Pacira BioSciences Reports Positive Topline Data From Phase 3 Study Of EXPAREL
Pacira BioSciences, Inc. (PCRX) announced Wednesday positive topline results from its Phase 3 study of EXPAREL as a single-dose sciatic nerve block in the popliteal fossa for postsurgical regional analgesia in patients undergoing bunionectomy.
EXPAREL achieved the study’s primary endpoint by demonstrating a statistically significant reduction in cumulative pain scores from 0 to 96 hours compared with bupivacaine HCl.
EXPAREL also achieved statistical significance for reduction in postsurgical opioid consumption and percentage of opioid-free subjects through 96 hours compared with bupivacaine HCl, which were key secondary endpoints. EXPAREL was well tolerated with a safety profile consistent with bupivacaine HCl.
Pacira plans to submit a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) early next year to expand the EXPAREL label to include sciatic nerve blocks in the popliteal fossa, as well as femoral nerve blocks in the adductor canal.
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Sesen Bio, Carisma To Merge
Sesen Bio, Inc. (SESN) and Carisma Therapeutics Inc. have entered into a merger agreement to combine the companies in an all-stock deal. Stockholders of Carisma will receive newly issued shares of Sesen Bio common stock pursuant to an exchange ratio formula set forth in the merger agreement. Pre-merger Sesen Bio stockholders are expected to own approximately 41.7% and pre-merger Carisma stockholders are expected to own approximately 58.3% of the combined company.
The combined company will focus on the advancement of Carisma’s cell therapy platform that utilizes engineered macrophages and monocytes to potentially transform the treatment of cancer and other serious disorders. The combined company is expected to operate under the name Carisma Therapeutics Inc. and trade on Nasdaq under the ticker symbol, CARM. It will be led by Steven Kelly, President and CEO of Carisma.
Carisma has secured commitments from a syndicate of investors for a $30 million financing. The combined company is expected to have approximately $180 million in cash, cash equivalents and marketable securities.
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Tesla ‘Megapack’ Fire In California Causes Shelter-in-place
A fire in a Tesla, Inc (TSLA) storage facility on Tuesday triggered shelter-in-place advisory at Monterey in California. The fire in the facility, maintained by PG&E, was immediately kept in check by the authorities and the advisory has since been lifted.
The fire first erupted at around 1:30 AM of Tuesday from a Tesla Megapack, according to the local reports, in the Elkhorn battery storage facility in Monterey, California. This triggered the administration as the fire could spread to other battery packs, creating a disaster. The roads were closed for more than 12 hours and the residents were asked to stay indoors and keep the windows locked to keep the toxic fumes away.
The battery, a 182.5 mW system was one of the 256 kept in the facility. While the fire stopped with prompt response from the authorities, the battery kept on releasing toxins into the air. “While the fire is considered fully controlled, smoke may still occur in the area for several days,” the public information for Monterey County tweeted.
This is not the first time a Tesla battery pack caught fire. Last year, a similar incident happened in Australia. There is another battery storage unit in Monterey’s Moss county, operated by Vistra which has also experienced two incidents of battery heating.
PG&E’s Jeff Smith noted, “Safety systems at the facility worked as designed when the issue was detected, and automatically disconnected the battery storage facility from the electrical grid.”
Chemours Cuts FY22 Adj. EBITDA Outlook; Stock Down
The Chemours Company (CC), a chemical firm, said on Wednesday that it has revised down its Adjusted EBITDA guidance for the fiscal 2022, after its Titanium Technologies segment experienced a continued fall in demand throughout the third quarter.
For the full-year, the Delaware-headquartered firm now expects its adjusted EBITDA to be in the range of $1.400 billion and $1.450 billion, or at its midpoint around 7 percent below the midpoint of the prior guidance range, but about 9 percent above the prior year.
On July 28, for the fiscal 2022, the firm had projected its Adjusted EBITDA to be at the high end of the previously updated outlook range of $1.475 billion to $1.575 billion.
For the fiscal 2021, Chemours had reported adjusted EBITDA of $1.313 billion.
Mark Newman, CEO of Chemours, said: “In our TT segment, we have experienced a continued decline in our demand outlook throughout the third quarter, most notably in Europe and Asia. Lower demand, coupled with continued high input costs, have impacted our projected results for the full year. In response, we will be extending a scheduled outage on one of our TT production lines, in addition to other cost actions…”
CC was trading down by 6.57 percent at $28.71 per share in pre-market on the New York Stock Exchange.
Grainger Backs Annual Outlook, Below Street View
W. W. Grainger, Inc. (GWW), an industrial supply company, said on Wednesday that it has reaffirmed its guidance for the fiscal 2022, following a significant growth in the business. It however came in below the Street view.
For the fiscal 2022, the Chicago-headquartered firm still expects to report adjusted EPS of $27.25 to $28.75, on sales of $15.0 billion – 15.2 billion. It also expects a 14.5 percent to 16.5 percent daily sales growth.
Analysts, on average, expect the firm to post EPS of $27.97, on sales of $15.09 billion.
For the fiscal 2025, the Grainger expects its net sales to be in the range of $19 – $20 billion, representing 8 percent to 10 percent compounded annual growth compared to the mid-point of 2022 guidance.
For the fiscal 2025, the company anticipates its adjusted income per share of around $40, a 43 percent increase from the mid-point of 2022 outlook.
GWW is trading up by 1.17 percent at $539.07per share on the New York Stock Exchange.