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CAPR
Wow
$21.60 now
I told you but since $4
I am millionaire
Keep going up everyday
Billion dollars FDA approval guaranteed
CAPR
Keep exploding
I have enough shares to become millionaire
CAPR
Keep going higher in anticipation of FDA BLA filing this month
$50 upon the news
Unstoppable beast running
CAPR
keep going higher
Super volcanic explosion
CAPR
keep going higher before FDA BLA filing this month
Billion dollars FDA approval is given
You are welcome
Many millionaires will be made very soon
$10 billion dollars potential with the first cardio therapy FDA approval guaranteed
Super volcanic explosion now
Enjoy the ride to $30 this month
CAPR
I told you super explosion coming
$13.40 now
CAPR
What a monster!
$20 coming this week
Super volcanic explosion
PT $50
CAPR
told you explosion keep going
$20 coming sooner
FDA approval is given now
CAPR
breaking out again
$20 coming baby
CAPR
just broke $10 mark
Oppenheimer analyst just raised PT to $43
FDA AA is given in a few months
Good luck all
CAPR
keep going higher again
FDA news was fantastic yesterday
FDA agreed to go ahead BLA submission without further data based on outstanding cardio results
$50 upon accelerated Approval in a few months
safe to think AA is given in a few months
$100 coming sooner
CAPR
monstrous move by huge FDA news today
Another explosion over $10 tmrw again
$50 by Christmas time and $100 by Spring next year
Super volcanic explosion
CAPR
keep going up
FDA news is humongous indeed
Analyst price target raised to $40 today
CAPR
Potential 1000% runner in a few months
FDA nodded to file BLA finally
99% Accelerated Approval now
CAPR
Keep going higher
$15 doable today or tmrw
Huge FDA BLA news!
We will be millionaires very soon
CAPR
breaking out now
Buy all you can before $10
CAPR
1000% runner in the making very soon
Good luck all
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.
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.
CAPR
Humongous news just announced
FDA BLA news!!!
CAPR
keep going up AH
Huge news pendingbtmrw
$10 tmrw
Big FDA AA news
CAPR
Huge explosion tmrw
FDA AA news coming
Billion dollars milestone
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.
CAPR
Huge explosion upon great news today
NKGN
keep going up
Huge Alzheimer news released this morning
The billion dollar stock indeed
NKGN
breaking out
NKGN
SANTA ANA, Calif., Sept. 12, 2024 (GLOBE NEWSWIRE) -- NKGen Biotech, Inc. (Nasdaq: NKGN) (“NKGen” or the “Company”), a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous and allogeneic natural killer (“NK”) cell therapeutics, today announced promising early interim data from the Phase 1 cohort and the dosing of the first Phase 2 patient in the Phase 1/2a clinical trial of troculeucel, NKGen’s cryopreserved autologous enhanced NK cell therapy for the treatment of moderate Alzheimer’s disease (“AD”).
The Phase 1 cohort is already demonstrating positive interim results. Early independent review of the data shows that after only three months treatment with a dose of 6 billion cells per treatment, the three patients in the Phase 1 cohort had no drug-related adverse reactions, and exploratory efficacy analyses showed that two of the three patients went from a moderate to a mild AD rating on the Clinical Dementia Rating-Sum of Boxes (“CDR-SB”) scale. These findings further support the company’s MX04 Phase 1 AD study, where the one moderate AD patient who received the highest dose in that study (4 billion cells) also went from a moderate to a mild rating on the CDR-SB. Additionally, six-month interim cognitive data from Phase 1 cohort patients receiving troculeucel is expected to be disclosed at an upcoming national Alzheimer’s conference in Q4 2024.
Building upon positive interim Phase 1 results of troculeucel in moderate Alzheimer’s patients, the Company is pleased to have dosed its first patient in the Phase 2 randomized, double-blind, placebo-controlled trial evaluating the efficacy of troculeucel compared to placebo in patients with moderate Alzheimer’s disease. Troculeucel will be evaluated for effectiveness and additional safety in a broader cohort of 30 patients with moderate Alzheimer’s disease, employing a randomized, double-blind setup (n=20 randomly assigned to the treatment arm and n=10 to placebo). The Phase 2 trial aims to provide a thorough understanding of both the potential benefits and limitations of troculeucel in treating Alzheimer’s disease, thereby validating its potential therapeutic efficacy. NKGen has now activated four clinical sites across North America and expects to increase enrollment in the coming months.
