Primary Cells Market Research Report by Origin (Animal Primary Cells and Human Primary Cells), by Cell Type (Dermatocytes, Gastrointestinal Cells, and Heart Cells), by End-user, by Region (Americas, Asia-Pacific, and Europe, Middle East & Africa) - Global Forecast to 2026 - Cumulative Impact of COVID-19

New York, Aug. 03, 2021 (GLOBE NEWSWIRE) -- Reportlinker.com announces the release of the report "Primary Cells Market Research Report by Origin, by Cell Type, by End-user, by Region - Global Forecast to 2026 - Cumulative Impact of COVID-19" - https://www.reportlinker.com/p06087175/?utm_source=GNW

The Global Primary Cells Market size was estimated at USD 1,025.78 Million in 2020 and expected to reach USD 1,144.46 Million in 2021, at a Compound Annual Growth Rate (CAGR) 11.90% from 2020 to 2026 to reach USD 2,014.78 Million by 2026.

Market Statistics:The report provides market sizing and forecast across five major currencies - USD, EUR GBP, JPY, and AUD. It helps organization leaders make better decisions when currency exchange data is readily available. In this report, the years 2018 and 2019 are considered historical years, 2020 as the base year, 2021 as the estimated year, and years from 2022 to 2026 are considered the forecast period.

Market Segmentation & Coverage:This research report categorizes the Primary Cells to forecast the revenues and analyze the trends in each of the following sub-markets:

Based on Origin, the Primary Cells Market was studied across Animal Primary Cells and Human Primary Cells.

Based on Cell Type, the Primary Cells Market was studied across Dermatocytes, Gastrointestinal Cells, Heart Cells, Hematopoietic Cells, Hepatocytes, Lung Cells, Musculoskeletal Cells, and Renal Cells. The Hepatocytes is further studied across Cryopreserved Hepatocytes and Fresh Hepatocytes.

Based on End-user, the Primary Cells Market was studied across Life Science Companies and Research Institutes.

Based on Geography, the Primary Cells Market was studied across Americas, Asia-Pacific, and Europe, Middle East & Africa. The Americas is further studied across Argentina, Brazil, Canada, Mexico, and United States. The Asia-Pacific is further studied across China, India, Indonesia, Japan, Malaysia, Philippines, South Korea, and Thailand. The Europe, Middle East & Africa is further studied across France, Germany, Italy, Netherlands, Qatar, Russia, Saudi Arabia, South Africa, Spain, United Arab Emirates, and United Kingdom.

Cumulative Impact of COVID-19:COVID-19 is an incomparable global public health emergency that has affected almost every industry, and the long-term effects are projected to impact the industry growth during the forecast period. Our ongoing research amplifies our research framework to ensure the inclusion of underlying COVID-19 issues and potential paths forward. The report delivers insights on COVID-19 considering the changes in consumer behavior and demand, purchasing patterns, re-routing of the supply chain, dynamics of current market forces, and the significant interventions of governments. The updated study provides insights, analysis, estimations, and forecasts, considering the COVID-19 impact on the market.

Competitive Strategic Window:The Competitive Strategic Window analyses the competitive landscape in terms of markets, applications, and geographies to help the vendor define an alignment or fit between their capabilities and opportunities for future growth prospects. It describes the optimal or favorable fit for the vendors to adopt successive merger and acquisition strategies, geography expansion, research & development, and new product introduction strategies to execute further business expansion and growth during a forecast period.

FPNV Positioning Matrix:The FPNV Positioning Matrix evaluates and categorizes the vendors in the Primary Cells Market based on Business Strategy (Business Growth, Industry Coverage, Financial Viability, and Channel Support) and Product Satisfaction (Value for Money, Ease of Use, Product Features, and Customer Support) that aids businesses in better decision making and understanding the competitive landscape.

