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PLX CHMP opinion This week!
"If we are going to see any sort of acquisition action, it will happen after CHMP and before FDA. The CHMP positive opinion is basically the same thing as EMA approval. They almost universally adopt the opinion. I also think FDA approval is almost a lock (can never say 100% until it’s finalized) .. Unigal met its agreed upon primary endpoint. This was agreed between PLX and the FDA. It should support approval as long as no hiccups with inspections.
I believe this time period provides the most value/risk for both entities involved in any negotiations.
A sure tell would be if we see any potential acquiring entity build a position at market after CHMP opinion. Doesn’t always happen prior to a BO, but clearly allows for a cheaper acquisition by already owning 5-10% of the stock, built at current market price.
I think with $1B milestones (estimate 50% capture) and then a multiple of 4-6 peak sales + pipe/platform - $350 Million fee for Chiesi
$500m + $600-900m + $250-500m (pure guess on pipe/tech) + $50 cash on hand (after warrants) - $350 if company other than Chiesi
$1b minimum = $11.50/sh fully diluted
$2b maximum = $23/sh fully diluted
Just my guess.. the hardest part is estimating valuation of the pipe/platform/tech and manufacturing capacity".
Shout out Thx Cashflow from ST
$PLX
Hostile take overs coming into this Market for instance Emerson and National Instruments this morning . Could see one with PLX soon.
$PLX
Over 95% of the patients in the last switchover trial stayed on PLX-102 for Fabry
$PLX
Added a few today New 52 week highs then double digits.
$VKTX
Looking good!
$SGMO
935% option hit in less then a week.
Time to go shopping tomorrow for some stocks that I want to add positions too.
$Mara
Buy out is coming in my opinion with the methodical accumulation over the last couple months. Hostile takeover. I think this gets taken out for $7.00-$10.00 somewhere between EU & FDA Approval maybe a bid comes in sooner by a company trying to get out in front of any competing offers.
Volume
Jan 12, 2023 1.6200 1.6200 1.5750 1.6000 1.6000 748,007
Jan 11, 2023 1.5900 1.6000 1.5500 1.5900 1.5900 659,400
Jan 10, 2023 1.4700 1.5800 1.4700 1.5500 1.5500 875,200
Jan 09, 2023 1.5600 1.5700 1.4500 1.5000 1.5000 1,394,500
Jan 06, 2023 1.4800 1.5400 1.4500 1.5300 1.5300 927,500
Jan 05, 2023 1.4300 1.4600 1.4000 1.4300 1.4300 607,200
Jan 04, 2023 1.4300 1.4300 1.3900 1.4300 1.4300 515,900
Jan 03, 2023 1.3800 1.4700 1.3400 1.3700 1.3700 1,256,100
Dec 30, 2022 1.3100 1.3800 1.3100 1.3700 1.3700 761,100
Dec 29, 2022 1.2100 1.3300 1.2000 1.3000 1.3000 797,200
Dec 28, 2022 1.2000 1.2100 1.1900 1.2100 1.2100 340,400
Dec 27, 2022 1.1600 1.2100 1.1500 1.2000 1.2000 478,400
Dec 23, 2022 1.2000 1.2200 1.1800 1.1800 1.1800 210,500
Dec 22, 2022 1.2000 1.2100 1.1500 1.1800 1.1800 548,600
Dec 21, 2022 1.3300 1.3400 1.2800 1.2800 1.2800 811,900
Dec 20, 2022 1.1800 1.3400 1.1800 1.3000 1.3000 1,525,100
Dec 19, 2022 1.1600 1.1800 1.1600 1.1800 1.1800 255,400
Dec 16, 2022 1.1500 1.1800 1.1500 1.1600 1.1600 307,100
Dec 15, 2022 1.1800 1.2400 1.1600 1.1600 1.1600 637,900
Dec 14, 2022 1.1300 1.1700 1.1300 1.1600 1.1600 385,700
Dec 13, 2022 1.1700 1.1900 1.1300 1.1300 1.1300 101,500
Dec 12, 2022 1.1900 1.2000 1.1400 1.1400 1.1400 162,300
Dec 09, 2022 1.1600 1.1900 1.1400 1.1700 1.1700 157,800
Dec 08, 2022 1.1800 1.1900 1.1500 1.1700 1.1700 55,100
Dec 07, 2022 1.1500 1.1800 1.1500 1.1700 1.1700 66,300
Dec 06, 2022 1.1900 1.1900 1.1700 1.1700 1.1700 85,300
Dec 05, 2022 1.1700 1.2000 1.1500 1.1900 1.1900 774,000
Dec 02, 2022 1.0900 1.1500 1.0900 1.1300 1.1300 59,200
Dec 01, 2022 1.1000 1.1200 1.1000 1.1000 1.1000 13,600
Nov 30, 2022 1.1200 1.1800 1.0700 1.1000 1.1000 124,900
Nov 29, 2022 1.1100 1.1400 1.1100 1.1100 1.1100 115,900
Nov 28, 2022 1.1600 1.1900 1.0800 1.1100 1.1100 428,200
About 15 Million shares Look for a Buyout in the coming weeks or months might just get it out of the blue the approvals look like a slam dunk a $150 million exit fee to Chiesi is peanuts for these biotech Behemoth's Alot of Fabry indications falling Flat PLX 102 is becoming more valuable by the day..
