Regenerx Biopharmaceuticals Inc (RGRX)

$0.00 0.00 (N/A)
Market Cap 0.00
Revenue (ttm) 80,000.00
Net Income (ttm) -1.73M
EPS (ttm) N/A
PE Ratio 0.00
Forward PE N/A
Profit Margin -2,162.50%
Debt to Equity Ratio 0.00
Volume 100
Avg Vol 1,826
Day's Range N/A - N/A
Shares Out 1.51M
Stochastic %K 0%
Beta 2.99
Analysts Strong Buy
Price Target $1.50

Company Profile

RegeneRx Biopharmaceuticals, Inc., a biopharmaceutical company, focuses on the development of therapeutic peptide, Thymosin beta 4, for tissue and organ protection, repair, and regeneration. The company is developing RGN-259, a preservative-free topical eye drop for regeneration of corneal tissues damaged by injury, disease, or other pathology; RGN-352, an injectable formulation for the treatment of cardiovascular diseases, central and peripheral nervous system diseases, and other medical indica...

Industry: Biotechnology
Sector: Healthcare
Phone: 301 208 9191
Address:
15245 Shady Grove Road, Suite 470, Rockville, United States
MrWolf69
MrWolf69 Jul. 1 at 6:56 PM
$RGRX ....If fake news is possible, then so is fake research!
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dontu1dr
dontu1dr Jun. 28 at 11:13 PM
$RGRX Sounds like the CRO left a message on HLB Thera's answer machine and they kinda ran with it for their PR... thus a verbal explanation... I think most people running clinical trials wait at least for an email or at least a telegram... Next time they can scan it and send it to chatbox or some such thing for an opinion... Maybe nerves got the best of them this time... But who knows??? THE DONKER
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ByeAndHold
ByeAndHold Jun. 28 at 4:37 PM
$RGRX Such a disappointing top line readout. While we await a full readout, but results cannot be viewed by anyone as a positive sign for RGRX or RGN259. Needing a confirmatory study to gain US approval this pretty much is yet another, if not the last nail in the RGN259 coffin. Having spoken with several in big pharma and research this pushes any approval back if not ends the clinical program for this molecule. There will be little to no interest in putting money behind an agent that is a multiple trial failure candidate. Curious to see what Allan and JJ have to say/do after full readout. Very disappointing if not devastating.
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dontu1dr
dontu1dr Jun. 27 at 1:03 PM
$RGRX Did any of you catch this info... I DIDN'T... HLB Thera group sold 10 billion won (7,359,705.61) to companies in the HLB GROUP on June 20th (4 days prior to disclosing Euro Clinical Trial results with "placebo problems" in Euro Trial... lol... IE: HLB Inc and associated subsidiaries "bought the dip" BIG TIME just 4 DAYS prior to the "stock crash" of HLB THERA'S announcement of "placebo problems" in the EURO TRIAL... LET THE GAMES BEGIN... Interesting situation to say the least... -when all else fails,,, follow the money trail in the trials... not sure you could get away with that move in the USA? THOUGHTS? quite a consolidation of stock ownership really... https://n.news.naver.com/article/018/0006045112 THE DONKER
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dontu1dr
dontu1dr Jun. 26 at 2:48 AM
$RGRX As Paul Harvey used to say, "...and now you know... the rest of the story." https://n.news.naver.com/article/018/0006049030 more clarification from HLB PAY ATTENTION to the following quote: "The official emphasized that although the US Phase 3 clinical trials and the European Phase 3 clinical trials have the same design, they are separate clinical trials, so the US clinical trial will proceed to the end regardless of the SEER -3 results. The US Phase 3 clinical trial is the SEER- 2 clinical trial that aims for FDA approval as the main clinical trial , while the European SEER- 3 clinical trial, which has the results from this time, is a secondary clinical trial conducted for the purpose of repeated efficacy verification." GET IT??? US clinical trial SEER-2 is the main trial for FDA approval... Euro was only a "secondary trial"... SO EURO TRIAL flushed a lot of retailers out of their position in KOREA---and it wasn't even the main trial for FDA APPROVAL... HANG TIGHT FOLKS, lol THE DONKER
