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Howee, what besides the testosterone drug is included in the ATRS "commercial division" to which you refer?
I hope you are right but there is no evidence that the pipeline is getting recharged.
In 10 months, it will already be 2025. At that point, with no new partnerships, the pipeline will be running conspicuously dry. That little detail will not be ignored by investors who look beyond simplistic ratios.
Howee, that's a great analysis and I'd put my name on the bottom of that too, except for one major disagreement. I'm not convinced that the perceived lack of deals is due to some requirement of confidentiality by secretive partners. There are no instances of this in the past. We've always been informed about the large outlines of a new partnership, although it's true that sometimes the targets are not disclosed. Can you point to an example where we found out about a partnership deal long after the ink was dry?
Don't know about CFRA but wonder about your confidence in future growth prospects. Where will this come from?
Howee, how will it get better if they do not sign new partnership deals to keep the pipeline flowing?
As I understand it, this deal calls for low single digit royalties because it is a non-exclusive deal.
The frustrating thing is that this could well be a $100 stock if management could execute a plan with good vision for the future. With only ~$300 million in the bank and more plans to spend $750 million buying HALO stock (bringing the total spent on buybacks to an astounding $2 Billion!!!), they are clearly not capable of any acquisition. The only thing left to hope for is new partnerships, but these are seemingly less and less likely.
You can say I told you so. Still the pps is much closer to a $20 handle than it is to a $50 and we've seen this movie before. The stock is bouncing from the low $30s to the low $40s and can't break out back to the highs. This won't change until Helen delivers some substantial new partnerships to prove that this company has the ability to fend off the competition. If she does not in a reasonably short period of time the doubts will re-surface and the pps will start to sag once more.
JMP reiterates $72 PT and Outperform rating.
Dr. Torley quite blatantly threw cold water on this platform when asked about it. She is a politician, extremely adept at feathering her own nest, aggrandizing herself with imagined concrete results and expropriating the actual accomplishments of those that came before her, surrounding herself with yes-men and -women. What she is not is a deal maker. The non-refrigerated enzyme may have a ready market, but she is not capable of monetizing that.
Thanks. What is your source for determining the link between YpsoMate and Vyvgart?
She did say they were in meetings after the first of the year. That might explain why she failed to appear at the usual investor conferences recently.
H. C. Wainwright raises PT from $48-$50, maintains BUY rating
argenx Announces FDA Acceptance of Supplemental Biologics License Application
with Priority Review for VYVGART Hytrulo in Chronic Inflammatory
Demyelinating Polyneuropathy
https://ih.advfn.com/stock-market/NASDAQ/argenx-ARGX/stock-news/93315912/form-6-k-report-of-foreign-issuer-rules-13a-16
Prescription Drug User Fee Act (PDUFA) target action date is June 21, 2024
If approved, VYVGART® Hytrulo will be the first neonatal Fc receptor (FcRn) blocker to treat CIDP
February 20, 2024, 7:00 AM CET
Amsterdam, the Netherlands – argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review a supplemental Biologics License Application (sBLA) for VYVGART Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP). The application has been granted a PDUFA target action date of June 21, 2024.
“Today’s announcement brings us one step closer to delivering the transformative innovation of VYVGART Hytrulo to CIDP patients,” said Luc Truyen, Chief Medical Officer of argenx. “CIDP is yet another example of an autoimmune disease that has not been well understood, and for which there has been insufficient innovation for patients. We chose to use a priority review voucher to accelerate review of our submission because CIDP patients have long been waiting for new treatment options. FDA’s acceptance of the sBLA represents an important milestone in our continued drive to bring novel treatments for rare, autoimmune diseases, and a significant step forward for people whose lives have been profoundly impacted by this devastating disease.”
The sBLA is supported by data from the ADHERE study, the largest clinical trial of CIDP to date, evaluating the safety and efficacy of subcutaneously administered VYVGART Hytrulo in adults with CIDP. The study met its primary endpoint (p=0.000039), demonstrating a 61% lower risk of relapse (HR: 0.39 95% CI: 0.25; 0.61) with VYVGART Hytrulo compared to placebo. In the open-label Stage A of the study, 67% of patients showed evidence of clinical improvement (ECI) following treatment with VYVGART Hytrulo. Given the mechanism of action of VYVGART Hytrulo as an FcRn blocker, the clinical results established that IgG autoantibodies play a significant role in the underlying biology of CIDP.
VYVGART Hytrulo was well-tolerated with a safety profile that is consistent with prior clinical trials and the known profile of VYVGART®. After completing ADHERE, 99% of eligible patients (226/228) continued to the ADHERE-+ open-label extension study.
About Chronic Inflammatory Demyelinating Polyneuropathy
Chronic inflammatory demyelinating polyneuropathy (CIDP) is a rare and serious autoimmune disease of the peripheral nervous system. Although confirmation of disease pathophysiology is still emerging, there is increasing evidence that IgG antibodies play a key role in the damage to the peripheral nerves. People with CIDP experience fatigue, muscle weakness and a loss of feeling in their arms and legs that can get worse over time or may come and go. These symptoms can significantly impair a person's ability to function in their daily lives. Without treatment, one-third of people living with CIDP will need a wheelchair.
About VYVGART® Hytrulo (efgartigimod alfa and hyaluronidase-qvfc)
VYVGART Hytrulo is a subcutaneous combination of efgartigimod alfa, a human IgG1 antibody fragment marketed for intravenous use as VYVGART®, and recombinant human hyaluronidase PH20 (rHuPH20), Halozyme’s ENHANZE® drug delivery technology to facilitate subcutaneous injection delivery of biologics. In binding to the neonatal Fc receptor (FcRn), VYVGART Hytrulo results in the reduction of circulating IgG. It is the first-and-only approved FcRn blocker administered by subcutaneous injection.
