Category Archives: Biotechnology

The biotech sector is one of the most dynamic and unpredictable industries. While some companies struggle to stay afloat, others thrive with the help of intelligent management and timely product launches. Biotech stocks are volatile, but these companies offer lucrative investment opportunities if you know where to look. Keep reading to learn more about the biotech sector and our top picks for 2022. Our list will help you find the best stocks to invest in now and in the future, no matter how volatile this sector becomes. These markets have proven growth potential due to their current size or recent expansion efforts. Each company on this list offers value as a long-term holding regardless of market fluctuations.

Avidity Biosciences is a clinical-stage biopharmaceutical company focused on developing RNA-based therapeutics. The companys lead candidate is CADATE-19, a potent antisense oligonucleotide, or ASO, designed to treat hypercholesterolemia. CADATE-19 has completed a Phase III clinical trial, and Avidity plans to submit a Neplannedg Application in 2021. If approved, CADATE-19 could capture a large share of the hypercholesterolemia treatment market, where the current market leader has an 80% share. The company also has a preclinical drug for Huntingtons disease. This rare genetic disorder causes nerve and muscle degeneration, leading to cognitive impairment, mood changes, and death. Overall, Avidity Biosciences has a strong product pipeline for treating several rare diseases, including hypercholesterolemia, hemophilia, and Huntingtons. In addition, the company has a good chance of success, given that its lead products have already completed Phase III clinical trials.

Syndax Pharmaceuticals is a biopharmaceutical company focused on discovering, developing, and commercializing drugs to treat rare diseases. The companys lead product is Texas, an intravenous treatment for patients with hereditary ATTR amyloidosis, an incurable, degenerative muscle disease that often leads to heart failure. Texas is currently in Phase III clinical trial. If approved, the drug will be reserved only for patients with ATTR amyloidosis who have already undergone a liver transplant. Syndax PharmaceuticalIn addition, s is also developing SD-101, a treatment intended to treat hereditary ATTR amyloidosis. If approved, SD-101 could capture a large share of the genetic ATTR amyloidosis treatment market, which is currently under $1 billion. Overall, Syndax Pharmaceuticals is a strong company with a good chance of success with its lead products. Although hereditary ATTR amyloidosis is a rare disease, the number of patients with this condition is expected to grow.

Alnylam Pharmaceuticals is a biopharmaceutical company focused on discovering and developing drugs based on RNA interference, or RNAi. The companys lead product is S1AL19, a treatment for patients with familial amyloidosis, a rare genetic disorder that causes the buildup of a protein called amyloid in the organs and tissues. S1AL19 is currently in Phase III clinical trial. If approved, the drug could capture a large share of the familial amyloidosis treatment market, which is currently worth $1 billion annually. In addition, the company also has a preclinical cure for hereditary ATTR amyloidosis, a rare genetic disorder affecting the heart and kidneys. Overall, Alnylam Pharmaceuticals is a strong company with a good chance of success with its two lead products. Familial amyloidosis is a rare disease, but the number of patients with this condition is expected to grow.

Travel Therapeutics Holdings is a biopharmaceutical company focused on developing therapies for neurological diseases. The companys lead product candidate is CT1819, an intravenous treatment for patients with hereditary ATTR amyloidosis. Travel Therapeutics drug is currently in Phase II/III clinical trial. If approved, CT1819 could capture a large share of the genetic ATTR amyloidosis treatment market, which is currently worth $1 billion annually. The company also has, In addition, there clinical drug candidates for familial amyloidosis. Overall, Cerevel Therapeutics Holdings is a strong company with a good chance of success with its two lead products. Like hereditary ATTR amyloidosis, familial amyloidosis is a rare disease, but the number of patients with this condition is expected to grow.

Biotech stocks are notoriously volatile, and its important to remember that a single good or bad day can wipe out months of progress. That being said, the top biotech stocks for 2022 are poised for significant gains over the long term. These companies have various innovative products in their pipelines, from RNA-based therapeutics to RNAi-based drugs. With support from stakeholders and the market, these biotech stocks could dramatically outperform the broader market in 2022 and beyond.

Excerpt from:
Top Biotechnology Stocks To Buy In 2022 - Best Stocks

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BEIJING & GUANGZHOU, China Biocytogen Pharmaceuticals (Beijing) Co., Ltd. (Biocytogen, HKEX: 02315) announced a strategic collaboration with Guangzhou FineImmune Biotechnology Co., LTD. (FineImmune) to co-develop cell-based therapeutic drugs targeting intracellular tumor-associated antigens. Biocytogen will use its proprietary TCR-mimic antibody platform to discover fully human antibody sequences that will be further developed using FineImmunes unique cell therapy platform.

Biocytogens TCR-mimic antibody development platform utilizes its proprietary fully human antibody RenMiceTM (RenMabTM and RenLite mice) that have been further engineered to express a human leukocyte antigen (HLA) gene. Antibodies against intracellular tumor-associated antigens are subjected to advanced high-throughput antibody screening technologies to discover antibodies with high specificity and affinity.