“We continue to make great progress with our troculeucel clinical program in AD,” said Paul Y. Song, MD, Chairman and CEO of NKGen. “In the Phase 1 cohort of the Phase 1/2a study, we can proudly announce two of our first three patients have been clinically upgraded from moderate to mild AD following only three months of treatment with troculeucel. Additionally, we have recently dosed the first patient in the Phase 2 cohort, which is a significant milestone, particularly since the dose used is cryopreserved and continuing at our highest dosing of 6 billion cells per treatment. With encouraging cognitive improvements and a favorable safety profile from the trial’s Phase 1 interim analysis, dosing our first patient in Phase 2 is a crucial step towards creating a much-needed treatment option for patients facing this challenging condition. We are particularly eager to explore the enhanced cognitive benefits that ongoing usage of the higher dosing may bring in our Phase 2 trial.”
SANTA ANA, Calif., Sept. 12, 2024 (GLOBE NEWSWIRE) -- NKGen Biotech, Inc. (Nasdaq: NKGN) (“NKGen” or the “Company”), a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous and allogeneic natural killer (“NK”) cell therapeutics, today announced promising early interim data from the Phase 1 cohort and the dosing of the first Phase 2 patient in the Phase 1/2a clinical trial of troculeucel, NKGen’s cryopreserved autologous enhanced NK cell therapy for the treatment of moderate Alzheimer’s disease (“AD”).
The Phase 1 cohort is already demonstrating positive interim results. Early independent review of the data shows that after only three months treatment with a dose of 6 billion cells per treatment, the three patients in the Phase 1 cohort had no drug-related adverse reactions, and exploratory efficacy analyses showed that two of the three patients went from a moderate to a mild AD rating on the Clinical Dementia Rating-Sum of Boxes (“CDR-SB”) scale. These findings further support the company’s MX04 Phase 1 AD study, where the one moderate AD patient who received the highest dose in that study (4 billion cells) also went from a moderate to a mild rating on the CDR-SB. Additionally, six-month interim cognitive data from Phase 1 cohort patients receiving troculeucel is expected to be disclosed at an upcoming national Alzheimer’s conference in Q4 2024.
Building upon positive interim Phase 1 results of troculeucel in moderate Alzheimer’s patients, the Company is pleased to have dosed its first patient in the Phase 2 randomized, double-blind, placebo-controlled trial evaluating the efficacy of troculeucel compared to placebo in patients with moderate Alzheimer’s disease. Troculeucel will be evaluated for effectiveness and additional safety in a broader cohort of 30 patients with moderate Alzheimer’s disease, employing a randomized, double-blind setup (n=20 randomly assigned to the treatment arm and n=10 to placebo). The Phase 2 trial aims to provide a thorough understanding of both the potential benefits and limitations of troculeucel in treating Alzheimer’s disease, thereby validating its potential therapeutic efficacy. NKGen has now activated four clinical sites across North America and expects to increase enrollment in the coming months.
“We continue to make great progress with our troculeucel clinical program in AD,” said Paul Y. Song, MD, Chairman and CEO of NKGen. “In the Phase 1 cohort of the Phase 1/2a study, we can proudly announce two of our first three patients have been clinically upgraded from moderate to mild AD following only three months of treatment with troculeucel. Additionally, we have recently dosed the first patient in the Phase 2 cohort, which is a significant milestone, particularly since the dose used is cryopreserved and continuing at our highest dosing of 6 billion cells per treatment. With encouraging cognitive improvements and a favorable safety profile from the trial’s Phase 1 interim analysis, dosing our first patient in Phase 2 is a crucial step towards creating a much-needed treatment option for patients facing this challenging condition. We are particularly eager to explore the enhanced cognitive benefits that ongoing usage of the higher dosing may bring in our Phase 2 trial.”
NKGN
Huge news out
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