Halozyme Therapeutics Incorporated (HALO) Options

Will be curious to see if South Korea tariffs will effect Merck deal with Alteogen. It might be cheaper to license from Halo rather than pay 40 percent tariff. Also looking like Risingers report is turning out to be totally off base. The stock acting well since the BBB passed with Orphan Drug provision.

Certainly a great idea for auto injection...a fixture to steady, aim & hold in position an auto injecting, timed device .
Eliminates the "YIKES" factor as one shoots them self !

Certainly give'em an "A" for effort.......but why they just didn't present the whole story at once...Who knows?......Why the continual updates with bits-and-pieces in HVAI patent filings, when they knew all along what was needed?

Maybe it is finally a platform for a deal?.........An investor can hope.....nano nano.....

"PLATFORM ATTACHMENT FOR ANGLED SUBCUTANEOUS INJECTION AND METHODS OF USE THEREOF "

https://www.freepatentsonline.com/WO2025144799A1.html

From Gemeni:"The "One Big Beautiful Bill Act" has been signed into law, and it includes the "Orphan Cures Act." This means that Darzalex and Darzalex Faspro, assuming they continue to have only orphan indications, will be exempt from CMS price negotiations. This legislative change is highly favorable for the future revenues of these drugs, shielding them from potential government-mandated price reductions that would have occurred under the original IRA provisions for multi-indication orphan drugs."
From Proplexity:"The legislative update confirms that Darzalex and Faspro will continue to be exempt from Medicare price negotiations under the new law, securing their revenue outlook for the foreseeable future"
From ChatGPT: "

The Orphan status for Darzalex in Multiple Myeloma has expires but it is active in Light Chain Amyloidosis.
"The exemption applies even if some orphan designations/exclusivities have expired, as long as all currently approved indications are for rare diseases"

"The bill also tweaks the timeline: it would exclude any period during which a drug had orphan designation from counting toward Medicare’s negotiation clock. Practically, this delays when a drug becomes eligible for government price-setting if it later gains a non-orphan use. For example, if a drug spent 7 years as orphan-only, those years wouldn’t count toward the IRA’s 9–13 year post-approval window for negotiations."
https://www.linkedin.com/pulse/cracking-down-orphan-drug-abuse-cures-act-its-impact-i-pliner-umdae

Darzalex (daratumumab) will benefit from the Orphan Cures Act and will not be subject to Medicare price negotiations under the Inflation Reduction Act (IRA) as long as all its approved uses are for rare (orphan) diseases.Here’s how the Orphan Cures Act (included in the Big Beautiful Bill being signed into law by Trump today) affects Darzalex: • Current Law (IRA): Only drugs with a single orphan indication are exempt from Medicare price negotiations. If a drug, like Darzalex, is approved for multiple rare diseases, it would lose that exemption under the original IRA rules. • Orphan Cures Act: The new law expands the exemption so that drugs with multiple orphan indications—but no non-orphan (common disease) indications—remain exempt from Medicare price negotiations. This is specifically designed to encourage companies to pursue additional rare disease indications without fear of losing revenue due to government price controls.Darzalex’s indications: • Darzalex is approved for multiple myeloma and light-chain (AL) amyloidosis, both of which are rare diseases with orphan drug designations. • It does not have any non-orphan indications.What this means: • Under the Orphan Cures Act, Darzalex will remain exempt from Medicare price negotiations for as long as its approved uses are limited to orphan indications. • If Darzalex were to receive approval for a non-orphan (common disease) indication in the future, it could lose this exemption.Additional context: • This change is intended to restore incentives for companies to research and develop additional orphan indications for drugs like Darzalex, which was a concern under the previous IRA framework.In summary:Darzalex will not be affected negatively by the Orphan Cures Act; in fact, it will benefit by remaining exempt from Medicare price negotiations as long as it is only approved for rare diseases.
Same goes for Opdivo, Vyvgart and most Enhnaze partnered drugs.

