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☆ Citi says the recent selloff in this biotech stock is 'overdone,' predicts shares can rally 30% from here
▼ + stars: | 2023-04-04 | by ( Samantha Subin | ) www.cnbc.com time to read: +1 min

The recent selloff in shares of Sarepta Therapeutics looks "overdone," according to Citi. Shares of Sarepta Therapeutics pulled back about 20% one day last month after regulators said they would hold an advisory committee meeting for SRP-9001, walking back previous plans to assess it without one. Despite these fears, Bitritto-Garg thinks an advisory committee was always in the cards for the treatment, but difficult to obtain as the FDA's Office of Therapeutic Products grappled with a restructuring and lack of resources. SRPT YTD mountain Shares so far this year She added that an advisory committee "may not be indicative of a meaningful change in FDA's position on the filing." Along with the buy rating, Bitritto-Garg slapped a $179 price target on shares, implying 30% upside from Monday's close.

☆ Here are Tuesday's biggest analyst calls: Apple, Amazon, Boeing, Chipotle, Rivian, Etsy, Exxon & more
▼ + stars: | 2023-04-04 | by ( Michael Bloom | ) www.cnbc.com time to read: +6 min

Here are Tuesday's biggest calls on Wall Street: Piper Sandler reiterates Apple as overweight Piper said iPhone share remains at near record levels for Apple. Bank of America reiterates Endeavor as buy Bank of America said it's bullish on Endeavor's plan to merge WWE and UFC. Piper Sandler upgrades Etsy to overweight from neutral Piper said it sees "continued share gains" for the e-commerce company. Deutsche Bank reiterates Citizens Financial and PNC as buy Deutsche said it's cautious on bank stocks overall, but that it likes Citizens and PNC as top picks. Bank of America reiterates Analog Devices as buy Bank of America said Analog Devices has "best-in-class" free-cash flow returns.

☆ Biden could help save cars, bicyclists, and pedestrians from being pulled under trucks in an accident with a simple fix, advocates say
▼ + stars: | 2023-04-04 | by ( Eliza Relman | ) www.businessinsider.com time to read: +6 min

Side guards can also stop people and cars from being crushed by a truck's rear wheels. A man stands on a truck's rear underride guard in Mexico City in 2021. Isaac Guzman/Getty Images'A catch-22'The US government and road safety experts have known for at least 50 years that underride guards save lives. Rear underride guards have been mandatory for most trucks in the US since the 1950s. Cahalan blames the trucking industry for "delaying and fighting against common sense safety reforms," not just with regard to underride guards.

☆ Pro-Iranian forces in Syria warn they can respond to further U.S. strikes
▼ + stars: | 2023-03-24 | by ( ) www.reuters.com time to read: 1 min

BEIRUT, March 24 (Reuters) - Pro-Iranian forces in Syria said in an online statement late Friday that they have a "long arm" to respond to further U.S. strikes on their positions, after tit-for-tat strikes in Syria over the last 24 hours. The statement, signed by the Iranian Advisory Committee in Syria, said U.S. strikes had left several fighters dead and wounded, without specifying their nationality. "We have the capability to respond if our centers and forces in Syria are targeted," the statement said. Reporting by Maya Gebeily; Editing by Leslie AdlerOur Standards: The Thomson Reuters Trust Principles.

Of the various potential rulings possible in the case involving the abortion pill mifepristone, either of those outcomes would be unprecedented judicial intervention in the agency's regulatory process. Some of the FDA's options could be politically and legally risky both for the agency and mifepristone suppliers, they said. The FDA said the pill was deemed safe after extensive studies and use, and that the challenge comes much too late. Under FDA statutes and regulations, drug approval withdrawal generally begins with an informal hearing, which can entail extensive document preparation and the convening of an advisory committee. Overseas provider Aid Access, an Austria-based service that ships abortion medication to U.S. patients, said it would continue providing the pill no matter how the FDA responds.

