SNBL to acquire all outstanding shares of Satsuma for upfront cash consideration of $0.91 per share
Satsuma stockholders to also receive non-tradeable CVR of up to $5.77 per share
With the goal of maximizing value for stockholders, Satsuma’s Board has carefully considered strategic options for Satsuma and STS101 and fully supports this transaction with SNBL
https://finance.yahoo.com/news/snbl-acquire-satsuma-pharmaceuticals-234100184.html
CNS Pharmaceuticals has announced the enrolment of more than 100 subjects in its potentially pivotal clinical trial of Berubicin for glioblastoma multiforme (GBM).
The company has launched 43 trial sites of the 60 sites selected across Italy, France, the US, Spain, and Switzerland.
An independent Data Safety Monitoring Board (DSMB) will conduct a pre-planned, non-binding futility analysis for recommending whether the study should continue as planned based on Berubicin showing value as a second-line treatment for GBM patients compared with Lomustine.
This analysis will be carried out after at least half of the patients to be analysed for the interim analysis can be assessed as having failed the primary efficacy endpoint (death).
A review will be performed by the DSMB with regard to the number of deaths in each arm for ensuring that the overall survival of patients receiving treatment with Berubicin shows at least a statistically significant comparability against those receiving Lomustine.
Comparisons of secondary endpoints, including progression-free survival (PFS), response rates, and safety assessments will be the additional analyses that will be provided based on the data.
During the interim analysis, the company will not pause subject enrolment.
CNS Pharmaceuticals CEO John Climaco said: “Enrolling over 100 patients in this relatively rare disease in a little more than 18 months is a remarkable achievement which speaks to the unmet clinical need in GBM and the excitement about Berubicin in the neuro-oncology clinical community worldwide.
“Lastly, having 100 patients in our study in Q2 2023 puts our interim analysis on target for Q3.”
The company’s lead product candidate Berubicin is a new anthracycline and is currently being evaluated in a potentially pivotal international study assessing its safety and efficacy to treat GBM.
The primary endpoint of this adaptive, multicentre, open-label, randomised controlled trial in adult patients with recurrent glioblastoma multiforme (WHO Grade IV) is overall survival (OS).
Results from the trial will compare Berubicin to current SOC (Lomustine), with a randomisation of patients in 2:1 ratio to receive either Berubicin or Lomustine.
Windtree Therapeutics, Inc. (“Windtree” or the “Company”) (NasdaqCM: WINT), a biotechnology company focused on advancing late-stage interventions for cardiovascular disorders, today announced that the European Patent Office has granted Patent No. 3599243, providing patent coverage for the dual mechanism SERCA2a Activator class of drug candidates. Windtree has preclinical drug candidates with dual mechanisms of action (inhibition of the Na+/K+ pump and activation of SERCA2a) as well as pure SERCA2a activators (devoid of action on the Na+/K+ pump). The new patent, titled: “17BETA-HETEROCYCLYL-DIGITALIS LIKE COMPOUNDS FOR THE TREATMENT OF HEART FAILURE,” provides patent protection until July 2038 for the family of compounds with a dual mechanism of action.
Like istaroxime, the intravenous late-stage development candidate for treatment of acute decompensated heart failure and cardiogenic shock, the dual mechanism compounds activate SERCA2a and inhibit the Na+/K+ pump. However, these product candidates are intended to be both oral and IV therapies and may represent a hospital inpatient therapy for acute decompensated heart failure as well as outpatient, oral therapy for hospital discharge and chronic heart failure treatment.
https://finance.yahoo.com/news/windtree-therapeutics-announces-issuance-dual-120000460.html
The trucking industry is sounding the alarm on consequential ripple effects of the Biden administration's latest move in the electric vehicle push.
While critics have voiced concerns about the EPA's recent emissions regulations, the Owner-Operator Independent Drivers Association (OOIDA), a trade organization that represents small business truckers, warns the restrictions are dangerous and threaten small businesses and the overall U.S. economy.
