TuesdayNov 05, 2024 8:00 am

Annovis Bio Inc. (NYSE: ANVS) Highlights Buntanetap Results at 17th Clinical Trials on Alzheimer’s Disease (‘CTAD’) 2024 Conference

Two posters were presented by Annovis’ President and CEO, Dr. Maria Maccecchini, focusing on the company’s lead drug candidate buntanetap and its performance in clinical trials for the treatment of Alzheimer’s disease (“AD”). A leading event for the Alzheimer’s research community, CTAD 2024, brought together key members of pharmaceutical companies, academic research centers, and patient advocacy groups to discuss avenues for AD treatment. Buntanetap has been shown to significantly improve cognition in early AD patients, both ApoE4 carriers and non-carriers, and normalize biomarkers associated with AD pathology. The company is preparing for Phase 3 clinical trials for buntanetap in early-stage…

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ThursdayOct 31, 2024 9:45 am

Calidi Biotherapeutics Inc. (NYSE American: CLDI) Is ‘One to Watch’

Calidi’s unique OV platforms are engineered to protect and amplify virus efficacy, enhancing tumor targeting and patient safety. Calidi’s lead programs, CLD-101, CLD-201, and CLD-400, are advancing through key development stages, with major milestones anticipated, including Phase 1b/2 enrollment for CLD-101 in Q1 2025 and Phase 1 trials for CLD-201 expected in 2H 2024. The company targets a $13-15 billion U.S. market across multiple high-need cancer types, including GBM, TNBC and lung cancer. Calidi’s leadership team combines business, scientific and operational expertise, with a track record of successful exits and growth. Calidi Biotherapeutics (NYSE American: CLDI) is a clinical-stage immuno-oncology…

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WednesdayOct 23, 2024 9:45 am

Annovis Bio Inc. (NYSE: ANVS) Receives FDA Clearance to Initiate Pivotal Phase 3 Alzheimer’s Studies, Paving the Way for NDA Filings

Annovis Bio received FDA clearance to move forward with Phase 3 trials for buntanetap following an End-of-Phase 2 meeting on October 10, 2024. The pivotal trials will investigate buntanetap’s short-term symptomatic effects and potential long-term disease-modifying benefits in early-stage Alzheimer’s disease (“AD”) patients. Annovis Bio is targeting potential NDA submission within one year of the study’s initiation for symptomatic treatment, based on the results of a well-executed 6-month trial. The FDA raised no safety concerns regarding buntanetap and supported the use of its new crystal form in development. Annovis Bio (NYSE: ANVS), a late-stage clinical drug platform company focused on…

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MondayOct 21, 2024 10:00 am

Study Explores Repurposing Drugs as a Way to Fight Brain Tumor Origins

Glioblastoma multiforme is a common and very aggressive type of cancer that primarily affects an individual’s brain and/or spinal cord. This cancer has an average survival rate of less than 22 months following diagnosis despite standard treatment including chemotherapy, irradiation and surgery. Various factors contribute to this poor outcome, including high tumor recurrence rates, tumor resistance to treatment, and intra-tumoral heterogeneity. In recent years, it has become clear to scientists that not all cells in brain tumors help drive tumor growth. This has led scientists to pay more attention to brain tumor stem cells, which they theorize are the main…

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FridayOct 18, 2024 12:00 pm

Clene Inc. (NASDAQ: CLNN) Presents Lead Candidate CNM-Au8(R) Updates, Latest Achievements at Top Investor Conferences

Clene gave a fireside presentation and held one-on-one investor meetings at the 2024 Maxim Healthcare Virtual Summit on October 15. On October 30, Clene will give a presentation and participate in one-on-one meetings at The ThinkEquity Conference 2024 at the Mandarin Oriental Hotel in New York. Clene’s lead drug candidate, CNM-Au8® has been shown to restore and protect neurological function, offering new hope for patients with ALS and other neurodegenerative conditions. Clene is seeking an accelerated approval pathway for CNM-Au8 for ALS and is scheduled to have a meeting with the FDA leadership in November. Clene (NASDAQ: CLNN) and its…

