Halozyme Therapeutics Incorporated (HALO) News

Keytruda® is a 28 billion dollar drug.... the key factor being, approvals for more cancer types. BMS will also have completed approvals for these additional cancers. Giving it the potential to have similar sales volumes (700M HALO). Too lazy to research timing of trials... some being simple BLA acceptances.

By Sneha S K and Sriparna Roy

(Reuters) -The U.S. Food and Drug Administration said on Friday that it has approved an injectable version of Bristol Myers Squibb's blockbuster cancer drug, Opdivo.

Opdivo is part of a class of drugs called PD-1 inhibitors, which enhance the immune system's ability to fight cancer by removing its natural brakes.

Like other PD-1 drugs such as Merck's Keytruda, it was previously available through infusions and patients received it via an intravenous drip in a health office.

The new injectable form is expected to be more convenient for patients and could help shield the company from erosion of sales when the patent for the intravenous version expires later this decade.

The injection, branded as Opdivo Qvantig, has been approved to treat all previously approved adult, solid tumor indications, either on its own, as maintenance therapy or in combination with chemotherapy.

The drug will be available in early January, and will be priced at parity with the list price of the IV version, Adam Lenkowsky, Bristol's chief commercialization officer, told Reuters ahead of the approval.

The IV version of the drug has a list price of $7,635 per infusion for two weeks for the lower dose and $15,269 per infusion for four weeks for the higher 480-milligram dose.


The approval was based on data from a late-stage study, which showed that the subcutaneous form of the drug was not inferior to the intravenous formulation in patients with advanced kidney cancer who have received prior systemic therapy.

The drugmaker is relying on newer treatments like Opdivo Qvantig to drive growth as patents on older drugs, such as cancer drug Revlimid and blood thinner Eliquis, expire later this decade.

Opdivo Qvantig was co-formulated with Halozyme Therapeutics' drug delivery technology, which helps reduce treatment administration from hours-long IV infusions to subcutaneous injections delivered in minutes.

(Reporting by Sneha S K and Sriparna Roy in Bengaluru; Editing by Pooja Desai, Shreya Biswas and Tasim Zahid)

Remember that subcutaneous Opdivo performed better (33% greater efficacy) vs IV Opdivo (see link below). This will lead to not only a combination patent effective until late 2030's BUT ALSO a higher conversion rate to subutaneous. Bristol will likely push the subcutaneous version hard to avoid the potential price negotiation from CMS on the IV version. All of this will lead to a 50% plus IV to SC conversion. For a $11 billion per year franchise and at 4% royalty, this will translate to  minimum $250 million per year royalty to halo.

After 8 months of minimum follow-up, ORR was 24.2% with subcutaneous nivolumab (95% CI 19.0%-30.0%) versus 18.2% with intravenous nivolumab [95% CI 13.6%-23.6%; relative risk: 1.33 (95% CI 0.94-1.87)]. https://www.annalsofoncology.org/article/S0923-7534(24)03996-6/fulltext

Biotechinvestor1,
You're sharing some awesome-good news (again!)...thanks!

Bristol-Myers: FDA approves nivolumab and hyaluronidase-nhy for subcutaneous injection
11:32 AM ET 12/27/2024 | Briefing.com
BMY
"On December 27, 2024, the Food and Drug Administration approved nivolumab and hyaluronidase-nhy (Opdivo Quantig, Bristol
Myers Squibb Company) for subcutaneous injection across approved adult, solid tumor nivolumab (Opdivo, Bristol Myers Squibb Company) indications as monotherapy, monotherapy maintenance following completion of Opdivo plus Yervoy (ipilimumab) combination therapy, or in combination with chemotherapy or cabozantinib.

argenx receives approval for VYVDURA in Japan 6:01 AM ET 12/27/2024 | Briefing.com
ARGX
Co announced that Japan's Ministry of Health, Labour and Welfare (MHLW) approved VYVDURA for adults with chronic inflammatory
demyelinating polyneuropathy (CIDP). VYVDURA is approved for CIDP as a once weekly 30-to-90 second subcutaneous injection, which can be self-administered at home, and is the first and only neonatal Fc receptor (FcRn) blocker approved for the treatment of CIDP. The MHLW approval is based on the ADHERE Study, the largest clinical trial to date studying CIDP. In the ADHERE study, 69% (221/322) of patients treated with VYVDURA, regardless of prior treatment, demonstrated evidence of clinical improvement, including improvements in mobility, function and strength.

This is the season...the birth of Jesus the reason !

And the same to all. Thank you.

Thank you and same to all.

To all who post and lurk here, if you celebrate Christmas or Chanukah or another or none at all, I wish you and yours a peaceful and loving holiday season.

