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EYEN" from the CEO-"Fortunately, we had taken actions throughout the development of MydCombi to minimize the impact of a potential reclassification by the FDA. We are preparing additional documentation requested by the FDA and look forward to resubmitting our NDA in early 2022 for the FDA’s review."
I have no idea(s) about what extra data they collected on the drug delivery device (their proprietary Optejet), but it is clear that the re-submission timeline now places a new PDUFA date in late 2022 at best. By that time, they should also have in the submission pipeline their pilocarpine studies.
This is now a "wait and see" investment, for sure. I don't have the time to research the specifics of the Genus Medical Technologies, LLC v. FDA, but will be looking at this case as time permits.
EYEN: Eyenovia Announces FDA Acceptance of the MydCombi NDA
EYEN
+0.51%
Tue, March 2, 2021, 6:30 AM
More content below
EYEN
+0.51%
PDUFA Date Expected 4Q 2021
Eyenovia, Inc. (NASDAQ: EYEN), a clinical stage ophthalmic biopharmaceutical company developing a pipeline of microdose array print (MAP™) therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has accepted the Company’s New Drug Application (NDA) for MydCombi™, a unique fixed combination mydriatic (pupil dilation) agent for potential use in the over 80 million comprehensive eye exams currently conducted each year in the United States. If approved, MydCombi would be the first microdosed ocular therapeutic applied with a high precision smart delivery system, the Optejet®.
"We are excited to see MydCombi, with our proprietary microdose array print technology, move closer to potential approval, with an expected PDUFA date in the fourth quarter of this year. MydCombi may address many of the current shortfalls of pupil dilation, which according to market research may be responsible for millions of people choosing not to undergo a comprehensive eye exam," said Dr. Sean Ianchulev, Chief Executive Officer and Chief Medical Officer of Eyenovia. "If approved, we believe MydCombi would provide patients with one of the biggest advances in clinical mydriasis in the last few decades."
https://finance.yahoo.com/news/eyenovia-announces-fda-acceptance-mydcombi-123000760.html
EYEN: Delivered on time by management.
"Eyenovia Submits New Drug Application to FDA for Pharmacologic Mydriasis with MydCombi Targeting 80 Million Patient Encounters in the U.S. Annually"
Tue, December 29, 2020, 6:00 AM CST
Eyenovia, Inc. (NASDAQ: EYEN), a clinical stage ophthalmic biopharmaceutical company with Phase 3 programs in presbyopia, myopia and mydriasis, today announced that it has submitted a New Drug Application (NDA) to the U. S. Food and Drug Administration (FDA) for MydCombi™, a unique fixed combination mydriatic (pupil dilation) agent. If approved, MydCombi would be the first microdosed ocular therapeutic with a high precision smart delivery system.
The NDA submission follows the initial enrollment of the VISION-1 study, Eyenovia’s Phase 3 study for MicroLine in presbyopia, with top-line data expected the first half of 2021.
MydCombi was developed to address several needs of the eye care practitioner’s office. Pupil dilation is conducted during most of the estimated 80 million office-based comprehensive and diabetic eye exams performed in the U.S. annually. The current standard of care for pupil dilation requires multiple eye drops given at least several minutes apart, which can take considerable time and often cause both discomfort and drug overflow. The design of eyedroppers also lends itself to the possibility of inadvertent contact with the eye itself, which may be an issue as the same eyedropper bottle is often shared among a number of patients. In contrast, MydCombi is delivered by Eyenovia’s proprietary Optejet® dispenser, designed to ensure consistent and easy application of two mydriatic medications in a quick, touchless micro-mist application. The product is also designed with no protruding parts, which may help prevent accidental touching of the ocular surface.
"The NDA application for MydCombi represents a milestone for Eyenovia. It is the first of our three late-stage programs to complete Phase 3 studies leading to this FDA submission, which not only validates our platform technology, but also demonstrates the passion and tireless efforts of all Eyenovians. If approved, MydCombi could be available late next year or early 2022 and improve a common clinical practice that has not advanced in nearly a century," said Dr. Sean Ianchulev, Chief Executive Officer and Chief Medical Officer of Eyenovia. "MydCombi, delivered by our proprietary Optejet touchless dispenser, may have several advantages over the current standard of care for in-office mydriasis that are especially important in today’s environment. With no protruding parts and recessed nozzle and shutter, Optejet’s design enables touch-free mydriasis and helps reduce the risk of cross contamination."
https://finance.yahoo.com/news/eyenovia-submits-drug-application-fda-120000940.html
EYEN: Inasmuch as each indication being studied requires to be thoroughly evaluated, I agree. However, the point I (and the company, i suspect) is trying to make is that this is a new delivery device that does not require any review process. Once the device has established itself in the marketplace, what barriers to allowing its use to deliver established ophthalmologic solutions to the eye will there be? If there are no barriers, there may be any number of uses for the optejet in the clinic and demand may be strong to cross over from old technology (eye droppers) to this new technology.
EYEN: Some detailed coverage of the company. The following is a "buried gem", IMO, about the optejet, "The Optejet micro-array print delivery platform is not regulated as a medical device or drug-device combination, which streamlines the therapeutic registration process."
Eyenovia micro-array print therapeutics targeting various ophthalmic indications
https://biotuesdays.com/2020/05/05/eyenovia-micro-array-print-therapeutics-targeting-various-ophthalmic-indications/
ABBV phase-3 trials in presbyopia hit primary endpoint
Interesting, might be why EYEN is pushing harder on the Myopia trial and partnering with Bausch and Lomb for this application.
