Halozyme Therapeutics Incorporated (HALO) News

Halozyme cannot proceed with additional contracts for pd-1 while it has an exclusive contract for pd(L)-1 target. That is why Impinji and Enhertu came to Alteogen. You are finished now.

You're sharp biotechinvestor1 !! I'm still pretty sure Merck STARTED Alteogen to copy Halo tech! (In S. Korea to try &
pull this off!)

You are clouding the point.
In recent years, Halozyme has not had a history of contracts, while Alteogen has concluded contracts with Daiichi Sankyo and AstraZeneca.

Yes, I remember now. You are the Alteogen share holder who posts here from time to time!

Nonsense!

Daiichi Sankyo and AstraZeneca have already completed the payment of the contract deposit. The contract deposit is not small, but did the global big pharma really make such a risky decision? If we look into it, it can be indirect evidence that the patent stability of Alteogen technology is considerably high.

So does the mdase patent have actual substances?
As far as I know, it is a broad scope with no actual substances.

The mdase patent is an empty patent with only a shell as an extension of the improved concept of the enhanze patent.

You are confusing ENHANZE and MDASE. Two different sets of molecules, patents and agreements. BMS has an exclusive contract for  Enhanze/hyaluronidase and PD-1's. This exclusivity does not extent to modifies hyaluronidase (i.e. MDASE)

If Merck resolves the patent issue through a licensing agreement with Halozyme, BMS, which has exclusive rights to Halozyme and Target, will sue you. BMS has exclusive rights to use Halozyme technology. Please refute me.

Thanks for the post. Very interesting! I did not know about this history. Merck seems to have a long history of infringing on others patents only to pay up for it. Won't be surprised if they end up paying to halo as well. JPM's Jessica Fye thinks they will.

Interesting fact from 2017 which gives insight into why BMS operated Opdivo the way they did and let Keytruda take the lead.


Merck Announces Settlement and License Agreement Resolving KEYTRUDA® (pembrolizumab) Patent Litigation

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January 20, 2017 4:01 pm ET

Merck (NYSE:MRK), known as MSD outside the United States and Canada), and certain of its affiliates, today announced it agreed to enter into a settlement and license agreement with Bristol-Myers Squibb Company and Ono Pharmaceutical Co., Ltd., resolving the worldwide patent infringement litigation related to the use of an anti-PD-1 antibody for the treatment of cancer, such as KEYTRUDA® (pembrolizumab).

Under the settlement and license agreement, the company will make a one-time payment of $625 million to Bristol-Myers Squibb and provide royalties on the worldwide sales of KEYTRUDA for a non-exclusive license to market KEYTRUDA in any market in which it is approved. For global net sales of KEYTRUDA, the company will pay Bristol-Myers Squibb royalties as follows:

6.5 percent of net sales occurring from Jan. 1, 2017 through and
including Dec. 31, 2023; and
2.5 percent of net sales occurring Jan. 1, 2024 through and including
Dec. 31, 2026.
The parties also agreed to dismiss all claims in the relevant legal proceedings.

“Today’s announcement eliminates uncertainty and enables us to continue to focus on KEYTRUDA, our immuno-oncology medicine, which is already helping thousands of patients around the world and becoming a foundation for the treatment of cancer through our industry-leading clinical development program,” said Kenneth C. Frazier, chairman and chief executive officer, Merck.

The $625 million payment will be recorded in the company’s fourth-quarter and full-year 2016 results. This expense will be excluded from Merck’s non-GAAP results.

About Merck

For more than a century, Merck has been a global health care leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to health care through far-reaching policies, programs and partnerships. For more information, visit www.merck.com and connect with us on Twitter, Facebook, YouTube and LinkedIn.

Forward-Looking Statement of Merck & Co., Inc., Kenilworth, N.J., USA

This news release of Merck & Co., Inc., Kenilworth, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s 2015 Annual Report on Form 10-K and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

 This is quality. With amazing fundamentals like these, all dips are buys. Institutions know and that's why it is 98% institutionally owned.

