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/
Monday, May 4, 2020
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-trialEpizyme 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.
https://seekingalpha.com/news/3568103-epizyme-eps-beats-0_21-misses-on-revenueSunday, May 3, 2020
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-diseasesU.S. equity futures dip as states strive to re-start, Buffett sticks to cash
U.S. equity futures fall, extending the decline that started on Thursday as risk-off sets the tone for the start of the week.
Warren Buffett over the weekend tried to sooth
(“never bet against America”), but he’s not a buyer here. Instead he’s
unloaded all of his airline investments, and is keeping Berkshire’s cash
hoard close.
S&P 500 futures fall 1.3%, Nasdaq futures slip 1.2% and the Dow futures are down 1.3%.
The fall comes after a number of states allow some non-essential businesses to open in an effort to re-start their economies.
Still, the World Health Organization reports that the U.S. suffered its highest 24-hour death toll yet from the coronavirus — 2,909 deaths as of 4AM Friday.
And tensions between the U.S. and China
increase after Secretary of State Mike Pompeo said there’s a
“significant amount of evidence” tying the coronavirus to a lab in the
Wuhan region of China.
Crude oil falls 5.0% to $18.80 per barrel; gold creeps up 0.4% to $1,707.10 per ounce.
The U.S. Dollar Index rises 0.2% to 99.22.
https://seekingalpha.com/news/3568063-u-s-equity-futures-dip-states-strive-to-re-start-buffett-sticks-to-cashTrump promises more federal aid for Americans
“There’s more help coming. There has to be,” President Trump said at a virtual town hall meeting on Fox News when asked by an unemployed worker if there will be more federal assistance.
Trump now expects 75K-100K deaths from coronavirus.
He said he expects a vaccine will be available by the end of the year.
Update at 8:16 PM: If he’s
elected to a second term, Trump said he’s going to work to reduce the
government’s deficit. “We’re going to cut back [spending] very
substantially plus we’re going to have great growth,” he said.
“We have tens of billions of dollars coming in” from other countries, Trump added.
On another topic, he aims to bring back the antibiotic supply chain to the U.S. is within two years.
8:27 PM: To help deal with
joblessness, Trump would like to see an infrastructure bill, which he
says the Democrats want as well. But “we’re not doing anything unless we
get a payroll tax cut,” he said.
8:33 PM: Asked if he would use tariffs to punish China for the coronavirus, Trump said they would be the “ultimate punishment.”
If China doesn’t buy the amount of U.S. goods they agreed to, the U.S. will end the trade deal, he said.
8:44 PM: “I’m absolutely convinced that by early summer, we can get the economy moving again,” Vice President Mike Pence said.
8:56 PM: Town hall ends.
The U.S. has 1.57M COVID-19 cases and 67,498 deaths, according to the Johns Hopkins University Coronavirus Resource Center.
https://seekingalpha.com/news/3568064-trump-promises-federal-aid-for-americansStranger Than Fiction
Over a year ago, I completed a script titled “Strangers,” a
psychological thriller in which the lead character, Joel, visualizes a
world where everyone wears a mask on his face. Joel is unable to relate
to anyone because the only face he can see is his own. Amid the Covid-19
pandemic, the world has found itself in an eerily similar scenario.
Nearly every person in Manhattan wears a mask these days. What was once
my creative fantasy has become a terrifying reality.
The crisis has changed the concept of “stranger” in New York. Seeing another person’s face usually sets us at ease, allowing us to learn something about how the other person is feeling, his personality, and his intentions. That’s gone. We have become fearful of one another. We make sure to stay far apart not just because of the virus but also because now there’s an element of the unknown in every person. Humans are social creatures; we communicate in subtle ways through expression and tone of voice. Now it’s hard to talk with anyone. Muffled voices sound on the streets. Paranoia ranges freely. Manhattan’s social character has been completely transformed. We have all been pushed into a world not unlike Joel’s.