"It's been our history with experience with EPA that the regulations that they come up with tend to be... not all that practical when it comes to how they actually will work on the road," OOIDA President Todd Spencer told Fox News Digital.
Spencer's fear is the new regulations are being pushed through mandates that have not addressed the side effects or considered additional ramifications such as costs and efficiency.
Fox News contributor Liz Peek predicts that a huge electric vehicle shift will cause electricity prices to 'go through the roof' on 'The Evening Edit.'
"It's one thing if you're talking about doing this on an automobile, that if you don't get where you're needing to go quite as quickly as you could, it's no big deal. There's no ramifications generally beyond you," Spencer explained. "But for truckers, it can mean that they don't make deliveries, that the goods that they're transporting don't get where they're needed to go, and certainly in many instances, people really need to have the stuff that trucks bring on a timely basis."
On Wednesday, the Biden White House announced aggressive regulations for tailpipe emissions as part of its sweeping climate agenda and efforts to push Americans to buy electric vehicles (EVs).
The tailpipe emissions regulations will impact light-duty and heavy-duty vehicles alike. The new standards for heavy-duty trucks, specifically, aim to reduce carbon emissions for trucks beginning with model year 2027.
According to the EPA, transportation accounts for 27% of the total greenhouse gas emission with heavy-duty vehicles making up 25% of that. By enforcing more stringent restrictions on the trucks, the EPA estimates the U.S. would avoid approximately 1.8 billion metric tons of greenhouse gas emissions.
Spencer said, historically, new restrictions from the EPA "significantly increase costs" for equipment and operations. What's more, they can "undermine reliability" which could be detrimental to the overall supply chain.
The EPA acknowledged the cost for manufacturers would be a staggering $6 billion which also accounts for nearly $3 billion in cost reductions provided by the Inflation Reduction Act. It's estimated that businesses would have to pay thousands to purchase zero-emission vehicles (ZEV).
"For a small business, any kind of problem that comes along that can shut you down, that can disable you for anywhere from a few days to maybe even a few weeks, it can put you out of business really, really, really quickly," Spencer said. "We certainly see the potential for these new proposed rules to have the exact same or maybe even a far worse impact on the operations of small business truckers."
The restrictions announced Wednesday come on the heels of regulations on nitrogen oxide pollution which raised similar concerns for small business truckers.
Andrew John of the John N John Trucking Company warned that the costs associated with the nitrogen oxide standards could kill many mom-and-pop trucking businesses.
"They go out of business," John said on "Varney & Co" last month. "They go out of business, and we all know how important small businesses are to the economy."
John stressed that the standards could cost thousands of dollars per vehicle but that there would also be other costs associated with the new technology, maintenance, and operations that many small businesses can't afford.
The latest emissions rules continue to put pressure on small businesses with little cost incentives or government aid. Spencer feared these rules could put truckers out of business.
Small-business truckers are "absolutely essential to every aspect of our economy," Spencer argued.
Trucking accounts for 70% of freight moved in the U.S. and 96% of trucking operations are run by small businesses with 20 trucks or fewer. With nearly $18 trillion in freight moved by trucks annually, disruptions in the flow of transportation would mean a lack of supplies to meet the demands of American consumers.
"If you're shut down, the supply chain is broke because that supply is not going to get delivered," Spencer said.
American Trucking Association CEO Chris Spear rips an EPA-approved California proposal that will require half of all trucks to be electric by the year 2035.
"Among the greatest contributions that trucks and truckers have made to our economy now is the concept of just-in-time deliveries, where we don't need warehouses, where we simply schedule and goods move, and we've sort of become accustomed to being able to look on our phone or our computer or to see and get an idea about where we might expect to get something. Well, if the truck stops, we're not going to get that," Spencer said.
Since the bulk of the trucking industry relies on small businesses, the EPA mandates put added strain on those companies that cannot easily and efficiently implement the changes, increasing supply chain uncertainty.
