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☆ US FDA staff flag 'serious' safety risks for Intercept's NASH treatment
▼ + stars: | 2023-05-17 | by ( ) www.reuters.com time to read: +2 min

The U.S. Food and Drug Administration's (FDA) briefing document highlighted increased risk of diabetes and liver injury from using the obeticholic acid (OCA) oral tablets for the treatment of nonalcoholic steatohepatitis (NASH). "During the course of our review, FDA identified modest benefits and serious risks of OCA for treatment of NASH," the staff said in the document and listed increased risk of sludge formation in the gall bladder and imbalance of certain lipids. The staff asked the regulator's panel of outside advisors, who are meeting on Friday, to consider whether the modest benefits from using the drugs for NASH treatment outweigh the serious risks associated with it. The panel's meeting on Friday is the first such meeting for a NASH treatment. However, due to risks of serious liver injury, FDA restricted its usage in 2021 to primary biliary cholangitis patients with advanced cirrhosis, or severe liver scarring.

☆ Citi names its top biotech and pharma stock picks, giving one nearly 90% upside
▼ + stars: | 2023-05-17 | by ( Weizhen Tan | ) www.cnbc.com time to read: +2 min

The healthcare sector outperformed in Europe, India and China last month, according to Citi, which named its top picks worldwide. It gave Amylyx a price target of $53, giving it upside of around 88% from current levels. It gave Beam a price target of $60, implying upside of around 67%. Other European picks from Citi include Swiss healthcare company Roche and British pharma and biotech firm AstraZeneca . Asia stocks In Asia, Citi named Japanese pharmaceutical company Daiichi Sankyo , South Korean biotech firm Samsung Biologics and China's Wuxi Biologics as top picks.

☆ S&P 500, Dow fall, dragged by Home Depot outlook, US retail sales
▼ + stars: | 2023-05-16 | by ( Chuck Mikolajczak | ) www.reuters.com time to read: +4 min

Home Depot (HD.N) shed 1.73%, the biggest drag on the Dow Industrials and among the heaviest weights on the S&P 500 after the home improvement retailer cut its annual sales forecast and projected a steeper-than-expected decline in profit. The Commerce Department reported retail sales rose 0.4% in April, short of the estimate for an increase of 0.8%. That slowing along with recent negotiations over the U.S. debt ceiling has focused attention on when the central bank will pause hiking, or cut interest rates. Cleveland Fed President Loretta Mester said she does not think the central bank can hold interest rates steady yet. The S&P 500 posted 10 new 52-week highs and 12 new lows; the Nasdaq Composite recorded 42 new highs and 163 new lows.

The Commerce Department reported retail sales rose 0.4% in April, at half the pace against an expected increase of 0.8%. "The retail sales data has been positive in several months, but it's still weak," said Jamie Cox, managing partner at Harris Financial Group. You are probably seeing the end of the decline in retail sales, but it's not going to be a smooth ride from here." Dow Jones Industrial Average (.DJI) component Home Depot (HD.N) shed 1.4%, hitting its lowest level in over six months after the company lowered its annual sales forecast. Shares of Capital One Financial Corp (COF.N) jumped 2.4%, rising the most on the S&P 500, after Berkshire Hathaway Inc (BRKa.N) on Monday disclosed it has begun investing in the consumer lender.

☆ Gene-Therapy Investors Have a Powerful Ally: Patients
▼ + stars: | 2023-05-16 | by ( David Wainer | ) www.wsj.com time to read: 1 min

Sarepta’s stock jumped after an FDA panel voted in favor of a drug to treat Duchenne muscular dystrophy. Photo: Kristoffer Tripplaar/Sipa USA/Associated PressImagine for a moment that you are an expert at a Food and Drug Administration advisory panel meeting trying to decide whether to vote in favor of a drug for a rare disease that robs boys of their ability to walk, eventually killing many of them by the time they reach young adulthood. During the meeting, you hear testimonials from doctors and patients, including a video showing a boy riding his bike years after receiving the therapy for the disease, known as Duchenne muscular dystrophy. At the same meeting, you also hear from FDA staff who warn you that the studies conducted by Sarepta Therapeutics don’t provide clear evidence that the drug is beneficial. They also highlight some safety concerns.