Halozyme PE ratios:


Earnings Growth:

PEG

https://www.nasdaq.com/market-activity/stocks/halo/price-earnings-peg-ratios

You can cherry pick a particular time span and claim that halo has not done well. You picked 4 years. Well, how about 1 year (halo up 54% and both NASDAQ and S&P down)? Or how about 3 years (again halo outperformed both indexes)? How about 10 years (again halo outperformed indexes). 
Those are too long for you? How about 6 months or year to date?
Too short for you? How about over its entire existence (halo outperformed handily)
You don't have to take my word for it. Do a chart of halo with comps against NASDAQ, S&P or XBI for yourselves. 
Regardsing the Astra Zeneca, there may or may not have be an exclusivity barrier. Nonetheless, once MERCK loses the MDASE dispute , Astra Zenca will have to pay halozyme as well. Remember that MDASE patents dont expire until 2034. The only way they can avoid paying halozy is to not bring anything to market until 2034.

One of the reasons is probably the patent cliffs. It would be interesting to know why Astra Zeneca chose Alteogen over Halo since I don't think there was an issue with exclusivity. It could be the patent issue. It could also be that they either got better terms or they think Alteogen has a better product, or a combination of the two.

The issue of the lack of significant deals is reflected in the stock action. Halo hit $50 at the beginning of 2021 and right now it is below the $59.44 high of November 2022. Buy and hold has not worked well for Halo shareholders in the past four years or so in spite of the fact that revenues and earnings have exceeded expectations. If we had sold in 2021 and bought the SPY, or even treasuries, we would have done a lot better and with a lot less risk.

Interesting how permabears are brushing off the important news from yesterday and are posting doom and gloom back and forth to each other in an echo chamber. The very conservative and skeptical JPM, Jessica Fye (whom perambears praise in their posts) adjusted her 2025 price target TO INCLUDE HALOZYME EARNINGS FROM KEYTRUDA SC. Keytruda is made by Merck. This means she believes Merck will sign a licensing agreement with halozyme in 2025.
Now, you permabears keep posting to each other as if nothing is going well. By the way, a Merck licensing agreement will be a significant deal as it will set the precedent for other deals to come (from all others who signed with alteogen)
My observation over the past 15 years on this board; nearly everytime the permabears increase the frequey of their nonsensical doom and gloom (eg "demand for enhanze has competely evaporated") postings, halozyme starts a major uptrend in shareprice. This one permabears was predicting doom when we were in low teens and single digits in 2018-2019. Look at the consistent and magnificent earnings growth and phat profit margins since then. Had you listened to him, you would have missed a 6x gain.

So, other than lousy management, what else could be the cause of no significant deals for 6 years when the product is arguably best in class?
Yes, there is some competition, but I don't believe that is the full story since all competitors have some potential negatives as compared to Enhanz.

I don't think demand has totally evaporated but the last significant partnership was signed on February 4, 2019 with Argenx. Ever since then the deals have been smaller and fewer. Also, the economics of the deals have not been as good in the past few years. That is why Jessica Fye wants to see new deals "with good economics."

... and by the way, the very JPM analyst that you praised in your second to last post, also thinks that Halozyme will win the Merck patent dispute and this is why she wrote today: "Raising Dec 2025 price target to $58 from $55 after refreshing projections for ENHANZE portfolio products and adding risk-adjusted credit for SC Keytruda." 

... and by the way, the very JPM analyst that you praised in your second to last point, also thinks that Halozyme will win the Merck patent disoute and this is why she wrote today: "Raising Dec 2025 price target to $58 from $55 after refreshing projections for ENHANZE portfolio products and adding risk-adjusted credit for SC Keytruda."

What nonsense! The permabears are at it again! Enhaze demand and utilization are at all time highs! If you are referring to new deals, yes, they have slowed down and Helen has under-delivered but the overall industry demand is as high as ever as evident by the deals Alteogen has signed. What you are not getting is that the deals Alteogen is making will make money for halozyme through the MDASE licensing. This will become crytal clear once Merck loses the post-registration appeal mid year and signs a deal with halo to avoid long delays in the launch of their Ketruda SC. Astra Zeneca will do the same.
Halozyme has the upper hand with a more compelling legal case (read the filings by both parties and see for yourself. Feed it to AI and ask who has a more compelling case). The only way Merck will be able to avoid paying licensing fees to halozyme is to accpet long delays in the launch of Keytruda SC or to buy Halozyme out.

