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First Trust NYSE Arca Biotech ETF ( NYSEArca: FBT ) The investment seeks investment results that correspond generally to the price and yield (before the fund's fees and expenses) of an equity index called the NYSE Arca Biotechnology Index(SM). The fund will normally invest at least 90% of its net assets plus the amount of any borrowings for investment purposes in common stocks that comprise the index. The index is an equal-dollar weighted index designed to measure the performance of a cross section of companies in the biotechnology industry that are primarily involved in the use of biological processes to develop products or provide services. The fund is non-diversified.
iShares US Healthcare ( NYSEArca: IYH ) The investment seeks to track the investment results of an index composed of U.S. equities in the healthcare sector. The fund generally invests at least 90% of its assets in securities of the underlying index and in depositary receipts representing securities of the underlying index. It seeks to track the investment results of the Dow Jones U.S. Health Care Index (the "underlying index"), which measures the performance of the healthcare sector of the U.S. equity market. The fund is non-diversified.
iShares US Healthcare Providers ( NYSEArca: IHF ) The investment seeks to track the investment results of an index composed of U.S. equities in the healthcare providers sector. The fund generally invests at least 90% of its assets in securities of the underlying index and in depositary receipts representing securities of the underlying index. It seeks to track the investment results of the Dow Jones U.S. Select Health Care Providers Index (the "underlying index"), which measures the performance of the healthcare providers sector of the U.S. equity market. The fund is non-diversified.
iShares US Medical Devices ( NYSEArca: IHI ) The investment seeks to track the investment results of an index composed of U.S. equities in the medical devices sector. The fund seeks to track the investment results of the Dow Jones U.S. Select Medical Equipment Index (the "underlying index"), which measures the performance of the medical equipment sector of the U.S. equity market. The underlying index includes medical equipment companies such as manufacturers and distributors of medical devices such as magnetic resonance imaging (MRI) scanners, prosthetics, pacemakers, X-ray machines, and other non-disposable medical devices. The fund is non-diversified.
iShares Nasdaq Biotechnology ( NasdaqGIDS IBB ) The investment seeks to track the investment results of an index composed of biotechnology and pharmaceutical equities listed on the NASDAQ. The fund generally invests at least 90% of its assets in securities of the underlying index and in depositary receipts representing securities of the underlying index. The underlying index contains securities of NASDAQ® listed companies that are classified according to the Industry Classification Benchmark as either biotechnology or pharmaceuticals and that also meet other eligibility criteria determined by the NASDAQ OMX Group, Inc. The fund is non-diversified.
Market Vectors Biotech ETF ( NYSE MKT:BBH ) seeks to replicate as closely as possible, before fees and expenses, the price and yield performance of the Market Vectors® US Listed Biotech 25 Index. The fund normally invests at least 80% of its total assets in securities that comprise the fund's benchmark index. The Biotech Index is comprised of common stocks and depositary receipts of U.S. exchange-listed companies in the biotechnology sector. Such companies may include medium-capitalization companies and foreign companies that are listed on a U.S. exchange. It is non-diversified.
PowerShares Dynamic Biotech & Genome ETF ( NYSEArca: PBE ) The investment seeks investment results that generally correspond (before fees and expenses) to the price and yield of the Dynamic Biotechnology & Genome IntellidexSM Index. The fund generally will invest at least 90% of its total assets in common stocks of biotechnology companies and genome companies that comprise the underlying intellidex. The underlying intellidex was composed of common stocks of 30 U.S. biotechnology and genome companies. These companies are engaged principally in the research, development, manufacture and marketing and distribution of various biotechnological products, services and processes, etc. It is non-diversified.
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4SC (XETRA: VSC.DE) is an innovative biotech company with a strong focus on clinical development. We discover and develop targeted small molecule drugs with an epigenetic mode of action for the treatment of cancer in indications with a high unmet medical need and major economic potential.
Aastrom Biosciences, Inc. (NasdaqCM: ASTM) is the leader in developing patient-specific expanded cellular therapies for use in the treatment of patients with severe diseases and conditions. Aastrom markets two autologous cell therapy products in the United States for the treatment of cartilage repair and skin replacement. Aastrom is also developing MACI(TM), a third-generation autologous chondrocyte implant for the treatment of cartilage defects in the knee, and ixmyelocel-T, a patient-specific multicellular therapy for the treatment of advanced heart failure due to ischemic dilated cardiomyopathy.
