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AUPH Initiates VOCOVID Trial, KALA Gets FDA Nod, NVAX Expands COVID-19 Vaccine Study Size In UK

biotech oct28 lt

Today's Daily Dose brings you news about Aurinia initiating a trial of its lead candidate Voclosporin in kidney transplant recipients with COVID-19, Exact Sciences' Q3 financial results, FDA approval of Kala Pharma's EYSUVIS 0.25% for dry eye disease, update on Novavax's COVID-19 vaccine trials, and Scholar Rock's spinal muscular atrophy trial results.

Read on…

1. Aurinia Initiates VOCOVID Trial in Kidney Transplant Recipients

Aurinia Pharmaceuticals Inc. (AUPH) (AUP.TO) has initiated the European open-label exploratory trial evaluating the antiviral effects of its lead candidate Voclosporin in kidney transplant recipients with COVID-19.

The study, dubbed VOCOVID, conducted in the Netherlands will compare Voclosporin against Tacrolimus, an immunosuppressive drug, over a 56-day period in stable kidney transplant recipients who contracted SARS-CoV-2. The primary endpoint is the reduction in SARS-CoV-2 viral load over 56 days, as measured by reverse transcription polymerase chain reaction (qRT-PCR).

Aurinia's investigational drug Voclosporin is a calcineurin inhibitor and an immunosuppressant.

In in vitro studies, Voclosporin has shown to inhibit viral replication of SARS-CoV-2 at an 8-fold lower concentration than Tacrolimus.

Voclosporin is under FDA review for the proposed indication as treatment for lupus nephritis, with a decision expected on January 22, 2021.

AUPH closed Tuesday's trading at $16.05, up 4.09%.

2. Exact Sciences Hits New High

Shares of Exact Sciences Corp. (EXAS), a provider of cancer screening and diagnostic tests, soared to a new 52-week high on Tuesday, following nearly 87% revenue growth in the third quarter ended September 30, 2020.

The total revenue was $408.4 million in the third quarter of 2020 compared to $218.8 million in the year-ago period. The net loss in the recent third quarter widened to $219.9 million or $1.46 per share from $40.5 million or $0.31 per share in the same quarter last year.

Wall Street analysts were expecting the company to incur a loss of $0.52 per share on revenue of $337.37 million.

Looking ahead, Kevin Conroy, Chairman and CEO, said, "We're confident in the long-term growth outlook for both Cologuard and Oncotype DX and are excited about our extensive pipeline of liquid biopsy tests. Our team and the depth and breadth of our capabilities position us at the forefront of advanced cancer diagnostics".

In other news, Exact Sciences announced that it has agreed to acquire Thrive Earlier Detection Corp., a healthcare company dedicated to incorporating earlier cancer detection into routine medical care, for cash and stock consideration of up to $2.15 billion. The transaction is anticipated to close during the first quarter of 2021.

In addition, the company has agreed to sell an aggregate of 8.60 million shares of its common stock, par value $0.01 per share, in a registered direct offering to ten institutional investors, including some of its largest shareholders as well as healthcare specialist firms Casdin Capital and Rock Springs Capital.

Each share is being sold for a purchase price of $101.00 per share, resulting in gross proceeds of approximately $869.2 million and net proceeds, after estimated offering expenses, of approximately $866.0 million. The offering is expected to close on or about October 29, 2020.

EXAS closed Tuesday's trading at $131.12, up 23.04%.

3. FDA Approves Kala Pharma's Dry Eye Drug, Stock Fails to Catch Eyes

The FDA has approved Kala Pharmaceuticals Inc.'s (KALA) EYSUVIS 0.25% for the short-term (up to two weeks) treatment of the signs and symptoms of dry eye disease.

EYSUVIS, or KPI-121, 0.25%, contains the corticosteroid Loteprednol etabonate. The onset of action with the current prescribed dry eye disease therapies like Novartis' Xiidra and Allergan's Restasis takes weeks or months while that with EYSUVIS is rapid, say just within two weeks, according to the company.

Dry eye disease is a chronic, episodic, multifactorial disease affecting the tears and ocular surface and can involve tear film instability, inflammation, discomfort, visual disturbance and ocular surface damage.

