conix
2 años hace
Adverum lays off 78 employees, bets it all on embattled eye treatment
By Gabrielle Masson
Jul 7, 2022 02:27pm
Adverum Biotechnologies is showing 78 employees the door as part of a new restructuring plan that bets it all on a wet age-related macular degeneration treatment candidate called ixo-vec. (iStock / Getty Images Plus)
Adverum Biotechnologies is slashing its workforce by nearly 40%, cutting 78 employees under a new restructuring plan that will funnel resources to ixo-vec, a wet age-related macular degeneration (AMD) treatment candidate.
The gene therapy biotech's shares have actually risen since the news broke yesterday—perhaps because the announcement was buried between clinical news that included an FDA green light to start testing ixo-vec in humans. Shares were sitting at just under $1.40 apiece Thursday afternoon, up about 15% compared to a previous close of $1.23.
The California biotech is cutting costs to prioritize the clinical development of ixo-vec, a single intravitreal injection and focus on prevalent eye diseases, said Laurent Fischer, M.D., Adverum president and CEO. The biotech is preparing to start a phase 2 trial, dubbed LUNA, for ixo-vec.
Less than a year ago, the biotech terminated its study assessing the same drug, known at the time as ADVM-022, in diabetic macular edema (DME) because of a dose-limiting toxicity—meaning the dose can’t be escalated due to side effects.
The biotech forged ahead with the drug in wet AMD, but the DME failure wiped out nearly half of the biotech’s pipeline, RBC Capital Markets analysts said last July.
While the cause of the toxicity is unknown, DME patients often have multiple comorbidities not seen in wet AMD. Adverum, which has no other clinical-phase assets, has limited options if ixo-vec doesn't find success in wet AMD.
The restructuring will extend the company’s expected cash runway by a year into 2025. As of March 31, the biotech had $271.1 million in cash, cash equivalents and short-term investments, Fischer said.
Adverum expects the layoffs to cut yearly operating costs by $15.3 million while the restructuring itself will cost around $4.2 million, according to a Securities and Exchange Commission filing. Adverum anticipates finishing the restructuring process in the fourth quarter of this year.
TraderNeoMtl
4 años hace
Adverum Appoints CMO and CSO
REDWOOD CITY, Calif., June 01, 2021 (GLOBE NEWSWIRE) -- Adverum Biotechnologies, Inc. (Nasdaq: ADVM), a clinical-stage gene therapy company targeting unmet medical needs in ocular and rare diseases, today announced the appointment of two highly experienced leaders, Julie Clark, M.D., as chief medical officer, and Brigit Riley, Ph.D., as chief scientific officer effective immediately, both reporting directly to Laurent Fischer, M.D., Adverum’s chief executive officer.
“Patient safety is our top priority as we continue to conduct a thorough review of data on the INFINITY SUSAR and the ADVM-022 program?,” said Dr. Fischer. “Our goal is to realize the potential of ADVM-022 and our pipeline to benefit patients worldwide and Julie and Brigit both bring extensive experience in gene therapy and ophthalmology drug development to Adverum. Julie and Brigit will collaborate cross functionally to understand the INFINITY SUSAR to advance the field of gene therapy and we are excited to have them take on these critically important roles. Their skill sets and collective deep knowledge of drug development, gene therapy, and retina from discovery into the clinic and through regulatory review, are invaluable as we conduct a thorough review of patient safety data from the ADVM-022 program and look to expand our pipeline.”
Dr. Clark added, “I have dedicated my career to clinical development programs and commercial launch initiatives for new therapies for ocular diseases. ADVM-022 is a potential transformative gene therapy program and as a physician and a leader I am thrilled to be part of the journey to advance the understanding and potential of this novel therapy on behalf of patients.”
Dr. Riley added, “AAV gene therapy represents the forefront of genomic medicines and Adverum has unique capabilities and world-class scientific minds that enable us to advance the science. I am excited to join at this important time to lead our pipeline expansion and the broader gene therapy field forward.”
realfast95
6 años hace
Adverum Biotechnologies Receives Orphan Drug Designation for ADVM-053, a Novel Gene Therapy Candidate for the Treatment of He...
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- ADVM-053 is a novel gene therapy candidate designed as a potential single-administration treatment for hereditary angioedema (“HAE”)
- Plans to submit an Investigational New Drug (IND) application to the FDA for ADVM-053 in 4Q18
Adverum Biotechnologies, Inc. (Nasdaq: ADVM), a clinical-stage gene therapy company targeting unmet medical needs in serious rare and ocular diseases, today announced that the United States (U.S.) Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to ADVM-053, a preclinical gene therapy candidate being investigated as a potential single-administration treatment which has the potential to provide sustained levels of the C1 esterase inhibitor (“C1EI”) protein.
HAE affects approximately 8,000 individuals in the U.S. This disease is caused by a genetic mutation that results in low levels of C1 esterase inhibitor which can be associated with sudden swelling and edema of respiratory airways, gastrointestinal tract, and extremities.
