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Tuesday, November 12, 2024

New Rescuer Guidelines Tackle Rise of Drowning Deaths in U.S.

 Mouth-to-mouth CPR with chest compressions are still the priority when rescuing victims of drowning, according to a focused update of American resuscitation and emergency cardiovascular guidelines.

The American Heart Association (AHA) and American Academy of Pediatrics (AAP) released a more codified and elaborate list of recommendations that replaces existing drowning guidelines from 2020opens in a new tab or window and years earlier.

Trained rescuers and laypeople alike are now formally advised that:

  • Anyone removed from the water without signs of normal breathing or consciousness should be presumed to be in cardiac arrest. Provide CPR -- with rescue breaths and chest compressions -- to all individuals in cardiac arrest following drowning after removal from the water. (Class I recommendation)
  • If a person is untrained, unwilling, or unable to give breaths, they can provide chest compressions only until help arrives. (Class IIa)
  • In both adults and children, automated external defibrillator (AED) use is reasonable in cardiac arrest even though shockable rhythms occur less commonly in the drowning process. (Class IIa)
  • Importantly, CPR should not be delayed to obtain or apply an AED on drowned people. (Class III)
  • Trained rescuers may find it reasonable to perform in-water rescue breathing on unresponsive adults and children only if it doesn't compromise their own safety. (Class IIb)
  • Supplemental oxygen should be provided by trained rescuers to all people with cardiac arrest after drowning. (Class I)

"CPR for cardiac arrest due to drowning must focus on restoring breathing as well as restoring blood circulation," said writing group co-chair Cameron Dezfulian, MD, critical care specialist of Baylor College of Medicine in Houston, in a joint press releaseopens in a new tab or window from AHA and AAP.

The present AHA-AAP drowning recommendations were published in two parts: a general publication addressing adult and pediatric victims in Circulationopens in a new tab or windowand a separate paper specific to the resuscitation of children in Pediatricsopens in a new tab or window.

Dezfulian and colleagues based their recommendations in part on recent systematic reviews from the International Liaison Committee on Resuscitation (ILCOR).

"These updated guidelines are based on the latest available evidence and are designed to inform trained rescuers and the public how to proceed in resuscitating people who have drowned. Drowning can be fatal. Our recommendations maximize balancing the need for rapid rescue and resuscitation, while prioritizing rescuer safety," Dezfulian said.

In most cases, cardiac arrest following drowning progresses from initial respiratory arrest due to submersion-related hypoxia. Less commonly, the drowning event may have occurred after a primary cardiac event.

"[T]hus, it can be challenging to distinguish respiratory arrest from cardiac arrest because pulses are difficult to accurately palpate within the recommended 10-second window. Therefore, resuscitation from cardiac arrest attributable to this specific circumstance must focus on restoring breathing as much as it does circulation," the writing group reasoned.

According to the CDC, drowning deaths are on the rise in the U.S.opens in a new tab or window after decades of decline. Over 4,500 people died due to drowning each year from 2020-2022, 500 more per year compared to 2019. Drowning is the top killer of children age 1-4 years old in the nation; most infants drown in bathtubs, and the majority of preschool-aged children drown in swimming poolsopens in a new tab or window.

AHA and AAP say it is reasonable to implement public access to defibrillators in aquatic environments pending cost-effectiveness data (Class IIa recommendation).

Meanwhile, the guideline writing group acknowledged that many questions in drowning resuscitation remain unanswered. The ILCOR reports had identified few studies with sufficient rigor to inform best practices, and topics such as extracorporeal CPR and the necessity of drying the victim's chest before applying an AED are among the important knowledge gaps.

"While we work on a daily basis to lower risks of drowning through education and community outreach on drowning prevention, we still need emergency preparedness training that can be used in tragic circumstances if a drowning occurs," said writing group co-chair Tracy McCallin, MD, of Rainbow Babies and Children's Hospital in Cleveland, in a statement.

Disclosures

Dezfulian and McCallin had no relevant disclosures.

Primary Source

Circulation

Source Reference: opens in a new tab or windowDezfulian C, et al "2024 American Heart Association and American Academy of Pediatrics focused update on special circumstances: resuscitation following drowning: an update to the American Heart Association guidelines for cardiopulmonary resuscitation and emergency cardiovascular care" Circulation 2024; DOI: 10.1161/CIR.0000000000001274.

