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RMB. P2 DME data due this month ( May ) . Long shot but theres some leading edge eye disease KOL's involved with this trial
Kiwi
Caddie ...After approval of the Marine indication mid 2012 the Ceo at the time floated 3 options ...sell the co , partner with a BP or GIA ( go it alone ) .
12 weeks went by as the Ceo ( Z ) explored these options and when no buyer or partner emerged they announced GIA and the stock tanked.
Kiwi
It's China ...it doesn't matter . They will rip it off anyway
Kiwi
Yep and it'll be a lot less expensive than Vascepa .
Meanwhile we await Denner/ Holts grand plan for cracking the remaining big 3 EU market ...where they at least have patent protection .
Kiwi
Cosa. So at least my wife's Nephrology Dept is now talking about trying Xphazoh on select patients who have very bad serum Pho numbers . Problem is they are all on Medicare or Medicaid and can't use ARDX's coupon or afford the roughly $1,000 a month copay currently required for this Tier 5 drug.
Kiwi
Mkt agrees with U . Heavy vol up around 20% as I type.
Recent funding
N7. Gr8 link
Thx
Kiwi
Hanging yourself out there FFS ...predicting breaking above the long term down trend line ( which you accurately called previously )
Good luck
Kiwi
FFS ...should we tweet out that FFS likes AMRN ?...ala Roaring Kitty likes GME ....:--)
Kiwi
I think micro caps are under $300m mkt cap ...but agree there are features about AMRN that are micro cap "ish "
You sound almost bullish on AMRN ...am I reading you correctly ?????
Kiwi
FFS
Enrollment delayed
AMRN unlikely to be a short squeeze candidate with this low amount of short interest
Short % As of Apr-30-2024. 4%
Shares short16.18 (M)+0.34 (M)
Days to cover12.88+0.34
JMO ...
Kiwi
You need very high short positions held by master of the universe hedge fund types, to effect a GME type short squeeze.
Kiwi
Jbog. re your comment
RGLS . I have a small position in this Co
Reasons for my position ?
Theres currently only 1 med available specific to ADPKD kidney disease and its poorly tolerated ( makes you pee a lot ) and not very effective.
There are around 160,000 ADPKD patients in the US and around 55% of them will have kidney failure and need dialysis by age 55.
My wife rounds dialysis clinics and writes reports on roughly 120 dialysis patients each month ..There is a high mortality rate for dialysis patients ...you can google or perplexity the numbers if you wish.
RGLS 's med slows the formation of cysts in the kidney filtration system and so far appears very safe and well tolerated.
This is P 1 data . P2 trials expected in 2025 will an expected application for accelerated approval .
So early days
Vivo Capital owns roughly 8% of the outstanding shares ( IIRC ) . Vivo specializes in a lot of niche kidney specific drugs in development ...UNCY for example
Kiwi
RMB. Thx ...Theres a lot of research going on in CKD . OT I've been doing some research on RGLS which has published some interesting clinical data recently
Kiwi
Thx Jbog Just to be clear ...and it's none of my business so ignore if necessary ...the cysts were liquid filled ? I thought that was one of the markers of ADPKD
In case anyone should venture here
Whalatane
Member Level
Re: None
Monday, May 13, 2024 6:59:02 PM
Post# of 251809
UNCY pivotal trial update
“This is an exciting time for Unicycive as we progress towards the conclusion of our pivotal clinical trial for our lead asset oxylanthanum carbonate (OLC),” said Shalabh Gupta, M.D., Chief Executive Officer of Unicycive. “The trial is evaluating the tolerability, safety, and pharmacokinetics of clinically effective doses of OLC in patients with chronic kidney disease (CKD) on dialysis and it remains on track with topline data expected later this quarter.
UNCY pivotal trial update
“This is an exciting time for Unicycive as we progress towards the conclusion of our pivotal clinical trial for our lead asset oxylanthanum carbonate (OLC),” said Shalabh Gupta, M.D., Chief Executive Officer of Unicycive. “The trial is evaluating the tolerability, safety, and pharmacokinetics of clinically effective doses of OLC in patients with chronic kidney disease (CKD) on dialysis and it remains on track with topline data expected later this quarter.
From ER
“This is an exciting time for Unicycive as we progress towards the conclusion of our pivotal clinical trial for our lead asset oxylanthanum carbonate (OLC),” said Shalabh Gupta, M.D., Chief Executive Officer of Unicycive. “The trial is evaluating the tolerability, safety, and pharmacokinetics of clinically effective doses of OLC in patients with chronic kidney disease (CKD) on dialysis and it remains on track with topline data expected later this quarter.