"Bausch Health Licenses Eyenovia's Investigational Treatment For The Reduction Of Pediatric Myopia Progression In Children Ages 3-12"
https://www.prnewswire.com/news-releases/bausch-health-licenses-eyenovias-investigational-treatment-for-the-reduction-of-pediatric-myopia-progression-in-children-ages-3-12-301149863.html
EYEN: Bausch Health Licenses Eyenovia's Investigational Treatment For The Reduction Of Pediatric Myopia Progression In Children Ages 3-12
Under the terms of the licensing agreement, Bausch Health will make an upfront $10 million payment to Eyenovia upon signing and will assume oversight and costs related to the ongoing Phase 3 CHAPERONE clinical trial. Eyenovia is eligible to receive up to $35 million in additional payments based on approval- and launch-based milestones, as well as royalties ranging from mid-single digit to mid-teen percentages of gross profit on sales in the United States and Canada.
https://finance.yahoo.com/news/bausch-health-licenses-eyenovias-investigational-110000815.html
EYEN IMO, a reasonable sale to flesh out their coffers in advance of the pending NDA and move to marketing their first product. Shares issued remain low (now around 24 million) and the float is only 13.18 million. As of this post (2:30 central) shares are trading well above the issue price ($3.73), a good sign from where I sit. I bought a substantial amount to add to my holdings this morning.
GLTA
AJ
EYEN "Eyenovia and Arctic Vision Announce Exclusive Collaboration and License Agreement to Develop and Commercialize MicroPine and MicroLine in Greater China and South Korea"
NEW YORK and SHANGHAI, China, Aug. 11, 2020 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), a clinical stage ophthalmic biopharmaceutical company developing a pipeline of microdose array print (MAP™) therapeutics and Arctic Vision, a clinical stage biotech company focused on developing and commercializing innovative ophthalmology therapies in China and Asia, today announced that they have entered into an exclusive license agreement for Arctic Vision to develop and commercialize MicroPine for the treatment of progressive myopia and MicroLine for the treatment of presbyopia in Greater China (mainland China, Hong Kong, Macau and Taiwan) and South Korea.
Under the terms of the agreement, Eyenovia may receive up to a total of $45.75 million in upfront payments as well as additional payments, based on various development and regulatory milestones, including the initiation of clinical research and approvals in Greater China and South Korea, and development costs. In addition, Arctic Vision will purchase its supply of MicroPine and MicroLine from Eyenovia or, for such products not supplied by Eyenovia, pay Eyenovia a mid-single digit percentage royalty on net sales of such products, subject to certain adjustments. Eyenovia will pay a mid-double digit percentage of such payments, royalties, or net proceeds of such supply to its Asian licensee pursuant to the arrangement by which Eyenovia reacquired rights to such products in Greater China and South Korea from the original licensee.
“This licensing agreement with Arctic Vision grows our commercial reach to address some of the largest progressive myopia markets in the world,” commented Dr. Sean Ianchulev, Eyenovia’s Chief Executive Officer and Chief Medical Officer. "With the continued validation of our therapeutic approach, the agreement also provides non-dilutive capital to further support our planned launch of MicroStat in the United States next year, as well as the ongoing development of our late stage ophthalmology pipeline including MicroPine for progressive myopia and MicroLine for improvement in near vision.”
Eddy (Hoi Ti) Wu, Ph.D., Founder and CEO, Arctic Vision added, “Eyenovia is a leader in the field of novel microdosing technology to treat myopia and presbyopia and we are committed to accelerating the development of MicroPine and MicroLine in Greater China and South Korea. In Asia, it is estimated that up to 50% of children in some regions are myopic, and the figure is increasing. On the other end of the spectrum, many people over the age of 40 are gradually suffering from age related presbyopia, which is currently corrected exclusively with medical devices or surgery-based modalities. We believe MicroPine and MicroLine have the potential to address the needs unmet by conventional eye drops and can play an important role in growing Arctic Vision’s innovative pipeline. Through this new partnership, we believe we can lead the Chinese ophthalmology market into the future.”
https://finance.yahoo.com/news/eyenovia-arctic-vision-announce-exclusive-120000011.html
EYEN Stock here has been experiencing a technical breakout from a recent low of $2.66 to today's current $4.13. 3 days of 6-10X volume on no official news except from two weeks ago when they announced that they were re-starting their atropine study enrollment for progressive myopia in children. This had been halted secondary to COVID issues. In the background, the company had reported their expectation to file the NDA for Mydriasis indication in 2H 2020 for in-clinic dilations.
The nice under-the-radar aspect of this company is that all of their treatments come with their patented piezo-electric microdosing system, the first real advancement of administration since the invention of the eye dropper. There is no news/information on pricing of the device.
Keep an eye on this company, shared issues are low and the float is low, news may move it in big steps.
AJ
Drug price reform: Hello Geoff, good to see you are still around lurking. I have no issues with your post. I'd want to add that the issue of price gouging for established drugs is more likely driving the populist rage with regard to this issue. Pricing on standard and old drugs like insulin and epipens has skyrocketed, generating the push for reform.
SPPI- Spectrum is a dog. It has over-promised and under-delivered for years. Dead-cat bounce? Yeah, maybe, but this is not a stock I'd consider after watching my investment do nothing but shrink, and shrink some more several years ago.
EYEN: This has traded in a range for the past couple of months. They are in process of submitting the NDA for in-clinic Mydriasis, which should be any easy win. The company is still strictly clinical development with no sales force or stated roll-out plans, by CEO, Dr. Sean Ianchulev, was a lead developer for Lucentis, is on faculty at UCSF. I'm confident that this company will move past a pure development stage to commercialization and it is likely (IMO) that the company has well-developed plans for this that they are keeping close to the vest until the NDA is accepted. I doubt that there will be a true breakout until that is announced.
NEO Beats on revenue estimates by $5+ million, earnings of 7c/share (GAAP, in line with estimates) and is hitting on all cylinders.
