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AYTU To Distribute COVID-19 Tests, MIST Flops, HOTH Sets Eyes On Virus Vaccine

pharma 010919 24mar20 lt

Today's Daily Dose brings you news about Aytu BioScience's progress in its COVID-19 diagnostic tests, Roche's myeloid leukemia trial results, Milestone Pharma's disappointing NODE-301 trial results and Hoth Therapeutics getting on the bandwagon of COVID-19 drug development.

Read on…

ADMA Biologics Inc. (ADMA), focused on developing specialty plasma-derived products for the prevention and treatment of infectious diseases, surged 36% on Monday, following FDA's statement there is also an interest in evaluating convalescent plasma, i.e., plasma taken from blood donated by people who have recovered from the novel coronavirus, as a treatment option for COVID-19.

The Company markets BIVIGAM and ASCENIV, its two lead intravenous immune globulin (IVIG) products for the treatment of patients with primary humoral immunodeficiency.

ADMA's total revenues for the full year 2019 were $29.3 million, compared to $17.0 million for the full year 2018, representing an increase of approximately 73%. The increase in revenues was primarily due to the first commercial sales of ASCENIV and commercial relaunch of BIVIGAM, as well as intermediate fraction sales and contract manufacturing revenue, none of which were present in 2018.

The Company ended the year 2019 with cash and cash equivalents of $26.8 million. In February 2020, the Company raised net proceeds of approximately $88.5 million in a public offering.

ADMA closed Monday's trading at $3.06, up 36.00%.

Aytu BioScience Inc. (AYTU) has received the go-ahead from the FDA to commence distribution of its Coronavirus Disease 2019 IgG/IgM Rapid Test throughout the United States.

The COVID-19 IgG/IgM Rapid Test is intended for professional use and delivers results between 2 and 10 minutes at the point-of-care. The delivery of its first shipment of 100,000 tests is expected this week.

Licensed from L.B. Resources, Ltd, the test has been validated in a 126 patient clinical trial and is CE marked.

AYTU closed Monday's trading at $1.87, up 37.50%.

Shares of Milestone Pharmaceuticals Inc. (MIST) plunged over 75 percent in after-hours trading on Monday, following disappointing results from the phase III trial of its investigational new drug, Etripamil nasal spray, in patients with paroxysmal supraventricular tachycardia.

Paroxysmal supraventricular tachycardia (PSVT) is a rapid heart rate condition characterized by intermittent episodes of supraventricular tachycardia (SVT) that start and stop suddenly and without warning. Episodes of SVT are often associated with symptoms including palpitations, sweating, chest pressure or pain, shortness of breath, sudden onset of fatigue, lightheadedness or dizziness, fainting, and anxiety.

In the phase III trial, dubbed NODE-301, Etripamil (70mg) did not achieve its primary endpoint of time to conversion of supraventricular tachycardia to sinus rhythm (SR) compared to placebo over the five hour period.

In addition to NODE-301, Milestone's pivotal phase III program of Etripamil in PSVT includes NODE-302, the ongoing open-label safety extension trial and NODE-303, the ongoing global safety trial and the largest trial ever conducted in PSVT.

MIST closed Monday's trading at $14.00, up 16.47%. In after-hours, the stock plummeted 75.21% to $3.47.

Hoth Therapeutics Inc. (HOTH) is another company that has jumped onto the COVID-19 vaccine development bandwagon. The Company has reached a deal with Voltron Therapeutics Inc. to form a joint venture entity, to be named HaloVax, to commence preclinical studies for the development of self-assembling vaccine for the potential prevention of COVID-19.

The self-assembling vaccine platform, VaxCelerate, is exclusively licensed by Voltron from the Vaccine and Immunotherapy Center (VIC) at Massachusetts General Hospital (MGH).

The deal entitles Hoth the right to receive single-digit royalties from the sale of any products developed, and the right to acquire up to a 30% equity interest in HaloVax.

In other news, Hoth Therapeutics announced that it intends to offer shares of its common stock in a "best efforts" underwritten public offering.

HOTH closed Monday's trading at $3.74, up 35.26%. In after-hours, the stock was down 6.42% at $3.50.

Roche (RHHBY.OB) announced that a phase III study evaluating Venetoclax, sold under the trade name Venclexta and Venclyxto, in combination with Azacitidine, a hypomethylating agent, showed a statistically significant improvement in overall survival in people with previously untreated acute myeloid leukemia compared to Azacitidine alone.

Venclexta has previously been granted accelerated approval by the FDA in combination with Azacitidine, or Decitabine, or low-dose Cytarabine for the treatment of people with newly-diagnosed acute myeloid leukemia who are aged 75 years or older, or for those ineligible for intensive induction chemotherapy due to coexisting medical conditions.

The drug is being developed by AbbVie and Roche. It is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the US, and commercialized by AbbVie outside of the US.

RHHBY.OB closed Monday's trading at $35.26, down 2.29%.

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