$PLX
I added a handful of new positions I was looking to enter end in Dec 2022
Loaded the 30's end of the last year not exactly the bottom but close enough.
Gold, Silver and much much more.
$LODE
Deep Pipeline blockbuster potential across the board.
Major partnerships.
Lots of headwinds entering 2023 Looking for substantial gains from here.
Chart just turned bullish.
$SGMO
PLX Golden Cross confirmed!
80 Million market cap with potential 200 Million on revenue not figuring in the gaucher revenue plus Milestone payments that start to kick in 1.05 Billion and then hefty royalties this looks like one of the most undervalued biotech companies under $100 Million market cap. Gap fill to 6.30 will get filled by FDA approval. The 6.30 was hit before the covid inspection delays delays Much more data since then compiled by PLX. Smart folks are gobbling up shares meticulously at these levels including insiders on the open market. 2+ Billion market standard of care market for Fabry
Suck not to be when an offer comes in. At least half a dozen blue chip biotech interested in Fabry Soc would be a great fit. Rare disease assets are being bought out. Multiple in the last week or so.
Delisting on the tase is a pretty solid indicator that there are suitors interested in buying PLX
Look for more insider buys and analyst coverage on PLX near term.
No PRAC no safety issues= Bullish 2.0
Recap PLX 80 Million market with hundreds of million in revenue coming annually plus mega milestone payments Billion+
Validated platform with Gaucher FDA approved drug with partner Pfizer.
PLX We close that gap to $6.00 in the next 3-4 Months.
$PLX
Director buying 110K shares at $1.41
SEC Form 4: Schwartz Aharon bought $155,815 worth of shares (110,000 units at $1.42), increasing direct ownership by 172% to 174,000 units
https://quantisnow.com/insight/3880231
$PLX
Sold 27k 3.20-3.330 I owe my friend one for pointing this out before the breakout.
what a start to the new year leaving where I left off last year.
$VVOS
Fabry Disease Treatment and Research Landscape
Added this am 8.23-8.25
$VKTX
2 for 1 Nice hit on Gern data this AM chart says continuation.
PLX The FDA indicated in the BLA filing communication letter that the resubmitted BLA was considered a complete, class 2 response and set an action date of May 9, 2023, under the Prescription Drug User Fee Act (PDUFA) CHMP Jan 26 2023.
$GERN
$PLX
Have a few family and friends buying here this week. I'm still adding here. Rarely do you see a company with a science that has a FDA approved drug with one of the biggest biotech in the world. And Entering a market with 2 drugs that either have little efficacy & and countless side effects.
PLX will be the new Standard of care for FABRY Disease a Multi Billion dollar market with a top notch partner in Chiesi who has 6000 employees & 3 Billion in revenue and will owe over a Billion dollars to PLX on Milestones for 102 & pay up to 35% in Europe & 40% in the USA which is about 200 Million per company per year that will grow and capture closer to half the market in a year or two. That's why I think Chiesi makes a bid for PLX for maybe 600-800 Million some people might think that's low ball offer but that's what I'm thinking. Takeda SNY or royalty Pharma might sneak in and try and steal this cash cow from PLX. The Fabry is a tight knit community that is eager to take 102 the switch over from the other drugs to 102 from the trials was nearly 100% that is a tell tale sign we have a blockbuster on our hands.
