Target $33
Monday, May 1, 2023
Illumina calls Icahn's nominees unqualified
Illumina Inc. (ILMN) said Monday that activist investor Carl Icahn's board nominees are "unqualified," urging shareholders to reject all three of Icahn's nominees and instead support its "highly qualified" nominees. That's the latest salvo between the genomics company and Icahn, who earlier Monday issued the second letter in as many business days to Illumina investors, saying that Chief Executive Francis de Souza and "protectors" seem "dead set on destroying the company." On its letter to shareholders, the company said it plans on creating "long-term shareholder value" in addition to the request for support for its nominees. "Illumina is the only pure-play genomics company with profitable revenue growth," it said. Shares of Illumina have dropped 32% in the past 12 months, contrasting with gains of about 1% for the S&P 500 index. Icahn started a proxy fight with Illumina in March, criticizing the company's plan to buy cancer-screening company Grail Inc.
https://www.morningstar.com/news/marketwatch/20230501342/illumina-icahns-nominees-unqualified
Flexing On Muscular Dystrophy, Truist Expects Upside For Edgewise
Truist initiated coverage on Edgewise Therapeutics Inc
with a Buy rating and a price target of $25.
The analyst notes encouraging data from lead drug EDG-5506 in Becker Muscular Dystrophy (BMD), suggesting a benefit to muscle injury sustained over six months.
The company is advancing the CANYON trial evaluating EDG-5506 in individuals with BMD. CANYON will assess the effect of EDG-5506 over 12 months on safety, pharmacokinetics (PK), biomarkers, and functional measures
Edgewise Therapeutics expects to amend the CANYON study to include a potentially registration-enabling cohort in 2H of 2023.
The company is evaluating EDG-5506 in Duchenne muscular dystrophy (DMD). LYNX Phase 2 trial is ongoing, with interim data expected in Q4 of 2023.
The analyst writes that EDG-5506 has the potential to become standard-of-care in BMD and enhance efficacy as a combo partner with different modalities in DMD.
While preclinical & early clinical data have been encouraging, long-term data from Ph1b & Ph2 data are likely needed to boost investor confidence, writes the analyst.
With data readouts expected over the next 12-18 months, Truist sees a favorable risk-reward profile for the stock
FDIC sees merits of increasing backstop for business accounts
A key U.S. banking regulator on Monday laid out a range of options for reforming the federal deposit insurance system and concluded that significantly increasing the backstop for bank accounts used for business purposes was the "most promising."
In the wake of March's lightning-fast bank failures, expanding coverage for accounts used to cover payroll, invoices and other large business transactions has emerged as the Federal Deposit Insurance Corp's preferred route for balancing financial stability and depositor protection, relative to its cost.
In order to effect any change to the government deposit protection scheme that has largely remained intact since its debut in the Great Depression in the 1930s, Congress would need to write a new statute describing what types of accounts would receive any additional coverage, FDIC officials said during a briefing with reporters.
The 76-page report also considered backstopping all accounts no matter what the amount, an option that would do the most to prevent bank runs, the report said, but would also have significant implications for market disruptions and could increase bank risk-taking.
Keeping the current system, where coverage is limited to $250,000 per-person per-bank, was the third option considered. While it would entail the least market disruption, it "fails to address the financial stability challenges" of large concentrations of uninsured deposits, the report said.
FDIC Chair Martin Gruenberg asked staff to undertake an analysis and review of options for reform of the deposit insurance system after the collapse of Silicon Valley Bank and Signature Bank in March, when regulators ended up backstopping all deposits to prevent contagion to the banking system.
Deposits at First Republic Bank, which was seized by regulators on Monday and sold to JPMorgan Chase & Co, did not require any formal government backstop, though the FDIC said the transaction would cost it $13 billion, on top of the $22.5 billion hit is has already taken from the SVB and Signature Bank failures.
The FDIC's deposit insurance fund helps to fulfill the agency's guarantee of bank deposits up to $250,000 per person. In the event an insured bank fails, the FDIC uses the deposit insurance fund to pay back customers who maintained accounts under the limit.
That $250,000 limit was enshrined in law by the 2010 Dodd-Frank reform law passed following the 2008 financial crisis, upped from what was before a $100,000 cap.
But following the collapse of SVB and Signature, there have been calls for a rethink.
U.S. Federal Reserve Chair Jerome Powell told Republican lawmakers in March that Congress should re-evaluate limits on the size of federally insured bank deposits.
Democratic Senator Elizabeth Warren told CBS's "Face The Nation" in March that lifting the cap would be "a good move," and Republican Senator Mike Rounds has questioned whether the $250,000 limit is still appropriate.
AN EXPLICIT GUARANTEE
Those in favor of getting rid of the cap argue that the government's full backstop of SVB and Signature deposits already signals an implicit guarantee of all bank deposits.
Eliminating the cap altogether could be expensive and could end up undermining financial stability, the report said, because banks might take greater risks if their deposit bases are considered more stable.
Any changes would need legislation from a deeply divided Congress. The Republican House Freedom Caucus said in a March statement that its members would oppose any universal federal guarantee on bank deposits above the current $250,000 limit.