Most tumor antigens are intracellular, and our TCR-mimic platform provides a solution for developing antibodies against these valuable targets, said Dr. Yuelei Shen, Founder, Chairman and CEO of Biocytogen. TCR-mimic antibodies generated by our TCR-mimic platform have potentials to be developed into multiple drug modalities such as T cell engagers, bispecific/multispecific antibodies and CAR-T therapies. We are pleased to collaborate with FineImmune to explore the application of our antibodies in the field of cell therapies.

FineImmune is a pioneering T cell therapy company, and has solved multiple critical barriers in the microenvironment of solid tumors by using multiple proprietary technology platforms, such as GSOP for T-cell engineering, HAP for TCR identification, CMP for personalized TCR-T cell production and in vivo T-cell delivery platform (TDP). FineImmunes product pipelines include TCR-T, CAR-T, TAL, TIL, etc. The company developed the first personalized neoantigen-specific TCR-T cell therapy, which is in phase I clinical trial now. In addition, FineImmune possesses technologies for the precision prediction of the efficacy and side effects of immunotherapy, enabling healthcare professionals to provide effective and safe immunotherapy to patients with common malignant tumors.

T cells play an important role in treating cancers. Biocytogens advanced TCR-mimic platform makes it possible for us to develop T cell therapies against crucial but low-expressed intracellular tumor antigens, said Dr. Penghui Zhou, Founder and Chief Technology Officer of FineImmune. We focus on providing efficient and safe immunotherapy using advanced technologies. This collaboration will promote the development of new cell therapeutic drugs and the expansion of the potential of immunotherapy to benefit patients.

About the TCR-Mimic Platform Biocytogens T Cell Receptor (TCR)-Mimic platform utilizes HLA-expressing fully human antibody mice (HLA/RenMice) to generate antibodies to intracellular tumor-associated antigens when immunized with MHC-antigen-peptide complexes. Subsequently, Biocytogens high-throughput antibody screening platform aims to swiftly identify TCR-mimic antibodies with higher specificity and affinity than endogenous TCRs derived from patients. Currently, antibody sequences against multiple intracellular targets have been obtained, and their efficacies have been verified in vitro and in vivo. Fully human antibody sequences obtained from the TCR-mimic platform can empower the development of T cell engagers, bispecific/multispecific antibodies, and CAR-T therapies.

About Biocytogen Biocytogen Pharmaceuticals (Beijing) Co., Ltd. is a global biotechnology company that drives the research and development of novel antibody-based drugs with innovative technologies. Using its proprietary RenMabTM /RenLite mice platforms for fully human monoclonal and bispecific antibody development, Biocytogen has integrated its in vivo drug efficacy screening platforms and strong clinical development expertise to streamline the entire drug development process. Biocytogen is undertaking a large-scale project to develop antibody drugs for more than 1000 targets, known as Project Integrum, and has entered ongoing collaborations with dozens of partners worldwide to produce a variety of first-in-class and/or best-in-class antibody drugs. The companys pipeline includes 12 core products, among which two products are in phase II multi-regional clinical trials and two products are in phase I. Headquartered in Beijing, Biocytogen has branches in Haimen Jiangsu, Shanghai, Boston, USA and Heidelberg, Germany. On September 1, 2022, Biocytogen was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code: 02315.HK. For more information, please visit http://en.biocytogen.com.cn.

About FineImmune Guangzhou FineImmune Biotechnology Co., Ltd. is an innovation driven company based in China. The company is mainly engaged in the development of solid tumor immunotherapy drugs and related businesses. It has solved key technical bottlenecks in solid tumor immunotherapy and possesses core technologies. A number of T-cell therapy products for solid tumors are in clinical trials, as well as diagnostic reagents for accurate identification of effective populations. It has a 2000 square meter immunotherapy R&D laboratory and a GMP production workshop for cell therapy products in Guangzhou Science City. The companys individualized TCR-T cell therapy product (new drug) has been carried out clinical research in the Affiliated Tumor Hospital of Sun Yat sen University. At present, more than 20 immune cell therapy products and technologies are under research and development. For more information, please visit http://www.fineimmu.com/.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220915005284/en/

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Biocytogen Platform and Assets: BD-Licensing@biocytogen.com Media: pr@bbctg.com.cn

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Biocytogen Announces Collaboration with FineImmune to Develop TCR-Mimic Antibody-Based Cell Therapy - Financial Post

LOS ANGELES--(BUSINESS WIRE)--Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced that Alan H. Auerbach, Chairman, Chief Executive Officer, President and Founder of Puma, will present an overview of the Company at the hybrid H.C. Wainwright 24th Annual Global Investment Conference, which will be held September 12-14, 2022. The virtual presentation will be available for 30 days beginning at 7:00 a.m. EDT on September 12, 2022 on the Companys website at https://www.pumabiotechnology.com.

