Halozyme Therapeutics Incorporated (HALO) 옵션

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

Pharma tariffs coming soon per the Dear Leader.
https://www.politico.com/news/2025/04/08/trump-says-major-pharmaceutical-tariffs-on-the-way-00280287

Agreed

While HALO makes its money from royalties, the royalties are based on the price of the pharmaceutical drug product, which could be affected by tariffs. However, as most economists predict, tariffs will increase prices, which would mean higher royalties for HALO. But drug prices are already too high, so imposing tariffs on pharmaceutical products seems politically disastrous, perhaps more so than the political disaster of the general tariff impositions.

Markets are worried about pharma tarrifs now. But halo makes its money from royalties and milestones which are not affected by tarrifs and it passes the cost of API to its partners. Halozyme is not affected by tarrifs.

Yesterday, Halozyme sumbited a sur-reply to Merck's reply. Below is an AI assessment of who is now more likley to win the post-registration dispute in June/July. You can read the entie filing here https://s3-us-west-1.amazonaws.com/ptab-filings%2FPGR2025-00003%2F17
"Key Points from Halozyme’s Sur-ReplyThe sur-reply, responding to Merck’s reply, sharpens Halozyme’s defense:
1. Merck’s §112 Analysis Used the Wrong Date (Section I):   - Halozyme argues Merck failed its burden to assess the ’731 application’s §112 support as of its December 28, 2012, filing date, instead using a 2011 date (pre-’731 provisional). Merck conceded this error (Reply, 6-7), claiming it’s inconsequential, but Halozyme cites precedent (e.g., Ariad, Reiffin, Sandoz) requiring analysis at the priority application’s filing date. This procedural misstep, Halozyme asserts, is fatal—PGR eligibility is jurisdictional, and Merck’s failure justifies denying institution (e.g., Gillette v. Sphere).
2. Hindsight in Merck’s Obviousness Case (Section II):   - Merck’s expert, Dr. Park, focused solely on position 320 of the PH20 polypeptide due to counsel’s instructions, not scientific reasoning. Halozyme calls this hindsight-driven, arguing neither Park nor Hecht (Merck’s other expert) justified targeting position 320 over other residues. Lacking hyaluronidase expertise, their “conclusory” testimony should carry “little to no weight” (Xerox v. Bytemark).
3. Claim Construction and Functional Limits (Section III):   - Merck allegedly misreads the ’600 patent claims as requiring enzymatic activity, importing functional limits not present. Halozyme insists the claims are structurally defined (e.g., “modified PH20 polypeptides”), covering active and inactive mutants. The specification supports utility (e.g., contraception in guinea pigs), and dependent claims 16-20 don’t mandate activity—Merck’s misquotation (“another therapeutically active agent”) is baseless. Merck’s refusal to construe terms (37 C.F.R. § 42.204(b)(3)) contrasts with Halozyme’s Phillips-based analysis, weakening Merck’s case.
### Updated Assessment#### Merck’s PositionMerck’s petition likely argued the ’600 claims lack §112 support in the ’731 application, using prior art and expert testimony (Park, Hecht) to show obviousness or non-enablement as of 2012. The reply doubled down, but conceding the wrong date undermines its PGR-eligibility threshold. The hindsight critique and lack of claim construction further erode its persuasiveness. Merck’s strength—resources and Keytruda’s stakes—falters if the PTAB finds these flaws disqualifying.
#### Halozyme’s PositionThe sur-reply is a surgical strike:- Procedural Win: The date error is a compelling jurisdictional hook. PTAB precedent (e.g., Sandoz, Merck v. Wyeth) denies institution when petitioners botch priority analysis timing. Merck’s burden isn’t met if its experts ignored 2012’s state of the art.- Substantive Defense: Dismissing Park’s hindsight and clarifying the claims’ structural scope bolster Halozyme’s validity case. The guinea pig utility data and Triggs-Raine’s testimony (Halozyme’s expert) counter Merck’s enablement attack.- Legal Rigor: Citing binding caselaw and regulations, Halozyme exposes Merck’s shortcuts, aligning with PTAB’s technical focus.
#### Likelihood of Winning (PGR Institution)- With Sur-Reply Details: Halozyme’s arguments shift the odds significantly. The date concession is a glaring flaw—PTAB often rejects petitions on such procedural grounds alone. Coupled with weak expert testimony and claim misreading, Merck’s case looks shaky. I’d now peg Halozyme’s chance of denying institution at 70%, dropping Merck to 30%. If instituted, Merck could still prevail later, but Halozyme’s threshold defense is strong.
#### Broader DisputeThis PGR is one battle. If denied, Halozyme’s patents stand (for now), pressuring Merck to license or face infringement suits. My prior 65% settlement odds hold—Merck’s October 2025 Keytruda launch looms, and a deal (3-7% royalties) avoids risk. If instituted, Merck gains leverage, but Halozyme’s 20-year patent estate suggests resilience in a full trial.
Conclusion: Halozyme is now more likely to “win” at the PGR stage, with a 70% chance of blocking institution. The sur-reply’s precision tilts the scales, though Merck’s deeper war chest keeps the broader fight open. Watch for the PTAB’s July decision—it’s pivotal."