Market Share Analysis:The Market Share Analysis offers the analysis of vendors considering their contribution to the overall market. It provides the idea of its revenue generation into the overall market compared to other vendors in the space. It provides insights into how vendors are performing in terms of revenue generation and customer base compared to others. Knowing market share offers an idea of the size and competitiveness of the vendors for the base year. It reveals the market characteristics in terms of accumulation, fragmentation, dominance, and amalgamation traits.

Company Usability Profiles:The report profoundly explores the recent significant developments by the leading vendors and innovation profiles in the Global Primary Cells Market, including AcceGen, Allcells, American Type Culture Collection, Axol Bioscience Ltd., BioIVT, Biopredic International, BPS Bioscience, Inc., Cell Biologics, Inc., Corning Incorporated, Creative Bioarray, Epithelix SRL, Ixcells Biotechnologies, Lonza Group AG, Merck KGaA, Neuromics, Ppa Research Group, Inc., Promocell GmbH, Reachbio LLC, Sciencell Research Laboratories, Inc., Sekisui Xenotech, LLC, Stem Cell Technologies, Inc., StemExpress, LLC, Thermo Fisher Scientific, Inc., and Zenbio, Inc..

The report provides insights on the following pointers:1. Market Penetration: Provides comprehensive information on the market offered by the key players2. Market Development: Provides in-depth information about lucrative emerging markets and analyze penetration across mature segments of the markets3. Market Diversification: Provides detailed information about new product launches, untapped geographies, recent developments, and investments4. Competitive Assessment & Intelligence: Provides an exhaustive assessment of market shares, strategies, products, certification, regulatory approvals, patent landscape, and manufacturing capabilities of the leading players5. Product Development & Innovation: Provides intelligent insights on future technologies, R&D activities, and breakthrough product developments

The report answers questions such as:1. What is the market size and forecast of the Global Primary Cells Market?2. What are the inhibiting factors and impact of COVID-19 shaping the Global Primary Cells Market during the forecast period?3. Which are the products/segments/applications/areas to invest in over the forecast period in the Global Primary Cells Market?4. What is the competitive strategic window for opportunities in the Global Primary Cells Market?5. What are the technology trends and regulatory frameworks in the Global Primary Cells Market?6. What is the market share of the leading vendors in the Global Primary Cells Market?7. What modes and strategic moves are considered suitable for entering the Global Primary Cells Market?Read the full report: https://www.reportlinker.com/p06087175/?utm_source=GNW

About ReportlinkerReportLinker is an award-winning market research solution. Reportlinker finds and organizes the latest industry data so you get all the market research you need - instantly, in one place.

__________________________

Story continues

See more here:
Primary Cells Market Research Report by Origin, by Cell Type, by End-user, by Region - Global Forecast to 2026 - Cumulative Impact of COVID-19 - Yahoo...

DetailsCategory: Small MoleculesPublished on Wednesday, 04 August 2021 13:55Hits: 305

NEW YORK, NY, USA I August 04, 2021 I BeyondSpring (the Company or BeyondSpring) (NASDAQ: BYSI), a global pharmaceutical company focused on the development of cancer therapeutics, announced today the positive topline data of DUBLIN-3 registrational trial in plinabulin in combination with docetaxel to treat 2nd and 3rd line NSCLC (EGFR wild type) compared to docetaxel alone (n=559). Plinabulin is a first-in-class, selective immunomodulating microtubule-binding agent (SIMBA), which is a potent antigen presenting cell (APC) inducer. The data released today showed that compared to docetaxel alone, the combination met the primary endpoint of increasing overall survival (mean OS, p = 0.03; OS log rank, p <0.04) and met key secondary endpoints, including significantly improving ORR, PFS and 24- and 36-month OS rates, and significant reduction in the incidence of Grade 4 neutropenia.

The DUBLIN-3 Phase 3 trial is a randomized, single blind to patients, active controlled, global trial that enrolled 559 patients in 2nd and 3rd line NSCLC, EGFR wild type, with measurable lung lesion. Patients were treated on a 21-day cycle with infusion of docetaxel (75 mg/m2 on day 1) and plinabulin (30 mg/m2 on days 1 and 8) vs. docetaxel alone (75 mg/m2, day 1). The primary endpoint was overall survival. Plinabulin in combination with docetaxel (DP) showed statistically significant improvements compared to docetaxel alone (D) with topline data summarized below for ITT population (DP: n=278; D: n=281).

