Halozyme Therapeutics Incorporated (HALO) Quote

argenx Announces European Commission Approval of VYVGART Subcutaneous Injection for Chronic Inflammatory Demyelinating Polyneuropathy
June 20 2025 - 1:00PM

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VYVGART® SC, first-and-only IgG Fc-antibody fragment which specifically targets the neonatal Fc receptor (FcRn), now approved for use in Europe for CIDP
Approval based on ADHERE clinical trial, the largest study of CIDP patients to date
First novel mechanism of action for CIDP treatment in more than 30 years

June 20, 2025, 7:00 PM 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 European Commission (EC) approved VYVGART® (efgartigimod alfa) 1000mg for subcutaneous (SC) injection as a monotherapy for the treatment of adult patients with progressive or relapsing active chronic inflammatory demyelinating polyneuropathy (CIDP) after prior treatment with corticosteroids or immunoglobulins. VYVGART for SC injection is available as a vial or prefilled syringe and can be administered by a patient, caregiver, or healthcare professional. Treatment is initiated with a weekly dose regimen and may be adjusted to every other week based on clinical evaluation.

"The EC’s decision has been met with hope and enthusiasm by the European Patient Organisation for Dysimmune and Inflammatory Neuropathies (EPODIN). We see the introduction of a new targeted therapy for CIDP as a major step forward for the patient community," said Jean-Philippe Plançon, President of EPODIN.

CIDP is a rare, debilitating, often progressive, immune-mediated neuromuscular disorder of the peripheral nervous system. Patients experience a range of disabling mobility and sensory issues, including trouble standing from a seated position, pain and fatigue, and frequent tripping or falling. People living with CIDP can also become wheelchair bound and unable to work as the disease progresses. Currently, 85% of patients require ongoing treatment and nearly 88% of treated patients experience residual impairment and disability.

“CIDP can severely affect quality of life by causing weakness, loss of balance and mobility, numbness and pain in a patient’s arms and legs. For far too long, physicians have had limited options for helping to improve patient outcomes,” said Dr. Luis Querol, M.D., Ph.D., ADHERE Investigator, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain. “The approval of VYVGART SC for the treatment of CIDP marks a turning point in clinical practice, as physicians now have access to a new, effective treatment option that, for the first time, precisely targets a key mechanism of disease and provides meaningful functional improvements to patients.”

The EC approval follows a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) and is based on positive results from the ADHERE clinical trial, the largest study of CIDP patients to date. In the study, 66.5% (214/322) of patients treated with VYVGART SC demonstrated evidence of clinical improvement, including in mobility, function and strength. Clinical benefit was seen across all patient subtypes, regardless of prior treatment. ADHERE met its primary endpoint (p

And on two more side notes......

HALO has been busy working on more patent filings .....5 new filings for this old work horse...."PH20 POLYPEPTIDE VARIANTS, FORMULATIONS AND USES THEREOF".....now up to 28 US filings with 19 patents............US20250197836, 5, 4, 3 ,2

But, great, a new filing for slight modification of an old AI, which is for ever being modified........

https://www.freepatentsonline.com/WO2025128428A1.html

Who knows what any of the filings are for, except to keep employees busy, so far....

Whatever.......

Even if CMS discount (2028) applies to Enhanze combo therapeutics (unlikely), according to this article (seeking alpha see below) only Darzelex Faspro will be on the discount list. Darzelx Faspro outside of US and for patients with commercial insurance (not Medicare or Medicaid) will not face this 25% discount. So in terms of the effects on Halozyme earnings, it will be limited to one product (out of 10 approved so far) for CMS patients in the US only and only for a limited time (once biosimilar Darzalex is available, CMS is not allowed to disount per IRB). Based on my calculations the net effect on halo earnings would be around 5-7% for a limited time. Based on PE and PEG ratios, Halo is already trading at 50% discount compared to sector and industry. Huge overreaction! https://seekingalpha.com/article/4794953-halozyme-therapeutics-waters-become-muddled#scroll_comments

And on a side note......

HALO is trying to expand the market of Xyosted in about 2.5 - 3.0 yrs.....

https://clinicaltrials.gov/study/NCT06689085?term=halozyme&viewType=Table&aggFilters=status:act%20rec&rank=2

Awesome, should give BI1 another reason to buy more shares every week......U Goooo HALOoooo

Every former & present employee of HALO, every stock holder, every person needing this miraculous subcutaneous solution to their medical health & dignity is praying for Halozyme Therapeutics to not have Merck steal away this intellectual property !