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dontu1dr
dontu1dr Jun. 25 at 1:32 PM
$RGRX ONE THING you should consider at this point IN THE GAME: HLB Group has somewhat of a history of having a taken a bit of a "poetic license" in reporting trial results to the public. ---A good example is doing a historical search of HLB's drug trial results for "rivoceranib" after the finish of the trial in late 2018... what a debacle that was... and still is in some sense... ---Also, there was an incident where research results were lost in a "Florida Hurricane" years ago and I haven't seen that ever disclosed... Time is seemingly the only "true test" of what HLB Inc see's as potential in their drug development... And spending money finishing the US NK TRIALS if TB4 NK was a total loser wouldn't make cents/sense... This latest announcement will flush retail out of the float of HLB Thera--- it'll be interesting to watch the institutional side tho. At this point in the GAME listen carefully to what HLB SAYS,,, BUT,,, WATCH EVEN MORE CAREFULLY what HLB DOES... FWIW,,, THE DONKER
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MrWolf69
MrWolf69 Jun. 17 at 10:25 PM
$RGRX ....Elsewhere it was pointed out that changes on the RGRX website business development tab were recently updated.
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dontu1dr
dontu1dr Jun. 8 at 3:13 PM
$RGRX This is why BIG EYE PHARMA needs TB4 Eye: quote from this article: https://eyewiki.org/Limbal_Stem_Cell_Deficiency great article really QUOTE: "Traumatic/Iatrogenic: Acquired causes also include trauma from chemical or thermal burns and prior ocular surgeries or cryotherapies performed around the limbus.[16][18] Radiation and chemotherapy are other potential causes, and systemic[19] as well as topical chemotherapeutic medications may cause LSCD.[20] LSCD has also been seen with benzalkonium chloride toxicity with glaucoma medications.[21] Inappropriate contact lens use with consequent hypoxia and ocular irritation with the destruction of the limbus may also contribute to both focal and total LSCD.[22] [23]" Search: "Iatrogenic definition" & "Iatrogenic eye disease" if you need to bring yourself "up to speed" on this subject... Eye Doc's need TB4 EYE & So does BIG EYE PHARMA & EYE PATIENTS THE DONKER
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dontu1dr
dontu1dr Jun. 8 at 3:00 PM
$RGRX Another article out in Korea, info is in the 2nd item in the article. But here's an important tidbit pertaining to the business end of things that is RELEVANT: 5-14-25 additional listing of stock 5/21/25 lower repricing of 17th convertible bonds 5/28/25 lower repricing of 18th convertible bonds So that would "naturally" take place "in the business end" of things prior to any large upward move or announcement... That's the way "business" is normally handled... Pay attention to this in the article:(quote) "including through strategies such as expanding indications to LSCD ( Limbal Stem Cell Deficiency )." n.news.naver.com/article/01... eyewiki.org/Limbal_Stem_Cel... above is a great article... ENJOY THE READ... THE DONKER Bullish
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genecat
genecat Jun. 5 at 6:58 AM
$RGRX HLB Therapeutics announced on the 2nd that it has been exempted from submitting a pediatric investigational plan ( PIP ) for its NK treatment ( RGN- 259) being developed by its US subsidiary Regentree by the Pediatrics Committee under the European Medicines Agency ( EMA ). A PIP is one of the EMA regulatory requirements that must be submitted when applying for new drug sales approval in Europe to prove safety and efficacy in pediatric subjects . If certain criteria are met, a PIP exemption can be granted by submitting an exemption request form. In order to submit a PIP , a protocol for pediatric clinical trials must be prepared, and it usually takes several months for EMA to review and approve the submission. Regentree is currently conducting the final check on the data freeze status after completing patient recruitment for the NK treatment European clinical trial ( SEER -3). It plans to soon go through the data lock procedure and announce the top line results .
