prfcnthtmi05 Posted - 32 minutes from now

$CAPR - Good morning, and now I am confused, is it Sunday or Monday ? What’s going on? We are trending today 🤯

Kingjake26 Posted - 28 minutes from now

$CAPR I would recommend folks listen to the call. https://viavid.webcasts.com/viewer/event.jsp?ei=1690092&tp_key=b821b4f411

Kingjake26 Posted - 26 minutes from now

$CAPR I like this article. Like I said holding for triple digits long term

WallStreetBuyDip Posted - 1 hour ago

$CAPR are you the type to trade momentum or the type to buy the dip for a reversal trade? Will trade CAPR like how I did for these tickers shown here. These only show 4 trades of 100+ others. The key is to buy when H% is low for a reversal trade. These tickers are just one example of many plays.

BioCapitalFund Posted - 1 hour ago

$CAPR Here is the screen shot of "TRENDING" section. ^_^ (12:39am, Sunday, California)

BioCapitalFund Posted - 2 hours ago

$CAPR Oh, what? A surprising event is just happening right now! After I just posted 11 times in a row on this board, Capricor is suddenly appearing on the "TRENDING" section on the top along with many bitcoins. Take a picture with your cell phone! ^_^ Wow........... (12:06am, Sunday, California)

BioCapitalFund Posted - 3 hours ago

$CAPR <Post #11 of 11> Ted Tenthoff from Piper Sandler said: Really exciting to be on the call and congrats on all the progress. Aydin Huseynov from Ladenburg said: Congratulations with the progress this quarter. (Excerpts end here.) Have a wonderful brand new week, all "patient" Capricor bulls! We are in good hands of Linda and her team! (11:10pm, Saturday, California)

BioCapitalFund Posted - 3 hours ago

$CAPR <Post #10 of 11> 30) So one of our goals has been to begin to discuss Becker with the agency. Our KOLs, especially our cardiology KOLs tell us that Becker cardiomyopathy is completely indistinguishable from Duchenne cardiomyopathy. So if you hand them an MRI, they can’t tell if it’s a Becker patient or a Duchenne patient. And furthermore, the Becker cardiomyopathy starts very young. These guys live longer and have better skeletal muscle function. So dealing with their cardiac disease is very important for them as well. We don’t want their life to be attenuated or shortened in any way based on the cardiac disease.

BioCapitalFund Posted - 3 hours ago

$CAPR <Post #9 of 11> 26) So currently, Nippon Shinyaku has rights to sell, market and distribute in Europe, the United States and Japan. All other areas of the world are still owned by Capricor. And so our current plan would be to market directly. 27) And the current guidance that we have is that the use of deramiocel would be independent of any of the other therapeutics available, gene therapies or exon skippers. We have had people in our clinical trials that have gotten exon skippers. We have people in our clinical trials that have received gene therapy. And so our current guidance is that we would use it in an open fashion available to anybody with DMD cardiomyopathy. 28) What I can tell you that our relationship with FDA has been extremely collaborative. They seem favorable to receiving the data. 29) So it’s not another skeletal muscle therapeutic. It’s really the only thing to be able to treat the cardiac disease.

BioCapitalFund Posted - 3 hours ago

$CAPR <Post #8 of 11> 22) But again, the nice part of this is that it’s not like a gene therapy where the manufacturing for scale-up is much more complicated, exponentially more difficult, trying to deal with empty capsids. This is a modular plug-and-play manufacturing paradigm where we just add more clean rooms to the mix. 23) So it comes with the RMAT designation. So we are expecting a priority review and are building our timelines around it. 24) So the takeaway from the World Muscle Society data is very clear which is let’s get deramiocel started early and young and let’s preserve that cardiac muscle and cardiac function while they have it. 25) It’s a treatment that not only has been shown to be effective but there are literally no side effects, can be given 4 times a year for life and can be used in conjunction with any and all cardiac medications, steroids and any of the therapies for skeletal muscle myopathy.