When I wrote the script, I loved the idea of someone unable to communicate by seeing other people’s faces. Now, not so much. I thought it was a fantastic idea for a movie; it isn’t so good for real life.
Joel finds himself staying mostly inside because of the terror he faces in the outside world. He grows desperate and depressed. For entertainment, he browses animal videos. His apartment is a mess because, despite having ample time to clean it, he’s too despondent to care. Self-isolation has driven him into a maddening boredom. Joel’s best “friend” is a poster of a cat he has named Zanny, to whom he expresses his thoughts and feelings. But Zanny can’t give Joel the social interaction he needs.
All of this has become a bit too real. We hold birthday parties over Skype. We dive deep into movies and YouTube videos. Everyone is bored and getting more frustrated at the lack of stimulation. It feels as if we’ve entered an alternative reality, in which we’re allowed only glimpses of real interaction.
In my script, I envisioned a huge “reveal,” just as Joel exits the subway into Columbus Circle: every person outside is casually wearing a mask, going about their business. The reality is somehow scarier. Once heavily populated areas now stand nearly empty. People haul huge carts of food home so that they don’t have to go outside again for weeks. They stand in huge lines outside supermarkets, staying several feet away from one another.
Mark Twain’s well-known quote—“Truth is stranger than fiction, but it is because Fiction is obliged to stick to possibilities; Truth isn’t”—will never cease to be relevant. It’s all somehow much more bizarre than I could’ve conjured. Never could I have anticipated that the world would actually be filled with people wearing masks. It was supposed to be a movie script! It was supposed to be thought-provoking, not life-changing. Reality took my fictional idea of one man seeing the world in a horrific way and made it into truth, for everyone.
https://www.city-journal.org/new-york-city-masks
The crisis has changed the concept of “stranger” in New York. Seeing another person’s face usually sets us at ease, allowing us to learn something about how the other person is feeling, his personality, and his intentions. That’s gone. We have become fearful of one another. We make sure to stay far apart not just because of the virus but also because now there’s an element of the unknown in every person. Humans are social creatures; we communicate in subtle ways through expression and tone of voice. Now it’s hard to talk with anyone. Muffled voices sound on the streets. Paranoia ranges freely. Manhattan’s social character has been completely transformed. We have all been pushed into a world not unlike Joel’s.
When I wrote the script, I loved the idea of someone unable to communicate by seeing other people’s faces. Now, not so much. I thought it was a fantastic idea for a movie; it isn’t so good for real life.
Joel finds himself staying mostly inside because of the terror he faces in the outside world. He grows desperate and depressed. For entertainment, he browses animal videos. His apartment is a mess because, despite having ample time to clean it, he’s too despondent to care. Self-isolation has driven him into a maddening boredom. Joel’s best “friend” is a poster of a cat he has named Zanny, to whom he expresses his thoughts and feelings. But Zanny can’t give Joel the social interaction he needs.
All of this has become a bit too real. We hold birthday parties over Skype. We dive deep into movies and YouTube videos. Everyone is bored and getting more frustrated at the lack of stimulation. It feels as if we’ve entered an alternative reality, in which we’re allowed only glimpses of real interaction.
In my script, I envisioned a huge “reveal,” just as Joel exits the subway into Columbus Circle: every person outside is casually wearing a mask, going about their business. The reality is somehow scarier. Once heavily populated areas now stand nearly empty. People haul huge carts of food home so that they don’t have to go outside again for weeks. They stand in huge lines outside supermarkets, staying several feet away from one another.
Mark Twain’s well-known quote—“Truth is stranger than fiction, but it is because Fiction is obliged to stick to possibilities; Truth isn’t”—will never cease to be relevant. It’s all somehow much more bizarre than I could’ve conjured. Never could I have anticipated that the world would actually be filled with people wearing masks. It was supposed to be a movie script! It was supposed to be thought-provoking, not life-changing. Reality took my fictional idea of one man seeing the world in a horrific way and made it into truth, for everyone.
https://www.city-journal.org/new-york-city-masks
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