☆ US FTC sues to block Amgen's $27.8 bln deal for Horizon Therapeutics
▼ + stars: | 2023-05-16 | by ( ) www.reuters.com time to read: +1 min

WASHINGTON, May 16 (Reuters) - The U.S. Federal Trade Commission said on Tuesday it would sue to stop Amgen Inc's (AMGN.O) $27.8 billion deal to buy Horizon Therapeutics Plc (HZNP.O). The agency said it was opposing the deal because it would give Amgen "monopoly positions" for medicines used to treat thyroid eye disease and chronic refractory gout. The deal, which was announced in December 2022, would give Amgen two fast-growing drugs, the thyroid eye disease treatment Tepezza and gout treatment Krystexxa. Other key drugs in Amgen's product portfolio, such as psoriasis therapy Otezla, face the loss of patent protections over the next few years. It is unusual for the agency to sue to stop a pharmaceutical deal.

☆ FTC sues to block Amgen's $27.8 bln deal for Horizon Therapeutics -statement
▼ + stars: | 2023-05-16 | by ( ) www.reuters.com time to read: 1 min

WASHINGTON, May 16 (Reuters) - The U.S. Federal Trade Commission said on Tuesday that it would sue to stop Amgen Inc's (AMGN.O) $27.8 billion deal to buy Horizon Therapeutics Plc (HZNP.O). The deal, which was announced in December 2022, would give Amgen two fast-growing drugs, the thyroid eye disease treatment Tepezza and gout treatment Krystexxa. Amgen hopes they can act as a bulwark against competition for its blockbuster arthritis drug Enbrel. Furthermore, other key drugs in its portfolio, such as psoriasis therapy Otezla, face loss of patents over the next few years. Reporting by Diane Bartz; editing by Tim AhmannOur Standards: The Thomson Reuters Trust Principles.

The Commerce Department reported retail sales rose 0.4% in April, at half the pace against an expected increase of 0.8%. "The retail sales data has been positive in several months, but it's still weak," said Jamie Cox, managing partner at Harris Financial Group. You are probably seeing the end of the decline in retail sales, but it's not going to be a smooth ride from here." "There is little chance we will see a resolution to the U.S. debt ceiling issue today," said Ipek Ozkardeskaya, senior analyst at Swissquote Bank. "The negotiations will likely remain tight as Republicans ask decent spending cuts to accept a debt ceiling relief, while Biden is not willing to compromise on spending into the election year."

☆ FTC Moves to Block Amgen’s $27.8 Billion Deal for Horizon Therapeutics
▼ + stars: | 2023-05-16 | by ( Dave Michaels | Joseph Walker | ) www.wsj.com time to read: 1 min

Amgen said it was disappointed by the FTC’s decision but doesn’t believe a merger presents any competitive issues. Photo: Eric Thayer/Bloomberg NewsThe Federal Trade Commission said Tuesday it is seeking to block Amgen ’s $27.8 billion acquisition of Horizon Therapeutics , in a new effort by antitrust enforcers to prevent a merger of pharmaceutical companies. The FTC filed a lawsuit in federal court seeking an injunction that would prevent the deal from closing. A federal judge would need to approve the injunction. That is part of a two-step legal process the agency typically uses to prevent mergers it believes are illegal.

☆ FTC’s Amgen Activism Will Spare Smaller Biotechs
▼ + stars: | 2023-05-16 | by ( David Wainer | ) www.wsj.com time to read: 1 min

The Federal Trade Commission’s effort to block Amgen’s acquisition of Horizon Therapeutics is putting a damper on the recent biotech stocks rally. Photo: Eric Lee for The Wall Street JournalBiotech stocks were on a tear in recent weeks, rebounding from the sector’s horrid performance of the last two years. The euphoria was based on the premise that pharma companies would keep paying massive premiums for biotech companies because their own blockbuster drugs were going off patent.