☆ FDA advisors reject Biogen's ALS drug for rare and aggressive form of the disease
▼ + stars: | 2023-03-22 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +3 min

The Food and Drug Administration's independent panel of advisors on Wednesday declined to endorse accelerated approval of Biogen's investigational ALS drug for a rare and aggressive form of the disease. The drug tofersen was developed to treat a rare genetic form of amyotrophic lateral sclerosis, or ALS. That number is even smaller in the U.S., with roughly 330 people affected by the SOD1 mutation. The median survival time from diagnosis with the rare form of ALS to death is 2.7 years, according to the company. The SOD1 mutation is associated with 20% of cases that occur within families.

☆ FDA advisors vote against effectiveness of Biogen's ALS drug for rare and aggressive form of the disease
▼ + stars: | 2023-03-22 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +3 min

The Food and Drug Administration's independent panel of advisors on Wednesday voted against the effectiveness of Biogen's investigational ALS drug for a rare and aggressive form of the disease. The drug tofersen was developed to treat a rare genetic form of amyotrophic lateral sclerosis, or ALS. That number is even smaller in the U.S., with roughly 330 people affected by the SOD1 mutation. The median survival time from diagnosis with the rare form of ALS to death is 2.7 years, according to the company. The SOD1 mutation is associated with 20% of cases that occur within families.

☆ FDA staff says Biogen's ALS drug may have a 'clinical benefit' on a rare form of the disease
▼ + stars: | 2023-03-20 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +6 min

U.S. Food and Drug Administration staff on Monday said Biogen's investigational ALS drug may have a "clinical benefit" on a rare and aggressive form of the disease, despite failing a broader late-stage clinical trial last year. A separate exploratory analysis of the drug suggests "a clinical benefit with a longer duration of treatment," the staff wrote. It also found that tofersen reduced levels of a protein called neurofilament light (NfL,) which is "correlated with disease severity, disease progression rate, and survival in patients with ALS," according to the FDA staff. The first is to move forward with recommending accelerated approval based on tofersen's reduction of NfL in ALS patients. "SOD1-linked ALS is a particularly rare and aggressive form of an already rare and devastating disease," said Dr. Neil Thakur, The ALS Association's chief mission officer.

Companies Signature Bank FollowSINGAPORE, March 17 (Reuters) - Oil prices firmed on Friday after a meeting between Saudi Arabia and Russia calmed markets amid strong China demand expectations, but were headed for their biggest weekly falls since December as a banking crisis rocked global financial and oil markets. U.S. West Texas Intermediate crude went up by 21 cents to $68.53 a barrel, after closing 1.1% higher in the previous session. China's demand rebound will be positive for oil prices if upcoming data shows a good recovery of the country's economy, said analyst Tina Teng of CMC Markets. However, contagion risks among banks are still keeping investors on edge, curbing their appetite for assets such as commodities, as they fear a further rout could trigger a global recession and cut oil demand. These issues regarding inflation, the central bank's rate hikes, and confidence in financial systems cannot be settled quickly," Teng said.

☆ Oil steadies as investors take stock of banking crisis
▼ + stars: | 2023-03-17 | by ( Florence Tan | ) www.reuters.com time to read: +2 min

SINGAPORE, March 17 (Reuters) - Oil prices were little changed on Friday after a meeting between Saudi Arabia and Russia calmed markets, but crude benchmarks were still headed for a second weekly fall after a banking crisis sparked a sell-off in global financial markets this week. Brent crude futures edged up 2 cents to $74.72 a barrel by 0133 GMT, having snapped three days of losses to settle 1.4% higher on Thursday. U.S. West Texas Intermediate crude was at $68.33 a barrel, down 2 cents after closing 1.1% higher in the previous session. Contagion risks among banks are still keeping investors on edge, curbing their appetite for assets such as commodities as they fear a further rout could trigger a global recession and cut oil demand. "The sudden failure of SVB and Signature Bank forced a rethink about the health of the broader economy and spooked markets," JPMorgan analysts said in a note.

