APDN = Applied DNA Sciences, Inc. (NASDAQ: APDN) a leader in large-scale Polymerase Chain Reaction (PCR)-based DNA manufacturing, announced today the successful DNA tagging of leather at one of the world’s largest tanneries based in Asia.
The work follows a successful research project undertaken within the UK that demonstrated SigNature® DNA could be successfully used to trace the hide of an animal from a farm to the product in a store. Traceability is essential when supporting claims of sustainability or the humane treatment of the animals. Further work in commercial tanneries by the Applied DNA UK team took place following the research project in other tanneries to identify the most practical ways to use SigNature DNA technology in the leather supply chain. We believe our research identified the most efficient and cost-effective methods to apply DNA at specific points in the leather-tanning process map.
The work recently carried out in Asia was focused on tagging both suede and numerous polyurethane leather finishes in a variety of different colors.
“The results are validation of previous work we carried out and we now look forward to the opportunity to apply our technology for the leather industry to help provide much needed traceability for the various stakeholders,” said Dr. James Hayward, president and CEO, Applied DNA. “We are pleased by the interest shown across the leather industry in offering to leather supply chains.”
On November 13, 2019 at Tapestry headquarters in New York City, MeiLin Wan, Vice President for Textiles at Applied DNA will be speaking about our latest developments in DNA traceability at the “Leather Compliance and Sustainability” conference hosted by Eurofins/ BLC. The Company feels that effective traceability of materials up the supply chain is the best way to manage sustainability risk and mitigate against potential environmental and social challenges.
On Thursday, 5 December 2019, Tony Benson, Managing Director of EMEA for Applied DNA, will also present a Keynote at the “SATRA Sustainable Footwear Forum” in Wyndham Way, UK.
Applied DNA has developed its CertainT® system for marking leather through the leather value chain by using a DNA tag. This molecular-based technology can help protect leather products, brands, entire supply chains, and consumers from theft, counterfeiting, fraud and diversion.
AMRN = Stifel analyst Derek Archila believes the questions raised in this morning’s briefing documents ahead of Amarin’s FDA panel meeting on November 14 “look pretty broad.” Investor fears of potential issues with Vascepa’s study design or safety should be alleviated given the tone of the documents, Archila tells investors in a research note. The analyst thinks Amarin shares trade up today ahead of the panel vote and believes there is a “high probability” the panel is positive and the FDA subsequently approves Vascepa’s supplemental new drug application to include cardiovascular risk reduction. Citing the “benign” briefing documents, Archila reiterates a Buy rating on Amarin shares with a $26 price target. The stock in early trading is up 17%, or $2.83, to $19.74. Reminder, shares of Amarin (AMRN) were rising in pre-market trading after the FDA posted briefing documents ahead of the November 14, 2019 Advisory Committee Meeting to discuss the benefits and risks of Vascepa for an indication to reduce the risk of cardiovascular events as an adjunct to statin therapy in adult patients with elevated triglyceride levels and other risk factors for cardiovascular disease.
ACST = Uptrending after November 7, 2019, PR where Acasti Pharma announced the publication as Articles in Press of a CaPre pharmacokinetics study, entitled, “Evaluation of OM3-PL/FFA Pharmacokinetics After Single and Multiple Oral Doses in Healthy Volunteers” in a leading peer-reviewed journal, Clinical Therapeutics. In this Phase I, open-label, randomized, multiple-dose, single-center, parallel-design study, 42 healthy volunteers received a single dose of CaPre at day 1, followed by multiple oral doses of 1, 2, and 4 grams per day for 14 days. At day 15, all subjects received a high fat breakfast. Key findings included: CaPre was well tolerated in healthy subjects when administered as multiple oral doses of 1, 2, and 4 grams per day. CaPre’s PK parameters appeared to be approximately dose proportional over the 1-4 grams/day dose range. The bioavailability of CaPre did not appear to be meaningfully affected by the fat content of the meal consumed before dose administration.
