Vir and Alnylam identify inhalable drug candidate for COVID-19

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 that 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.

https://seekingalpha.com/news/3568167-vir-and-alnylam-identify-inhalable-drug-candidate-for-covidminus-19

Anixa Bio up on discovery of first COVID-19 candidate

Anixa Biosciences (NASDAQ:ANIX), together with partner OntoChem GmbH, has identified its first therapeutic candidate against COVID-19 and has advanced the compound into biological testing.

The compound works by disrupting the interaction of the virus’s endoribonuclease with a host human protein that is necessary for the virus to replicate upon infection.

https://seekingalpha.com/news/3568129-anixa-bio-up-62-premarket-on-discovery-of-first-covidminus-19-candidate

Applied DNA Sciences up on encouraging COVID-19 vaccine data

Nano cap Applied DNA Sciences (NASDAQ:APDN) and COVID-19 vaccine development partner Takis Biotech announce that the first injections of their DNA vaccine candidates against the SARS-CoV-2 spike protein produced neutralizing antibodies in test animals in work performed in Italy.

Linear DNA dose-response studies will start this week.

https://seekingalpha.com/news/3568107-applied-dna-sciences-up-24-premarket-on-encouraging-covidminus-19-vaccine-data

BioMerieux COVID testing product gets U.S. emergency use authorization

Biomérieux, a French healthcare company specialising in diagnostics, said on Monday it had won more positive feedback from the U.S. Food & Drug Administration (FDA) regulator for its product aimed at helping test for the coronavirus.
BioMerieux’s shares rose 3 percent in early session trading.
BioMerieux said its ‘BIOFIRE® RP2.1′ panel testing product, which includes 22 pathogens that cause respiratory infections including SARS-CoV-2 which causes the COVID-19 coronavirus, had won ’emergency use authorisation’ from the FDA.
While the ‘BIOFIRE® RP2.1′ test has not had full clearance or approval from the FDA, the decision to give the product ’emergency use authorisation’ nevertheless marks more progress.
BioMérieux said it was looking to scale up supply of the BIOFIRE® RP2.1 panel at its production facilities in Salt Lake City (Utah, USA).
Test kits will be available for commercial distribution in the USA under the emergency use authorisation, as well as internationally where regulatory approval allows.
BioMérieux added it expected to steadily build inventory levels to address the needs of the thousands of labs and healthcare professionals given an expected rise in demand for products aimed at testing for the presence of the coronavirus.

https://www.marketscreener.com/BIOMERIEUX-37839085/news/BioMerieux-COVID-testing-product-gets-U-S-emergency-use-authorization-30531349/

Aridis Pharm enrolls first COVID-19 patient in late-stage AR-301 trial

Aridis Pharmaceuticals (NASDAQ:ARDS) enrolls first COVID-19 patient in its ongoing Phase 3 clinical trial of AR-301, a monoclonal antibody against S. aureus-induced pneumonia in patients who were already on mechanical ventilators.

COVID-19 patients on prolonged mechanical ventilation are prone 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.

“While AR-301 does not treat the virus that causes COVID-19 disease, it can potentially mitigate secondary S. aureus bacterial pneumonia, which represents a serious coronavirus complication and a cause of death in such patients,” says Vu Truong, CEO.

The study is expected to enroll 240 patients.

https://seekingalpha.com/news/3568101-aridis-pharm-enrolls-first-covidminus-19-patient-in-late-stage-arminus-301-trial

Epizyme EPS beats by $0.21, misses on revenue

Epizyme (NASDAQ:EPZM): Q1 GAAP EPS of -$0.51 beats by $0.21.

Revenue of $1.35M (-82.9% Y/Y) misses by $1.28M.

Press Release

https://seekingalpha.com/news/3568103-epizyme-eps-beats-0_21-misses-on-revenue

BioMarin, DiNAQOR to develop gene therapies for rare heart diseases

BioMarin Pharmaceuticals (NASDAQ:BMRN) enters a preclinical collaboration and license agreement with DiNAQOR AG to develop gene therapies to treat rare genetic heart diseases.

DiNAQOR will get an undisclosed upfront payment and is eligible to receive development, regulatory, and commercial milestones on product sales as well as tiered royalties on worldwide sales.

Simultaneously, BMRN is investing in DiNAQOR; financial terms weren’t disclosed.

BMRN reiterates its 2020 GAAP net income guidance of $20M-$80M, including this collaboration.

The license initially covers DiNAQOR’s lead program, DiNA-011 for MYBPC3 hypertrophic cardiomyopathy.

Additionally, the companies will collaborate on several of DiNAQOR’s other pipeline programs on similar terms.

https://seekingalpha.com/news/3568062-biomarin-dinaqor-to-develop-gene-therapies-for-rare-heart-diseases