Target to $82 from $72
Monday, January 9, 2023
Regeneron Hit As Eylea Gives Ground To Avastin
Biotech giant Regeneron Pharmaceuticals (REGN) said Monday that sales of its linchpin Eylea drug in the final quarter of 2022 have been negatively impacted by a short-term shift to off-label use of rival drug Avastin. REGN stock plunged on the news.
Citing preliminary data, Regeneron reported that full-year 2022 sales of its Eylea (aflibercept) injection for retinal diseases rose 8%, year over year, to $6.26 billion.
But Eylea sales, down 3% to $1.5 billion, capped a weak fourth quarter, the company said. A Regeneron presentation Monday revealed that Eylea sales were "negatively impacted by a short-term shift to off-label use of compounded Avastin."
It also cited the "temporary closing in Q4 2022 of fund that provides patient copay assistance." The presentation added that the "most recent Q4 2022 market data suggests that shift to off-label Avastin is already beginning to reverse."
REGN Stock Plunges On News
Avastin is an immunotherapy drug. First approved to treat cancer, it now also treats wet age-related macular degeneration as an "off-label" use.
Avastin is made by Genentech, owned by Switzerland's Roche Holding (RHHBY), which trades over the counter.
Analysts polled by FactSet were expecting Eylea sales of $6.43 billion in full-year 2022. Regeneron is due to report fourth-quarter and full-year results on Friday, Feb. 3.
Regeneron stock plunged 8.2%, near 681, on the stock market today. REGN stock decisively undercut the 50-day moving average Monday while hitting its lowest level since Sept. 8 last year. But the biotech stock found support at the 200-day line in morning trade.
New Eye Drug Shows Promise
On Sept. 8, REGN stock skyrocketed on news that an 8-milligram dose of eye drug aflibercept successfully treated patients with diabetic macular edema. Also, it treated wet age-related macular degeneration.
Roche stock added 0.4% Monday.
Aflibercept, the generic form of Regeneron's eye drug Eylea, is used to treat various retinal diseases. Further, it generated $5.8 billion in sales in 2021. Regeneron estimates 2022 sales of $6.3 billion in 2022.
In the past year, REGN stock has climbed 11.3% vs. a 15.9% decline for the S&P 500 index.
https://www.investors.com/news/technology/regn-stock-sinks-as-eylea-sales-suffer/
Old Dominion men's basketball player collapses during game vs Georgia Southern
An Old Dominion University men’s basketball player suffered a terrifying ordeal on Saturday as the team took on Georgia Southern.
The incident occurred with about 13:13 left in the first half. Old Dominion sophomore guard Imo Essien was on the defensive side of the ball when he fell onto his backside on the court. He struggled to get back to his feet and started to lay down on his back appearing to be in pain.
Medical personnel for Old Dominion rushed over to attend to Essien. He didn’t appear to lose consciousness and was helped to his feet and walked off the court with the trainers.
"Imo Essien was evaluated by the ODU Athletic Training staff along with the GA Southern medical staff," the school stated. "He was responsive throughout and was able to sit with the team for the duration of the game and drove home with the team."
"He is in good spirits and will work with the ODU Sports Medicine Staff when they return to Norfolk," the statement continued.
Essien joined the Monarchs before the start of the 2021-2022 season and averaged about 7.1 minutes per game. His minutes increased this season to 29.4 per game and his scoring average jumped from 1.2 to 5.4 points per game.
The Wylie, Texas, native was a high school standout who was a two-time All-State selection and scored 1,000 points in his career.
Old Dominion won the game, 81-75, in overtime.
JPM Day 1: Bristol-Myers
10:30 AM: Bristol-Myers Squibb revealed its plans to move beyond key patent expires later this decade. In the company’s presentation Monday morning, Bristol’s Executive Vice President and Chief Commercial Officer Chris Boerner, Ph.D. said the pharma titan expects annual sales to rise by low- to mid-single digits over the course of 2020 to 2025.
In-line brands such as the Pfizer-partnered blood thinner, Eliquis, ought to contribute $8 billion to $10 billion in sales growth over this five-year period. Meanwhile, newer product launches ought to deliver between $10 billion to $13 billion in additional sales during the same time frame.
Looking forward, Boerner said the company’s late-stage pipeline has the potential to deliver upwards of $10 billion in risk-adjusted sales in the second half of the decade. BMS's vice president highlighted six late-stage product candidates as key growth drivers for the company in the back half of the decade: (milvexian, iberdomide, mezigdomide, BMS-986278, repotrectinib and cendakimab).
Why Editas Is Sliding
Shares of Editas Medicine (EDIT -6.79%) are sliding today, down by 7.2% as of 11:26 a.m. ET. The decline came after the company announced a big shake-up with its research and development focus.
Editas stated that it won't invest any further in inherited retinal disease programs. These include previous lead pipeline candidate EDIT-101 in treating Leber congenital amaurosis 10 and EDIT-103 in treating rhodopsin-associated autosomal dominant retinitis pigmentosa. The company is also discontinuing funding of its EDIT-202 program targeting solid tumors.
In connection with these changes, Chief Scientific Officer Mark Shearman is leaving Editas effective March 31, 2023. The company has already begun to search for Shearman's replacement. It's also cutting staff by around 20%.
Editas said that it plans to look for partners to develop its inherited retinal disease and induced pluripotent stem cell derived natural killer (iNK) cell programs. However, today's announcement clearly marks a major shift for the company.
Why didn't the gene-editing stock plunge more than it did on this news? Probably because many investors had already seen the writing on the wall. Editas had previously revealed that it was seeking a partner for its EDIT-301 program.
Editas now plans to focus on hemoglobinopathies and in vivo (gene-editing therapies delivered inside the body) discovery. It will prioritize funding of EDIT-301, which is being evaluated in phase 1/2 clinical testing as a potential treatment of severe sickle cell disease and transfusion-dependent beta-thalassemia. The company will also continue to work with partners Bristol Myers Squibb and Immatics N.V. to develop T-cell therapies.\
https://www.fool.com/investing/2023/01/09/why-editas-medicine-stock-is-sliding-today/
Argenx timeline for pipeline
Reported $402 million in preliminary* full-year 2022 global net VYVGART sales
ADHERE topline results now expected in second quarter of 2023; Stage B enrollment has surpassed projected target of 130 patients
Registrational trial of efgartigimod in thyroid eye disease (TED) to start in 2023; additional proof-of-concept trials to start in ANCA-associated vasculitis and antibody mediated rejection (AMR)
Submission for marketing approval in Japan of VYVGART for immune thrombocytopenia (ITP) expected in mid-2023
https://finance.yahoo.com/news/argenx-highlights-2023-strategic-priorities-060000802.html
Selecta, Astellas in Licensing and Development Pact
Next-generation IgG protease candidate Xork to be licensed for development with AT845, an investigational Astellas Gene Therapies' product, for the treatment of Pompe Disease
Selecta to receive a $10M upfront payment and eligible to receive up to $340M for certain additional development and commercial milestones plus royalties on commercial sales
https://finance.yahoo.com/news/selecta-biosciences-astellas-announce-exclusive-123000572.html
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