About Puma Biotechnology

Puma Biotechnology, Inc. is a biopharmaceutical company with a focus on the development and commercialization of innovative products to enhance cancer care. Puma in-licenses the global development and commercialization rights to PB272 (neratinib, oral), PB272 (neratinib, intravenous) and PB357. Neratinib, oral was approved by the U.S. Food and Drug Administration in 2017 for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, following adjuvant trastuzumab-based therapy, and is marketed in the United States as NERLYNX (neratinib) tablets. In February 2020, NERLYNX was also approved by the FDA in combination with capecitabine for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. NERLYNX was granted marketing authorization by the European Commission in 2018 for the extended adjuvant treatment of adult patients with early stage hormone receptor-positive HER2-overexpressed/amplified breast cancer and who are less than one year from completion of prior adjuvant trastuzumab-based therapy. NERLYNX is a registered trademark of Puma Biotechnology, Inc.

Further information about Puma Biotechnology may be found at https://www.pumabiotechnology.com.

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Puma Biotechnology to Present at the H.C. Wainwright 24th Annual Global Investment Conference - Business Wire

The biotech industry is heavily regulated by the federal government and its science watchdog, the Food and Drug Administration (FDA). As a consequence, biotech investors often evaluate a possible investment by looking at the company's pipeline of future assets. Research and development is a key factor in this sector.

So what biotech companies have the most exciting future prospects? Three Fool.com healthcare contributors like Vertex Pharmaceuticals (VRTX 1.88%), Repligen (RGEN 4.51%), and Recursion Pharmaceuticals (RXRX 9.43%). Here's why they believe these three stocks are the future of biotechnology.

George Budwell (Vertex Pharmaceuticals): Vertex Pharmaceuticals has become a cash-printing machine recently thanks to its groundbreaking cystic fibrosis treatments like Trikafta. This single drug generated a whopping $5.7 billion in sales in 2021.

The company has been using the proceeds from its mega-blockbuster cystic fibrosis franchise to expand into cutting-edge treatment modalities such as stem cell therapy and gene editing. For example, Vertex dipped into its cash reserves in the recent past to buy the privately held biotechs Semma Therapeutics and ViaCyte. These complementary transactions have suddenly made Vertex a potential juggernaut in the world of diabetes care.

The 2019 Semma Therapeutics deal gave the biotech the allogeneic stem-cell product VX-880, aimed at curing type 1 diabetes. And earlier this year, Vertex bought ViaCyte for its cell replacement therapy platform, which is also initially aimed at curing type 1 diabetes.

This ViaCyte transaction also stands out because the biotech has an ongoing collaboration with Vertex's blood disease collaborator, CRISPR Therapeutics. This ViaCyte/CRISPR partnership centers around the development of genetically modified beta cells for the treatment of both type 1 and type 2 diabetes. CRISPR and ViaCyte are reportedly on track to release top-line data from an early-stage trial in type 1 diabetes next year. Human trials for the duo's type 2 therapy could kick off in either late 2023 or early 2024.

In sum, Vertex's cell- and gene-editing-based diabetes care therapies have the potential to bend the curve in terms of the standard of care for this worldwide epidemic. Wall Street, however, doesn't appear to have taken notice of this deep value proposition -- at least not yet. Vertex's stock, after all, seems to be being valued mainly for its cystic fibrosis franchise and pipeline assets in various blood disorders.

Patrick Bafuma (Repligen): When it comes to the future, Repligen is creating the tools that make it all possible. From cell and gene therapy to cutting-edge mRNA vaccines to monoclonal antibody treatment, Repligen is there. This biotech provides the equipment and associated consumables needed for various steps in the manufacturing of today's most complex treatments.

And in a year marred by supply chain and geopolitical issues, Repligen has seemingly been insulated. There was hardly a mention of either of these issues in the last few earnings conference calls. Not bad considering its sales are spread throughout the globe with Europe, North America, and Asia representing 35%, 45%, and 20% of second-quarter revenue, respectively. Despite sales slowing down for COVID-19 treatments and vaccines that Repligen helps manufacture, the company's base business in Q2 was up 41% year over year. The record quarterly revenue of $207.6 million -- up 32% year over year on a constant currency basis -- is a welcome sight for biotech investors in 2022's uncertain market.

If you believe cell and gene therapy are the future of healthcare, then Repligen deserves a second look. The bioprocessing company's cell and gene therapy segment is seeing accelerated growth. Revenue from this business line increased 40% in full year 2021, and growth in Q2 2022 was up almost 70% from the same period a year ago. This puts Repligen on track to smash its own 40% growth target for the division for 2022. There are other signs the future is bright, too. At the end of 2020, there were over 1,200 clinical trials underway worldwide in the cell and gene therapy segment, according to the company. Then there are the FDA estimates for annual revenue growth of over 25% for the entirety of said market through 2025. Put it all together, and Repligen is well positioned to thrive as the backbone of the industry.

