Alzamend Neuro To Start Next-Gen Therapy Study For Bipolar

 Alzamend Neuro Inc ALZN received the FDA's "Study May Proceed" letter to initiate study AL001-BD01, a Phase 2A clinical study of AL001 for bipolar disorder type 1. 

The company expects the first patient to be dosed in the first quarter of 2024

As a follow-up to our "IND submission" release in August, the FDA has granted us a "Study May Proceed" notification. Therefore, trial is expected to start in Q1. Data from previous Phase I and Phase 2A for AL001 will allow this trial to begin in Phase 2 rather than in Phase 1, the company told Benzinga.

This will be the 2nd "indication" for AL001. We began clinical trials for the indication of Alzheimer's Disease, and we expect to submit two more INDs by the end of 2023 for AL001…Major Depressive Disorder and PTSD, the company told Benzinga.

"If we are able to develop a next-generation lithium product (AL001) that would not routinely require therapeutic drug monitoring, it would constitute a major improvement over current lithium-based treatments and positively impact the 7 million Americans who have bipolar disorder, said Stephan Jackman, Chief Executive Officer of Alzamend. 

The company says Alzamend's recently completed Phase IIA study of AL001 in Alzheimer's patients and healthy subjects identified a candidate dose unlikely to require therapeutic drug monitoring. 

Safety aspects of AL001 development may qualify for a Section (505)(b)(2) NDA pathway in support of FDA approval.

https://www.benzinga.com/general/biotech/23/10/35024361/exclusive-alzamend-neuro-to-start-next-gen-therapy-study-for-bipolar-disorder

FDA Declines To Approve Eli Lilly's Eczema Drug

 The U.S. Food and Drug Administration (FDA) issued a complete response letter for Eli Lilly And Co's 

LLY-1.67%+ Free Alerts

 lebrikizumab biologic license application (BLA) for the treatment of moderate-to-severe atopic dermatitis (eczema). 

The letter cited findings that arose during a multi-sponsor inspection of a third-party, contract manufacturing organization that included the monoclonal antibody drug substance for Lilly's lebrikizumab.

The letter stated no concerns about the clinical data package, safety, or label for lebrikizumab. No other marketed or pipeline Lilly products are affected. 

Lilly has submitted data to the FDA from ADvocate 1, ADvocate 2, and ADhere studies, which included over 1,000 adults and adolescents (ages 12 and older) with moderate-to-severe eczema who could not control their symptoms with topical medicines or other systemic treatments.

In May, a new secondary analysis from Eli Lilly's Phase 3 clinical development program showed that patients receiving lebrikizumab who were assessed at 16 weeks experienced up to 73% improved or cleared face or hand dermatitis.

An additional secondary analysis further demonstrated lebrikizumab's stable and long-lasting results at one year of treatment.

https://www.benzinga.com/general/biotech/23/10/35031584/fda-declines-to-approve-eli-lillys-eczema-drug

FDA approves Novo Nordisk's therapy for rare genetic condition

 Novo Nordisk said on Monday the U.S. Food and Drug Administration (FDA) had approved its therapy to treat a rare genetic condition that affects the kidneys.

The once-monthly injection, to be sold under the brand name Rivfloza, is approved for use in people nine years and older with a type of primary hyperoxaluria and relatively preserved kidney function.

The Danish drugmaker had gained access to the therapy through its $3.3 billion buyout of Dicerna Pharmaceuticals in 2021.

The therapy, which helps to lower urinary oxalate levels, uses the RNA interference technology, or RNAi, where genes that contribute to disease are silenced or rendered ineffective.

Novo Nordisk plans to make the therapy available for eligible patients early next year and said it plans to price the therapy according to "demonstrated clinical value and benefit to those living with PH1 (primary hyperoxaluria type 1)".

Primary hyperoxaluria is a rare condition characterized by recurrent kidney and bladder stones that prevents the liver to make enough of a certain protein leading to the over production of a natural chemical known as oxalate in the urine.

Alnylam Pharmaceuticals Inc's Oxlumo was the first to receive the health regulator's nod for the treatment of the condition.

The approval for Novo's therapy is based on studies in which the drug reduced the levels of 24 hour-urinary oxalate excretion measured against a pre-decided baseline value and when compared to placebo.

The company estimates that more than 2,000 people are living with the condition in the United States.

https://finance.yahoo.com/news/1-us-fda-approves-novo-152718354.html

Danaher Completes Separation of Veralto

 Danaher Corporation (NYSE: DHR) announced today that it has completed the separation of its Environmental & Applied Solutions segment, through the spin-off of Veralto Corporation. Veralto will begin "regular way" trading on the New York Stock Exchange on October 2, 2023, under the symbol "VLTO."