Do you think demand for Enhanz has totally evaporated?

Jessica is among the most realistic show-me analysts and is immune to Helen's empty promises. If memory serves, she was the one who pinned Helen on the definition of "mid-single digits" royalties (which is a truly deplorable and shameless case of mendacious BS and should give pause to all who think they are getting straight stories from this mgt team). Unless we get some progress on business development I believe that the more bullish analysts will start to reassess after the next call in 3 weeks when she trots out even more excuses and moves the timelines for new deals for the upteenth time.

From JPM:
"Halozyme Therapeutics
Model Update

By Jessica Fye AC
Click here for the full document and disclaimers
Neutral
HALO, HALO US
Price (16 Apr 25):$58.82
Price Target (Dec-25):$58.00
Prior (Dec-25):$55.00

We are updating our model and raising our year-end 2025 PT to $58 after refreshing our projections for the ENHANZE portfolio products and reflecting risk-adjusted credit for a low-single-digit royalty to HALO on SC Keytruda."

What I find interesting and a bit surprising is that she is including a risk-adjusted credit for royalties on SC Keytruda but she is still neutral with a PT only $3 higher than it was. She really wants to see new deals with good economics to get more bullish. There are more bullish analysts on Halo but I think Jessica Fye is among the most influential.

Helen was able to sign several partnership agreements years ago. Why do you think better management would be able to sign more deals now? It just seems that demand is not what it used to be.

I agree with you that it’s very frustrating waiting for the announcement of new deals when we have been promised them for so long. But I am wondering if prospective partners are waiting for announcement of extension of patent and/or outcome of Merck patent dispute before signing. Just a thought.

HALO is sitting on a wealth of IP assets which evidently are garnering little interest in the world marketplace. Sadly, it appears that our current management team would have a hard time selling ice cold beer on a sunny day in a baseball stadium. Time for a change, IMHO.

Well, back for a well deserved, "Tried to tell ya so.".......Looks like one FTR (For the Record) has proven correct........with little fanfare.....

It really isn't a SC injector per-say.....more of an Infusion SC injector.....note the "Tubing" which readers where directed to focus on in the other two HVAI injectors...............

PREFILLED AUTOINFUSION DEVICE

https://www.freepatentsonline.com/WO2025081072A1.html

Can't wait for other FTR to come to fruit.......such as hinted here..........nano nano.....

"34. The method of any one of claims 1-33, wherein the active ingredient is a small molecule, a peptide fragment, a biologic, or a nanoparticle. "

Whatever, let's hope Helen can sell it.........not batting to well on the others.......

Anyhoot..thanks for the comments........Way to go SR, .....Attaboy.......U R always welcome here with your dumb comments and hard facts......

Helen has about 3 weeks until the next quarterly call to come up with some fresh excuses on why she can't land any new deals.

Bought some more shares of HALO today with proceeds from the nice Palantir pop! Long term bullish on both, but HALO fundamentals are much better!

JNJ reported today. DARZALEX sales exceeded expectations for Q1 2025. Johnson & Johnson reported worldwide DARZALEX sales of $3.24 billion, surpassing the analyst forecast of approximately $3.1 billion.[](https://uk.investing.com/news/earnings/johnson--johnson-cuts-2025-profit-raises-sales-guidance-q1-print-tops-estimates-4030775)

Someone left the door open again, and guess who snuck in…….