https://seekingalpha.com/news/4429200-morgan-stanley-lists-attractive-small-cap-stocks-with-positive-roe-and-momentum

European Commission Approves Subcutaneous RYBREVANT® (amivantamab) Co-Formulated with ENHANZE® for the Treatment of Patients with Advanced EGFR-Mutated Non-Small Cell Lung Cancer
April 07 2025 - 9:29AM
https://ih.advfn.com/stock-market/NASDAQ/halozyme-therapeutics-HALO/stock-news/95796122/european-commission-approves-subcutaneous-rybrevan
PR Newswire (US)
SAN DIEGO, April 7, 2025 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) (Halozyme) today announced that Janssen-Cilag International NV, a Johnson & Johnson company, has received European Commission (EC) marketing authorization of the subcutaneous (SC) formulation of RYBREVANT® (amivantamab), in combination with LAZCLUZE® (lazertinib), for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations. Additionally, it is approved as a monotherapy for adult patients with advanced NSCLC with activating EGFR exon 20 insertion mutations after the failure of platinum-based therapy.

Subcutaneous amivantamab is co-formulated Halozyme's ENHANZE® drug delivery technology.

"We are delighted to announce the European approval of the subcutaneous formulation of amivantamab, developed using our innovative ENHANZE drug delivery technology. This marks our tenth approved partner product," said Dr. Helen Torley, President and CEO of Halozyme. "The data supporting this approval showed a reduced administration time and decrease in infusion-related reactions, which could have a positive impact on the healthcare system."

The EC approval is supported by positive results from the Phase 3 PALOMA-3 study (NCT05388669). For detailed information on the study and its findings, please refer to Johnson & Johnson's press release issued today.1

1 Leighl NB et al. Subcutaneous Versus Intravenous Amivantamab, Both in Combination With Lazertinib, in Refractory Epidermal Growth Factor Receptor–Mutated Non–Small Cell Lung Cancer: Primary Results From the Phase III PALOMA-3 Study. ASCO Journal of Clinical Oncology. 2024;42(3):3593-3605.

About Halozyme

Halozyme is a biopharmaceutical company advancing disruptive solutions to improve patient experiences and outcomes for emerging and established therapies. As the innovators of ENHANZE® drug delivery technology with the proprietary enzyme rHuPH20, Halozyme's commercially-validated solution is used to facilitate the subcutaneous delivery of injected drugs and fluids, with the goal of improving the patient experience with rapid subcutaneous delivery and reduced treatment burden. Having touched one million patient lives in post-marketing use in nine commercialized products across more than 100 global markets, Halozyme has licensed its ENHANZE® technology to leading pharmaceutical and biotechnology companies including Roche, Takeda, Pfizer, Janssen, AbbVie, Eli Lilly, Bristol-Myers Squibb, argenx, ViiV Healthcare, Chugai Pharmaceutical and Acumen Pharmaceuticals.