Secondary Source

Pediatrics

Source Reference: opens in a new tab or windowMcCallin TE, et al ""2024 American Heart Association and American Academy of Pediatrics focused update on special circumstances: resuscitation following drowning: an update to the American Heart Association guidelines for cardiopulmonary resuscitation and emergency cardiovascular care" Pediatrics 2024; DOI: 10.1542/peds.2024-068444.


https://www.medpagetoday.com/emergencymedicine/emergencymedicine/112876

Neumora Q3 results, update

 Phase 3 data from KOASTAL-1 study of navacaprant in MDD expected around the end of 2024; KOASTAL-2 and KOASTAL-3 topline data expected in the first half of 2025

Ongoing clinical studies evaluating navacaprant in bipolar depression and NMRA-511 in Alzheimer’s disease agitation with data expected in second half of 2025

Clinical study for next M4 PAM program expected to commence clinical in the first half of 2025

Strong financial position with $341.3 million in cash, cash equivalents and marketable securities now expected to support operations into mid-2026

Conference call today at 8:00am ET

https://www.globenewswire.com/news-release/2024/11/12/2978862/0/en/Neumora-Therapeutics-Reports-Third-Quarter-2024-Financial-Results-and-Provides-Business-Update.html

Axsome FDA Milestones Could Fuel Even Bigger Gains

 Axsome Therapeutics (NASDAQ:AXSM) just hit a 52-week, skyrocketing more than 55% over the past year. What's driving the surge? Simple: a red-hot pipeline and big wins on the regulatory front. Investors are all-in on Axsome's potential, especially with FDA action dates looming. AXS-07, the migraine fighter, could get the green light by the beginning of 2025, and Phase 3 trial results for AXS-05 in Alzheimer's agitation are set to drop this quarter. Throw in Auvelity, their antidepressant, smashing sales with a jaw-dropping 113% year-over-year growth, and you've got the kind of momentum that turns heads on Wall Street.

The numbers don't just impressthey stun. Axsome raked in $104.8 million in Q3 revenue, an 81% jump year-over-year. Their gross profit margin? A sizzling 90.3%. With $327.3 million in cash and plans to expand Auvelity's sales force again in 2025, Axsome is setting itself up to dominate. Analysts are bullish too. Mizuho doubled down on their Outperform rating with a $106 price target, pointing to the company's knack for hitting both scientific and commercial milestones.

Looking ahead, it's clear the best might still be coming. Axsome has nine late-stage clinical programs targeting CNS disorders like narcolepsy, fibromyalgia, and ADHD. Key trial results and regulatory decisions are just around the corner, and CEO Herriot Tabuteau is confident about delivering new therapies to millions of patients. The takeaway? Axsome isn't just winning nowit's building a foundation for sustained growth that could deliver big returns for investors willing to ride this wave.


https://finance.yahoo.com/news/axsome-hits-52-week-high-174242780.html

Heron narrows guidance after Q3

 

  • Reported positive YTD 2024 Adjusted EBITDA of $1.4 million
  • Company expects Q4 2024 Net Revenue in the range of $37 million - $43 million
  • ZYNRELEF® (bupivacaine and meloxicam) extended-release solution Vial Access Needle ("VAN") approved in September and on track for Q4 2024 launch
  • CMS Final Rule Non-Opioid Policy for Pain Relief includes ZYNRELEF as a qualifying product for separate payment in both the hospital outpatient department and ambulatory surgical center settings of care

"We are pleased to report that with our prudent financial management and continued revenue growth we were able to achieve positive Adjusted EBITDA for the quarter," said Craig Collard, Chief Executive Officer. "The future looks bright as we continue to grow all product revenue. The CrossLink partnership roll out, FDA approval of the VAN in September, and inclusion in the CMS Final Rule Non-Opioid Policy for Pain Relief, positions ZYNRELEF for significant growth within the surgical setting."

"We continue to deliver on our commitment to financial efficiency while growing revenue. The team has made great strides in the transformation of Heron over the past year. We are looking forward to a strong fourth quarter which is off to a great start. As such, we are narrowing guidance for full-year 2024."

