Group 1 - Adverum Biotechnologies is a clinical-stage company focused on gene therapy for prevalent ocular diseases, aiming to establish it as a new standard of care [2] - The company is developing a gene therapy candidate, ixoberogene soroparvovec (Ixo-vec), for a one-time intravitreal injection to treat neovascular or wet age-related macular degeneration [2] - Adverum's proprietary intravitreal platform is designed to provide durable therapies that eliminate the need for frequent ocular injections, thereby transforming the treatment paradigm for ocular diseases [2] Group 2 - Laurent Fischer, M.D., the CEO of Adverum, will participate in a fireside chat at the H.C. Wainwright 4th Annual Ophthalmology Virtual Conference on August 15, 2024 [1] - The webcast of the fireside chat will be accessible on Adverum's website, with a replay available for at least 30 days post-presentation [1]

REDWOOD CITY, Calif., Aug. 01, 2024 (GLOBE NEWSWIRE) -- Adverum Biotechnologies, Inc. (NASDAQ:ADVM), a clinical-stage company pioneering the use of gene therapy as a new standard of care for highly prevalent ocular diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation for Ixo-vec, its clinical-stage gene therapy product candidate, for the treatment of wet AMD. "The RMAT designation is based on the clinical data from I ...

Ixoberogene Soroparvovec (Ixo-vec) IVT Gene Therapy for Neovascular AMD: First Time 26-Week Interim Analysis Results from the Phase 2 LUNA Study Charles C. Wykoff, MD, PhD Director of Research, Retina Consultants of Texas Professor of Clinical Ophthalmology, Blanton Eye Institute, Houston Methodist Hospital Paul Hahn, MD, PhD, Eduardo Uchiyama, MD, Sean D. Adrean, MD, Mark R. Barakat, MD, Cameron Javid, MD, Dante J. Pieramici, MD, Bill Tan, PharmD, Adam Turpcu, PhD, Kalliopi Stasi, MD, PhD, Star Seyedkazemi ...

Adverum Biotechnologies, Inc. (NASDAQ:ADVM) 26-Week Interim Analysis of the LUNA Phase 2 Trial Update Call July 17, 2024 8:00 AM ET Company Participants Mike Zanoni - Head of IR Laurent Fischer - President & CEO Charles Wykoff - Director of Research, Retina Consultants of Texas Conference Call Participants Joon Lee - Truist Securities Joseph Thome - TD Cowen Francois Brisebois - Oppenheimer Graig Suvannavejh - Mizuho Securities Luca Issi - RBC Capital Daniil Gataulin - Chardan Operator Hello, ladies and gen ...