Trevor M. Feinstein, M.D., of the Piedmont Cancer Institute and a principal investigator for DUBLIN-3 commented, The treatment of 2nd and 3rd line NSCLC, especially with EGFR wild type where tyrosine kinase inhibitors do not work, is an area of severe unmet medical needs. Now that checkpoint inhibitor immunotherapy has moved into first line, there is a vacuum in this indication, where treatment is heavily centered around docetaxel. Currently, docetaxel-based therapies have limited survival benefit and >40% severe neutropenia. In DUBLIN-3, a prolonged survival benefit, characterized by a long-tailed OS curve, was observed with plinabulin that represents an immune associated anti-cancer benefit. The opportunity that plinabulin offers to these patients is not only to live longer, but also with significantly reduced severe neutropenia, which are both meaningful for these very sick patients.

Yan Sun, M.D., co-founder and former Chairman of Chinese Society of Clinical Oncology (CSCO), Chairman of NCCN Guidelines of NSCLC in China, and Director of GCP Center at Cancer Hospital of Chinese Academy of Medical Sciences added, DUBLIN-3 is a pivotal study which succeeded in demonstrating OS benefit for the first agent with a novel mechanism plinabulin since the 2015 nivolumab approval. It was very rewarding to be the global Principal Investigator throughout the 6 years for the DUBLIN-3 trial that serves to address this severe unmet medical need. In the DUBLIN-3 study, it is especially gratifying to see the doubling of 24- and 36-month OS rate with a favorable safety profile in the plinabulin combination arm; this profile not only significantly advances NSCLC patients care, but also signals plinabulins profound immune anti-cancer benefit. The success of the DUBLIN-3 study is the gateway of plinabulin into multiple tumor indications within IO combinations.

Dr. Ramon Mohanlal, CMO and EVP of R&D of BeyondSpring said, The success of the DUBLIN-3 study represents proof-of-concept of plinabulins immune-enhancing mechanism of action that is complimentary to that of checkpoint inhibitors, and which is the rationale for it to be combined as triple IO combinations in multiple tumor indications. These programs are already in Phase 1/2 stage and preliminary positive results were reported at ASCO 2021.

Dr. Lan Huang, BeyondSpring's co-founder, CEO and Chairwoman concluded, A pre-NDA meeting will be scheduled with the FDA in 2021 to agree on the contents for our NDA, to support a NSCLC indication NDA submission in the first half of 2022. This will be the second indication and second NDA for plinabulin. The superior benefit of plinabulin in reducing severe neutropenia of docetaxel in DUBLIN-3 further supports our first NDA submission in CIN prevention, which received FDA priority review with a PDUFA date of November 30, 2021. Importantly, the strong results from DUBLIN-3 further validate our conviction that plinabulin, as an immune anti-cancer agent, has the potential to be a cornerstone therapy for many solid tumors. I'd like to take the time to thank everyone who helped make this 6-year study run smoothly at more than 60 sites across the U.S., China and Australia, including all participating patients and their families, the investigators and clinical staff and the dedicated BeyondSpring team.

Conference Call and Webcast InformationBeyondSprings management will host a conference call and webcast today at 8:30 a.m. Eastern Time. The dial-in numbers for the conference call are 1-877-451-6152 (U.S.) or 1-201-389-0879 (international). Please reference conference ID: 13722298. A live webcast will be available on BeyondSprings website atwww.beyondspringpharma.comunderEvents & Presentationsin the Investors section. An archived replay of the webcast will be available for 30 days.