BioCapitalFund Posted - 3 hours ago

$CAPR <Post #7 of 11> 19) To remind you, the StealthX vaccine platform will not only serve as a clinical proof of concept for the StealthX technology but our vaccine is comprised of native proteins and not reliant on mRNA which enables us to rapidly adapt the protein to a new pandemic or to changes in viral epitopes. 20) Further, our vaccine uses no adjuvant. Recently, there has been much ado about the potential toxicity of certain adjuvants in existing vaccines. 21) When we built the San Diego manufacturing facility, it’s small but it’s commercial scale. So we know exactly how to do it. We’ve been preparing for PLI really for about 2 years since we designed and opened that facility. So that one is ready to go. We have high confidence that we should be able to pass inspection.

BioCapitalFund Posted - 3 hours ago

$CAPR <Post #6 of 11> 16) While our primary focus has been on advancing deramiocell, we remain committed to our StealthX exosome platform technology as part of our next-generation drug delivery platform. We have been planning to build a pipeline of exosome products which are engineered to enhance drug delivery and can be targeted. 17) We also have been able to show life-extending enzyme replacement in an ARG1 knockout mouse using nanogram doses of protein, suggesting successful uptake and utilization of the protein. We are planning for an IND for a therapeutic exosome program based on some of this exciting data. 18) Currently, our StealthX vaccine candidate is in the manufacturing phase with plans to deliver to NIAID which is the National Institute of Allergy and Infectious Disease in the first quarter of 2025. The NIAID will then conduct and fully fund a Phase I clinical trial.

BioCapitalFund Posted - 3 hours ago

$CAPR <Post #5 of 11> 14) Based on our current agreements with Nippon Shinyaku, if we enter into a definitive agreement for the European region on the anticipated terms, we would have the potential for milestone payments totaling $1.5 billion payable to Capricor. In addition, in the U.S., we are entitled to between 30% to 50% of revenue share based on sales of the product, inclusive of cost of goods sold. 15) ...we are now actively exploring the opportunity to potentially expand into Becker muscular dystrophy with deramiocel as the cardiac manifestations are very similar to that of DMD. We continue to believe in deramiocel’s potential to be a transformational treatment for DMD cardiomyopathy and beyond. And our current plan is to make indication expansion an important goal for 2025.

BioCapitalFund Posted - 3 hours ago

$CAPR <Post #4 of 11> 11) As you know, we manufacture deramiocel in-house at our GMP facility. And while we know that our current facility can meet initial demand, we are currently in late-stage planning for scaling up manufacturing. 12) The clinical shelf life of the frozen product is currently 5 years, so we are able to stockpile doses in order to meet increasing demand clinically and commercially. Currently, as we reported last quarter, our San Diego manufacturing facility is fully operational and actively underway generating doses. 13) Factoring this raise in our Q3 cash balance, we have approximately $165 million in cash which gives us a strong runway into 2027.

BioCapitalFund Posted - 3 hours ago

$CAPR <Post #3 of 11> 7) I am pleased to report that the first module of the BLA was submitted and we are on track to fully submit our BLA package by year-end 2024. 8) While we believe that an AdCom may not be necessary, we are preparing internally for that eventuality. 9) If approved, we are anticipating that approximately 50% to 60% of the overall DMD population in the United States or around 8,000 people with DMD would be eligible for treatment with deramiocel. Because deramiocel would be a first-in-class therapeutic for an aspect of DMD that has no approved medicines, our initial discussions with payers have been very positive. 10) Based on market research and discussions with advocacy groups, we anticipate rapid adoption of deramiocel. We are actively focusing on scaling our manufacturing capacity as well as supporting NS Pharma and working with payers as we prepare for robust patient and physician demand.

