Watch and learn. Increasing positive divergence since more than 8 months is indicating a high upward bullmove this year into double Digit USD price range.
Above 22 USD the PPS will hit 45-75 USD.
L
Adverum Biotechnologies Granted Orphan Drug Designation by FDA for Gene Therapy Candidate in Preclinical Development for the Treatment of Blue Cone Monochromacy- ADVM-062 is designed as a potential treatment for blue cone monochromacy (X-linked incomplete achromatopsia) REDWOOD CITY, Calif., Jan. 04, 2022 (GLOBE NEWSWIRE) -- Adverum Biotechnologies, Inc.(ADVM) , a clinical-stage gene therapy company targeting unmet medical needs in ocular and rare diseases, announced the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to ADVM-062 (AAV.7m8-L-opsin), a novel gene therapy product candidate being developed as a potential single intravitreal (IVT) administration for blue cone monochromacy (BCM) by delivering a functional copy of the OPN1LW gene.
“We are excited to introduce ADVM-062, which builds on our ophthalmology and gene therapy expertise to address the significant unmet medical needs of patients living with blue cone monochromacy. We are pleased the FDA has recognized the patient need by granting Orphan Drug Designation and we look forward to advancing ADVM-062 towards the clinic and generating important data,” stated Laurent Fischer, M.D., president and chief executive officer of Adverum Biotechnologies(ADVM).
BCM affects approximately 1 to 9 in 100,000 males, worldwide. This X-linked recessive hereditary condition is caused by mutations in either the L or the M opsin gene(s) and can manifest in loss of visual acuity, photophobia, myopia and infantile nystagmus that can persist into adulthood. Consequently, individuals with BCM have visual impairments to important aspects of daily living such as facial recognition, learning, reading, and daylight vision. Currently, there is no cure for BCM.
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 or disorders that affect fewer than 200,000 people in the United States. 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-062 should the company receive FDA approval for the treatment of BCM for this product candidate.
Anticipated Milestones for ADVM-062
Plan to present preclinical data supporting proof of concept of ADVM-062 in 1H2022. Plan to submit an Investigational New Drug (IND) application by year-end 2022. About ADVM-062 Gene Therapy
ADVM-062 is a gene therapy candidate specifically designed to deliver a functional copy of the OPN1LW gene to the foveal cones of patients suffering from BCM via a single IVT injection. ADVM-062 utilizes Adverum’s propriety vector capsid, AAV.7m8
C
I have brought today more shares of ADVM. I expect to make a Million USD when the PPS will hit the 470-895+x USD range.
T
Here's the information that helped me with my decision, Philip's post 2 month ago (thanks Phil). "I’m heavily vested in this industry. Hope this helps you make informed decisions:
Since ~2001 AntiVEGF compounds started being used to treat wet AMD, and then later, numerous other vascular and diabetic diseases of the retina.
Of these, Aflibercept (Eylea - regeneron) went on to hold the largest market share since it had the best durability, equivalent or superior effect, and equivalent or inferior complications.
When Brolizumab (Beovu - Novartis) was released it was expected to wipe out Eylea’s market share given it’s higher durability and great study results. But, on wide scale use patients developed inflammatory/vascular problems.. Now some of us suspect this is not related to the formulation of the compound but instead to the high molarity of the drug compared to all previous competitors at the time.
Interestingly, there are other high molarity Intravitreal drugs on the market that ran into the same inflammatory problems leading to vasculitis, hypotony, etc. (coincidence doesn’t make fact). Indeed, ADVM made this list having this issue with it’s high dose vector treatments for Diabetic retinopathy and it dropped that arm of it’s study as a result.
Now coming down the AntiVEGF pipeline multiple companies have created viral vectors that will make host cells produce AntiVEGF. Different companies hold different rights to the AntiVEGF the host cells produce. ADVM has the right to Aflibercept (Eylea). All other companies hold AntiVEGFs that maintain minimal dominance in the current intravitreal AntiVEGF industry.
The routes of viral vector delivery include intravitreal [ADVM], suprachoroidal, and subretinal. Currently, all AntiVEGF delivery is done intravitreal so ADVM has the delivery system that could go mainstream immediately. The other two would require additional training of the physicians, however, suprachoroidal is easy to learn. (Subretinal can only be done in the OR - thus excluding the entire medical retina specialist market)
To further complicate things, the amount/molarity of viral vector needed is greater in intravitreal and suprachoroidal injections compared to the [harder] subretinal injections. Thus, the risk of inflammatory issues may likely be greater in intravitreal and suprachoroidal injections compared to subretinal..? (This is the real question that needs to be pondered about ADVM)
Coming much later down another pharma pipeline is a sustained AntiVEGF delivery system through intravitreal pellet injection. Expected to last 6 months, twice that of current intravitreal injections. Additionally the pellet delivery system has a much easier road to success given its modality has already been proven successful in the intravitreal steroid market.
However, the viral vectors could potentially last forever or at least significantly reduce the intravitreal Injections needed in the future. If successful, their ability to program cells to make AntiVEGF indefinitely make any temporary sustained release pellet obsolete.