Taylor Carmichael (Recursion Pharmaceuticals): Vertex and Repligen are great picks. Both companies are already highly profitable, so the future prospects are grounded in what these companies have already accomplished. Recursion is a different animal. The company doesn't have profits yet, and revenue is still small. But I've opened up a small position here because the upside is so high. If this company has any success, it will dramatically transform drug discovery.

Here's the current paradigm for finding a new drug candidate. You notice a problem in the world of healthcare. You read academic articles to see what has been tried and what has not been tried. You formulate your own hypothesis. And then you collect data by testing your hypothesis in animals, and then in people. That's the basic model for drug discovery -- and it has a spectacular failure rate of over 90%.

Recursion is using supercomputers and artificial intelligence (AI) to create maps of biology. The company's software has already generated 16 petabytes of biological and chemical data. One petabyte equals 1.5 million CD-ROM discs. It's estimated the human brain can store 2.5 petabytes of memory data. So Recursion's AI solution now has more data than six human brains.

Even more importantly, the company's AI solution is running experiments with this data all the time. Recursion's computers have now made 2.4 trillion predictions about biological and chemical relationships. Research scientists can search all this data to create a more informed hypothesis. This is a fundamentally superior model, in my opinion. First you collect and analyze the scientific data, and then you form the hypothesis.

The company has major partners inBayerand Roche. And Recursion has quickly found drug candidates. In the first quarter, the company initiated a phase 2 study for a drug to treat cerebral cavernous malformation. In Q2, the company started a phase 2 study for a molecule to treat neurofibromatosis type 2. This quarter the company will initiate yet another phase 2 study, in a drug treating familial adenomatous polyposis (FAP).

Of course improving the odds does not mean that these drugs are sure things. But I definitely think Recursion is on the right track, and the future of drug discovery will follow this model. So I've made a small investment here while it's early and the company is still small. (Its market cap is under $2 billion.) If I'm right, Recursion will be a foundational holding for biotech investors for many years to come.

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These 3 Stocks Are the Future of Biotechnology - The Motley Fool

DUBLIN, Ireland, Sept. 01, 2022 (GLOBE NEWSWIRE) -- Prothena Corporation plc (NASDAQ:PRTA), a late-stage clinical biotechnology company with a robust pipeline of investigational therapeutics built on protein dysregulation expertise, announced today the appointment of Helen S. Kim, MBA, to its Board of Directors. Ms. Kim has over 27 years of experience in leadership roles in biotechnology, including her previous role as Executive Vice President of Business Development at Kite Pharma, Inc. where she led all business and corporate development initiatives, leading to a successful acquisition by Gilead in 2017. With the appointment of Ms. Kim, Prothena will expand its Board to 10 directors.

Ms. Kims background and expertise in leadership roles across biotechnology companies for nearly three decades will be a welcome addition to the Board and will help guide Prothenas robust portfolio as the company moves towards commercialization, commented Lars G. Ekman, M.D., Ph.D., Prothenas Chairman. We welcome Ms. Kim to our Board and look forward to her many contributions.

After watching the strong execution of Prothena over the past years, Im excited to join the Board of Directors at this pivotal stage for the company. Their expertise in pioneering drugs targeting protein dysregulation is clearly reflected in the robust and promising pipeline of novel programs in areas of high unmet need, said Ms. Kim. I look forward to working with the other board members and the leadership team to continue Prothenas progress in advancing novel medicines for neurodegenerative and rare peripheral amyloid diseases, which affect millions of people and their families worldwide.

Currently, Ms. Kim serves as a Senior Managing Director at Vida Ventures, LLC (a venture capital firm), a position which she has held since April 2019. Prior to her current role, Ms. Kim was a Partner at the Column Group (a venture capital firm) from 2018-2019 and the Executive Vice President, Business Development at Kite Pharma, Inc. from 2014-2018. Previously, Ms. Kim held positions as Chief Business Officer (2009-2012) and then Strategic Advisor (2012-2014) of NGM Biopharmaceuticals, Inc. Prior to NGM, she was the Chief Executive Officer and President of Kosan Biosciences (a pharmaceutical company) where she restructured and repositioned the company prior to a successful transaction with Bristol Myers Squibb in 2008. Ms. Kims additional industry experience includes executive and leadership positions at Affymax, Inc., Onyx Pharmaceuticals, Inc., Protein Design Labs, Inc. (a technology company), and Chiron Corporation.

Ms. Kim currently serves on the Board of Directors for A2 Biotherapeutics, Inc., ReCode Therapeutics, Inc., IconOVir Bio, Inc., Aktis Oncology, PACT Pharma, Protego Therapeutics, and InduPro Labs. Ms. Kim received a B.S. in Chemical Engineering from Northwestern University and an MBA from the University of Chicago.