About PlinabulinPlinabulin, BeyondSprings lead asset, is a selective immunomodulating microtubule-binding agent (SIMBA), which is a potent antigen presenting cell (APC) inducer. It is a novel, intravenous infused, patent-protected, NDA stage asset for CIN prevention and a Phase 3 anti-cancer candidate for non-small cell lung cancer (NSCLC). Plinabulin triggers the release of the immune defense protein, GEF-H1, which leads to two distinct effects: first is a durable anticancer benefit due to the maturation of dendritic cells resulting in the activation of tumor antigen-specific T-cells to target cancer cells, and the second is early-onset of action in CIN prevention after chemotherapy by boosting the number of hematopoietic stem/progenitor cells (HSPCs). Plinabulin received Breakthrough Therapy designation from both U.S. and China FDA for the CIN prevention indication. As a pipeline in a drug, plinabulin is being broadly studied in combination with various immuno-oncology agents that could boost the effects of the PD-1/PD-L1 antibodies and re-sensitize PD-1/PD-L1 antibody-resistant patients.

About BeyondSpringHeadquartered in New York City, BeyondSpring is a global biopharmaceutical company focused on developing innovative cancer therapies to improve clinical outcomes for patients who have high unmet medical needs. BeyondSprings first-in-class lead asset plinabulin, is being developed as a pipeline in a drug. It is filed for approval and has received Priority Review in the U.S. and China for the prevention of chemotherapy-induced neutropenia (CIN) with a PDUFA date of November 30, 2021 in the U.S., and has a fully enrolled pivotal study (DUBLIN-3) to test an anti-cancer benefit with an overall survival primary endpoint in NSCLC. Additionally, it is being broadly studied in combination with various immuno-oncology regimens that could boost the effects of PD-1 / PD-L1 antibodies. In addition to plinabulin, BeyondSprings extensive pipeline includes three pre-clinical immuno-oncology assets and a subsidiary, SEED Therapeutics, which is leveraging a proprietary targeted protein degradation drug discovery platform.

SOURCE: BeyondSpring

See the original post here:
BeyondSpring Announces Positive Topline Results from its DUBLIN-3 Registrational Trial of Plinabulin in Combination with Docetaxel for the Treatment...

Though IPO activity typically slows down in the summer months, this summer has been atypical. The public markets continue to welcome new companies at a breakneck pace, and healthcare is well represented. Of the 20 companies that went public in the last week, 11 of them are doing work in some aspect of the life sciences.

Five of these newly public companies are developing new cancer treatments. Rare disease and heart disease are represented as well. But the biggest biotech IPO belongs to a clinical-stage company that is making progress with vaccine candidates offering the potential to address variants of SARS-CoV-2. According to IPO research firm Renaissance Capital, the 20 IPOs make up the biggest IPO total for a single week since 2000. However, Bill Smith, CEO and co-founder of Renaissance, said this level of activity comes at a price.

Simply put, investors are tired, he wrote in the firms newsletter published on Sunday. Combine that fatigue with increased pricing pressure, and performance starts to suffer. Three companies postponed, citing either volatility or market conditions. Of the IPOs that did get done, nearly half priced below the midpoint, and returns were a mixed bag.

IPO activity might take a break for August. Renaissance notes that new filings have slowed in the runup to these dog days of summer. Heres a recap of the weeks IPO activity from the life sciences side, mixed bag and all.

Icosavax reels in $182M for clinical trials of its VLP vaccines

Vaccine developer Icosavax had the biggest life sciences IPO of the week, raising $182 million. After initially planning to offer 11.5 million shares in the range of $14 to $16 each, the company was able to boost the deals size to 12.1 million shares priced at the midpoint of the targeted price range. Icosavax shares trade on the Nasdaq under the stock symbol ICVX. On the companys first day of trading Thursday, the stock price more than doubled. Shares closed Friday at $34.97, up more than 133% from the IPO price.

Seattle-based Icosavax produces vaccines by engineering proteins into virus-like particles. These particles contain no genetic material but resemble a virus closely enough to elicit an immune response. Lead Icosavax vaccine candidate IVX-121 has reached Phase 1 testing in respiratory syncytial virus (RSV). That vaccine is also part of an experimental bivalent vaccine called IVX-A12, which is comprised of the RSV candidate along with a candidate for human metapneumovirus (hMPV), which is another respiratory virus. Icosavax has also used its VLP platform to develop a SARS-CoV-2 vaccine candidate, IVX-411.

