Safety Board Recommends BioCardia's Heart Failure Cell Therapy To Continue Unchanged

 The independent Data Safety Monitoring Board (DSMB) has completed its prespecified data review for BioCardia Inc's 

BCDA -7.79%

 (Get Free Alerts for BCDA) ongoing Phase 3 CardiAMP Cell Therapy Heart Failure Trial.

• The DSMB based its review on all available data for the 108 patients enrolled with an additional six crossover patient procedures in the trial to date. 
• The monitoring board's assessment indicated no significant safety concerns and recommended that the study continue as designed.  
• The ongoing CardiAMP Heart Failure Trial is expected to enroll 260 patients. 
• CardiAMP Cell Therapy System received FDA Breakthrough Device status for heart failure earlier this month.
• The trial's primary endpoint is an outcomes composite score based on a hierarchical analysis of the three-tiered Finkelstein-Schoenfeld (FS).
• The FS procedure is a ranked analysis that compares the occurrence of cardiovascular and other health-related events, along with functional capacity measures, through one year in patients.

https://www.benzinga.com/general/biotech/22/02/25599908/safety-board-recommends-biocardias-heart-failure-cell-therapy-to-continue-unchanged

Data Committee Recommends Veru's COVID-19 Trial To Continue Unmodified

 The Independent Data Monitoring Committee (IDMC) has conducted a planned conditional power analysis of the first 75 randomized patients in Veru Inc's 

VERU +0.31%

 (Get Free Alerts for VERU) Phase 3 trial of sabizabulin.

• The trial included hospitalized patients with moderate to severe COVID-19 infection at high risk for acute respiratory distress syndrome (ARDS) and death.
• IDMC has concluded that the clinical study should continue as initially designed.
•  The IDMC performed this planned conditional statistical power analysis and review of the safety of the first 75 study patients to reach the primary endpoint. 
• Current full study recruitment is on track to yield clinical results in 1H of 2022.
• The Phase 3 COVID-19 clinical study is evaluating daily oral 9 mg sabizabulin for up to 21 days versus placebo in 300 hospitalized patients.
• The primary efficacy endpoint will be the proportion of patients that die on study up to Day 60. 

https://www.benzinga.com/general/biotech/22/02/25601573/data-committee-recommends-verus-covid-19-trial-to-continue-unmodified

Gilead: Updated Data From Remdesivir Study In Pediatric COVID-19 Patients

 Gilead Sciences Inc 

GILD -1.1%

 (Get Free Alerts for GILD) announced new data from an interim analysis of its ongoing, Phase 2/3 study of Veklury (remdesivir) in pediatric patients hospitalized with COVID-19.

• The data will be presented at the 29th Conference on Retroviruses and Opportunistic Infections (virtual CROI 2022).
• The latest data demonstrate that Veklury was generally well-tolerated among pediatric patients hospitalized with COVID-19, with a high proportion of participants showing clinical improvement and recovery. 
• Overall, no new safety findings for Veklury were noted, and 85% of patients showed clinical improvement based on the clinical ordinal scale, and the recovery rate was 83% at the last assessment (N=53).
• In January, the FDA expanded the pediatric Emergency Use Authorization (EUA) of Veklury to include non-hospitalized pediatric patients.

https://www.benzinga.com/general/biotech/22/02/25595856/gilead-shares-updated-data-from-remdesivir-study-in-pediatric-covid-19-patients

Denali Receives Formal Letter Regarding FDA Hold On Alzheimer's Potential Program

 As previously announced, Denali Therapeutics Inc 

DNLI +0.79%

 (Get Free Alerts for DNLI) was informed via e-mail communication from the FDA that DNL919 (ATV:TREM2) Investigational New Drug (IND) application was placed on clinical hold. 

• Denali has now received a formal clinical hold letter and is moving forward to address the FDA's observations related to the preclinical toxicology assessment.
• The Company will also provide the information requested to initiate clinical studies, including proposed changes to the clinical trial protocol, the informed consent form, and the investigator brochure. 
• Denali intends to update once a clear path forward has been established.

https://www.benzinga.com/general/biotech/22/02/25597158/denali-receives-formal-letter-regarding-fda-hold-on-alzheimers-potential-program

Ontario lifting vaccine proof requirements

Ontario announced that it's moving on to its next phase of reopening, which includes lifting its COVID-19 proof-of-vaccination requirements, starting Feb. 17. 

