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 2,400
Avg Vol 1,950
Day's Range N/A - N/A
Shares Out 1.44M
Stochastic %K 0%
Beta 152.26
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
dontu1dr
dontu1dr Oct. 22 at 12:18 PM
$RGRX It will be interesting to read fda's "fda plausible mechanism pathway" to be published in a week or two in the New England Journal, won't it? This would/could negate the NK Euro Trial results being needed. And when you consider "dompe's oxervate" price, complexity of using for seniors, side effects, ect--- Humanitarian decision would make sense/cents. Also, take in consideration RFK Jr's interest in peptides... Just because most folks don't follow such things, doesn't mean BIG PHARMA is ignorant about what is happening behind the scenes. ALSO, don't forget about Wayne States world patent app: https://patents.google.com/patent/WO2024233903A1/en?oq=WO%2f2024%2f233903 A real break-thru for diabetic eye problems... read that patent app if you have time... All this makes sense/cents doesn't it? THE DONKER
1 · Reply
NachoQueso
NachoQueso Oct. 18 at 9:28 PM
$RGRX Curious if there have been any notable updates or shifts with RGRX lately. Appreciate any insights or quick recaps from those who’ve been following more closely!
0 · Reply
dontu1dr
dontu1dr Aug. 15 at 5:39 PM
$RGRX Keep in mind that the Euro Trial ended: Date of completion: 04/02/2025 And HLB Thera reported the "oral/audible" placebo problem call on 6/24/25 with no paperwork (HLB THERA claims) ... ---almost 2 full months after trial ended... What you need to understand, in Europe you have to report the true trial results "one year after trial ended" or by April 2026... That's the proverbial pharma "show me what your holding in your hand" date in Europe... UNTIL APRIL 2026: EXACT TRIAL RESULTS are known only by HLB THERA... Come APRIL 2026, we'll see the true reported trial results OF RECORD... It'll be interesting to see what they actually disclose on 4/2/026... And what happens in the interim? Also, did you notice that Immunomic Therapeutics (owned by HLB Thera) looks like it's set up to go PUBLIC... review their: ---SEC FILINGS (amount of money invested and when***) --- recent changes in ***Directors***(Won S Yang is back) and recent management changes... Interesting times... THE DONKER
1 · Reply
ByeAndHold
ByeAndHold Aug. 8 at 12:58 AM
$RGRX From JJ: Communicating additional trial information is up to our Korean partners as they are managing and funding the entire effort. I do not think we will hear any more specific data until we receive top line data from SEER-2, but that's just my expectation. No update on negotiations with third parties but my sense is that there won't be any until SEER-2 has topline info, as that obviously is critical to any potential deal. Yes, it's be a long road and slower than we all anticipated. I intend to hang in there until we find out one way or the other if RGN-259 is an effective therapy for NK. J.J. Finkelstein President & CEO RegeneRx Biopharmaceuticals, Inc. 301.208.9191
0 · Reply
12e456789o
12e456789o Jul. 30 at 9:58 PM
$RGRX HLB Thera at an interesting juncture. Currently just shy of A=C on a daily closing basis. Also previous (blue) wave 2 at 3629 should also offer support. Turn here quite possible.
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dontu1dr
dontu1dr Jul. 20 at 3:24 PM
$RGRX I think this article will kinda "tie together the future pathways for orphan drugs" for investors: https://www.knobbe.com/blog/rare-disease-therapies-gain-momentum-with-regulatory-support-and-continued-market-growth/ NOTEABLE QUOTES: "the orphan drug market is currently valued at about $216 billion USD.[xv] The market is expected to continue to grow at a compound annual growth rate (CAGR) of between about 10-12%, reaching valuation in excess of $500 billion by 2032." While it remains to be seen how the FDA will streamline the process for regulatory approval, the promised conditional approvals combined with expanded post-market surveillance may soon redefine how novel rare-disease therapies reach patients. THINK: Conditional approvals Phase IV studies afterwards This situation would UNLOCK: TB4 NK (orphan) EYE wouldn't it??? But think abit folks... Same situation would apply to: RGN-137 for EB or Epidermolysis Bullosa (orphan) skin -which has been patented: https://patents.google.com/patent/US11179443B2/en?assignee=hlb+therapeutics&oq=hlb+therapeutics clinical trials setup and couldn't recruit: -did JJ allude to this in his latest letter???