About ProthenaProthena Corporation plc is a late-stage clinical biotechnology company with expertise in protein dysregulation and a pipeline of investigational therapeutics with the potential to change the course of devastating neurodegenerative and rare peripheral amyloid diseases. Fueled by its deep scientific expertise built over decades of research, Prothena is advancing a pipeline of therapeutic candidates for a number of indications and novel targets for which its ability to integrate scientific insights around neurological dysfunction and the biology of misfolded proteins can be leveraged. Prothenas pipeline includes both wholly-owned and partnered programs being developed for the potential treatment of diseases including AL amyloidosis, ATTR amyloidosis, Alzheimers disease, Parkinsons disease and a number of other neurodegenerative diseases. For more information, please visit the Companys website at http://www.prothena.com and follow the Company on Twitter @ProthenaCorp.

Media and Investor Contact:

MediaMichael Bachner, Senior Director, Corporate Communications609-664-7308, michael.bachner@prothena.com

InvestorsJennifer Zibuda, Director, Investor Relations & Communications650-837-8535, jennifer.zibuda@prothena.com

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/f753c7c6-4b3d-4059-ad0a-8515de183e27

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Prothena Announces Appointment of Biotechnology Industry Leader Helen S. Kim to its Board of Directors - GlobeNewswire

Sana Biotechnology Inc. (NASDAQ: SANA) stock fell -4.59% on Friday to $6.23 against a previous-day closing price of $6.53. With 1.08 million shares changed hands, the volume of the stock remained lighter than its average volume of 1.48 million shares. During the session, the Biotechnology company that operates in wider Healthcare sector, reached to the highest price of $6.63 whereas the lowest price it dropped to was $6.13. The 52-week range on SANA shows that it touched its highest point at $26.60 and its lowest point at $3.92 during that stretch. It currently has a 1-year price target of $13.33.

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Stock performance is one of the indicators that investors use to determine whether they will profit from a stock. The price performance of SANA was down-trending over the past week, with a drop of -3.26%, but this was down by -24.30% over a month. Three-month performance surged to 25.86% while six-month performance rose 18.89%. The stock lost -74.82% in the past year, while it has lost -59.75% so far this year. A look at the trailing 12-month EPS for SANA yields -1.61 with Next year EPS estimates of -2.37. For the next quarter, that number is -0.53. This implies an EPS growth rate of -37.80% for this year and -12.40% for next year.

At present, 187.63 million SANA shares are outstanding with a float of 168.88 million shares on hand for trading. On Jul 14, 2022, short shares totaled 22.35 million, which was 11.78% higher than short shares on Jun 14, 2022. In addition to Dr. Steven D. Harr M.D. as the firms Pres, CEO & Director, Dr. Richard C. Mulligan Ph.D. serves as its Exec. Vice Chairman & Head of SanaX.

Through their ownership of 85.43% of SANAs outstanding shares, institutional investors have majority control over the company. Other institutions hold 32.91% of SANA, in contrast to 26.79% held by mutual funds. Shares owned by individuals account for 15.06%. As the largest shareholder in SANA with 5.79% of the stake, Baillie Gifford & Co. holds 11,011,462 shares worth 11,011,462. A second-largest stockholder of SANA, Canada Pension Plan Investment Bo, holds 10,175,000 shares, controlling over 5.35% of the firms shares. SSgA Funds Management, Inc. is the third largest shareholder in SANA, holding 8,594,413 shares or 4.52% stake. With a 4.51% stake in SANA, the Canada Pension Plan is the largest stakeholder. A total of 8,581,595 shares are owned by the mutual fund manager. The SPDR S&P Biotech ETF, which owns about 3.67% of SANA stock, is the second-largest Mutual Fund holder. It holds 6,969,103 shares valued at 46.55 million. Scottish Mortgage Investment Trus holds 2.95% of the stake in SANA, owning 5,586,264 shares worth 37.32 million.

Reading analyst opinions is an effective way to decide where to invest, and there are several opinions available for SANA since 4 analysts follow the stock currently. There are 2 analysts who recommend BUY ratings, while 0 suggest SELL ratings. Of the remaining analysts, 2 believe that the stock is worth HOLDING, 0 give it an OVERWEIGHT rating, and 0 thinks that its UNDERWEIGHT. In the same way, a target price assigned to a stock can also reveal much about its potential. With SANA analysts setting a high price target of $18.00 and a low target of $7.00, the average target price over the next 12 months is $12.75. Based on these targets, SANA could surge 188.92% to reach the target high and rise by 12.36% to reach the target low. Reaching the average price target will result in a growth of 104.65% from current levels.

It is also common to use earnings estimates to evaluate a firms growth potential and to determine trading strategy. SANA will report FY 2022 earnings on 03/22/2023. Analysts have provided yearly estimates in a range of -$1.64 being high and -$2.30 being low. For SANA, this leads to a yearly average estimate of -$1.94. The earnings surprise of a firm occurs when the actual results change from the consensus earnings estimate. Sana Biotechnology Inc. surprised analysts by $0.04 when it reported -$0.47 EPS against a consensus estimate of -$0.51. The surprise factor in the prior quarter was $0.30. Based on analyst estimates, the high estimate for the next quarter is -$0.39 and the low estimate is -$0.53. The average estimate for the next quarter is thus -$0.48.

