GRTX Awaits Pancreatic Cancer Trial Data, GENE Jumps, MNK Gets FDA Panel Backing, TCDA Disappointed

Today’s Daily Dose brings you news about Galera Therapeutics’ upcoming milestone, Genetic Technologies’ progress on its COVID-19 Severity Risk Test, FDA panel backing of Mallinckrodt ‘s Terlipressin, PDS Biotech accelerating its PDS0202 vaccine program for influenza and FDA notifying Tricida of deficiencies in the New Drug Application for Veverimer, among others.

Read on…

1. Galera To Report Pancreatic Cancer Trial Data In 2H2020

Galera Therapeutics Inc. (GRTX) has completed patient enrollment in its pilot phase Ib/IIa safety and anti-cancer efficacy clinical trial of its lead product candidate Avasopasem manganese in combination with stereotactic body radiation therapy in patients with locally advanced pancreatic cancer.

The topline data from the pilot trial is expected in the second half of 2020.

A phase III trial evaluating whether Avasopasem manganese reduces the severity of radiation-induced oral mucositis in patients with head and neck cancer, dubbed ROMAN, is also underway.

GRTX closed Wednesday’s trading at $8.58, up 9.02%.

2. Genetic Technologies Hits New High on COVID-19 Severity Risk Test

Shares of Genetic Technologies Limited (GENE) jumped as much as 355 percent in intraday trading on Wednesday to touch a high of $10.30, following an update on the development of the Company’s COVID-19 Severity Risk Test.

The COVID-19 Severity Risk Test is a Polygenic Risk Score (PRS) test, which may enable an assessment of the risk of an individual developing a serious disease should they contract the COVID-19 virus. The test is intended to predict ‘disease severity’ using a combination of genetic and clinical information.

A provisional patent for the COVID-19 Severity Risk Test has been filed by the Company with the Patent Office in Australia.

The Company has confirmed with major manufacturers like Thermo Fisher Scientific that the COVID-19 Severity Risk Test is capable of being rolled out on a large scale.

Discussions have been held with Centres for Medicare and Medicaid Services (CMS) and the National Association of Testing Authorities, Australia for regulatory Approval for the COVID-19 Severity Risk Test in the United States and Australia, the Company noted.

GENE closed Wednesday’s trading at $5.67, up 150.88%.

3. Mallinckrodt’s Terlipressin Narrowly Wins Backing of FDA Panel

Mallinckrodt plc.’s (MNK) investigational agent Terlipressin to treat adults with hepatorenal syndrome type 1 has narrowly won the support of an independent advisory committee to the FDA, which voted 8-7 recommending its approval.

Hepatorenal syndrome type 1 (HRS-1) is an acute and life-threatening syndrome involving acute kidney failure in people with cirrhosis. If left untreated, HRS-1 has a median survival time of approximately two weeks and greater than 80 percent mortality within three months. At present, there are no approved drug therapies for HRS-1 in the U.S., and it is estimated to affect between 30,000 and 40,000 Americans annually.

The final FDA decision on Terlipressin is expected on September 12, 2020.

Terlipressin is approved for use outside the U.S. and Canada.

MNK closed Wednesday’s trading at $3.10, up 12.73%. In after-hours, the stock was up another 6.45% at $3.30.

4. Neuronetics Appoints Keith Sullivan as New CEO

Neuronetics Inc. (STIM), a commercial-stage medical technology company, has appointed Keith J. Sullivan as its President and Chief Executive Officer effective immediately.

Keith most recently served as Chief Commercial Officer and President (North America) of ZELTIQ Aesthetics Inc., from January 2016 until the company was acquired by Allergan, Inc. in April 2017.

In the first quarter ended March 31, 2020, Neuronetics’ total revenue declined to $11.5 million from $12.7 million in the year-ago quarter as a result of the COVID-19 pandemic, related governmental responses, and resulting economic turmoil.

STIM closed Wednesday’s trading at $2.75, up 38.89%.

5. PDS Biotech To Accelerate PDS0202 Development

PDS Biotechnology Corp.’s (PDSB) collaborator, Professor J. Woodward of the University Of Kentucky School Of Medicine, has been awarded a grant by the National Institute of Allergy and Infectious Diseases’ (NIAID) Collaborative Influenza Vaccine Innovation Centers (CIVICs) program to progress the development of a Versamune-based universal influenza vaccine.