1 · Reply
dontu1dr
dontu1dr Jul. 18 at 3:42 PM
$RGRX read the following article and get the gist of what's happening in CBER (TB4 is a biologic), FDA, & PHS... TB4 NK is not in some "binary event"--- More possibilities now than any time in the past if you understand what is said in this article: https://www.biospace.com/fda/fdas-prasad-vows-to-make-rare-disease-drugs-available-at-first-sign-of-promise NOTABLE QUOTES: -Prasad said, and make use of surrogate endpoints to get new medicines to patients before they clear the traditional efficacy bar for authorization. -“We will take action at the first sign of promise for rare diseases. We’re not going to wait,” Prasad said. -FDA Commissioner Marty Makary: "The FDA will grant conditional approval to “scientifically plausible” rare disease medicines based on data from single-arm trials when it is not feasible for companies to run randomized studies." GET IT? "BASED on DATA from SINGLE ARMS TRIALS" which would solve eye trials with tb4 eye Things are anything but the same "ol', same ol" THE DONKER
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dontu1dr
dontu1dr Jul. 16 at 4:29 PM
$RGRX SOME QUOTES: The FDA is eyeing a “new pathway” for rare disease drugs, potentially allowing for their approval even without data from a randomized, controlled clinical trial, recently confirmed FDA Commissioner Marty Makary said in an interview on Friday. Speaking on The Megyn Kelly Show in his first major interview since taking the reins at the FDA, Makary said the agency will open a new regulatory pathway based on what he called a “plausible mechanism,” focusing mainly on rare or incurable diseases that affect “a small number of people.” If there is an investigational drug, Makary explained, “that makes sense physiologically. The mechanism is scientifically plausible that this treatment would help these individuals.” The FDA could approve that therapy on “a conditional basis . . . even though we don’t have a randomized controlled trial because it’s not feasible.” YOU NEED TO READ UP ON THIS A BIT, THE DONKER
1 · Reply
dontu1dr
dontu1dr Jul. 16 at 4:09 PM
$RGRX You may want to read this fairly recent article from Forbes on the FDA's new approach which would apply to "orphan drugs" such as TB4 & NK (consider a subscription to Forbes maybe): forbes.com/sites/greglichol... maybe also take into consideration RFK jr's positive view of "peptides"... VS: A "knee jerk" reaction of interpreting HLB Thera's "sketchy PR of clinical trial" as some kind of "binary event" for TB4 NK eye... A lot of "double speak" from HLB Thera at this point which allows them a lot of latitude to "reverse" or "clarify" that "sketchy PR" in a month or two... best be patient at this point, THE DONKER
1 · Reply
ByeAndHold
ByeAndHold Jul. 11 at 5:46 PM
$RGRX JJ, Wondering what your take is on the SEER-3 top line results. I know it had to have been a surprise and very disappointing. I’m hopeful that the full readout which should be coming shortly is more positive and enlightening on the potential future of RGN-259. Not sure how to read this - part of me says that without confirmatory positive results from 2 separate clinical trials(assuming SEER-2 is positive), the FDA won’t grant an approval. I would also think that financially, is HLB/ReGenTree going to go back to the drawing board to finance yet another trial? I would think that would require a large commitment from what is left of RGRX. Options are getting slim and without a positive readout, it would come down to a fire sale of assets to Big Pharma to take the next steps and get it over the finish line. We know we have a good molecule, but all these years of clinical missteps have delayed and potentially erased any value in a high potential product.