Insiders traded SANA stock several times over the past three months with 3 Buys and 0 Sells. In these transactions, 70,390 shares were bought while 0 shares were sold. The number of buy transactions has increased to 9 while that of sell transactions has risen to 6 over the past year. The total number of shares bought during that period was 142,888 while 126,481 shares were sold.

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Stocks of Sana Biotechnology Inc. (SANA) are poised to climb above their peers - SETE News

PARIS & CAMBRIDGE, Mass. & SHANGHAI, China & PRINCETON, N.J.--(BUSINESS WIRE)-- Regulatory News:

NANOBIOTIX (Euronext: NANO Nasdaq: NBTX), a late-stage clinical biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, and LianBio (Nasdaq: LIAN), a biotechnology company dedicated to bringing paradigm-shifting medicines to patients in China and major Asian markets today announced randomization of the first patient in Asia in NANORAY-312, a global Phase 3 registrational trial evaluating NBTXR3 for the treatment of elderly patients with locally advanced head and neck squamous cell carcinoma (LA-HNSCC) who are ineligible for platinum-based chemotherapy.

We believe NBTXR3 has demonstrated the potential to improve treatment outcomes in multiple solid tumor indications, including in Study 102, the Nanobiotix Phase 1 trial evaluating the product candidate for the treatment of elderly patients with locally advanced head and neck squamous cell carcinoma, said Yizhe Wang, Ph.D., Chief Executive Officer, LianBio. We look forward to working with our clinical partners at sites across Greater China and South Korea to evaluate NBTXR3 in this difficult-to-treat patient population. With radiotherapy usage on the rise in Asia, we believe NBTXR3 may become an important part of the treatment landscape for patients with cancer in the region.

NANORAY-312 is a global, two-arm, randomized, Investigators Choice Phase 3 registrational study that is designed to investigate the efficacy and safety of radiotherapy-activated NBTXR3 with or without cetuximab versus radiotherapy with or without cetuximab in high-risk, chemotherapy-ineligible elderly patients with LA-HNSCC. Eligible participants for NANORAY-312 will be treated with NBTXR3 at a 1:1 ratio after an Investigators Choice of radiotherapy alone or radiotherapy in combination with cetuximab. This pivotal trial is expected to enroll 500 patients globally, with approximately 100 patients expected to be enrolled in LianBios licensed territories participating in the study.

NANORAY-312 builds on Nanobiotix Study 102, a Phase 1 trial evaluating safety and early signs of efficacy for radiotherapy-activated NBTXR3 in high-risk elderly LA-HNSCC patients who are chemotherapy-ineligible and intolerant to cetuximab. To date, Study 102 has demonstrated median overall survival of 17.9 months in the all-treated population (n=56) and 23.0 months in the evaluable patients (n=44).

LianBio holds exclusive rights to develop and commercialize NBTXR3 in Greater China, South Korea, Singapore and Thailand.

***

About NBTXR3

NBTXR3 is a novel, potentially first-in-class oncology product composed of functionalized hafnium oxide nanoparticles administered via one-time intratumoral injection and activated by radiotherapy. The product candidates physical mechanism of action (MoA) is designed to induce significant tumor cell death in the injected tumor when activated by radiotherapy, subsequently triggering adaptive immune response and long-term anti-cancer memory. Given the physical MoA, Nanobiotix believes that NBTXR3 could be scalable across solid tumors that can be treated with radiotherapy and across different therapeutic combinations. The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the investigation of radiotherapy-activated NBTXR3 in the NANORAY-312 population.

About NANOBIOTIX

Nanobiotix is a late-stage clinical biotechnology company pioneering disruptive, physics-based therapeutic approaches to revolutionize treatment outcomes for millions of patients; supported by people committed to making a difference for humanity. Nanobiotix is leveraging its proprietary nanoparticle platform, including its lead product candidate, radiotherapy activated NBTXR3, to develop a pipeline of therapeutic options designed to enhance local and systemic control of solid tumors with an initial focus on the treatment of head and neck cancers.

For more information about Nanobiotix, visit us at http://www.nanobiotix.com or follow us on LinkedIn and Twitter

About LianBio

LianBio is a cross-border biotechnology company on a mission to bring transformative medicines to patients in China and other Asian markets. Through partnerships with highly innovative biopharmaceutical companies around the world, LianBio is advancing a diversified portfolio of clinically validated product candidates with the potential to drive new standards of care across cardiovascular, oncology, ophthalmology, inflammatory disease and respiratory indications. LianBio is establishing an international infrastructure to position itself as a partner of choice with a platform to provide access to China and other Asian markets. For more information, please visit http://www.lianbio.com.

