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REGENXBIO Inc. (RGNX)
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Zolgensma update from Novartis as of Sept 23, 2020.
Novartis Provides Update on AVXS-101 Intrathecal Clinical Development Program | Novartis
RGNX seems very undervalued to me at these levels. Last sold at about $49. Finally bought back today, at 26.50. If it goes much lower, I'll add more. Longer-term, getting in at the current price appears to be a no-brainer.
It doesn't look like there are any near-term catalysts here. Hard telling how far down we go. They need some good news and positive updates for ongoing trials.
Good news this morning regarding RGX-314 for Diabetic Retinopathy. I am looking forward to data for WMD with Suprachoroidal Delivery later this year. Those data will be very important. Good data will propel stock substantially higher by December. It will also be a good precursor for data for Diabetic Retinopathy next year.
Buy zone was below 30$ mark grabbed another 450 shares yesterday now riding close to 2K shares. Once we get the wet AMD data out closer to the last part of the year we are going to fly I believe. If we get a home run on the wet AMD data sky is the limit BO offers would be dropped in my opinion. This is not a crowded space and Eylea by Regeneron and Lucentis by our partner Novartis both have multiple visits and injections with anti-VEGF ab treatment. Ours is once which is why we have the best option in my opinion that is if we get a grandslam on the data. We also have Zolgensma and milestone payments starting to kick in soon hopefully on 1 billion sales. REGN or NVR better get their action together :)
When will Novartis purchase rgnx...it would make a lot of sense and Tinos bargain.
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Regenxbio is down 7.54% to 26.72
I have two really bad stocks in my portfolio spwr and this one. I've stopped selling covered calls which I have been selling the last two years which has limited my losses. I am no longer selling covered calls in either one.
Chardan lowered the price target on RGNX from $150 to $100 following today’s RGX-314 trial update.
They have the cure for wet AMD.
bullish falling wedge, buy
Still holding but big loss...disappointed
We look like we are in a new basing pattern. Support in the $35 - $36 range. Resistance in the $43 range. Let's see if we get back down to $36 and bounce off. We need to breakout above $43 and see this thing run.
ADVM gave an update on their wet AMD programme: similar/better compared to RGNX data but I believe they (=ADVM) are >6months behind...
Zolgensma 2Q sales are $205 million.
My #1 Mid-Cap Biotech Stock Pick For 2019
June 10, 2019 by Sultan Beardsley Leave a Comment
The four qualities that I assign the most weight when evaluating a biotech company for viability is 1) An efficacious product 2) Sufficient funding 3) Competent leadership and 4) Relationships with big pharma. Generally speaking, when these qualities converge a company should succeed. Until the 1987 stock market crash it was widely accepted that the market was efficient; meaning that stocks traded at fair value. But, after the market shed 20% of its capitalization in a single day, that assumption went out the window.
Regenexbio (RGNX) is a company that emulates the aforementioned qualities and I believe is priced incorrectly by an inefficient market. I say this with a smile. Market inefficiencies are what makes it possible to have an “edge” in trading and investing. By identifying moments of deviation from fair value (above or below) we can capitalize (long or short) on the inevitable correction back to equilibrium. For these reason, I believe accumulating shares of RGNX now will pay off massively in the next 1-2 years.
REGENXBIO is a revenue generating clinical-stage biotechnology company. Using their proprietary NAV vector platform technology RGNX is developing curative gene therapies for an array of disease. The technology was first discovered in the lab of Dr. James Wilson at the University of Pennsylvania. In 2009 RGNX secured the intellectual property (IP) rights to the adeno-associated virus (AAV) Dr. Wilson was experimenting with. Not long after, RGNX licensed their AAV9 vector to AveXis Biotechnology, who was acquired by Novartis (NVS) in 2018 for $8.7 billion.
Presently, RGNX holds exclusive rights to over 100 AAV vectors. In addition to developing gene therapies internally, RGNX generates revenue from licensing agreements. As of March 31st, 2019 more than 20 product candidates were being developed through partnerships with 11 licensees. Big pharma names aside from Novartis, are Takeda (TKPHF) and Biogen (BIIB). This spells significant potential upside for RGNX via milestone payments, royalties, and sub-licensing fees.
