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GNFT Soars On LabCorp Deal, INO's COVID-19 Vaccine Trial On Partial Hold, FDA Expands Xeljanz Label

biotech sept29 lt

Today's Daily Dose brings you news about Abeaona's leadership and Board transitions, GENFIT's deal with LabCorp., FDA hold on Inovio's planned Phase 2/3 Covid-19 vaccine trial, the new CEO of Merck KGaA, and label expansion of Pfizer's blockbuster drug Xeljanz.

Read on…

1. Abeona Plunges as CEO, Directors Resign

Abeona Therapeutics Inc. (ABEO) announced that João Siffert resigned from his positions as CEO, Head of Research and Development, and Chief Medical Officer, as well as member of the Board of Directors, on September 23, 2020.

The company added that on September 27, 2020, Brian Pereira, Stefano Buono, Stephen Howell, George Migausky and Shawn Tomasello had all stepped down from the Board, effective immediately.

Abeona is reviewing and exploring all strategic options and alternatives to maximize stakeholder value, including its sale.

ABEO touched a new 52-week low of $1.07 in intraday trading Monday, before closing at $1.09, down 41.40%.

2. GENFIT in Deal with LabCorp for NASH Diagnostic Test

Shares of GENFIT (GNFT) soared over 30% on Monday on news of the company entering into a five-year exclusive licensing agreement with LabCorp (LH).

As part of the agreement, LabCorp will develop and commercialize a blood-based molecular diagnostic test powered by GENFIT's NIS4 technology throughout the U.S. and Canada to help identify patients with at-risk non-alcoholic steatohepatitis (NASH).

NASH remains a highly underdiagnosed disease due to its asymptomatic nature and the limitations of existing diagnostic approaches. Liver biopsy, a highly invasive procedure, is the current clinical standard to formally diagnose NASH and to determine the stage of fibrosis, the company noted.

The diagnostic test is expected to be available from LabCorp by early 2021.

GENFIT's lead candidate is Elafibranor, currently under a global pivotal phase III study in Primary Biliary Cholangitis, a severe cholestatic liver disease that impacts and gradually destroys the bile ducts, leading to inflammation and scarring in the liver.

GNFT closed Monday's trading at $5.50, up 31.26%.

3. Inovio's Planned Phase 2/3 Covid-19 Vaccine Trial Placed On Partial Hold

Shares of Inovio Pharmaceuticals, Inc. (INO) plunged over 28% on Monday, following the FDA's decision to place the company's planned phase II/III trial of COVID-19 vaccine candidate INO-4800 on partial hold.

INO-4800 is a nucleic-acid based vaccine that is stable at room temperature for more than a year and does not require to be frozen in transport or storage. In the clinical trial, INO-4800 is injected directly into the participant's skin via the device CELLECTRA 2000, where the vaccine prompts the body's immune system to drive a robust immune response.

The FDA has asked for additional questions about the company's planned phase II/III trial of INO-4800, including its CELLECTRA 2000 delivery device to be used in the trial. Inovio plans to respond to the questions posed by the FDA in October, after which the regulatory agency has up to 30 days to notify the company of its decision as to whether the trial may proceed.

INO-4800 is under an expanded phase I study in the U.S., and the partial hold will not affect the ongoing phase I trial. The company noted that the partial clinical hold is not due to the occurrence of any adverse events related to the ongoing expanded phase I study of INO-4800.

A phase I/II clinical trial of INO-4800 in South Korea that is being conducted by Inovio and the International Vaccine Institute in partnership with Seoul National University Hospital is also underway.

INO closed Monday's trading at $12.14, down 28.34%. In after-hours, the stock fell another 3.62% to $11.70.

4. Merck KGaA Names New CEO

Merck KGaA (MKGAY.PK) has appointed Belén Garijo as new Chair of the Executive Board and CEO of the company, effective May 1, 2021, replacing Stefan Oschmann.

Garijo is currently Vice-Chair of the Executive Board and Deputy CEO of Merck as well as CEO of the company's healthcare unit. Oschmann who has served the company ten years on the Executive Board, five of them as Chairman and CEO, is stepping down "to turn to other tasks".

Peter Guenter, the CEO of Spain-based pharma company Almirall, has been roped in as a replacement for Garijo in the company's healthcare business sector.

5. FDA expands Label of Pfizer's Blockbuster Drug Xeljanz

Pfizer Inc.'s (PFE) rheumatoid arthritis drug Xeljanz has been approved by the FDA for yet another indication, i.e., for the treatment of children and adolescents 2 years and older with active polyarticular course juvenile idiopathic arthritis.

Xeljanz is the first and only Janus kinase (JAK) inhibitor approved in the U.S. for the treatment of polyarticular course juvenile idiopathic arthritis.

Juvenile idiopathic arthritis, or JIA, defined as arthritis that begins before 16 years of age and persists for at least six weeks and is of unknown cause, affects about 300,000 children in the U.S. There are 6 categories of JIA - systemic, oligoarticular, polyarticular, enthesitis-related, psoriatic, and undifferentiated. Polyarticular JIA is characterized by arthritis in five or more joints and affects both the small joints of the hands and feet, and large joints like the knees, hips, and ankles.

Xeljanz is already approved for three other indications - rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis.

The drug brought in global annual sales of $2.24 billion in 2019, up 29% over 2018.

PFE closed Monday's trading at $36.39, up 0.94%.

6. Stocks That Moved On No News

Galectin Therapeutics Inc. (GALT) closed Monday's trading at $3.64, up 32.36%.

Trxade Group Inc. (MEDS) closed Monday's trading at $5.96, up 22.38%.

Anavex Life Sciences Corp. (AVXL) closed Monday's trading at $4.66, up 20.41%.

COMPASS Pathways plc (CMPS) closed Monday's trading at $37.00, down 14.29%.

PolyPid Ltd. (PYPD) closed Monday's trading at $11.00, down 13.45%.

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