Orgenesis

Orgenesis, Inc. is a biotechnology company, which engages in the development, manufacturing and provision of technologies and services in the cell and gene therapy industry. It operates through the Contract Development and Manufacturing Organization (CDMO) and Point-Of-Care Cell Therapy (POC) segments. The CDMO segment, through MaSTherCell, consists of services from cell therapy development through cell therapy manufacturing and companies that provide an end-to-end solution. The POC segment provides a multitude of cell therapies including, but not limited to, cell-based immunotherapies, therapeutics for metabolic diseases, neurodegenerative diseases and tissue regeneration. The company was founded by Sarah Ferber on June 5, 2008 and is headquartered in Germantown, MD.

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Orgenesis, Inc. is a biotechnology company, which engages in the development, manufacturing, and provision of technologies, and services in the cell and gene therapy industry. It operates through the Morgenesis and Therapies segments. The Morgenesis segment refers to the POCare services. The Therapies segment is involved in therapeutic development operations. The company was founded by Sarah Ferber on June 5, 2008 and is headquartered in Germantown, MD.

The stock price of Orgenesis Inc (NASDAQ: ORGS) increased 14.06% pre-market (from $4.48 to $5.11). This is why it happened.

ORGS Stock: 14.06% Increase Pre-Market (From $4.48 To $5.11) Explanation

Orgenesis Inc (NASDAQ:ORGS) (FRA:45O) is poised to carry out the first-in-human trial of its Tissue Genesis Icellator2 to treat Acute Respiratory Distress Syndrome (ARDS) caused by the coronavirus (COVID-19) after receiving the go-ahead from the US Food and Drug Administration (FDA).  The cell and gene therapies (CGTs) focused biotech described being granted the Investigational Device Exemption (IDE) approval for the pilot trial as a 'significant milestone' for the company.

Orgenesis reaches milestone with US FDA approval of Tissue Genesis Icellator2 pilot trial

GERMANTOWN, Md., May 05, 2021 (GLOBE NEWSWIRE) -- Orgenesis Inc . (NASDAQ: ORGS) (“Orgenesis” or the “Company”), a global biotech company working to unlock the full potential of cell and gene therapies, today announced that it plans to host a conference call at 8:30 AM Eastern Time on Friday, May 7, 2021 to discuss the Company's corporate progress and other developments.

Orgenesis Schedules First Quarter 2021 Business Update Conference Call

Orgenesis Inc (NASDAQ:ORGS) (FRA:45O) has announced a tie-up with Rome's Bambino Gesù children's hospital - the first such hospital in Italy - to establish a point-of-care cell therapy centre there.  Work will focus on supporting clinical trials related to therapies developed by both the hospital and Orgenesis, joint research, development of new approaches in advanced cell and gene therapies, the biotech said.

Orgenesis to collaboration with Bambino Gesù Children's Hospital in Rome on new therapy centre

GERMANTOWN, Md., March 29, 2021 (GLOBE NEWSWIRE) -- Orgenesis Inc . (NASDAQ: ORGS) (“Orgenesis” or the “Company”), a global biotech company working to unlock the full potential of cell and gene therapies, announces that it has entered a collaboration with the Bambino Gesù Children's Hospital in Rome to establish a Point of Care Cell Therapy center at the Hospital. Process work will be focused on supporting clinical trials related to therapies developed by both the Hospital and Orgenesis, joint research, development of new approaches, and validation activities for advanced cell and gene therapies.

Orgenesis Enters into Collaboration Agreement with the Bambino Gesù Children's Hospital in Rome to Establish Point of Care Cell and Gene Therapy Center

Orgenesis Inc (NASDAQ:ORGS) announced Thursday that it is collaborating with MIDA Biotech BV to establish point-of-care centers at hospitals and other medical institutions across western Europe. Orgenesis said it and MIDA plan to deploy Orgenesis Mobile Processing Units and Labs (OMPULs) at leading hospitals for the onsite development of promising cell and gene therapies and immunotherapies from MIDA.

Orgenesis collaborates with MIDA Biotech to establish point-of-care centers at hospitals and other medical institutions across western Europe

Orgenesis Inc (NASDAQ:ORGS) (FRA:45O) announced Thursday that it has entered the second phase of its collaboration with Hospital Infantil Universitario Niño Jesús in Madrid, Spain, focused on the hospital's proprietary solid tumor treatment, Celyvir.  The collaboration is focused on an exclusive license agreement to further develop and commercialize Celyvir.

