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Thursday, June 13, 2024

Vanda Gets Revised Unsolicited Takeover Proposal from Future Pak

  Vanda Pharmaceuticals Inc. ("Vanda" or the "Company") (Nasdaq: VNDA) today confirmed that it has received a revised unsolicited proposal from Future Pak, LLC ("FP") to acquire Vanda for $8.50-$9.00 per share in cash plus certain Contingent Value Rights.

Consistent with its fiduciary duties, and in consultation with its financial and legal advisors, Vanda's Board will carefully review and evaluate the revised, non-binding proposal to determine the course of action that it believes is in the best interests of the Company and its shareholders.

Vanda does not intend to comment further on the revised, non-binding proposal before the Board has completed its review. There is no action for shareholders to take at this time.

https://www.prnewswire.com/news-releases/vanda-pharmaceuticals-confirms-receipt-of-revised-unsolicited-takeover-proposal-from-future-pak-302172066.html

Vivani Diabetes Implant's IND Gains FDA Clearance For Clinical Use

Vivani Medical, Inc. (NASDAQ:VANI) announced that the U.S. FDA has cleared its Investigational New Drug Application for NPM-119, paving the way for the commencement of the LIBERATE-1 Phase 1 trial.

This study will assess the safety, tolerability, and pharmacokinetics of Vivani’s innovative six-month GLP-1 implant, designed to treat type 2 diabetes.

LIBERATE-1 is a 12-week randomized trial designed to evaluate the safety, tolerability, and pharmacokinetics of NPM-119 in patients with type 2 diabetes.

Participants in this study will discontinue their existing GLP-1 therapy to either receive NPM-119 or a comparator drug. VANI anticipates launching LIBERATE-1 in the second half of the year.

Vivani is advancing its portfolio of unique drug implants using its NanoPortal technology. These implants aim to improve medication adherence and outcomes in chronic diseases like type 2 diabetes and chronic weight management.

“Today marks a significant milestone for Vivani as we transition to a clinical-stage company with a promising drug candidate that has the potential to address medication non-adherence, which affects approximately 50% of patients with type 2 diabetes. LIBERATE-1 represents our first-in-human study of NPM-119 in type 2 diabetes patients, as well as the first clinical application of our innovative NanoPortal™ implant technology in humans,” commented Adam Mendelsohn, Ph.D., Vivani President and Chief Executive Officer.

“This seminal work will characterize how NPM-119’s promising preclinical pharmacokinetic profile translates to humans versus the marketed once-weekly exenatide active comparator, Bydureon BCise®,” Mendelsohn added.

Additionally, Vivani is developing NPM-115 (high-dose exenatide implant) and NPM-139 (semaglutide implant), both targeting chronic weight management, with NPM-139 potentially offering annual dosing.

Dr. Mendelsohn stated that the findings from the study would also benefit their main project, NPM-115, aimed at chronic weight management. Earlier this year, preclinical studies showed NPM-115’s weight loss effects were comparable to semaglutide injections used in Ozempic and Wegovy.

Pending regulatory approval, he highlighted the potential of NPM-115’s six-month dosage to stand out in the growing obesity market.

https://finance.yahoo.com/news/exclusive-vivani-medicals-type-2-110158286.html

Longeveron up 2nd day

 Longeveron (NASDAQ:LGVN) stock continues to rally on Thursday as investors celebrate positive trial news from the clinical-stage biotechnology company.

The big news that boosted shares of LGVN stock higher was investigator data from a Phase 2 trial of Lomocel-B. This is the company’s treatment candidate for patients suffering from hypoplastic left heart syndrome (HLHS).

The Phase 2 trial of Lomocel-B is still ongoing and the investigator meeting was positive. That’s a win for the company and investors in LGVN stock. There’s also demand for its product as HLHS is often fatal and requires many surgeries.


https://investorplace.com/2024/06/why-is-longeveron-lgvn-stock-up-46-today/

BioRestorative Therapies Eyes License Agreement for Metabolic Disease Program

 Brown adipose derived stem cells with brown adipogenic potential would represent a new modality for the treatment of obesity and related metabolic disorders –

- ThermoStem® is an off-the-shelf platform, well-protected by a comprehensive portfolio of issued patents that cover both the U.S. and international markets –

- Potential license partner is a leading commercial stage regenerative medicine company –

https://www.globenewswire.com/news-release/2024/06/13/2898141/0/en/BioRestorative-Therapies-in-Substantive-Discussions-for-Potential-License-Agreement-for-ThermoStem-Metabolic-Disease-Program.html

Initial Claims Surge To 10-Month Highs As California Joblessness Soars

Did we suddenly get a peek at economic reality?

The number of Americans applying for jobless benefits for the first time surged last week to 242k (up from 229k and well above the 225k exp). That is the highest since August 2023...

Biden, Zelensky To Sign 10-Year 'Arm & Train' Defense Deal at G7

As they meet on the sidelines of the Group of Seven summit in Italy, President Biden and Ukrainian President Volodymyr Zelensky are planning to sign a deal for long-term US military assistance for Ukraine.

The deal commits Washington to ten years of arming and training the Ukrainian military, and which bolsters the military-industrial complex toward producing more of its own needs for the nation's armed forces. However, given the pledge is an "executive agreement" and not a formal treaty, it can be undone by future American administrations.

CNN previewed of the expected soon to be announced deal, "The US-Ukraine agreement does not make a specific monetary pledge to support Ukraine’s defense, two of the sources familiar with the agreement said."

"An annex in the agreement will lay out how the Biden administration plans to work with Congress on the implementation of the security commitments, one of the sources said, specifically the long-term funding that will be needed to support Ukraine’s defense," the report added.

White House National Security Council spokesman John Kirby had further previewed Tuesday that the US "will continue to be right up front and clear" at the G7, and that Washington "will take bold steps to show Mr. Putin that time is not on his side and that he cannot outlast us, as we support Ukraine fight for freedom."

While the big decade-long security pact will provide "consultations" for Kiev in the event of another future Russian attack on Ukraine, there's nothing in it that legally binds the United States to direct intervention in its behalf in the future.

Despite the continued talk out of Brussels of future Ukrainian membership in NATO, European powers continue to line up their own separate defense pacts with Ukraine.

NATO still wants to "Trump-proof" its future commitments to Ukraine...

"The pledge the US and Ukraine are expected to sign will be similar to the 14 other bilateral agreements Ukraine has already reached with other allies, including the UK, France and Germany," CNN writes.

"The US-Ukraine agreement will be the 15th such deal signed, one of the sources said, and 17 other countries have committed to negotiating similar bilateral security pacts with Ukraine," the report underscores.

https://www.zerohedge.com/geopolitical/biden-zelensky-sign-10-year-arm-train-military-deal-g7

Agenus Immunotherapy Acts on Colorectal Cancer on the Rise in Under-50s

 BOT/BAL Combination Shows Promising Results in the Most Prevalent Form of Colorectal Cancer, Affecting 95% of Diagnosed Patients

A randomized Phase 2 study to confirm the comparative safety and efficacy of the BOT and BAL combination has completed enrollment and will be included in an upcoming discussion with the U.S. Food and Drug Administration at a scheduled End-of-Phase 2 Meeting in July. A Phase 3 trial is planned to initiate later this year.

Access the Full Publication:

The full details of this study can be found here.

https://www.biospace.com/article/releases/nature-medicine-reports-agenus-novel-immunotherapy-demonstrates-clinical-activity-against-a-deadly-form-of-colorectal-cancer-on-the-rise-in-americans-under-50/