ABBOTT LABORATORIES (NYSE: ABT) is a global healthcare company devoted to improving life through the development of products and technologies that span the breadth of healthcare. With a portfolio of leading, science-based offerings in diagnostics, medical devices, nutritionals and branded generic pharmaceuticals, Abbott serves people in more than 150 countries and employs approximately 69,000 people.76
Abeona Therapeutics Inc. (NasdaqCM:ABEO) develops and delivers gene therapy and plasma-based products for severe and life-threatening rare diseases. Abeona's lead programs are AB0-101 (AAV NAGLU) and ABO-102 (AAV SGSH), adeno-associated virus (AAV)-based gene therapies for Sanfilippo syndrome (MPS IIIB and IIIA). We are also developing ABO-201 (AAV CLN3) gene therapy for juvenile Batten disease (JBD); and ABO-301 (AAV FANCC) for Fanconi anemia (FA) disorder using a novel CRISPR/Cas9-based gene editing approach to gene therapy program for rare blood diseases. In addition, we are also developing rare plasma protein therapies including SDF Alpha™ (alpha-1 protease inhibitor) for inherited COPD using our proprietary SDF™ (Salt Diafiltration) ethanol-free process.
Ablynx (Brussels: ABLX.BR) is a biopharmaceutical company engaged in the discovery and development of Nanobodies®, a novel class of therapeutic proteins based on single-domain antibody fragments, for a range of serious and life-threatening human diseases, including inflammation, thrombosis, oncology and pulmonary disease.
Acadia Pharmaceuticals Inc. (NasdaqGS: ACAD) is a biopharmaceutical company focused on the development and commercialization of innovative medicines that address unmet medical needs in neurological and related central nervous system disorders. ACADIA has a pipeline of product candidates led by pimavanserin, for which we have reported positive Phase III trial results in Parkinson's disease psychosis and which has the potential to be the first drug approved in the United States for this disorder. We are currently completing NDA-enabling clinical and manufacturing activities for pimavanserin and are planning to submit an NDA with the FDA near the end of 2014. Pimavanserin is also in Phase II development for Alzheimer's disease psychosis and has successfully completed a Phase II trial in schizophrenia. ACADIA also has clinical-stage programs for chronic pain and glaucoma in collaboration with Allergan, Inc. and two preclinical programs directed at Parkinson's disease and other neurological disorders. All product candidates are small molecules that emanate from internal discoveries.
Access Pharmaceuticals, Inc. (OTC:ACCP) is an emerging biopharmaceutical company that develops and commercializes proprietary products for the treatment and supportive care of cancer patients. Access developed MuGard and ProctiGard and is developing multiple follow-on products. Access also has other advanced drug delivery technologies including CobaCyte™-mediated targeted delivery and CobOral-oral drug delivery, its proprietary nanopolymer delivery technology based on the natural vitamin B12 uptake mechanism.
AcelRx Pharmaceuticals, Inc. (NasdaqGM:ACRX) is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of moderate-to-severe acute pain. The Company's late-stage pipeline includes ARX-04 (sufentanil sublingual tablet, 30 mcg), designed for the treatment of moderate-to-severe acute pain in medically supervised settings; and Zalviso® (sufentanil sublingual tablet system), designed for the management of moderate-to-severe acute pain in adult patients in the hospital setting. Zalviso delivers 15 mcg sufentanil sublingually through a non-invasive delivery route via a pre-programmed, patient-controlled analgesia device. Zalviso is approved in the EU as well as Norway, Iceland, and Liechtenstein and is investigational and in late-stage development in the U.S. Grunenthal Group holds the rights for Zalviso in Europe and Australia, while AcelRx retains all other world-wide rights.
