Sunday, 22 Sep 2024

PolarityTE Says Study Proposed In IND Application For SkinTE Placed On Clinical Hold – Quick Facts

Rupee edges 3 paise higher to close at 74.19 against U.S. dollar

Rupee finally ended at 74.19 against the American currency, registering a rise of 3 paise over its previous close of 74.22

The rupee appreciated by 3 paise to close at 74.19 (provisional) against the U.S. dollar on August 24, supported by a strong rally in the domestic equity market.

However, a strong dollar in the overseas markets and rising crude prices weighed on the investor sentiment, Forex traders said.

At the interbank Forex market, the local unit opened strong at 74.12 against the greenback and moved in a range of 74.11 to 74.20 in the day trade.

It finally ended at 74.19 against the American currency, registering a rise of 3 paise over its previous close of 74.22.

On the domestic equity market front, the BSE Sensex ended 403.19 points or 0.73% higher at 55,958.98, while the broader NSE Nifty advanced 128.15 points or 0.78% to 16,624.60.

Meanwhile, the dollar index, which gauges the greenback’s strength against a basket of six currencies, rose 0.07% to 93.04.

Brent crude futures, the global oil benchmark, increased 1.34% to $69.67 per barrel.

Foreign institutional investors remained net sellers in the capital market on Monday as they offloaded shares worth ₹1,363.36 crore, according to the exchange data.

Pre-market Movers: BXRX, CARA, HGBL, REKR, TBPH…

The following are some of the stocks making big moves in Tuesday’s pre-market trading (as of 5.45 A.M. EDT).

In the Green

Baudax Bio, Inc. (BXRX) is up over 58% at $0.83

Cara Therapeutics, Inc. (CARA) is up over 26% at $18.10

Heritage Global Inc. (HGBL) is up over 17% at $2.05

Rekor Systems, Inc. (REKR) is up over 13% at $8.83

Pinduoduo Inc. (PDD) is up over 11% at $90.13

Palo Alto Networks, Inc. (PANW) is up over 11% at $414.00

Quipt Home Medical Corp. (QIPT) is up over 5% at $6.35

In the Red

Theravance Biopharma, Inc. (TBPH) is down over 29% at $10.00

ABVC BioPharma, Inc. (ABVC) is down over 8% at $2.3

Greenpro Capital Corp. (GRNQ) is down over 4% at $0.97

Best Buy Co Inc. Q2 adjusted earnings Beat Estimates

Best Buy Co Inc. (BBY) reported a profit for its second quarter that advanced from last year.

The company’s profit totaled $734 million, or $2.90 per share. This compares with $432 million, or $1.65 per share, in last year’s second quarter.

Analysts had expected the company to earn $1.85 per share, according to figures compiled by Thomson Reuters. Analysts’ estimates typically exclude special items.

The company’s revenue for the quarter rose 19.6% to $11.85 billion from $9.91 billion last year.

Best Buy Co Inc. earnings at a glance:

-EPS (Q2): $2.98 vs. $1.71 last year.
-Analysts Estimate: $1.85
-Revenue (Q2): $11.85 Bln vs. $9.91 Bln last year.

-Guidance:
Next quarter revenue guidance: $11.4 – $11.6 Bln
Full year revenue guidance: $51.0 – $52.0 Bln

Mister Car Wash’s Selling Stockholders To Offer 12 Mln Shares For Sale

Mister Car Wash, Inc. (MCW) on Tuesday announced that several of its selling stockholders including investment funds affiliated with Leonard Green & Partners, L.P., and members of its management team, and pre-IPO investors are offering 12,000,000 shares of its common stock in a secondary offering.

The company would not be receiving any proceeds from the sale of the shares of common stock by the selling stockholders. The selling stockholders also expect to grant the underwriter a 30-day option to purchase up to 1,800,000 additional shares of common stock.

Morgan Stanley is acting as the sole underwriter for the offering.

Theravance Biopharma Sinks 30% After Ulcerative Colitis Drug Trial Misses Primary Goals

Shares of Theravance Biopharma Inc. (TBPH) are currently down over 30% after its ulcerative colitis drug trial failed to meet primary goals.

TBPH is currently trading at $9.87, down $4.30 or 30.35%, on the Nasdaq, on a volume of 3.5 million shares, far above the average volume of 431 thousand shares. The stock has traded between $9.66 and $22.74 in the 52-week period.

On Monday evening, Theravance Biopharma announced that a dose-finding study of its drug izencitinib failed to meet primary endpoint. Izencitinib is an orally administered, gut-selective pan-Janus kinase inhibitor in development for the treatment of ulcerative colitis. The phase 2b dose-finding induction study did not meet its primary endpoint of change in the total Mayo score or the key secondary endpoint of clinical remission at week 8, relative to placebo.

There was a small dose-dependent increase in clinical response measured by the adapted Mayo score, which was driven by a reduction in rectal bleeding.

PolarityTE Says Study Proposed In IND Application For SkinTE Placed On Clinical Hold – Quick Facts

Biotechnology company PolarityTE, Inc. (PTE) announced Tuesday that the U.S. Food and Drug Administration (FDA) has placed a clinical hold on the study proposed in its Investigational New Drug Application (IND) for SkinTE with a proposed indication for chronic cutaneous ulcers. The IND application was filed on July 23, 2021.

The FDA provided feedback that certain Chemistry, Manufacturing, and Control (CMC) items need to be addressed prior to proceeding with a pivotal study. As a result, In accordance with standard practice and regulations, the FDA has advised that it will issue a clinical hold letter providing details on the basis for the hold to the Company by September 21, 2021.

PolarityTE previously disclosed that there was the potential for a wide range of outcomes with respect to its SkinTE IND submission, including but not limited to a clinical hold, and the Company is already formulating a plan to address the issues identified by the FDA.

Based on FDA feedback the Company is confident that the modifications made to its proposed clinical trial protocol in Wagner Grade 2 diabetic foot ulcers will enable this pivotal study to begin enrolling once the CMC issues are resolved.

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