Bioventus to Release Third Quarter of Fiscal Year 2021 Financial Results on November 9, 2021
By Dr. Matthew Watson
DURHAM, N.C., Oct. 27, 2021 (GLOBE NEWSWIRE) -- Bioventus Inc. (Nasdaq: BVS) (“Bioventus” or the “Company”), a global leader in innovations for active healing, today announced that third quarter of fiscal year 2021 financial results will be released before the market opens on Tuesday, November 9, 2021.
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Bioventus to Release Third Quarter of Fiscal Year 2021 Financial Results on November 9, 2021
Checkmate Pharmaceuticals Announces CEO Transition
By Dr. Matthew Watson
Alan Fuhrman, experienced biotech executive and Checkmate board member, appointed as interim President and CEO Alan Fuhrman, experienced biotech executive and Checkmate board member, appointed as interim President and CEO
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Checkmate Pharmaceuticals Announces CEO Transition
Dyadic to Report Third Quarter 2021 Financial Results on Wednesday, November 10, 2021
By Dr. Matthew Watson
JUPITER, Fla., Oct. 27, 2021 (GLOBE NEWSWIRE) -- Dyadic International, Inc. (“Dyadic”, “we”, “us”, “our”, or the “Company”) (NASDAQ: DYAI), a global biotechnology company focused on further improving, applying and deploying its proprietary C1-cell protein production platform to accelerate development, lower production costs and improve the performance of biologic vaccines and drugs at flexible commercial scales, today announced that it will report its financial results for the third quarter ended September 30, 2021 and host a corporate update conference call on Wednesday, November 10, 2021.
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Dyadic to Report Third Quarter 2021 Financial Results on Wednesday, November 10, 2021
Myriad Genetics to Release Third Quarter Financial Results on November 2, 2021
By Dr. Matthew Watson
SALT LAKE CITY, Oct. 27, 2021 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in genetic testing and precision medicine, today announced that it will hold its quarterly earnings conference call for the quarter ended September 30, 2021, at 4:30 p.m. EDT on Tuesday, November 2, 2021. The company’s quarterly earnings will be released the same day prior to the market opening. During the call, Paul J. Diaz, president and CEO, and R. Bryan Riggsbee, chief financial officer, will provide a financial overview and business update of Myriad Genetics’ performance for the third quarter of 2021.
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Myriad Genetics to Release Third Quarter Financial Results on November 2, 2021
Greenrose Acquisition Corp. Stockholders Approve Business Combination
By Dr. Matthew Watson
- All Stockholder Proposals Were Approved -
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Greenrose Acquisition Corp. Stockholders Approve Business Combination
PharmaTher Provides Business Update and Releases Financial Results for the First Quarter of Fiscal 2022
By Dr. Matthew Watson
TORONTO, Oct. 27, 2021 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a clinical-stage psychedelics biotech company, today released its business update and financial results for the three months ended August 31, 2021. All amounts are stated in Canadian dollars unless otherwise indicated.
Supernus to Announce Third Quarter 2021 Financial Results and Host Conference Call on November 3, 2021
By Dr. Matthew Watson
ROCKVILLE, Md., Oct. 27, 2021 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today announced that the Company expects to report financial and business results for the third quarter of 2021 after the market closes on Wednesday, November 3, 2021.
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Supernus to Announce Third Quarter 2021 Financial Results and Host Conference Call on November 3, 2021
HUTCHMED Initiates ESLIM-01, a Phase III Trial of HMPL-523 in Patients with Immune Thrombocytopenia in China
By Dr. Matthew Watson
HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., Oct. 28, 2021 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that it has initiated a Phase III trial in China of HMPL-523, a novel, investigational spleen tyrosine kinase (“Syk”) inhibitor, in adult patients with primary immune thrombocytopenia (“ITP”), an autoimmune disorder that can lead to increased risk of bleeding. The first patient received their first dose on October 27, 2021.
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HUTCHMED Initiates ESLIM-01, a Phase III Trial of HMPL-523 in Patients with Immune Thrombocytopenia in China
Phathom Pharmaceuticals Withdraws Public Offering
By Dr. Matthew Watson
FLORHAM PARK, N.J., Oct. 27, 2021 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a late clinical-stage biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases, announced today the withdrawal of the previously announced, proposed primary and secondary public offering. With our strong balance sheet, we believe that current market conditions are not conducive to an offering on terms that would be in the best interests of our stockholders. We are well capitalized, with cash and cash equivalents of $225 million as of September 30, 2021, which we believe, together with the drawdown of the remaining $100 million under our term loan facility, will be sufficient to fund our operations into mid-2023.