RGNX 1-Year Chart From Trading View
NAV Vector is A Validated Gene-Therapy Platform
As I discussed in my previous article “Could This Biotech Stock Get Bought For $5.5 Billion? Either Way I’m Buying It” FDA approval of Novartis’s (NVS) gene therapy, Zolgensma, for spinal muscular atrophy (SMA), validated RGNX’s gene therapy platform. Investors now have material proof that RGNX’s NAV vector platform can yield a commercial gene therapy product. With the risk of platform failure abated I feel confident in the probability of success of RGNX’s internal programs, and those of its licensees.
The fact that Novartis is licensing a product from Regenxbio should not be glossed over. The implication is that high caliber scientist at Novartis saw enough potential in AAV9 to pay RGNX to license it over alternatives (such as develop their own product or license other technologies). I imagine the license agreement between RGNX and AveXis played a significant role in Novartis’s decision to buy AveXis. It looks like Novartis management can pat themselves on the back for that one. They now own the most expensive drug in the world priced at $2.1 million!
RGNX now has its first commercial revenue stream. Additionally, Zolgensma is up for approval in Europe and Japan. I’d bet that if it is approved in these regions that RGNX will get another milestone payment on top of the $3.5 million it received from FDA approval of Zolgensma. Moreover, RGNX is about to enjoy high single to low double digit royalty payments from Zolgensma sales, and an $80 million milestone once Novartis banks $1 billion in sales. All-in-all, RGNX has earned $190 million to date from AveXis in relation to Zolgensma.
RGNX Therapeutic Programs
RGNX has four phase 2 internal developmental stage product candidates. The one with the most eyes on it is RGX-314, which is targeting wet age-related macular degeneration (wet AMD). Wet AMD is an eye disease that causes blurred vision, the formation of blind spots, and blindness. Disease pathology is generally linked to leaky blood vessels. Current treatment options (Eylea, Lucentis, and Avastin) require eye injections every 4-8 weeks. If successful, RGX-314 would alleviate this burdensome regimen by providing a one-time treatment option. Thus, has monstrous disruptive potential.
Roche Holdings (RHHBY) and Regeneron (REGN) own the rights to Lucentis and Eylea, respectfully. Interestingly, Novartis own exclusive commercial rights to Lucentis outside of the U.S. The way I see it, if the phase 2 data is compelling, there will be a race to either acquire RGNX, or license RGX-314. Either option would enable the suitor to enjoy a sizable market opportunity. According to a 2019 research report from Prescient & Strategic Intelligence, the global wet-AMD market is g
Negotiations with payers are in advanced stages, but final pricing will only be set after the drug's approval. Novartis has offered payment alternatives, such as reimbursement in installments over three to five years, or providing discounts if a patient does not see specific benefits from the therapy.
Most payers, however, are focused on a one-time payment and seek discounts to secure reimbursement, Lennon said.
Novartis expects to have agreements with insurers covering 30% of the 160 million Americans who have commercial health plans within 30 days of Zolgensma's approval, he said.
The therapy is key to Novartis Chief Executive Vas Narasimhan's push into treatments for rare diseases. Wall Street analysts forecast Zolgensma sales of $350 million this year, rising to $2 billion in 2024, according to Refinitiv data.
Regenxbio: A Stellar Gene Therapy Innovator With Multiple Upsides
May. 1, 2019 1:51 PM ETREGENXBIO Inc. (RGNX
I highly recommend all read this balanced depth article about RGNX. Values company at 181 three to four years out and provides excellent risk / reward analysis while addressing multiple risks including the second infant death and Zolgensma approval and roll out. The “crown jewel is RX-314 for wet AMD with a market opportunity much bigger than SMA.....Be patient longs
Gene therapy may have its first blockbuster
Novartis awaits approval to sell Zolgensma to treat spinal muscular atrophy.
by Antonio Regalado May 23, 2019
A newborn. A fatal diagnosis. And soon, a one-time gene replacement cure in the first weeks of life.
The cost? You don’t want to know.
Gene therapy is about to achieve a milestone. As soon as tomorrow, drug giant Novartis expects to win approval to launch what it says will be the first “blockbuster” gene-replacement treatment. A blockbuster is any drug with more than $1 billion in sales each year.
The treatment, called Zolgensma, is able to save infants born with spinal muscular atrophy (SMA) type 1, a degenerative disease that usually kills within two years. But its expected cost is shocking, too: between $1.5 and $2 million, which would make it the most expensive one-time medicine ever sold.
