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Friday, August 9, 2019

Takeda submits application for ulcerative colitis med

Takeda Pharmaceutical Company Limited (“Takeda”) (TSE: 4502/NYSE: TAK) today announced that it has submitted a New Drug Application (NDA) to the Ministry of Health, Labour and Welfare in Japan for a subcutaneous (SC) formulation of vedolizumab, a gut-selective biologic for maintenance therapy in adults with moderately to severely active ulcerative colitis (UC). Takeda proposes to make vedolizumab SC available in both syringe and pen options.
“This NDA filing is an important step in our commitment to deliver innovative medicines and treatment modalities that meet the needs of patients living with ulcerative colitis in Japan,” said Naoyoshi Hirota, Head of the Takeda Development Center Japan. “By making it possible to select the treatment modality that suits a patient’s desired administration method and lifestyle, we are aiming to enhance the patient experience and help fulfill their needs.”
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Novo Nordisk : GLP-1 Medicine Impresses, Guidance Upgraded

Novo Nordisk AS (NOVO-B.KO) reported its second-quarter results on Friday. Here’s what you need to know:
SALES: The Danish pharmaceutical company said that sales in the quarter rose 9.6% to 30.04 billion Danish kroner ($4.51 billion), ahead of the DKK29.50 analyst consensus forecast compiled by FactSet.
NET PROFIT: Net profit was DKK 9.6 billion in the second quarter, compared with DKK10.34 billion in the year-earlier period, and slightly below the FactSet-compiled consensus estimate of DKK9.62 billion.
WHAT WE WATCHED:
-GLUCAGON-LIKE PEPTIDE-1: Novo Nordisk’s diabetes medicine, Ozempic, helped drive up the top-line in an strong quarterly performance, in what Jefferies called an impressive beat to expectations. The glucagon-like peptide-1, or GLP-1, drug now holds 35% of the new-to-brand market share in the U.S.
-MARGINS: Gross margins in the half year contracted to 83.9% from 84.3%, in line with Sydbank’s models. The company attributed the margin move to lower U.S. prices, as well as sales growth in its lower-margin insulin products, partially offset by positive currency effects.
-GUIDANCE: The drugmaker will have impressed investors with a guidance upgrade. After a solid half-year performance, Novo Nordisk said it now sees full-year sales growth in 2019 at between 4%-6% on a constant currency basis. This is up from its previous range of 2%-5%. It also narrowed its operating profit outlook to the upper end of its range, to between 4%-6%, from a previous range of 2%-6%. It attributed the upgrade to an expected strong performance from Ozempic, as well as another GLP-1 diabetes product, Victoza, together with obesity medicine Saxenda.
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Bayer has not proposed paying $8 billion to settle U.S. Roundup claims: mediator

Bayer AG has not proposed paying $8 billion to settle all U.S. claims related to the Roundup herbicide, mediator Ken Feinberg said in an email on Friday.

“Such a statement is pure fiction,” Feinberg said. “Compensation has not even been discussed in the global mediation discussions.”
Bayer acquired Roundup and other glyphosate-based weedkillers through its $63 billion takeover of Monsanto last year. It has faced a wide array of litigation over Roundup’s alleged cancer risks.
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AnaptysBio EPS beats by $0.10

AnaptysBio (NASDAQ:ANAB): Q2 GAAP EPS of -$0.89 beats by $0.10.
Revenue of $5M
Press Release
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Biohaven Pharmaceuticals EPS misses by $3.40

Biohaven Pharmaceuticals (NYSE:BHVN): Q2 GAAP EPS of -$4.67 misses by $3.40.
Cash of $465.74M.
Press Release
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Eidos +15.4% as BridgeBio floats takeout at 20% premium

Eidos Therapeutics (NASDAQ:EIDX) is up 15.4% after hours following a filingthat shareholder BridgeBio Pharma (NASDAQ:BBIO) has made a nonbinding proposal to acquire the rest of the company’s shares.
The offer is for a fixed exchange ratio of 1.3 BridgeBio shares for each share of Eidos.
As of today’s close, that values Eidos shares at $38.77 each; the stock closed today at $32.06.
The filing discloses beneficial ownership of 66.6% of Eidos by BridgeBio.
BridgeBio is down 0.1% after hours.
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Novo Nordisk reports Q2 results

Novo Nordisk (NYSE:NVO): Q2 GAAP EPS of DKK4.03.
Revenue of DKK30.04B (+9.6% Y/Y)
Shares +0.18% PM.
Press Release
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