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Wednesday, July 12, 2023

AVROBIO to Explore Strategic Alternatives

AVROBIO, Inc. (Nasdaq: AVRO), a leading clinical-stage gene therapy company working to free people from a lifetime of genetic disease, today announced that it has completed a review of its business, including the status of its programs, resources, and capabilities. AVROBIO has made the determination to halt further development of its programs and to conduct a comprehensive exploration of strategic alternatives focused on maximizing shareholder value.

As part of this evaluation process, AVROBIO will explore potential strategic alternatives that may include, but are not limited to, an acquisition, merger, business combination, or other transaction. There can be no assurance that its exploration will result in AVROBIO pursuing a transaction or that any transaction, if pursued, will be completed on attractive terms, if at all. AVROBIO has not set a timetable for completion of this evaluation process and does not intend to disclose further developments unless and until it is determined that further disclosure is appropriate or necessary.

 https://finance.yahoo.com/news/avrobio-explore-strategic-alternatives-110000485.html

Why Are NanoViricides Shares Gaining

 NanoViricides Inc 

 shares are trading higher after the company reported preclinical data from an antiviral clinical drug candidate for Respiratory Syncytial Virus (RSV).

The company reported on the strong effectiveness of its broad-spectrum antiviral clinical drug candidate NV-387 in an animal model of lethal lung infection with RSV.

NV-387 is the active ingredient of NV-CoV-2, the company's drug for COVID and possibly long COVID. 

As previously reported, it is already in Phase 1a/1b human clinical trials for evaluating safety in healthy volunteers and of safety and preliminary efficacy in COVID patients.

The company says that NV-387 can be advanced into Phase 2 studies against RSV once the current Phase 1 studies of NV-CoV-2 are completed. This will significantly speed up the development of the RSV drug, save costs, and improve return on investments.

Two vaccines have recently been approved for RSV prophylaxis. GSK plc's 

 Arexvy and Pfizer Inc's  Abrysvo (for use in adults over 60 years of age and both reduced severity of RSV infection. 

There are no vaccines currently approved for infants and children. There are no effective therapeutics for RSV to date.

https://www.benzinga.com/general/biotech/23/07/33188392/why-are-nanoviricides-shares-gaining-today

Silk Road Medical fell sharply on downgrade following proposal from Medicare

  Shares of the medical device maker dropped 24% in premarket trading as investors reacted to a proposed decision memorandum from the Centers for Medicare & Medicaid Services that could have implications for Silk Road's business.

Silk Road is the company behind the transcarotid artery revascularization (TCAR) procedure, which is a minimally invasive surgical procedure to protect against stroke by treating carotid artery disease. With alternative treatments having demonstrated certain shortcomings, Silk Road believes that TCAR has become the best-in-class option for patients.

However, analysts at J.P. Morgan (NYSE: JPM) downgraded Silk Road stock from overweight to neutral, slashing its price target from $50 to $28 per share. The move came after the federal agency overseeing Medicare proposed conditions under which patients suffering from carotid artery stenosis would be able to get coverage for percutaneous transluminal angioplasty procedures along with carotid stents.

Investors are always concerned when major funding sources make decisions that could adversely impact businesses, and Silk Road faces such a threat right now. The Medicare proposal isn't final yet, but shareholders are preparing for what could be a worst-case scenario for the TCAR procedure and Silk Road's future prospects.

https://www.fool.com/investing/2023/07/12/dominos-is-heating-up-but-this-healthcare-stock-is/

Salarius to Begin a Phase 1 Clinical Trial in Relapsed/Refractory Non-Hodgkin Lymphoma

 Salarius Pharmaceuticals, Inc. (NASDAQ: SLRX), a clinical-stage biopharmaceutical company using protein inhibition and protein degradation to develop cancer therapies for patients in need of new treatment options, announces U.S. Food and Drug Administration (FDA) clearance of the company’s investigational new drug (IND) application to commence a Phase 1 clinical trial with SP-3164 in patients with relapsed/refractory non-Hodgkin lymphoma (NHL). Salarius expects to begin treating patients in the dose-escalation portion of the trial in the second half of 2023 to evaluate safety, clinical activity, pharmacokinetics and pharmacodynamics.

https://www.biospace.com/article/releases/salarius-pharmaceuticals-receives-fda-clearance-of-sp-3164-investigational-new-drug-application-to-begin-a-phase-1-clinical-trial-in-relapsed-refractory-non-hodgkin-lymphoma-patients/

Tuesday, July 11, 2023

Quest Launches Consumer-Initiated Genetic Test

 First consumer genetic health test under the Quest brand provides insights based on DNA, with unique features that include next-generation sequencing, robust support services, physician ordering, and access to one-on-one genetic counseling

Quest Diagnostics (NYSE: DGX), the leader in diagnostic information services, today announced the launch of its first consumer-initiated genetic test, now exclusively available through the company's consumer health business at questhealth.com. Called Genetic Insights, the new offering helps people understand their potential risk of developing certain inheritable health conditions, with advanced technology and end-to-end support that includes personalized health reports and access to genetic counseling.