Companies Signature Bank FollowSINGAPORE, March 17 (Reuters) - Oil prices rebounded by about 1% on Friday after a meeting between Saudi Arabia and Russia calmed markets amid strong China demand expectations, after a banking crisis sparked a sell-off in global financial and oil markets this week. U.S. West Texas Intermediate crude climbed 78 cents to $69.13 a barrel, after closing 1.1% higher in the previous session. China's demand rebound will be positive for oil prices if upcoming data shows a good recovery of the country's economy, said analyst Tina Teng of CMC Markets. However, contagion risks among banks are still keeping investors on edge, curbing their appetite for assets such as commodities, as they fear a further rout could trigger a global recession and cut oil demand. These issues regarding inflation, the central bank's rate hikes, and confidence in financial systems, cannot be settled quickly," Teng said.

☆ San Francisco officials weigh giving Black residents $1 homes and $97,000 a year of as part of a massive reparations plan
▼ + stars: | 2023-03-17 | by ( Alcynna Lloyd | ) www.businessinsider.com time to read: +5 min

San Francisco policymakers are considering reparations for many of its Black residents. Proposals include giving qualifying residents $5 million, $97,000 a year for 250 years, or $1 homes. Supervisors unanimously supported the presentation from the San Francisco African American Reparations Advisory Committee, but its proposals remain far from reality. If enacted, though, San Francisco's reparations plan stands to become one of the most substantial packages ever approved in the United States. "This conversation we're having in San Francisco is completely unserious," John Dennis, chair of the San Francisco Republican Party, told the AP.

☆ Stocks making the biggest moves midday: FRC, FDX, NVDA, BMBL & more
▼ + stars: | 2023-03-17 | by ( Yun Li | ) www.cnbc.com time to read: +2 min

Investors breathed a sigh of relief after the Swiss National Bank said it would provide a liquidity backstop for Credit Suisse. First Republic — The regional bank shares shed over 20% even after the company is set to receive aid from other financial institutions. Credit Suisse — U.S.-listed shares of the Swiss bank fell nearly 11% on Friday, a day after soaring on news the bank will borrow up to 50 billion Swiss francs ($54 billion) from the Swiss National Bank. Warner Bros Discovery — The media company gained 2% after Wells Fargo upgraded the stock to overweight from equal weight. FedEx — The shipping company saw its stock jump over 8% after the company's fiscal third-quarter earnings topped analysts expectations.

☆ FDA advisors recommend full approval of Pfizer Covid treatment Paxlovid for adults 50 and over and other high-risk people
▼ + stars: | 2023-03-16 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +4 min

The Food and Drug Administration's independent panel of advisors recommended full approval of Pfizer's Covid-19 antiviral pill Paxlovid for high-risk adults 16-1 on Thursday, but flagged potentially harmful drug interactions. The FDA first made Paxlovid available in December 2021 for emergency use in high-risk individuals ages 12 and up. More than half of Paxlovid-eligible Medicare and Veterans Affairs patients are on medications that have drug interactions with Paxlovid, according to an FDA review of safety surveillance data. Roughly 74% of Paxlovid prescriptions were from adult primary care practitioners who may not be experienced with managing the possible adverse drug interactions, the FDA review added. To complete a full course of the drug, patients must take three Paxlovid pills twice a day for five days.

☆ FDA staff report says data shows Pfizer's Covid treatment Paxlovid is effective in high-risk adults
▼ + stars: | 2023-03-14 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +2 min

More than 12 million courses of Paxlovid have been delivered to pharmacies across the U.S., according to federal data. The FDA staff reviewed Pfizer's mid-to-late stage clinical trials of Paxlovid. In one trial called EPIC-HR, Paxlovid showed an 86% reduction in the risk of hospitalization or death in high-risk adults who hadn't received a Covid vaccine. Paxlovid has been plagued by reports of "rebound" Covid infections, where patients see their Covid symptoms or a positive test return after finishing a five-day course of the oral drug. That was also regardless of patients' risk of severe disease, or whether Covid's omicron variant or an earlier strain was dominant, according to the staff.