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Phathom Pharmaceuticals Withdraws Public Offering
CytoDyn Announces FDA Accepts Revised Rolling Review Timeline for Resubmission of its BLA
By Dr. Matthew Watson
Management expects the non-clinical and CMC sections of the BLA to be resubmitted to FDA in November
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CytoDyn Announces FDA Accepts Revised Rolling Review Timeline for Resubmission of its BLA
argenx Reports Third Quarter 2021 Financial Results and Provides Business Update
By Dr. Matthew Watson
– U.S. and Japan commercial teams fully staffed ahead of potential launches of efgartigimod in generalized myasthenia gravis (gMG) –
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argenx Reports Third Quarter 2021 Financial Results and Provides Business Update
Novadip Biosciences announces EUR 19 million Series B financing backed by international investors
By Dr. Matthew Watson
Novadip Biosciences announces EUR 19 million Series B financing backed by international investors
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Novadip Biosciences announces EUR 19 million Series B financing backed by international investors
MDxHealth Announces Launch of Proposed Initial Public Offering of ADSs in the United States
By Dr. Matthew Watson
NEWS RELEASE - REGULATED INFORMATIONINSIDE INFORMATION28 OCTOBER 2021, 07:00 CEST
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MDxHealth Announces Launch of Proposed Initial Public Offering of ADSs in the United States
Sanofi : Strong Q3 performance drives guidance upgrade to around 14% business EPS growth at CER(1)
By Dr. Matthew Watson
Paris, October 28, 2021
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Sanofi : Strong Q3 performance drives guidance upgrade to around 14% business EPS growth at CER(1)
Vistin Pharma ASA: Third quarter 2021 financial results
By Dr. Matthew Watson
To Read More: Vistin Pharma ASA: Third quarter 2021 financial resultsUNM Scientist Jennifer Gillette Tricks the Bone Marrow …
By daniellenierenberg
Our bone marrow harbors thousandsof rare hematopoietic stem cells tiny shape shifters that can morph into red or white blood cells. But conditions like sickle cell anemia or immune deficiency can damage these cells, and treatments for blood cancers may destroy them altogether.
To rebuild bone marrow, researchers have perfected the art of transplanting stem cells either those belonging to the patient or ones that have been donated.
You only have so many of these cells, says Jennifer Gillette, PhD, associate professor inThe University of New Mexico Department of Pathology. These are cells that are with us our entire life. They stay turned off when youre healthy and things are moving along. But in a stress condition, these are cells that get turned on and rev up and then go quiescent again.
Gillette has been devising ways to trick donors bone marrow into releasing more stem cells into the bloodstream so they can be harvested and transfused.
Ina new paper published onlinein the journalStem Cell Reports, Gillette and her colleagues describe manipulating a protein called CD82 that sits on the surface of each stem cell and helps them migrate into and out of the bone marrow.
Gillettes team found that when CD82 disruption is coupled with existing medications used to stimulate stem cell release into the bloodstream, the process is significantly amplified, causing more stem cells to find their way into circulation.
One of those medications AMD3100 costs $10,000 for a single dose, she says, and it is hoped that treatment with antibodies might be less expensive.
Patients diagnosed with leukemia or lymphoma may be treated with chemotherapy and/or radiation, which destroy cancerous cells in the bone marrow along with stem cells.
It wipes out everything, Gillette says. For leukemia or blood cancers youre trying to get rid of that malignant population and replace it with healthy cells.
Patients may bank some of their stem cells beforehand for autologous transplants, or they could receive allograft transplants from suitable donors.
There are some patients that just dont mobilize well, she says. Were looking for any way that we can enhance cell release, because the number and quality of cells going in really enhance the response of the patients.
Gillette has applied for a provisional patent to repurpose the antibodies originally developed to study CD82 functioning as a clinical treatment. The next step is to see exactly how that antibody is working, she says.
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UNM Scientist Jennifer Gillette Tricks the Bone Marrow ...
Community members rally behind teen in need of transplant – WVVA TV
By daniellenierenberg
TAZEWELL, Va. (WVVA) - Gabe is a seventeen year old who has battled and beat HLH, however recently he was diagnosed with leukemia and is in need of a blood stem cell and bone marrow transplant. Community members of Gabe's family are holding a bake sale, pumpkin contest and raffles to fund Gabe's cost of medical bills and travel expenses.