Acorda Therapeutics, Inc. (NasdaqGS:ACOR) is a biotechnology company focused on developing therapies that improve the lives of people with neurological disorders. Acorda markets three FDA-approved therapies including: AMPYRA (dalfampridine) Extended Release Tablets, 10 mg, a treatment to improve walking in patients with multiple sclerosis (MS); ZANAFLEX CAPSULES® (tizanidine hydrochloride) and Zanaflex tablets, a short-acting drug for the management of spasticity; and QUTENZA® (capsaicin) 8% Patch, for the management of neuropathic pain associated with postherpetic neuralgia. AMPYRA is marketed outside the United States as FAMPYRA® (prolonged-release fampridine tablets) by Biogen Idec under a licensing agreement from Acorda. Acorda has one of the leading pipelines in the industry of novel neurological therapies. The Company is currently developing six clinical-stage therapies and one preclinical stage therapy that address a range of disorders including post-stroke deficits, epilepsy, stroke, peripheral nerve damage, spinal cord injury, neuropathic pain, and heart failure.
Acrux Limited (ASX:ACR.AX) is a dynamic Australian drug delivery business developing and commercialising a range of patient-preferred pharmaceutical products for global markets, using innovative, patented technology to administer drugs through the skin. Fast drying, non-occlusive topical sprays or liquids provide an enhanced transdermal delivery platform with low or no skin irritation, superior cosmetic acceptability, and simple, accurate and flexible dosing.
See the full stock directory hereTRU NIAGEN® PRO to be Featured at the Academy of Integrative Health & Medicine Annual Conference Healthcare practitioners will have first look at new high-dose TRU NIAGEN PRO product IRVINE, Calif., Sept. 21, 2018 (GLOBE NEWSWIRE) -- ChromaDex Corp. (NASDAQ:CDXC), an integrated, science-based, nutraceutical company devoted to improving the way people age with its flagship ingredient NIAGEN® and consumer product TRU NIAGEN®, today announced it will exhibit at the AIHM Annual Conference 2018 in San Diego, CA. The sole active ingredient in Tru Niagen is nicotinamide riboside, a unique form of vitamin B3 clinically proven to safely increase one’s levels of NAD (nicotinamide adenine dinucleotide). Decreased NAD levels have been associated with many age-related changes in overall health. At the Academy of Integrative and Health Medicine Annual Conference, taking place Sept. 22-26, integrative clinicians who embrace a patient-centered, team-based approach to healthcare will get their first look at the new Tru Niagen Pro product at booth #304. Tru Niagen Pro, which will be available exclusively for sale through healthcare providers, contains 60 capsules – each delivering 300 mg of Niagen nicotinamide riboside (NR), the highest dose of NR available in a single capsule. Tru Niagen team members will be on-site to discuss the latest published human evidence behind its proprietary nutrient. During their visit, practitioners can quickly get registered for the new practitioner-exclusive NAD education hub and discuss how they can bring Tru Niagen Pro directly to their patients. The first 50 practitioners to visit the booth will receive a complimentary bottle of new Tru Niagen Pro. For additional information on Tru Niagen Pro visit practitioner.truniagen.com. About TRU NIAGEN®: TRU NIAGEN® is a branded dietary supplement brought to market by key nicotinamide riboside innovator and patent holder, ChromaDex. NIAGEN® nicotinamide riboside (NR), also supplied by ChromaDex, is the sole active ingredient in TRU NIAGEN®. Multiple clinical trials demonstrate NIAGEN® is proven to boost NAD (nicotinamide adenine dinucleotide) levels, which decline with age. Only NIAGEN® has twice been successfully reviewed under FDA's new dietary ingredient (“NDI”) notification program, and has also been successfully notified to the FDA as generally recognized as safe (“GRAS”). About ChromaDex: ChromaDex Corp. is an integrated, global nutraceutical company devoted to improving the way people age. ChromaDex scientists partner with leading universities and research institutions worldwide to uncover the full potential of NAD and identify and develop novel, science-based ingredients. Its flagship ingredient, NIAGEN nicotinamide riboside, sold directly to consumers as TRU NIAGEN®, is backed with clinical and scientific research, as well as extensive IP protection. TRU NIAGEN is helping the world AGE BETTER®. To learn more about ChromaDex, please visit www.ChromaDex.com. Forward-Looking Statements: This release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities and Exchange Act of 1934, as amended, including statements related to results of the NIAGEN® studies and their significance. Statements that are not a description of historical facts constitute forward-looking statements and may often, but not always, be identified by the use of such words as "expects", "anticipates", "intends", "estimates", "plans", "potential", "possible", "probable", "believes", "seeks", "may", "will", "should", "could" or the negative of such terms or other similar expressions. More detailed information about ChromaDex and the risk factors that may affect the realization of forward-looking statements is set forth in ChromaDex's Annual Report on Form 10-K for the fiscal year ended December 30, 2017, ChromaDex's Quarterly Reports on Form 10-Q and other filings submitted by ChromaDex to the SEC, copies of which may be obtained from the SEC's website at www.sec.gov. