Capricor Therapeutics Inc (CAPR) Quote

$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.

I told you all
1000% runner here

would be a bigger player with my other holdings cooperation. Do not have volcanos view but feel it is a great vehicle for slow steady progress.

Hey Ed this is probably going to 8 this month at a minimum. Fingers crossed.

Sold some at 6 re bought at 4 so more shares and money

How did that work out for you, ed? Did you get some 5's assigned to you last month? I only picked up another 100 shares in February, after doing the same in January. It was December when I increased my position here by 60%. Now all those shares are up for grabs at 5. We will find out in 10 days if that is a bargain or not. At worst it will be a 25% gain in 3 months.

I only have one position in cash covered puts. Those will also expire on the 15th. It will be like scoring a 20% dividend out of something that does not pay a dividend.* Wish I had more put positions; I will the next time this "pos" dips. BTW, I trade this in an IRA, so no Wash Sale worries. I won't presently become a millionaire like Volcano. But maybe future me will.

Obvious statement: I am not ed3/6me's financial advisor or anyone else's. Just demonstrating how you can milk a ticker for almost monthly income without it being a blue chip dividend payer. I can't say it removes those anxious feelings you get when it dumps (or pumps), but it will remove some cash off the table.

*I could use more such scores to keep up with inflation; you know, just in case Biden scapegoating evil corporations doesn't do the trick.

Capricor Therapeutics Announces Upcoming Type-B Meeting with the FDA to Discuss Commercial Manufacturing Planning with an Aim to Expedite BLA Pathway for CAP-1002 in Duchenne Muscular Dystrophy

SAN DIEGO, Feb. 27, 2024 (GLOBE NEWSWIRE) -- – Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment and prevention of rare diseases, announced today that the Company has been granted an in-person Type-B meeting with the U.S. Food & Drug Administration (FDA) scheduled for late March. In the upcoming meeting with the FDA, the Company intends to discuss its proposed chemistry, manufacturing and controls (CMC) plans for commercial launch, if approved which may enable opportunities to expedite the pathway to a Biologics License Application (BLA) submission. The Company has previously been granted Regenerative Medicine Advanced Therapy (RMAT) and orphan drug designations for the use of CAP-1002 in Duchenne muscular dystrophy (DMD) and these designations enable sponsors to work closely with the FDA and receive its guidance on potential expedited pathways for approval.

“At this time, with our pivotal Phase 3, HOPE-3 trial fully enrolled in Cohort A and top-line data expected in the fourth quarter of this year, we believe that discussing our CMC plans for potential commercialization with the FDA will allow us the opportunity to bring CAP-1002 to patients in the most expeditious manner possible for patients in need,” said Linda Marbán, Ph.D., Capricor’s chief executive officer. “At Capricor, we remain focused on getting to approval as quickly as possible and we look forward to providing more details after this meeting.”

https://www.capricor.com/investors/news-events/press-releases/detail/271/capricor-therapeutics-announces-upcoming-type-b-meeting

https://www.capricor.com/investors/news-events/press-releases/detail/270/capricor-therapeutics-to-present-fourth-quarter-and-full February 29.

https://www.capricor.com/investors/news-events/press-releases/detail/269/capricor-therapeutics-announces-manufacturing-scale-up-of

Capricor is pleased to be featured in a Scientific Session being held today at the International Duchenne Parent Project Italy Conference in Rome. To view the full agenda and additional details on the session please, click here: https://t.co/nOg382Rcj3 pic.twitter.com/pNg2sdUuHk— Capricor Therapeutics (@Capricor) February 17, 2024

Wrong

Looks like nobody is interested in this shitty scam that'll never see FDA approval

Damn your dumb ass can't even form a complete sentence.

Bcs you are ignorant and dumb
Why do you think huge Japanese bio firm made a deal?
They are much smarter than you dumbo

You will not be be a millionaire. Will be no FDA approvals. You've been warned

I have huge shares here
I will be multi millionaire this year
I am so happy to hold long term
This is the year for FDA approval

It is coming
Be patient
We will be millionaires this year
$100 upon FDA approval

When????? Been holding this pos for two years

Super huge news