Two Canadian Provinces Lift Licensing Barriers for US Doctors
Hoping to lure US physicians northward, the Canadian provinces of Nova Scotia and Ontario are now allowing those who are board certified to start practicing medicine immediately with full licensure. They'll no longer have to start with a limited license and take additional exams or be supervised for up to a year to become fully licensed.
Canada is experiencing an acute shortage of licensed physicians that's expected to intensify over the next decade. The shortfall is estimated to be about 44,000 physicians by 2028, with family doctors accounting for 72% of the deficit.
"Reducing licensing barriers should make Canada a more attractive option for US doctors who may be considering a move north," said Tom Florence, president of AMN Healthcare's Physician Solutions division, which recruits American physicians to work in Canada.
"Canada also has a truly expedited work visa process for qualifying physicians who have a job offer and wish to practice there," said Florence. It usually takes about 6 months compared with at least 18 months for Canadian physicians who want to work in the US, he said.
Few US-trained physicians work in Canada, which has a population of nearly 39 million. Just 812 of them practiced in Canada in 2019, the last year data was collected, according to the Canadian Medical Association.
But Canada may attract American physicians who find US medicine to be fraught with ethical dilemmas and restrictions from insurance companies and elected officials, said Theresa Rohr-Kirchgraber, MD, an internist and immediate past-president of the American Medical Women's Association.
"Rather than give up practicing medicine, a move to Canada may be a welcome respite for some US physicians," she said.
Physician recruiters in Ontario and Nova Scotia welcomed the news. About 13% of the population is without a family doctor, according to news reports.
A number of US physicians have started practice in Nova Scotia in recent years, said Katrina Philopoulos, Nova Scotia Health's director of physician recruitment. "I think this momentum will help us," she said.
Other Canadian provinces with physician shortages are also considering making similar changes. Alberta recently announced a 5-year pilot project to waive some licensing requirements for family doctors and general practitioners trained in Australia, Ireland, United Kingdom, and the US.
What Are the Pros and Cons of Working in Canada?
"Some US physicians may be attracted by a single-payer system in which all patients have access to coverage, but there are a range of drawbacks and benefits to consider in both systems," said Florence.
US physicians generally earn more than their Canadian counterparts, so income is not likely to be a draw, said Florence.
That appears to be the case for both family medicine physicians and specialists when comparing average net annual salaries. (To obtain Canadian salaries, 2021 gross income data from the Canadian Institute for Health Information were used; 20% was deducted for operation costs; and Canadian dollars were converted into US dollars based on the current exchange rate.)
A family medicine doctor in Canada will earn an annual average salary of $195,853 USD compared with $236,000 in the US. A cardiologist in Canada will earn $314,051 USD annually compared with $459,000 in the US. A dermatologist in Canada will earn $270,018 annually compared with $394,000 in the US.
Everett Fuller, MD, an emergency medicine physician who moved from Texas to Nova Scotia in 2015 for his Canadian wife, recently wrote about the pros and cons of working there compared with the US. For him, it was a worthwhile move.
"It's getting back to making medicine and patient care the priority instead of the business of medicine," Fuller wrote.
"I have the comfort of knowing that a patient and their family will not go bankrupt trying to pay medical bills if I make a catastrophic diagnosis. There's no out-of-pocket cost, other than prescriptions (depending on their drug plan)."
Fuller also doesn't have to fight insurers for reimbursement or pre-approvals, and he pays much less for medical malpractice premiums in a less litigious environment, he said.
But he also mentioned a few negatives. Some treatment is rationed, which can lead to long wait times for patients to get appointments. Also, "hospitals aren't in it for the profit, so you're not going to get a CT, MRI, and cath lab in every hospital," he noted.
Florence doesn't think either system "offers a panacea for many of the challenges physicians face today. Even with reduced barriers to licensure, we do not anticipate an exodus to US physicians to the north."
Bristol: Reblozyl expanded use to get priority review
Applications based on results from Phase 3 COMMANDS study in which first-in-class Reblozyl demonstrated a highly statistically significant and clinically meaningful improvement compared to an erythropoiesis-stimulating agent in patients with very low/low/intermediate-risk MDS
U.S. FDA has assigned a target action date of August 28, 2023
Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) and the European Medicines Agency (EMA) has validated the Type II Variation Application for Reblozyl® (luspatercept-aamt), a first-in-class treatment option, to expand its current indication to include treatment of anemia without previous use of erythropoiesis-stimulating agents (ESA-naïve) in adult patients with very low- to intermediate-risk myelodysplastic syndromes (MDS) who may require red blood cell (RBC) transfusions. In the U.S., the FDA has granted the application Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) goal date of August 28, 2023. Priority Review designation underscores the high unmet need and value that Reblozyl could bring to this patient population. In Europe, the EMA’s validation of the application confirms the submission is complete and begins the EMA’s centralized review process.
https://finance.yahoo.com/news/u-fda-accepts-priority-review-110500943.html
Avadel: FDA OKs narcolepsy treatment
Avadel Pharmaceuticals PLC said Monday that its Lumryz narcolepsy treatment received final approval from the U.S. Food and Drug Administration to address excessive day-time sleepiness.
Shares rose 14% to $12.04 at 13:31 E.T.
The pharmaceutical company said Lumryz is a single dose at bedtime that treats narcolepsy in adults, a chronic neurological condition that effects about one in 2,000 people in the U.S.
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