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and actual results may differ materially from those suggested by these forward-looking statements. All forward-looking statements are qualified in their entirety by this cautionary statement and ChromaDex undertakes no obligation to revise or update this release to reflect events or circumstances after the date hereof. ChromaDex provided research materials and a portion of the grant funding as a collaborator for the study. ChromaDex Media Contact: ChromaDex Investor Relations Contact: |
Catalyst Pharmaceuticals to Participate in Two Upcoming Investor Conferences
CORAL GABLES, Fla., Sept. 20, 2018 (GLOBE NEWSWIRE) -- Catalyst Pharmaceuticals, Inc. (Catalyst) (Nasdaq: CPRX), a biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating, chronic neuromuscular and neurological diseases, today announced that management will participate in the following upcoming investor conferences: - Oppenheimer Fall Summit Focused on Specialty Pharma and Rare Diseases on September 27th at The Langham Hotel in New York City Management will attend one-on-one investor meetings during the Oppenheimer conference. - Cantor Fitzgerald Global Healthcare Conference on October 3rd at the InterContinental New York Barclay Hotel in New York City Management will present at the Cantor Conference on Wednesday, October 3rd at 9:45 AM ET. The presentation materials will be posted at www.catalystpharma.com in the Investor section under Events and Presentations. About Catalyst Pharmaceuticals Catalyst Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating, chronic neuromuscular and neurological diseases, including Lambert-Eaton myasthenic syndrome (LEMS), congenital myasthenic syndromes (CMS), MuSK antibody positive myasthenia gravis, and spinal muscular atrophy type 3. Firdapse® (amifampridine phosphate) has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for the treatment of LEMS and Orphan Drug Designation for LEMS, CMS and myasthenia gravis. Firdapse is the first and only approved drug in Europe for symptomatic treatment in adults with LEMS. Catalyst is also developing CPP-115 to treat refractory infantile spasms. CPP-115 has been granted U.S. Orphan Drug Designation for the treatment of infantile spasms by the FDA and has been granted E.U. Orphan Medicinal Product Designation for the treatment of West syndrome by the European Commission. In addition, Catalyst is developing a generic version of Sabril® (vigabatrin). Forward-Looking Statements This press release contains forward-looking statements. Forward-looking statements involve known and unknown risks and uncertainties, which may cause Catalyst's actual results in future periods to differ materially from forecasted results. A number of factors, including (i) whether Firdapse will ever be approved for commercialization, (ii) whether, even if Firdapse is approved for commercialization, Catalyst will be successful in commercializing Firdapse, (iii) whether Catalyst will be the first company to receive an approval for amifampridine (3,4-DAP), giving it 5-year marketing exclusivity for its product, and (iv) those other factors described in Catalyst's Annual Report on Form 10-K for the fiscal year 2017 and its other filings with the U.S. Securities and Exchange Commission (SEC), could adversely affect Catalyst. Copies of Catalyst's filings with the SEC are available from the SEC, may be found on Catalyst's website, or may be obtained upon request from Catalyst. Catalyst does not undertake any obligation to update the information contained herein, which speaks only as of this date. CONTACT: Investor Contact Brian Korb Solebury Trout (646) 378-2923 bkorb@troutgroup.com Company Contact Patrick J. McEnany Catalyst Pharmaceuticals Chief Executive Officer (305) 420-3200 pmcenany@catalystpharma.com Media Contact David Schull Russo Partners (212) 845-4271 david.schull@russopartnersllc.com |