BioCapitalFund Posted - 3 hours ago

$CAPR <Post #2 of 11> 3) FDA noted the strength of our data and also noted that there were no approved therapies for cardiomyopathy associated with DMD. Based on that meeting and subsequent meetings with FDA, we have decided to move forward to file for full approval. 4) No more clinical data is theoretically necessary... 5) And while we are pleased thus far with the effect of deramiocel on upper limb function, it is not as important for the first indication which will now be cardiomyopathy and which presents a greater initial market opportunity for deramiocel. Therefore, we have decided after conferring with FDA to combine cohorts A and B and use that data to serve as a post-approval supplement and add skeletal muscle myopathy to the label in the future. 6) We expect to hear from FDA by the end of the first quarter of 2025 regarding the status of the application. And if the FDA review goes well, we anticipate a potential PDUFA date set for the second half of 2025.

BioCapitalFund Posted - 3 hours ago

$CAPR <Post #1 of 11> Here are 30 key excerpts from Linda's conference call comments. I am immensely thrilled to be a part of this ground-breaking biotech company with 10+ billion dollar market cap potential ! Don't be swayed by those endless & "inevitable" ups and downs of the share price down the road until Capricor reaches that potential within a year or two. This conference call reminded me of Johnny Nash's 1972 legendary song lyrics: "I can see clearly now the rain is gone. I can see all obstacles in my way. Gone are the dark clouds that had me blind. It's gonna be a bright, bright sun shiny day." <Excerpts start here.> 1) We have consistently presented the data as it has become available to the FDA and the data has shown clinically meaningful as well as statistically significant improvements. 2) ...we position our organization to become a revenue-generating commercial stage company should we receive FDA approval for which I am very optimistic.

STR33 Posted - 6 hours ago

$CAPR Lutnick at Treasury..... He is the CEO of Cantor Fitzerald which were the 1st 'major' to began covering CAPR a year ago, before Openheimer and PiperSandler. https://www.politico.com/news/2024/11/16/elon-musk-backs-lutnick-for-treasury-00190015

zuccolilo Posted - 10 hours ago

$CAPR ...an original opinion on why biotech has been in the gutter since COVID. And on JFKs impact on the industry. I like this article bc he's saying biotech is gonna start absolutely booming soon :) "Fortunately, this three-year period is about to come to an end. And what follows will make the 2013–2021 bull market look meek." "And RFK Jr.’s approach to the Department of Health and Human Services will put the COVID lunacy to an end and transform the CDC, the FDA, and the NIH in ways that will open the door to innovation again in the biotech sector." https://www.brownstoneresearch.com/

bentleysmom Posted - 19 hours ago

$CAPR source aside. Whatever gets us out there to highlight our platform and gives us the exposure. https://finance.yahoo.com/news/capricor-therapeutics-capr-best-multibagger-062804781.html

quito_yume Posted - 1 day ago

$CAPR I'm 66 and could fight better than Tyson did. I think Tyson was fighting injured.

Haha1978 Posted - 1 day ago

$CAPR tyson time.

Asher77 Posted - 1 day ago

$CAPR Discovery is wonderful but these biologics will require effective delivery. https://venturebeat.com/ai/google-deepmind-open-sources-alphafold-3-ushering-in-a-new-era-for-drug-discovery-and-molecular-biology/

Poppylee1 Posted - 1 day ago

$CAPR What was that ?

HypnoTrader Posted - 1 day ago

@Poppylee1 $capr and the option expiration from the Trump Trade took down the rest of the stocks.

Haha1978 Posted - 1 day ago

$CAPR Mike Tyson fight next. Go Tyson. If he doesn't knock Jake out fast I'm afraid he might lose.

patatechaude Posted - 1 day ago

$CAPR

Poppylee1 Posted - 1 day ago

$CAPR

WBintheHouse Posted - 1 day ago

$CAPR I don’t know if this was posted before but here it goes. https://d1io3yog0oux5.cloudfront.net/_5f82beb0d2808815e619b10a0f6246e7/capricor/files/pages/capricor/db/2348/authors/CAPR_ASGCT_2024_(Presentation).pdf

Poppylee1 Posted - 1 day ago

$CAPR Take it off take it off take it all off. ☺️☺️☺️☺️☺️☺️☺️