Third-Quarter Highlights:
Consolidated revenue increased 51% to $104.7 million
Clinical Services revenue increased 56% to $92.6 million
Pharma Services revenue increased 26% to $12.1 million
Pharma Services backlog increased 22% to $118.3 million
Gross profit increased 57% to $50.8 million
Full-year 2019 guidance increased
The company has revised revenue estimates up (again), and hs solid earnings profile.
https://finance.yahoo.com/news/neogenomics-reports-51-revenue-growth-110000433.html
NEO CC Highlights: "Revenue per test increased 12% over the second quarter of 2018, marking the fourth straight quarter in which revenue per test has increased year-over-year. We also achieved very strong growth in our Pharma Services Division, with revenue up 55% year-over-year to a record $12.7 million. We signed $20 million of new contracts during the quarter, and our backlog was up 18% year-over-year to $106 million. We drove growth across all testing platforms and are seeing an increase in Phase II and Phase III trials being placed with us."
"Adding to our global footprint, we recently opened our new lab in Singapore and are working on plans for a laboratory in China in 2020."
"Pharma Services revenue increased 55% to almost $13 million, which is the new high watermark for the division and was ahead of our internal projections."
"Combined gross profit increased by $18 million to $49 million, up 60% from the prior year. This increase represents a 54% contribution on the $34 million of revenue growth."
"Notably, our Pharma Services gross margin was outstanding, reaching 50% for the first time ever."
"As we have discussed on previous calls, our capabilities with regard to companion diagnostics are unique and powerful. We have wide scale and scope across pharma and clinical markets, a broad reach to oncologists and pathologists and access to a massive quantity of oncology-specific test result data."
" I believe right now, we have something like 30 projects with pharma companies in our Pharma pipeline for companion diagnostic test. "
"Our organic growth as a company was in the range of 20% for the quarter. So there's really very strong momentum, and we're trying to be prudent with our guidance."
"Right now, we're more focused on our M&A opportunities in the Pharma business. We have got an integration going on in our clinical business. So we've got -- our cup is full on that one. But there are some very interesting things that we're looking at in the pharma side and we'll continue to pursue those. If we can find the right opportunity with the right cultural fit and the right economics, we would be all in."
I looked carefully at what might be considered downside news in the CC and there was precious little to report. I would, however, note that management reported that the Physician Fees are projected to drop 1-3% (which they report is not significant) and that they will be spending $50-60 million on a new "home office/lab" in FL. They recently raised $150 million by issuing shares and have a new credit facility of $250 million. They reported that the cash raised by the stock offering was NOT going to be used for construction, and, as can be gleaned from one of the above quotes, it appears that they are shopping for a Pharma co. purchase.
https://finance.yahoo.com/news/edited-transcript-neo-earnings-conference-211546246.html
LJPC H.C. WAINWRIGHT CALLS LJPC A "BUY" ON DRUG DATA
"Fellow biopharmaceutical concern La Jolla is seeing a surge, as well, after the company reported positive data for its experimental hereditary hemochromatosis (HH) treatment, LJPC-401, in a mid-stage trial. The news has LJPC stock vying for its highest close in over five months, and its biggest one-day jump since 2012, surging 86% to trade at $10.25, at last check. Plus, the equity is testing resistance at its 180-day moving average after briefly trading atop it earlier today, for the first time since its peak last August.
LJPC's surge had H.C. Wainwright chiming in, lifting its price target to $27 from $25, while maintaining its "buy" rating. The analyst's price target is the highest on Wall Street, but analysts are anything but bearish on the pharma name. La Jolla currently boasts a consensus 12-month target price of $19.50 -- about a 90% premium to current levels. Plus, 80% of the analysts following the stock dub it a "strong buy."
Options buyers are in a frenzy over La Jolla stock, too. Currently 15.3 million contracts have crossed the tape, an eyebrow-raising 52 times the intraday amount. It looks like the June 8- and 9-strike puts are getting the most action, with majority of contracts being sold to open."
(I don't own this stock but have it on my tracking list. The jump today is considerable, nearly a double from it's recent levels, but well below the $30/share value just over a year ago.
https://www.schaeffersresearch.com/content/news/2019/06/06/2-pharma-stocks-surging-on-drug-data
(ALNY)—How big is the “residual” hypertension market
In my little corner of the world down in the south, where a good portion of my patients are treated for HTN with a polypharmacy approach, I have no doubt that if the drug is safe and effective, it will be used.
JM2C
aj
EYEN: Had some time to do a little digging on the people running the company. It was not difficult to be impressed and allay any reservations that the co. is just a shell. Read the following from Bloomberg's public website on the CEO, Dr. Tsontcho Ianchulev.