Newman. My guess is that its positioning in advance of the expected UK approval of the share buyback
Share buybacks can positively impact a company's stock price through several mechanisms:
Increased earnings per share (EPS): By reducing the number of outstanding shares, the company's earnings are divided among fewer shares, resulting in a higher EPS. A higher EPS can make the stock more attractive to investors and drive up the share price.
Increased demand: When a company repurchases its own shares, it creates additional demand for those shares in the market, which can lead to an increase in the stock price.
Signaling effect: Share buybacks can be interpreted by investors as a signal that the company's management believes the stock is undervalued. This positive signal can boost investor confidence and drive up the stock price.
Increased ownership stake: As the number of outstanding shares decreases, the remaining shareholders' ownership stake in the company increases proportionally. This can make the stock more valuable to investors.
Improved financial metrics:
Share buybacks can improve financial metrics such as return on equity (ROE) and return on assets (ROA), making the company more attractive to investors and potentially increasing the stock price.
Vin re RGLS . I have a small position in this Co and am also interested in why Jbog is high on it ?
Reasons for my position ?
Theres currently only 1 med available specific to ADPKD kidney disease and its poorly tolerated ( makes you pee a lot ) and not very effective.
There are around 160,000 ADPKD patients in the US and around 55% of them will have kidney failure and need dialysis by age 55.
My wife rounds dialysis clinics and writes reports on roughly 120 dialysis patients each month ..There is a high mortality rate for dialysis patients ...you can google or perplexity the numbers if you wish.
RGLS 's med slows the formation of cysts in the kidney filtration system and so far appears very safe and well tolerated.
This is P 1 data . P2 trials expected in 2025 will an expected application for accelerated approval .
So early days
Vivo Capital owns roughly 8% of the outstanding shares ( IIRC ) . Vivo specializes in a lot of niche kidney specific drugs in development ...UNCY for example
Kiwi
Chromosome , isn't the market in Canada split between Cardiologists and Primary Care with PFE only marketing to Primary Care ?
It would seem that since the R-IT trial was mostly secondary prevention CAD patients ...Cardiologists would be the main market .
Primary Care have enough trouble keeping their CAD patients on Statins which are very low cost and in the case of Crestor at least ...small pills and only once a day .
Secondary prevention patients ( prior MI , stroke etc ) are probably more willing to add 4 large caps to their daily med routine .
But IMHO all this is largely irrelevant to AMRN's bottom line .
Their main challenge is to gain more reimbursements in the EU and ramp up sales there before US revenue declines any faster then already seen in Q1 numbers
Kiwi
Nope ...good news for the new weight loss drugs
Now if Vascepa could be proven to reduce obesity ...then you're talking
Kiwi
Ram. it typically takes 1-5 yrs to get a patent on a drug . You're dealing with prior art and USPTO actions .
IIRC in the 2010 / 2011 period the patent office originally rejected the Marine patent . Eventually it was approved because AMRN could prove that Vascepa ( AMR101 at the time ) was DEVOID of DHA . Epadel by contrast has up to 10% DHA .
Poster North may have a better memory of this period.
AMRN doesn't have this time if they continue on their current path and especially if they use $50m on a share buyback.
The reality is that revenue in the US is crashing and revenue growth in the EU is minuscule .
And so far mgt has yet to come up with an effective plan to convince the market , they can change that .
Which is why the PPS is under $1.
JMO
Kiwi
Because Dr Ketchum probably knows this already ...and knows AMRN will not spend time and $ on pursuing this since for one thing they would need to prove it better than an EPA/DHA combination .
A network meta-analysis study provided compelling evidence that high-dosage EPA/DHA (omega-3 fatty acid) supplementation can be considered a first-choice treatment for migraine prophylaxis.
Another study found that high-dosage omega-3 fatty acids, including EPA/DHA, outperformed existing pharmacological options for migraine prophylaxis. The researchers concluded that EPA/DHA supplementation can be considered as a first-choice treatment for migraine prevention.
A review article discussed the potential therapeutic role of omega-3 fatty acids, including EPA, in the treatment of migraine through their anti-inflammatory effects. The review highlighted several clinical studies examining the use of omega-3 fatty acids, either alone or in combination with other substances, for migraine treatment.
In summary, the search results indicate that multiple studies have investigated the use of EPA, either alone or as part of omega-3 fatty acid supplementation, for the treatment and prophylaxis of migraine.
Capt. I believe thats a lot of Prior Art regarding Omega 3's and migraines ...so patent protection might be a challenge.
The exclusivity route ...see previous posts .