Novartis will announce the price as soon as it gets final approval from the US Food and Drug Administration, something the company expects to occur this week.
Gene therapy uses viruses to insert healthy genes into patients’ cells, but the growing success of the concept may bring a reckoning for US health care.
The FDA predicts that by 2025 between 10 and 20 gene or cell treatments will reach the market each year, potentially roiling the US insurance market if costly treatments for hemophilia and muscular dystrophy win approval.
“The issue with many of these drugs is that they are expensive but also life-changing for those who need them,” says Michael Sherman, chief medical officer of the insurer Harvard Pilgrim Health Care, who has been negotiating with Novartis. “For this and other gene therapies coming down the pike, it’s not about saying no, but how do you say yes without bankrupting the system?”
Executives with Novartis say their SMA drug launch will include programs to help insurers pay, including a prototype “pay-as-you-go” plan as well as offers to reimburse a fraction of the drug’s price if patients die or end up on a ventilator.
“We’d like to pay over time,” says Sherman, “and to stop paying if it stops working. At these ever-increasing prices, I think it’s fair to ask.”
Sherman says such novel payment concepts can’t be fully implemented until insurers agree to take on patients’ outstanding bills when they switch plans. Also, a rule guaranteeing state Medicaid agencies the “best price” for all drugs means Novartis can’t offer a full money-back guarantee.
The treatment was created by a team in Ohio, where scientists and clinicians at Nationwide Children’s Hospital tested it on children with spectacular results. The kids were injected with trillions of viruses carrying a correct copy of a gene called SMN1, which they have in a mutated form that causes loss of motor neurons in the spinal cord.
The Nationwide researcher who perfected the idea, Brian Kaspar, formed a startup called AveXis, which Novartis acquired for $8.7 billion last year. Another researcher, Arthur Burghes of Ohio State University, also played a critical role by developing a mouse with SMA, and physician Jerry Mendell led the first human studies.
Since only about 400 kids a year in the US are born with SMA the acquisition price guaranteed a sky-high price for the drug. “They can do the math,” says Sherman.
Zolgensma, when it gets the expected green light, will become the sixth gene therapy approved in the US or Europe. But some of these have struggled to reach patients. One, Glybera, was pulled from the market after being purchased only once. Another, Strimvelis, which treats immune deficiency, has been used by fewer than a dozen paying customers, in part because it involves a bone marrow transplant. A third, Luxturna, addresses an eye disease that affects very few people.
In contrast, Novartis says, the SMA treatment is already in high demand. So far, 150 patients have received the gene therapy in clinical trials or through special access programs, says David Lennon, president of AveXis. In some cases, the treatment is being given to children at six weeks of age, highlighting how soon after birth a child’s genes can be fixed.
States including Minnesota and Pennsylvania recently added SMA to a panel of diseases kids are checked for in maternity wards. As other states follow suit, that is likely to add a steady number of new candidates for the drug.
I had not heard this name mentioned before, but the QURE mb said Novo Nordisk (108B market cap) has expressed interest in buying gene therapy companies. Nova is apparently one of the world's largest insulin producers. their profile is:
Novo Nordisk A/S, a healthcare company, engages in the development, manufacture, and marketing of pharmaceutical products worldwide. It operates in two segments, Diabetes Care and Obesity, and Biopharmaceuticals. The Diabetes Care and Obesity segment provides products in the areas of insulins, GLP-1 and related delivery systems, oral anti-diabetic products, obesity, and other chronic diseases. The Biopharmaceuticals segment offers products in the areas of haemophilia, growth disorders, and hormone replacement therapy. The company has a strategic alliance with Evotec AG to discover and develop small molecule therapies to treat patients suffering from diabetes, obesity, and co-morbidities, as well as has a research collaboration with Kallyope Inc. It also has a collaboration agreement Lund University to develop stem cell-derived treatment for Parkinson's diseases; and Staten Biotechnology B.V. to develop novel therapeutics for the treatment of dyslipidaemia. The company was founded in 1925 and is headquartered in Bagsvaerd, Denmark.
If they are looking to buy, maybe they will be a suitor for RGNX. This may not be new news, but it is at least different from what we normally see on this board.
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