"Dr. Tsontcho Ianchulev also known as Sean, M.D., MPH, has been Chief Executive Officer, Chief Medical Officer and Director at Eyenovia, Inc since March 12, 2014 and served as its Managing Director. Dr. Ianchulev served as Chief Medical Officer, Head of technology and business development and Vice President of Medical Affairs & Business Development of Transcend Medical, Inc from 2009 to February 2016. Dr. Ianchulev is the President of the KeepYourSight.org foundation. He serves on the faculty of the University of California San Francisco as a Clinical Assistant Professor. He is a prolific inventor, innovator, physician-executive and public health expert with deep life- science and medical technology expertise covering the spectrum of biotech and med-tech. As an innovator and technology developer, he has been at the core of medical products and technologies which have transformed the ophthalmic field and are impActing medical care for hundreds of thousands of patients every year. As the Founder of Eyenovia, Dr. Ianchulev is also spearHeading new technology for piezostatic high-precision micro-therapeutics and as the Founder of Iantech, Inc. he is the inventor of micro-interventional, energy-free, phaco-fragmentation for cataract surgery. He served as a Venture Partner at Tullis Health Investors Inc. which he joined in 2008. He served as an Advisor of Tullis Health Investors Inc. also served as a Member of Advisory Board of the firm. In this role, Dr. Ianchulev Headed clinical development and medical affairs activities and was instrumental to the launch and success of Lucentis. He led a team of medical Directors and Scientists and oversees the clinical development and medical affairs activities in the ophthalmology group. He was the Founder of the Peristat Group, Inc, and was instrumental in the development of one of the few virtual diagnostic devices to receive FDA clearance for population screening via telemedicine and developed the first diagnostic device for remote telemonitoring of visual function and disease management of patients with glaucoma and macular degeneration. Dr. Ianchulev has over 15 years of experience in public health, life-science and medical technology. He was a Therapeutic Area Head in the Specialty Bio-Therapeutics and Non-Oncology Development organization at Genentech. Dr. Ianchulev was the Group Medical Director for the ophthalmology division and the Lucentis franchise at Genentech. While at Genentech, he Headed the ophthalmology research group and directed the development and the FDA approval of Lucentis, the most successful specialty biologic in the field of ophthalmology with more than $4Bn of annual sales. He is also the inventor of the first ophthalmic intraoperative biometry device, ORA - intraoperative aberrometry for high precision, infrared laser-guided cataract surgery, which dramatically improved the outcomes of cataract surgery with more than half a million patients treated to date. He was the patent holder and technology Founder of Wavetec Inc., which was acquired by Alcon/Novartis. In the glaucoma field, Dr. Ianchulev leads all the research and development efforts of the first suprachoroidal micro-stent (CyPass). He has been at the forefront of the next generation MIGS (Micro- Incisional Glaucoma Surgery) innovation and oversaw one of the largest glaucoma surgical research programs. For his leadership in public health, innovation and medicine, he was an invited expert by Congress during the deliberations on medical innovation and FDA regulation. He is a holder of multiple issued and pending patents. Dr. Ianchulev has multiple high-impact publications in the field, which have been cited by more than 2,000 peer-reviewed publications. He is a Professor of Ophthalmology at the New York Eye and Ear Infirmary and sits on the Boards of Iantech Medical, Kurobe Pharmaceuticals and The American Society of Cataract and Refractive Surgery Foundation. He also sits on a number of corporate and advisory Boards. He completed his specialty training at the Doheny Eye Institute, University of Southern California. Dr. Ianchulev earned an M.D. degree from Harvard Medical School, Harvard University. He also holds an M.P.H. in Health Policy, Management and Finance from the Harvard School of Public Health, Harvard University. Dr. Ianchulev received his bachelor of science from the University of Rochester."
EYEN-"Eyenovia Announces FDA Acceptance of IND Application for MicroPine to Reduce the Progression of Myopia"
NEW YORK, Feb. 06, 2019 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (EYEN), a clinical stage ophthalmic biopharmaceutical company developing a pipeline of microdose therapeutics utilizing its patented piezo-print delivery technology, today announced that the U.S. Food and Drug Administration (FDA) has accepted the Company’s Investigational New Drug (IND) application to initiate the CHAPERONE study - the Company's Phase III registration trial of MicroPine to reduce the progression of myopia in children.
Currently, there are no FDA-approved therapies to slow the progression of myopia, a condition that, if uncontrolled, can in some cases be associated with major pathologic changes such as retinal atrophy, macular staphylomas, retinal detachment and visual impairment. It is estimated that approximately 9% of children in the United States have myopia resulting in a potential U.S. market for MicroPine of approximately $5 billion. Outside of the United States, we estimate the market potential for MicroPine is even larger – with up to approximately 80% of children starting out myopic in Asian markets. There is a growing body of evidence that supports the therapeutic effect of low dose atropine, potentially slowing myopia progression by 60-70%2-3.
(You can read more from this PR at: https://finance.yahoo.com/news/eyenovia-announces-fda-acceptance-ind-133000662.html
I posted on this little company about a month ago, with my heads up about their new microstat technology for eye drop delivery, their phase 3 trials for resolution of mydriasis and a general discussion of their potential pipeline. The company has since posted positive phase 3 results for use of their technology for inducing mydriasis in the clinic, and I expect that they will report on the resolution of clinic mydriasis in the next quarter. The above PR is icing as far as I'm concerned.
The basic investment premise, for me at least, is that their technology looks good, the applications for inducement and resolution of mydriasis in the clinic have a wide appeal, and there has been no development of similar technology or product in this space for some time. I have always been keen on the ophthalmology market (I have 3 contact lens patents) and know the space for having some of the highest margin products in healthcare. That said, this is a tiny "story" stock so far, with a very small float, no reported infrastructure for commercialization at this point, and will likely have to use a recently reported shelf registration to acquire the money to move towards commercialization. I'm in, take a closer look if you'll are interested in a ride.
NEO: QIAGEN and NeoGenomics collaborate to offer cancer patients Day-One access to innovative companion diagnostics for newly approved drugs
QIA) and NeoGenomics, Inc. (NEO) today announced a master service agreement to accelerate the availability of innovative companion diagnostics that enable precision medicine for cancer patients. The partnership between QIAGEN and NeoGenomics, a leading provider of cancer-focused genetic testing services, will ensure Day-One patient access to FDA-approved molecular tests paired with newly approved drugs for cancer.
Building on the U.S. Food and Drug Administration’s modernized regulatory approach to advanced diagnostics, especially next-generation sequencing (NGS) tests, the collaboration with NeoGenomics will allow QIAGEN and pharmaceutical partners to streamline the development and launch of targeted drugs and companion diagnostics to guide treatment decisions. The partnership offers flexible pathways leading to introduction of FDA-approved companion diagnostics simultaneously with launch of new therapies.
(NEO continues to rack up deals and build the business. Not bad for a company that was doing $30 million/year 6 years ago.)
https://finance.yahoo.com/news/qiagen-neogenomics-collaborate-offer-cancer-220147677.html
EYEN: Anyone ever heard of Eyenovia, a microcap eyecare product development company? I came across this today because they had a PR about initiation of a Phase 3 trial for one of their lead products, Microstat, a fixed-combination of phenylephrine and tropicamide for in-office mydriasis (pupil dilation). Anyone who sees an Ophthalmologist on a regular basis has had their eyes dilated for routine exam and then likely had to wear some cheap sunglasses out of the office because the dilation takes several hours to resolve. This appears to be a product that pharmacologically resolves the problem. I can say, if given the chance to have these drops applied after dilation, that I would take the treatment (unless the price was too unreasonable.)
