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Q4 2020 COMMERCIALIZATION - “Should the trials prove positive, Humanigen envisions applying for a BLA, and based on the strength of tits data obtaining emergency use authorization (EUA) for lenzilumab, followed by a launch of initial commercial activities as soon as the fourth quarter. Within six months, the company envisions an expanded product launch and commercialization, followed by work on additional dose formulations and further international studies.“
https://www.genengnews.com/gen-edge/a-human-touch-vs-covid-19/
November Phase 3 Readout :” HGEN “the Phase III study, it is about halfway through enrollment, and expected to finish by end of September or early October, with data expected to be released about a month later”
https://www.genengnews.com/gen-edge/a-human-touch-vs-covid-19/
ISEE presenting at 3 meetings between now and
9/16 -just as Stargardts P2b trial ends - much news to relate
https://www.businesswire.com/news/home/20200903005119/en/IVERIC-bio-Participate-Upcoming-September-Investor-Industry
AMZN & BABA down 5% while HGEN even - hmm....
Trump and Durrant shaking hands at the White House over 80% improvement in the need for Ventilators- Cha Chiing !
Can't Imagine FDA Ignores MAYO 39 patient 80% benefit trial after approving Convalescent plasma which had NONE! EUA soon.
Such a difficult conference to access- wait for Company PR- I am
The Most Promising COVID baby was thrown out with the Bath water- Buying time- In what Bizzaro Universe is a study with such excellent data performed at the MAYO CLINIC not the stuff thyat Dreams are made of?!
Jim Birchenough MD WFargo- The Dean of HALO analysts- sounds like he will Upgrade HGEN based on the Mayo MD's answer to his questions.
My pleasure- great to confirm our decision to recognize a truly helpful Rx.
EUA, DSMB Interim Read, Uplisting all in Q3-4.
CFO gives Uplisting Guidance- makes it evident that its Coming Soon
Only Dexamethasone Patient out of 39 in MAYO study did poorly - Lenz helped more without Dexa- Not Needed.
TOO MANY ANALYST QUESTIONS!
Sirilumab Failed THIS WEEK- No Surprise- It Elevates GMCSF! This is More Evidence that HGEN Lenzilumab - Upstream of Myeloid Cell Activation- Works.
DMSB INTERIM P3 READ SOON - Should be a great fork in the road
HGEN Lenz EUA on 39 patient MAYO Data ? News at 11:30 ET - KOL conference
Added at 2.50 before the close- Data from Mayo Clinic on 39 patients is getting truly exciting - the price action is from Bizzaroland but an 80% reduction in Mechanical Ventilation at America’s #1 hospital is impressive- the better the data and the lower the price, the more I’ll add.
AS I Said Mayo 1st then the Beef
https://www.biospace.com/article/releases/humanigen-company-update/
Open Access Major ISEE Publication out in #1American Eye Journal Ophthalmology :
“Intravitreal administration of avacincaptad pegol 2 mg and 4 mg led to a significant reduction of GA growth in eyes with AMD over a 12 month period. As C5 inhibition theoretically preserves C3 activity it may offer additional safety advantages. A second confirmatory pivotal clinical trial is underway to confirm the efficacy and safety of avacincaptad pegol in slowing the GA growth (GATHER2 Study).”
Ssfety is key - disqualifies APLS in AMD.
https://www.aaojournal.org/article/S0161-6420(20)30845-9/fulltext?dgcid=raven_jbs_aip_email
ECOR promised “knock your socks off” data on Fox Business - now here’s 1st presentation since: Thursday-
https://www.google.com/amp/s/finance.yahoo.com/amphtml/news/electrocore-present-ld-500-virtual-120000040.html
I think Mayo additional data then BET - because of the NIAID ability to recruit - then P3 confirmatory
Hi Jay - I am not well versed in dilution - I’m a radical fundamentalist when it comes to investing - good data floats as many boats as Are lined up. Yes Actemra& Kevzara failed miserably and GILD showed us that the best GM CSF blocker is the one that attacks the ligand (Lenz) not the receptor (Mav) - so we’re in the right place dven though too many are joining us. Won’t be a problem at $50.
“The company has appointed David J. Kovacs, initially in a consulting role, to the newly created role of head of public policy relating to COVID-19 issues.
Commenting on the appointment, Dr. Cameron Durrant stated, "Given the recent news regarding our plans for a Phase III study of coronavirus treatment, we will be required to work across disciplines when interacting with regulatory and administrative agencies at the municipal, state, and federal levels, not only domestically but also abroad. David brings a unique perspective to the development of public policies relating to such issues and will assist in formulating and executing our plans in this area."
Mr. Kovacs has extensive experience shaping policy and financial strategy in both mature and emerging markets and currently serves as a strategic advisor for multiple public and private companies. Previously, Mr. Kovacs served in senior roles in private equity and the investment banking industry at such organizations as Blackstone Group, Citigroup, and the Hinduja Group*”
Not one to settle, David J. Kovac's work in leadership began with taking various investment banking and private equity positions to learn more about working with people and corporations. He became the managing director of The Hinduja Group*, a highly diversified organization with more than $50 billion under management, where he successfully implemented his talents with networking and understanding of people’s needs to cultivate smart business connections”.
David J. Kovacs has extensive experience with investment banking, private equity, and venture capital for new and established industries.
Read more: http://www.digitaljournal.com/pr/3874630?noredir=1#ixzz6WWHRjQDL
BET trial will introduce Lenz to the world. GILD will wish they bought ahead of data and held through.