The next quarter or two should be telling the deslisting from TASE from PLX is a clear signal to me some M&A is in the cards. That's why I'm adding at these levels. Any day we can get news that an offer for PLX is on the table. Got 2 buyouts for hefty premiums looking for more in 20023
$PLX
$TAK
$SNY
$RPRX
$PFE
Took a starter yesterday for a buyout. Patent situation should help the stock turn around.
$AUPH
Sold half on the pop was holding this for years. Let the rest ride house money that's how I do dis.
$GERN
Bought on a whim at the open just sold.
Profits going back to core positions.
$JSPR
Picked up a few heavy racks of shares under 2.95 today.
$GLYC
Added some today at 8.05-8.10
$VKTX
I'm going to keep my entire position and double my stash next week.
Made a fortune in the space and I think gains will continue to increase next 12-24 months.
$VKTX
PLX Why now after 15 years of a dual listing?
Simplifying for buyout?
Making calculation of a multiple simpler?
Making milestone payments easier to reflect as cash per share?
No significance just coincidence that this move occurs just ahead of EMA and FDA decision dates?
Simplifying accounting for buyout!
$PLX
$TKD
$SNY
$PFE
Chiesi’s marketing team PLX partner on 102 has a lot to work with when compared to Fabrazyme. Read about it. Less antibodies. Less pain. Less dosing. Probably less decline in renal function. Perhaps the greatest advantage may be subjective wellness of Fabry patients who simply feel better on PLX 102 perhaps due to a longer half-life. Fabry doctors will suggest a change from Fabrazyme to PLX 102 in many patients IMO based on these differences.
Cost may also cause governments and insurance companies to change. 1X/month dosing is an obvious cost-saving for drug and ancillary infusion services. The production cost of the Procellex platform is also significantly less than mammalian cells and thus saving may be able to be passed on.
Chiesi is already working on its marketing plan. They claim to be a Fabry company based solely on their PLX partnership. They have spent significant cash and resources already. I’m assuming they know what they’re doing. Milestones and royalties coming.
PLX
$500 will be here soon enough!
$MDGL
No one loved it under $3.00
always early!
$VKTX
PLX sitting on the standard of care (will become) in a current $2.1 billion Fabry ERT market - growing to nearly $3 billion by end of decade… and sport a $65 million market cap. Ridiculously undervalued is an understatement. Companies Platform is validated with FDA approved drug with Pfizer for Gaucher. 2023 Approvals in Europe & the US are expected to pass with flying colors Q1 & Q2 2023. Chiesi PLX partner on 102 Fabry has negotiated 15-35% royalties is Europe & 15-40% royalties in the USA with 1.1 Billion in milestones that kick in on Approvals. 3 Phase 3 Completed.
Happy New Year!
$PLX
Sanofi or Takeda might throw a curve ball and steal PLX from Chiesi before the approval dates CHMP EU in a few weeks.
Lots of M & A happens as early as Phase 2 PLX has three Phase 3 Trials completed + more data following up on those patients.
The key is on the switch over trial there was over 97%+ retention from patients who switched from Fabrazyme to PLX 102 wanted to stay on PLX drug less side effects and half the infusion times a month is a key factor. SNY might want to monopolize the Fabry space. Takeda can also come in and swoop 102 from Chiesi time will tell.
$PLX
$SNY
$TAK
"The efficacy is there.. facts! Just as effective as Fabrazyme and more effective than Replagal (I believe will show LT superiority to Fabrazyme in efficacy as well)
Fewer premeds needed
Fewer reactions
Fewer AEs
Fewer ADAs
Potentially 50%+ fewer infusions
No risk of contamination and drug shortages, unlike FAB and REP
97% retention rate on switch over trials patients wanted to stay on PLX 102 three phase trials 3 completed The Fabry community is relatively small and well connected. Don’t think for a minute that they don’t understand these benefits and hear these testimonials. Most are eagerly awaiting its approval" Also the platfrom has been validated as Pfizer partnered with them for FDA approved drug for gaucher.
$PLX
$SNY
$PFE
$TAK
Some people see the angles before they are being played others don't simple as that up over 300% here.
$ALT
Selling half my shares at $12.50 then let the other half run the houses money.
Adding end of Feb options.
