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written by reader Questions for Doc KSS

By xiexgp, July 20, 2015

Guys: Lots of people are asking KSS questions, which he’s keen to answer. But tracking/remembering them all, without constantly re-reading the whole thread, is bustin’ his balls. So the below aims to act as a queuing list. Write it up and post your associated links to assist his research. The better the starter info, the more likely an answer.
Please also help the process by reminding others who post q’s on the main bio threads, that if they want an answer, this is the place to post or likely he will NEVER respond.

This is a discussion topic or guest posting submitted by a Stock Gumshoe reader. The content has not been edited or reviewed by Stock Gumshoe, and any opinions expressed are those of the author alone.

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danmcco
danmcco
July 20, 2015 4:32 pm

$TGXSF Tigenix – a Brussels based Biotech.

They have a Phase III trial for Cx601 an adipose-derived allogeneic stem cell suspension for the treatment of complex perianal fistulas in Crohn’s disease patients.

Phase II. Cx611 is an intravenous injection of allogeneic expanded adipose-derived stem cells (eASC’s) in development for the treatment of early rheumatoid arthritis and for severe sepsis.

As always, the science is over my head, but it does look interesting.

Institutional Holdings
Grifols S.A. / Gri-CEL S.A. 34,188,034 21.30%
Novartis AG/Novartis Bioventures Ltd 5,534,905 4.55%
Roche Holding AG/Roche 3%

Analyst Report
http://www.edisoninvestmentresearch.com/t/rl-download/14182/394/193/tigenix
Pipeline
http://static.cdn-seekingalpha.com/uploads/2015/1/13/7818891-14211502523559704-Logribel_origin.jpg
Marketing Request to EMA
http://www.tigenix.com/en/download/?s=EVmR%2F3e2Ke8oYFSrPjjI%2Fy45xFoQuFH8x2rdkmKj%2BvVzcTS9Y92cO0xXfAuUwTgGb8VnQuzhAfSU9HBIuhY3SA%3D%3D

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Gui_
Gui_
July 21, 2015 8:58 pm

Not a question, but a follow up to a post earlier (and a mention in another) on Honig and Blauser, 2 punks that attach themselves by whatever means to many Frost plays. These two are responsible for the losses I’ve suffered in 3 of the 7 Frost plays I’ve been involved with over the years.

A hit piece in SA just destryed IDI today to the point it may not recover. How much of the aricle is fact? No way for me to know, but I run away anymore, like a scalded dog when I smell their fetid prescence show up around my “stuff”.

“IDI: Strong Sell On Fraud Lawsuits, Bankruptcy And Technology Failure, -92.4% Downside – IDI, Inc. (NYSEMKT:IDI) ”

http://seekingalpha.com/article/3342225-idi-strong-sell-on-fraud-lawsuits-bankruptcy-and-technology-failure-minus-92_4-percent-downside

IDI: chart
http://stockcharts.com/h-sc/ui
.

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Owzat
Irregular
Owzat
July 22, 2015 5:39 pm

Immusoft Corp
Programming Cells to Cure Disease.
I have gained much from Dr. Kss’s writings and Gummie chats on the GS boards. Although I have a technical background, it is from a more mundane field of engineering, I do not have the skills to assess the technological merits of this prospect, or any biotech for that matter, the main reason you do not hear much from me here.
However, I attended an interesting presentation by Immusoft, an (very) early stage company last week. The website provides links to the company resources, technology and pipeline status.
If the technology/prospect checks out, it may be an appropriate target for a Gummie early stage investment at pre IPO via convertible debentures or such vehicle… some Gummie interest in identifying such opportunities in thread chat last week. I would certainly be interested in participating.

This is from the Immusoft website:
http://www.immusoft.com
Immusoft’s mission is to develop a breakthrough autologous cell therapy platform for treating a variety of human diseases through our proprietary Immune System Programming (ISP™) technology. ISP™ technology can effectively re-programming a patient’s own cells to become miniature drug factories in the body. The technology was designed to address current challenges faced with the production and delivery of conventional protein therapeutic drugs (biologics). The ISP™ platform enables safe insertion of genes encoding the correct human homolog of a missing or defective protein(s) into a patient’s immune cells using the Sleeping Beauty (SB) transposon system – a non-viral vector.
For decades, researchers have focused on gene therapy approaches to treat human diseases. Engineering viruses to insert or replace missing or defective genes with functional copies has been commonplace. However, engineered viruses require significant modification to efficiently infect target cell types, may be difficult to produce in the quantities needed for therapeutic use, most viruses’ have payload limitations, and are subject to immune clearance if seen as immunogenic (foreign to the body). Gene therapy involving viral transduction continues to be associated with real or perceived safety issues for therapeutic use in humans.
Immusoft’s ISP™ platform technology is hybrid cell/gene therapy approach, which uses a clinically validated, non-viral vector for safe, reliable insertion of functional genes into immune cells. Once administered back into the patient, a subset of ISP™ modified cells reside within survival niches in the body, continuously secreting gene-encoded protein(s). The platform’s broad utility to produce virtually any biologic drug entity, i.e. antibodies, proteins or enzymes, has the potential to disrupt the current standard of care for many diseases requiring recombinant enzyme replacement therapy, as well as, address orphan diseases with very small patient populations.