A DKMS drive was set up along with the bake sale at the Crab Orchard Veterinarians Services today to help find donors to give the gift of life to families just like Gabe's. All of the proceeds of the bake sale, contest and raffles will be given to Gabe's family.
'It's been a very stressful time for us but it's also been a very blessed time for us and I'm grateful for the outpouring from my community. My church family has been real big. My pastor and his wife and everybody involved at City on a Hill, I love you guys.
"I'm just grateful for everybody at Crab Orchard Vet Services and Honaker Animal Health for doing this for us and stepping up in a big way."
The process of becoming a potential donor for DKMS is simple. You get a swab kit and swab the inside of your cheeks. You fill out a paper with your contact info and from there you are registered into a database to see if you are a match with someone who needs stem cells or bone marrow.
"It means that we can not only help a family in the community but one of our own. Clifford works for our sister office in Honaker and it just means a lot to be able to reach out and help a family."
If you are interested in becoming a potential donor you can go to the DKMS website found here to get a donor kit: Register as a Stem Cell and Bone Marrow Donor | DKMS | DKMS
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Community members rally behind teen in need of transplant - WVVA TV
Biohaven Enrolls Phase 1a/1b Clinical Trial of BHV-1100, Lead Asset from its ARM (Antibody Recruiting Molecule) Platform, in Combination with NK Cell…
By daniellenierenberg
-- Biohaven initiates a clinical trial of the novel antibody recruiting molecule BHV-1100 to assess safety, tolerability, and exploratory clinical activity in Multiple Myeloma
Published: Oct. 27, 2021 at 7:30 AM EDT|Updated: 18 hours ago
NEW HAVEN, Conn., Oct. 27, 2021 /PRNewswire/ --Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN), announced the enrollment of the first patient in a Phase 1a/1b trial in Multiple Myeloma using the ARM, BHV-1100, in combination with autologous cytokine induced memory-like (CIML) natural killer (NK) cells and immunoglobulin (Ig) to target and kill multiple myeloma cells expressing the cell surface protein CD38 (Figure 1). BHV-1100 is the lead clinical asset from Biohaven's ARM Platform, developed from a strategic alliance with PeptiDream Inc. This clinical trial will assess the safety and tolerability, as well as exploratory efficacy endpoints, in newly diagnosed multiple myeloma patients who have tested positive for minimal residual disease (MRD+) in first remission prior to autologous stem cell transplant (ASCT).
NK cells are part of the innate immune system, which is designed to recognize and destroy "non-self" or diseased cells in the body. However, tumor cells can evade detection by immune effector cells, allowing the tumor to advance. BHV-1100 targets a cell-surface protein, CD38, that is heavily overexpressed on multiple myeloma and binds to it, recruiting primed autologous cytokine induced memory-like (CIML) natural killer (NK) cells to destroy the tumor.
Charlie Conway, Ph.D., Chief Scientific Officer at Biohaven commented, "While many recent advances have been made to benefit multiple myeloma patients, most patients will unfortunately still relapse. We are excited to investigate BHV-1100 for its ability to recruit autologous CIML NK cells to the site of the tumor. Based on preclinical data from Biohaven Labs, we anticipate that our CD38 targeting ARM-enabled NK cells will kill CD38-positive multiple myeloma cells, and recruit other immune effector cells to assist in reducing the tumor burden."
Biohaven has initiated enrollment in the clinical trial and plans to enroll 25 patients for this single-center, open-label study (ClinicalTrials.gov Identifier: NCT04634435; https://clinicaltrials.gov/ct2/show/NCT04634435). The study will enroll newly diagnosed multiple myeloma patients who have minimal residual disease (MRD+) in first remission prior to an autologous stem cell transplant (ASCT).
David Spiegel M.D., PhD, inventor of the ARM technology and Professor of Chemistry and Pharmacology at Yale University, commented, "This is an important milestone in the development of the ARM therapeutic platform taking a novel technology from 'benchtop to bedside'. It also highlights Biohaven's commitment to benefit patients in need."
About ARMs: Antibody Recruiting Molecules
ARMs,antibody recruiting molecules, are engineered with modular components that are readily interchangeable, giving the platform tremendous flexibility and rapid development timelines. ARM compounds are being developed at Biohaven Labs to redirect a patient's own antibodies for therapeutic effect with multiple benefits over traditional monoclonal antibody therapies, including the potential for oral dosing. For BHV
1100, the ARM platform is being used to provide antigen targeting to NK cell-based therapies without genetic engineering. This NK cell targeting approach is also being investigated with allogeneic, or 'off-the-shelf', immune cell-based therapies.
