Pulmatrix Announces Positive Top Line Results In Phase 1 Study With PUR3100 For Acute Migraine

6,884 Ukrainian Civilians Killed In Russia's Invasion: UN

Nearly 7,000 Ukrainian civilians were killed in Russia’s 10 month-old invasion, the UN Human Rights agency said in its latest update. At least 6,884 Ukrainian civilians have been killed since Russia’s invasion of the country began in February.

The Office of the UN High Commissioner for Human Rights said that it has recorded 17,831 civilian casualties between February 24, when Russian forces attacked Ukraine, and December 26. This includes 6,884 deaths and injuries to 10,947 people. The dead include 1,832 women, 175 girls, and 216 boys.

Most of the deaths (4,052) were recorded in Donetsk and Luhansk, the two eastern border regions that Russia seized from Ukraine.

Most of the civilian casualties were caused by explosive weapons, including shelling from heavy artillery, multiple launch rocket systems, missiles and air strikes.

OHCHR said it believes that the actual figures are considerably higher, as the receipt of information from some locations where intense hostilities have been going on has been delayed and many reports are still pending confirmation.

Meanwhile, Russian forces shelled Kherson 50 times since Tuesday, reports quoting Ukrainian officials said. The targets included a maternity ward in the southern region.

Ukraine’s energy minister Herman Halushchenko has warned that Russia would intensify shelling on New Year’s Eve, and he thinks they will “try to cause maximum damage to the energy system.”

Bicycle Therapeutics' BT8009 Gets FDA Fast Track Designation To Treat Urothelial Cancer

Bicycle Therapeutics plc (BCYC) announced Wednesday that the U. S. Food and Drug Administration has granted Fast Track Designation or FTD to its BT8009 monotherapy to treat adult patients with previously treated locally advanced or metastatic urothelial cancer.

BT8009 is a potential first in class Bicycle Toxin Conjugate or BTC targeting Nectin-4, a protein that is highly expressed in urothelial cancer and other solid tumors.

FTD is intended to facilitate and expedite development and review of new drugs to address unmet medical need in the treatment of a serious or life-threatening condition.

Clinical programs conducted under FTD may be eligible for Accelerated Approval and Priority Review if relevant criteria are met.

Kevin Lee, Chief Executive Officer, said, “FTD represents another positive step in the development of BT8009 and reflects the pressing need for a clinically meaningful, differentiated therapy compared to what is available for patients.”

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U.S. Pending Home Sales Unexpectedly Show Another Steep Drop In November

A report released by the National Association of Realtors on Wednesday unexpectedly showed a continued slump in U.S. pending home sales in the month of November.

NAR said its pending home sales index tumbled by 4.0 percent to 73.9 in November after plunging by 4.7 percent to a revised 77.0 in October.

The extended nosedive came as a surprise to economists, who had expected pending home sales to increase by 0.6 percent.

Pending home sales slid for the sixth consecutive month and are now down by 37.8 percent compared to the same month a year ago.

A pending home sale is one in which a contract was signed but not yet closed. Normally, it takes four to six weeks to close a contracted sale.

“Pending home sales recorded the second-lowest monthly reading in 20 years as interest rates, which climbed at one of the fastest paces on record this year, drastically cut into the number of contract signings to buy a home,” said NAR Chief Economist Lawrence Yun.

“There are approximately two months of lag time between mortgage rates and home sales,” he added. “With mortgage rates falling throughout December, home-buying activity should inevitably rebound in the coming months and help economic growth.”

The report showed particularly steep drops in pending home sales in the Northeast and Midwest, where pending home sales plummeted by 7.9 percent and 6.6 percent, respectively.

Pending home sales in the South also slumped by 2.3 percent, while pending home sales in the West fell by 0.9 percent.

UniFirst Q1 Profit Up, Beats Estimates

UniFirst Corp. (UNF) Wednesday reported an increase in first-quarter profit on 11.4 percent increase in revenue compared to the prior year.

Earnings climbed to $33.96 million from $33.71 million last year. On a per-share basis, earnings increased to $1.81, from $1.77 in the prior year. Adjusted earnings were $2.21 per share. On average, 4 analysts polled by Thomson Reuters expected the company to earn $1.94 per share. Analysts’ estimates usually exclude special items.

Revenue for the quarter increased to $541.79 million from $$486.16 million in the previous month.

Looking ahead to the full year 2023, the company expects earnings per share to be between $5.50-$5.90 per share and adjusted earnings per share in a range of $7.10 to $7.50 per share. Analysts are looking for $7.21 per share.

Revenue for the quarter is projected to be in the range of $2.145 to $2.160 billion. Wall Street expects $2.15 billion.

Pulmatrix Announces Positive Top Line Results In Phase 1 Study With PUR3100 For Acute Migraine

Biopharmaceutical company Pulmatrix, Inc. (PULM) announced Wednesday the successful completion of a Phase 1 trial evaluating safety and pharmacokinetics of PUR3100 in healthy volunteers for the treatment of acute migraine.

PUR3100 uses the Company’s iSPERSE formulation technology to create an orally inhaled dry powder formulation of dihydroergotamine (DHE) to treat acute migraine.

The Phase 1 trial, performed at Nucleus Network in Melbourne, Australia, was a double-dummy, double-blinded design to assesses the safety, tolerability, and pharmacokinetics (PK) of three dose groups of inhaled PUR3100 with intravenous (IV) placebo, compared to a single dose of IV DHE (DHE mesylate injection) with inhaled placebo. Twenty-six healthy subjects were enrolled and each of the four groups contained at least six subjects.

PUR3100 was well-tolerated and there was a lower incidence of nausea in PUR3100 dose groups compared to IV DHE.

Dose selection is underway for the Phase 2 study and an FDA meeting will be requested this month.