I have the slide deck from the presentation that I attended in pdf format if there is interest and a way up uploading or linking pdf’s to the Board.

I would be most interested and appreciative of Dr. KSS’s thoughts on this prospect. It’s in the queue and hopefully the good Dr. may find a moment to take a look.

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danmcco
danmcco
July 25, 2015 9:26 am

$MGNX

MacroGenics has a diverse portfolio of product candidates focused in three therapeutic areas: oncology, autoimmune disorders and infectious diseases.

In oncology, MacroGenics is conducting Phase 2 clinical development of MGAH22 (or margetuximab). MGAH22 is the first Fc-modified anti-cancer mAb produced from the company’s proprietary Fc optimization technology and targets tumors that over-express the HER2 oncoprotein, potentially including breast, bladder and gastric cancers. In mid-2011, MacroGenics began clinical development of its second anti-cancer mAb, MGA271, which recognizes a novel target (B7-H3), which is expressed on several solid tumor types. MGA271 is a humanized, Fc-optimized mAb that is being studied for the treatment of multiple solid tumors, potentially including prostate, renal and pancreatic cancers as well as melanomas. MacroGenics’ earlier stage oncology pipeline includes multiple programs for which the company expects to select clinical development candidates over the next several years.

The company’s lead autoimmune program, teplizumab, is an anti-CD3 antibody being developed for the prevention and treatment of early onset type 1 diabetes. In June 2011, MacroGenics announced the publication in The Lancet of results from Protégé, a Phase 3 clinical study of teplizumab in type 1 diabetes. Exploratory, post-hoc analyses suggest that teplizumab, an anti-CD3 monoclonal antibody, when used in a full dose regimen may preserve C-peptide and increase the percentage of patients requiring very low doses of insulin compared to those on placebo. In addition, these analyses identified certain subpopulations to be studied in future trials.

MacroGenics is also pursuing development of its own proprietary molecules for the treatment of inflammatory disease.MacroGenics’ infectious disease portfolio includes several antibody-based therapeutics for the treatment of infectious diseases from pathogens, including Dengue, smallpox and H5N1.

Management:
Scott Koenig, M.D., Ph.D.
President and CEO and Director

Dr. Koenig has been our President and Chief Executive Officer and a director since September 2001 and was one of our co-founders. Prior to joining us, Dr. Koenig served as Senior Vice President of Research at MedImmune Inc., where he participated in the selection and maturation of their product pipeline. From 1984 to 1990, he worked in the Laboratory of Immunoregulation at the National Institute of Allergy and Infectious Diseases at the National Institutes of Health, where he investigated the immune response to retroviruses and studied the pathogenesis of AIDS. Dr. Koenig currently serves as Chairman of the Board of Directors of Applied Genetic Technologies Corporation and the Children’s Research Institute. Additionally, Dr. Koenig serves on the Board of Directors of Children’s National Medical Center, the International Biomedical Research Alliance, and the Biotechnology Industry Organization (BIO). Dr. Koenig received his A.B. and Ph.D. from Cornell University and his M.D. from the University of Texas Health Science Center in Houston. We believe that Dr. Koenig’s detailed knowledge of our company and his over 29 years in research and the biotechnology industry provide a valuable contribution to our board of directors.

Dr. Bonvini, Senior Vice President, Research
From 1985 to 2003, Dr. Bonvini was with the FDA in the Center for Biologics Evaluation and Research, or CBER, which is responsible for regulating therapeutic monoclonal antibodies and other proteins, ultimately serving as Acting Deputy Director, Division of Monoclonal Antibodies and Chief, Laboratory of Immunobiology

Dr. Wigginton Senior Vice President, Clinical Research
Dr. Wigginton was previously the Therapeutic Area Head, Immuno-Oncology, Early Clinical Research and Executive Director, Discovery Medicine-Clinical Oncology at Bristol-Myers from October 2008 to August 2013.