About Multiple Myeloma Multiple myeloma is a type of blood cancer of the plasma cell that develops in the bone marrow, the soft tissue inside our bones. Healthy plasma cells produce antibodies, which are critical for the immune system's ability to recognize disease-causing entities, such as bacteria, viruses and tumor cells. In multiple myeloma, however, genetic abnormalities in a single plasma cell cause it to divide uncontrollably. This leads to the over-production of a single (monoclonal) antibody protein, referred to as an "M protein". Also, these cancerous cells divide to the point of crowding out normal, healthy cells that reside in the bone marrow. Many patients are diagnosed due to symptoms such as bone pain or fractures, kidney failure (thirst, dehydration, confusion), nerve pain, fever, and weakness. The American Cancer Society estimates that approximately 34,920 new cases will be diagnosed, and 12,410 deaths will occur in 2021 from multiple myeloma.
About BiohavenBiohaven is a commercial-stage biopharmaceutical company with a portfolio of innovative, best-in-class therapies to improve the lives of patients with debilitating neurological and neuropsychiatric diseases, including rare disorders and areas of unmet need. Biohaven's neuro-innovation portfolio includes FDA-approved NURTEC ODT (rimegepant) for the acute and preventive treatment of migraine and a broad pipeline of late-stage product candidates across three distinct mechanistic platforms: CGRP receptor antagonism for the acute and preventive treatment of migraine; glutamate modulation for obsessive-compulsive disorder, Alzheimer's disease, and spinocerebellar ataxia; and MPO inhibition for amyotrophic lateral sclerosis. More information about Biohaven is available atwww.biohavenpharma.com.
About PeptiDream PeptiDream Inc. is a public(Tokyo Stock Exchange 1st Section 4587) biopharmaceutical company founded in 2006 employing their proprietary Peptide Discovery Platform System (PDPS), a state-of-the-art highly versatile discovery platform which enables the production of highly diverse (trillions) non-standard peptide libraries with high efficiency, for the identification of highly potent and selective hit candidates, which then can be developed into peptide-based, small molecule-based, or peptide-drug-conjugate-based therapeutics. PeptiDream aspires to be a world leader in drug discovery and development to address unmet medical needs and improve the quality of life of patients worldwide. Further information regarding PeptiDream can be found at: http://www.peptidream.com.
Forward-looking Statement This news release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements involve substantial risks and uncertainties, including statements that are based on the current expectations and assumptions of Biohaven's management about BHV-1100 as a treatment for multiple myeloma. Forward-looking statements include those related to: Biohaven's ability to effectively develop and commercialize BHV-1100, delays or problems in the supply or manufacture of BHV-1100, complying with applicableU.S.regulatory requirements, the expected timing, commencement and outcomes of Biohaven's planned and ongoing clinical trials, the timing of planned interactions and filings with the FDA, the timing and outcome of expected regulatory filings, the potential commercialization of Biohaven's product candidates, the potential for Biohaven's product candidates to be firstin class or best in class therapies and the effectiveness and safety of Biohaven's product candidates. Various important factors could cause actual results or events to differ materially from those that may be expressed or implied by our forward-looking statements. Additional important factors to be considered in connection with forward-looking statements are described in the "Risk Factors" section of Biohaven's Annual Report on Form 10-K for the year ended December 31, 2020, filed with the Securities and Exchange Commission onMarch 1, 2021, and Biohaven's subsequent filings with the Securities and Exchange Commission. The forward-looking statements are made as of this date and Biohaven does not undertake any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
NURTEC and NURTEC ODT are registered trademarks of Biohaven Pharmaceutical Ireland DAC.Neuroinnovation is a trademark of Biohaven Pharmaceutical Holding Company Ltd.
ARM is a trademark of Kleo Pharmaceuticals, Inc.
Biohaven ContactDr. Vlad CoricChief Executive OfficerVlad.Coric@biohavenpharma.com
Media ContactMike BeyerSam Brown Inc.mikebeyer@sambrown.com312-961-2502
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SOURCE Biohaven Pharmaceutical Holding Company Ltd.
The above press release was provided courtesy of PRNewswire. The views, opinions and statements in the press release are not endorsed by Gray Media Group nor do they necessarily state or reflect those of Gray Media Group, Inc.