Icosavax plans to spend $120 million to take its bivalent RSV/hMPV vaccine into Phase 2b testing, according to the prospectus. Another $35 million will go toward the development of other vaccines, including advancing the Covid-19 vaccine candidate through Phase 1/2 and Phase 2 testing.

Candel cuts deal size, raises $72M for oncolytic viruses

Candel Therapeutics raised $72 million for its cancer drugs, but it had to shrink the size of the deal to go public. The biotech initially planned to offer more than 6 million shares in the range of $13 to $15 per share. Candel ended up selling 9 million shares for $8 apiece. Those shares trade on the Nasdaq under the stock symbol CADL.

Needham, Massachusetts-based Candel is developing oncolytic viral therapies, engineered viruses that kill cancer cells. It has two technology platforms, one using a genetically modified adenovirus and the other based on herpes simplex virus. The adenovirus platform has produced Candels most advanced therapeutic candidate, CAN-2409, which is currently in Phase 3 testing in newly diagnosed prostate cancer. According to the IPO filing, the company expects to complete enrollment in the third quarter of this year and report final data in 2024. A separate Phase 3 study testing CAN-2409 in newly diagnosed high-grade glioma is expected to start in the first half of next year. The most advanced program from the herpes simplex virus platform, CAN-3110, is in Phase 1 testing in recurrent high-grade glioma. The IPO cash will go toward clinical trials, including the construction of a manufacturing facility to produce its oncolytic viruses for those studies.

Rare disease biotech Rallybio raises $80.6M from IPO

Rallybio, a clinical-stage developer of therapies for rare diseases, raised $80.6 million from its IPO. The New Haven, Connecticut-based company planned to offer 5.75 million shares. The company ended up selling 6.2 million shares for $13 each, the low end of the $13 to $15 price range it had set. Rallybio shares trade on the Nasdaq under the stock symbol RLYB.

The most advanced Rallybio program is RLYB211, a polyclonal antibody in development to prevent fetal and neonatal alloimmune thrombocytopenia (FNAIT). The rare and potentially life-threatening blood disorder develops when platelets of a pregnant woman have a surface protein that the platelets of the fetus see as foreign, sparking antibodies to the protein. The Rallybio lead therapy is in Phase 1/2 testing. According to the prospectus, the company plans to spend $75 million to $83 million to complete the clinical trial. That cash will also support completion of Phase 1 tests of RLYB212, a monoclonal antibody for FNAIT.

IPO brings $166M in new cash for Nuvalents cancer drugs

Nuvalents IPO raised $165.75 million to advance its cancer drugs to clinical trials. The Cambridge, Massachusetts-based biotech planned to offer 8.9 million shares in the range of $16 to $18 each. The company was able to boost the size of the deal to 9.75 million shares priced at the midpoint of the projected price range. Those share trade on the Nasdaq under the stock symbol NUVL.

Nuvalent is developing small molecule kinase inhibitors. While drugs from this class have already been approved to treat cancer, the company said in its IPO filing that it designs its small molecules to overcome drug resistance, adverse events, the ability to penetrate into the brain, and other limitations to currently available kinase inhibitors. The companys two lead programs target cancers driven by genomic alterations in the ROS1 and ALK kinases. According to the IPO filing, between $60 million and $65 million is earmarked for NVL-520, which is being readied for the Phase 1 part of a Phase 1/2 study in ROS1-positive non-small cell lung cancer (NSCLC) and other solid tumors. Another $55 million to $60 million is set aside for NVL-655, which is on track to advance to the Phase 1 portion of a Phase 1/2 study in ALK-positive NSCLC and other advanced cancers.

