Capricor Therapeutics Inc (CAPR) Quote

Three dips today while hitting multi-year highs. Opportunity to get in or reminder that even the hottest tickers cool off?

Are profit-takers wrong or just doing what they do? Maybe thinking that usually when something pops, the odds of a drop only increase. Me, I remind myself that there are two sides to every spike; that is what makes them so pointy.

But I will give it to the promoters here. Doubling in a couple of days, price hitting triple what it was a couple of weeks ago ... arguments that the $5 trading range would be a thing of the past are looking legit. So where is the next plateau where we will hang out for a while? Double digit percentage gains every day this week ... is that sustainable? Some of my options orders will like that. Some are underestimating that.

By the time I finished typing this, one more big dip; price down another point. Gain of 25% not there any more. FOMO over? Still... another double digit gain. Maybe that makes two more such days possible. And more reasonable. It's kind of a shame we aren't even on the Hot Board yet. Not that I would want us to get to #1; that is always a sell signal. But completely flying under the radar--what's up with that?

High Pressure!

Just another day at the office!

What a year Viking, Summit, Wave, and Capricor those are my bios that hit so far!

$CAPR

Super volcanic explosion
PT $50

Complete Parabolic Mover got to see the angles before they are played
Examples SMMT $1.50 this year & CAPR $2.68 Patients and Forecasting pays!

CAPR double digits around the corner!

$CAPR

Hilarious listening to the boards about how awful the executive team was in the $2.00 area last year now they are the toast of the town.

$CAPR

safe to think AA is given in a few months
$100 coming sooner

CAPR new 52 week high

Patience Pays off been holding this since the 2.50 Level[color=red][/color]

$CAPR

$50 by Christmas time and $100 by Spring next year
Super volcanic explosion

LOL ... not even noon and we've traded over half the OS.

CAPR 7.96 resistance and 30m float so now all those shares have to churn but shareholders taking profit after a long wait

$8.15 next resistance

Its been a long wait but I think our time has finally arrived 🤑

We will be millionaires very soon

Capricor Therapeutics Announces Intent to File Biologics License Application for Full Approval of Deramiocel for the Treatment of Duchenne Muscular Dystrophy Cardiomyopathy

Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment of rare diseases, announced today, following recent meetings with the U.S. Food and Drug Administration (FDA), its intent to file a Biologics License Application (BLA) based on existing cardiac and natural history data for deramiocel to treat all patients diagnosed with Duchenne muscular dystrophy (DMD) cardiomyopathy.
Following the FDA meetings:

Capricor plans to commence the filing of a BLA in October of 2024 seeking full approval of deramiocel for the treatment of DMD-cardiomyopathy with full submission expected by year-end 2024.
The BLA filing will be based on existing cardiac data from the Phase 2 HOPE-2 and HOPE-2 Open Label Extension (OLE) trials compared to natural history data provided by Vanderbilt University Medical Center and Cincinnati Children’s Hospital Medical Center.
In order to support potential label expansion to treat DMD skeletal muscle myopathy, Capricor plans to combine Cohorts A and B of the Phase 3 HOPE-3 clinical trial to serve as a post-approval study and does not intend to unblind Cohort A at this time, which was expected to occur in the fourth quarter of 2024.
“There are currently no approved therapies for DMD cardiomyopathy, which is the leading cause of death in those with Duchenne. Based on the strength of our cardiac data, combined with the FDA’s commitment to advancing therapeutics for the treatment of rare diseases, we are seeking approval for the cardiomyopathy associated with DMD and will look to expand the label for skeletal muscle myopathy post-approval,” said Linda Marbán, Ph.D., Capricor’s chief executive officer. “This approach is the result of multiple in-depth meetings with FDA where we showed robust and positive cardiac data from our HOPE-2 and HOPE-2 OLE studies compared to natural history data from a large cohort of patients.”

Dr. Marbán continued, “Deramiocel has shown in multiple clinical trials attenuation of the cardiac implications of DMD. Based on the totality of evidence of the safety and efficacy data deramiocel has shown, we believe this is the best path forward to potential approval, allowing us to bring this novel, first-in-class treatment to patients in need in the most expeditious manner. We want to extend our appreciation to the patients, their families and advocates who continue to work with us and to the FDA for their commitment to accelerating treatments for DMD.”

Deramiocel for the treatment of DMD, has received FDA Orphan Drug Designation and the regulatory pathway for deramiocel is supported by RMAT (Regenerative Medicine Advanced Therapy Designation). In addition, if Capricor were to receive FDA marketing approval for deramiocel for the treatment of DMD, Capricor would be eligible to receive a Priority Review Voucher (PRV) based on its previous receipt of a rare pediatric disease designation.