Orgenesis collaboration with Madrid hospital to develop solid tumor treatment Celyvir enters second phase

Orgenesis. (ORGS) CEO Vered Caplan on Q4 2020 Results - Earnings Call Transcript

Global biotech unlocking the potential of personalized therapies and closed processing systems helpful in manufacturing Maryland-based firm has a Cell and Gene Therapy (CGT) Biotech platform The platform consists of three core elements: POCare Therapeutics, POCare Technologies, and POCare Network What Orgenesis does: Orgenesis Inc (NASDAQ:ORGS) is focused on unlocking the potential of personalized therapies and closed processing systems through its cell and gene therapy platform. Cell and gene therapies (CGTs) use modified cells or cellular matter to treat, prevent or cure serious health issues.

Orgenesis leads the charge at an exciting time for cell and gene therapy

Orgenesis Inc (NASDAQ:ORGS) (FRA:45O), the cell and gene therapies (CGTs) focused biotech, told investors it expects revenue to more than double in 2021, based on its existing contracts alone.  In a statement reporting its 2020 full year results, the company said it was seeing traction and growth across its therapeutic pipeline, technology and network activity.

Orgenesis expecting revenue to more than double in 2021 as it updates on growth strategy

Revenue increases 96% to $7.7 million for 2020

Orgenesis Provides Fiscal 2020 Year-End Results and Corporate Update; Expands POCare Therapeutic Pipeline, POCare Technologies, and POCare Network

Orgenesis Inc (NASDAQ:ORGS) (FRA:45O) announced Monday it has signed a collaboration agreement with Dong-a University Hospital in South Korea and Cure Therapeutics Inc to utilize Orgenesis Mobile Processing Units and Labs (OMPULs).  The company said the teams will align to use the OMPULs for point-of-care development of cell and gene therapies and immunotherapies that meet regulatory and governmental approval standards to scale through to commercialization.

Orgenesis teams with Dong-a University Hospital in South Korea and Cure Therapeutics to utilize its Mobile Processing Units and Labs, or OMPULs

GERMANTOWN, Md., March 08, 2021 (GLOBE NEWSWIRE) -- Orgenesis Inc . (NASDAQ: ORGS) (“Orgenesis” or the “Company”), a global biotech company working to unlock the full potential of cell and gene therapies (CGTs), Dong-a University Hospital in South Korea, and Cure Therapeutics, Inc. (“Cure Therapeutics”), a developer of immuno-oncology and cell and gene therapies to target cancer and infectious diseases, today announced the signing of a collaboration agreement. The teams will align to utilize Orgenesis Mobile Processing Units and Labs (“OMPULs”) for point-of-care development of cell and gene therapies and immunotherapies that meet regulatory and governmental approval standards to scale through to commercialization.

Orgenesis Mobile Processing Units and Labs (OMPULs) to be Used for Point-of-Care Production and Commercialization of Cell and Gene Therapies in Collaboration with Dong-a University Hospital and Cure Therapeutics in South Korea

GERMANTOWN, Md., March 04, 2021 (GLOBE NEWSWIRE) -- Orgenesis Inc . (NASDAQ: ORGS) (“Orgenesis” or the “Company”), a global biotech company working to unlock the full potential of cell and gene therapies, today announced that it plans to host a conference call at 8:30 AM Eastern Time on Tuesday, March 9, 2021 to discuss the Company's financial results for the 2020 fiscal year ended December 31, 2020, as well as the Company's corporate progress and other developments.

Orgenesis Schedules Fiscal 2020 Year-End Business Update Conference Call

Orgenesis is a $151m market cap biotech focused on cell and gene therapy technologies. It has a technology, therapeutics, and point of care platform that enables its CGT partners to develop products in a safe and sterile environment near to health / research centres.

Orgenesis: A Cell And Gene Therapy Disruptor With A Nice Risk Reward Profile

Reports rapid advancement of therapeutic pipeline

Orgenesis Third Quarter 2020 Revenue Increases 40% Reflecting Continued Progress of POCare Platform

GERMANTOWN, Md., Nov. 03, 2020 (GLOBE NEWSWIRE) -- Orgenesis Inc. (NASDAQ: ORGS) (“Orgenesis” or the “Company”), a global biotech company working to unlock the full potential of cell and gene therapies, announced today that due to the public health impact of the COVID-19 pandemic and to support the health and well-being of its stockholders, the 2020 Annual Meeting, scheduled for November 18, 2020 at 10:00 am Eastern Time, will be held in a virtual format only. An in-person meeting will not be held this year.