Omega Therapeutics pulls in $126M for programmable drugs

Omega Therapeutics is developing drugs that act on genes. But rather than turning them on or off, the companys drugs, which it calls epigenomic controllers, are more like a dimmer switch that can dial a genes activity up or down. The companys drugs are comprised of messenger RNA encapsulated in a lipid nanoparticle. The company says its approach has potentially applications in regenerative medicine and immunology but cancer is the first target. Lead program OTX-2002 is being developed to down-regulate c-Myc, a gene frequently dysregulated in cancer.

Cambridge-based Omega priced its offering of 7.4 million shares at $17 each, which was the midpoint of its targeted price range. The company raised $125.8 million to apply to its drug pipeline. According to the IPO filing, the company plans to file the paperwork to begin clinical trials in 2022, evaluating an epigenomic controller as a treatment for liver cancer. Omegas shares trade on the Nasdaq under the stock symbol OMGA.

Tenaya Therapeutics takes in $180M for heart drug R&D

In a crowded field of newly public cancer drug developers, the heart disease focus of Tenaya Therapeutics stands out. But this focus gives it a large addressable market. Heart disease is the leading cause of death worldwide, the company points out in its IPO filing.

San Francisco-based Tenaya aims to treat heart disease with gene therapies, biologics, and small molecules. The companys most advanced gene therapy program, TN-201, is being prepared for clinical testing as a treatment for hypertrophic cardiomyopathy caused by genetic mutations. The gene therapy is designed to deliver a fully functional version of the mutated gene. The pipeline also includes a small molecule, TYA-11631, with potential applications in heart failure and genetic dilated cardiomyopathy.

Tenaya planned to offer 10 million shares in the range of $14 to $16 each. But the preclinical biotech found enough investor interest to boost the offering to 12 million shares priced at the midpoint of the targeted price range, raising $180 million. The biotechs shares trade on the Nasdaq under the stock symbol TNYA. According to Tenayas IPO filing, the company plans to spend $35 million to $40 million on its lead gene therapy and $10 million to $15 million on its lead small molecule, including the planned start of Phase 1/2 testing for both programs.

Immuneerings IPO raises $112M for a better MEK inhibitor

Immuneerings IPO raised $112.5 million to bring its lead cancer drug candidate into clinical testing. That program, IMM-1-104, is type of cancer drug called a MEK inhibitor. Other MEK inhibitors have been approved by the FDA previously, but the biotech says in its prospectus that its drug has features that enable it to avoid drug resistance while improving its tolerability. Immuneering expects to file the investigational new drug application paperwork in the first quarter of 2022, with plans to begin a Phase 1 study in patients with advanced solid tumors characterized by RAS mutations.

Cambridge-based Immuneering offered 7.5 million shares at $15 apiece, which was the midpoint of the projected price range. The company plans to spend between $33 million and $38 million on its lead program; $38 million to $43 million is budgeted for research on its other preclinical programs. The companys shares trade on the Nasdaq under the stock symbol IMRX.

Cancer biotech In8bio prices $40M IPO below targeted price range

IN8bio, a clinical-stage company developing cell therapies for cancer, raised $40 million in its stock market debut. The biotech offered 4 million shares for $8 each, well below the $10 to $12 per share range it had planned. IN8Bio shares trade on the Nasdaq under the stock symbol INAB.

New York-based IN8bio is developing cell therapies from gamma-delta T cells, which are immune cells that have properties of both the innate and adaptive immune systems. The company said in its IPO filing that these cells can differentiate between healthy and diseased tissue and may kill tumors directly, and also recruit and direct immune cells to kill tumors as well. Lead therapeutic candidate INB-200 is in Phase 1 testing in newly diagnosed glioblastoma; INB-100 is in early-stage testing for treating leukemia patients who are undergoing stem cell transplants. The biotech plans to apply the IPO proceeds toward its ongoing clinical research.