$VKTX
$PLX Takeda (Replagal) was never able to enter the US market. It would be interesting to see if they make a play for (Unigal PLX 102) Would take about $350m (includes $150m exit fee) to erase Chiesi from the picture. What’s another $2b for them to buy the WW rights to Unigal and have a direct, potentially superior Fabry ERT that can compete globally with Fabrazyme in a $3.Billion annual market by 2030. Protalix could sell the rights outright, collect $2B cash, and then manufacture Unigal for Takeda as additional revenue source.
At a minimum, maybe this potential scenario causes Chiesi to consider an acquisition they may not normally consider? Free markets cause interesting moves. At the end of the day, it’s mainly about the money and ROI.
The delisting from TASE and focusing on a single listing the NYSE American is a signal of a buyout or Merger is in the works.
$PLX
$TAK
$SNY
Riding free shares 300% profits last week was holding for 6 months worth the wait being patient & nailed some of the Jan 2023 calls a few weeks ago. It's going to go higher! 300 Million in financing to complete remaining trails Nash market is worth tens of Billions of dollars should be years ahead of the rest. Look for Buyout in 2023.
$MDGL
Sold last week .85 to 8.75-$9.00 in less than 4 months.
$CABA
PLX 102 for Fabry disease Chmp in January 2023 (350 Million milestone payment on EU approval & 650 Million on US approval Quarter 2 2023 + 15-35% royalties in Europe & up to 40% royalty in US looking to capture new standard of care for Fabry 2.1 Billion market. over 95% retention rate from PLX 102 on switch over trials Patients wanted to stay on PLX 102. Three Phase 3 completed. Partner is Chiesi 3 Billion revenue generating company with 6000 employees Chiesi has over well over 200 Million invested in 102 for Fabry with PLX look for a possible buyout. I believe Takeda or Sanofi could make a bid also possibly Pfizer might be in the mix partnered with PLX with FDA approved drug for Gaucher disease. validating the platform Chiesi & PLX look to make 150-200 Million each in year 1 capturing 25% of the market & growing each additional year. Positive EPS scheduled in 2023 Happy Holidays!
KOL Pegunigalsidase alfa (PRX-102) for Fabry Disease KOL Event December 2022
https://protalixbiotherapeutics.gcs-web.com/static-files/eaedf07b-6f15-4c61-9e4d-0cd3465b583b
$PLX
PLX has potential to see significant gains in the coming weeks and months. Milestone payments due on approvals =over $14.50 a share
1. 60 Million market cap today. $1.19 per share
2. 1.1 Billion due on milestone payments for approvals in Europe in the US from Chiesi Italian conglomerate with 3 Billion in revenue and 6000 employees. Also PLX will receive between 15-40% on top of those milestone payments.
3. PLX 102 for Fabry will most likely be the new standard in care in Fabry a 2.2 Billion dollar market
4. Over 95% retention rate from trials who switched over to 102 they wanted to stay on PLX 102 for Fabry (less side effects & once a month infusion instead of 2 infusions.
5. This stock was trading in the 6-7 dollar range before a CRL was issued for inspection due to Covid 19 restrictions.
PLX & Chiesi look to capture 25% first year stating in 2023 equaling 150-200 Million in revenue for each company.
6. PLX 102 I believe will take over 50% of the Fabry market with in 2 years and more than 50% in year 3
7. I believe Chiesi will buy PLX they have 220 Million invested in PLX 102 so far and have Billions owed in the coming years.
8. I believe there are other companies interested in buying PLX including Takeda, Sanofi & possibly Pfizer who is already partnered with them for an FDA approved drug for Gaucher. I believe Chiesi will end up with PLX.
9. CHMP schedule in a few weeks from now in January 2023 (350 Million Milestone payment due on European approval)
10. PDUFA scheduled early Q2 2023 over 650 Million on US approval in milestone payments due.
11. PLX will be cash flow positive with 150-200 Million in revenue coming in for PLX 102 starting in 2023.
12. Pegunigalsidase alfa (PRX-102) for Fabry DiseaseKOL Event December 2022 https://protalixbiotherapeutics.gcs-web.com/static-files/eaedf07b-6f15-4c61-9e4d-0cd3465b583b
$PLX
good morning duck dung quantum leap orbit launch bean stalk mover
Weeeeeeeeeeeee
$NERV
Weeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeee
https://tenor.com/view/airtime-weeee-jump-truck-tricks-gif-17480246
$NERV
Weeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeee
$NERV