The exclusion of Orphan Drugs from CMS price negotiations got approved by the House today (included in the Big Beautiful Bill) and will be signed into law by Trump tomorrow. Darzlex, Opdivo and most Halozyme Enhanze partnered products already have the Orphan Designation. Halozyme's share price decline in May form high $60's to low $50's was due to an analyst (Leerink Partners) downgrade based on his concern with CMS price negotiations affecting halozyme's earnings from Darzelx/Faspro. Since this threat is removed, expect share price recovering in short order. I wouldn't hold your breath on the analyst reversing his call. They are typically slow. 
https://www.mmm-online.com/news/one-big-beautiful-bill-passes-heres-what-pharma-marketers-need-to-know/

Garbage article.

He also got the market cap for halo wrong. Way wrong.

Good article till the end....not sure about this comment...."Competitor Threats: Subcutaneous delivery alternatives (e.g., Amgen's Hyaluronidase) may erode margins."

Searched, and can not find anything on Amgen's hyaluronidase......they must have meant Alteogen.....

https://www.ainvest.com/news/halozyme-therapeutics-catalyst-fueled-ascension-russell-1000-2507/

...& we're all praying!

I’m sure that’s part of it, but in the Bible, David was victorious, and from what I’ve been reading on this board, HALO’s position seems very strong.

They are thinking that Goliath will prevail over David.
They are wrong!!!

Another 1/2 million shares sold short. I can’t imagine what they are thinking!

Didn't know either, saw the info in Monday morning research....figured the switch would cause a big shuffle in shares.....so posted it.....

Keep up the good effort.....one thing for sure, something will happen........

FWIW...Lindy Biosciences is another company like Elektrofi, encapsulates biomolecules, patents show it uses hyaluronidase in some form.....watching both....

https://www.freepatentsonline.com/WO2024177927A1.html

SMART AI lol. go 4 it!

I was clearly wrong. The volume was due to Russell 2k to 1k transition. 
Having said this the Orphan Drug exemption from CMS price negotiations would be great for Halozyme. Darzelex, Opdivo and most other Enhanze partnered drugs laready have orphan drug status.