Major Holders Breakdown
% of Shares Held by All Insider and 5% Owners: 27%
% of Shares Held by Institutional & Mutual Fund Owners: 44%
% of Float Held by Institutional & Mutual Fund Owners: 60%
Number of Institutions Holding Shares: 86

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danmcco
danmcco
July 25, 2015 2:05 pm
Reply to  danmcco

Xencor $XNCR is similar to $MGNX. Seemingly good mgmt, partnerships, Phase II products, larger institutional/insider holdings.

Unfortunately, I have no clue as to whether mAB technology is likely to succeed. Sorry 🙁

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Tim
July 26, 2015 5:50 pm

To: Dr. KSS
Re: AMBS
Amarantus Bioscience Holdings, inc.
I would love to get your opinion of this company?

The company has two divisions, but I see it’s greatest potential in Neurodiagnostics!
IMHO, I think AMBS has the potential to become a market leader in neurodiagnostics! Which currently has a 2.2 B Market cap!
Distribution channel in place to support U.S. / EU trials
Blood-based biomarkers…
LymPro test, BIG!
Screening subjects
CLIA certification of MSPrecise and LymPro
3B- commercial market.
AMBS’s modified MANF application for retinal artery occlusion should be cleared in Europe for orphan drug designation this week.

http://www.readability.com/m?url=http://finance.yahoo.com/news/amarantus-bioscience-holdings-inc-promising-221800517.html
http://www.readability.com/m?url=http://www.noodls.com/view/B884B4B36284681E7C35718D2F6C480EBEBE9B56
Thank you, for any opinions you can give?

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Dr. Shizz
July 26, 2015 6:38 pm
Reply to  Tim

Sorry, guess I didn’t sign in first. I just wanted to make sure I posted on the correct thread.

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raehepburn
July 26, 2015 9:54 pm

Dr. KSS, I would greatly value your opinion on Catalyst Pharmaceuticals – $CPRX. Below is some information on the company. Thanks.
6/25/15 CPRX Catalyst Pharmaceuticals Inc shares gained 7 percent to $4.27 after the company reported encouraging top-line results in proof-of-concept trial of vigabatrin in patients with Treatment-Refractory Tourette’s Disorder. Catalyst Pharmaceuticals, Inc. a biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating diseases, today announced top-line results in an open-label, proof-of-concept trial of CPP-109 (vigabatrin) used to treat patients suffering from Tourette’s Disorder (TD) that were refractory to all other previous treatments. One of four patients demonstrated a very clear, clinically significant reduction in tics, and two others showed about a 25% reduction in tics, but without subjective clinical improvement.
Catalyst Pharmaceuticals (CPRX +5.8%) initiates the rolling submission of its New Drug Application for Orphan Drug- and Breakthrough Therapy-tagged Firdapse (amifampridine) for the treatment of Lambert-Eaton Myasthenic Syndrome (LEMS). The rolling submission, intended to shorten the regulatory review clock, is a benefit of BTD status. LEMS is a rare autoimmune disorder that is characterized by muscle weakness in the arms and legs caused by the buildup of antibodies at the connection between nerve and muscle (neuromuscular junction). It commonly strikes people over the age of 40 and is prevalent in those with lung cancer. It affects ~4,700 people in North America. The European Commission approved Firdapse for the treatment of LEMS in 2010. Catalyst acquired the North American rights to the product in October 2012 from developer BioMarin Pharmaceutical (BMRN) as part of a strategic collaboration. Amifampridine enhances neuromuscular transmission by blocking the potassium channel. This causes depolarization of the presynaptic membranes which opens the calcium channel.
MLV & Co. initiated coverage on CPRX with a Buy rating and a $14.00 price target.