EYEN has several other products, including Micropine, an eye-drop treatment for myopia, and Microprost, a prostaglandin eye-drop for angle-closure glaucoma. I've no opinions regarding these latter potential products and it appears that their entire portfolio of eye-drop candidates are based upon a technology innovation(?) of a hand-held microdosing eye-drop dispenser. You can read more about the company and their platform here:
https://eyenoviabio.com/technology/
PACB Illumina to buy rival Pacific Biosciences in $1.2 bln deal
(PACB is a gene sequencing equipment manufacturer that has been on my watch list for some time. Sales have been modest but their technology appears to be top notch. Is this a sign of some consolidation in the genetics testing space after NEO's purchase of Genoptix?)
Nov 1 (Reuters) - Gene sequencing company Illumina Inc said http://pdf.reuters.com/htmlnews/htmlnews.asp?i=43059c3bf0e37541&u=urn:newsml:reuters.com:20181101:nBw18KCRQa on Thursday it plans to buy smaller rival Pacific Biosciences of California Inc in an all-cash deal valued at $1.2 billion, expanding its capabilities as the market grows.
Illumina's offer of $8 per Pacific share represents a premium of about 77 percent to Pacific's Thursday close.
Illumina is a major player in the nascent gene sequencing space and last year unveiled its NovaSeq sequencing platform, which is designed to deliver faster and cheaper gene sequencing over existing models.
Gene sequencing is a method to analyze the genome, and can among other uses, help identify inherited disorders and markers of disease progression.
Evercore ISI analysts said the deal is a positive as it allows Illumina to deploy capital in a constructive manner as it will acquire a leader in long-read sequencing technology, thus complementing the company's current portfolio.
"PacBio's unmatched accuracy mirrors that of Illumina's in short-read sequencing," said Francis deSouza, President and Chief Executive Officer of Illumina.
"Combining the two technologies positions us to reach more applications and accelerate the pace of genomic discovery."
Goldman Sachs & Co LLC is serving as financial adviser and Covington & Burling LLP as legal adviser to Illumina.
https://finance.yahoo.com/news/illumina-buy-rival-pacific-biosciences-210752332.html
NEO "[NeoGenomics Signs Definitive Agreement to Acquire Genoptix/i]
https://finance.yahoo.com/news/neogenomics-signs-definitive-agreement-acquire-110000136.html
FT. MYERS, Fla., Oct. 23, 2018 (GLOBE NEWSWIRE) -- NeoGenomics, Inc. (NEO), a leading provider of cancer-focused genetic testing services, announced today that it has entered into a definitive agreement to acquire Genoptix, Inc. for $125 million in cash and 1 million shares of NeoGenomics common stock. Genoptix is a leading clinical oncology laboratory, specializing in hematology and solid tumor testing, with an outstanding reputation and relationship with community oncologists across the United States. Genoptix’s strong capabilities complement NeoGenomics’ leadership position with hospitals and pathologists.
Genoptix has gone from a publicly traded co. (IPO value at $85 million), then purchased by Novartis in 2011 for $470 million, the parted out (Pharma business retained by Novartis) and sold to a private investment group for an undisclosed amount in 2017.
This purchase is similar to NEO's purchase of Clarient from GE a couple of years ago. Not sure what kind of digestion issues will ensue, but I'm bullish overall on the purchase. NEO keeps growing and growing.
TTPH U.S. FDA approves Tetraphase Pharma's antibiotic
(Not sure than even this announcement can save the share value as the lawsuits are piling up)
Aug 27 (Reuters) - Tetraphase Pharmaceuticals Inc said on Monday U.S. health regulators approved its drug to treat complicated intra-abdominal infections, providing a new option to combat the growing threat from treatment-resistant bacteria.
Xerava, the company's lead drug, uses a technology licensed from Harvard University that helps to "revitalize" the decades-old tetracycline class of antibiotics to overcome traditional resistance mechanisms that bacteria have developed over time.
Tetraphase, which expects to launch the drug in the United States in October, is considering a list price in the range of $200 to $300 per day, Chief Executive Officer Guy Macdonald told Reuters, noting that other recently-approved antibiotics used as a last line of treatment are priced at nearly $1,000 per day.
"We're trying to price Xerava at the lower end, so that patients can get access to the product when they need it in first or second line therapy," he said.
A committee to the European Medicines Agency recently gave a positive opinion on the drug and regulators are expected to make a final decision in a couple of months.
H.C. Wainwright analyst Ed Arce estimates that the drug will bring in peak sales of about $340 million in the United States and the European Union in 2027.
The market is worth between $400 million and $600 million in the U.S. and Europe, according to the company.
The approval comes at a time when several drugmakers are shying away from developing antibiotics as combating resistant "superbugs" become increasingly challenging.
AstraZeneca Plc and Novartis AG have exited the space, and earlier this year Allergan Plc said it was planning to sell its infectious disease unit, which includes antibiotic treatments.
"Given that a lot of these companies are looking to exit or have already recently... I don't think M&A is necessarily on the table (for Tetraphase) in the near-term," Arce told Reuters ahead of the approval.
Xerava has been approved for the treatment of complicated intra-abdominal infections in patients 18 years of age and older, the company said.
"But I think it's reasonable to assume that ...there would be some meaningful degree of off-label use as well," Arce said.
https://finance.yahoo.com/quote/TTPH?p=TTPH
HOLL If it sounds like a scam, looks like a scam and reads like a scam.....it's probably a scam.
Updates of business developments.
Been rather quiet here, I doubt that NEO has garnered the attention it deserves but I also suspect that people will start to sit up and take notice as the business news starts to hit the street when the upside of new developments becomes clear. Here are some important milestone:
1. NEO inked a deal with PPD for strategic partnership:
Pharmaceutical Product Development, LLC (PPD), a leading global contract research organization (CRO), and NeoGenomics Laboratories, Inc., a leading provider of cancer-focused genetic testing services, are forming a strategic alliance to provide a seamless and fully integrated global pathology and molecular testing solution to PPD’s pharmaceutical and biotech clients.