☆ Giving babies $1,000 at birth is an 'unprecedented opportunity for financial security,' Ayanna Pressley and Cory Booker say
▼ + stars: | 2023-03-08 | by ( Ayelet Sheffey | ) www.businessinsider.com time to read: +4 min

Rep. Ayanna Pressley and Sen. Cory Booker urged the Treasury Department to support their "Baby Bonds" legislation. "This policy would provide every child in America with unprecedented opportunity for financial security," Pressley and Booker wrote in their letter. They cited reports from Columbia University and Morningstar that found Baby Bonds would "substantially" close the racial wealth gap. When we introduce baby bonds, this gap narrows to 71% for Black families and 67% for Hispanic families." Along with Pressley and Booker, other Democratic lawmakers have been stressing the benefits of Baby Bonds over the past year.

☆ Yellen warns climate change could trigger asset value losses, harming US economy
▼ + stars: | 2023-03-07 | by ( Andrea Shalal | ) www.reuters.com time to read: +3 min

WASHINGTON, March 6 (Reuters) - Climate change is already having a major economic and financial impact on the United States and may trigger asset value losses in coming years that could cascade through the U.S. financial system, Treasury Secretary Janet Yellen will warn on Tuesday. "As climate change intensifies, natural disasters and warming temperatures can lead to declines in asset values that could cascade through the financial system. She said severe storms and wildfires in states like California, Florida, and Louisiana, tornadoes across the South and intensifying storms on the West Coast show how climate change is accelerating. Yellen said the new Climate-related Financial Risk Advisory Committee, set up last October by the Financial Stability Oversight Council (FSOC), would boost U.S. efforts to mitigate the risks that climate change poses to financial stability. That in turn could spill over to other parts of the financial system, she said.

☆ Treasury Secretary Yellen warns that losses tied to climate change could 'cascade through the financial system'
▼ + stars: | 2023-03-07 | by ( Emma Newburger | ) www.cnbc.com time to read: +1 min

U.S. Treasury Secretary Janet Yellen delivers remarks on "Next Steps in the Evolution of Development Finance" at a Center for Strategic and International Studies (CSIS) in Washington, U.S., February 9, 2023. \Treasury Secretary Janet Yellen on Tuesday warned that climate change is already taking a significant economic toll and could cause extensive losses to the U.S. financial system in the coming years. Yellen made the remarks during the first meeting with the Climate-related Financial Risk Advisory Committee (CFRAC), an advisory board that was set up last year by the Financial Stability Oversight Council in an effort to bolster U.S. action to minimize climate risk to the economy. "As climate change intensifies, natural disasters and warming temperatures can lead to declines in asset values that could cascade through the financial system," she said during the meeting. "A delayed and disorderly transition to a net-zero economy can lead to shocks to the financial system as well."

☆ The FAA won't have to establish seating size and space rules despite all the complaints, US court rules
▼ + stars: | 2023-03-03 | by ( Jordan Hart | ) www.businessinsider.com time to read: +4 min

On Friday, a US court ruled against FAA having to establish minimum seat sizes and spacing for safety, Reuters reports. On Friday, the DC Circuit Court of Appeals ruled that advocacy group FlyersRights.org couldn't force the FAA to adopt seating dimension rules. That is why some passengers pay for wider seats and extra legroom," Walker wrote. There needs to be a minimum size established, and it needs to be larger than the current sizing," commenter Epiphany Pizor wrote. In 2018, Congress passed the FAA Reauthorization Act, directing the agency to issue seat dimension rules regarding passenger safety.

The panelists seemed significantly more confident about the demographic profile used during the GSK study in comparison to Pfizer's (PFE.N) RSV vaccine, which was recommended by the FDA panel on Tuesday. Pfizer and GSK are running a tight race to tap into the RSV vaccine market, which is estimated to be over $5 billion and could exceed $10 billion by 2030, according to analysts. There is currently no approved vaccine to prevent lower respiratory tract disease caused by RSV in older adults, which causes death of 14,000 adults aged 65 and older annually in the United States. In October, late-stage data of GSK's RSV vaccine showed it to be 82.6% effective in preventing lower respiratory tract disease in people aged 60 and over, while Pfizer's vaccine was 66.7% effective. If approved, we estimate peak sales for GSK vaccine to be about $2.8 billion globally, said Evan Wang, Guggenheim Securities analyst, ahead of the panel vote.