From Perplexity after it reviewed PGR legal documents from Halozyme, Merck: “Halozyme presents the more compelling legal arguments, particularly on PGR eligibility and claim construction. Here’s a breakdown:1. PGR Eligibility (Threshold Issue) • Halozyme’s Argument:?Merck failed to prove the patent is PGR-eligible by analyzing only a 2011 priority date (provisional applications) instead of the critical 2012 non-provisional filing date. The ’731 Application (filed Dec. 28, 2012) predates the PGR cutoff (March 16, 2013), and Merck provided no evidence that the claims lack § 112 support as of this date. The panel ignored precedent (e.g., Merck v. Wyeth, Sandoz v. Biogen) where institutions were denied for similar errors.“Merck presented no evidence as to whether the claims were entitled to the 2012 priority date.” (Halozyme Request, p. 6-7). • Merck’s Response:?Claims the Petition analyzed all priority dates and that the ’731 Application lacks § 112 support. Asserts the Board addressed eligibility adequately.“The Petition did not limit its § 112 analysis to a pre-2011 date” (Merck Response, p. 1). • Assessment:?Halozyme prevails. PGR eligibility requires evaluating the correct priority date. Merck’s focus on 2011 undermines its burden, and the panel’s conclusion that the “effective filing date is no earlier than 2023” (DI, p. 36) overlooks the 2012 filing.2. Claim Construction (“Modified PH20 Polypeptide”) • Halozyme’s Argument:?The patent expressly defines the term structurally (Ex. 1001, 48:38–53), not functionally. The panel erred by importing a “hyaluronidase activity” requirement, contradicting Phillips v. AWH Corp. (Fed. Cir. 2005) and Alnylam v. IONIS (Fed. Cir. 2021). This error tainted the written description/enablement analysis.“The claims are purely structural … the panel’s decision runs counter to established Federal Circuit law” (Halozyme Request, p. 3). • Merck’s Response:?The claims inherently include “active mutants,” and the specification’s definition requires activity. Cites the patent’s language: “so long as the resulting modified PH20 polypeptide exhibits hyaluronidase activity” (DI, p. 14). • Assessment:?Halozyme prevails. The patent’s definition is unambiguous: structural changes define the term, while function is a separate attribute. The panel’s functional reading (DI, p. 13–16) disregards the specification’s plain language and Federal Circuit precedent.3. Discretionary Denial Under Fintiv • Halozyme’s Argument:?Parallel district court litigation (D.N.J., filed April 2025) involves 11 of 13 challenged patents, including PGR-ineligible patents. Granting institution wastes PTAB resources and creates inefficiency. No stay is likely without a Sotera stipulation.“The Fintiv factors weigh heavily in favor of denying institution” (Halozyme Request, p. 3–4). • Merck’s Response:?PGRs promote efficiency by resolving validity issues early. The court’s median time to trial (2030) allows the PTAB to rule first.“These PGRs will provide enormous efficiencies” (Merck Response, p. 4). • Assessment:?Halozyme is stronger. The district court will proceed regardless due to PGR-ineligible patents, risking duplicative efforts. Fintiv Factor 1 (overlap) and Factor 4 (timing) favor denial.ConclusionHalozyme’s arguments are more compelling: • PGR Eligibility: Merck’s failure to analyze the 2012 priority date is a critical flaw. • Claim Construction: The panel’s functional reading contradicts the patent’s explicit structural definition. • Fintiv: Parallel litigation involving non-PGR patents justifies discretionary denial.
Recommendation: Director Review should grant Halozyme’s request, vacate institution, and deny the PGR.

Get ready HALO longs.

Latest news about Halozyme Therapeutics, Inc.

Halozyme Therapeutics, Inc.(NasdaqGS:HALO) added to Russell 1000 Index. 1h ago

Halozyme Therapeutics, Inc.(NasdaqGS:HALO) dropped from Russell 2000 Index 1h ago

Halozyme Therapeutics, Inc.(NasdaqGS:HALO) dropped from Russell 2000 Growth Index 11:40pm

Halozyme Therapeutics, Inc.(NasdaqGS:HALO) added to Russell Midcap Index 10:16pm

https://www.marketscreener.com/quote/stock/HALOZYME-THERAPEUTICS-INC-50245/news/Halozyme-Therapeutics-Inc-NasdaqGS-HALO-dropped-from-Russell-2000-Index-50367620/

This might be the reason behind the large volume on Friday (if so, expect a sharp price appreciation in halozyme):
"Senate Republicans have included an expansion of a Medicare drug price negotiation exemption for orphan drugs (medicines treating rare diseases) in updated text of their sweeping domestic policy bill. This expansion could allow for the exclusion of drugs that treat multiple rare diseases, whereas currently, only drugs treating a single rare disease are exempted."Darzalex, Opdivo and in fact most of halozyme partnered drugs are already designated Orphan drugs.

I went back multiple years and looked at the annual Russel 2000 rebalancing days and the highest volume for Halo was about 3 million ahares. Something else must be going on with a 21 mil shares volume on Friday.
In fact, Friday was the highest trading volune for halo EVER. The second highest volume ever was 14 million shares.

Possibly between funds within a group. There is no way the stock didn’t move on this volume unless it was pre arranged.

Rebalancing of indexes? Russell 2000? But why such high after hour volume?

Maybe it was one of those negotiated trades between two institutions. That would explain the narrow price range.

But usually on such large volume, the share price spikes up big or down big. This large stayed within a narrow range. Why?

More than half of the volume is from after hours. None of the theories posted so far make much sense. The only thing consistent with this huge spike in volume is pending news.

It was a lot. Maybe Helen is cashing out. LOL!