Endpoint: If ADVM is truly having the success it claims with it’s viral vector system for Aflibercept in treating wet AMD (without inflammation!) - then there is a high probability it will dominant the industry given its ability to easily assimilate and provide cell production of a superior AntiVEGF. (This assumes the cells have appropriate production of aflibercept compared to competitor viral vectors - ADVM data makes this seem plausible..)
My concern is that the small sample size in data is hiding the potential inflammatory fallout on a large scale. Similar to what happened with brolizumab (beovu). But if successful, this is like buying regeneron when it was 15$, but it’s on a fire sale for 2$. It’s a gamble, no doubt.
Side note: In capitalist America - money talks. Wet AMD is the most important and first market all AntiVEGF agents seek approval for.. because Medicare will pay for it. Diabetics, especially those in need, are often younger and may not be insured thus their large market size is difficult to capitalize on monetarily. I say this in reference to ADVM dropping its diabetic arm. Dropping the diabetic arm is essentially irrelevant if they deliver on wet AMD.
That being said, this viral vector technology has the most utility in the younger poor compliance diabetic population. In the future, those are the ones whose vision will truly be saved. "
m
$3.44 cash per share vs $1.68. close down and give back the cash may be best option
M
ADVM - 22 USD per share at the end of 2022?
It is possible.
Take a look at the gaps in the chart.
If ADVM hits 22 USD by year end, then a big upward cycle with triple digits price in the follow up is presumably.
IMO
T
6 million shares short, 6 million shares traded today.
b
regn owns 10% here....320 million in cash, 74% fund ownership calling a bottom here.....
M
Gene therapy of AMD is the future of retinal ophthalmology.
Annual globall sales of 12-15 billion USD are possisble from my point if view.
Currect Elyea revenues are at around 5 billion USDeach year at the USA
Lucentis at aorund 2 billion USD per year.
b
lil mike is SHORT, he is mad the stock was up today....soon the 6.5 million short will have to pay higher prices, keep buying this will go higher....
A
ADVM + IQST Gain 50 % week + AABB New Global Currency Aabbg stock + ALPP + VSBGF AI tech.
M
Nice buying opportunity.
Positive divergence is increasing since 3-4 months.
I expect a strong upward impuls at this stock.
C
Institutionals are buying. Upcoming Shorts squeeze will Booster the PPS of ADVM Up to 40 USD.
M
ADVM - bullish harami pattern as bladed candle-
Shortseller will be toasted. See you at 10 USD per share until eastern.
IMO.
L
FDA approval! Wake up!!!
C
ADVM - 100 Percent upside potential next week!
Stock of ADVM is able to catapult PPS beyond 3.9 USD until the end of next week.
Watch and learn.
C
COVID-19 mRNA vaccines inducing retinal damage and retinal bleeding in age related maculadegeneration.
Further retinal branch vein occlusion has been observed at mRNA vaccine treated patients.
Do your own due dilligence.
W
Michael can you share what you know about this company. please don't share conclusions, share details and allow us to derive conclusions.
b
hoping to scoop shares here before it goes back up..just way over sold here.... from the bottom up to make some big money here.........
C
ADVM is extremly undervalued.
Blockbuster Potential in the AMD marcet of several billion USD a year.
Current market cap ist das xttemly Low.. Upside Potential of 35 USD within the next 24-36 months.
Watch and learn. Increasing positive divergence since more than 8 months is indicating a high upward bullmove this year into double Digit USD price range.
Above 22 USD the PPS will hit 45-75 USD.
REDWOOD CITY, Calif., Jan. 04, 2022 (GLOBE NEWSWIRE) -- Adverum Biotechnologies, Inc.(ADVM) , a clinical-stage gene therapy company targeting unmet medical needs in ocular and rare diseases, announced the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to ADVM-062 (AAV.7m8-L-opsin), a novel gene therapy product candidate being developed as a potential single intravitreal (IVT) administration for blue cone monochromacy (BCM) by delivering a functional copy of the OPN1LW gene.
“We are excited to introduce ADVM-062, which builds on our ophthalmology and gene therapy expertise to address the significant unmet medical needs of patients living with blue cone monochromacy. We are pleased the FDA has recognized the patient need by granting Orphan Drug Designation and we look forward to advancing ADVM-062 towards the clinic and generating important data,” stated Laurent Fischer, M.D., president and chief executive officer of Adverum Biotechnologies(ADVM).
BCM affects approximately 1 to 9 in 100,000 males, worldwide. This X-linked recessive hereditary condition is caused by mutations in either the L or the M opsin gene(s) and can manifest in loss of visual acuity, photophobia, myopia and infantile nystagmus that can persist into adulthood. Consequently, individuals with BCM have visual impairments to important aspects of daily living such as facial recognition, learning, reading, and daylight vision. Currently, there is no cure for BCM.
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 or disorders that affect fewer than 200,000 people in the United States. 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-062 should the company receive FDA approval for the treatment of BCM for this product candidate.
Anticipated Milestones for ADVM-062
Plan to present preclinical data supporting proof of concept of ADVM-062 in 1H2022.