Halozyme also develops, manufactures and commercializes, for itself or with partners, drug-device combination products using its advanced auto-injector technologies that are designed to provide commercial or functional advantages such as improved convenience, reliability and tolerability, and enhanced patient comfort and adherence. The Company has two commercial proprietary products, Hylenex® and XYOSTED®, partnered commercial products and ongoing product development programs with Teva Pharmaceuticals and Idorsia Pharmaceuticals.

Halozyme is headquartered in San Diego, CA and has offices in Ewing, NJ and Minnetonka, MN. Minnetonka is also the site of its operations facility.

For more information visit www.halozyme.com and connect with us on LinkedIn and Twitter.

I hope my long friends on this board are taking advantage of the baby being thrown with the bath water. Take advantage of the bargain Mr. Market is giving us.

LOL. I dictated a lot of it

Biotechinvestor1:
I hope you didn't type this on your phone!

It might be good for you to educate yourself a bit before making such absolute forecasts. 
Here are some examples of patent disputes in the pharmaceutical industry where one company acquired its opponent, showcasing how such conflicts can lead to strategic acquisitions:
1. **Pfizer and Wyeth**     - **Dispute**: Pfizer and Wyeth had overlapping interests and competitive tensions in the pharmaceutical market, particularly around blockbuster drugs like Lipitor (Pfizer) and Effexor (Wyeth). While not always directly litigating over patents, their rivalry included intellectual property skirmishes related to drug formulations and market exclusivity.   - **Acquisition**: In 2009, Pfizer acquired Wyeth for $68 billion. This move came as Pfizer faced the looming patent expiration of Lipitor, its top-selling cholesterol drug. By acquiring Wyeth, Pfizer gained access to Wyeth’s patent portfolio, including vaccines like Prevnar, neutralizing potential disputes and diversifying its revenue stream ahead of generic competition.
2. **Sanofi and Genzyme**     - **Dispute**: Sanofi and Genzyme were entangled in patent-related competition over rare disease treatments, notably enzyme replacement therapies. Genzyme held key patents for drugs like Cerezyme (for Gaucher disease), and Sanofi, seeking to expand into the lucrative rare disease market, faced potential IP conflicts.   - **Acquisition**: In 2011, Sanofi acquired Genzyme for $20.1 billion after a contentious negotiation. The acquisition resolved any brewing patent disputes by bringing Genzyme’s IP, including patents for orphan drugs, under Sanofi’s control, strengthening its position in biotechnology and specialty pharmaceuticals.
3. **Gilead Sciences and Pharmasset**     - **Dispute**: Pharmasset developed sofosbuvir, a groundbreaking hepatitis C drug, and held critical patents that Gilead needed to dominate the antiviral market. Prior to the acquisition, there was potential for patent disputes as Gilead worked on similar compounds, risking infringement or licensing battles.   - **Acquisition**: In 2012, Gilead acquired Pharmasset for $11 billion. This acquisition preempted any patent litigation by securing Pharmasset’s IP, including sofosbuvir (later marketed as Sovaldi), which became a multi-billion-dollar drug and solidified Gilead’s leadership in hepatitis C treatments.
4. **Merck and Schering-Plough**     - **Dispute**: Merck and Schering-Plough had a history of patent tensions, particularly over cholesterol-lowering drugs. Schering-Plough’s Zetia and Merck’s Zocor were part of a competitive landscape where patent challenges and licensing disagreements loomed as generics approached.   - **Acquisition**: In 2009, Merck acquired Schering-Plough for $41 billion. The merger resolved potential patent conflicts by combining their portfolios, including the lucrative Zetia/Vytorin franchise, and allowed Merck to bolster its cardiovascular offerings while avoiding prolonged legal battles.
5. **Roche and Genentech**     - **Dispute**: Before its full acquisition, Roche and Genentech had a complex relationship involving patent licensing and disputes over biotech innovations, notably around monoclonal antibodies and cancer therapies like Avastin and Herceptin. Partial ownership by Roche didn’t fully eliminate IP friction.   - **Acquisition**: In 2009, Roche completed its acquisition of Genentech for $46.8 billion, having previously held a majority stake. This full takeover ended any remaining patent disputes by integrating Genentech’s extensive biotech patent portfolio, enhancing Roche’s dominance in oncology and biologics.