This BARGAIN will not last forever:

2024 PE Estimates 12.41
2025 PE Estimates 10.34
2026 PE Estimates 7.8
PEG .43
https://www.nasdaq.com/market-activity/stocks/halo/price-earnings-peg-ratios


Institutional ownership 98.8%
https://www.nasdaq.com/market-activity/stocks/halo/institutional-holdings

Agreed, but biotechs were pretty strong today, xbi up 1.64%, and high volume on option expiration day doesn’t necessarily lead to a lower stock price. Part of the selling is hopefully tax loss harvesting.

We're coming to the end of yet another year in which Helen Torley has utterly failed to deliver on any of her promises, so I'm not prone to seeing good news in the current state of Halozyme, Inc.

Today was option expiration day. Always with large volumes. Nothing unexpected. 

What’s interesting is that with the thin trading in HALO stock, a sell off of this magnitude would normally have caused the stock to fall $2 or $3. So, maybe the fact that it only fell $.36 might be a good sign?

I'm guessing it's the last options expiry of the year that caused part of the volume, along with the fact that it is really the last true trading day of the year because all the trading bosses are heading out to their ski chalets until after New Years.

4.22M shares traded today and another 577k in after hours so far. The biggest risk is that halo doesn’t get the US patent extension, imho. Hopefully, whoever sold today did it for other reasons.

Looks like someone dumped a lot of share in the last 9 minutes of trading.

Ask yourself what would be the shareprice be when:

1) HVAI deal is announced
2) US Enhanze patent is extended to 2029
3) Alteogen agrees (or is compelled to) pay licensing fees to Halo
4) OPDIVO SC is approved

North of $80

Loading up more. Current PE is 15. Forward PE is 10. PEG OF 0.4

https://finviz.com/quote.ashx?t=HALO&p=d

Halozyme Therapeutics Price Target Maintained With a $68.00/Share by HC
Wainwright & Co.

Stupid judge!

Law360, London (December 16, 2024, 8:35 PM GMT) -- A London judge on Monday rejected Halozyme's bid to protect an active ingredient in two breast cancer drugs with a supplementary protection certificate, after finding that it was actually an inactive substance used to enhance other therapeutic effects

In the table below, we summarize the PDUFA and advisory committee dates for several notable FDA approvals that could happen in 2024 and 2025. In the following sections, we’ll review each one in greater detail.


Opdivo (nivolumab)

Subcutaneous (under the skin) administration

December 29, 2024

Higher volune today than normal. News brewing?

"In Halozyme Therapeutics, the short percent of float has declined by 18.07%, a notable shift in sentiment. Such a sharp reduction in bearish positions might indicate improving fundamentals or positive expectations among investors. It may also suggest that recent developments have alleviated concerns that previously drove traders to short the stock."


https://stocksrunner.com/posts/2024-12-12-Short-Interest-Shifts

Thanks for the reminder......

He's upset that B1 got 2 thumbs up.🤣😂😂
You just can't make this up.
He used to be a great poster. Perma Bears got to him.

... I wonder if he was amused by the volumes; 10, 20, 30 all the way up to 50ml given in short duration without an on-body wearable pump. No one else (other than halo) can do this. Truly innovative.

What’s perplexing? Looks like a possible solution to the limits of spring powered large volume injections.

Yes, they never get it.....

Need to encourage not discourage........never know what arises from some of those hidden crumbs, and some are hidden way down there, but why down there of all places....

This one is perplexing, to say the least........what are they up to now.....

https://worldwide.espacenet.com/patent/search/family/093429904/publication/AU2023430176B1?q=pn%3DAU2023430176B1

Interesting......

bi1 gets two thumbs for a twisted reply to some incredible bread crumbs, in which it was clearly stated info wasn't competition related...."for a break from the old competition, and MDASE stuff......... "

Time will definitely tell on this big one.....

Greg Frost was CEO when I bought my shares...BOTH Greg & Helen are AWESOME CEOs !!!
THEY know who is infringing !!

Very nice day.
Considering the markets were down including the XBI
this was a solid day. Hope the momentum continues.

Correct, he was CEO before Helen Torley.

This is no competition. Greg Frost is one of the co-founders of Halozyme, co-inventor of human hyaluronidase and former CEO of halozyme.

This weekends breadcrumb leads an investor on a whole new interesting path, for a break from the old competition, and MDASE stuff.........

"Exuma Biotech".......the possibilities........ "The use of claim 2, wherein the modified lymphocytes are administered subcutaneously in the presence of hyaluronidase." ...... bi1 looks like the Frost character you mentioned has been keeping busy.........

Nearly everyting you post is either misinformed or incorrect. I never asked for a patent number from you. Show me the post (the message number) where you claim ai asked for it.

I mean there was a fraudulent accounting news on one of the dates I listed, where do you focus on it?
In the end, it was all falsehood articles, and it will be the same this time.

I wonder if Goldman Sachs' analyst really has knowledge of the patent field.