“Given how well Ontario has done in the Omicron wave we are able to fast track our reopening plan,” the province's Premier Doug Ford said in a press release. “This is great news and a sign of just how far we've come together in our fight against the virus. While we aren’t out of the woods just yet we are moving in the right direction.”

Ford said the decision to move forward is not due to the trucker-borne protests in Ottawa and Windsor, which have led to multiple road closures, blockages and arrests.

“Let me very clear: We are moving in this direction because it is safe to do so," he said, according to the Associated Press. "Today’s announcement is not because of what’s happening in Ottawa or Windsor but despite it."

“We need law and order. Our country is at risk now. It’s not just not happening here in Ottawa, but it’s happening in Alberta and British Columbia,” Ford added. “We won’t accept. it”

Ford noted that he would support the government if it proposed more measures to curb protests.

The next phase will further ease multiple health measures, such as removal of its 50 percent capacity limit on restaurants on Thursday, four days earlier initially than planned. People will also no longer need to show proof of vaccination before entering restaurants, gyms, and sporting events.

"Thanks to the province’s high vaccination rates and the continued sacrifices of Ontarians, we are now in a position where we can move forward in our plan earlier than anticipated,” said Christine Elliott, Deputy Premier and Minister of Health.

Prime Minister Justin Trudeau virtually met with the leaders of Canada’s provinces on Monday morning, according to the AP, and has rejected calls for military use. However, he said “all options are on the table” to end the protests, including turning to emergency measures.

https://thehill.com/policy/international/americas/594127-ontario-lifting-vaccine-proof-requirements

UNITY Biotech: Additional Data from Phase 1 Vascular Eye Disease Study

 24-week UBX1325 Phase 1 data presented at Angiogenesis, Exudation, and Degeneration 2022 Conference

Patients with diabetic macular edema (DME) and wet age-related macular degeneration (wAMD) showed improvement in visual acuity through 24 weeks following single dose of UBX1325

Phase 2 clinical studies of UBX1325 currently enrolling patients with DME and wAMD

https://finance.yahoo.com/news/unity-biotechnology-announces-additional-data-130000317.html

'Fed poses bigger market risk than Russian invasion of Ukraine'

 During an interview on "Mornings with Maria" Ironsides Macroeconomics director of research, Barry Knapp, said the Fed poses a bigger risk to markets than a potential Russian invasion of Ukraine. 

BARRY KNAPP: You had a pretty good move in S&P 500 implied volatility, the VIX index had a pretty significant move through Thursday and Friday. The vast majority of which is attributable to the Fed. But clearly going into a weekend, you caught a pretty good bid. The term structure, meaning six month versus one month, got inverted a little bit. And so, yeah, there's a bit of a risk premium in the markets for a potential of a Russian invasion. So any easing of that will take a little pressure off. But you can see, even with that announcement, crude hasn't come down all that much this morning. And that's because the underlying fundamentals there are really strong. You know, even as demand still hasn't come all the way back, you know, supply remains very, very tight. And so the energy story is not going to really get alleviated all that much by some easing of tensions. 

The real story for the equity market is the Fed and whether they're going to be incredibly aggressive about removing policy. There's going to be a debate underway as to whether they should go 50 or whether they should get more active with their balance sheet management, meaning start the balance sheet run-off as soon as the March meeting. That, I think, would be a much more surgical approach that would cause much less uncertainty in the markets and be more effective and actually cooling housing inflation. So they haven't given that a lot of, we haven't heard from the leadership essentially. So we haven't heard from Powell. We haven't heard from Brainard, even John Williams, the president of the New York Fed, who is scheduled to speak Friday. But that to me is the bigger, broader issue for the stock market. Here is, you know, it has the Fed panicked as a consequence of these off-the-charts inflation numbers. 

https://www.foxbusiness.com/markets/how-will-russia-ukraine-conflict-impact-markets