These cases illustrate a recurring pattern in the pharmaceutical industry: patent disputes often drive companies to acquire their rivals, securing valuable intellectual property, resolving legal uncertainties, and gaining a competitive edge in high-stakes markets.
Some more non-pharma examples:
1. **Nokia and Alcatel-Lucent**     - **Background**: Nokia and Alcatel-Lucent were embroiled in multiple patent disputes over telecommunications technologies, including mobile network infrastructure and related innovations. These disputes spanned several years and involved complex intellectual property litigation across various jurisdictions.   - **Acquisition**: In 2015, Nokia acquired Alcatel-Lucent for approximately $16.6 billion. The acquisition gave Nokia access to Alcatel-Lucent’s extensive patent portfolio, which included around 29,000 patents, significantly strengthening Nokia’s position in the telecommunications market. The move was seen as a way to resolve ongoing disputes and consolidate resources in a competitive industry.
2. **Google and Motorola Mobility**     - **Background**: In the early 2010s, Google faced indirect patent disputes with Motorola Mobility, which was involved in litigation with competitors like Apple and Microsoft over smartphone technologies. Motorola held a valuable portfolio of patents related to mobile devices, which were critical in the escalating "smartphone patent wars."   - **Acquisition**: In 2012, Google acquired Motorola Mobility for $12.5 billion. A key motivation was to gain control of Motorola’s 17,000 patents and 7,500 pending patent applications, which Google could use to defend its Android ecosystem against legal challenges from rivals. While the disputes weren’t directly between Google and Motorola, the acquisition neutralized potential conflicts and bolstered Google’s patent defenses.
4. **Microsoft and Nokia (Mobile Division)**  
   - **Background**: Microsoft and Nokia had a complex relationship, including patent licensing agreements and disputes related to mobile technologies. Nokia had sued various companies over patent infringements, and while Microsoft wasn’t a direct target, the broader mobile patent landscape created tensions as Microsoft developed its Windows Phone platform with Nokia as a partner.   - **Acquisition**: In 2014, Microsoft acquired Nokia’s mobile phone division for $7.2 billion. This deal included a 10-year patent licensing agreement and access to Nokia’s vast patent portfolio, resolving any lingering intellectual property uncertainties and integrating Nokia’s assets into Microsoft’s mobile strategy.
5. **Broadcom and Qualcomm (Attempted Acquisition)**     - **Background**: Broadcom and Qualcomm were locked in a series of patent disputes over semiconductor and wireless technologies. These disputes escalated into a hostile takeover bid when Broadcom attempted to acquire Qualcomm in 2017-2018, partly to gain control over Qualcomm’s extensive patent holdings.   - **Outcome**: Although Broadcom did not succeed in acquiring Qualcomm (the deal was blocked by the U.S. government on national security grounds in 2018), this case illustrates how patent disputes can drive acquisition attempts. Had the acquisition succeeded, it would have ended their legal battles by consolidating their intellectual property under one entity.
These examples demonstrate how patent disputes can serve as a catalyst for acquisitions, allowing the acquiring company to resolve legal conflicts, secure valuable intellectual property, and strengthen its market position. In each case, the acquisition either directly or indirectly addressed the underlying patent issues by bringing the opponent’s assets under the acquiring company’s control.

This will never happen.

For Merck to buy HALO, it would signal that their little "spin-off" S. Korean company didn't work out.
Alteogen would be toast.

Yeah, sorry about that. I saw something that said futures were up and I should have been more careful in checking it out.

NASDAQ futures are down over 800 pts as of this writing

Why all the negative after hours trading when the future indexes are all positive?