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Latest News on RGRX
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MrWolf69
MrWolf69 Jul. 1 at 6:56 PM
$RGRX ....If fake news is possible, then so is fake research!
0 · Reply
dontu1dr
dontu1dr Jun. 28 at 11:13 PM
$RGRX Sounds like the CRO left a message on HLB Thera's answer machine and they kinda ran with it for their PR... thus a verbal explanation... I think most people running clinical trials wait at least for an email or at least a telegram... Next time they can scan it and send it to chatbox or some such thing for an opinion... Maybe nerves got the best of them this time... But who knows??? THE DONKER
0 · Reply
ByeAndHold
ByeAndHold Jun. 28 at 4:37 PM
$RGRX Such a disappointing top line readout. While we await a full readout, but results cannot be viewed by anyone as a positive sign for RGRX or RGN259. Needing a confirmatory study to gain US approval this pretty much is yet another, if not the last nail in the RGN259 coffin. Having spoken with several in big pharma and research this pushes any approval back if not ends the clinical program for this molecule. There will be little to no interest in putting money behind an agent that is a multiple trial failure candidate. Curious to see what Allan and JJ have to say/do after full readout. Very disappointing if not devastating.
0 · Reply
dontu1dr
dontu1dr Jun. 27 at 1:03 PM
$RGRX Did any of you catch this info... I DIDN'T... HLB Thera group sold 10 billion won (7,359,705.61) to companies in the HLB GROUP on June 20th (4 days prior to disclosing Euro Clinical Trial results with "placebo problems" in Euro Trial... lol... IE: HLB Inc and associated subsidiaries "bought the dip" BIG TIME just 4 DAYS prior to the "stock crash" of HLB THERA'S announcement of "placebo problems" in the EURO TRIAL... LET THE GAMES BEGIN... Interesting situation to say the least... -when all else fails,,, follow the money trail in the trials... not sure you could get away with that move in the USA? THOUGHTS? quite a consolidation of stock ownership really... https://n.news.naver.com/article/018/0006045112 THE DONKER
1 · Reply
dontu1dr
dontu1dr Jun. 26 at 2:48 AM
$RGRX As Paul Harvey used to say, "...and now you know... the rest of the story." https://n.news.naver.com/article/018/0006049030 more clarification from HLB PAY ATTENTION to the following quote: "The official emphasized that although the US Phase 3 clinical trials and the European Phase 3 clinical trials have the same design, they are separate clinical trials, so the US clinical trial will proceed to the end regardless of the SEER -3 results. The US Phase 3 clinical trial is the SEER- 2 clinical trial that aims for FDA approval as the main clinical trial , while the European SEER- 3 clinical trial, which has the results from this time, is a secondary clinical trial conducted for the purpose of repeated efficacy verification." GET IT??? US clinical trial SEER-2 is the main trial for FDA approval... Euro was only a "secondary trial"... SO EURO TRIAL flushed a lot of retailers out of their position in KOREA---and it wasn't even the main trial for FDA APPROVAL... HANG TIGHT FOLKS, lol THE DONKER
0 · Reply
dontu1dr
dontu1dr Jun. 25 at 1:32 PM
$RGRX ONE THING you should consider at this point IN THE GAME: HLB Group has somewhat of a history of having a taken a bit of a "poetic license" in reporting trial results to the public. ---A good example is doing a historical search of HLB's drug trial results for "rivoceranib" after the finish of the trial in late 2018... what a debacle that was... and still is in some sense... ---Also, there was an incident where research results were lost in a "Florida Hurricane" years ago and I haven't seen that ever disclosed... Time is seemingly the only "true test" of what HLB Inc see's as potential in their drug development... And spending money finishing the US NK TRIALS if TB4 NK was a total loser wouldn't make cents/sense... This latest announcement will flush retail out of the float of HLB Thera--- it'll be interesting to watch the institutional side tho. At this point in the GAME listen carefully to what HLB SAYS,,, BUT,,, WATCH EVEN MORE CAREFULLY what HLB DOES... FWIW,,, THE DONKER
0 · Reply
MrWolf69
MrWolf69 Jun. 17 at 10:25 PM
$RGRX ....Elsewhere it was pointed out that changes on the RGRX website business development tab were recently updated.