🌋 time!!! I still think we break 12 tomorrow if things align. Maybe 18 this week. Fingers crossed.

Always early CAPR & ICCM

$CAPR

$10 tmrw
Big FDA AA news

$5.84 + 15% Tuesday, September 24, 2024 at 8:30 a.m. ET to provide an update on its Duchenne muscular dystrophy (DMD) program. The update will consist of the latest regulatory updates following the Company's recent meetings with the U.S. Food and Drug Administration (FDA).Click here for full release.

🌋

SAN DIEGO, Sept. 17, 2024 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment of rare diseases, today announced it has entered into a binding term sheet with Nippon Shinyaku Co., Ltd., a Japanese pharmaceutical company listed on the TYO, for the commercialization and distribution in Europe of Capricor’s lead asset, deramiocel, for the treatment of Duchenne muscular dystrophy (DMD), a rare neuromuscular disease with limited treatment options. The potential transaction covered by the term sheet is similar to the existing Commercialization and Distribution Agreements with Nippon Shinyaku in the United States and Japan with an opportunity for further product reach globally. In addition, Nippon Shinyaku has agreed to purchase approximately $15 million of Capricor common stock at a 20% premium to the 60-day VWAP.

Under the terms of the binding term sheet and further subject to finalization of a Definitive Agreement, which is expected to occur in the fourth quarter of 2024, Capricor will be responsible for the development and manufacturing of deramiocel for potential approval in all countries in the European Union, United Kingdom and several other countries in the region. Nippon Shinyaku will be responsible for the sales and distribution of deramiocel in those territories. Capricor will also receive an upfront payment of $20 million subject to execution of the Definitive Agreement and there are potential additional development and sales-based milestone payments to Capricor of up to $715 million and Capricor will receive a double-digit share of product revenue.

“Our expanded partnership with Nippon Shinyaku into the European region marks a pivotal moment for Capricor as we work together to bring deramiocel to DMD patients worldwide,” said Linda Marbán, Ph.D., Capricor’s Chief Executive Officer. “With the addition of the upfront payment and equity investment, we will be able to extend our runway into 2026 and be well positioned to advance toward potential approval of deramiocel in the United States and beyond. Furthermore, these funds will provide necessary capital for commercial launch preparations, manufacturing scale-up and product development for Europe, as we envision high global demand for deramiocel.”

Dr. Marbán continued, “As previously reported, we held a successful pre-BLA meeting with the U.S. Food and Drug Administration (FDA) in August. Since that meeting, we have now had several additional informal meetings with the agency to continue to refine our approval pathway for deramiocel in the United States and we plan to provide further updates as they become available.”

Toru Nakai, President of Nippon Shinyaku, commented, “We look forward to building deramiocel’s commercial footprint around the world and this partnership would allow us to continue to invest in Nippon Shinyaku’s DMD franchise and to potentially advance life-changing therapies for patients in need.”

Contemporaneously with the term sheet, Nippon Shinyaku has also agreed to purchase 2,798,507 shares of common stock at a price of $5.36 per share, which price represents a 20% premium to the 60-day volume-weighted average price (VWAP) of Capricor’s common stock, for an aggregate purchase price of approximately $15 million. The closing of the offering is expected to take place on or about September 20, 2024. The Company expects to use the proceeds from the transaction primarily to support product development as well as general, administrative and corporate purposes.

The offer and sale of the foregoing securities are being made in a transaction not involving a public offering and have not been registered under the Securities Act of 1933, as amended (the “Securities Act”), or applicable state securities laws. Accordingly, the securities may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. As part of the transaction, the Company has agreed to file a registration statement with the Securities and Exchange Commission for purposes of registering the resale by the investors of the shares of common stock purchased by such investors.

It's VOLCANO TIME!!!! 🌋.

Well worth a 22 minute listen.

Capricor was recently featured in an interview conducted by BioTech Health X where we discussed the our recent progress and work in developing groundbreaking therapies for the treatment of rare diseases. Click to watch the interview
>>> https://t.co/OZXa3yHZBt >>>$CAPR pic.twitter.com/oJyOPNpEQr— Capricor Therapeutics (@Capricor) August 28, 2024

I have a lot of shares here
The final stage for FDA approval for billion dollars market
My price target is $50 by the end of this year and $100 by June next year
I will make million dollars here

Uh, oh, when is that FDA thing happening? If it is coming soon, then the 60 cents Ask on Sept 5s looks like a bargain. I see there are over 1200 calls expiring on September 20 with a $5 strike price--and almost twice as many at the 7.5 strike. While only 360 puts at $5 are in play for next month. I have a little piece of that action. My position here will either shrink or increase by 50% depending on what side of 5 we are on in four weeks.