Feb 28 (Reuters) - A panel of outside advisers to the U.S. health regulator on Tuesday recommended Pfizer Inc's (PFE.N) respiratory syncytial virus (RSV) vaccine, bringing it closer to becoming one of the first approved RSV shots for older adults in the United States. GSK (GSK.L), which is another forerunner in a crowded race to develop the first RSV vaccine, will face scrutiny from a panel of experts to the FDA on Wednesday. "The population where the vaccine is going to potentially have the biggest impact is less represented in this study," said Hana Sahly, one of the 12 FDA panelists. The FDA is scheduled to decide on the vaccines by May, and typically follows the recommendations of its independent panel of experts. Pfizer's vaccine was 66.7% effective in preventing RSV-related lower respiratory tract illness with over two symptoms, while GSK's vaccine was 82.6% effective in preventing lower respiratory tract disease in people aged 60 and over.

☆ FDA advisors recommend Pfizer RSV vaccine for older adults, despite possible Guillain-Barre risks
▼ + stars: | 2023-02-28 | by ( Spencer Kimball | ) www.cnbc.com time to read: +5 min

The vote followed concerns at the FDA and among advisory committee members about two cases of Guillain-Barre syndrome among about 20,000 vaccine recipients. The FDA has asked Pfizer to conduct a safety study on Guillain-Barre syndrome, which the company has agreed to do. There currently is no approved RSV vaccine for the elderly. Pfizer's vaccine contains both strains of RSV, which circulate at the same time during fall and winter. Dr. David Kaslow, a senior official in the FDA's vaccine division, said safety monitoring will be "critically important" if Pfizer's RSV vaccine is approved.

☆ Biden taps CEOs of 3M, CVS, FedEx, Citi, others to join his Export Council on trade
▼ + stars: | 2023-02-28 | by ( Emma Kinery | ) www.cnbc.com time to read: +3 min

U.S. President Joe Biden has appointed the heads of Citigroup , United Airlines , CVS , 3M and FedEx , among other top executives, to sit on a White House advisory committee overseeing international trade. The President's Export Council gives recommendations and insight into the ways government policies impact U.S. trade performance. The group also provides feedback on how Biden's trade policies are affecting businesses across sectors from industry and labor to agriculture. She previously served as chief operating officer and group president of Starbucks and CEO of Sam's Club. The Export Council features expertise from labor, real estate, national security and law, and leaders of Fortune 200 companies.

☆ U.S. FDA panel votes for Pfizer's RSV vaccine
▼ + stars: | 2023-02-28 | by ( ) www.reuters.com time to read: 1 min

Feb 28 (Reuters) - A panel of outside advisers to the U.S. Food and Drug Administration (FDA) on Tuesday recommended Pfizer Inc's (PFE.N) respiratory syncytial virus (RSV) vaccine, paving the way for one of the first approved RSV shots in the United States for older adults. The FDA advisory committee voted 7 to 4 in favor of the drug, saying data from the clinical study conducted by the company established that the treatment was effective and safe in preventing the lower respiratory tract disease caused by RSV in 60 years and older. (This story has been corrected to change the voting ratio to "7 to 4" from "7 to 12" in paragraph 2)Reporting by Mariam E Sunny and Khushi Mandowara in Bengaluru; Editing by Maju SamuelOur Standards: The Thomson Reuters Trust Principles.

☆ FDA says Guillain-Barre syndrome is possible risk of Pfizer's RSV vaccine for older adults
▼ + stars: | 2023-02-24 | by ( Spencer Kimball | ) www.cnbc.com time to read: +5 min

Guillain-Barre syndrome, or inflammatory neuropathy, is a rare disorder in which the body's immune system mistakenly attacks the nerves. There was also a possible case of Guillain-Barre syndrome in GSK 's RSV vaccine trials, but the company said there was insufficient evidence to confirm a diagnosis. They will also vote Wednesday on GSK's RSV vaccine for older adults. The Guillain-Barre casesIn Pfizer's trial, a 66-year-old man in the U.S. with a history of hypertension developed Guillain-Barre symptoms seven days after vaccination. He was hospitalized again after suffering a fall and was subsequently diagnosed with Guillain-Barre Syndrome.

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