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ThursdayOct 10, 2024 11:15 am

Clene Inc. (NASDAQ: CLNN) Closes $7.3 Million Registered Direct Offering and Concurrent Private Placements

Proceeds from the offerings will support the company’s operations into the first quarter of 2025. Clene also amended its existing debt facility with Avenue Venture Opportunities Fund, L.P. to reduce or defer future monthly principal payments and to extend principal amortization period and the final maturity date into the first half of 2025. The company’s lead drug candidate, CNM-Au8® has been shown to restore and protect neurological function, offering new hope for patients with ALS and other neurodegenerative conditions. Clene is seeking an accelerated approval pathway for CNM-Au8 for ALS, with a meeting scheduled with the FDA before the end…

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TuesdayOct 08, 2024 9:45 am

Astiva Health Inc. Integrates Key Medicare Components into Single Plan, Making It Easier to Manage Healthcare, Access Resources

This year enrollment in Medicare Advantage plans reached 32.8 million members, representing 52% of all Medicare recipients. Medicare Advantage plans typically integrate various health services under one umbrella. Astiva Health’s approach helps members manage existing health conditions and also focuses on promoting overall wellness. Over the past two decades, Medicare Advantage has transformed from a niche option into a primary choice for millions of seniors across the United States. Medicare Advantage plans bundle Part A, Part B and sometimes Part D coverage into one plan, along with often offering extra benefits that original Medicare doesn't cover. A fast-growing Medical Advantage…

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FridayOct 04, 2024 11:15 am

Annovis Bio Inc. (NYSE: ANVS) Seeking to Strengthen Intellectual Property Portfolio, Protecting Multifaceted Approach for Treatment of Neurodegenerative Diseases

Annovis Bio recently filed three new patents covering combinations of buntanetap, its lead compound, with a GLP-1 agonist (such as dulaglutide/Trulicity) and with PDE5 inhibitors (such as sildenafil/Viagra), as well as a combination of all three The company believes these combinations create a broader approach to treating neurodegenerative diseases Preclinical studies have demonstrated these combinations significantly improve cognition in Alzheimer’s mouse models Combinations of buntanetap with PDE5 inhibitors and GLP-1 agonists are now ready to enter phase 3 clinical studies (buntanetap is in phase 3, and a number of PDE5 inhibitors and GLP-1 agonists are already on the market) Annovis…

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WednesdaySep 25, 2024 9:00 am

Annovis Bio Inc. (NYSE: ANVS) Presented Recent Achievements and Strategic Direction at H.C. Wainwright Investment Conference

The event was attended by Annovis Founder, President and CEO Maria L. Maccecchini, Ph.D. Dr. Maccecchini discussed the company’s notable achievements and plans for the future and held a Q&A session with attendees. The company CEO also participated in an expert panel discussing innovative non-amyloid approaches in Alzheimer’s disease. Recent clinical trials of the company’s lead compound buntanetap obtained encouraging results and was shown to improve cognition in both Alzheimer’s and Parkinson’s patients. Annovis Bio (NYSE: ANVS), a late-stage clinical drug platform company pioneering transformative therapies for neurodegenerative diseases such as Alzheimer’s disease (“AD”) and Parkinson’s disease (“PD”), participated in…

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TuesdaySep 24, 2024 9:45 am

Clene Inc. (NASDAQ: CLNN) to Discuss Lead Candidate CNM-Au8(R) Biomarker, Clinical Data for ALS with Food and Drug Administration Leadership

The company is seeking an accelerated approval regulatory pathway for CNM-Au8® for ALS. The FDA agreed to an in-person meeting to reevaluate Clene’s submission. Lead drug candidate CNM-Au8 has been shown to restore and protect neurological function, offering hope for patients with neurodegenerative conditions. The FDA meeting will be held before the end of November and will be attended by top FDA officials and key opinion leaders in ALS, biostatistics and biomarkers. Clene (NASDAQ: CLNN) and its wholly owned subsidiary Clene Nanomedicine Inc., a late clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including…

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