I'm buying every week

The stock performance is because a LOT of investors are waiting to see if Merck (Goliath) gets away with STEALING
over 25 years of hard work from Halo (David).

Today’s stock performance, in my non expert opinion, is attributed to short selling. Looking at the short position in HALO, the last reporting period shows a 1.2 million share increase in the short position. How dumb and stupid do you have to be to short this company?!!!

Let's for a moment, assume the worst possible scenarios:
1) Merck does not sign a licencing agreement for MDASE
2) Merck succeeds (very unlikely) to invalidate every single claim (about 20 in each patent) in all 13 patents that are in PGR's
3) Merck wins the infringement New Jersey court case (also unlikely)
4) CMS final guidelines does not recognize (unlikely) the significant clinical benefits (reduces side effects, improved efficacy, pt funstion, etc.) of ENHANZE 
Even if all 4 of these unlikely scenarios take place, should a company with an EPS CAGR of +25% (far better than market and industry averages) and EBITDA margins growing 8% per year from 51% to 73%-75% (also better than market and industry averages) be trading at a PEG ratio of 0.3 and 2025 PE ratio of 10 when average S&P 500 and average biopharma is trading in PE ratios of mid 20's? 
For the discerning investors, the answer is no. Anybody spending enough time to read quarterly reports knows that halozyme has given multi-year earnings projections that are based on Enhanze and does not include a dime of revenue from MDASE. So if halo win the MDASE battle with Merck, it would be icing on the cake but if Halo loses, it will not diminish their multi-year guidance by a dime.
Regarding CMS, if the decision goes against Halo, at worst, one or two of halo's partnered products may end up on the list of 15 CMS negotiated/discounted drugs. This means a 25% discount only on those 2 meds and only in the US. About half of Enhanze earnings come from outside US and will not be affected. So it would really be a 12.5% discount only.

I was confused by that as well.

Today Mark said "the first-filed PGR instituted for trial on March 2, 2026, with the decision to follow by June 2, 2026. That's really where the action is."
 He was asked a follow-up question about multiple patents that are in dispute and under PGR potentially. He replied "we think that the issues of importance are going to be in this first trial. That's really where the action is going to be. That's really the thing to be paying attention to ...that's the next big event that we would like people to be paying attention to."
But on the May 6 earnings call, Helen said the PGRs were "a little bit of a sideshow and the most important one is actually the actual lawsuit that we filed. I'd keep your attention on that one."

Why the mixed messages? 

Thank you for all your work on these postings.

Helen at GS today (transcript):https://www.investing.com/news/transcripts/halozyme-at-goldman-sachs-conference-subcutaneous-innovation-drives-growth-93CH-4087223

During the last earnings call, CEO stated: “Obviously, the PGR we consider to be frankly a little bit of a sideshow. PGRs tend to be filed when companies are concerned that they are infringing and they seek to invalidate the patents. We feel very confident in our ability to prevail in those PGRs. And even if they were to win one or two of the PGRs because there are several in place, we do not believe that will have any impact at all on our infringement at case where we have multiple additional claims that are not subject to the PGR that are the basis of that infringement case. So, two very separate things. The most important one is actually the actual lawsuit that we filed. I’d keep your attention on that one.” https://www.stockinsights.ai/us/0001159036/earnings-transcript/fy25-q1-e012

Merck clearly knew they were infringing on Halozyme's patents. There is a good chance they (Merck) is now putting up a fight simply to get the best terms in a negotiated MDASE license with halo. They (Merck) were successful in getting the USPO to institute a review on one of Halozyme's patents. Although Merck will ultimately lose some (if not all) of the PGR's, this (the initiation of a review) is a small win for Merck. However, it will likely be all downhill from here for Merck's position. If they don't negotiate a deal with halo now, they will have to do so from a weaker position later, especially if New Jersey court puts a hold on SC Keytruda in an injuction.

Let's see what Helen has to say about Merck at Goldman Sachs at 10 am ET.

What's the Ackman Harvard story to do with HALO?

