BioRestorative gets 4th patent for obesity program

 -Notice of allowance will be the fourth U.S. patent granted under Company’s ThermoStem® program targeting obesity and metabolic disorders, including type 2 diabetes--

BioRestorative Therapies, Inc. (“BioRestorative”, “BRTX” or the “Company”) (NASDAQ:BRTX), a clinical stage company focused on stem cell-based therapies, today announced that the United States Patent and Trademark Office has issued a notice of allowance for a patent application related to the Company’s metabolic ThermoStem® program. The notice of allowance was issued on October 26, 2023. The application is scheduled to issue as U.S. Patent No. 11,851,682 on December 26, 2023.

This will be the fourth U.S. patent granted under this particular patent family. Claims granted under the new patent cover methods of using differentiated human brown fat adipocytes as a platform to screen and identify compounds that can activate and regulate metabolic activity. These compounds, if discovered to provide metabolic benefits, can then be further developed into drugs targeting weight loss. Therapeutic benefits of using activated brown adipose have been demonstrated in various models and may provide a valuable therapeutic tool for treating a range of metabolic disorders. For example, studies have shown that GLP-based therapeutics interact with brown adipose tissue.

https://www.globenewswire.com/news-release/2023/12/12/2794841/0/en/BioRestorative-Therapies-Receives-a-Notice-of-Allowance-by-the-United-States-Patent-and-Trademark-Office-for-a-Patent-Application-Related-to-its-Obesity-Program.html

Amgen upped to Outperform from Sector Perform by RBC

 Target to $300 from $256

https://finviz.com/quote.ashx?t=AMGN&ty=c&ta=1&p=d

CareCloud Suspends Dividends on Non-Convertible Series A, B Cumulative Redeemable Perpetual Preferred

 CareCloud, Inc. (the “Company”) (Nasdaq: CCLD, CCLDP, CCLDO), a leader in healthcare technology solutions for medical practices and health systems nationwide, today announced that its Board of Directors has suspended its monthly cash dividends for its 11% Series A Cumulative Redeemable Perpetual Preferred Stock ("Series A Preferred Stock") and its 8.75% Series B Cumulative Redeemable Perpetual Preferred Stock ("Series B Preferred Stock") beginning with the payment scheduled for December 15, 2023. The suspension of these dividends will defer approximately $1.3 million in cash dividend payments each month. During this suspension, dividends will continue to accrue on the Series A and Series B Preferred Stock. The Board of Directors will regularly review and consider when the suspension should be lifted.

https://www.globenewswire.com/news-release/2023/12/11/2794304/16541/en/CareCloud-Announces-Suspension-of-its-Dividends-on-Non-Convertible-Series-A-and-Series-B-Cumulative-Redeemable-Perpetual-Preferred-Stock.html

Intra-Cellular Therapies gains amid repeated takeover speculation

Intra-Cellular Therapies (ITCI) rises as takeover speculation continues, with JPMorgan and Centerview possibly involved.

https://seekingalpha.com/news/4045676-intra-cellular-therapies-gains-amid-repeated-takeover-speculation

US diabetes patients face delays as insurers tighten Ozempic coverage

Some patients with type 2 diabetes say they are having more difficulty getting reimbursed for drugs like Ozempic as U.S. insurers implement restrictions designed to deter doctors from prescribing the medication for weight loss.

Novo Nordisk confirmed in a recent email that it is seeing tighter health plan management of GLP-1 drugs including Ozempic and is working to minimize disruption for type 2 diabetes patients. The trend has contributed to a recent dip in U.S. prescriptions, an executive at the Danish drugmaker said at an investor conference last month.

Out of 24 diabetes patients contacted by Reuters on Reddit, 13 reported recent problems getting their health plans to cover Ozempic or Mounjaro, a similar drug sold by Eli Lilly.

Elizabeth Beddow in Texas said her Blue Cross Blue Shield plan required two other drugs be tried before it would pay for Mounjaro, which her doctor prescribed after a diagnosis of type 2 diabetes. Instead, she was prescribed Ozempic in March, which caused extreme fatigue and gastrointestinal issues.

In September, Beddow, 57, was switched to an older drug, Lilly's Trulicity, but said her blood sugar levels are still rising.

Having to start a low dose before moving up to a maximum dose with two different medications was "really hard on my body," she said. "Ironically, my insurance covers Mounjaro without step therapy on January 1."

U.S. regulators approved Ozempic for diabetes in 2017 and Mounjaro in 2022. The drugs, more recently sold under the brand names Wegovy and Zepbound for weight loss, are designed to mimic a hormone called GLP-1 to regulate blood sugar, slow digestion and suppress appetite.

Most U.S. health plans cover GLP-1s for type 2 diabetes, which if uncontrolled can lead to serious complications, including kidney failure and limb amputations.

Sales of the self-injected medications, which have U.S. list prices of over $1,000 a month, quickly soared into the billions, making the companies among the world's most valuable. Sales have been limited in large part only by manufacturing capacity.

https://finance.yahoo.com/news/focus-us-diabetes-patients-face-120000464.html

Achieve down on an FDA update

 

• Achieve Life Sciences (ACHV) stock is down alongside an update from the FDA.
• The agency is seeking more information for the company’s cytisinicline NDA.
• This could delay the company’s submission time for the drug candidate.

Achieve Life Sciences (NASDAQ:ACHV) stock is dropping on Tuesday after the company provided an update on its New Drug Application (NDA) for cytisinicline.

A meeting with the Food and Drug Administration (FDA) saw the agency request additional data concerning cytisinicline before it will approve its NDA. This has it seeking long-term exposure data beyond 12 weeks to ensure the safety profile of the drug candidate.

Achieve Life Sciences notes that it’s contacting the FDA for more details about the data it wants. That means its NDA filing for cytisinicline could be delayed as it looks to obtain that information. The company says it will provide investors with an update on its NDA plans in the first quarter of 2024.

https://investorplace.com/2023/12/why-is-achieve-life-sciences-achv-stock-down-44-today/

Candel Fast Tracked for CAN-2409 in Pancreatic Cancer

 Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical stage biopharmaceutical company focused on developing multimodal biological immunotherapies to help patients fight cancer, today announced that the U.S. Food and Drug Administration (FDA) granted Fast Track Designation for its lead investigational adenovirus asset CAN-2409 plus prodrug (valacyclovir) for the treatment of patients with pancreatic ductal adenocarcinoma (PDAC) to improve overall survival.

https://www.globenewswire.com/news-release/2023/12/12/2794671/0/en/Candel-Therapeutics-Receives-FDA-Fast-Track-Designation-for-CAN-2409-in-Pancreatic-Cancer.html