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☆ Bayer Shares Tumble After Clinical Trial Failure, Loss in Roundup Case
▼ + stars: | 2023-11-20 | by ( Adrià Calatayud | Jared S. Hopkins | ) www.wsj.com time to read: 1 min

Bayer’s court loss on its Roundup weedkiller was the fourth decision in a row to go against the company. Photo: wolfgang rattay/ReutersBayer shares fell sharply after the company stopped a late-stage study for a blood-thinning drug early because of lack of efficacy and was told to pay $1.56 billion in a lawsuit relating to its Roundup weedkiller. Bayer said late Sunday that it discontinued a Phase 3 clinical trial to test its experimental drug asundexian for prevention of stroke and systemic embolism for patients with the heart-rhythm disorder atrial fibrillation.

Persons: wolfgang rattay, Bayer Organizations: Bayer

☆ Bayer stops blood thinner drug trial due to lack of effect, in major setback
▼ + stars: | 2023-11-20 | by ( Ludwig Burger | ) www.reuters.com time to read: +3 min

Logo and flags of Bayer AG are pictured outside a plant of the German pharmaceutical and chemical maker in Wuppertal, Germany August 9, 2019. REUTERS/Wolfgang Rattay/File Photo Acquire Licensing RightsNov 19 (Reuters) - Germany's Bayer (BAYGn.DE) has aborted a large late-stage trial testing a new anti-clotting drug due to lack of efficacy, dealing a fresh blow to the embattled drugmaker and throwing its most promising medium-term development project in doubt. The trial halt, which followed recommendation of independent trial supervisors, marks another setback for a company burdened by a weak herbicide business, high debt and by U.S. lawsuits over the alleged carcinogenic effect of its commonly used Roundup weedkiller. Bayer said it will further analyse the data of the discontinued trial, known as OCEANIC-AF, which was initiated in August 2022. It said the independent trial supervisors recommended the continuation of a separate phase III trial, OCEANIC-STROKE, testing asundexian to prevent repeated strokes in participants who have already suffered one.

Persons: Wolfgang Rattay, Germany's Bayer, Bill Anderson, Bayer, Stefan Oelrich, Johnson, Ludwig Burger, Jose Joseph, Miranda Murray, Christopher Cushing Organizations: Bayer AG, REUTERS, Bristol, Myers Squibb, Johnson, Thomson Locations: Wuppertal, Germany, United States, asundexian, U.S, Frankfurt, Bengaluru

☆ Stocks making the biggest premarket moves: Boeing, Bristol-Myers Squibb, Chegg, Krispy Kreme and more
▼ + stars: | 2023-11-20 | by ( Michelle Fox | ) www.cnbc.com time to read: +3 min

Check out the companies making the biggest moves in premarket trading: Boeing — The aerospace stock added 1.5% following an upgrade to buy from hold by Deutsche Bank. PENN Entertainment — The gambling stock popped 4.4% on the back of a Bank of America upgrade to buy from neutral. The Food and Drug Administration won't be able to meet to make a decision by the target date of Dec. 16. Krispy Kreme — Shares of the doughnut chain slipped 1.8% following a downgrade by JPMorgan to neutral from overweight. Vale — U.S.-listed shares of the Brazil-based metal and mining company added 2.6% following an upgrade by Bank of America to buy from neutral.

Persons: Sam Altman, Cantor Fitzgerald, Bristol Myers, Krispy, Krispy Kreme, Goldman Sachs, Iovance, Morgan Stanley, Terri Kelly, Kelly, —, Sarah Min, Alex Harring, Michael Bloom Organizations: Boeing, Deutsche Bank, Microsoft, PENN Entertainment, Bank of America, ESPN Bet, Myers, Drug Administration, Bristol, JPMorgan, Bros, Rentals, United Rentals Locations: Bristol, Vale — U.S, Brazil

☆ Bayer Cancels Asundexian Phase III Study Program
▼ + stars: | 2023-11-19 | by ( Nov. | At P.M. | ) www.usnews.com time to read: +1 min

(Reuters) - Germany's Bayer AG said on Sunday it is cancelling a phase III study program to investigate the efficacy and safety of asundexian, an oral Factor XIa (FXIa) inhibitor. The decision to stop the study is based on the recommendation by the Independent Data Monitoring Committee (IDMC). IDMC monitoring showed an inferior efficacy of asundexian compared to the control arm of the study. "A phase III study investigating asundexian compared to Apixaban in patients with atrial fibrillation at risk for stroke is being stopped early," the company said in a statement. Bayer, which initiated the study in August 2022, said it will further analyze the data to understand the outcome and will take appropriate measures.