BI1 stuff is okay good info but mostly just a summary of known info wishing for more info…..So this pesky investor quickly snuck in thru the open door again to leave some good speculative stuff…

First old news, but good news……depending on what one is interested in and how they connect the pieces…..…..

https://www.elektrofi.com/news/thermo-fisher-collaboration

New news…. Fisher recently stated……”In addition to traditional biologics, Thermo Fisher is expanding its mRNA capabilities through a collaboration with biotech company Elektrofi to establish a platform cGMP line to support Elektrofi’s planned clinical trials of self-injectable therapies. In late 2024, the companies successfully delivered the first lipid nanoparticle solution and in 2025 are progressing to drug product fill and clinical trial manufacturing. “

https://www.pharmamanufacturing.com/all-articles/article/55281157/thermo-fisher-grows-capacity-capabilities-for-its-pharma-services-in-strategic-expansion

And any investor with any interest would know by now, from you know who…….Elektorfi needs Enhanze for its self-injecting SC injections……but few are talking about it….

https://www.freepatentsonline.com/y2025/0082736.html

https://www.freepatentsonline.com/WO2025054552A1.html

191. The method of claim 124, wherein the composition is administered by a syringe or portable drug delivery injection device.

Or

224. A kit comprising: a syringe or portable drug delivery injection device; and a composition comprising: a plurality of particles suspended in a pharmaceutically acceptable liquid carrier, wherein substantially all of the particles comprise at least one therapeutic biologic or a salt thereof, and a hyaluronan degrading agent.

And knowing the personal connections between the two companies......if that info don’t scream a Halozyme combo deal in the making and soon to be announced.....….well blow me down……and kick me out……

With that said FTR………sneaking out of here again…….…..……

Thank You biotechinvestor1
You please have a wonderful weekend!!!

https://www.investors.com/stock-lists/sector-leaders/biotech-stock-bounces-from-support-shows-relative-strength-amid-volatile-market/

Halo did well today outperforming XBI and broader markets. With so many catalysts on the near horizon, don't be surprised to see  $70's soon:
1) Enhanze US patent extension to 2029 (EU already extended to 2029)
2) Official announcement of the un-named auto-injector partner. During last quarter CC, Helen said halo signed an greement already but was unable to name the partner for competitive reasons. 
3) US patent office decision against Merck's post-registration petition. With Halo's sur-reply, odds of a win for halo improved to 75% (per AI's legal analysis of all documents submitted by both parties)
4) Once Merck's petition fails, Merck will likely sign an agreement with halo for licensing MDASE. Astra Zeneca will follow Merck's example.
5) New HVAI deal. Helen gave guidance for at least one HVAI in 2025.
6) Market realization that tariffs have little to no effect on halozyme earnings or profit margins. Royalties and milestones (halo's revenue sources) are not tariffed. Halozyme's manufactoring cost for enhanze is passed along to its partners + margin.

Alteogen is subject to tariffs up to 25% Korea and as high as 145% (China facility). Another nudge to drop the patent challenge and partner with HALO.

Halozyme will likely get bought! 

It's not an auto-injector, but a simple pre-filled syringe, so probably not a HALO product.

Agreed! Eapecially if you factor in the sur-reply halozyme submitted to the patent office a few days ago which was surgical strike against Merck's argument improving the odds of success for halo. (See my earlier post on this). You can submit the PDF of the fillings by Merck and halozyme to the AI of your choice. Grock puts the odds of halozyme at 75%

Given the last 3 announcements we would be at 80 if the market were normal, imo. Time will tell. 

I think it's a "prefilled syringe" to which the patient attaches a subcutaneous needle and injects. I don't think it's a true auto-injector. But I could be wrong. 
None-the-less, it's a an important milestone and important news for halo and Argx. 

Is the injector HALO's?

argenx Announces FDA Approval of VYVGART Hytrulo Prefilled Syringe for Self-Injection in Generalized Myasthenia Gravis and Chronic Inflammatory Demyelinating Polyneuropathy
https://ih.advfn.com/stock-market/NASDAQ/argenx-ARGX/stock-news/95826761/argenx-announces-fda-approval-of-vyvgart-hytrulo-p
April 10 2025 - 5:47PM

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VYVGART, the first-in-class FcRn blocker, now offers three administration options, including self-injection with a prefilled syringe
Self-injection provides gMG and CIDP patients with flexibility for when and where to receive treatment – at home, while ‘on the go’ or in a healthcare setting
Approval reflects commitment to innovating the patient experience with individualized, safe and effective therapies

April 10, 2025, 11:45 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 U.S. Food and Drug Administration (FDA) approved a new option for patients to self-inject VYVGART® Hytrulo with a prefilled syringe (efgartigimod alfa and hyaluronidase-qvfc) for the treatment of adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive and adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP).