Spencer added that trucks and truckers are often transporting emergency goods and supplies. He fears that unforeseen ramifications from the new restrictions could prevent drivers from getting those supplies to Americans facing emergency situations such as hurricanes and tornadoes.
"If your battery goes down in the middle of a windstorm, a snowstorm, a flood, a hurricane, there are no simple solutions and there may not be any remedies available. So we have to make certain things like that don't can't happen. If they [do], our total transportation system can shut down when it's most urgently needed."
"It absolutely can be life and death," Spencer warned.
Overall, if the regulations are finalized, a staggering 67% of new sedan, crossover, SUV and light truck purchases could be electric by 2032, the White House projected. In addition, up to 50% of bus and garbage trucks, 35% of short-haul freight tractors and 25% of long-haul freight tractor purchases could be electric.
Spencer called out the irony behind the administration touting the value of the EPA rules but ultimately mandating the changes to achieve their environmental goals.
America First Legal founder Stephen Miller calls out President Biden's push for electric vehicles on 'Kudlow.'
"The other thing that's extremely frustrating is that when we talk about these things, we hear this word mandate. They tell us all how all the benefits, how great this stuff is going to be. And then they say, 'you got to do it anyway.' Realistically, we're more in tuned to incentives," Spencer said. "If you're talking about something that actually really does deliver benefits for all around, you don't have to mandate stuff like that. People gravitate to it. They go after it and say I want it because it'll make everything better."
"So rather than the mandates, we'd like to see the incentives," he concluded.
Shanghai stocks rose to a nine-month high on Monday, as China's March home price data and signs of corporate earnings recovery fuel optimism ahead of the release of first-quarter economy data. Hong Kong shares also gained.
** The Shanghai Composite Index .SSEC, which had posted five consecutive weekly gains on Friday, climbed nearly 1% by the lunch break, touching its highest level since July 8. The bluechip CSI300 Index .CSI300 was up 0.9%.
** In Hong Kong, both the benchmark Hang Seng Index .HSI and the Hang Seng Tech Index .HSTECH rose 0.5%.
** China's new home prices rose in March at the fastest pace in 21 months, official data showed on Saturday.
** More than 300 China-listed companies have published, or forecast first-quarter results, 70% of which have reported year-on-year profit increases, official Securities News reported.
** Underscoring consumption recovery, restaurant operator China Quanjude Group 002186.SZ reported a 49% jump in sales during the January-March period, and turned to a profit.
** Travel-related companies including Lijiang Yulong Tourism Co 002033.SZ and BTG Hotels Group 600258.SS also expect a quarterly profit.
** "The stock market is expected to trend higher on the back of economic recovery, and expectations of improving liquidity situations overseas," Guotai Asset Management Co said in a note.
** A Reuters poll showed that China's gross domestic product (GDP), data for which will be published on Tuesday, likely grew 4.0% in the first quarter from a year earlier, from 2.9% in the previous three months. That would be the fastest growth since the first quarter of last year. nL4N36F339
** An index tracking hotel and catering industry .CSIH30036 jumped 2.5%, while energy stocks .CSIEN also gained 2.5%, reflecting recovery hopes.
** Investors continued to plough money into China's state-owned companies .CSI000926 on reform hopes. China Mobile 600941.SS shares jumped 3.8% in Shanghai, their highest since its debut last January. Its Hong Kong-listed stock rose 1.6%
At least eleven people died on Sunday after suffering from sunstroke at an event attended by India's home minister on the outskirts of Mumbai, the chief minister of Maharashtra state said.
Hundreds of thousands of people attended an award function on Sunday afternoon where federal home minister Amit Shah presented an award to a well-known social activist, on the outskirts of the country's financial capital of Mumbai in Maharashtra.
The event was held outdoors in the afternoon in Khargar, where the maximum temperature recorded was 38 degrees Celsius (100.4°F), normal for this time of the year.
Around 50 people were admitted to hospital after the event and 11 had died, Maharashtra's chief minister, Eknath Shinde, told reporters late on Sunday night.
India is likely to experience heat waves between March and May, the weather office said in February this year.