☆ FTC’s Amgen Activism Will Spare These Biotechs
▼ + stars: | 2023-05-16 | by ( David Wainer | ) www.wsj.com time to read: 1 min

The Federal Trade Commission’s effort to block Amgen’s acquisition of Horizon Therapeutics is putting a damper on the recent biotech stocks rally. Photo: Eric Lee for The Wall Street JournalBiotech stocks were on a tear in recent weeks, rebounding from the sector’s horrid performance of the last two years. The Federal Trade Commission’s effort to block Amgen ’s acquisition of Horizon Therapeutics is putting a damper on that rally. The SPDR S&P Biotech exchange-traded fund was down 3.4% on Tuesday morning, with Horizon plunging 18%. Seagen , which agreed to sell itself to Pfizer for $43 billion in March, was down 6%.

The main indexes started the week with modest gains as trading was range-bound amid a wrangling in Washington between the White House and Republicans. "There is little chance we will see a resolution to the U.S. debt ceiling issue today," said Ipek Ozkardeskaya, senior analyst at Swissquote Bank. Shares of rival Lowe's Companies Inc (LOW.N) fell 3.2%, while retail giant Walmart Inc (WMT.N) slipped 0.4%. Focus will also be on economic data, with retail sales expected to increase by 0.8% in April after falling 0.6% in the month before. ET, Dow e-minis were down 80 points, or 0.24%, S&P 500 e-minis were down 3 points, or 0.07%, and Nasdaq 100 e-minis were up 5.25 points, or 0.04%.

☆ FTC Poised to Block Amgen’s $27.8 Billion Deal for Horizon Therapeutics
▼ + stars: | 2023-05-16 | by ( Dave Michaels | Joseph Walker | ) www.wsj.com time to read: 1 min

Amgen said it isn’t aware of any decision by the Federal Trade Commission. Photo: Eric Thayer/Bloomberg NewsThe Federal Trade Commission is preparing to block Amgen ’s acquisition of Horizon Therapeutics , a person familiar with the matter said, marking a new effort by antitrust enforcers to prevent a merger of pharmaceutical companies. The FTC is preparing to seek an injunction in federal court that would prevent the deal from closing, according to the person familiar with the matter. A federal judge would need to approve the injunction. That is part of a two-step legal process the agency typically uses to prevent mergers it believes are illegal.

☆ FTC to block Amgen's $27.8 billion deal for Horizon Therapeutics - source
▼ + stars: | 2023-05-16 | by ( ) www.reuters.com time to read: +2 min

May 15 (Reuters) - The U.S. Federal Trade Commission is expected to file a lawsuit as early as Tuesday to block Amgen Inc's (AMGN.O) $27.8 billion deal to buy Horizon Therapeutics PLC (HZNP.O), a person familiar with the matter told Reuters. Amgen struck a deal last year to buy Horizon to strengthen its rare diseases drugs portfolio. Senator Elizabeth Warren, an outspoken critic of corporate consolidation, wrote to the FTC earlier this year expressing her concerns about pharmaceutical deals including the Amgen purchase of Horizon. The Democratic Senator said both Amgen and Horizon Therapeutics "have engaged in brazen price increases," including on Amgen's Enbrel for arthritis and Horizon’s Krystexxa, a gout medication. The deal would give Amgen two fast-growing drugs, the thyroid eye disease treatment Tepezza and Krystexxa.