I’ll have to admit the end of day volume is strange for sure. With no announcement of any kind it has to be some trading strategy. Did anyone check option volume?

...and 6/30/23 the volume was 1.5 million
https://www.nasdaq.com/market-activity/stocks/halo/historical?page=5&rows_per_page=100&timeline=y5

For example, last year this time (6/28/24 which was the true last day of the quarter) the volume was 2.3 million. Today we are trading nearly 10 times that.
https://www.nasdaq.com/market-activity/stocks/halo/historical?page=3&rows_per_page=100&timeline=y5

Even so, we have never had an "end of quarter repositioning" volume like this. Not even ons third of this volume.
21 million plus shares so far today.

A lot of traders are off next week as it is a shortened week due to July 4th.

... also never before have we had +21 million share trading day for end of quarter in this name before. Not even close.

That would be Monday, not today.

One of those two possibilities is what happened. Nothing big either way.

I'm guessing end of Q re-positioning.

Maybe halo buy back of whole 250m.

Would of been nice if we ended up
the session higher with that volume.

Huge volume at the end. 11 million. Something is up

Reviewed Halozyme request for Director review and Merck’s reply. Comparison and ConclusionHalozyme’s Overall Case:Halozyme’s arguments are well-supported:- Fintiv Factors: Strong due to PGR-ineligible patents and no Sotera stipulation, creating inefficiency (NHK Spring), though weakened slightly by the litigation’s early stage.- PGR Eligibility: Very strong, as Merck’s 2011 focus is a clear error under Federal Circuit (Reiffin, Chiron, Ariad) and PTAB (Merck v. Wyeth, Sandoz) precedent, undermining jurisdiction.- Claim Construction: Very strong, supported by the patent’s explicit structural definition, “Inactive Mutants,” and Alnylam/Boehringer II, directly invalidating Merck’s § 112 grounds.
Merck’s Overall Case:Merck’s arguments are less persuasive:- Fintiv Factors: Credible in highlighting litigation’s early stage and PGR efficiency, but weakened by failure to address duplication risks from PGR-ineligible patents and no Sotera stipulation.- PGR Eligibility: Weak due to the documented 2011 focus (EX1003, EX1004), with the petition’s general priority chain analysis insufficiently specific to counter Halozyme’s precedent-driven argument.- Claim Construction: Weak, as it contradicts the patent’s clear definition and disclosures, and the Amgen argument lacks detailed support. Director precedent is less compelling than Halozyme’s textual and legal evidence.
Conclusion:Halozyme presents the more compelling legal argument. Its PGR eligibility and claim construction arguments are particularly strong, identifying clear PTAB errors supported by robust precedent and the patent’s text. The Fintiv argument, while strong, is slightly less decisive but still favors Halozyme due to inefficiency concerns. Merck’s responses rely on general assertions, Director precedent from related PGRs, and a questionable claim construction, but fail to overcome Halozyme’s specific evidence and legal grounding. Therefore, Halozyme’s legal arguments are more compelling in this dispute.

I lost some confidence in her when she made the bid for Evotec (which would have been a terrible acquisition for halo). She redeemed herself some when she course corrected (walked away from the bid). But she has not been able to attract retail investors in years. We need a better story teller. We are chronically about 98% institutionally owned. 2025 PE of 9!!! We need better IR and better storytelling CEO.

First time that you have said something like this about Helen. Sure hope if it happens it happens fast as the share price is in a world of hurt.

We need a new CEO

I find it hard to see this as a good sign. It’s an awful lot of shares she is selling.

Usually sell a third to pay taxes so expect 80,000 if there is 240,000 awarded.

Well she's sold 60k shrs so far... https://www.sec.gov/Archives/edgar/data/1159036/000141588925018118/xslF345X05/form4-06242025_090608.xml ...r

She knows MERCK is going to lose & wants tons of shares just before it goes for more than $100 a share when Merck buys HALO.