As part of the collaboration, NeoGenomics will provide a wide range of lab testing services to support PPD® Laboratories’ oncology clinical trial activities in the U.S., Europe and Asia. Operationally, the collaboration will leverage NeoGenomics sites in the U.S. and Europe, and both companies expect to jointly invest in PPD’s existing labs in China and Singapore. The companies will provide an integrated global IT solution, leveraging PPD’s award-winning Preclarus® system to offer real-time visibility and analytics for informed decision-making.
Fully integrated with PPD’s CRO capabilities, PPD Laboratories offers the industry’s most comprehensive set of lab services, spanning bioanalytical, biomarkers, central lab, GMP and vaccine sciences. NeoGenomics provides one of the most comprehensive oncology-focused testing menus in the world to support physicians in the diagnosis and treatment of cancer and pharmaceutical clients in clinical trials and drug development.
The new collaboration focuses on centralized pathology review, as well as specialty lab services, including flow cytometry, fluorescence in situ hybridization (FISH), immunohistochemistry (IHC), cytogenetics, molecular assays, next-generation sequencing and MultiOmyx™, NeoGenomics’ proprietary, multi-omics multiplexing methodology.
Together, the companies also will provide clients a comprehensive companion diagnostics offering from biomarker discovery through regulatory approval and commercialization. Additionally, the teams are committed to leveraging their combined data assets to find more efficient methods of identifying appropriate patients for oncology trials.
PPD is a privately owned company so their finances are opaque, but consider they are global, wholly a CRO/drug development company with a considerable presence in both China and India, and have 20,000 employees, this deal could be huge. Read the details here:
https://finance.yahoo.com/news/ppd-neogenomics-forming-global-strategic-120000105.html
2. NeoGenomics Redeems 100% of Series A Redeemable Preferred Stock
NeoGenomics, Inc. (NEO) (the “Company”), a leading provider of cancer-focused genetic testing services, announced today that it redeemed 6,864,000 million shares of Series A Redeemable Preferred Stock (“Series A Preferred Stock”) held by an affiliate of General Electric Company for approximately $50.1 million. The shares were redeemed at approximately $7.30 per share, reflecting $7.16 per share, which is the applicable 4.5% redemption discount to the original liquidation preference, plus an additional $0.14 per share in respect of accrued and unpaid dividends for 2018. The Company has now redeemed 100% of the Series A Preferred Stock outstanding.
This has an obvious impact on share value as it reduces the outstanding share from about 80 million to about 66 million. At recent market cap value, this would put share value at about $16.67/share. The market doesn't always catch up (and may have already priced this reduction in) but I'm confident that there will be an upside to this move. Reading between the lines, the company executed this because their finances were strong enough to manage it and forward-looking anticipation of business is good.
Next quarter's CC will be exciting to here. Business is growing in a big way in the sector (CRO) that has the biggest margins.
PRTK-RockRat, thanks for your reply.
For Sarecycline, the pricing versus existing competition is a worry. It certainly won't be first line. For Omadacycline, the worry is combos of existing antibiotics is supposedly the new paradigm, so the ability of Omadacycline to compete and get on formularies is being questioned.
Just a couple of additional thoughts-
Seracycline-Acne Vulgaris cuts a wide swath through healthcare, wide enough for even my discipline to study it (I'm a psychologist and there have been articles written about both the suicide risk associated with it as well as Biofeedback as an adjunctive treatment), there will always be parents willing to tell their kids' physician that they want to try something new on the market.
Omadacycline-From what I can tell, drug resistant strains of bacterial infection will always evolve to meet the current treatment(s); an evolutionary reality. Given the relative lack of new antibiotic agents, I assume that there will always be room for new arrows in the quiver, even if combination therapies appear to have gained the upper hand for the time being. Not that I am expecting it, but think of the unintended consequence of the development of a new bacterial "superbug" that is linked to combination therapy. Hospitals are already contending with infection complications never dreamed of 30 years ago. Oy!
PRTK appears well-positioned from both an outpatient and inpatient use standpoint. They deserve a respectable market cap and $350M seems low if/when they have two marketable drugs.
My position in TTPH is relatively modest but I recently added, trading out of MNTA and picking up substantially more. The timing was good, I'm well into the black and may diversify for the antibiotic space investment. I can again thank the content of the information from this board for a new investment idea.
PRTK- Sarecycline looks like a NDA approval candidate shoo-in and Omadacycline a strong candidate. Allergan at the ready for marketing of Sarecycline (Acne Vulgaris market is fairly extensive) and my cursory read of the balance sheet looks pretty good. Market cap is low. All in all, I wish I had found this earlier, my money's been on TTPH in this space. Why this stock has slid down is puzzling. Did they dilute? The only other thing I caught was their website had the NDA for Omadacycline being submitted Q1, '18. Doesn't appear that they've met that deadline.
NEO-PPD and NeoGenomics Forming Global Strategic Alliance for Pathology and Molecular Testing Solutions
(For those following NEO, this is another step in their developing CRO business segment and appears to be a big step in becoming a leader in advanced genetics testing for drug development. I was not familiar with PPD before today, but the company has a considerable world-wide footprint, with 20,000 employees worldwide. The CRO business is likely to become the fastest growth segment for NEO as well as the segment with the highest margins. Price action today indicates that this is VERY good news.)
WILMINGTON, N.C., June 01, 2018 (GLOBE NEWSWIRE) -- Pharmaceutical Product Development, LLC (PPD), a leading global contract research organization (CRO), and NeoGenomics Laboratories, Inc., a leading provider of cancer-focused genetic testing services, are forming a strategic alliance to provide a seamless and fully integrated global pathology and molecular testing solution to PPD’s pharmaceutical and biotech clients.