My pleasure Jay / great time to add/ so I did
$ISEE
Zimura as a Rx of Wet AMD with Lucentis-
“All 4 groups achieved significant gains in visual acuity at 6 months, defined as gaining greater than or equal to 3 lines of vision, or 15 ETDRS letters. The group with the highest percentage of patients achieving significant visual acuity gains (60%) was the group that received .5 mg of Lucentis and 2 mg of Zimura on the same day. This was the same dosing group that achieved the highest success rates in the previous 1/2a trial of Zimura. Other dosing groups had the 2 drugs staggered or had the 2 drugs in combination with a follow-up dose of Zimura only at 2 weeks.” *
so 2 points- 1. It helps explain why Wet AMD is 1/2 as common with
$ISEE
Zimura than with
$APLS
Pegcetacoplan.
2.
$AGN
needs a new Wet AMD treatmeNT- makes
$ISEE
a more likely target for GA, Wet AMD, and Gene therapy.
* https://www.hcplive.com/view/zimura-lucentis-combo-safe-but-company-decides-not-to-move-forward
GM CSF regulates Compement in ARDS -HGEN is earlier and controls APLS Target - more important therapy in COVIID 19.
“ This study establishes immunoglobulin-driven dysregulated complement activation as a critical pathobiological mechanism regulating proinflammatory and pro-proliferative processes in the initiation of experimental hypoxic PH and demonstrates complement signaling as a critical determinant of clinical outcome in PAH.“
https://scholar.google.com.hk/scholar?as_ylo=2019&q=GM+CSF+and+complement&hl=en&as_sdt=0,33#d=gs_qabs&u=%23p%3DzXRexO4HUHwJ
@winnerpicker - welcome - this should be a profitable ride. Yes I see a very good chance GILD makes an offer in the 20’s (with run up ahead on MAYO data)
“If the antibodies work, a study from the Duke University Margolis Center for Health Policy estimates the United States alone could require nearly 40 million doses next year. But no one knows how far those doses would stretch, says Janet Woodcock, who is on leave from running the drug evaluation and research division of the Food and Drug Administration”
https://www.sciencemag.org/news/2020/08/designer-antibodies-could-battle-covid-19-vaccines-arrive
ISEE - Chairman of Ophthalmology at the Cleveland Clinic is pumping it over
$APLS
- case closed / Long,
Why Hire a CCO unless there something to COMMERCIALIZE?
https://www.businesswire.com/news/home/20200824005096/en/Humanigen-Appoints-Edward-P.-Jordan-Chief-Commercial
I added on today’s bargain price.
BMRN shorts will be “suprised and burned” by CHMP - will be SO NICE.
Hey Shorts-why didn’t the FDA inspect BMRN Valrox factory in Nevada, while the EMA inspected the BMRN Valrox factory in Ireland 3 months ago? Actions speak louder than words - FDA had no intention of Approving without more data and EMA does - Ask BA CSI Wedbush and Cantor.
MAYO next Catalyst
Durrant said @BET presser that MAYO additional data is next catalyst - soon
ECOR Only Noninvasive Vagal Stimulator for NHS - “Transparency Tender Notice on behalf of NHS England, citing electroCore as the sole supplier of non-invasive vagus nerve stimulation therapy to patients within NHS England. ”
https://www.globenewswire.com/news-release/2020/08/24/2082503/0/en/electroCore-Inc-Announces-Publication-of-a-Voluntary-ex-ante-Transparency-Tender-Notice-Award-by-NHS-England-to-Fund-Continued-Use-of-gammaCore-in-England.html
BMRN
Cantor Fitzgerald Note on BMRN 8/19- Price Target $125 from $129 - Overweight maintained:
“We think the base business alone (NPV, removing spend for pipeline) is worth $90/sh vs. shares at $76/sh currently. While CRL is a setback, we still see significant growth ahead for BMRN. We see potential for upside from execution across EU Roctavian review, vosoritide (achondroplasia, regulatory submissions accepted), and emerging gene therapy portfolio, coupled with manufacturing expertise. We note that the PKU gene therapy program is expected to dose its first patient this quarter and we think shares reflect limited credit to that program.”
BMRN
Wedbush analyst Liana Moussatos reiterated a Buy rating on BioMarin Pharmaceuticals-
– Research Report) today and set a price target of $136.00. The company’s shares closed last Wednesday at $75.04.
According to tipranks.com, Moussatos is a 5-star analyst with an average return of 12.2% and a 53.4% success rate.
HGEN will have new GILD partner - Tecartus for Mantle Cell Lymphoma
$GILD Gilead's Kite bags second CAR-T okay with Tecartus nod in mantle cell https://www.fiercepharma.com/pharma/gilead-s-kite-bags-second-car-t-okay-tecartus-nod-mantle-cell-lymphoma
“After receiving brexucabtagene autoleucel, large numbers of white blood cells are activated and release inflammatory cytokines which can lead to cytokine release syndrome, sometimes severe cases are referred to as cytokine storms”
https://www.oncolink.org/cancer-treatment/oncolink-rx/brexucabtagene-autoleucel-tecartus-r
“Planning for Launch” New CCO -“ We have been actively planning for launch as we develop our lead drug candidate, lenzilumab, for COVID-19. Ed’s long tenure in senior commercial leadership roles, coupled with his track record of building cross-functional teams to achieve significant objectives in highly competitive markets, make him ideally suited to further strengthen Humanigen’s commercialization plans," said Dr. Durrant.”