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Why Gammacore will work in COVID 19 - “One of the receptors that is affected by acetylcholine is the alpha-7 nicotinic acetylcholine receptor (a7nAChR). Activating a7nAChR by acetylcholine reduces the production and release of pro-inflammatory cytokines, such as TNF-a and IL-6, from the immune system. As a result, activating the anti-inflammatory reflex mechanism modulates the exaggeration of pro-inflammatory cytokine effects (Reardon 2016; Zila et al. 2017; Chu et al. 2020). Although no drug that can be clinically effective on a7nAChR with minor side effects in humans has been discovered yet, however, vagus nerve stimulation has been used for therapeutic purposes.“
https://scholar.google.com.hk/scholar?as_ylo=2020&q=vagal+stimulation+and+COVID+19&hl=en&as_sdt=0,33#d=gs_qabs&u=%23p%3DcNoIlHFn7o8J
ECOR
No News is GILD News.
“Among patients with severe or life-threatening COVID-19, convalescent plasma therapy added to standard treatment, compared with standard treatment alone, did not result in a statistically significant improvement in time to clinical improvement within 28 days.”
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7270883/
Convalescent Plasma Fail - Lenzilumab next EUA. HGEN
Yes and Director of NIAID -Fauci - chose HGEN
No I’m not saying it’s public information - but GILD know Yescarta data- dropped MAV kept LENZ - so any positive BET data that their Rem investigators recognize may (I think it would( trigger HGEN purchase.
GILD related data - BET and Yescarta-Lenz data.
I expect Spanish data at the Neuromodulation meeting in Cadiz Spain on Sept 26. The principal ll Gamnacore investigator is Pres. Of Society.
Yes GMCSF is key - so Lenz is as well- HGEN CMO makes a great case in his discussion of knockout mice lacking one of each cytokine.
Data driven elevation of Lenz as sole Yescarta partner as NIAID pairs HGEN with GILD - data drives M&A .
Yes it was a wild ride!
Yes BET teams HGEN with GILD and GILD drops Mav for Lenz- partnering Yescarta solely with Lenz- has to be data driven- a GILD buyout may be reason for current silence. Durant doesn’t leave CEO or Chairman position if O’Day is taking over.
POTUS has criticized FDA- accuses them of Politically dragging their feet - he had no trouble recommending Placquenil- so he may be trying to light the fire under NIAID to release interim data on BET trial ahead of Election Day - he’s said that they’re going to wait Until after Election Day.
CYDY P2 - where’s Significance? “In the study, the primary endpoint showed early clinical improvement in symptom score at day 3 in patients receiving leronlimab. At day 3, more patients treated with leronlimab reported improvement in total clinical symptom score compared to the placebo group (90% on leronlimab arm versus 71% on placebo).” No p value or Hazard Ratio- merely more misrepresentation by a CEO who years ago misrepresented Vietnamese trinkets As “Genuine Indian Artifacts” - past is prologue. FDA will respond as they did on AIDS submission by CYDY.
Treating Severe COVID19 in Cancer Patients - “Severe cases of CRS can be associated with hemophagocytic lymphohistiocytosis (HLH) or macrophage activation syndrome (MAS), which involves, besides IL6, also interferon gamma (IFN-?) and granulocyte-macrophage colony stimulating factor (GM-CSF). Such cases may benefit from treatment with high dose steroids as well as precision medicines such as emapalumab, an FDA-approved monoclonal antibody that binds and neutralizes IFN-? and LENZILUMAB , an investigational monoclonal antibody that binds and neutralizes GM-CSF”
https://www.worldwide.com/wp-content/uploads/2020/04/Oncology-Article-COVID-19-In-Cancer-Patients-20200504.pdf
EIGR - Lambda is most paradoxical interferon :
“ IFN-lambda responses to dsRNA in the human infant airway epithelium are regulated by p38-MAPK and NF-kB signaling. High in vivo IFN-lambda production is influenced by virus type and associated with recurrent respiratory sick visits in young children.”
https://scholar.google.com.hk/scholar?start=50&q=interferon+lambda&hl=en&as_sdt=0,33&as_ylo=2020#d=gs_qabs&u=%23p%3DpIKe3q7igMIJ
ECOR “cytokine storm and the worsening of patients’ health status can be dampened or even prevented by specifically targeting the vagal-driven cholinergic anti-inflammatory pathway (CAP). The CAP is a concept that involves an anti-inflammatory effect of vagal efferents by the release of acetylcholine (ACh). Nicotinic acetylcholine receptor alpha7 subunit (a7nAChRs) is required for ACh inhibition of macrophage-TNF release and cytokine modulation. Hence, targeting the a7nAChRs through vagus nerve stimulation (VNS) could be of interest in the management of patients with SARS-CoV-2 infection. Indeed, through the wide innervation of the organism by the vagus nerve, especially the lungs and gastrointestinal tract, VNS appears as a serious candidate for a few side effect treatment that could dampen or prevent the cytokine storm observed in COVID-19 patients with severe symptoms. Finally, a continuous vagal tone monitoring in patients with COVID-19 could be used as a predictive marker of COVID-19 illness course but also as a predictive marker of response to COVID-19 treatment such as VNS or others.”
https://scholar.google.com.hk/scholar?as_ylo=2020&q=vagal+stimulation+and+COVID+19&hl=en&as_sdt=0,33#d=gs_qabs&u=%23p%3DolcEMIow6dEJ
Cowboy, SEngineering happy to share great HGEN news!