“Today’s FDA approval provides a new self-injection option across both approved indications in the U.S. that is designed for patients who seek more independence with their treatment,” said Luc Truyen M.D., Ph.D., Chief Medical Officer, argenx. “We understand patients experience MG and CIDP in different ways, and our prefilled syringe is an important innovation that provides patients with more freedom and flexibility to self-administer VYVGART Hytrulo. Whether patients prefer to receive their treatment in a physician’s office, at home, or while traveling, they can experience treatment on their own terms and continue to benefit from VYVGART Hytrulo’s favorable safety profile and strong efficacy.”

VYVGART Hytrulo prefilled syringe for self-injection is approved as a 20-to-30-second subcutaneous injection administered by a patient, caregiver, or healthcare professional. Patients are able to self-inject after proper instruction in subcutaneous injection technique. The single dose prefilled subcutaneous injection was developed as part of argenx’s exclusive partnership with Halozyme’s ENHANZE® drug delivery technology, which enables rapid, high-volume delivery of biologics.

“I am excited to offer my patients living with gMG and CIDP the option of the new prefilled syringe for VYVGART Hytrulo,” said Dr. Beth Stein, M.D., Director of Neuromuscular Diseases, St. Joseph’s Health, Clifton, NJ. “This new self-injection option will lead to more convenient and flexible administration for patients, empowering them to decide when and where they receive treatment. A ready-to-use option enhances patient independence and reduces the time required for treatment, making disease management and control more seamless.”

The approval of VYVGART Hytrulo prefilled syringe for self-injection is supported by data from studies evaluating its bioequivalence to VYVGART Hytrulo in a vial. In addition, human factors validation studies demonstrated that participants with gMG or CIDP, or their caregivers, safely and successfully prepared and administered VYVGART Hytrulo with the prefilled syringe. Previous FDA approval of VYVGART Hytrulo for patients with gMG and CIDP was based on the global Phase 3 ADAPT, ADAPT-SC and ADHERE trials.

“argenx is a trusted partner in the MG patient community, continuously innovating to meet the evolving needs of patients. This new self-injection option is a natural progression, empowering individuals to take control of their treatment and working toward achieving a greater sense of normalcy in their lives,” said Samantha Masterson, President and CEO of the Myasthenia Gravis Foundation of America.

“The daily burden of CIDP from both the symptoms of the disease and interruption to daily life creates profound unseen challenges for patients,” said Lisa Butler, Executive Director, GBS-CIDP Foundation. “Effective new treatments that reduce the need for frequent clinic visits are a welcome option for active patients seeking to regain time and a sense of normalcy in their daily routine. Today’s news about the approval of argenx’s prefilled syringe for at-home self-injection is a significant step forward for those patients seeking a new treatment option.”

Access Support for VYVGART Hytrulo Prefilled Syringe
The argenx patient support program, My VYVGART® Path, can help patients and healthcare providers navigate access. My VYVGART Path resources include disease and product education, access support and benefits verification, and financial assistance programs for eligible patients. argenx is committed to supporting access for patients to its medicines, including VYVGART Hytrulo prefilled syringe.

More information is available at VYVGART.com.

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 adults with:

generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive.
chronic inflammatory demyelinating polyneuropathy (CIDP).
It is not known if VYVGART HYTRULO is safe and effective in children.

IMPORTANT SAFETY INFORMATION
Do not take VYVGART HYTRULO if you are allergic to efgartigimod alfa, hyaluronidase, or any of the ingredients in VYVGART HYTRULO. VYVGART HYTRULO can cause serious allergic reactions and a decrease in blood pressure leading to fainting.