As part of the collaboration, NeoGenomics will provide a wide range of lab testing services to support PPD® Laboratories’ oncology clinical trial activities in the U.S., Europe and Asia. Operationally, the collaboration will leverage NeoGenomics sites in the U.S. and Europe, and both companies expect to jointly invest in PPD’s existing labs in China and Singapore. The companies will provide an integrated global IT solution, leveraging PPD’s award-winning Preclarus® system to offer real-time visibility and analytics for informed decision-making.
Fully integrated with PPD’s CRO capabilities, PPD Laboratories offers the industry’s most comprehensive set of lab services, spanning bioanalytical, biomarkers, central lab, GMP and vaccine sciences. NeoGenomics provides one of the most comprehensive oncology-focused testing menus in the world to support physicians in the diagnosis and treatment of cancer and pharmaceutical clients in clinical trials and drug development.
The new collaboration focuses on centralized pathology review, as well as specialty lab services, including flow cytometry, fluorescence in situ hybridization (FISH), immunohistochemistry (IHC), cytogenetics, molecular assays, next-generation sequencing and MultiOmyx™, NeoGenomics’ proprietary, multi-omics multiplexing methodology.
Together, the companies also will provide clients a comprehensive companion diagnostics offering from biomarker discovery through regulatory approval and commercialization. Additionally, the teams are committed to leveraging their combined data assets to find more efficient methods of identifying appropriate patients for oncology trials.
“NeoGenomics has world-class scientific talent, significant oncology trial experience, and a broad geographic presence that will allow us to further enhance our global laboratory services for oncology trials,” said Christopher Fikry, M.D., executive vice president of PPD Laboratories. “Working with NeoGenomics will enable us to jointly provide a premier global oncology and specialty laboratory solution for our customers.”
“We are pleased to be joining PPD in this important strategic alliance and look forward to collaborating with the many scientific professionals on their team,” said Douglas VanOort, chairman and chief executive officer of NeoGenomics. “Our company is committed to saving lives by improving patient care through communication, accuracy, reliability and efficiency. That commitment aligns closely with PPD’s mission and purpose to help its customers deliver life-changing therapies that improve health.”
As a premier cancer diagnostics and pharma services company, NeoGenomics has a network of CAP-accredited (College of American Pathologists), CLIA-licensed (Clinical Laboratory Improvement Amendments) facilities across the U.S.
https://finance.yahoo.com/news/ppd-neogenomics-forming-global-strategic-120000105.html
RMTI "How will it end? Who cares! It’s so wonderful. I mean, no, obviously it will end with everyone suing and with a court eventually deciding which of RMTI-A or RMTI-B is “really” Rockwell Medical Inc., but how boring that will be.
Of course, there is now blood on the street and the legal sharks are circling, with announcements of litigious "shareholder rights" firms ready to sue as well.
RMTI has been a dog for so long that I dropped it from my watch list a long time ago. The company's core business will continue (yawn) and the litigation will do nothing but hurt shareholders and share value. This is not even worth popping popcorn and watching.
NVIV- This has been the biggest dog in my portfolio for some time, an epic failure of management with regard to the business end of this start-up. I'm way under water here but will continue to hold on the technological prospects. The procedure continues to show excellent response, and the company has comfortable funding and a first rate list of research sites. The biggest underlying problem with the trial has to do with the 96-hour limit for enrollment after injury; a tough sell for patients/families who have just sustained a life-changing injury.
That said, only the most risk tolerant investors should even consider this. Enrollment will open back up as the deaths were not related to the procedure (as best as I can tell). The company should announce the latest 6-month recovery rates for enrollees in the next quarter.
aj
TTPH public offering: LOL, just signed back in to post the very same. That didn't take too long. At the close of today, the offering would dilute on the order of 20%. They have plenty of cash, but my guess is the burn rate will increase significantly with application, market development, AND plans to get the next compound into clinical trials.
TTPH: "how long do you think it will be before the FDA approves Eravacycline?"
I am no expert on this process. Maybe Dew would care to comment on the typical timing of review and approval.
TTPH +26%/AH on phase-3 data for IV eravacycline
Expected, at least from this corner of the world. The company has yet to dilute to fund ongoing operations and might yet be able to get this to market without needing to, but it will be close. I suspect that they will start working on the next round of phase one trials. Recall that they have proprietary process for generating new tetracycline antibiotics.
NVIV: InVivo Therapeutics Announces Positive Motor Recovery Assessments in Two Patients in the INSPIRE Study of the Neuro-Spinal Scaffold™
InVivo Therapeutics Holdings Corp. (NVIV) today announced that two patients in the INSPIRE study of the Neuro-Spinal Scaffold have improved from sensory incomplete AIS B spinal cord injury (SCI) to motor incomplete AIS C SCI in their most recent INSPIRE assessments. These are the second and third patients in the INSPIRE study to have reached AIS C motor incomplete classification.
One of these patients was enrolled in May 2016 and converted from complete AIS A SCI to incomplete AIS B SCI at the three-month exam in August 2016. At the 12-month visit, the patient regained motor function associated with the most sacral segments of the spinal cord and was assessed to be AIS C. Stuart Lee, M.D., is the Principal Investigator at Vidant Medical Center in Greenville, North Carolina, where this patient was implanted with the Neuro-Spinal Scaffold.
Dr. Lee said, “The patient’s continued improvement at the one year exam is encouraging. Return of sacral motor function may be related to improvements in bowel and bladder function that can have an appreciable impact on a patient’s quality of life. We look forward to monitoring this patient’s recovery and hope for continued progress.”
The second patient was enrolled in June 2015 and converted from complete AIS A SCI to incomplete AIS B SCI at the one-month exam in July 2015. At the 24-month per protocol ISNCSCI exam (see About the ISNCSCI Exam below), the patient was assessed to be AIS C with the ability to contract two muscles of one leg. The motor function was not noted in a separate medical evaluation earlier in the day that did not include a full ISNCSCI exam. Domagoj Coric, M.D., of Carolina Neurosurgery and Spine Associates, and William Bockenek, M.D., of Carolinas Rehabilitation, are Co-principal Investigators at the site where this patient was implanted.