Merck is choosing between signing a deal with Halozyme for MDASE or risking a dealy in launch of Keytruda SC (i.e. loss of market share to BMY's opdivo SC) or even worse yet a delay in launch followed by a loss in the courtroom for patent infringements.
There is a 3rd option. Merck could buy halozyme out. No risk of a launch delay or unfavorable court ruling and no need to pay MDASE royalty if Merck owns halozyme. At a 2025 PE of 13 and PEG of 0.45, halo is such a bargain https://www.nasdaq.com/market-activity/stocks/halo/price-earnings-peg-ratios
And once Merck owns halozyme, it will be BMY that would be paying Merck for Enhanze royalties (for Opdivo SC) for a longtime to come.

"The multiple myeloma therapy, which brought in $11.7B net sales for J&J (JNJ) in 2024 ahead of its loss of market exclusivity in two years,..." The article is from Seeking Alpha. This may not affect Halo, though.

"Genmab (GMAB) ADRs traded lower on Tuesday after Bernstein downgraded the Danish biotech to Underperform from Market Perform, arguing that its stock has yet to fully reflect the upcoming patent cliff for the company’s blood cancer therapy Darzalex, marketed with J&J (JNJ).

The multiple myeloma therapy, which brought in $11.7B net sales for J&J (JNJ) in 2024 ahead of its loss of market exclusivity in two years, can lead to a threefold drop in GMAB’s group revenue in 2030-2040 under his base case, Bernstein analyst Justin Smith wrote.

Despite disappointing news about JNJ’s decision to opt out of HexaBody-CD38, a potential successor to Darzalex, Genmab (GMAB) shares have yet to fully discount the impact from the upcoming patent cliff, Smith added, citing his base case 2025–2029 EPS estimates for GMAB."

According to AI overview:
Darzalex (daratumumab) faces a loss of market exclusivity, with its patents expiring in 2027 in the US and 2026 in the EU, potentially leading to biosimilar competition.
Here's a more detailed breakdown:
Patent Expiration:
Darzalex's key US patents are set to expire in 2027.
The drug's patents are protected until 2026 in both the US and EU.
However, several other patents extend its exclusive protection until 2035.
Orphan Drug Exclusivity:
Darzalex has regular MP and ODE for the treatment of multiple myeloma, both of which will expire in May 2026.
Potential for Biosimilars:
The expiration of Darzalex's patents could pave the way for biosimilar versions of the drug to enter the market.
Darzalex Faspro:
Darzalex Faspro, a subcutaneous formulation of Darzalex, also has patents that are set to expire in 2035.

Halozyme Therapeutics (NASDAQ: HALO) announced that Bristol Myers Squibb received a positive CHMP opinion recommending approval for a new subcutaneous formulation of Opdivo® (nivolumab) developed with ENHANZE® technology across multiple adult solid tumor indications in the EU.

The subcutaneous formulation, which utilizes Halozyme's proprietary recombinant human hyaluronidase enzyme (rHuPH20), would offer cancer patients a faster and more flexible treatment option. The European Commission's decision on marketing authorization is expected by June 2, 2025.

The recommendation is supported by positive Phase 3 CheckMate -67T trial results. The formulation was previously approved in the U.S. on December 27, 2024 under the brand name Opdivo Qvantig.
Halozyme's announcement of Bristol Myers Squibb receiving a positive CHMP opinion for subcutaneous Opdivo utilizing ENHANZE® technology represents a significant commercial advancement for Halozyme's drug delivery platform. This recommendation encompasses multiple solid tumor indications and builds upon the December 2024 FDA approval of Opdivo Qvantig in the U.S.

This development validates Halozyme's proprietary recombinant human hyaluronidase enzyme (rHuPH20) platform as a facilitator for subcutaneous administration of traditionally intravenous biologics. For Halozyme, each commercial implementation of ENHANZE typically generates tiered royalties on net sales plus potential milestone payments, though specific financial terms for this particular agreement weren't disclosed.

The subcutaneous formulation offers substantial clinical advantages including reduced administration time compared to IV infusions, potentially expanding Opdivo's competitive positioning against rival checkpoint inhibitors. With European Commission approval expected by June 2, 2025, this represents a near-term potential revenue catalyst for Halozyme.