☆ Stocks making the biggest moves midday: Horizon Therapeutics, Capital One, RH, Home Depot and more
▼ + stars: | 2023-05-16 | by ( Michelle Fox | ) www.cnbc.com time to read: +4 min

Western Alliance Bancorp — Western Alliance shares jumped 3.6% after Bank of America reinstated coverage on the stock with a buy rating. Home Depot , Lowe's — Shares of home improvement retailers Home Depot and Lowe's lost 1.4% and 1% in midday trading Tuesday. On Monday, Daniel Welch, a director at Seagen, disclosed the sale of 1,864 shares, a stake worth more than $370,000. GE HealthCare — The medtech company's shares gained nearly 3% after Oppenheimer initiated coverage with an outperform rating on Monday. GE HealthCare separated from parent company General Electric earlier in 2023 and began publicly trading on the Nasdaq Jan. 4.

☆ U.S. Sues to Block Amgen’s $27.8 Billion Takeover of Horizon Therapeutics
▼ + stars: | 2023-05-16 | by ( Rebecca Robbins | ) www.nytimes.com time to read: +1 min

The Federal Trade Commission on Tuesday sued to block the drug maker Amgen’s $27.8 billion acquisition of the pharmaceutical company Horizon Therapeutics, saying it would thwart competition in the drug industry. said the deal would allow Amgen to use its large portfolio of top-selling drugs to pressure insurers and others to favor two Horizon medications that lack competition. The commission’s move is its most aggressive yet after years of signaling that it would be tougher in scrutinizing pharmaceutical mergers. This case is unusual because Amgen and Horizon do not sell competing products. won’t hesitate to challenge mergers that enable pharmaceutical conglomerates to entrench their monopolies at the expense of consumers and fair competition.”

The Commerce Department reported retail sales rose 0.4% in April, at half the pace against an expected increase of 0.8%. "The retail sales data has been positive in several months, but it's still weak," said Jamie Cox, managing partner at Harris Financial Group. You are probably seeing the end of the decline in retail sales, but it's not going to be a smooth ride from here." The S&P 500 retail index (.SPXRT) lost 0.6%. Shares of Capital One Financial Corp (COF.N) jumped 5.4%, rising the most on the S&P 500, after Berkshire Hathaway Inc (BRKa.N) on Monday disclosed it has begun investing in the consumer lender.

☆ Jefferies' Michael Yee expects Amgen's Horizon Therapeutics deal will go through despite FTC block
▼ + stars: | 2023-05-16 | by ( ) www.cnbc.com time to read: 1 min

In this videoShare Share Article via Facebook Share Article via Twitter Share Article via LinkedIn Share Article via EmailJefferies' Michael Yee expects Amgen's Horizon Therapeutics deal will go through despite FTC blockMichael Yee, Jefferies managing director, joins 'Power Lunch' to discuss the FTC's move to block Amgen's $27.8 billion deal for Horizon Therapeutics.

☆ FTC sues to block Amgen acquisition of Horizon Therapeutics
▼ + stars: | 2023-05-16 | by ( ) www.cnbc.com time to read: 1 min

In this videoShare Share Article via Facebook Share Article via Twitter Share Article via LinkedIn Share Article via EmailFTC sues to block Amgen acquisition of Horizon TherapeuticsThe Federal Trade Commission on Tuesday said it has sued to block Amgen's $27.8 billion acquisition of Horizon Therapeutics. CNBC's David Faber reports.

☆ Horizon Therapeutics stock plunges on report FTC is preparing to block Amgen deal
▼ + stars: | 2023-05-16 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +1 min

Horizon Therapeutics ' stock price plunged more than 17% in premarket trading Tuesday after a report that the Federal Trade Commission is preparing to file a lawsuit to block the biotech company's $27.8 billion sale to Amgen . The FTC could sue to stop the acquisition as soon as Tuesday, Bloomberg reported, citing an unnamed source. An Amgen spokesperson told CNBC the company isn't aware of any decision made by the FTC. Representatives for Horizon Therapeutics did not immediately respond to a request for comment from CNBC. Thousand Oaks, California-based Amgen struck the deal to buy Horizon Therapeutics in early December and said it expected to complete the sale in the first half of this year.