0 · Reply
dontu1dr
dontu1dr Jun. 8 at 3:13 PM
$RGRX This is why BIG EYE PHARMA needs TB4 Eye: quote from this article: https://eyewiki.org/Limbal_Stem_Cell_Deficiency great article really QUOTE: "Traumatic/Iatrogenic: Acquired causes also include trauma from chemical or thermal burns and prior ocular surgeries or cryotherapies performed around the limbus.[16][18] Radiation and chemotherapy are other potential causes, and systemic[19] as well as topical chemotherapeutic medications may cause LSCD.[20] LSCD has also been seen with benzalkonium chloride toxicity with glaucoma medications.[21] Inappropriate contact lens use with consequent hypoxia and ocular irritation with the destruction of the limbus may also contribute to both focal and total LSCD.[22] [23]" Search: "Iatrogenic definition" & "Iatrogenic eye disease" if you need to bring yourself "up to speed" on this subject... Eye Doc's need TB4 EYE & So does BIG EYE PHARMA & EYE PATIENTS THE DONKER
1 · Reply
dontu1dr
dontu1dr Jun. 8 at 3:00 PM
$RGRX Another article out in Korea, info is in the 2nd item in the article. But here's an important tidbit pertaining to the business end of things that is RELEVANT: 5-14-25 additional listing of stock 5/21/25 lower repricing of 17th convertible bonds 5/28/25 lower repricing of 18th convertible bonds So that would "naturally" take place "in the business end" of things prior to any large upward move or announcement... That's the way "business" is normally handled... Pay attention to this in the article:(quote) "including through strategies such as expanding indications to LSCD ( Limbal Stem Cell Deficiency )." n.news.naver.com/article/01... eyewiki.org/Limbal_Stem_Cel... above is a great article... ENJOY THE READ... THE DONKER Bullish
0 · Reply
genecat
genecat Jun. 5 at 6:58 AM
$RGRX HLB Therapeutics announced on the 2nd that it has been exempted from submitting a pediatric investigational plan ( PIP ) for its NK treatment ( RGN- 259) being developed by its US subsidiary Regentree by the Pediatrics Committee under the European Medicines Agency ( EMA ). A PIP is one of the EMA regulatory requirements that must be submitted when applying for new drug sales approval in Europe to prove safety and efficacy in pediatric subjects . If certain criteria are met, a PIP exemption can be granted by submitting an exemption request form. In order to submit a PIP , a protocol for pediatric clinical trials must be prepared, and it usually takes several months for EMA to review and approve the submission. Regentree is currently conducting the final check on the data freeze status after completing patient recruitment for the NK treatment European clinical trial ( SEER -3). It plans to soon go through the data lock procedure and announce the top line results .
0 · Reply
dontu1dr
dontu1dr May. 27 at 12:37 PM
$RGRX New article posted in Korea: https://n.news.naver.com/article/421/0008275044 NOTABLE QUOTES: " RGN -259 could be a 'game changer' for neurotrophic keratitis ( NK ) treatment. Let's see again when the data comes out in June." ---Ahn expressed his confidence in the phase 3 clinical trial results that will be released in June, saying, “Another global pharmaceutical company contacted us first and said, ‘We want to be the first to meet you once the top-line results are out,’ ---RGN -259 is an NK treatment based on ‘thymosin beta-4 .’ Since it is a natural substance in the human body, it hardly causes an immune response and does not accumulate even if taken for a long period of time. RGN -259 has completed data collection for the phase 3 clinical trial currently underway in Europe and is in the data freeze stage for analysis . The top-line results are scheduled to be released in June . ENJOY your read and INFO,,, THE DONKER
1 · Reply
jdlman
jdlman May. 20 at 3:39 PM
$RGRX hmm will this ever move ?