2 · Reply
Latest News on RGRX
No data available.
dontu1dr
dontu1dr Oct. 22 at 12:18 PM
$RGRX It will be interesting to read fda's "fda plausible mechanism pathway" to be published in a week or two in the New England Journal, won't it? This would/could negate the NK Euro Trial results being needed. And when you consider "dompe's oxervate" price, complexity of using for seniors, side effects, ect--- Humanitarian decision would make sense/cents. Also, take in consideration RFK Jr's interest in peptides... Just because most folks don't follow such things, doesn't mean BIG PHARMA is ignorant about what is happening behind the scenes. ALSO, don't forget about Wayne States world patent app: https://patents.google.com/patent/WO2024233903A1/en?oq=WO%2f2024%2f233903 A real break-thru for diabetic eye problems... read that patent app if you have time... All this makes sense/cents doesn't it? THE DONKER
1 · Reply
NachoQueso
NachoQueso Oct. 18 at 9:28 PM
$RGRX Curious if there have been any notable updates or shifts with RGRX lately. Appreciate any insights or quick recaps from those who’ve been following more closely!
0 · Reply
dontu1dr
dontu1dr Aug. 15 at 5:39 PM
$RGRX Keep in mind that the Euro Trial ended: Date of completion: 04/02/2025 And HLB Thera reported the "oral/audible" placebo problem call on 6/24/25 with no paperwork (HLB THERA claims) ... ---almost 2 full months after trial ended... What you need to understand, in Europe you have to report the true trial results "one year after trial ended" or by April 2026... That's the proverbial pharma "show me what your holding in your hand" date in Europe... UNTIL APRIL 2026: EXACT TRIAL RESULTS are known only by HLB THERA... Come APRIL 2026, we'll see the true reported trial results OF RECORD... It'll be interesting to see what they actually disclose on 4/2/026... And what happens in the interim? Also, did you notice that Immunomic Therapeutics (owned by HLB Thera) looks like it's set up to go PUBLIC... review their: ---SEC FILINGS (amount of money invested and when***) --- recent changes in ***Directors***(Won S Yang is back) and recent management changes... Interesting times... THE DONKER
1 · Reply
ByeAndHold
ByeAndHold Aug. 8 at 12:58 AM
$RGRX From JJ: Communicating additional trial information is up to our Korean partners as they are managing and funding the entire effort. I do not think we will hear any more specific data until we receive top line data from SEER-2, but that's just my expectation. No update on negotiations with third parties but my sense is that there won't be any until SEER-2 has topline info, as that obviously is critical to any potential deal. Yes, it's be a long road and slower than we all anticipated. I intend to hang in there until we find out one way or the other if RGN-259 is an effective therapy for NK. J.J. Finkelstein President & CEO RegeneRx Biopharmaceuticals, Inc. 301.208.9191
0 · Reply
12e456789o
12e456789o Jul. 30 at 9:58 PM
$RGRX HLB Thera at an interesting juncture. Currently just shy of A=C on a daily closing basis. Also previous (blue) wave 2 at 3629 should also offer support. Turn here quite possible.
0 · Reply
dontu1dr
dontu1dr Jul. 20 at 3:24 PM
$RGRX I think this article will kinda "tie together the future pathways for orphan drugs" for investors: https://www.knobbe.com/blog/rare-disease-therapies-gain-momentum-with-regulatory-support-and-continued-market-growth/ NOTEABLE QUOTES: "the orphan drug market is currently valued at about $216 billion USD.[xv] The market is expected to continue to grow at a compound annual growth rate (CAGR) of between about 10-12%, reaching valuation in excess of $500 billion by 2032." While it remains to be seen how the FDA will streamline the process for regulatory approval, the promised conditional approvals combined with expanded post-market surveillance may soon redefine how novel rare-disease therapies reach patients. THINK: Conditional approvals Phase IV studies afterwards This situation would UNLOCK: TB4 NK (orphan) EYE wouldn't it??? But think abit folks... Same situation would apply to: RGN-137 for EB or Epidermolysis Bullosa (orphan) skin -which has been patented: https://patents.google.com/patent/US11179443B2/en?assignee=hlb+therapeutics&oq=hlb+therapeutics clinical trials setup and couldn't recruit: -did JJ allude to this in his latest letter???