☆ Oppenheimer says investors are missing opportunities in three biotech areas and the related stocks
▼ + stars: | 2023-05-16 | by ( Christina Cheddar Berk | ) www.cnbc.com time to read: +4 min

As biopharma investors follow the latest buzz around advancements in clinical research, they may be under-appreciating opportunities in neurology, psychiatry and genetic medicine, according to a report from Oppenheimer. "Valuation multiples across disease areas show CNS [ or central nervous system] and Genetic Medicine at relative low points." In July, the Food and Drug Administration could grant full approval to Leqembi , its Alzheimer's Disease treatment. As a very new area of medicine, gene therapy has greatest potential to accelerate sales growth as treatments come to market. He described immunology multiples as "generally stable" and genetic medicine multiples as highly volatile.

☆ Jim Cramer's top things to watch in the stock market Tuesday
▼ + stars: | 2023-05-16 | by ( Jim Cramer | ) www.cnbc.com time to read: +3 min

As a subscriber to the CNBC Investing Club with Jim Cramer, you will receive a trade alert before Jim makes a trade. Jim waits 45 minutes after sending a trade alert before buying or selling a stock in his charitable trust's portfolio. If Jim has talked about a stock on CNBC TV, he waits 72 hours after issuing the trade alert before executing the trade. THE ABOVE INVESTING CLUB INFORMATION IS SUBJECT TO OUR TERMS AND CONDITIONS AND PRIVACY POLICY , TOGETHER WITH OUR DISCLAIMER . NO FIDUCIARY OBLIGATION OR DUTY EXISTS, OR IS CREATED, BY VIRTUE OF YOUR RECEIPT OF ANY INFORMATION PROVIDED IN CONNECTION WITH THE INVESTING CLUB.

☆ Options Action: Investors feeling bearish on pharma company Horizon Therapeutics
▼ + stars: | 2023-05-16 | by ( ) www.cnbc.com time to read: 1 min

In this videoShare Share Article via Facebook Share Article via Twitter Share Article via LinkedIn Share Article via EmailOptions Action: Investors feeling bearish on pharma company Horizon TherapeuticsMike Khouw, Optimize Advisors president, joins CNBC’s Melissa Lee and the Options Action traders to discuss traders attitude towards Horizon Therapeutics

☆ Sarepta surges after FDA panel backs Duchenne gene therapy
▼ + stars: | 2023-05-15 | by ( ) www.reuters.com time to read: +2 min

May 15 (Reuters) - Shares of Sarepta Therapeutics (SRPT.O) soared 29% premarket on Monday as a backing by the U.S. health regulator's advisers increased the certainty of an accelerated approval for the company's gene therapy for a muscle-wasting genetic disorder. Eight of the 14 advisers to the Food and Drug Administration late Friday voted that the company had enough data to support an accelerated approval for its gene therapy for Duchenne muscular dystrophy (DMD). The vote came after FDA staff had earlier last week voiced concerns that the data from the company's mid-stage trial lacked "unambiguous evidence" about benefits from the therapy. TD Cowen analyst Ritu Baral expects an approval for the therapy, especially considering the FDA leadership's interest in promoting biomarker-based accelerated approvals for gene therapies. The FDA, often follows the advice of its expert advisers but is not obligated to do so, is slated to make a decision on accelerated approval by May 29.

☆ Mutation Protected Man From Alzheimer’s Disease, Hinting at Treatment
▼ + stars: | 2023-05-15 | by ( Gina Kolata | ) www.nytimes.com time to read: +1 min

Dr. Arboleda-Rodriguez is a co-founder of a biotechnology company looking to produce drugs that could act on this research. The mutation results in a potent version of a protein, Reelin, in the entorhinal cortex. That super-potent Reelin ultimately prevents tangled strands of tau proteins from sticking together and forming the structures that are a characteristic of Alzheimer's. “We don’t know what sort of damage it might do, sticking needles in and dropping in chemicals,” he said. The man with what the researchers are calling “resilience” to Alzheimer’s was part of a decades-long study of 6,000 people living in Colombia who have a gene mutation that causes Alzheimer’s in middle age.

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