The percentage of profitable recommendations made by Mohit Bansal is 50%, and the average return per transaction is 2.40%.

i'm sorry... :(

https://news.bloomberglaw.com/health-law-and-business/halozyme-shares-dip-as-wells-fargo-flags-review-in-patent-case

https://www.gurufocus.com/news/2869932/harvard-on-fire-ackman-demands-entire-board-resign-in-explosive-showdown

You are forgetting that Merck would have to prevail in invalidating every single claim in every single PGR. For example in patent #600 (PGR 006) alone, there are about 21 claims in different categories. Claims 1-4, 8-10: Focus on the modified PH20 polypeptide itself, either as a base composition •  Claims 11-13: Cover genetic tools (nucleic acid, vector, host cell) for producing the polypeptide. •  Claims 14-18: Cover pharmaceutical compositions containing the polypeptide, alone or with other agents. •  Claims 19-20: Describe methods of administering the compositions. •  Claim 21: Describes a method of manufacturing the polypeptide. “If any of these remaining claims are upheld as patentable following the trial, the ’600 patent will remain valid with respect to those claims. Conversely, if all remaining claims are found unpatentable, the patent would be invalidated.” So for Merck to succeed they have to successfully invalidate every single claim (about 20 in each patent) in every single patent (the 13 they are trying to invalidate through 13 PGR  filings), AND win the jury infringement trial (separate matter than PGR’s) for everyone of these 13patents plusthe additional 2 patents that they are not even disputing through PGR’s. 
Odds are against Merck.

pgr2025-00053 has been added. A total of 13 pgrs have been registered, 1 pgr has been initiated and will be initiated sequentially. Halozyme's breathing is getting tight.

"Btw, Merck is using the PTAB, a mechanism to review wrongly-granted patents, to challenge Halozyme’s patents. Ironically, PhRMA, where Merck is a long-standing member, is lobbying to pass the PREVAIL Act to gut that very mechanism."

GO FOR IT!

Not all these PGR's are the same. For some (eg. 003, 004 and 009), Halozyme did not file a Discretionary Denial motion. But for others (eg. 006 and 017), Halozyme did.
Merck needs to win all of these PGR's. Halo needs only one to go its way.
https://portal.unifiedpatents.com/ptab/case/PGR2025-00006

That is the truth. 

Merck will lose this against HALO !
You can't steal the technology & prevail !!

Sold out. Paid a great dividend and got a great price. Look up refac technologies inc. Eugene lang was the ceo and chairman. Long time ago.

Because there’s an underlying lack of confidence in the company’s long term growth.

I don’t understand—just because the Patent Office has agreed to review a claim, why does that weaken HALO’s patent? Is it possible that HALO’s patent is strong and that they will prevail? Another analyst reaching speculative conclusions.

Wells Fargo analyst Mohit Bansal notes that PTAB has instituted Merck’s (MRK) patent grant review against Halozyme Therapeutics (HALO) MDASE patents. This patent is one of the patents Merck is fighting against Halozyme. The firm believes this likely reduces the probability of Halozyme prevailing in this case and weakens the bull argument. Wells has an Equal Weight on Halozyme with a price target of $65 on the shares.

What happened to them? I don’t see a ticker for them.

Years ago I owned stock in a company called Refac. All they did was own license and protect patents. Did very well. The fact that Mdase has no sales is not relevant.

Nobody has signed a single deal involving Mdase.

Correction: PGR 003 (not 006)

One more reason (not mentioned in my previous post) why odds favor Halozyme's sucsess in the patent dispute: Merck would have to prevail in invalidating every single claim in every single PGR. For example in patent #600 (PGR 006) alone, there are about 21 claims in different categories. Claims 1-4, 8-10: Focus on the modified PH20 polypeptide itself, either as a base composition •  Claims 11-13: Cover genetic tools (nucleic acid, vector, host cell) for producing the polypeptide. •  Claims 14-18: Cover pharmaceutical compositions containing the polypeptide, alone or with other agents. •  Claims 19-20: Describe methods of administering the compositions. •  Claim 21: Describes a method of manufacturing the polypeptide.
“If any of these remaining claims are upheld as patentable following the trial, the ’600 patent will remain valid with respect to those claims. Conversely, if all remaining claims are found unpatentable, the patent would be invalidated.” So for Merck to succeed they have to successfully invalidate every single claim (about 20 in each patent) in every single patent (the 12 they are trying to invalidate through 12 PGR  filings), AND win the jury infringement trial (separate matter than PGR’s) for everyone of these 12 patents plus the additional 3 patents that they are not even disputing through PGR’s. 

XBI up 1,3%, HALO down 4,1%, Alteogen up 8,8% today. Clearly, the market doesn’t think we got good news yesterday.

…or tank on any bad news. This stock is highly sensitive. Any negative patent news or new rival tech in advanced stages would put this somewhere in the 40’s. And why hasn’t there been a significant new deal in the last couple of years when the CEO keeps telling us they’ve been in talks that whole time? They need either a new major partnership or something innovative. Without either of those, this stock is a ticking time bomb.