Acasti’s prescription drug candidate, CaPre, is a highly purified omega-3 phospholipid concentrate derived from krill oil, and is being developed to treat severe hypertriglyceridemia, a metabolic condition that contributes to increased risk of cardiovascular disease and pancreatitis. Its omega-3s, principally EPA and DHA, are either “free” or bound to phospholipids, which allows for better absorption into the body. Acasti believes that EPA and DHA are more efficiently transported by phospholipids sourced from krill oil than the EPA and DHA contained in fish oil that are transported either by triglycerides (as in dietary supplements) or as ethyl esters in other prescription omega-3 drugs, which must then undergo additional digestion before they are ready for transport in the bloodstream. Clinically, the phospholipids may not only improve the absorption, distribution, and metabolism of omega-3s, but they may also decrease the synthesis of LDL cholesterol in the liver, impede or block cholesterol absorption, and stimulate lipid secretion from bile. In two Phase 2 studies, CaPre achieved a statistically significant reduction of triglycerides and non-HDL cholesterol levels in patients across the dyslipidemia spectrum from patients with mild to moderate hypertriglyceridemia (patients with TG blood levels between 200mg/dl and 500mg/dl) to patients with severe hypertriglyceridemia (those with TG levels above 500mg/dl). Furthermore, in the Phase 2 studies, CaPre demonstrated the potential to actually reduce LDL, or “bad cholesterol”, as well as the potential to increase HDL, or “good cholesterol”, especially at the therapeutic dose of 4 grams/day. The Phase 2 data also showed a significant reduction of HbA1c at a 4 gram dose, suggesting that due to its unique omega-3/phospholipid composition, CaPre may actually improve long-term glucose metabolism. Acasti’s TRILOGY Phase 3 program is currently underway.
CRSP = Oppenheimer analyst Silvan Tuerkcan upgraded Crispr Therapeutics to Outperform from Perform with a $65 price target. In a research note to investors, Tuerkcan says Crispr has made significant progress in moving CRISPR/Cas9-based editing from the bench into the clinic, and expects to see first proof-of-concept data from several assets over the next 12-18 months. The analyst views Crispr as well positioned and says he views Crispr’s development strategy as well thought out, as its clinical pipeline is most focused on improving “established” approaches while more complex projects are pursued in a second wave.
TSN = Reports Q4 revenue $10.88B, consensus $11B. “Fiscal 2019 was highlighted by significant progress in our strategy to grow our business through differentiated capabilities, deliver service and value to our customers, and sustain our company and our world for future generations. We expanded our global footprint, launched innovation in our iconic brands and our new alternative protein brand, and prepared for future growth by investing in technology and infrastructure. We’re very optimistic about fiscal 2020, and we currently expect to meet or exceed our long-term earnings algorithm of high single-digit adjusted earnings per share growth as we’re well positioned to take advantage of opportunities in the global marketplace,” said Noel White, Tyson Foods’ president and CEO.
Tyson Foods said: “For fiscal 2020, USDA indicates domestic protein production – beef, pork, chicken and turkey – should increase approximately 2-3% from fiscal 2019 levels, but we expect export markets should absorb the increased production. As our accounting cycle results in a 53-week year in fiscal 2020 as compared to a 52-week year in fiscal 2019, the fiscal 2020 outlook is based on a comparable 52-week year. We expect industry fed cattle supplies to increase approximately 2% in fiscal 2020 as compared to fiscal 2019. We expect ample supplies in regions where we operate our plants. For fiscal 2020, we believe our Beef segment’s adjusted operating margin will be 6.5% to 7.5%, absent impacts from ASF. We expect industry hog supplies to increase approximately 3% in fiscal 2020 as compared to fiscal 2019. We expect increased livestock costs in fiscal 2020 as compared to fiscal 2019. For fiscal 2020, we believe our Pork segment’s adjusted operating margin will be 6% to 8%, absent impacts from ASF. USDA projects a 2-3% increase in chicken production in fiscal 2020 as compared to fiscal 2019. For fiscal 2020, we believe our Chicken segment’s adjusted operating margin will be 6% to 8%, absent impacts from ASF. We expect raw material costs in prepared foods to rise in fiscal 2020 as compared to fiscal 2019, but we expect to recover the increased raw material costs through pricing. Many of our sales contracts are formula based or shorter-term in nature, but there may be a lag time for price changes to take effect. For fiscal 2020, we believe our Prepared Foods segment’s adjusted operating margin will be 10% to 12%. For fiscal 2020, we expect capital expenditures to be approximately $1.3 billion. Capital expenditures will include spending for production growth, safety, animal well-being, infrastructure replacements and upgrades, and operational improvements that are expected to result in production and labor efficiencies, yield improvements and sales channel flexibility.”