(RTTNews) – Today’s Daily Dose brings you news on Abeaona’s leadership and board transitions, GENFIT’s agreement with LabCorp. , FDA postpones testing of planned Covid-19 Phase 2/3 vaccine through from Inovio, the new CEO of Merck KGaA and the expansion of Pfizer is a successful brand of Xeljanz drugs.
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1. Abeona dives in as CEO, resigns
Abeona Therapeutics Inc. (ABEO) announced that João Siffert stepped down as CEO, Research and Development Director and Medical Director, as a member of the Board of Directors on September 23, 2020.
Abeona reviews and explores all the strategic and choice characteristics to maximize for stakeholders, adding your sale.
ABEO touched a fresh 52-week low of $ 1. 07 intraday on Monday, before the end at $ 1. 09, down 41. 40%.
2. GENFIT with LabCorp for NASH Diagnostic Test
GENFIT (GNFT) shares rose more than 30% on Monday when the company announced that the company had entered into a five-year exclusive license agreement with LabCorp (LH).
NASH remains a highly underdiagnosed disease due to its asymptomatic nature and the limitations of existing diagnostic approaches. The liver biopsy, a highly invasive procedure, is the existing clinic to officially diagnose NASH and determine the level of fibrosis, the company noted.
Diagnostic verification is expected to be obtained from LabCorp in early 2021.
The lead candidate for GENFIT is Elafibranor, recently in a pivotal Phase III global screening in biliary cholangitis number one, a severe cholestatic liver disease that affects and destroys the bile ducts, causing inflammation and scarring in the liver.
GNFT closed Monday at $ 5. 50, up 31. 26%.
Shares of Inovio Pharmaceuticals, Inc. (INO) fell more than 28% on Monday, following the FDA’s resolution to suspend the company’s phase II / III trial of the COVID vaccine candidate. 19 INO-4800.
INO-4800 is a nucleic acid vaccine that remains solid at room temperature for over a year and does not want to be frozen in shipment or storage. In the clinical trial, INO-4800 is injected directly into the participant’s skin through the CELLECTRA 2000 device, where the vaccine activates the body’s immune formula to carry out a physically powerful immune response.
The FDA requested further questions about the phase II/III trial planned by the INO-4800 company, its CELLECTRA 2000 management device for use in the trial. Inovio plans to answer questions posed through the FDA in October, after which the regulatory firm has up to 30 days to notify the corporation of its resolve to continue the trial.
The INO-4800 is the subject of an expanded Phase I exam in the United States, and partial suspension will not be the ongoing Phase I trial. The company noted that partial clinical suspension is not due to adverse situations related to the ongoing Phase I Extended Examination of INO-4800.
The INO closed Monday’s consultation at $12. 14, down 28. 34%. Out of hours, inventory fell 3. 62% to $11. 70.
4. Merck KGaA appoints new CEO
Merck KGaA (MKGAY. PK) appointed Belén Garijo as the new president and CEO of the company, on May 1, 2021, replacing Stefan Oschmann.
Garijo is recently vice president and deputy CEO of Merck and CEO of the company’s health unit. Oschmann, who worked at the company for ten years on the executive board, adding five as chairman and CEO, retires “to pursue other tasks. “
5. La FDA expands Pfizer Xeljanz’s flagship drug label
Pfizer Inc. ‘s rheumatoid arthritis (PFE) drug, Xeljanz, has been approved through the FDA for some other indication, i. e. for the remedy of young people and adolescents 2 years of age or older with juvenile polyartic active idiopathic arthritis.
Xeljanz is the first and only Janus kinase inhibitor (JAK) approved in the United States for juvenile polyartic juvenile idiopathic arthritis remedy.
Juvenile idiopathic arthritis, or AJI, explained as arthritis that begins before age 16 and persists for at least six weeks and is of unknown cause, affects approximately 300,000 young people in Etts-Unis. There are 6 categories of JIAs: systemic, oligoric, polyarticular, enthesitis, psoriatic and undifferentiated. Polyarticular AJI is characterized by arthritis in five or more joints and affects small joints of giant hands and feet and joints such as knees, hips and ankles.
The drug generated annual sales of $2. 24 billion in 2019, up 29% from 2018.
PFE closed Monday at $36. 39, up 0. 94%.
6. Actions that have had something new
Galectin Therapeutics Inc. (GALT) closed Monday at $ 3. 64, up 32. 36%.
Anavex Life Sciences Corp. (AVXL) closed Monday at $4. 66, an increase of 20. 41%.
COMPASS Pathways plc (CMPS) closed on Monday at $37. 00, down 14. 29%.
PolyPid Ltd. (PYPD) closed monday at $11. 00, down 13. 45%.