Dr. Bockenek said, “This patient moved from AIS A to AIS B shortly after the initial injury and implantation with the Neuro-Spinal Scaffold two years ago, and now is noted on the ISNCSCI exam to have moved to an AIS C based on trace movements in one leg. Though the clinical significance of this change is unknown at this time, we remain cautiously optimistic that there may be a possibility for additional changes.”
https://finance.yahoo.com/news/invivo-therapeutics-announces-positive-motor-120000071.html
NEO- This guy has hired on as the money/investment manager, a more targeted placement of management resources. Just makes me wonder if he will be managing the interest from funds for transactions like strategic private placements or other investments etc. I would assume he is more savvy about working with investment shops. I'm also hoping that this is an addition to the team because growth prospects are looking up now that Clarient has been fully digested and integrated. For those who have not kept up with the details, NEO announced starting a lab in Europe to handle the Clinical study action, stating that some of the multinationals were asking for a physical presence there for study support. Also, behind the announcement last quarter of a big uptick in requests for PDL1 testing from new customers (who do not use other company tests), is the prospect that sales will move up as new customers get acquainted with the full range of the test menu.
One can hope.
aj
NEO NeoGenomics Appoints Bill Bonello as Vice President, Treasurer, and Director of Corporate Development
"FORT MYERS, FL--(Marketwired - April 20, 2017) - NeoGenomics, Inc. (NEO), a leading provider of cancer-focused genetic testing services, announced today the appointment of Bill Bonello as Vice President, Treasurer, and Director of Corporate Development.
From 2012 to present, Mr. Bonello served as Senior Research Analyst at Craig Hallum Capital Markets, where he was responsible for equity research coverage of healthcare tools and diagnostics companies. From 2010 to 2012, he served as Senior Research Analyst for RBC Capital Markets, and from 2009 to 2009, he served as Senior Vice President of Investor Relations for Laboratory Corporation of America, a leading global clinical testing laboratory. Prior to that, Mr. Bonello was Managing Director, Equity Research at Wachovia Capital Markets and also served in a similar capacity at Piper Jaffray. Bill has a B.A. from Carleton College and M.B.A. from the Kellogg School of Management at Northwestern University."
I'm intrigued by this pick, someone who is so clearly "wired in" to the investment world. I can speculate about it but wonder if anyone has thoughts on why the company would pick such an obvious investment player who knows the lab business from this end of the game.
TTPH: Tetraphase Pharmaceuticals Completes Enrollment of IGNITE4 Phase 3 Clinical Trial of Eravacycline in Complicated Intra-abdominal Infections
"WATERTOWN, Mass., April 03, 2017 (GLOBE NEWSWIRE) -- Tetraphase Pharmaceuticals, Inc. (TTPH), a clinical stage biopharmaceutical company developing novel antibiotics to treat life-threatening multidrug-resistant (MDR) infections, today announced completion of enrollment in IGNITE4, its ongoing phase 3 clinical trial evaluating the efficacy and safety of intravenous (IV) eravacycline compared to meropenem in complicated intra-abdominal infections (cIAI). The Company expects to report top-line data from this trial in the third quarter of 2017.
“Completing IGNITE4 enrollment ahead of schedule speaks to the strong investigator support for this study, along with the dedication and hard work by our internal team and collaborating clinical research organization,” said Guy Macdonald, President and CEO of Tetraphase. “Following the protocol-specified follow-up period, requisite data validation and subsequent database lock activities, we now expect top-line data from IGNITE4 to be available during the third quarter of 2017. Assuming a positive outcome, we believe the data from IGNITE4, along with data from the successfully completed IGNITE1 trial, will form the basis of a U.S. NDA filing for IV eravacycline in cIAI.”
https://finance.yahoo.com/news/tetraphase-pharmaceuticals-completes-enrollment-ignite4-120000758.html
TTPH-This may be the reason for the value rise. The article was published today, but I'm sure the local investment community has known about this news.
These 5 Mass. biotechs are getting $12M to fight ‘superbugs’
A Boston-based accelerator program that funds the development of potential life-saving antibacterial drugs has awarded more than $12 million to five local biotechs.
The public-private partnership, called Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator — or CARB-X — said Thursday that it will invest $24 million in 11 drug and diagnostic companies, five of which are based in Massachusetts, and could make up to an additional $24 million in milestone payments.
(You have to view the slide show to see each of the 5 featured co's, but to cut to the chase, TTPH is getting $4 million over the next 18 months without any apparent dilution. The investment is the single biggest one for the 5 companies listed, indicating some robust confidence.)
http://www.bizjournals.com/boston/news/2017/03/31/these-5-mass-biotechs-are-getting-12m-to-fight.html?ana=yahoo&yptr=yahoo
A little more detail on TP-6076, which is the candidate that this grant will support:
About TP-6076
TP-6076 is a novel, synthetic, fluorocycline antibiotic candidate generated through Tetraphase’s proprietary chemistry technology. It has demonstrated potent in vitro activity against multidrug-resistant bacteria including carbapenem-resistant Enterobacteriaceae and carbapenem-resistant Acinetobacter baumannii. As part of an ongoing phase 1 clinical development program, Tetraphase has evaluated intravenous TP-6076 in a phase 1 single-ascending dose clinical trial and is planning to initiate a phase 1 multiple-ascending dose clinical trial in 2017.
https://finance.yahoo.com/news/tetraphase-pharmaceuticals-tp-6076-selected-200100771.html
TTPH at these prices, I doubt I'll bother reacquainting myself . . . things that make you go "hmmm."
Rockrat, I took a tiny position in TTPH before the fall, knowing that a binary event was coming. Obviously the event was negative, but I had reported that this co. looked good from a management standpoint, funding standpoint and technology standpoint, so I held and waited for this move off the bottom. I am reasonably certain that they will have the results necessary for an NDA sometime this or next year, and new tetracycline antibiotics (and a platform for mass production AND introducing variant formulae for future drugs) are all attractive to my risk/benefit tolerance.