1 · Reply
dontu1dr
dontu1dr May. 19 at 7:34 PM
$RGRX The other day I was reading some articles from Korea about NK and I came across an article from late March that was more descriptive/detailed than others, see what you think: https://www.koreabiomed.com/news/articleView.html?idxno=27078 -Really makes a good comparison between Dompe's NK and TB4 NK. -and notice the possible price point of TB4 NK --- :-) -also consider the "off label" needs already built in when you consider TB4 eye healing effects... Hit translate and enjoy the read...!!! THE DONKER
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dontu1dr
dontu1dr May. 18 at 2:13 PM
$RGRX They are now campaigning TB4 injectable for heart attack due to thrombus to prevent heart failure afterwards. -timely injection/iv that would save many lives! https://www.mdpi.com/1422-0067/26/9/4131 -Block-Marquette long time "Knight of TB4" -NOVEL pathway would/could get NEW PATENT rights in future note-able quote: "we propose a potential utilization for TB4 as a ROCK1 inhibitor in the future." PLUS there's a special issue on Thymosin in the works that was deadlined about the time of the NK trial wrap up: 2/20/25 https://www.mdpi.com/journal/ijms/special_issues/HBRTOY5R5I The "timing" couldn't be better to CAMPAIGN TB4 injectable after release of NK trial success... -You'll see the KOREANS submitted an article to special issue & I'm pretty sure "jungkee kwon" is affiliated with one of the companies HLB bought or started in Korea (if my memory serves me well?) And he's been involved in other good articles on TB4. -Good things on deck for TB4 in near future... ENJOY the read, THE DONKER
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MrWolf69
MrWolf69 May. 15 at 6:12 PM
$RGRX ....check the website for an updated Letter to Shareholders!!!
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dontu1dr
dontu1dr Apr. 24 at 10:05 PM
$RGRX Here's a rather interesting "tidbit"... https://www.kff.org/policy-watch/the-effect-of-delaying-the-selection-of-small-molecule-drugs-for-medicare-drug-price-negotiation/ With notable quote:2nd paragraph "Under current law..." "This translates into 9 years for small molecule drugs or 13 years for biologics following FDA approval when Medicare’s negotiated prices take effect." What concerns RGRX and BIOLOGICS is: The essentially get 13 years of un-negotiated pricing with Medicare. TB4 as NK Orphan Drug: -- will be one very EX[ENSIVE biologic eye drop --- and will have many "off label" possibilities. Think: Bacterial Keratitis, eye wound healing, severe dry eye, post eye operations, and maybe even to treat DIABETIC EYE COMPLICATIONS... REGENTREE, the joint venture with the KOREANS, will get some big momo from BIG EYE PHARMA if NK trial results have good data. WHY: BIG EYE PHARMA needs healing modality to backstop any and all post operative eye complications or infections and: TB4 for eye drops covers that for them BETTER than any existing product. THE DONKER
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dontu1dr
dontu1dr Apr. 22 at 7:14 PM
$RGRX Take a close look at these two links: https://www.mdpi.com/2079-6374/13/11/974 title: A Novel Combination Therapy Tβ4/VIP Protects against Hyperglycemia-Induced Changes in Human Corneal Epithelial Cells ---What's really interesting is that Tβ4/VIP protects the cornea even with the high glucose levels in diabetes. Quote: up to 70% of the 460+ million diagnosed diabetics worldwide present with signs of diabetic corneal complications HUGE MARKET AND this world patent app for the above: 2024-11-14 https://patents.google.com/patent/WO2024233903A1/en?oq=WO2024233903 read the patent app---very interesting... BUT: For all the research that Wayne State (Berger & Sosne) has done with TB4 supplied by RGRX, this is the ONLY INDICATION that WAYNE STATE has filed a PATENT APP for. SO (THINK future TECHNOLOGY TRANSFER from Wayne State to whomever is standing in the wings for TB4 license out). That's quite a TELL and HUGE ADDED VALUE for TB4 NK eye when you consider it would be a very expensive biologic with 12 year exclusivity. enjoy the read, THE DONKER