Using a saliva specimen, Genetic Insights analyzes 36 genes to identify potential risk of nearly two dozen inheritable conditions, including breast and colon cancer; a number of heart and blood disorders; and carrier status for cystic fibrosis, sickle cell anemia, and Tay-Sachs disease. Designed to address gaps in existing consumer genetic tests, the new test is powered by advanced next-generation sequencing (NGS) technology*, which can analyze thousands of DNA variants in genes associated with disease and looks at more regions in a person's genome than microarray testing technology.

https://www.biospace.com/article/releases/quest-launches-consumer-initiated-genetic-test-on-questhealth-com-to-deliver-personalized-actionable-health-risk-insights/

'VP Kamala Harris unveils proposed rule change to cut US childcare costs'

 U.S. Vice President Kamala Harris on Tuesday announced new steps to lower the cost of childcare for American families with a proposal that would cap co-payments under a block grant program that serves 1.5 million children and their families each month.

"This is a critical issue for almost every family in our country," Harris told reporters. "Low-income families often spend one-third, one-third of their yearly income on childcare, more than they spend on their rent or mortgage."

"No family should have to choose between high quality care for their child or to give up their career or put food on the table," she added.

The proposed rule would limit working parents' co-payments under the Child Care & Development Block Grant (CCDBG) program to no more than 7% of a family’s income.

The program subsidizes child care for families with income below 85% of their state's median income level, but requires most to pay a small co-payment.

The proposal, which will have a 45-day comment period, will encourage states to waive co-payments for families at or below 150% of the federal poverty level, the White House said in a fact sheet on the changes. A senior administration official said the Department of Health and Human Services (HHS) hoped to publish the final rule in spring 2024.

Lowering childcare costs has been a big priority for the Biden administration, but a deeply divided Congress has thwarted adoption of some key proposals, including a push to make permanent an expanded child tax credit that was implemented during the COVID-19 pandemic, and other measures aimed at aiding licensed and regulated childcare providers.

The proposal would also ensure that childcare providers participating in the program are paid on time, based on program enrollment instead of attendance, the White House said.

It will also try to make it easier for families to access the block grant program, by encouraging states to accept online applications and making siblings of children who already receive the subsidy presumptively eligible for benefits.

HHS estimates the average co-payment for child care for families benefiting from the block grants rose nearly 20% between 2005 and 2021, prompting many families to reduce their work hours or exit the workforce entirely.

Costs are also disproportionately high for families with low incomes, the White House said, citing a U.S. Census Bureau survey which found that families with low incomes paid five times more than families with higher incomes, as a portion of their income.

If enacted, the proposed changes would reduce co-payments for some 80,000 families, the White House said.

A senior administration official said the rule would use existing resources to maximize benefits for families and child care providers.

https://sports.yahoo.com/harris-unveils-proposed-rule-change-162750046.html

Russian hackers lured embassy workers in Ukraine with an ad for a cheap BMW

 Hackers suspected of working for Russia's foreign intelligence agency targeted dozens of diplomats at embassies in Ukraine with a fake used car advert in a bid to break into their computers, according to a cybersecurity firm report seen by Reuters.

The wide-reaching espionage activity targeted diplomats working in at least 22 of the roughly 80 foreign missions in Ukraine's capital, Kyiv, analysts at the Palo Alto Networks' Unit 42 research division said in the report, due to be published later on Wednesday.

"The campaign began with an innocuous and legitimate event," said the report. "In mid-April 2023, a diplomat within the Polish Ministry of Foreign Affairs emailed a legitimate flyer to various embassies advertising the sale of a used BMW 5-series sedan located in Kyiv".

The Polish diplomat, who declined to be identified citing security concerns, confirmed the role of his advertisement in the digital intrusion.

The hackers, known as APT29 or "Cozy Bear", intercepted and copied that flyer, embedded it with malicious software, then sent it to dozens of other foreign diplomats working in Kyiv, Unit 42 said.

"This is staggering in scope for what generally are narrowly scoped and clandestine advanced persistent threat (APT) operations," said the report, using an acronym often used to describe state-backed cyberespionage groups.

In 2021, U.S. and British intelligence agencies identified APT29 as an arm of Russia's foreign Intelligence Service, the SVR. The SVR did not respond to a request from Reuters for comment about the hacking campaign.

In April, Polish counterintelligence and cybersecurity authorities warned that the same group had conducted a "widespread intelligence campaign" against NATO member states, the European Union, and Africa.

Researchers at Unit 42 were able to tie the fake car advert back to the SVR because the hackers re-used certain tools and techniques which have previously been connected to the spy agency.