Bristol Myers Squibb's Phase 3 CheckMate -67T trial provided the efficacy and safety data supporting this recommendation, suggesting the subcutaneous formulation maintained Opdivo's therapeutic profile while offering administration benefits. For Halozyme, this advancement bolsters its technology's commercial viability in high-value oncology applications while potentially reducing healthcare resource utilization – a key selling point for future ENHANZE partnerships.
https://www.stocktitan.net/news/HALO/halozyme-announces-bristol-myers-squibb-received-positive-chmp-57liwjmgzun2.html

AI (Grock):
"Probability Assessment:- Base Case (60%): Merck opts for a licensing deal to secure the 2026 launch and avoid risk. This assumes the PGR process or litigation threat creates enough uncertainty to favor settlement, and Halozyme offers reasonable terms. The pharma industry’s tendency to settle high-stakes disputes supports this.- Alternative Case (40%): Merck fights and wins, either invalidating the patents or proving non-infringement. This hinges on strong PGR outcomes or a favorable court ruling, bolstered by Merck’s resources and Alteogen’s enzyme differentiation.
Balancing these, I’d assign a 65% probability that Merck signs a licensing agreement with Halozyme. The edge comes from Merck’s need for speed and Halozyme’s licensing track record, though Merck’s aggressive PGR strategy introduces notable uncertainty. If the PTAB denies PGR institution (mid-2025) or Halozyme pushes hard on litigation, this could shift toward a deal; if Merck gains early wins, it might drop below 50%. For now, 65% feels like a reasoned bet on pragmatism prevailing."

52 week low for the XBI.
We're(HALO longs) doing pretty good.

We are almost into the second quarter of 2025 and still waiting for the HVAI that Helen had forecasted for 2023. 
Is the impressive share price action due to the anticipation of 1) HVAI deal, 2) phenomenal valuations (PE/ PEG ratios and growing earnings and profit margins) or 3) anticipation of a win against Merck?
I think the former 2 reasons are more likely.This week we had a couple of articles that made me think a halozyme win might not be such a slam dunk (I still think that halo is more likely to win) and yet stock is acting well.

Great article. Wish I could understand it.

BRIEF-Merck Says FDA PDUFA Date For Subcutaneous Pembrolizumab Set For Sept 23

"While Merck and Alteogen could face a potential patent challenge from biotech Halozyme Therapeutics (HALO.O), over the enzyme, Merck said it will not delay the launch of the drug.
"We believe we have a very strong position relative to the claims from Halozyme," Merck's Monahan said."

https://www.reuters.com/business/healthcare-pharmaceuticals/merck-plans-us-launch-subcutaneous-version-keytruda-october-1-2025-03-27/

https://www.markmanadvisors.com/blog/2025/3/27/w7lv67t4yzfvbmrph1blwz17mkbee0
It's hard to say who will win the post-registration dispute but even if Merck wins that round, that will take care of only 7 of more than 100 applicable patents that Merck is infringing. 

Does anyone have a copy of halozyme's 2012 priority application for patent 11,655,600?

Howee, that was a little early for your April Fools joke. LOL!

Because I originally thought that Merck and halo were testing Enhanze in the past. It looks like that wasn’t the case. It was pegph20 and not Enhanze.

Why would you post a 10 year old article?
I'm totally confused??????

It is certainly exhibiting strength on a day where xbi, ibb and big pharma were all very weak. And
alteogen has dropped 18% in the past 5 days.

Yet another interesting close.

Right, 2015. Disregard.

This is a 10 year old article ??

That is weird. HALO is sponsoring it.

Looks like wasn’t Enhanze but Pegph20.

https://www.prnewswire.com/news-releases/first-patient-dosed-in-clinical-trial-of-halozyme-investigational-drug-pegph20-in-combination-with-merck-immuno-oncology-drug-keytruda-300173008.html

Another strong finish with high volume. No option expiry to explain this one.