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dontu1dr
dontu1dr Apr. 1 at 5:40 PM
$RGRX The RELEVANCE of the 2nd NK Trial in Europe COULD WELL be this: REGENTREE is at the point where they're looking at the DATA RESULTS of the PREVIOUS NK EUROPE TRIAL and they will now actually SEE THE DATA... good or bad.... VS. USA NK trial is STILL BLIND to them... So, you'd think they wouldn't start another trial with the same design of the previous trial if they TANKED the first EURO NK TRIAL... I take that as a bit of a TELL on the results of the FIRST EURO NK trial "at this point" in the GAME... That's my take , THE DONKER
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dontu1dr
dontu1dr Mar. 28 at 6:55 PM
$RGRX Interesting link that describes NK market from 2025 to future: https://www.researchnester.com/reports/neurotrophic-keratitis-market/5557 Read Article if you have the time... Purchase if you have the money... Quick Quotes: -Neurotrophic Keratitis Market size is projected to increase from USD 5.37 billion in 2024 to USD 13.1 billion by 2037, reflecting a CAGR of over 7.1% during the forecast period, from 2025 to 2037. Currently in 2025, the industry revenue of neurotrophic keratitis is assessed at USD 5.64 Billion.
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dontu1dr
dontu1dr Mar. 27 at 2:43 PM
$RGRX Fresh Korean article yesterday on NK Euro trial: https://www.ntoday.co.kr/news/articleView.html?idxno=114313 Quotes: -Regentry, has completed drug administration and two-week follow-up observation, and has entered the final analysis phase -We plan to review the data of the clinical trial-conducted institution (site) and related institutions, and then proceed with the final statistical analysis through data lockup as soon as possible. CEO Ki-Hong Ahn said, “As the last patient in the European Phase 3 clinical trial for NK treatment has finally been administered and followed-up observations have been completed, we will now focus all of our company’s capabilities on quickly deriving a top line and securing detailed analysis data.” He added, “If the high efficacy that we expect is confirmed, licensing-out negotiations with global big pharmas that are awaiting the results of the European Phase 3 clinical trial will also proceed. TB4 NK is the only thing even close to fruition that will "float HLB Thera's boat". The Donk
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dontu1dr
dontu1dr Mar. 21 at 5:01 PM
$RGRX HLB Thera has NO direct connection to HLB's liver drug, that's a totally FAKE assumption. But HLB Thera does have: TB4 via joint venture Regentree NK trials -only thing Possible that could move big in the near horizon!!! OKN-007 from OMRF -via a OBLATO (sitting dead in the water, so to speak, look up in clinical trials.gov) -only thing of interest in OBLATO is sometime ago HLB Thera routed millions $ thru OBLATO to Immunomic Thera it would seem if HLB Korean filings are accurate. HLB Thera: has Korean Vaccine Storage/Distribution business that brings in some cash flow. HLB Thera has hung "their hat" or "future on TB4 NK trials... And they might have a relationship with "Immunomic Thera" in the making... Focus on what's RELEVANT vs meaningless "liver drug relationship" with HLB Thera Follow the money trail folks... The Donk
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MrWolf69
MrWolf69 Mar. 10 at 3:48 PM
$RGRX .... something going on here. Why all the fuss and research over a supposedly dead company where some really smart people and credible institutions are taking part in studies using TB 4 as the 'secret sauce'. Also, their largest shareholder recently passed away. The current low valuation of RGRX surely helps when it comes to estate taxes, I would think? Once that process is finalized, any positive developments thereafter don't come into play. Timing is everything....maybe it's that time!
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