Aytu Biopharma Inc. (NASDAQ: AYTU ) (NASDAQ: AYTU)
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Vir Biotechnology (NASDAQ:VIR) and collaboration partner Alnylam Pharmaceuticals (NASDAQ:ALNY) announce a new COVID-19 candidate, VIR-2703, an inhalable RNAi therapeutic that targets the SARS-CoV-2 genome for the potential treatment and/or prevention of the respiratory illness.
VIR-2703 has predicted reactivity against more than 99.9% of the 4,300+ SARS-CoV-2 genomes currently available in public databases, including the SARS-CoV genome from the 2003 SARS outbreak.
The companies intend to meet with the FDA to discuss an accelerated path to clinical trials.
VIR is up 4% premarket while ALNY is up 2%, both on light volume.
According to Reuters, AmerisourceBergen (NYSE:ABC) has approached Walgreens Boots Alliance (NASDAQ:WBA) about a purchase of its pharmaceutical wholesaling division (known as Alliance Healthcare).
ABC is willing to pay about $6B for the unit.
WBA +1.9% after-hours.
Gilead Sciences (GILD +0.1%) has rebounded off session lows, albeit on below-average volume, on the heels of reports that the World Health Organization (WHO) plans to seek talks with the company about wider use of remdesivir in COVID-19.
The FDA gave its emergency use nod on Friday, May 1, the first antiviral approved for the respiratory infection anywhere in the world.
The FDA has accepted for review KemPharm’s (KMPH -2.0%) marketing application for KP415 for the treatment of attention deficit hyperactivity disorder (ADHD). The agency’s action date should be in March 2021.
The action triggers a $5M milestone payment to the company from an affiliate of Gurnet Point Capital.
Corium will lead commercialization, if approved.
KP415 is prodrug of the stimulant methylphenidate (brand name: Ritalin). The company says the prodrug formulation enables its controlled release while having less abuse potential. A prodrug is a chemically altered form of the parent drug. When ingested, metabolic processes, such as those in the GI tract, release the parent drug which can then produce its therapeutic effect.
Kala Pharmaceuticals (NASDAQ:KALA) has resubmitted its U.S. marketing application for Eysuvis (loteprednol etabonate ophthalmic suspension) 0.25% for the short-term treatment of symptoms of dry eye disease.
The company received a CRL in August 2019 citing the need for another clinical trial to demonstrate efficacy.
If all goes well, commercial launch will commence by year-end.