Before taking VYVGART HYTRULO, tell your healthcare provider about all of your medical conditions, including if you:

have an infection or fever.
have recently received or are scheduled to receive any vaccinations.
have any history of allergic reactions.
have kidney (renal) problems.
are pregnant or plan to become pregnant. It is not known whether VYVGART HYTRULO will harm your unborn baby.
Pregnancy Exposure Registry. There is a pregnancy exposure registry for women who use VYVGART HYTRULO during pregnancy. The purpose of this registry is to collect information about your health and your baby. Your healthcare provider can enroll you in this registry. You may also enroll yourself or get more information about the registry by calling 1-855-272-6524 or going to VYVGARTPregnancy.com
are breastfeeding or plan to breastfeed. It is not known if VYVGART HYTRULO passes into your breast milk.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

VYVGART HYTRULO can cause side effects which can be serious, including:

Infection. VYVGART HYTRULO may increase the risk of infection. If you have an active infection, your healthcare provider should delay your treatment with VYVGART HYTRULO until your infection is gone. Tell your healthcare provider right away if you get any of the following signs and symptoms of an infection: fever, chills, frequent and painful urination, cough, pain and blockage or nasal passages, wheezing, shortness, sore throat, excess phlegm, nasal discharge.

Allergic reactions (hypersensitivity reactions). VYVGART HYTRULO can cause allergic reactions that can be severe. These reactions can happen during, shortly after, or weeks after your VYVGART HYTRULO injection. Tell your healthcare provider or get emergency help right away if you have any of the following symptoms of an allergic reaction: rash, swelling of the face, lips, throat, or tongue, shortness of breath, hives, trouble breathing, low blood pressure, fainting.

Infusion or injection-related reactions. VYVGART HYTRULO can cause infusion or injection-related reactions. These reactions can happen during or shortly after your VYVGART HYTRULO injection. Tell your healthcare provider if you have any of the following symptoms of an infusion or injection-related reaction: high blood pressure, chills, shivering, chest, stomach, or back pain.

The most common side effects of VYVGART HYTRULO include respiratory tract infection, headache, urinary tract infection, and injection site reactions.

These are not all the possible side effects of VYVGART HYTRULO. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Please see accompanying full Prescribing and Patient Information for VYVGART HYTRULO.

About VYVGART and VYVGART Hytrulo
VYVGART® (efgartigimod alfa fcab) is a first-in-class human IgG1 antibody fragment that binds to the neonatal Fc receptor (FcRn), resulting in the reduction of circulating IgG autoantibodies. VYVGART® Hytrulo is a subcutaneous combination of efgartigimod alfa (VYVGART) and recombinant human hyaluronidase PH20 (rHuPH20), Halozyme’s ENHANZE® drug delivery technology to facilitate subcutaneous injection delivery of biologics. VYVGART is approved for generalized myasthenia gravis (gMG) and immune thrombocytopenia (Japan only). VYVGART Hytrulo is approved for gMG and chronic inflammatory demyelinating polyneuropathy (CIDP). VYVGART Hytrulo may be marketed under different proprietary names in other regions.

About Generalized Myasthenia Gravis (gMG)
Generalized myasthenia gravis (gMG) is a rare and chronic autoimmune disease where IgG autoantibodies disrupt communication between nerves and muscles, causing debilitating and potentially life-threatening muscle weakness. Approximately 85% of people with MG progress to gMG within 24 months¹, where muscles throughout the body may be affected. Patients with confirmed AChR antibodies account for approximately 85% of the total gMG population.

About Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Chronic inflammatory demyelinating polyneuropathy (CIDP) is a rare and serious autoimmune disease of the peripheral nervous system. 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 argenx
argenx is a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases. Partnering with leading academic researchers through its Immunology Innovation Program (IIP), argenx aims to translate immunology breakthroughs into a world-class portfolio of novel antibody-based medicines. argenx developed and is commercializing the first approved neonatal Fc receptor (FcRn) blocker and is evaluating its broad potential in multiple serious autoimmune diseases while advancing several earlier stage experimental medicines within its therapeutic franchises. For more information, visit www.argenx.com and follow us on LinkedIn, X/Twitter, Instagram, Facebook, and YouTube.