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This press release contains certain forward-looking statements within the meaning of applicable securities laws, including the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by words such as at this time, anticipate, believe, expect, intend, on track, plan, scheduled, and will, or the negative of these and similar expressions. These forward-looking statements, which are based on Nanobiotix and LianBios current expectations and assumptions and on information currently available to management, include statements about NBTXR3s potential as a clinical candidate, including: (i) its potential role as part of the treatment landscape for cancer patients; (ii) the timing and progress of clinical trials; (iii) the expected timing of Nanobiotix or LianBios presentation of data; (iv) the results of Nanobiotixs preclinical or clinical studies and their potential implications; (v) the potential for results from NANORAY-312 to support regulatory approval in LianBios licensed territories in Asia; and (vi) the development of NBTXR3 in Asian markets under Nanbiotixs license agreement with LianBio. Such forward-looking statements are made in light of information currently available to Nanobiotix and LianBio and are based on assumptions that Nanobiotix and LianBio consider to be reasonable. However, these forward-looking statements are subject to numerous risks and uncertainties, including: (i) with respect to the risk that subsequent studies and clinical trials may not generate favorable data notwithstanding positive preclinical results; and (ii) the risks associated with the evolving nature, duration, and severity of the COVID-19 pandemic along with governmental and regulatory measures implemented in response. Furthermore, many other important factors, including: (i) those described in Nanobiotixs Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission (the SEC) on April 8, 2022 under Item 3.D. Risk Factors; (ii) those set forth in the universal registration document of Nanobiotix filed with the French Financial Markets Authority (Autorit des marchs financiers) under number D.21-0272 on April 8, 2022 (a copy of which is available on http://www.nanobiotix.com); and (iii) in LianBios Annual Report on Form 10-K for the year ended December 31, 2021 and subsequent filings with the SEC, as well as other known and unknown risks and uncertainties, may adversely affect such forward-looking statements and cause actual results, performance, or achievements to be materially different from those expressed or implied by the forward-looking statements. Except as required by law, neither Nanobiotix nor LianBio assume any obligation to update these forward-looking statements publicly, or to update the reasons why actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future.

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NANOBIOTIX and LianBio Announce First Patient Enrolled in Asia in Phase 3 NANORAY-312 Trial Evaluating NBTXR3 for the Treatment of Head and Neck...

Marketreports.info has released a report titled Global Separation Systems For Commercial Biotechnology Market that includes industry growth factors for the projected period of 2022-2030. The information looks at a significant global Separation Systems For Commercial Biotechnology market, the dynamics driving it, the factors restraining it, and the opportunities for growing demand.

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The regions and countries are discussed in the global Separation Systems For Commercial Biotechnology market report:

North America (United States, Canada and Mexico)

Europe (Germany, France, United Kingdom, Russia, Italy, and Rest of Europe)

Asia-Pacific (China, Japan, Korea, India, Southeast Asia, and Australia)

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Segments covered in this report are:

By TypeType Type Type Type Type By ApplicationApplication Application Application Application Application

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SAN FRANCISCO BAY AREA, Calif., Sept. 7, 2022 /PRNewswire/ -- Rondo Therapeutics, a privately-held biotechnology company advancing next-generation immuno-oncology platforms, announces the addition of Carolyn Bertozzi, Ph.D., to its Scientific Advisory Board. Dr. Bertozzi is a Professor of Chemistry and Director of the Sarafan ChEM-H institute at Stanford Universityand is a world leader in the field of glycobiology, generating new insights regarding disease-associated changes in cell surface glycosylation patterns. Jessica Stark, Ph.D., an American Cancer Society postdoctoral fellow in the Bertozzi Research Group, is also joining Rondo as a scientific consultant. Dr. Stark has pioneered new approaches in understanding the role of glycobiology in the functioning of the innate immune system.

Dr. Bertozzi has been recognized with many honors and awards for both her research and teaching accomplishments. She is an elected member of the National Academy of Sciences, the American Academy of Arts and Sciences, and the German Academy of Sciences Leopoldina. Recent awards of note include the Welch Award in Chemistry (2022); The Dickson Prize in Medicine, University of Pittsburgh (2022); Dr H.P. Heineken Prize for Biochemistry and Biophysics (2022); Wolf Prize (2022); AAAS Lifetime Mentor Award (2022). Dr. Bertozzi is also an accomplished entrepreneur, having founded several biotech companies including Palleon Pharma and Lycia Therapeutics.

"We are excited and privileged to be working with both Carolyn and Jessica in an exciting new area of biology," said Nathan Trinklein, Ph.D., co-founder and President of Rondo Therapeutics. "By combining their deep biological knowledge with Rondo's unique ability to rapidly develop bispecific antibodies, we are aiming to create a new class of biologics with a unique mechanism of action."

"We are thrilled to be working with the Rondo team to take on glycobiology as an emerging frontier for immunotherapy," said Jessica Stark, Ph.D., American Cancer Society postdoctoral fellow at Stanford University. "Through development of a novel class of bispecifics, we hope to make a difference for patients in multiple solid tumor indications."

Dr. Bertozzi is joining a group of highly distinguished scientists and clinicians on Rondo's Scientific Advisory Board: James Ford, M.D., Professor of Medicine, Stanford University; Alessandra Cesano, CMO, ESSA Pharmaceuticals; and Leonard Presta, Ph.D., renowned Protein Engineer.