Selling both puts and calls is still my way to pull income from a stock like this that does not pay a dividend*. Of course the risk in that strategy is that you can be left behind if the stock really takes off and never comes back down. (That has not been a problem here so far.) For instance, up 11% Wednesday, and another 5% early yesterday morning before cooling off a bit. That's why you keep some shares safe from the options action.

*Come to think of it, I do that with blue chip dividend payers, too. Perhaps even more so. : - )

Breaking out over $10 upon FDA news

FDA news is imminent

Time for super volcanic explosion
FDA BLA news imminent

--FDA Grants Pre-BLA Meeting Request and Rolling BLA Submission after Review of HOPE-2 and HOPE-2 OLE 3-Year Results--

SAN DIEGO, June 11, 2024 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment of rare diseases, today announced the successful completion of a Type-B meeting with the U.S. Food and Drug Administration (FDA) on next steps for the Biologics License Application (BLA) submission with its lead asset, CAP-1002 for the treatment of Duchenne muscular dystrophy (DMD). Additionally, Deramiocel has been selected as the proposed International Nonproprietary Name (INN) for CAP-1002 by the World Health Organization.

“The last year has been transformative for Capricor as we have moved rapidly towards potential approval for CAP-1002 for the treatment of DMD,” said Linda Marbán, Ph.D., Capricor’s chief executive officer. “The most recent meeting had several very important outcomes; the first of which was that the FDA has agreed to a pre-BLA meeting based on their review of our clinical data from HOPE-2, HOPE-2 open label extension (OLE) and available data from HOPE-3. This key agreement will allow us to begin our BLA filing with a rolling submission planned to initiate in the third quarter of 2024.”

The rolling submission process allows for the submission of pre-agreed components of the BLA to be submitted as they are completed, which can streamline the regulatory review process and de-risk the BLA. Capricor plans to further outline the submission schedule with the FDA in the coming months.

Dr. Marbán continued, “We continue to make significant progress on this program as we are awaiting final data in the fourth quarter of 2024 from our already enrolled HOPE-3 pivotal trial and prepare for potential commercialization, including completion of our commercial manufacturing facility and actively preparing for our pre-BLA meeting and rolling BLA submission. Furthermore, we are looking forward to our presentation of additional 3-year data from our HOPE-2 OLE study at the upcoming PPMD conference which we believe will add further evidence of the efficacy and safety of CAP-1002.”

Deramiocel (CAP-1002) for the treatment of DMD has received Orphan Drug Designation and the regulatory pathway for this drug is supported by RMAT (Regenerative Medicine Advanced Therapy Designation). In addition, if Capricor were to receive FDA marketing approval for Deramiocel for the treatment of DMD, Capricor would be eligible to receive a Priority Review Voucher (PRV) based on its previous receipt of a rare pediatric disease designation. Capricor retains full rights to the PRV, if received.

https://www.capricor.com/investors/news-events/press-releases/detail/281/capricor-therapeutics-announces-positive-type-b-meeting

Thank you. Lets hope!!!

More news this month. Should be good !MO!

How is everybody thinking still about this company?

Institutions have been buying big time!

Where is the BlA????

Capricor announces positive Type-B meeting with FDA for CAP-1002 program for DMD. We will host a webcast to discuss this meeting and the latest program updates on Monday, April 29 at 8:30 am ET. #CAPR #CAP1002 #DMD > Click here to view the press release > https://t.co/cNGDQ7zL34 pic.twitter.com/gVNLVPMJNS— Capricor Therapeutics (@Capricor) April 24, 2024

Lol I sold it for a little profit mon

Maybe after a R/S

Thanks looks like 8s coming here

Nice move on VERI.

I loaded VERI instead

Gl I loaded instead

Its going to 8 based on the weekly chart.

Fell off a cliff today

Sold last at 6 bought bach at 4 so have a few more shares. Not like Enthalpy

You did not sell at 6 this time around, I hope. : - )
I added some shares under 6, because waiting for a big dip was not working. Patience is a virtue or so I've heard, but... I've had to add more 7.5 strikes to my options orders. I thought we could enjoy hanging around 5 for a while, but this thing is not accommodating that plan.

Is everyone enjoying this steady climb? We are just pennies away from being 100% up from the low for the year and yet this ticker is not on the breakout board. Which is good. Hitting #1 on the Hot Board is nearly always a sell signal.

Haha looks like it

I think it get to 8 next week or so. We will see!!! Gltu!!!

I'm waiting for 4s for a flip lol...Looks bearish

I doubled my position in the 4s. We will see. Secretly hoping for a green light on AA BLA in some form. So many other companies have a 500 million or billion dollar market cap and capr is right there but beaten down. At point it will get discovered.