1 · Reply
dontu1dr
dontu1dr Jul. 18 at 3:42 PM
$RGRX read the following article and get the gist of what's happening in CBER (TB4 is a biologic), FDA, & PHS... TB4 NK is not in some "binary event"--- More possibilities now than any time in the past if you understand what is said in this article: https://www.biospace.com/fda/fdas-prasad-vows-to-make-rare-disease-drugs-available-at-first-sign-of-promise NOTABLE QUOTES: -Prasad said, and make use of surrogate endpoints to get new medicines to patients before they clear the traditional efficacy bar for authorization. -“We will take action at the first sign of promise for rare diseases. We’re not going to wait,” Prasad said. -FDA Commissioner Marty Makary: "The FDA will grant conditional approval to “scientifically plausible” rare disease medicines based on data from single-arm trials when it is not feasible for companies to run randomized studies." GET IT? "BASED on DATA from SINGLE ARMS TRIALS" which would solve eye trials with tb4 eye Things are anything but the same "ol', same ol" THE DONKER
0 · Reply
dontu1dr
dontu1dr Jul. 16 at 4:29 PM
$RGRX SOME QUOTES: The FDA is eyeing a “new pathway” for rare disease drugs, potentially allowing for their approval even without data from a randomized, controlled clinical trial, recently confirmed FDA Commissioner Marty Makary said in an interview on Friday. Speaking on The Megyn Kelly Show in his first major interview since taking the reins at the FDA, Makary said the agency will open a new regulatory pathway based on what he called a “plausible mechanism,” focusing mainly on rare or incurable diseases that affect “a small number of people.” If there is an investigational drug, Makary explained, “that makes sense physiologically. The mechanism is scientifically plausible that this treatment would help these individuals.” The FDA could approve that therapy on “a conditional basis . . . even though we don’t have a randomized controlled trial because it’s not feasible.” YOU NEED TO READ UP ON THIS A BIT, THE DONKER
1 · Reply
dontu1dr
dontu1dr Jul. 16 at 4:09 PM
$RGRX You may want to read this fairly recent article from Forbes on the FDA's new approach which would apply to "orphan drugs" such as TB4 & NK (consider a subscription to Forbes maybe): forbes.com/sites/greglichol... maybe also take into consideration RFK jr's positive view of "peptides"... VS: A "knee jerk" reaction of interpreting HLB Thera's "sketchy PR of clinical trial" as some kind of "binary event" for TB4 NK eye... A lot of "double speak" from HLB Thera at this point which allows them a lot of latitude to "reverse" or "clarify" that "sketchy PR" in a month or two... best be patient at this point, THE DONKER
1 · Reply
ByeAndHold
ByeAndHold Jul. 11 at 5:46 PM
$RGRX JJ, Wondering what your take is on the SEER-3 top line results. I know it had to have been a surprise and very disappointing. I’m hopeful that the full readout which should be coming shortly is more positive and enlightening on the potential future of RGN-259. Not sure how to read this - part of me says that without confirmatory positive results from 2 separate clinical trials(assuming SEER-2 is positive), the FDA won’t grant an approval. I would also think that financially, is HLB/ReGenTree going to go back to the drawing board to finance yet another trial? I would think that would require a large commitment from what is left of RGRX. Options are getting slim and without a positive readout, it would come down to a fire sale of assets to Big Pharma to take the next steps and get it over the finish line. We know we have a good molecule, but all these years of clinical missteps have delayed and potentially erased any value in a high potential product.
2 · Reply
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
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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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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
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jdlman
jdlman May. 20 at 3:39 PM
$RGRX hmm will this ever move ?
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