About Rondo Therapeutics

Rondo Therapeutics is a biopharmaceutical company exploring new frontiers in cancer therapy. Rondo is committed to advancing the field of immuno-oncology, with a focus on treating solid tumors that fail to respond to current therapies. Our solution is to create a new class of bispecific antibodies that safely engage the immune system to initiate and sustain a robust anti-tumor response and overcome the suppressive tumor microenvironment.

Learn more at: http://www.rondotx.com.

SOURCE Rondo Therapeutics

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Carolyn Bertozzi, Professor and Director of the Sarafan ChEM-H institute at Stanford University, Joins the Rondo Therapeutics Scientific Advisory...

Nearly half (44%) of top 50 biopharma companies are now involved in RNA work sparking new demand for tools purpose built for the full spectrum of RNA R&D

SAN FRANCISCO, Sept. 7, 2022 /PRNewswire/ -- Benchling, the R&D Cloud powering the biotechnology industry, today launched the industry's first full set of capabilities for designing, modeling, and studying both natural and chemically modified RNA in a single solution. As the biopharmaceutical industry increases its focus on developing RNA therapeutics, Benchling's new RNA solution is the first purpose-built offering on the market to help R&D organizations accelerate the delivery of drug candidates. Featuring an RNA-aware registry with visualization tools for oligo and mRNA design and the only tool with support for chemical modification of mRNA sequences, RNA biologists and chemists can now collaborate more efficiently, standardize their work across teams, and develop drug candidates faster.

Following the successful deployment of RNA technology in the Pfizer-BioNTech and Moderna Covid-19 vaccines, biopharma companies have quickly shifted their pipelines to uncover therapeutic opportunities with RNA and mRNA. RNA therapeutics include a diverse group of therapeutic molecules that range from mRNA vaccines to antisense oligos, RNA-based gene therapy, and guide RNA-based CRISPR complexes. The unique function of these molecules, combined with the ability to adjust key properties through chemical modification or conjugation, has opened up novel ways of treating and preventing diseases. Nearly half (44%) of top 50 global biopharma companies are involved in RNA work through their own pipelines, M&A, or strategic alliances, based on GlobalData research1. Venture capital has also invested $3 billion into RNA-based therapies in 2020 alone, according to Nature.

While RNA therapeutics hold tremendous potential to impact human health, the R&D tools to create, test, and develop these molecules have been severely limited. Traditional chemistry tools cannot model the intricacies of RNA biology, while biology tools ignore the chemistry involved with RNA modifications altogether. As a result, there has not been a single software solution to date that addresses the combined biological and chemical nature of RNA therapeutics. Scientists have had to contend with manual, low-throughput, and disconnected software to manage their R&D work. Meanwhile, 82% of the pipeline of disclosed RNA and nucleotide therapeutics is in the research or preclinical stage of development2.

"We're at a tipping point for RNA therapeutics, having figured out tough challenges like durability and stability, the industry is now looking for the right tools to accelerate RNA R&D," said Ashu Singhal, co-founder and president of Benchling. "Covid vaccines were really just the beginning - as we put more tools in the hands of scientists to help support their RNA therapeutics R&D, this field will really take off. With Benchling's new RNA capabilities, scientists can now design, develop, and test a new mRNA vaccine or RNA cancer treatment from start to finish on a single platform."

"RNA has nearly unlimited potential to cure a wide range of diseases. Benchling's full set of purpose-built tools for RNA therapy development is going to enable us to realize this potential at an even greater pace than before," said Francois Vigneault, co-founder and CEO of Shape Therapeutics, an RNA technology company advancing programmable medicine and a longtime Benchling customer. "We are excited to see Benchling's continued investment in RNA innovation, and appreciate their commitment to helping companies like ShapeTX accelerate next-generation biopharma solutions."

Benchling's complete RNA solution is available today, and scientists working in RNA and mRNA therapeutics, RNA-based gene therapy, and gene editing will benefit from:

Along with the general availability launch of the RNA full solution, Benchling is making additional new product features generally available, including:

Benchling's mission is to unlock the power of biotechnology by creating modern software for modern science that empowers R&D teams to focus more time on science (not their software)! To learn more about Benchling and these new capabilities, please visit the company's What's New page.

About BenchlingBenchling is the pioneer of the R&D Cloud, software that unlocks the power of biotechnology. More than 200,000 scientists at over 1,000 companies and 7,500 academic and research institutions globally have adopted the Benchling R&D Cloud to make breakthrough discoveries and bring the next generation of medicines, food, and materials to market faster. The Benchling R&D Cloud helps these organizations modernize their scientific processes and accelerate collaboration so they can convert the complexity of biology into world-changing results. For more, please visit Benchling.comor follow us on Twitter at @Benchling.

1GlobalData by Benchling, August 20222GlobalData by Benchling, August 2022

Contact: [emailprotected]

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Benchling Launches the First Complete Solution for RNA R&D to Accelerate mRNA and RNA Therapeutics Development - PR Newswire