Orgenesis Announces Virtual 2020 Annual Meeting of Stockholders

Icellator® commercially available for lipotransfer in first two countries with more approvals expected Icellator® commercially available for lipotransfer in first two countries with more approvals expected

Orgenesis Completes Acquisition of Koligo Therapeutics and Announces Additional Acquisition of Icellator® Technology from Tissue Genesis in Related Transaction

Acquisition  to support accelerated commercialization of Koligo’s KYSLECEL®,  a personalized islet cell therapy available in the U.S.  for chronic and recurrent acute pancreatitis

Orgenesis Announces Agreement to Acquire Koligo Therapeutics, a Leader in Personalized Cell Therapies

GERMANTOWN, Md., Sept.  09, 2020  (GLOBE NEWSWIRE) --  Orgenesis Inc  . (NASDAQ: ORGS) (“Orgenesis” or the “Company”), a global biotech company working to unlock the full potential of cell and gene therapies (CGTs), today announced that CEO, Vered Caplan, will participate on a virtual panel, entitled, “New Approaches to COVID-19: Hidden Breakthroughs,” being held on Thursday, September 10, 2020 at 1:00 p.m. ET.  The event brings together executives from leading biopharmaceutical companies to discuss how their companies are helping address the COVID-19 pandemic.

Orgenesis CEO to Participate in Webinar Panel on “New Approaches to COVID-19” on Thursday, September 10th

GERMANTOWN, Md., Aug.  20, 2020  (GLOBE NEWSWIRE) --   Orgenesis Inc . (NASDAQ: ORGS) (“Orgenesis” or the “Company”), a global biotech company working to unlock the full potential of cell and gene therapies (CGTs), has entered into a Services Agreement with Therapeutics, Inc., a premier U.S. Clinical Research Organization (CRO) dedicated to dermatology product development. Under the agreement, the parties will collaborate for the development of Orgenesis’ Ranpirnase topical drug formulation for the treatment of external genital warts (EGW) caused by human papilloma virus (HPV) in advance of an investigational new drug (IND) submission. Once those studies are underway, the teams will investigate enhanced intracellular targeting of Ranpirnase using Orgenesis’ Bioxomes™ technology.

Orgenesis Selects Therapeutics, Inc. as CRO to Support Development and Planned Phase 2 Clinical Study of Ranpirnase for the Treatment of External Genital Warts

Provides update on COVID-19 therapeutic programs

Orgenesis Second Quarter 2020 Revenue Increases 55% Reflecting Progress of POCare Platform

GERMANTOWN, Md., July  14, 2020  (GLOBE NEWSWIRE) --   Orgenesis Inc . (NASDAQ: ORGS) (“Orgenesis” or the “Company”), a pioneering global biotech company committed to accelerating commercialization and transforming the delivery of cell and gene therapies (CGTs), today announces that it has entered into a Collaboration Agreement with Educell Ltd., a premier European cell therapy company. Under the agreement, the parties plan to conduct one or more collaborative cell-based research projects aligned with local medical centers.

Orgenesis to Collaborate with Educell to Conduct Clinical Validation of Cell Therapies Using Orgenesis’ Proprietary POCare Technologies for the Generation and Expansion of T-Cells

GERMANTOWN, Md., June  29, 2020  (GLOBE NEWSWIRE) --   Orgenesis Inc . (NASDAQ: ORGS) (“Orgenesis” or the “Company”), a pioneering, global biotech company committed to accelerating commercialization and transforming the delivery of cell and gene therapies (CGTs), today announced that it has been added to the Russell 3000® Index, following the annual Russell indexes reconstitution, effective after the market open on June 29, according to a final list of additions posted on June 26.

Orgenesis Added to Russell 3000® Index

GERMANTOWN, Md., June  22, 2020  (GLOBE NEWSWIRE) --   Orgenesis Inc . (NASDAQ: ORGS) (“Orgenesis” or the “Company”), a pioneering, global biotech company committed to accelerating commercialization and transforming the delivery of cell and gene therapies (CGTs), today announces it has entered into a preliminary, non-binding term sheet with  Leidos  (“Leidos”) (NYSE: LDOS), a FORTUNE® 500 science and technology leader, to develop, and potentially obtain FDA marketing approval of Orgenesis’ Ranpirnase for the systemic treatment of patients suffering with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes COVID-19.

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