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SoGiAm
July 26, 2015 11:19 pm
Reply to  raehepburn

CPRX-Rae, there are quite a few comments on this equity in this thread:
http://www.stockgumshoe.com/2015/03/the-great-gallic-foie-gras-hack/
You may try going to the Search on the main page and querying the most recent threads first. No position. Best2Ya-Ben

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raehepburn
July 27, 2015 9:07 pm
Reply to  SoGiAm

Thanks, Ben. 🙂

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raehepburn
July 27, 2015 11:09 pm
Reply to  raehepburn

Hi Ben – I read through the article and there was no mention of $CPRX in the article so I started checking the most recent threads using the Control F feature. I have a really hard time getting this feature to work. Here’s what happens. I press Control F and a blue box opens at the bottom left side of the screen. I enter $CPRX in the blue box. Next to the blue box are two arrows one pointing up and one pointing down. I press the down arrow as I’m at the beginning of a thread, and the button ‘Highlight all matches.’ My computer gives a loud clang and the blue box turns red and nothing else happens. I then press the ‘x’ on the bottom right hand side of the screen to close out the box. I tried this with three different threads and the same thing happened each time. Then the Control F stopped working. By the box turning red, does that mean there are no matches in that thread or in all the threads? Why would the computer not let me use the Control F feature after 3 or 4 tries? Sorry to be a pain with all of this, but I don’t know who to ask. Thanks. Rae

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SoGiAm
July 27, 2015 11:27 pm
Reply to  raehepburn

Rae practice on a common word like “and” you shall see it it gives x number of them….every time you arrow down (or up) the cursor moves to that highlighted occurrence
don’t use the $ sign and since pagination you will have to move to the next block of 50 posts and repeat….as far the function not working try to close your browser and come back in….I have not experienced this.
While you are doing this I shall attempt to locate most recent CPRX post(s) by ZKSS Best-Ben

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SoGiAm
July 28, 2015 12:12 am
Reply to  raehepburn

CPRX-Rae, I give for the evening…I’m pretty sure Dr. KSS is not keen on this equity and his last comment was it was one of the most shorted for good reason Good night. Best-Ben

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raehepburn
July 28, 2015 11:31 am
Reply to  raehepburn

Thanks, Ben. I’m not having much success, but will try again a little later.

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jimbecker
jimbecker
July 27, 2015 2:43 pm

Does anyone have any thoughts on $BPTH?

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invest405
invest405
July 28, 2015 11:57 am

Dr. KSS,
What are your current thoughts on $PARN?
Thank you in advance for this, and for all your shared knowledge. You are very much appreciated.
SH

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SoGiAm
July 28, 2015 12:12 pm
Reply to  invest405

PARN-Simon check out this: http://www.stockgumshoe.com/2015/07/the-second-coming-of-transenterix/comment-page-6/#comment use ctrl+f once you get there Best-Ben

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invest405
invest405
July 28, 2015 12:32 pm
Reply to  SoGiAm

Thank you !

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raehepburn
July 31, 2015 2:03 pm

Long $EGLT – Egalet
Dr. KSS would really value your opinion on this company. I have listed some information below. Thanks.
Egalet, a fully integrated specialty pharmaceutical company, is focused on developing, manufacturing and commercializing innovative pain treatments. The Company has two approved products: OXAYDO (oxycodone HCI, USP) tablets for oral use only –CII and SPRIX® (ketorolac tromethamine) Nasal Spray. In addition, using Egalet’s proprietary Guardian™ Technology, the Company is developing a pipeline of clinical-stage, opioid-based product candidates that are specifically designed to deter abuse by physical and chemical manipulation. The lead programs, Egalet-001, an abuse-deterrent, extended-release, oral morphine formulation, and Egalet-002, an abuse-deterrent, extended-release, oral oxycodone formulation, are in late-stage clinical development for the management of pain severe enough to require daily, around-the-clock opioid treatment and for which alternative treatments are inadequate. Egalet’s Guardian Technology can be applied broadly across different classes of pharmaceutical products and can be used to develop combination products that include multiple active pharmaceutical ingredients with similar or different release profiles.

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kruffin
August 4, 2015 12:28 am

$BXLT, Dr.KSS or anyone interested, I offer we take a look at Baxalta. This was spun off by Baxter. If I knew how to copy and paste, I would have been glad to provide you with pertinent info. That said, you need only go to Yahoo, to get the full story.

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TomN
TomN
August 4, 2015 8:11 am
Reply to  kruffin

$BXLT (Yahoo) – Shire plc (SHPG) confirms that it made a proposal to Baxalta on July 10, 2015, to combine the companies in an all-stock transaction pursuant to which Baxalta shareholders would receive, for each Baxalta share, 0.1687 Shire ADRs. The proposal implies a value of $45.23 per Baxalta share and represents a significant premium of 36% over Baxalta’s stock price as of August 3, 2015. Baxalta has declined to engage in substantive discussions regarding the proposal.

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kruffin
August 4, 2015 11:51 am
Reply to  TomN

Hi Tom, I received 300 shares of $BLXT when it was spun off from Baxter. Shire has been in a buying mood lately. Would like to see Baxlata resist this offer.