"Today marks an exciting milestone for Danaher. The successful spin-off of Veralto as an independent company creates exceptional opportunities for both Danaher and Veralto to better serve their customers, deliver on their respective strategic priorities and create greater long-term shareholder value," said Rainer M. Blair, Danaher President and Chief Executive Officer.

In connection with the separation, on September 30, 2023, Danaher stockholders received one share of common stock of Veralto for every three shares of Danaher common stock held at the close of business on September 13, 2023 (other than fractional shares, which will be aggregated and sold and the proceeds distributed to Danaher stockholders). Because the separation was completed on a Saturday and not a business day, the shares are expected to be credited to "street name" stockholders through the Depository Trust Corporation on October 2, 2023.  Approximately 246 million shares of Veralto common stock were distributed in the distribution.  

https://www.prnewswire.com/news-releases/danaher-corporation-completes-separation-of-veralto-corporation-301943632.html

Acurx: Successful Completion and Early Discontinuation of Ibezapolstat Phase 2b Trial for C. dif

 

• Based on observed aggregate blinded data the Company has determined that both treatments, ibezapolstat and the control antibiotic vancomycin, have performed as expected
• High rates of Clinical Cure were observed without any emerging safety concerns
• Data will be analyzed and topline efficacy results will be reported as soon as possible
• This successful milestone will allow advancement of this first-in-class, FDA QIDP/Fast Track-designated antibiotic candidate to Phase 3 clinical trials more expeditiously

https://www.prnewswire.com/news-releases/acurx-pharmaceuticals-announces-successful-completion-and-early-discontinuation-of-the-ibezapolstat-phase-2b-trial-for-treatment-of-c-difficile-infection-301943990.html

immix Data: 95% Overall Response Rate in Multiple Myeloma

 

• 95% overall response rate observed in relapsed/refractory multiple myeloma patients not previously treated with BCMA-targeted therapy. Median progression free survival (mPFS) was 12.9 months as of the July 17, 2023 data cut-off
• 90% overall response rate observed in relapsed/refractory multiple myeloma at the therapeutic dose including patients with, and without prior BCMA-targeted therapy
• Class-Leading Response Rate in BCMA-exposed patients (frequently excluded from BCMA CAR-T clinical trials) has the potential to meet an important market need
• ImmixBio plans to submit a BLA for FDA approval in multiple myeloma once 100 patients are treated with NXC-201
• The expected primary endpoints for NXC-201 in relapsed/refractory multiple myeloma are overall response rate and duration of response

https://www.globenewswire.com/news-release/2023/10/02/2752722/0/en/Immix-Biopharma-Announces-72-Patient-NXC-201-Clinical-Data-at-the-IMS-20th-Annual-Meeting-95-Overall-Response-Rate-in-Multiple-Myeloma.html

AI Company GEDiCube and Renovaro Biosciences Sign Definitive Agreement to Combine

Message from Renovaro Biosciences CEO, The Hon. Mark Dybul, MD

LOS ANGELES, Oct. 02, 2023 (GLOBE NEWSWIRE) -- Renovaro Biosciences Inc. (Nasdaq: RENB)

Dear Shareholders,

I am writing to provide you with an update on our recent news of signing a definitive agreement to combine with GEDiCube (GEDiCube Press Release) (Renovaro Press Release) and to share our vision for the promising future of our newly combined company if you, as shareholders, approve the agreement. As we embark on this next chapter, we want to express our appreciation for your ongoing support and investment.

Renovaro Biosciences and GEDiCube strategically decided to combine our two companies just months ago. We believe the combination will accelerate our shared mission to transform medicine and promote healthy longevity through the synergistic applications of advanced AI technology and pioneering biotherapeutics.

The parties intend that I will serve as the CEO of the combined company. I am humbled and honored to serve in that role. I firmly believe that we will achieve far more together than either company could on its own. GEDiCube spent over a decade developing a proprietary AI platform that has already shown accuracy in detecting cancers earlier through analysis of complex molecular data. Renovaro leveraged decades of collective immunology expertise to develop a robust pipeline of novel immunotherapies.

By joining forces, our two technology divisions will collaborate to push new boundaries in precision diagnostics and targeted treatments. At the same time, we will maintain nimble independent operations, allowing each platform to advance rapidly.

https://www.globenewswire.com/news-release/2023/10/02/2752845/0/en/AI-Company-GEDiCube-and-Renovaro-Biosciences-Sign-Definitive-Agreement-to-Combine.html