facility for PLX cells • Aging is often associated with debilitating medical conditions, massive unmet needs • Over 617 million people in the world are over 65 years old • Over 70 million people in the U.S. are over […]
Bria-IMT Combination Study with KEYTRUDA®: What the Early Data Show
BriaCell presented some data from the ongoing Phase IIa combination clinical trial of Bria-IMT™ with Merck’s (NYSE: MRK) KEYTRUDA® [(pembrolizumab)], as listed in ClinicalTrials.gov as NCT03328026, in advanced breast cancer at SABCS, as well as some additional monotherapy data. While the poster does not provide a lot of data on combination patients (as expected given […]
CEO Interview: Bellus Outlook Post the Positive Ph1 Chronic Cough Study
Back in August I published my deep dive report “Bellus – David vs. Goliath, Can BLU Deliver A Better Chronic Cough Drug Than Merck?” (Link) with a bull thesis stating that Bellus Health (TSX: BLU.TO) (OTC: BLUSF) have a good chance to pass the first true hurdle and achieve positive results from their clinical trial […]
Dave-Trading November 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 […]
Bria-IMT Combination Study with KEYTRUDA®: What to Know and Why
In a previous interview, BriaCell (TSX:BCT.V) (OTCQB:BCTXF) (or the Company)’s President and CEO, Dr. Bill Williams cited as a near-term catalyst data from the Company’s ongoing Phase IIa combination clinical trial of Bria-IMT™ with Merck’s (NYSE: MRK) KEYTRUDA® [(pembrolizumab) ], as listed in ClinicalTrials.gov as NCT03328026, in advanced breast cancer. Initiated in October, the study […]
Opinion: No, The Antibiotics Market Is Not Broken
In light of slow drug launches and disappointing sales, there is a growing chorus of voices saying the antibiotics drug market is broken; that the government must step in to save one of our most important resources. With no profits to pursue, it is said, companies will abandon antibiotics, leaving society vulnerable to the spread […]
Bellus – David vs. Goliath Round 2 – Can BLU Expand the Pipeline Following Merck Lead?
Back in August I published my first deep dive report “Bellus – David vs. Goliath Can BLU Deliver A Better Chronic Cough Drug Than Merck?” (Link) about Bellus Health (BLU.TO) (BLUSF) a biopharmaceutical development company based in Montreal, Canada. Its lead drug candidate is BLU-5937 which is a highly selective P2X3 antagonist that has the […]
APTO – We Came for A Trade and Back for The Long-Term Potential
The First time I met Aptose Biosciences (APTO) was at the Bloom-Burton conference in Toronto back in May 2018 following the request of several Chimera Research Group (CRG) subscribers. They asked me to check out the company’s presentation and try to get more info about the status of the clinical hold and when we might […]
Briacell Interview
Chimera Research Group: What sets Briacell apart from other immuno-oncology approaches? Dr. William V. Williams, President and CEO of Briacell: Briacell is developing a novel cancer immunotherapy based on a cancer cell line called SV-BR-1-GM a.k.a. Bria-IMT™. It was originally taken from a breast cancer patient, and further genetically altered to express GM-CSF, a stimulator […]
SRPT – Again, WMS-2018 Dystrophin Data Beating the Market Expectation
Yesterday 10/04, at 7:00 am ET, Sarepta Therapeutics (SRPT) with Dr. Mendell released the biopsy data from the fourth patient including full 4 patients “Functional Data” from Argentina at #WMS2018 the 23rd International Annual World Muscle Society meeting Link to the full slide deck: https://www.sec.gov/Archives/edgar/data/873303/000119312518292068/d616670dex992.htm The after-hours share price reaction was wild swing, spiking up […]
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 Pipeline Keep Growing – Is XEN007 The Next Surprise?
Last week, Xenon pharmaceuticals (XENE) passed one of the most important tests in the stock market, where the share price closed on Friday at $14.05, above the $14.03 resistance line, despite the news of the $50 million public offering, followed by the news of upsizing the offering to $63 million at $14.00 per share, only […]
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 – Quick note, Q2 Earnings and Epilepsy Long Term Value Creation
Follow up to my previous report “XENE – Epilepsy and Advocacy Under the New FDA” (Link) XENE released their Q2 earning report and hosted a conference call and webcast to discuss the 2Q 2018 financial results and provide corporate update. Xenon pharmaceutical (XENE) story keep evolving, with plenty of cash runway through at least mid-2020, as of […]
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 […]
BIIB Option Trade – A Response to Dave
Dave made a good case to play the BIIB data next week. He is leaning bullish, which could make price explode past $400. his downside expectation is between $300 and $320. Whenever I see elevated IV going into a catalyst, especially a biotech data catalyst, I like to see if there is a way to […]
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 […]
