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ARDS In COVID-19 Battle, AKBA's Kidney Disease Drug Hits Goals, VAPO On A Roll

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Today's Daily Dose brings you news about the acquisition of Portola by Alexion; encouraging results from TG Therapeutics' chronic lymphocytic leukemia trial; Akebia's INNO2VATE trial results; and Vapotherm's Q1 financial results.

Read on…

Aridis Pharmaceuticals Inc.'s (ARDS) ongoing phase III clinical trial of AR-301, a monoclonal antibody against S. aureus induced pneumonia in patients who were already on mechanical ventilators, has enrolled the first COVID-19 patient.

COVID-19 patients on prolonged mechanical ventilation in the intensive care unit are susceptible to secondary infections (also called 'superinfections') by opportunistic pathogens such as bacteria. Superinfection is a reported complication in COVID-19 patients, which exacerbates morbidity and rate of mortality, noted the Company.

The AR-301 phase III clinical study was initiated in the first quarter of 2019 and is expected to enroll 240 patients. The study allows for the enrollment of patients with baseline characteristics that are inclusive of certain COVID-19 patients.

ARDS closed Tuesday's trading at $8.21, up 10.95%. In after-hours, the stock was up 9.62% at $9.00.

Akebia Therapeutics Inc.'s (AKBA) global phase III cardiovascular outcomes program of its drug candidate Vadadustat, dubbed INNO2VATE, has yielded positive results.

The INNO2VATE program included two separate phase III studies, which evaluated Vadadustat versus Darbepoetin alfa for the treatment of anemia due to chronic kidney disease in adult patients on dialysis.

In each of the two INNO2VATE studies, Vadadustat achieved the primary and key secondary efficacy endpoint demonstrating non-inferiority to Darbepoetin alfa as measured by a mean change in hemoglobin between baseline and the primary evaluation period (weeks 24 to 36) and secondary evaluation period (weeks 40 to 52).

Vadadustat also achieved the primary safety endpoint of the INNO2VATE program, defined as non-inferiority of Vadadustat versus Darbepoetin alfa in time to first occurrence of major adverse cardiovascular events (MACE), which is the composite of all-cause mortality, non-fatal myocardial infarction, or non-fatal stroke across both INNO2VATE studies, according to the Company.

A global phase III program studying Vadadustat in adult patients not on dialysis with anemia due to chronic kidney disease, dubbed PRO2TECT, is underway, with top-line data readout expected in mid-2020.

AKBA closed Tuesday's trading at $11.95, up 37.99%.

Shares of Portola Pharmaceuticals Inc. (PTLA) surged over 130 percent on Tuesday, following news that the Company will be acquired by Alexion Pharmaceuticals Inc. (ALXN) for a price of $18 per share in cash.

Portola is a commercial-stage biopharmaceutical company focused on life-threatening blood-related disorders. The Company markets andexanet alfa as Andexxa in the U.S., and as Ondexxya in Europe, the first and only approved Factor Xa inhibitor reversal agent. Bevyxxa, an oral anticoagulant, is another marketed drug of Portola.

For Alexion, the acquisition is expected to add near-term diversification to its commercial portfolio.

The transaction is expected to close in the third quarter of 2020.

PTLA closed Tuesday's trading at $17.85, up 130.03%. ALXN closed the day's trading at $91.07, down 3.91%.

TG Therapeutics Inc.'s (TGTX) global phase III trial evaluating the combination of Umbralisib plus Ublituximab (U2) compared to Obinutuzumab plus Chlorambucil in patients with previously untreated and relapsed/refractory chronic lymphocytic leukemia has met the primary endpoint of improved progression-free survival.

The trial, dubbed UNITY-CLL, which is being conducted under Special Protocol Assessment agreement with the FDA, will be stopped early for superior efficacy observed at the interim analysis, the Company added.

Some of the other anticipated milestones are:

-- The completion of the submission of a New Drug Application for Umbralisib to treat adult patients with previously treated marginal zone lymphoma and follicular lymphoma in the first half of 2020.
-- Two phase III trials evaluating Ublituximab monotherapy in relapsing multiple sclerosis, dubbed ULTIMATE I, and ULTIMATE II, are underway, with top-line data expected in the second half of this year.

TGTX touched a new 52-week high of $16.98 in intraday trading on Tuesday, before closing at $16.69, up 33.95%.

Shares of Vapotherm Inc. (VAPO) were up over 11 percent in extended trading on Tuesday, after the developer and manufacturer of advanced respiratory technology reported financial results for the first quarter ended March 31, 2020, and provided a solid outlook for the month of April.

Net loss for the first quarter of 2020 was $13.8 million or $0.66 per share compared to a net loss of $13.0 million or $0.76 per share in the first quarter of 2019. Revenue for the first quarter of 2020 was $19.1 million compared to $12.3 million in the year-earlier quarter.

For the month ended April 30, 2020 alone, the Company expects revenue to be between $19.0 million and $19.3 million.

The worldwide installed base of Precision Flow Hi-VNI systems grew by over 2,200 for the month ended April 30, 2020, compared to nearly 1,300 during the entire first quarter of 2020.

Vapotherm's Precision Flow Hi-VNI system which includes capital units and single-use disposables is used to deliver non-invasive ventilation to spontaneously breathing patients using Mask-Free NIV technology.

VAPO closed Tuesday's trading at $22.30, up 6.70%. In after-hours, the stock was up 11.43% at $24.85.

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