Morgan Stanley analyst Matthew Harrison noted that Novartis’ (NVS) gene therapy for the rare disease spinal muscular atrophy, Zolgensma, is expected to be approved by the FDA this month. He also noted that Biogen’s (BIIB) Spinraza is currently the only approved drug for SMA and represents 17% of Biogen’s estimated 2019 sales. The public data for Novartis’ Zolgensma are only in type 1 patients, or infants, said Harrison, who sees three potential scenarios for the drug’s label. In the first, which would involve broad approval across the three patient classes of infants, children and adults, Harrison thinks Novartis shares could be up 1-2%, Biogen could fall about 5%, Ionis (IONS), which receives royalties from Biogen, could be down about 10%, and Regenxbio (RGNX), which will receive royalties from Novartis, could be up 10-15% or more. In the second case, where Zolgensma is granted a Type 1 approval with no restriction, Harrison sees Novartis unchanged, Biogen down 1-3%, Ionis falling 3-5% and Regenxbio rising 5%. In the third scenario, where Zolgensma gets a Type 1 approval but with a weight/age restriction, the analyst thinks Novartis would be down 1-2%, Biogen would be up 2-3%, Ionis could rise 5% and Regenxbio could fall 5-10%. Harrison’s base case assumption is that Zolgensma will ultimately capture the majority market share in type 1 patients and a “significant portion” of type 2, or pediatric, patients.
Tuesday, May 7, 2019
Sutro regaining U.S. rights from Celgene a ‘clear positive,’ says Piper Jaffray
The FDA has cleared the investigational new drug application for Sutro Biopharma’s Celgene-partnered BCMA ADC, which is on track to enter the clinic in 2019, Piper Jaffray analyst Edward Tenthoff tells investors in a research note. In addition, Celgene not exercise an option on a second program, meaning Sutro has regained U.S. rights, adds the analyst. He views this as a “clear positive” for Sutro, saying the company has regained the U.S. rights to “another exciting preclinical program.” Importantly, there is no impact on Sutro’s wholly-owned clinical programs, Tenthoff adds. He reiterates an Overweight rating on Sutro Biopharma with a $23 price target.
Mylan revenue misses on Morgantown plant issues
Mylan NV missed first-quarter revenue estimates on Tuesday, hurt by lower demand for its products and manufacturing problems at its Morgantown plant, sending its shares down nearly 8 percent.
The company has been grappling with problems at its Morgantown facility in West Virginia and had last year announced discontinuation of some products and job cuts at the plant.
The U.S. Food and Drug Administration had issued a warning letter to Mylan, raising concerns such as the failure to follow the procedures for cleaning and maintaining equipment at the plant.
Only five of its top 50 and one of the top 10 gross margin generating products will be manufactured in the facility in 2019, the drugmaker said in February.
Revenue from its North America business, its biggest, fell 6 percent to $922.9 million and missed estimates of $952.43 million.
Total revenue fell 7 percent to $2.50 billion and missed estimates of $2.69 billion, according to IBES data from Refinitiv.
It was also impacted by a 14 percent drop in sales at its Europe business to $895.3 million, partly due to a stronger dollar. Analysts were expecting revenue from Europe to be $1.06 billion.
The company reported a net loss of $25 million, or 5 cents per share, in the first quarter ended March 31, compared with profit of $87.1 million, or 17 cents per share, a year earlier.
Excluding items, the company earned 82 cents per share and beat expectations of 79 cents per share.
Mylan on Tuesday did not provide an update on its decision last year to review possible strategic options.
Akcea Therapeutics, Ionis Pharmaceuticals announce EC approval of Waylivra
Akcea Therapeutics () and Ionis Pharmaceuticals (IONS), announced that Waylivra has received conditional marketing authorization from the European Commission, or EC, as an adjunct to diet in adult patients with genetically confirmed FCS and at high risk for pancreatitis, in whom response to diet and triglyceride lowering therapy has been inadequate.
https://thefly.com/landingPageNews.php?id=2904769
https://thefly.com/landingPageNews.php?id=2904769
U.S. corporate bond update: Bristol-Myers announced a jumbo 9 part deal
U.S. corporate bond update: Bristol-Myers announced a jumbo 9 part deal to fund its Celgene purchase. It could total about $21 B and includes a 1.5-year FRN, along with a 3-year FRN, as well as 2-, 3-, 5-, 7-, 10-, 20-, and 30-year maturities. The offering could sap some demand from the Treasury's auction today.
https://thefly.com/landingPageNews.php?id=2904783
https://thefly.com/landingPageNews.php?id=2904783
Sanofi announces Dupixent approved for severe asthma by European Commission
Sanofi announced that the European Commission has approved Dupixent for use in adults and adolescents 12 years and older as an add-on maintenance treatment for severe asthma with type 2 inflammation characterized by raised blood eosinophils and/or raised fractional exhaled nitric oxide, who are inadequately controlled with high dose inhaled corticosteroid plus another medicinal product for maintenance treatment. “Today’s approval marks an important moment for adolescents and adults in the European Union who suffer from severe asthma with type 2 inflammation,” said John Reed, M.D., Ph.D., Head of Research and Development at Sanofi. “In clinical trials, Dupixent not only reduced exacerbations and oral corticosteroid use, but it also improved lung function and patients’ overall quality of life. Dupixent offers a new treatment option for those who remain inadequately controlled with current medications, including those dependent on oral corticosteroids – which may have potentially serious side effects when used chronically.” The EC approval is based on clinical data from 2,888 adults and adolescents who participated in three pivotal trials from the global LIBERTY ASTHMA program, including the Phase 3 QUEST and VENTURE trials and a Phase 2b trial. QUEST enrolled 1,902 patients with persistent asthma and evaluated whether adding Dupixent to standard-of-care therapy could reduce severe exacerbations and improve lung function. VENTURE enrolled 210 patients with severe oral corticosteroid-dependent asthma and evaluated whether adding Dupixent to standard-of-care therapy could reduce the use of maintenance oral corticosteroids. The Phase 2b trial enrolled 776 adult patients with moderate-to-severe asthma and evaluated whether adding Dupixent to standard-of-care therapy could improve lung function.
https://thefly.com/landingPageNews.php?id=2904797
https://thefly.com/landingPageNews.php?id=2904797
TherapeuticsMD price target lowered to $4 from $5 at Jefferies
Jefferies analyst Chris Howerton lowered his price target for TherapeuticsMD to $4 from $5 saying the company reported “weak” Q1 results with Imvexxy sales missing expectations. The analyst keeps a Hold rating on the shares.
https://thefly.com/landingPageNews.php?id=2904799
https://thefly.com/landingPageNews.php?id=2904799
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