Caladrius Biosciences tumbles on disappointing results

Caladrius says no improvement in primary endpoint in T-Rex study results

Caladrius tumbles on results, Stockwinners
Caladrius tumbles on results, Stockwinners

Caladrius (CLBS) announced top-line results from the Sanford Project: T-Rex study, a prospective, randomized, placebo-controlled, double-blind Phase 2a clinical trial of 110 subjects to evaluate the safety and efficacy of the company’s CLBS03 as a treatment for recent-onset type 1 diabetes, or T1D, in adolescents.

The initial analysis of the one-year follow-up data for all subjects shows that CLBS03 was well tolerated at the doses tested in the study, however, no improvement in the primary endpoint of preservation of C-peptide levels vs. placebo at one year was observed at the group level.

As with many Phase 2a trials, the database from this study is large and the analysis and interpretation of all the information will require several months of intensive evaluation and will be critical to the decision regarding the next steps in development of CLBS03.

In addition, the data from the 2-year follow-up, once complete, will afford supplemental information and are necessary to complete the evaluation of this therapy.

Type 1 diabetes, once known as juvenile diabetes or insulin-dependent diabetes, is a chronic condition in which the pancreas produces little or no insulin. Insulin is a hormone needed to allow sugar (glucose) to enter cells to produce energy.

Different factors, including genetics and some viruses, may contribute to type 1 diabetes. Although type 1 diabetes usually appears during childhood or adolescence, it can develop in adults.

Despite active research, type 1 diabetes has no cure. Treatment focuses on managing blood sugar levels with insulin, diet and lifestyle to prevent complications.

CLBS is down $1.26 to $4.08.

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Retail Sales Plunged in December

U.S. retail sales dropped 1.2% in December with ex-autos plunging 1.8%.

Retail sales plunge in December, Stockwinners
Retail sales plunge in December, Stockwinners

November’s 0.2% headline gain was revised down to 0.1%, while the 0.2% ex-auto figure was unrevised after strong gains in October of 1.0% (revised from 1.1%) and 0.8% (revised from 1.0%), respectively.

Sales excluding autos, gas, and building materials tumbled 1.6% versus the prior 0.7% jump (revised from 0.6%). Motor vehicle sales climbed 1.0% after a 0.7% prior gain (revised from 0.2%).

Gas station sales declined 5.1% from -4.4% (revised from -2.3%). Food, beverage prices were down 0.4% compared to 0.1% previously (revised from 0.4%).

Building materials edged up 0.3% from -1.5% (revised from -0.3%). Furniture sales dropped 1.3% from 0.5% (revised from 1.2%).

Clothing sales fell 0.7% from 0.4% (revised from -0.2%). Nonstore retailers were down 3.9% from 2.8% (revised from 2.3%).

Miscellaneous sales crashed down 4.1% from 4.0% (revised from 0.4%). This is a very disappointing result and should knock yields and equities lower.

Some analysts blame the drop on the government shutdown while others are seeing a worrying consumers above the situation in Washington as the main reason.

Retailer Stocks to Watch: FIVE, OLLI, ULTA, and BOOT.

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