RedHill Biopharma to Present at Ladenburg Thalmann 2018 Healthcare Conference TEL-AVIV, Israel and RALEIGH, N.C., Sept. 20, 2018 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (Nasdaq: RDHL) (Tel-Aviv Stock Exchange: RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company primarily focused on proprietary drugs for gastrointestinal diseases, today announced that Mr. Dror Ben-Asher, chief executive officer of RedHill, will present a corporate overview at the Ladenburg Thalmann 2018 Healthcare Conference, on Tuesday, Oct. 2, 2018, at 10:30 a.m. ET, at the Sofitel Hotel in New York City. The presentation will be broadcast live and available for replay on the Company's website, http://ir.redhillbio.com/events, for 30 days. Please access the website at least 15 minutes ahead of the presentation to register, download, and install any necessary audio software. About RedHill Biopharma Ltd.: This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company’s research, manufacturing, preclinical studies, clinical trials, and other therapeutic candidate development efforts; (ii) the Company’s ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials; (iii) the extent and number of additional studies that the Company may be required to conduct and the Company’s receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company’s therapeutic candidates; (v) the Company’s ability to successfully promote Donnatal®, Mytesi® and Esomeprazole Strontium Delayed-Release Capsules 49.3 mg and commercialize EnteraGam®; (vi) the Company’s ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company’s therapeutic candidates and the results obtained with its therapeutic candidates in research, preclinical studies or clinical trials; (ix) the implementation of the Company’s business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company’s expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse experiences using investigative drugs under the Company's Expanded Access Program; and (xiv) competition from other companies and technologies within the Company’s industry. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on February 22, 2018. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise, unless required by law. CONTACT: Company contact: Adi Frish Senior VP Business Development & Licensing RedHill Biopharma +972-54-6543-112 adi@redhillbio.com IR contact (U.S.): Timothy McCarthy, CFA, MBA Managing Director, Relationship Manager LifeSci Advisors, LLC +1-212-915-2564 tim@lifesciadvisors.com |
New TRU NIAGEN PRO Launched for Expansive Distribution by Healthcare Practitioners Addressing aging population, TRU NIAGEN PRO now available for distribution by healthcare practitioners for patient health and wellness IRVINE, Calif., Sept. 20, 2018 (GLOBE NEWSWIRE) -- ChromaDex Corp. (NASDAQ:CDXC), an integrated, science-based, nutraceutical company devoted to improving the way people age with its flagship ingredient NIAGEN® and consumer product TRU NIAGEN®, today announced the launch of TRU NIAGEN PRO (60ct, 300mg per capsule), a partnership with Natural Partners Fullscript, and a new online NAD education hub for healthcare practitioners. Tru Niagen Pro, which will be available exclusively for sale through healthcare practitioners, is the first of its kind, offering 60 capsules – each delivering 300 mg of Niagen® nicotinamide riboside (NR). Dr. Phillip Milgram, Medical Director of the NAD Treatment Center in San Diego, CA, commented, “I have dedicated my career to increasing patients’ NAD levels for multiple medical indications, health and longevity. We are very excited to offer Tru Niagen Pro through our clinic. The growing body of science pointing to the importance of maintaining NAD levels via the use of daily supplementation of clinically proven precursors such as NR continues to build, and we are delighted to be associated with ChromaDex, the pioneers of NR development. We have a clinically proven dose of NR to deliver an effective increase in NAD in a single capsule.” “NAD is required for all cells in the body to function,” says Dr. Alyssa Dweck, OB/GYN and Assistant Clinical Professor in the Department of Obstetrics, Gynecology, and Reproductive Science at the Mount Sinai School of Medicine. “I recommend Tru Niagen to my patients.” In addition to offering Tru Niagen Pro direct to practitioners, ChromaDex has entered into a newly signed distribution agreement with Natural Partners Fullscript (Scottsdale, AZ), making Tru Niagen products available to their extensive network of over 40,000 healthcare practitioners. Fran Towey, Natural Partners Fullscript CEO commented, “Tru Niagen uniquely addresses the most critical issues facing patients today and is proving to make a real positive difference in people’s lives. We’re excited to be partnering with ChromaDex to bring its innovation to our Natural Partners Fullscript community as well as to bring Tru Niagen Pro exclusively to healthcare practitioners.” ChromaDex CEO Robert Fried notes, “We are delighted to be associated with Natural Partners Fullscript. They are the leaders and innovators in the healthcare practitioner channel and will help us bring the Tru Niagen brand to this important and influential community.” Healthcare practitioners can also now have access to convenient online wholesale purchasing as well as a practitioner-exclusive education hub with a searchable, categorized database of the over 100 published pre-clinical and clinical studies detailing the ability of NAD and NR to support human