Kala Pharma plans to launch EYSUVIS in the U.S. by the end of this year.

KALA closed Tuesday's trading at $6.28, down 18.72%.

4. Novavax Expands Phase 3 Study Size of COVID-19 vaccine candidate in UK

Novavax Inc. (NVAX) has provided an update on its COVID-19 vaccine candidate NVX-CoV2373.

A phase III trial of NVX-CoV2373 in the U.K. has so far enrolled 5,500 volunteers. The trial, which was originally designed to enroll 10,000 participants, has been expanded to enroll 15,000 volunteers. This trial is expected to be fully enrolled by the end of November, with interim data expected as soon as early first quarter 2021.

The company's COVID-19 vaccine candidate is expected to move into phase III testing in the United States and Mexico by the end of November. About 30,000 participants are expected to be enrolled in the phase III trial in the U.S. and Mexico.

The company also noted that it will present data from its ongoing phase I/II clinical trial of NVX-CoV2373, including new phase II reactogenicity data, during public CDC Advisory Committee on Immunization Practices (ACIP) meeting on October 30.

NVAX closed Tuesday's trading at $89.59, up 2.53%.

5. TOPAZ Data of Spinal Muscular Atrophy Adds Sheen to Scholar Rock

Shares of Scholar Rock Holding Corporation (SRRK) surged over 100% on Tuesday, following promising six-month results of a phase II study of SRK-015 in the treatment of patients with spinal muscular atrophy.

Spinal muscular atrophy, or SMA, characterized by the loss of motor neurons, atrophy of the voluntary muscles of the limbs and trunk and progressive muscle weakness, is said to affect about 30,000 to 35,000 children and adults in the United States and Europe.

Scholar Rock's investigational drug SRK-015 is designed to improve muscle strength and motor function in SMA patients.

In the phase II study, dubbed TOPAZ, motor function improvements were observed for all three SRK-015 treatment cohorts in the primary efficacy endpoints of Hammersmith scale scores.

The 12-month results of the TOPAZ trial are anticipated in the second quarter of 2021.

Novartis' gene therapy Zolgensma, Biogen's Spinraza, and Roche's Evrysdi are the available FDA-approved treatments of spinal muscular atrophy.

In other news, the company announced that it intends to offer and sell in an underwritten public offering $150 million of shares of its common stock. In addition, Scholar Rock intends to grant the underwriters a 30-day option to purchase up to an additional $22.50 million of shares of common stock.

SRRK rose to an all-time high of $31.69 in intraday trading Tuesday, before closing the day's trading at $30.02. In after-hours, the stock gained another 13.29% and rose to $34.01.

6. SWK Holdings Receives Milestone Payment from Cara

SWK Holdings Corp.'s (SWKH) wholly-owned subsidiary, Enteris BioPharma, has received a milestone payment of $2.5 million from Cara Therapeutics (CARA) related to the license agreement for Peptelligence oral formulation technology utilized in Oral KORSUVA.

Of the $2.5 million, SWK Holdings is entitled to receive $1.5 million per the contractual splits agreed to in the Enteris acquisition agreement. SWK is eligible to receive additional potential milestone payments over the next several quarters, subject to the achievement of certain development milestones for Oral KORSUVA.

Cara's Oral KORSUVA has successfully completed a phase II trial for the treatment of pruritus in patients with chronic kidney disease and is currently in phase II trials in atopic dermatitis and primary biliary cholangitis patients with moderate-to-severe pruritus.

SWKH closed Tuesday's trading at $13.95, down 1.76%.

7. Stocks That Hit New Highs/Lows

Shattuck Labs Inc. (STTK) closed at a new high of $24.95, up 4.92%.

Kodiak Sciences Inc. (KOD) closed at a new high of $97.74, up 1.12%.

Amicus Therapeutics, Inc. (FOLD) closed at a new high of $18.93, up 0.96%.

Catabasis Pharmaceuticals Inc. (CATB) closed at a new low of $1.56, down 70.90%.

Jaguar Health Inc. (JAGX) closed at a new low of $0.23, down 8.71%.

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