Capricor Therapeutics Inc (CAPR) News

--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

K.

Because the pumpers stopped posting

Fda meeting will happening shortly. Hopefully the get the greenlight this time.

On what grounds?

This unfunded part is their actual worth. If it gets teeth...they are going to the moon

going under 3s next few weeks

Steady progress on DMD is great. But the elephant in the room are the partnerships for the Exosome platforms.
Here is what the company has said...
"Exosome-Based Therapeutics and Vaccines (Preclinical): We are focused on developing a precision-engineered exosome platform technology that has the ability to deliver defined sets of effector molecules which exert their effects through defined mechanisms of action. We recently published preclinical data on our StealthXTM platform showing the rapid development of a recombinant protein-based.... At this time, we are developing vaccines and therapeutics for infectious diseases, monogenic diseases and other potential indications. Our platform builds on advances in fundamental RNA and protein science, targeting technology and manufacturing, providing us the opportunity to potentially build a broad pipeline of new therapeutic candidates. Our current strategy is FOCUSED on SECURING PARTNERS who will provide capital and additional resources..."

I forgot to add that they will also earn a Priority Review Voucher (PRV) which have sold recently for $110 million.

Lol well im okay with it. No reason really to go down. Ill hold out Q4 is almost here.

The recent $10 million milestone is only the start. There is another $90 million coming upon approval. And another $600 million in future milestones. And the ROW rights outside US and Japan should be significant. And very few shares out. Future exosome partnerships could be huge...with buy-out potential anytime IMO.

sell the news lol