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kuczynski
kuczynski
August 4, 2015 10:45 am

Dr. KSS,
When you have some “free time” (yeah, right, lol!) I would like your opinion/analysis on the products that ABMD manufactures. The stock has gone up from $25 in November to $87 today and I believe that it still has further to run. I’m long $ABMD with an average, for me, starter position.

$ABMD

Headquartered in Danvers, Massachusetts and founded in 1981, Abiomed Inc. (ABMD) is engaged in developing, manufacturing and marketing of medical products designed to assist or replace the pumping function of the failing heart. The company’s strategy focuses on heart recovery as the goal for all acute cardiac attacks. Abiomed’s products are designed to enable the heart to rest, heal and recover. The company’s products can be used in a range of clinical settings, including by heart surgeons for patients in profound cardiogenic shock. Profound cardiogenic shock is starvation of the cells, or not enough blood flow to the organs as a result of an imbalance between oxygen supply and oxygen demand. Shock is a result of a weakened heart that is unable to pump blood as efficiently as it once did. Shock commonly occurs after a heart attack. The company’s products can also be used by interventional cardiologists for patients who are in pre-shock or in need of prophylactic support in the cardiac catheterization lab (cath lab). The company has designed two FDA-approved products for heart recovery following acute events: the BVS 5000 biventricular support system (BVS) and the AB5000 circulatory support system (AB5000). There are two primary types of devices used in the cath lab and surgery suite for circulatory support for pre-shock and profound shock patients: intra-aortic balloons (IABs), an inflatable balloon inserted by a catheter that is used as an initial line of therapy in the cath lab or the surgery suite for patients with diminished heart function, and ventricular assist devices (VADs) that are mechanical devices which helps in the pumping function of the failing heart. To support the IAB, the company developed its iPulse multi-purpose console which also supports its AB5000 and BVS 5000 systems. The company also developed the AbioCor Implantable Replacement Heart for severe biventricular heart failure when chronic patients are ineligible for a heart transplant. In Europe, Abiomed offers the minimally invasive Impella Circulatory Support System.

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kuczynski
kuczynski
August 4, 2015 2:40 pm
Reply to  kuczynski

02:20 PM EDT, 08/04/2015 (MT Newswires) — ABIOMED(ABMD) saw its price target boosted to $96 from $89 by The Benchmark Company while the firm retained its buy rating on the stock.

Price: 89.51, Change: +12.11, Percent Change: +15.65

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Ron Oliver
Ron Oliver
September 14, 2015 2:04 pm

Dr. KSS,
RE: $PTLA
(I am a newbie at Gumshoe –this is my first post). My wife and I greatly enjoy your writing, the breadth of you knowledge, experience and style.
You provide a sense of security in a field that is new to us (Biotech) in a market that is challenging. You wrote about $PTLA in your article “Payola from Portola” on 11/12/14 and just last week my cardiologist recommended I start taking Eliquis. He did mention I could bleed to death if I were in a car crash as there is currently no “reversal medication.” He did say one is in the pipeline for the not too distant future.
He said that my taking Eliquis would reduce my current risk factor of a stroke or heart attack from 2% to less than 1 in 500, based on the risk factors of age (69) some arthrosclerosis of the aorta and my unresolved treatment so far of paroxysmal atrial fibrillation. I did notice that there have been many lawsuits related to internal bleeding from Xarelto (same class of medication) mention of bleeding from Pradaxa and that the “reversal drug” for Pradaxa was just given fast track for approval. I agree with you, “What was the FDA thinking when it approved these” to paraphrase your comments at the time.
My feeling about starting any these blood thinners at this point is that they pose a greater risk (from uncontrolled bleeding) than the risk they are offering to protect me from (stroke or heart attack), and my inclination is to wait until the reversal drug is in stock at the local ERs. My question is do you think this is a good time to invest in $PTLA or will the earlier release of a reversal drug for Pradaxa possibly keep it from doing as well as it might have without competition. and
RE: $ESPR
At the same cardiology appointment, as I was put on time release Cardizem and on Flecainide for the Afib, my statin medication had to be lowered to what we be a subtherapeutic level. Long $ESPR.
It is odd how personal your articles and the gumshoe discussions have suddenly become for me. Many thanks to all of you. Don

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pozoblue
Member
September 30, 2015 7:25 pm

PARN. Dr. KSS, any updated thoughts on this company at 9/30/15?

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