CMA for BMRN - BMRN will receive a “Conditional marketing authorisation“ -for Valoctocogene Roxaparvovec Gene Therapy for Severe Hemophilia A-
“The approval of a medicine that address unmet medical needs of patients on the basis of less comprehensive data than normally required. The available data must indicate that the medicine’s benefits outweigh its risks and the applicant should be in a position to provide the comprehensive clinical data in the future.”
https://www.ema.europa.eu/en/glossary/conditional-marketing-authorisation
“Make ElectroCore a Core Holding after an Outstanding Q2
8/20/2020“
https://www.google.com/amp/s/investorplace.com/2020/08/make-ecor-stock-a-core-holding-after-an-outstanding-q2/amp/
EMA will ignore Trumps FDA -greater Hemophilia need :
BA Analyst Meachum says we can still see EU
$BMRN
approval in 2020- EMA says 210 days til word on
$BMRN
Hemophilia approval - wow - even with clock stops - any day now : SAN RAFAEL, Calif., Dec. 23, 2019 /PRNewswire/ -- “BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) announced today that the European Medicines Agency (EMA) validated the Company's Marketing Authorization Application (MAA) for its investigational gene therapy, valoctocogene roxaparvovec, for adults with severe hemophilia A. The MAA review will commence in January 2020 under accelerated assessment.
EMA granted access to its Priority Medicines (PRIME) regulatory initiative in 2017 and recently granted BioMarin's request for accelerated assessment of this MAA-This submission marks the first marketing application submission in Europe for a gene therapy product for any type of hemophilia.
Evaluating a MAA under the EMA centralized procedure can take up to 210 days.”
BioMarin Submits New Drug Application to U.S. Food and Drug Administration for Vosoritide to Treat Children with Achondroplasia
Published: Aug 20, 2020
= “near term growth “- as is pending Hemophilia approval in EU - a larger market for Hemophiia than is the US
https://www.biospace.com/article/releases/biomarin-submits-new-drug-application-to-u-s-food-and-drug-administration-for-vosoritide-to-treat-children-with-achondroplasia/
BMRN
Sorry CitI - BA analyst Geoff Meachum (maintains Buy with $105 price target) and Canaccord Genuity analyst Michelle Gilson say you’re wrong-Gilson maintains a Buy rating on BioMarin Pharmaceutical yesterday and set a price target of $95.00.
According to tipranks.com/, Gilson is a 5-star analyst with an average return of 35.1% and a 63.8% success rate.
Bank America note on BMRN
”Approval still in the cards...just delayed
-perhaps 2 years“
Reiterate Rating: BUY | PO: 105.00 USD
$ECOR could erupt any minute on “data that will knock your socks off” -CMO on Fox Business.
No accelerated approval for $SGMO $PFE on 4/6 WEEK followup - $BMRN has triggered 2 year followup for all- Lead maintained.
https://endpts.com/sangamo-pfizer-are-catching-up-to-biomarin-and-spark-on-a-gene-therapy-for-hemophilia-a-with-a-long-way-to-go/
$BAC On $BMRN
“FDA has requested BioMarin provide 2-year annualized bleed rate (ABR) data for Roctavian to complete the filing package (which BioMarin expects to have in November 2021). 6-month phase 3 data showed 85%/100% reduction in mean/median ABR and 4- year phase 1/2 data showed a 95%/100% reduction, which gives us comfort in the reproducibility in 2-year phase 3 data. Notably, in the phase 1/2 dataset, the 2-year mean bleed rate improvement was better than in year 1 (99% vs. 92%) so we could see the 85% reduction potentially improve. If Roctavian can show anything near this in November 2021, we think BioMarin should have no problem getting approval.”
BABA will Bounce on Biden
EIGR is expected to release interim data from its Stanford Lambda Trial - I’m not too excited, given the emergent need for any slightly positive data regarding the treatment of SARS2 -see Remdesivir 4 day advantage- and the failure of the data monitoring committee - who already had their interim look/- to halt the study on efficacy - a little bird told me (when I was a vocal advocate of EIGR on Twitter)- that the data was less than compelling to that point weeks ago - certainly that might have changed. The recent insider buy certainly makes on hopeful that it has. A recent seeking alpha pump suggests the upcoming Progeria approval carries tge rest of the pipeline - have you seen how rare Progeria is?
HGEN Lenzilumab is now the sole GILD partner for Yescarta (CAR-T) Cytokine Storm:
“ClinicalTrials.gov Identifier: NCT04314843
Recruitment Status : Recruiting
First Posted : March 19, 2020
Last Update Posted : July 31, 2020
See Contacts and Locations
Sponsor:
Kite, A Gilead Company
Collaborator:
Humanigen, Inc.