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Biohaven Enrolls Phase 1a/1b Clinical Trial of BHV-1100, Lead Asset from its ARM (Antibody Recruiting Molecule) Platform, in Combination with NK Cell...
Global Cell Therapy Market Research Report 2021: Opportunities with the Approval of Kymriah and Yescarta Across Various Countries -…
By daniellenierenberg
DUBLIN--(BUSINESS WIRE)--The "Global Cell Therapy Market Size, Share & Trends Analysis Report by Use-type, by Therapy Type (Autologous, Allogenic), by Region (North America, Europe, Asia Pacific, Latin America, MEA), and Segment Forecasts, 2021-2028" report has been added to ResearchAndMarkets.com's offering.
The global cell therapy market size is expected to reach USD 23.0 billion by 2028 and is expected to expand at a CAGR of 14.5% from 2021 to 2028.
The emergence of new technologies to support the development of advanced cellular therapies has aided in market growth. Companies are leveraging new technologies not only for the expansion of their product portfolio but also for establishing out-licensing or co-development agreements with other entities to support their product development programs.
Cell-based therapies hold great potential for replacing, repairing, restoring, or regenerating damaged tissues, and organs. Researchers are making huge investments in the development of such effective and safe treatments as an alternative to conventional treatment strategies which can be further attributed to the market growth.
Out of all therapeutic areas, oncology has the highest number of ongoing clinical trials. T cells, CD34+ and/or CD133+ stem cells, mesenchymal stem/stromal cells are predominantly employed for clinical investigation.
The majority of biopharmaceutical entities have been affected by the COVID-19 pandemic, while several cellular therapy development companies have witnessed a strongly negative impact, which can be attributed to complications in logistics as well as the manufacturing models employed in this industry. In addition, substantial and stable funding is imperative to ensure successful commercial translation of cell-based therapeutics, a factor that was negatively affected in 2020, further affecting the market growth.
A survey conducted recently among executives of more than 15 European and U.S. cellular therapy companies indicated that disruption caused by the pandemic was significant, which demanded market entities to create strategies to sustain themselves and plan the next wave of innovative therapies.
Key issues faced by companies operating in the market include on-time delivery of therapies to patients at required clinical sites. In addition, the administration of these therapeutics poses several post-pandemic challenges. Hospitals are hesitant in offering services, owing to concerns over transmission of SARS-CoV-2, particularly to vulnerable individuals. Moreover, patients have not been able to visit cellular therapy centers either, owing to the lockdowns and travel bans.
Cell Therapy Market Report Highlights
Market Dynamics
Market driver analysis
Market restraint analysis
Market opportunity analysis
COVID-19 Impact Analysis
Challenges analysis
Opportunities analysis
Challenges in manufacturing cell therapies against COVID-19
Companies Mentioned
For more information about this report visit https://www.researchandmarkets.com/r/n1u89x
New Treatments and Tips for Dealing With Blood Cancer – Curetoday.com
By daniellenierenberg
Did you know that every three minutes someone receives a diagnosis of a blood cancer? According to the National Foundation for Cancer Research, blood cancers account for nearly 10% of new cancer diagnoses in the United States annually. That means that approximately 178,520 people will receive a diagnosis this year most commonly with leukemia, lymphoma or myeloma. And although survival rates have increased dramatically over the past 20 years, theres still a long way to go when it comes to this patient population.
In this special issue of CURE, youll read about some of the research going on in blood cancer right now, including new treatment options for acute myeloid leukemia and a novel therapy using BK virus-specific T cells to treat BK virus-associated hemorrhagic cystitis (a painful side effect of stem cell transplants).
Dive into the issue for two patient stories, one about a three-time acute lymphoblastic leukemia survivor who now works as a nurse on the bone marrow transplant floor at Barnes-Jewish Hospital in St. Louis. This year also marks the 20th anniversary of the Food and Drug Administrations approval of Gleevec (imatinib mesylate), the tyrosine kinase inhibitor that saved Mel Mann. Who is Mel Mann? He is the longest-living survivor who was treated with the drug as a part of a clinical trial for chronic myeloid leukemia.
And because cancer is not a disease one should have to face alone, our cover story looks at the responsibilities and experiences of caregivers to patients with blood cancer. Not only will you read about what theyve gone through, but youll also find extra resources and tips for navigating the patient-caregiver relationship.
As always, thank you for reading.
For more news on cancer updates, research and education, dont forget tosubscribe to CUREs newsletters here.
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New Treatments and Tips for Dealing With Blood Cancer - Curetoday.com