RxSights IPO raises $117M for intraocular lens technology

RxSight stands apart from most of this group of newly public life science companies in that it has reached the commercial stage. The RxSight Light Adjustable Lens is an implantable intraocular lens that can be adjusted after surgery. The product is intended to offer better visual outcomes compared to cataract surgeries that replace the lens with one that is not adjustable after the surgery. The FDA approved the RxSight technology in 2017; it also has marketing authorization in Europe and Mexico. The company reported $14.6 million in 2020 sales, a 554% increase over the prior year, according to the prospectus.

Aliso Viejo, California-based RxSight priced its offering of 7.35 million shares at $16 per share, raising $117.6 million. The company plans to spend $40 million to support commercialization of its product and $44 million on product development, research, and clinical development. RxSights shares trade on the Nasdaq under the stock symbol RXST.

MaxCyte rides the cell therapy R&D wave to a $175M IPO

MaxCyte, a company that already trades on the London stock exchange operated AIM, raised $175.5 million in its U.S. stock market debut. The company initially planned to offer more than 12 million shares in the range of $11.50 and $13.50 per share. It was able to boost the deal size, selling 13.5 million shares for $13 apiece, raising $175.5 million. On the Nasdaq, MaxCyte now trades under the stock symbol MXCT.

Gaithersburg, Maryland-based MaxCyte has commercialized a proprietary flow electroporation technology, which is used in the engineering of a wide variety of cells for cell therapies. The companys customers include cell therapy developers, large biopharmaceutical companies, and government and academic institutions. MaxCyte reported $26.1 million in revenue in 2020, a 21% increase over 2019 sales, according to the IPO filing. MaxCyte plans to spend $20 million to $30 million on R&D, including commercialization of its VLX system, which is designed for extremely large volume cell engineering. Another $20 million to $30 million is set aside for manufacturing; and $10 million to $20 million on sales and marketing and business development.

Drug/device company Rani Therapeutics reels in $73M for oral biologics

One of the reasons that biologic drugs come in an injectable and not oral formulations is that these large molecules cant survive the digestive environment. Rani Therapeutics is developing a capsule that carries a biologic payload that withstands stomach acid, then, in the upper half of the small intestine, dissolves and exposes a microneedle that injects the drug into the intestinal wall.

San Jose, California-based Rani plans to develop its RaniPill for oral delivery of biologic drugs that are already approved and have been available for years only in injectable form. Phase 1 tests have been completed. Rani said in its IPO filing that it plans to meet with the FDA in the second half of this year to discuss its drug pipeline. Ranis IPO raised $73 million. The company priced its offering of 6.7 million shares at $11 each, well below the $14 to $16 per share range it projected. Rani shares trade on the Nasdaq under the stock symbol RANI.

Photo by Getty Images

Original post:
5 days, 11 life science IPOs & more than $1.3B in new capital - MedCity News

VioletaStoimenova/Getty

Im severely anemic. Hence, I have approximately the same skin tone as the Vampire Lestat. Its sort of punk rock/goth-y, so it doesnt bother me. But I also get so tiredthat I nap almost every afternoon, and thats decidedlynot punk rock. That fatigue is brutal: Ive cried because I couldnt walk up a mountain Id traipsed up before. Those are traditional signs of iron deficiency anemia. Most people know them. But there are plenty of signs youve probably never heard of.

You probably know anemia comes in several flavors: sickle-cell anemia, which is inherited and has to do with the shape of the red blood cells, for example. But the Mayo Clinic explains that there are more: Thalassemia, another inherited blood disorder, when your red blood cells dontmakeenough hemoglobin; aplastic anemia, when your body simply stops producing new red blood cells; vitamin deficiency anemia, which happens when you dont get enough Vitamin B-12, Vitamin C, and folate; and iron deficiency anemia, which occurs when you simply dont ingest enough iron.

I have iron deficiency anemia.

According to Hematology.org, anemia is the most common blood disorder. One study by the National Health and Nutrition Examination Survey found that 11%, or 3.3 million American women, have iron deficiency anemia. It happens, simply, when your body doesnt have enough red blood cells. Biology 101 flashback: red blood cells, the Mayo Clinic explains, contain hemoglobin. Thats the stuff that makes blood red. Hemoglobin lets blood cells carry oxygen from the lungs to the body, and carbon dioxide from the body back to the lungs.