VYVGART Hytrulo is the proprietary name in the U.S. for subcutaneous efgartigimod alfa and recombinant human hyaluronidase PH20. It may be marketed under different proprietary names following approval in other regions.
See FDA-approved Important Safety Information below and full Prescribing Information for VYVGART Hytrulo for additional information
Important Safety Information
What is VYVGART® HYTRULO (efgartigimod alfa and hyaluronidase-qvfc)?
VYVGART HYTRULO is a prescription medicine used to treat a condition called generalized myasthenia gravis, which causes muscles to tire and weaken easily throughout the body, in adults who are positive for antibodies directed toward a protein called acetylcholine receptor (anti-AChR antibody positive).
FWIW, today on mainstream daytime TV I saw a well-produced ad for Vyvgart and Vyvgart Hytrulo. I rarely turn on the television and almost never see daytime TV, so I don't know how often this spot runs but it was good to see.
On the other hand, if you look at the Halozyme.com website, you would be confused to find out that this drug is still in phase 3 and not listed among the commercially launched products.
You would also be falsely led to believe that subcu efgartigimod is still being developed for thrombocytopenia and pemphigus vulgaris despite these trials having been terminated for failure to meet endpoints.
At least Argenx is on the ball. Glad Helen is not running that company or any of our other partners.
Where does our new AI division manufacture their injectors?
I see your point but I wonder do we know if they are standard syringes or AI products?
Catalent is a CDMO, i.e., Novo bought them out to gain additional drug manufacturing capacity to meet the surging demand for the semaglutide products. I don't know how much the syringe part of Catalent played a role in the deal, if any at all.
Thanks for sharing the results of your hard work. Truly enlightening. If Halozyme is bought out, the drinks are on me, OncoJock.
Query: in the competitive battle between Merck and BMY that you mentioned, it would seem to me that Merck may have made a strategic blunder in choosing an independent and not yet approved subcu path over taking the shorter and surer route by partnering with HALO. Do you have any thoughts on this?
Thanks again,
-Fritz
As Biotechinvestor said, it's all about volume, i.e. mL. Have a look at the link in my response to the question.
Maumar, Thx. That is the heart of the matter, isn't it? There will be hard questions asked - but probably not answered - in the call next week.
Lighten up, Francis.
Geez........
Thanks, Oncojock, great analysis and I think you are on to something. The interest rate environment is certainly not conducive to biotech as a whole and your reasons are likely at the forefront.
That being said, there are many, perhaps hundreds of existing MABs and other IV drugs that would be clear candidates for an Enhanz partnership, with all of its commercial and clinical benefits and these are not coming to fruition, except in the instances where Halozyme's competitors are getting the deals. This is despite the fact that one would assume Enhanz might be the cheaper path to market due to its already robust safety and efficacy regulatory record.
Again, I accuse current management as just being plainly incapable of deal making.
The gentle reminder pertains to everyone, and I am the moderator because I am the co-founder of this discussion group.
(Rod , now lamentably long gone, was the true founder when we migrated over from Yahoo soon after HALO was uplisted and changed its ticker from HTI to HALO.)
I am biased against personal attacks and bad corporate management, so I plead guilty as charged.
A healthy debate is encouraged here and is of value to us all.
Once more, a gentle reminder to address the ideas in the posts and not your assumptions about the person behind the opinions.
No worries, the current happy talk narrative is that HALO, with its ginormous cash flow, will simultaneously be able to buy back shares, service the debt, and acquire new bolt on assets; all without any actual money in the bank. Get in now on this incredible opportunity!
Thus far, Helen has failed to deliver in 2024 as well.
It's true that HALO can't announce the exact target without the permission of the partner but they have always been free to announce the broad outlines of a new partnership (i.e., nature of exclusivity, number of targets, price of upfront payments and royalties) and have always done so.
Howee, I confess I'm not sure what you are referring to when you say "Xers".
I think all who are active on this board can agree on one thing: this is rather unusual behavior.
Correction: Guggenheim Biotechnology Conference has been taking place this week, not next.
Also it's Guggenheim not Oppenheimer. But you get my drift. LOL!
Generally agreed. I have learned, and am still learning, to take analysts' findings with a grain of salt, because, as you said, their interests are not necessarily aligned with the retail investor; nor are they infallible and all-knowing. Sometimes participants in message boards are more knowledgeable and have a better feel for the trajectory of a company. The analysts' collectively wide price target range for HALO (from the low $40s to the low $70s) speaks to a broad gap in motives, as well as, perhaps, full understanding. That being said, it's good to listen to their lines of questioning and to try to hear their unspoken subtexts.
In any event, Helen is not, as we speak, slated to perform at the Oppenheimer event, and that raises questions. But what about her leadership has not raised questions?
Friendly debate is good. I generally agree that the tenor of the calls is gentle and not overtly accusatory; but there are questions posed to her relating to the buyback program as it relates to the lack of cash and plans for future growth. Note that there were two downward revisions of the PT after the last dog and pony show, which I suspect are directly related to her answers, or lack thereof, on that front.
Equally true is the possibility that our CEO is aware that her happy talk is wearing thin and would prefer not to subject herself to the inconvenient chorus of increasingly skeptical questions.
Oppenheimer Healthcare conference is next week. Do you all think Helen will skip another chance to present? That would make a trend if she does.