Information provided by (Responsible Party):
Gilead Sciences ( Kite, A Gilead Company )
Study Details Tabular ViewNo Results PostedDisclaimerHow to Read a Study Record
Study Description
Go to sections
Brief Summary:
The primary objectives of this study are:
Phase 1: To evaluate the safety of sequenced therapy with lenzilumab and axicabtagene ciloleucel in participants with relapsed or refractory large B-cell lymphoma and identify the most appropriate dose of lenzilumab for Phase 2.
Phase 2: To evaluate the incidence of neurologic events with sequenced therapy given at the recommended Phase 2 dose (RP2D) of lenzilumab in participants with relapsed or refractory large B-cell lymphoma.”
No Mavrilimumab Trial to be found - it was the second choice back up anyway- apparently there is no need.
Cytokine Storm are Cytokine storms - same agents have elevated presence whether due to SARS2 infection or
CAR-T. This recent change in Gilead strategy is a not so subtle hint that Lenzilumab is working in their trial and will in NIH and HGEN trials. I’m all in.
CYDY Expose dragging on HGEN Price?
“ CytoDyn is in financial and clinical distress, newly filed annual report shows
By ADAM FEUERSTEIN @adamfeuerstein
AUGUST 17, 2020”
mRNA technology has the advantage over
$NVAX
prefusion protein/nanoparticle and
$JNJ
Adenovirus vaccines -“mRNA technologies have the potential to transform areas of medicine, including the prophylaxis of infectious diseases. The advantages for vaccines range from the acceleration of immunogen discovery to rapid response and multiple disease target manufacturing. A greater understanding of quality attributes that dictate translation efficiency, as well as a comprehensive appreciation of the importance of mRNA delivery, are influencing a new era of investment in development activities.” https://scholar.google.com.hk/scholar?hl=en&as_sdt=0%2C33&as_ylo=2019&q=advantages+of+mRNA+Vaccine+production+&btnG=#d=gs_qabs&u=%23p%3DsSlYIGLb08oJ
and of the 3 mRNA Vaccines,
$CVAC
requires the least nucleotide for dosing - so manufacturing will be fastest - a Billion doses via micro factory printing by mid 2021 - -Why Musk chose CVAC.
CVAC - Dirk and Bionewman -Self proclaimed Biotech “gurus”’ on $TWTR
have CVAC dropping from the Stratosphere today -so is my opinion of them.
HGEN will be September’s CVAC.
CVAC-I can’t keep my eyes off of it in the 90’s...
Hi Cowboy. With completion of total enrollment guided in the 3rd Q and primary completion listed as Sept 2020 - the end of Q3, the primary endpoint can still be read out before Q4- certainly there may be a short delay, but assuming the response is similar to the Comp use data, I believe only secondary endpoints will extend deeper into Q4 - the EUA however will be based on the primary endpoint. Durrant’s guidance takes the worry over Data Monitoring Committee halting for futility out of the equation.
P3 not futile & Set I up to win- Observations on 8/5 HGEN P3 update - P3 now mirroring Remdesivir
NIAID trial (300+100 BET patients will form the basis of a registration application )- “not requiring supplemental oxygen-no longer requires ongoing medical care; Not hospitalized, limitation on activities and/or requiring home oxygen; Not hospitalized, no limitations on activities).“ CEO has already gone on record that P3
Population is “NOT AS SICK” as the Comp use patients-YET ARDS is STILL included in secondary endpoints “Incidence of severe ARDS) Time Frame: Up to 28 days ]
Duration of ICU Stay [Up to 28d]
Ventilator-free Days [Up to 60d)”
Estimated Study Completion Not Changed - still 9/20-clearly the interim DMC futility analysis has come and gone & they recommended additional powering for current endpoints. Humanigen is clearly targeting the large middle ground choosing not to compete with Dexamethasone. Good move.
Just Out “ CVAC Doesn't Rule Out Accelerated Approval For COVID-19 Vaccine” - will have needed cooperation of German regulators.
https://www.google.com/amp/s/www.ndtv.com/world-news/curevac-doesnt-rule-out-accelerated-approval-for-covid-19-vaccine-2280291%3famp=1&akamai-rum=off
CVAC “ As determined by the Securities and Exchange Commission (SEC), which is in charge of IPO regulation in the United States, the underwriters of the IPO are not allowed to lend out shares for a short sale for 30 days.”
Mar 31, 2020
Investopedia › ask › answers
When Are Short Sales Accepted for IPOs? - Investopedia
HGEN Lenzilumab Anti-Cytokine competitor “ LLY baricitinib is associated with increased thromboembolic events, which is concerning given that COVID-19 patients are at risk of developing these events“ Not an issue for Lenz. Advantage Lenz.
When Durrant preannounced the impressive nature of the Comp Use Data - I couldn’t believe a CEO could make such a positive “forward looking statement” legally - so I didn’t add and wished I had- I have added another 50% since based on his preannouncing the additional Mayo data and again stating it is impressive.