Your body needs iron to make red blood cells.

Iron deficiency anemia means, simply, that your body doesnt have enough iron to make an adequate number of blood cells. It happens in a lot of pregnant people, and it can also happen from heavy periods.

But iron deficiency anemia often causesheavy periods, too, as Jacques Moritz, MD, director of gynecology at Mount Sinai St. Lukes Roosevelt in New York City told Health.com, They lose too much blood, replace about half of it, and then lose too much again the following month. Its like filling up a car with a small hold in the tank.

It can also happen simply because you dont ingest enough iron.

Ive always gotten heavy periods. And I really, really suck at ingesting iron.

I hate meat. I came into this world hating meat, and Ill eat some of it (bacon, occasionally chicken, steak or pulled pork BBQ), but generally, Im a vegetarian. And I dont eat seafood either (other than oysters). Last week, I ate meat once: I scavenged my kids chicken tenders.

Then I bled half of my iron out again. My periods are bad enough that if I was immediately postpartum, Id send ER docs running, not walking. Think the worst period youve ever had. Multiply it. Think multiple layers of period protection. Think days when I cant leave the house.

Three months ago, because of my Lestat-like complexion and severe fatigue, coupled with dark lines at the tops of my fingernails and cracks at the corners of my mouth (both signs of a vitamin deficiency, usually iron), my primary care doc drew my blood and eyeballed my hemoglobin values. Normal levels for a woman are 12 grams per deciliter, according to Hematology.org. My hemoglobin value was an eight. I wasmissing a third of my red blood cells.

My doctor looked at me and said, Look. I can refer you to a hematologist now. Theyll give you iron infusions. I had severe iron deficiency anemia during my last pregnancy and received iron infusions: twice a week I drove to a clinic where they stuck a needle in my arm and dripped iron into me for three hours while I played on my phone. It didnt bother me much until the next day, when my entire skeleton hurt. Every. Single. Bone. Ached. For like, two days. Then I had a good day. Then I had another freaking infusion.

I did not want infusions.

So I begged for three months.Look, if we cant get them up, Ill take the referral then. Please, please, please.He agreed to give me three months and sent me home with some medical-grade iron pills.

Real talk: I could not have averted this with over-the-counter iron pills. I cant take them. They do things to my digestive system. The kind of things that necessitate lots of prunes and Miralax and Metamucil, and all that still doesnt work.

Some of my problems with iron probably stem from disordered eating left over from anorexia: I generally eat one full meal a day. I dont freak about the calories in it, but I hardly snack; I never liked breakfast; and I dont get hungry for lunch.

My husband knew two more meals a day was probably a losing battle, because I wasnt going to eat a substantial breakfast, and I legitimately forget about lunch (that happens when youdont get hungry). So he concocted a chili recipe involving pureed iron-rich greens, a ton of legumes, and lots of veggies. Basically, its a superfood. And as long as Ilikesomething, Ill eat it every goddamn day, because I dont have to think about it (my ADHD gives me choice paralysis: I cant make a simple decision and freak out. This usually happens at dinnertime). And no, you cant taste the spinach.

So I eat chili. I eata lotof chili. I also eat a lot of chickpea pasta, which contains about half of your daily iron needs.

But clearly this isnt enough to defeat iron-deficiency anemia, so I have to take pills and drink a vitamin supplement called Floradix. It doesnt taste great, and I throw it down like a frat boy.

But when I went in three months later, despite three hellish periods, my iron levels had gone up to a 9.5. So Im only missing a little less than a quarter of my blood cells now.Moral: never underestimate the power of chili.

Ill have to keep this up. If I dont, my levels willdrop again. So hello, life of supplements and chili. Youll be with me forever. But at least I wont sleep for four hours every day, and I look a little less vampire and a little more standard goth.

And at least I really, really like that chili.

The rest is here:
What Its Like To Have Severe Iron Deficiency Anemia - Scary Mommy