Financial Guidance for 2024

The Company narrows its full-year 2024 guidance for Product Revenues, Net, Adjusted Operating Expenses and Adjusted EBITDA:


Original

Q2 Updated Guidance

Q3 Updated Guidance

Product Revenues, Net

$138.0 to $158.0 million

$140.0 to $146.0 million

Adjusted Operating Expenses

$108.0 to $116.0 million

$107.0 to $111.0 million

$101.0 to $105.0 million

Adjusted EBITDA

$(22.0) to $3.0 million

$(10.0) to $3.0 million

$2.0 to $5.0 million

Business Highlights

  • The ZYNRELEF VAN will be available for initial use in the fourth quarter following approval by the U.S. Food and Drug Administration ("FDA") on September 24, 2024. The VAN will replace the current vented vial spike and has the potential to simplify aseptic preparation, while also significantly reducing ZYNRELEF's withdrawal time down to between twenty and forty-five seconds.
  • ZYNRELEF will continue to receive separate payment from April 1, 2025, until at least the end of 2027 as the result of inclusion in the "CMS OPPS and ASC Final Rule CY 2025 Non-Opioid Policy for Pain Relief" by the Centers for Medicare & Medicaid Services ("CMS"). The payment limitation for ZYNRELEF is set at $2,267.26, in line with similar products, and it will be granted the status indicator of "K1" – for Non-Opioid Drugs and Biologicals For Post-Surgical Pain Relief. The goal of the policy is to ensure there are no financial incentives to use opioids instead of non-opioid alternatives like ZYNRELEF. To qualify under the new policy, ZYNRELEF needed to meet strict criteria establishing that it does not act upon the body's opioid receptors and that it successfully demonstrated the ability to replace, reduce, or avoid intraoperative or postoperative opioid requirements in clinical trials or peer reviewed literature. These criteria set a strong precedent from CMS that we expect other payors to follow.
  • Cash and Cash Equivalents were $70.9 million as of September 30, 2024, compared with $80.4 million on December 31, 2023.

Conference Call and Webcast

Heron will host a conference call and live webcast on Tuesday, November 12, 2024, at 8:00 a.m. ET. The conference call can be accessed by phone by utilizing the following registration link which will provide participants with dial-in details. To avoid delays, we encourage participants to dial into the conference call fifteen minutes ahead of the scheduled start time. The conference call will also be available via webcast under the Investor Relations section of Heron's website at www.herontx.com. An archive of the teleconference and webcast will also be made available on Heron's website for sixty days following the call.

https://www.prnewswire.com/news-releases/heron-therapeutics-announces-third-quarter-2024-financial-results-and-narrows-financial-guidance-302302018.html

'Trump Bets Cashed in Before US CPI'

 A look at the day ahead in Asian markets. 

Investors sobered up from post-election euphoria over Republican Donald Trump's victory and took some profits ahead of Wednesday's October U.S. CPI report, which kicks off a calendar thick with U.S. news events markets will be watching the rest of the week. 

While CPI will not be a trading factor for Asia until Thursday, it has ramifications for global markets already nervous about how Trump's hardline trade policies might impact U.S. growth, inflation, interest rates and thereby the Federal Reserve's easing trajectory.  

U.S. stocks eased and bitcoin faltered after flirting with $90,000 on Tuesday while Treasury yields jumped on reopening from a long weekend as the ramifications of tax cuts, trade tariffs and wider budget deficits under the new administration were priced in.

Wall Street's stumble was similar to downward moves in Asia, in what looks like a negative feedback loop.  

Trump's agenda should be easily pushed through Congress, now that Republicans appear to have won a majority of U.S. House seats, marking a government sweep.

The S&P 500 and other indexes spent the day in the red. Bitcoin pulled back during the session before making another run that barely cleared the early high at $89,982. 

Crypto stocks like Coinbase and Riot Platforms slumped, as did Tesla, another stock expected to perform well during Trump's presidency, given the close ties between the president-elect and Elon Musk, its billionaire CEO and another outspoken bitcoin promoter.