Great graphics tho
Kiwi
So I'll answer my own question about lack of patent protect for the migraine indication...exclusivity is an option
Based on the search results, the key differences between patents and regulatory exclusivity for drugs are:
Patents are granted by the U.S. Patent and Trademark Office and protect the intellectual property of the drug inventor, typically lasting 20 years from the filing date. Exclusivity is granted by the FDA upon drug approval and prevents competitors from submitting generic or similar versions for a specified period of time.
Patents can be obtained at any stage of drug development, while exclusivity only comes into play after the drug is approved by the FDA.
Exclusivity periods are typically shorter than patent terms, ranging from 3-12 years depending on the type of exclusivity (e.g. new chemical entity, orphan drug, pediatric).
Patents can be challenged and invalidated, while exclusivity is more secure and guaranteed as long as the statutory requirements are met.
Patents and exclusivity can run concurrently, but exclusivity often expires before the patent term ends. The expiration of the later of the two is what determines when generic competition can enter the market.
In summary, patents and exclusivity serve complementary but distinct purposes in protecting drug products, with exclusivity providing an additional layer of protection beyond just the patent term. The interplay between the two is complex but critical for understanding the timing of generic drug entry.
Capt. What would you have AMRN do with this info ?
AMRN doesn't have any patents covering composition or method of action for treating migraines that I'm aware of .
The trial was run using Epadel ...and it only enrolled 70 people using a drug not FDA regulated
Studies a U.S. FDA-regulated Drug Product: No
FFS. re this post
Combine that behavior with the noted indicator reversals and we have the TA ingredients for powerful move
Price. 0.8741
RMB. I think we are due for data from the LYNX trial
, Edgewise Therapeutics expects to report 3-month data from the Phase 2 LYNX trial for EDG-5506 in the second quarter of 2024. The LYNX trial is a Phase 2 dose-ranging study to evaluate the safety and efficacy of EDG-5506 in patients with Duchenne muscular dystrophy (DMD).
Prior Art on EPA for Migraine Relief
A 12-week randomized, single-blind clinical trial found that dietary supplementation with fish oil, which contains EPA, led to a reduction in the number of headaches per month in patients with chronic migraine. The authors suggest this beneficial effect could be due to decreased production of pro-inflammatory molecules like prostaglandins, leukotrienes, and cytokines.
A randomized controlled trial published in The BMJ in 2021 looked at 182 people with chronic migraines. Participants on diets high in EPA and DHA (1.5 grams total per day) from fish had 30-40% fewer headache days per month and headache hours per day compared to those on a control diet low in EPA/DHA.
Another study found that 2 months of supplementation with 1 gram of omega-3 fatty acids, which are primarily EPA, significantly decreased the frequency and duration of migraines, with patients reporting a 74% reduction in headache duration.
The mechanisms by which EPA may reduce migraines include its anti-inflammatory effects, modulation of pain-regulating oxylipins, inhibition of vasodilation, and reduction of nociceptive (pain) responses in the brain.
However, some earlier studies did not find a significant difference in migraine outcomes between omega-3 supplementation and placebo. Overall, the evidence suggests EPA from fish oil has promise as a migraine treatment, but more research is needed to confirm its efficacy.
Congrats on your Gr8 find / hold
Kiwi
They don't have any patent protection for use in treating migraines ( no method of action or composition of matter patents ) ...so I'm sure the generics and supplement Co's would love AMRN to waste time and $ on such a study .
Kiwi
Thx Dew. Do U use Perplexity at all ?
A quick search on the difference between Eyepoint and Ocular
Answer
Eyepoint Pharmaceuticals and Ocular Therapeutix are two different pharmaceutical companies focused on developing treatments for various eye diseases:
Eyepoint Pharmaceuticals is focused on developing sustained-release intraocular drug delivery products, including YUTIQ® for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye and EYP-1901, an investigational sustained delivery intravitreal anti-VEGF treatment for wet age-related macular degeneration.
Ocular Therapeutix is a biopharmaceutical company developing transformational treatments that enhance vision and quality of life through consistent and sustainable drug delivery, including for retinal diseases, glaucoma, ocular surface diseases, and ophthalmic surgery.
The key differences are:
Product focus - Eyepoint is focused on posterior segment eye diseases like uveitis and wet AMD, while Ocular Therapeutix has a broader portfolio across retinal, glaucoma, ocular surface, and surgical applications.
Drug delivery technology - Eyepoint utilizes its proprietary Durasert® technology for sustained intraocular drug delivery, while Ocular Therapeutix has its own ELUTYX™ technology platform.
Commercialization - Eyepoint has two commercial products, YUTIQ and DEXYCU, while Ocular Therapeutix is still in the clinical development stage for most of its pipeline.
In summary, while both are ophthalmology-focused pharmaceutical companies, they have distinct product portfolios, drug delivery approaches, and stages of commercial development.