I bought more today too

Added more trading shares today. They will be ready to jettison between $68-$75+ based on news, partnerships, deals etc. Probably by next earnings call we should hear of something tangible lol! GLTA

Halozyme’s officers and directors, if you so not have enough confidence to personally buy shares at a PEG ratio of 0.3 and 2025 PE ratio of 11, you should step down and let others lead. It is absolutely absurd for a company withEPS CAGR of +25% and EBITDA margins growing 8% per year from 51% to 73%-75% to be trading at such ridiculously low valuations. Do your jobs or step down.

See page 19 on Nanoform's presentation (link below). They have the one pill (oral) in clinical trials. Their subcutaneous technology has not even finished preclinical (animal trials) yet. Then they will have to do phase 1-3 trials in humans. It willl be 7-10 years before they have anything subcutaneous on the market (that is if they find a partner who would fund the trials). They are hoping to find a partner in 2026-2027 to fund the clinical trials. Then you are looking ag another 5-7 years.
They are not a threat for several years but should stay on halo's management radar. If clinical trials are looking good, maybe Halo should buy them out.
https://nanoform.com/en/wp-content/uploads/sites/2/2025/05/Nanoform-Management-Presentation-Q1-2025-Report.pdf

Time to buy more.
The losers have come out on a bad trading day.
They will be eating crow in the near future.

One of the 12 has been started and will proceed gradually. As a result, the mdase patent will be invalidated and the patent dispute lawsuit of Halozyme will be dismissed. Because the infringed patent itself will disappear. lolololololololo

Oh my god! Halozyme's breathing is getting tighter and tighter!

"Obviously, the PGR, we consider to be, frankly, a little bit of a sideshow. PGRs tend to be filed when companies are concerned that they are infringing and they seek to invalidate the patents. We feel very confident in our ability to prevail in those PGRs.
And even if they were to win 1 or 2 of the PGRs because there are several [7] in place, we do not believe that will have any impact at all on our infringement case where we have multiple additional claims that are not subject to the PGR that are the basis of that infringement case, so two very separate things. The most important one is actually the actual lawsuit that we filed. l'd keep your attention on that one."

I’m losing confidence in Halozyme. It’s a one trick pony that can’t make new deals. Very fragile. I should have sold off a bunch more at $70.

To little, to late, to slow to attack. Try making some dang deals!!!

"This innovation marks a significant step forward in patient-centric care, enabling a simple, hyaluronidase-free subcutaneous injection of a full dose in a single 2mL syringe,” said Prof. Edward Hæggström, CEO of Nanoform. "

This is going to hurt, IMO.

"DEVELOPMENT OF NANOFORMED TRASTUZUMAB FOR SUBCUTANEOUS INJECTION TO BE PRESENTED AT DDF SUMMIT IN BERLIN "

https://storage.mfn.se/bb1a1c0e-aea9-4d00-bfa3-2f09d3bdb954/development-of-nanoformed-trastuzumab-for-subcutaneous-injection-to-be-presented-at-ddf-summit-in-berlin.pdf

Merck is infringing on 15 of Halozyme's MDASE patents. Merck has asked US Patent trial and Apeal Board (UPTAB) to invalidate 12 of these 15 patents. UPTAB started the review process on one these patents (Patent 11,952,600, PGR2025-00003) yesterday. A decision will be made after April 2026 per UPTAB document released yesterday.
For Merck to succeed, it needs to win all of the 12 invalidation cases and still win the NJ Federal Distrist Court infringement case (separate jury trial than the UPTAB review). Unlike Merck, for Halozyme to succeed, it only needs to a) win one of the UPTAB reviews, or b) win the jury trial, or c) have Merck sign a licensing deal. Not only halozyme has the more compelling legal arguments but also unlike Merck, halo has multiple paths to succeed. 

"A phase I clinical study to evaluate rapid, high-volume, subcutaneous auto-injector tolerability with recombinant human hyaluronidas"

They keep trying, from preclinical testing to running their own Phase 1 trial. Info looks good and again, Takeda IgG was used.

"The test solution was composed of 10% (100 mg/mL) IgG solution (GAMMAGARD LIQUID [32], Baxalta Inc., a Takeda Company, Lexington, MA, USA) co-administered with 4000 U/mL rHuPH20. The viscosity of the IgG solution was 3.4 cP."

One of these days......a HVAI deal......