The ten-year yield posted its biggest basis point rise since June and the yield on the two-year note looked set for its biggest jump in more than a month -- excellent support for the dollar. Dollar/yen hit its highest since July 30, trading at 154.73 in late U.S. trade and China's yuan was at 7.2423 per dollar after hitting its lowest since Aug 1.

Chinese shares slid on concerns that Trump's administration would be loaded with China hawks. The Shanghai Composite closed 1.4% lower. MSCI's all world index fell 0.7%, after its index of Asian shares ex-Japan ended down 2% along with the Nikkei's 0.4% drop.

Datawise, U.S. October producer prices on Thursday and retail sales on Friday fill out the week. Fed Chair Jerome Powell speaks on the economic outlook on Thursday, another reason to keep the powder dry.  

https://money.usnews.com/investing/news/articles/2024-11-12/morning-bid-trump-bets-cashed-in-before-us-cpi


US scrutinizes Russia accounts UBS took over from Credit Suisse, sources say

 The United States is pursuing an inquiry into Russian clients that UBS took on when it bought Credit Suisse, three people familiar with the matter said, heightening scrutiny of one of the world's biggest wealth managers.

The U.S. sanctions enforcement agency, OFAC, has written to the bank as part of this inquiry, two people familiar with the matter told Reuters. A U.S. official, asking not to be named, said the Swiss bank and the enforcer have held discussions.

OFAC, or the Office of Foreign Assets Control, the globe's most powerful sanctions agency, wrote to UBS in recent weeks, said one of the people.

Spokespeople for UBS and OFAC declined to comment.

The review concerns Russian customers at Credit Suisse that UBS is now overseeing after rescuing the lender, two of the people said. Credit Suisse, UBS' smaller Swiss peer, imploded in March 2023 following years of scandals from spying to laundering drug money.

UBS is seeking to contain any potential fallout from OFAC's queries by cordoning off suspect money and decommissioning the accounts to avoid the threat of a penalty, one of those people said.

The U.S. uses sanctions as a foreign policy tool, imposing restrictions to constrain the activities of nations such as Russia and Iran.

Handling Russian money has become increasingly risky, after the U.S. and Western allies rolled out an unprecedented web of sanctions in response to Moscow's invasion of Ukraine.

While the U.S. official praised UBS for being cooperative, one of the other sources said it was made clear that failure to deal with the problem could be punished.Regulators in Switzerland have been scrutinizing how UBS is handling Credit Suisse clients and the bank's anti-money laundering policies as they worry the Swiss bank could end up with risky clients, Reuters has reported.


https://uk.finance.yahoo.com/news/exclusive-us-scrutinizes-russia-accounts-215448049.html

Repligen Up on Record Growth and Bold Moves

 Repligen Corporation (NASDAQ:RGEN) is stealing the spotlight after reporting a standout third quarter, with revenue climbing 10% year-over-year to $155 million. The bioprocessing tech leader saw CDMO revenue skyrocket 20%, with equipment sales and new modality revenues hitting all-time highs. CEO Olivier Loeillot didn't hold back, crediting the team's execution and improving market trends for the stellar results. The company narrowed its full-year revenue guidance to $630$639 million, signaling confidence as order intake outpaced sales by 4%. Translation? Repligen is riding a wave of momentum that's showing no signs of slowing.

Wall Street noticed. Shares popped 10% on the news, fueled by Repligen's adjusted net income doubling to $24 million and adjusted EPS soaring to $0.43 from $0.23 a year ago. The company isn't just riding market recoveryit's paving new paths. Big moves like the opening of their new Repligen Training and Innovation Center (RTIC) and the strategic acquisition of chromatography innovator Tantti Laboratory Inc. are proof they're playing the long game. And with CDMO and consumables demand staying strong, Repligen is positioning itself to dominate in 2025 and beyond.

The takeaway? Repligen is crushing it where it countsinnovation, market leadership, and execution. With differentiated tech fueling record revenues and a clear growth roadmap, investors have plenty to be excited about. As the bioprocessing market heats up, Repligen looks primed to lead the charge. This quarter was just the opening act; the real show starts in 2025.


https://finance.yahoo.com/news/repligen-stock-soars-10-record-165507526.html