The Company noted that under the award, it will continue the development of its PDS0202 vaccine program, which combines Versamune with novel influenza vaccine antigens, with a goal of rapidly progressing into a human clinical trial.

Preclinical development studies will be performed at three sites – PDS Biotech’s Princeton, NJ laboratories, The University of Kentucky School of Medicine, and the CIVICs Center for Influenza Vaccine Research for High-Risk Populations (CIVR-HRP), the Company added.

The other compounds which are based on the Versamune platform are PDS0201 for tuberculosis and PDS0203 for COVID-19, all of which are in preclinical development.

PDSB closed Wednesday’s trading at $2.72, up 33.33%.

6. RTI Surgical To Get A Makeover

RTI Surgical Holdings Inc. (RTIX), a global surgical implant company, is all set to sell the OEM business and become a pure-play spine company beginning July 20, 2020.

The Company will also change its name to Surgalign Holdings Inc., and ticker symbol on the NASDAQ to “SRGA”. Trading under the new ticker symbol is expected to begin on July 23, 2020.

Upon the closing of the transaction, Camille Farhat, President, and CEO, will be retiring from his role and vacating his seat on the Board of Directors. Terry M. Rich, who currently serves as RTI Surgical’s President of Global Spine, will take over as the Company’s new President and CEO, effective upon the closing of the transaction.

RTIX closed Wednesday’s trading at $3.80, up 12.09%.

7. Taiwan Liposome Sets Eyes on COVID-19 Battle

Shares of Taiwan Liposome Company, Ltd. (TLC) jumped more than 30% on Wednesday after a manuscript on the Company’s strategy to treat COVID-19 disease with targeted delivery of inhalable liposomal Hydroxychloroquine was made publicly available.

According to the manuscript, compared to intravenous unformulated Hydroxychloroquine (HCQ), inhalable liposomal HCQ achieved 30-fold exposure in the lungs at a significantly lower dose while reducing systemic and cardiac toxicities.

Hydroxychloroquine, the anti-malarial and anti-inflammatory drug, has been shown to inhibit SARS-CoV-2 infection in vitro studies. However, recent clinical trials studying orally ingested HCQ have shown inconclusive results due to the extremely high doses required to achieve effective antiviral levels, according to the Company.

George Yeh, President of TLC, said, “TLC has long been aware of the advantages of inhalable liposomal formulations in the treatment of infectious and inflammatory lung diseases, and we are grateful to have started the development of a potential treatment for COVID-19 before it became a pandemic. We hope that the promising results seen in our animal studies will draw attention from organizations around the world and result in a global and expedited development of inhalable liposome HCQ to deliver a potential treatment that the world needs as quickly as possible.”

TLC closed Wednesday’s trading at $8.50, up 30.77%.

8. Is The Writing on the Wall for Tricida’s Veverimer?

Shares of Tricida Inc. (TCDA) plunged more than 30% in extended trading on Wednesday after being notified by the FDA of the deficiencies that prevent discussion of labeling and postmarketing requirements/commitments related to the New Drug Application for Veverimer.

Veverimer, proposed for the treatment of metabolic acidosis in patients with chronic kidney disease, is being reviewed by the FDA under the accelerated approval program, with a decision expected on August 22, 2020.

The Company is currently conducting its confirmatory postmarketing trial of Veverimer, dubbed VALOR-CKD.

TCDA closed Wednesday’s trading at $26.20, up 0.96%. In after-hours, the stock fell 33.40% to $17.45.

9. Stocks That Moved On No News

Immutep Limited (IMMP) closed Wednesday’s trading at $1.46, up 32.73%.

Equillium, Inc. (EQ) closed Wednesday’s trading at $17.33, up 23.96%.

Galmed Pharmaceuticals Ltd. (GLMD) closed Wednesday’s trading at $5.69, up 20.55%.

Rigel Pharmaceuticals Inc. (RIGL) closed Wednesday’s trading at $3.28, down 20.48%.

Caladrius Biosciences Inc. (CLBS) closed Wednesday’s trading at $2.48, down 17.33%.

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