Persons: Bayer, Jose Joseph, Chris Reese Organizations: Reuters, Germany's Bayer AG, Independent Data Monitoring, Bayer Locations: Bengaluru

A few compounds picked by AI are now in development, but those bets will take years to play out. Reuters interviews with more than a dozen pharmaceutical company executives, drug regulators, public health experts and AI firms show, however, that the technology is playing a sizeable and growing role in human drug trials. The U.S. Food and Drug Administration (FDA) said it had received about 300 applications that incorporate AI or machine learning in drug development from 2016 through 2022. Without AI, Bayer said it would have spent millions more, and taken up to nine months longer to recruit volunteers. Finding real-world patients by mining electronic patient data can be done manually, but using AI speeds up the process dramatically.

Persons: Dado Ruvic, Jeffrey Morgan, Amgen, Badhri Srinivasan, Sameer Pujari, drugmaker Bayer, Bayer, Blythe Adamson, Roche, Richard Pazdur, Gen Li, John Concato, Natalie Grover, Martin Coulter, Julie Steenhuysen, Josephine Mason, David Clarke Organizations: Pharmaceutical Research, REUTERS, Pharmaceutical, Bayer, Novartis, Deloitte, U.S . Food, Drug Administration, Reuters, World Health, Flatiron Health, FDA, European Medicines Agency, FDA's Oncology, Excellence, Medical, FDA's Center, Drug, Research, Thomson Locations: U.S, Johannesburg, Texas, Finland, United States, London, Chicago

A version that was leaked earlier this year showed that Brussels was preparing to shorten an additional period of intellectual property protection, known as data exclusivity, which comes on top of drug patent protection. "The duration of data exclusivity, which may be reduced, could actually have a catastrophic impact for Europe," he said. He said the intentions of Brussels lawmakers - improving patient access to innovative drugs while making the European pharma sector more competitive - were noble but any shortening of intellectual property protection would have the opposite effect. Bayer shares lag'HIGHLY ATTRACTIVE'In the United States, a different set of drug market rule changes are underway, with some of the highest-selling products set to see negotiated price discounts under the Inflation Reduction Act (IRA). Among the biggest drivers was the company's decision to prepare a U.S. launch of its next-generation stroke prevention drug asundexian on its own.

Companies Bayer AG FollowNEW YORK, March 9 (Reuters) - Bayer AG (BAYGn.DE) plans to spend $1 billion on drug research and development in the U.S. this year as it works to double its sales in the country by the end of the decade, Bayer's top U.S. pharmaceutical executive told Reuters. "It's time for us to double down on the U.S.," Guth said, noting that Bayer plans to sell the drugs it is developing itself in the country, rather than partner with U.S. companies like it has in the past. Bayer is looking to build up its portfolio of new drugs as it hopes to improve share prices, which have been hit by concerns over litigation surrounding weedkiller Roundup and a lack of trust in the company's leadership. Guth said he expects peak sales of 12 billion euros from cancer drug Nubeqa, kidney medication Kerendia, and two of its top pipeline assets, experimental stroke drug asundexian and experimental women's health drug elinzanetant. Reporting by Michael Erman; Editing by David GregorioOur Standards: The Thomson Reuters Trust Principles.

☆ Bayer’s rude health lays better path for breakup
▼ + stars: | 2023-01-11 | by ( Aimee Donnellan | ) www.reuters.com time to read: +4 min

Activists like Jeff Ubben’s Inclusive Capital Partners may now, however, be in a better position to push for a breakup. Smaller peer Bluebell Capital Partners has also bought in recently. Using UBS forecasts, they would be worth 50 billion euros and 88 billion euros respectively. Its smaller consumer drugs division might fetch another 18 billion euros, using peer Reckitt Benckiser’s (RKT.L) 12 times multiple. Add them up, take off debt, pension liabilities and a further 6 billion euros of future Roundup litigation costs, and Bayer’s equity could be worth nearly 110 billion euros.

Both are legacy issues from Monsanto, which Bayer acquired for more than $60 billion in 2018. Another activist, Elliott, took a 1.1 billion euro stake in Bayer in 2019 but has kept a low profile. The next-generation blood thinner is one of four new drug hopefuls that Bayer said on Tuesday had combined peak sales potential of more than 12 billion euros. That included an improved outlook for kidney drug Kerendia, with potential annual sales now seen at more than 3 billion euros. ($1 = 0.9313 euros)Reporting by Ludwig Burger and Patricia Weiss Editing by Mark PotterOur Standards: The Thomson Reuters Trust Principles.

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