Plan to submit an Investigational New Drug (IND) application by year-end 2022.
About ADVM-062 Gene Therapy
ADVM-062 is a gene therapy candidate specifically designed to deliver a functional copy of the OPN1LW gene to the foveal cones of patients suffering from BCM via a single IVT injection. ADVM-062 utilizes Adverum’s propriety vector capsid, AAV.7m8
"I’m heavily vested in this industry. Hope this helps you make informed decisions:
Since ~2001 AntiVEGF compounds started being used to treat wet AMD, and then later, numerous other vascular and diabetic diseases of the retina.
Of these, Aflibercept (Eylea - regeneron) went on to hold the largest market share since it had the best durability, equivalent or superior effect, and equivalent or inferior complications.
When Brolizumab (Beovu - Novartis) was released it was expected to wipe out Eylea’s market share given it’s higher durability and great study results. But, on wide scale use patients developed inflammatory/vascular problems.. Now some of us suspect this is not related to the formulation of the compound but instead to the high molarity of the drug compared to all previous competitors at the time.
Interestingly, there are other high molarity Intravitreal drugs on the market that ran into the same inflammatory problems leading to vasculitis, hypotony, etc. (coincidence doesn’t make fact). Indeed, ADVM made this list having this issue with it’s high dose vector treatments for Diabetic retinopathy and it dropped that arm of it’s study as a result.
Now coming down the AntiVEGF pipeline multiple companies have created viral vectors that will make host cells produce AntiVEGF. Different companies hold different rights to the AntiVEGF the host cells produce. ADVM has the right to Aflibercept (Eylea). All other companies hold AntiVEGFs that maintain minimal dominance in the current intravitreal AntiVEGF industry.
The routes of viral vector delivery include intravitreal [ADVM], suprachoroidal, and subretinal. Currently, all AntiVEGF delivery is done intravitreal so ADVM has the delivery system that could go mainstream immediately. The other two would require additional training of the physicians, however, suprachoroidal is easy to learn. (Subretinal can only be done in the OR - thus excluding the entire medical retina specialist market)
To further complicate things, the amount/molarity of viral vector needed is greater in intravitreal and suprachoroidal injections compared to the [harder] subretinal injections. Thus, the risk of inflammatory issues may likely be greater in intravitreal and suprachoroidal injections compared to subretinal..? (This is the real question that needs to be pondered about ADVM)
Coming much later down another pharma pipeline is a sustained AntiVEGF delivery system through intravitreal pellet injection. Expected to last 6 months, twice that of current intravitreal injections. Additionally the pellet delivery system has a much easier road to success given its modality has already been proven successful in the intravitreal steroid market.
However, the viral vectors could potentially last forever or at least significantly reduce the intravitreal Injections needed in the future. If successful, their ability to program cells to make AntiVEGF indefinitely make any temporary sustained release pellet obsolete.
Endpoint:
If ADVM is truly having the success it claims with it’s viral vector system for Aflibercept in treating wet AMD (without inflammation!) - then there is a high probability it will dominant the industry given its ability to easily assimilate and provide cell production of a superior AntiVEGF. (This assumes the cells have appropriate production of aflibercept compared to competitor viral vectors - ADVM data makes this seem plausible..)
My concern is that the small sample size in data is hiding the potential inflammatory fallout on a large scale. Similar to what happened with brolizumab (beovu). But if successful, this is like buying regeneron when it was 15$, but it’s on a fire sale for 2$. It’s a gamble, no doubt.
Side note:
In capitalist America - money talks. Wet AMD is the most important and first market all AntiVEGF agents seek approval for.. because Medicare will pay for it. Diabetics, especially those in need, are often younger and may not be insured thus their large market size is difficult to capitalize on monetarily. I say this in reference to ADVM dropping its diabetic arm. Dropping the diabetic arm is essentially irrelevant if they deliver on wet AMD.
That being said, this viral vector technology has the most utility in the younger poor compliance diabetic population. In the future, those are the ones whose vision will truly be saved. "
It is possible.
Take a look at the gaps in the chart.
If ADVM hits 22 USD by year end, then a big upward cycle with triple digits price in the follow up is presumably.
IMO
calling a bottom here.....
Annual globall sales of 12-15 billion USD are possisble from my point if view.
Currect Elyea revenues are at around 5 billion USDeach year at the USA
Lucentis at aorund 2 billion USD per year.
will have to pay higher prices, keep buying this will go higher....
Positive divergence is increasing since 3-4 months.
I expect a strong upward impuls at this stock.
Shortseller will be toasted. See you at 10 USD per share until eastern.
IMO.
Stock of ADVM is able to catapult PPS beyond 3.9 USD until the end of next week.
Watch and learn.
Further retinal branch vein occlusion has been observed at mRNA vaccine treated patients.
Do your own due dilligence.
please don't share conclusions, share details and allow us to derive conclusions.
from the bottom up to make some big money here.........
Blockbuster Potential in the AMD marcet of several billion USD a year.
Current market cap ist das xttemly Low.. Upside Potential of 35 USD within the next 24-36 months.