Halozyme Therapeutics, Inc. has added a new press release to its website:

Halozyme Announces FDA Approval of argenx's VYVGART® Hytrulo Prefilled Syringe Co-Formulated with ENHANZE® for Self-Injection for Generalized Myasthenia Gravis and Chronic Inflammatory Demyelinating Polyneuropathy

Click here for a complete listing of Halozyme Therapeutics, Inc. press releases.

China tarrifs have very little to do with halo

More opportunity to catch the baby being thrown with bath water.

Yes sir!!

EU Commission Approved Subcu DARZALEX® (daratumumab)-based Quadruplet Regimen for the Treatment of Patients with Newly Diagnosed Multiple Myeloma, Regardless of Transplant Eligibility
April 09 2025 - 8:45AM
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Subcutaneous DARZALEX® is co-formulated with Halozyme's ENHANZE® drug delivery technology

SAN DIEGO, April 9, 2025 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) (Halozyme) today announced that Janssen-Cilag International NV, a Johnson & Johnson company, received European Commission (EC) approval for an indication extension of DARZALEX® (daratumumab) subcutaneous (SC) co-formulated with ENHANZE® in the frontline setting. The approval is for daratumumab SC in combination with bortezomib, lenalidomide, and dexamethasone (daratumumab-VRd) for the treatment of adult patients with newly diagnosed multiple myeloma.1

"The continued expansion of DARZALEX delivered subcutaneously with ENHANZE into additional settings highlights its status as a cornerstone of therapy for multiple myeloma," said Dr. Helen Torley, President and CEO of Halozyme. "This approval means that newly diagnosed patients can receive daratumumab subcutaneous plus VRd and avoid the need for lengthy IV infusions."

This approval follows the indication extension approval for daratumumab-VRd in October 2024, for the treatment of newly diagnosed patients with multiple myeloma who are eligible for autologous stem cell transplant, based on the results from the Phase 3 PERSEUS (NCT03652064) study. The study evaluated this daratumumab SC-based quadruplet regimen for induction and consolidation therapy, followed by daratumumab SC and lenalidomide maintenance.2,3

1 European Medicines Agency. DARZALEX (daratumumab) Summary of Product Characteristics. April 2025.

2 Rodríguez-Otero P, et al. Daratumumab (DARA) + bortezomib/lenalidomide/dexamethasone (VRd) in transplant-eligible (TE) patients (pts) with newly diagnosed multiple myeloma (NDMM): Analysis of minimal residual disease (MRD) in the PERSEUS trial. 2024 American Society for Clinical Oncology Annual Meeting. June 3, 2024.

3 Johnson & Johnson Innovative Medicine EMEA. DARZALEX® (daratumumab)-SC based quadruplet regimen approved by the European Commission for patients with newly diagnosed multiple myeloma who are transplant-eligible. Available at: https://www.jnj.com/media-center/press-releases/darzalex-daratumumab-sc-based-quadruplet-regimen-approved-by-the-european-commission-for-patients-with-newly-diagnosed-multiple-myeloma-who-are-transplant-eligible. Last accessed: April 2025.
https://ih.advfn.com/stock-market/NASDAQ/halozyme-therapeutics-HALO/stock-news/95813280/european-commission-approved-subcutaneous-darzalex

I hope the longs on this board bought some cheap shares :)

Juicy bargain:

PE ratios:

2024 Actual14.492025 Estimates12.142026 Estimates9.222027 Estimates7.95
Growth rates:

Growth 202519.29Growth 202631.8


PEG ratio0.42

Source: https://www.nasdaq.com/market-activity/stocks/halo/price-earnings-peg-ratios

The baby is thrown with the bath water. I hope you are enjoying this fantastic buying opportunity. It’s alo time for halozyme insiders to buy shares. “Applied Materials CEO Gary Dickerson acquires $6.87 million in stock” https://www.investing.com/news/insider-trading-news/applied-materials-ceo-gary-dickerson-acquires-687-million-in-stock-93CH-3972413