“We are pleased to receive the Orphan Drug Designation for ADVM-053 from the FDA," said Leone Patterson, interim president and chief executive officer of Adverum Biotechnologies. “We are committed to developing effective treatments for patients living with HAE and the support from the FDA will be invaluable towards this goal. We look forward to submitting our IND application in the fourth quarter.”
Orphan drug designation is granted by the FDA to novel drugs and biologics, which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the U.S. The designation provides incentives for sponsors to develop products for rare diseases, which may include tax credits towards the cost of clinical trials and prescription drug user fee waivers. The orphan drug designation also could entitle Adverum Biotechnologies to a seven-year period of marketing exclusivity in the United States for ADVM-053 should the company receive FDA approval for the treatment of HAE for this product candidate.
stocktrademan
9 años hace
$AAVL recent news/filings
bearish 7.75
## source: finance.yahoo.com
Tue, 10 Nov 2015 19:10:07 GMT ~ Avalanche (AAVL) Reports Wider-than-Expected Loss in Q3
read full: http://finance.yahoo.com/news/avalanche-aavl-reports-wider-expected-191007558.html
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Mon, 09 Nov 2015 21:29:43 GMT ~ AVALANCHE BIOTECHNOLOGIES, INC. Files SEC form 8-K, Results of Operations and Financial Condition, Financial Statemen
read full: http://biz.yahoo.com/e/151109/aavl8-k.html
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Mon, 09 Nov 2015 21:26:18 GMT ~ Avalanche Biotechnologies, Inc. Reports Third Quarter 2015 Financial Results
[at noodls] - MENLO PARK, Calif., Nov. 9, 2015 (GLOBE NEWSWIRE) -- Avalanche Biotechnologies, Inc. (Nasdaq:AAVL), a biopharmaceutical company committed to improving or preserving the sight of people suffering from serious ...
read full: http://www.noodls.com/view/7BA8C0F3832BA4190C0E90DCA89F85CD858F833E
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Mon, 09 Nov 2015 21:05:00 GMT ~ Avalanche Biotechnologies, Inc. Reports Third Quarter 2015 Financial Results
[GlobeNewswire] - MENLO PARK, Calif. -- Avalanche Biotechnologies, Inc. , a biopharmaceutical company committed to improving or preserving the sight of people suffering from serious eye diseases with an unmet medical need, ...
read full: http://finance.yahoo.com/news/avalanche-biotechnologies-inc-reports-third-210500549.html
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Thu, 05 Nov 2015 21:19:06 GMT ~ AVALANCHE BIOTECHNOLOGIES, INC. Files SEC form 8-K, Other Events
read full: http://biz.yahoo.com/e/151105/aavl8-k.html
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Ticker: $AAVL
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Company name: Avalanche Biotechnologies, Inc.
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$AAVL extra dd links
Company name: Avalanche Biotechnologies, Inc.
## STOCK DETAILS ##
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## COMPANY NEWS ##
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## STOCK ANALYSIS ##
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Guru Analysis (nasdaq.com): http://www.nasdaq.com/symbol/AAVL/guru-analysis
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Spoke company information (spoke.com): http://www.spoke.com/search?utf8=%E2%9C%93&q=Avalanche+Biotechnologies%2C+Inc.
Corporation WIKI (corporationwiki.com): http://www.corporationwiki.com/search/results?term=Avalanche+Biotechnologies%2C+Inc.&x=0&y=0
## FUNDAMENTALS ##
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Key Statistics (yahoo.com): http://finance.yahoo.com/q/ks?s=AAVL+Key+Statistics
Insider Roster (yahoo.com): http://finance.yahoo.com/q/ir?s=AAVL+Insider+Roster
Income Statement (yahoo.com): http://finance.yahoo.com/q/is?s=AAVL
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Cash Flow (yahoo.com): http://finance.yahoo.com/q/cf?s=AAVL+Cash+Flow&annual
## HOLDINGS ##
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Insider transactions (yahoo.com): http://finance.yahoo.com/q/it?s=AAVL+Insider+Transactions
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Insider transactions (insidercrow.com): http://www.insidercow.com/history/company.jsp?company=AAVL
Ownership Summary (nasdaq.com): http://www.nasdaq.com/symbol/AAVL/ownership-summary
Institutional Holdings (nasdaq.com): http://www.nasdaq.com/symbol/AAVL/institutional-holdings
Insiders (SEC Form 4) (nasdaq.com): http://www.nasdaq.com/symbol/AAVL/insider-trades
Insider Disclosure (otcmarkets.com): http://www.otcmarkets.com/stock/AAVL/insider-transactions
## SOCIAL MEDIA AND OTHER VARIOUS SOURCES ##
PST (pennystocktweets.com): http://www.pennystocktweets.com/stocks/profile/AAVL
Market Watch (marketwatch.com): http://www.marketwatch.com/investing/stock/AAVL
Bloomberg (bloomberg.com): http://www.bloomberg.com/quote/AAVL:US
Morningstar (morningstar.com): http://quotes.morningstar.com/stock/s?t=AAVL
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