I am referring to Sanofi v AMGEN's lawsuit as it relates to a violation of activation requirements.
It's very close with this case. You really don't know?

I can see your level when you say it's not related and sarcastically say martial law 2.0 lol

I am a shareholder of Alteogen and a shareholder of Halozyme. I'm just a regular person who wants to know the truth.

Previously, you asked me to bring the patent document number, but when I mentioned the patent document number and claim, I saw your level of answering with stock price. BI1 rofl.

At your level, it's only a mocking level of conversation, and I don't think it's going to be an in-depth conversation related to patents, so I'll end it now.

FAREWELL!

None of the dates you mentioned show a 33% drop in a span of few days with no real/material news and purely based on drevitives manipulations (or martial law) as you initially postulated on this board. Now you have changed your story to "fradulant accounting"!!! By whom? Alteogen? Of course Alteogen's stock should have gone down if there were concerns about "fraudulant accounting." That would be significant/material news/concern.

And "malicious news"!!! Get real! We don't need conspiracy theories. The simplest explanation tends to be the real truth. Here is the simple truth: right after the market learned about Alteogen's patent viloation through Goldman Sacs, alteogen dropped 33%. No consoiracy theory needed. The market participants believe Alteogen will lose. You can come up with all the comical alternatives explanations you want!

Also, news of halo buying Evotec broke out and Halo's stock dropped immediately. No conspiracy theory needed. Simple and perfect explanation.

The news of Meck patent challenge against halo was not made PUBLIC for many days after the filing. So agian nice try, but you are wrong.

You keep referring to another patent dispute with two other companies (Amgen and Sanofi) with different merits that has little relevence to the matter between Halo and Alteos. 

You keep repeating the nonsensical argument from alteo's CEO. Do you work for Alteogen? 

You will have the answers you seek for the merits of halozyme patent arguments once halo's attorney file their response. 

In the meantime, keep entertaining us with your conspiry theories! Martial law 2.0?

Answer the patent document & violation of enablement requirement.
(If you don't understand, search Amgen v Sanofi. i told you this so many time.)

Your answer is tied only to the stock price view.

And, find chart
09/20/20 ~ 05/20/21
12/13/21 ~ 01/27/22
08/22/22 ~ 10/13/22
03/26/24 ~ 04/05/24
and recent days.

Every time that fell, there was always malicious news, like termination of his contract with Merck and malicious - fraudulent accounting news.

According to your logic, the date Merck requested USTPO to judge is the 12th. Since then, Halozyme has fallen 30%, and the stock has not returned.

Judging by the stock price is only fragmentary, and it is correct to judge by the scope of patent rights.

Leaving aside the facts of the patent, it is rather silliness to judge only in the direction of the stock price.

MDASE's scope of a patent claim(distinct polypeptide is 1.50 x 10^63 and 1.35 x 10^66) is so large.
That scope of the claim is the scope that another inventor cannot complete even if he studies for life.
-----> this is violation of enablement requirement.


MDASE US9,447,401's claim seq id no:3 / 204 F replace to P
---> Alteogen's not use seq id no;3 and do not replace them

US 11,952,600 claim 1, at least 95% of the residues of the amino acid sequence of the modified PH20 polypeptide are identical to the residues in an amino acid sequence selected from the group consisting of SEQ ID NOs: 3
and 32-66 the modification at position 320 is a replacement selected from among H, K, R and S.

It is almost impossible for competitors to choose the best sequence, truncate position, and replacement targets while experimenting with such a large number of cases.

I wonder who will laugh in the end haha

For the true halo investors on this board: I hope you are getting the same sense of confidence as I am when you see how the bears have to resort to silly arguments to explain their position. Just in the past 24 hours we have read about Martial Law and deravatives causing alteogen's 33% drop, company size determining patent outcomes, etc etc.

This level of silliness is reassuring. They have no good arguments.

Which do you want in your body at this time? Altogen's testing is about 15 years behind FDA proven HALO. Why doesn't Alteogen need testing? Because they've copied HALO? (Merek knows!)

Alteogen has many other profitable products. The fact that it's market cap is larger than halozyme has nothing to do with the patent issue or even with hyaluronidases.

I have a feeling you already knew this.

You are saying that Alteogen's stock price has fallen 30%.

Alteogen's market capitalization is twice that of Halozyme. Since Alteogen's market capitalization is high, does this mean that Alteogen is better than Halozyme?

No. Halo was at $62 right when the idiotic Evotec acquisition news came out. It hasn't fully recovered because some of the investors who left the stock lost trust in Helen and have not come back. Others are still worried that she might try to buy another company prematurely.

Of course you already knew all this, but as our permabear moderator try to confuse the readers heres.

HALO is down ~30% also. But that's just the market being stupid, right?

.... and the market participants handicapped the odds with a 33% drop in Ateogen's stock price