health. For additional information on the science supporting TRU NIAGEN visit www.truniagen.com. About TRU NIAGEN®: About ChromaDex: Forward-Looking Statements: This release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities and Exchange Act of 1934, as amended. Statements that are not a description of historical facts constitute forward-looking statements and may often, but not always, be identified by the use of such words as "expects", "anticipates", "intends", "estimates", "plans", "potential", "possible", "probable", "believes", "seeks", "may", "will", "should", "could" or the negative of such terms or other similar expressions. More detailed information about ChromaDex and the risk factors that may affect the realization of forward-looking statements is set forth in ChromaDex's Annual Report on Form 10-K for the fiscal year ended December 30, 2017, ChromaDex's Quarterly Reports on Form 10-Q and other filings submitted by ChromaDex to the SEC, copies of which may be obtained from the SEC's website at www.sec.gov. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and actual results may differ materially from those suggested by these forward-looking statements. All forward-looking statements are qualified in their entirety by this cautionary statement and ChromaDex undertakes no obligation to revise or update this release to reflect events or circumstances after the date hereof. ChromaDex provided research materials and a portion of the grant funding as a collaborator for the study. ChromaDex Media Contact: ChromaDex Investor Relations Contact: |
MENLO PARK, Calif., Sept. 19, 2018 (GLOBE NEWSWIRE) -- Adverum Biotechnologies, Inc. (Nasdaq: ADVM), a clinical-stage gene therapy company targeting unmet medical needs in serious rare and ocular diseases, today announced the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for ADVM-022. ADVM-022 is a novel gene therapy candidate for the treatment of wet age-related macular degeneration (wAMD). “The FDA’s Fast Track designation is an important recognition of our ADVM-022 gene therapy program,” said Leone Patterson, interim president and chief executive officer of Adverum Biotechnologies. “We look forward to working with the FDA and benefiting from the potential expedited development and regulatory path offered by their Fast Track program.” A Fast Track designation is intended to facilitate the development and expedite the review of drugs and biologics to treat serious conditions and fill unmet medical needs. The designation enables more frequent communication with the FDA throughout a product candidate’s development and review process. The designation also provides eligibility for Priority Review and Accelerated Approval, which may potentially result in a shorter FDA review process. About the OPTIC Phase 1 Trial of ADVM-022 in wAMD About ADVM-022 Gene Therapy Candidate In May 2018, long-term preclinical efficacy data on ADVM-022 was presented at the American Society of Gene & Cell Therapy 21st Annual Meeting. In this preclinical study in non-human primate models of wAMD, the efficacy of ADVM-022 at 13 months post-administration was consistent with earlier reported data, demonstrating that single intravitreal injection of ADVM-022 was found to be safe and statistically significant (p<0.0001) in preventing the development of Grade IV lesions compared to the untreated vehicle control group. ADVM-022 induced long-term efficacy that was comparable to aflibercept, an anti- VEGF standard-of-care therapy. In this preclinical study, ADVM-022 was well-tolerated, with no serious adverse events. In the same preclinical study, ADVM-022 induced sustained intraocular expression of aflibercept for up to 16 months following a single intravitreal injection. Robust levels of aflibercept protein were detected up to 16 months in aqueous and vitreous humor and, more importantly, in retina and choroid tissues, where neovascularization occurs in wAMD. About Wet Age-related Macular Degeneration (wAMD) wAMD is a leading cause of vision loss in subjects over 60 years of age. A significant number of individuals are impacted by this disease, which has a prevalence of approximately 1.2 million individuals in the U.S. The incidence of new cases of wAMD in the U.S. is approximately 150,000 to 200,000 annually, and this number is expected to grow significantly based on the country’s aging population. The current treatment regimen can be burdensome, as patients generally require intravitreal injections with anti-VEGF proteins every 4-12 weeks. Compliance with this regimen can be difficult for patients and their caregivers, leading to compliance deficiencies and loss of vision from underdosing of treatment. About Adverum Biotechnologies, Inc. Forward-Looking Statements CONTACT: Investor and Media Inquiries: Katherine Bock Vice President Investor Relations & Corporate Communications Adverum Biotechnologies, Inc. 650-656-9347 kbock@adverum.com |
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