Summary of Adverum Biotechnologies, Inc. Conference Call on LUNA Phase 2 Trial Company and Industry Overview - **Company**: Adverum Biotechnologies, Inc. (NASDAQ:ADVM) - **Industry**: Gene therapy for ophthalmic conditions, specifically targeting wet age-related macular degeneration (AMD) Key Points and Arguments 1. **LUNA Phase 2 Trial Overview**: The call discussed the 26-week interim analysis of the LUNA Phase 2 trial for Ixo-vec, a gene therapy product candidate aimed at treating wet AMD, presented at the 2024 ASRS Annual Meeting in Stockholm, Sweden [6][3][4]. 2. **Goals of the LUNA Study**: The primary objectives include selecting the appropriate dose and regimen for pivotal Phase III trials, expected to start in the first half of 2025 [7][49]. 3. **Clinical Activity and Efficacy**: The interim analysis showed a greater than 90% reduction in treatment burden, with 76% of patients remaining injection-free at the 6E10 dose and 83% at the 2E11 dose after six months [9][24]. Visual acuity was maintained, and central subfield thickness (CST) remained stable [9][28]. 4. **Safety Profile**: Ixo-vec demonstrated an improved safety profile compared to previous studies, with no serious adverse events related to the drug. Over 90% of participants experienced no or minimal inflammation [10][36]. The most common adverse event was dose-dependent anterior cellular inflammation, manageable with local corticosteroids [35][34]. 5. **Patient Preference Survey**: A survey indicated that 88% of patients preferred Ixo-vec over prior treatments, with 100% of patients in the 6E10 difluprednate cohort expressing a desire for Ixo-vec therapy in their other eye if affected by wet AMD [12][48]. 6. **Market Potential**: The wet AMD market is large and growing, with a significant need for innovative treatments that reduce the treatment burden associated with current anti-VEGF therapies [13][14]. Ixo-vec's potential for lifelong therapeutic benefit positions it favorably against existing treatments [16]. 7. **Long-term Efficacy**: Data from the OPTIC trial indicated sustained therapeutic levels of Ixo-vec beyond four years, suggesting a long-term solution for wet AMD patients [17][18]. 8. **Regulatory Engagement**: The company is actively engaging with regulatory bodies like the FDA and EMA to facilitate the development and approval of Ixo-vec [49]. Additional Important Content 1. **Challenges in Current Treatments**: The treatment burden of wet AMD is significant, often leading to under-treatment and poor outcomes due to missed visits and limited access [14][15]. 2. **Comparative Analysis**: Ixo-vec showed superior reduction in annualized injections compared to other gene therapy agents, with a higher injection-free rate [45][46]. 3. **Prophylactic Regimens**: The study evaluated various prophylactic regimens to minimize inflammation, leading to protocol amendments that improved safety outcomes [37][38]. 4. **Future Directions**: The company plans to present further data from the LUNA trial in the fourth quarter of 2024 and initiate pivotal trials in 2025 [49]. This summary encapsulates the critical insights from the conference call regarding Adverum Biotechnologies' ongoing efforts in the gene therapy space for treating wet AMD, highlighting the promising results of the LUNA Phase 2 trial and the potential market impact of Ixo-vec.

-   6E10 combined with local prophylaxis selected for Phase 3 pivotal trials, with a favorable safety profile and potential best-in-class product profile at 26 weeks -   Efficacy: 76% of 6E10 patients were injection free, with maintained visual acuity and fluid control -   Safety: 100% of 6E10 difluprednate-alone patients had no or minimal inflammation, and none received corticosteroids for treatment of inflammation beyond the scheduled prophylaxis -   Patient Preference Survey: 88% of patients indicated a ...

Adverum Biotechnologies (ADVM) closed the last trading session at $8.67, gaining 18.4% over the past four weeks, but there could be plenty of upside left in the stock if short-term price targets set by Wall Street analysts are any guide. The mean price target of $33.86 indicates a 290.5% upside potential.The average comprises seven short-term price targets ranging from a low of $20 to a high of $60, with a standard deviation of $14.05. While the lowest estimate indicates an increase of 130.7% from the curre ...

REDWOOD CITY, Calif., July 10, 2024 (GLOBE NEWSWIRE) -- Adverum Biotechnologies, Inc. (NASDAQ:ADVM), a clinical-stage company pioneering the use of gene therapy as a new standard of care for highly prevalent ocular diseases, today announced that the company will host a webcast to review the interim 26-week landmark data from its ongoing LUNA Phase 2 study of ixoberogene soroparvovec (Ixo-vec) for the treatment of wet age-related macular degeneration (wet AMD) being presented at the American Society of Retin ...

REDWOOD CITY, Calif., June 11, 2024 (GLOBE NEWSWIRE) -- Adverum Biotechnologies, Inc. (NASDAQ:ADVM), a clinical-stage company pioneering the use of gene therapy as a new standard of care for highly prevalent ocular diseases, today announced the appointments of Dr. Rabia Gurses Ozden to the Company's executive leadership team as chief medical officer and Dr. Szilárd Kiss to the Company's Board of Directors. Dr. Ozden has stepped down from the Company's Board of Directors, with Dr. Kiss filling the existing B ...

Adverum Biotechnologies (ADVM) has been on a downward spiral lately with significant selling pressure. After declining 19.7% over the past four weeks, the stock looks well positioned for a trend reversal as it is now in oversold territory and there is strong agreement among Wall Street analysts that the company will report better earnings than they predicted earlier.Guide to Identifying Oversold StocksWe use Relative Strength Index (RSI), one of the most commonly used technical indicators, for spotting whet ...