Latest news with #Spero
Yahoo
29-05-2025
- Business
- Yahoo
SPRO Stock Soars 245% on GSK-Partnered UTI Drug Meeting Study Goal
Shares of Spero Therapeutics SPRO more than tripled in market value yesterday after a phase III study evaluating its investigational oral antibiotic for complicated urinary tract infections (cUTIs) was stopped early due to efficacy. The drug, called tebipenem HBr, is being developed in partnership with GSK plc GSK. This late-stage study, called PIVOT-PO, enrolled hospitalized adult patients with cUTIs, including pyelonephritis (a type of kidney infection). The decision to stop the study early was made following a recommendation from an independent committee, which found that the study met its primary endpoint of non-inferiority. In other words, treatment with tebipenem was as effective as intravenously (IV) administered antibiotic imipenem-cilastatin, a commonly prescribed treatment for cUTIs. These findings are based on an interim analysis of data from 1,690 patients enrolled in the study. Based on the positive results, Spero's partner, GSK, plans to submit a regulatory filing seeking approval for the drug with the FDA later this year. Full data from the PIVOT-PO study will be presented at a future medical meeting. Per Spero, around 2.9 million cases of cUTIs are treated annually in the United States alone. The current standard of care for cUTIs typically involves IV antibiotics, which require hospital administration. If approved, tebipenem HBr will be the first oral carbapenem antibiotic for cUTIs. An effective oral alternative would represent a major shift in the treatment paradigm, potentially reducing hospital stays, lowering costs and improving patient convenience. Year to date, shares of Spero have skyrocketed 128% against the industry's 5% decline. Image Source: Zacks Investment Research Tebipenem is being developed as part of a licensing agreement between Spero Therapeutics and GSK, signed in 2022. Per the terms, Spero is responsible for certain development work, including the PIVOT-PO study, while GSK holds exclusive rights to market the drug globally, except in certain Asian territories. The drug has also been granted Qualified Infectious Disease Product (QIDP) and Fast Track designations from the FDA, which are intended to expedite development and review. QIDP status provides priority review and five additional years of market exclusivity upon approval, whereas Fast Track allows for more frequent FDA interaction and rolling submissions. Notably, this is the second anti-infective program stopped early by GSK due to efficacy. Like tebipenem, GSK had also stopped the late-stage EAGLE 2 and 3 studies, which evaluated Blujepa (gepotidacin), an oral antibiotic for treating uncomplicated urinary tract infections (uUTIs). This drug was recently approved by the FDA for uUTIs. Spero currently carries a Zacks Rank #4 (Sell). Spero Therapeutics, Inc. price | Spero Therapeutics, Inc. Quote A couple of better-ranked stocks from the industry are Adaptive Biotechnologies ADPT and Agenus AGEN, each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. In the past 60 days, estimates for Adaptive Biotechnologies' 2025 loss per share have improved from 92 to 87 cents. During the same timeframe, estimates for 2026 loss per share have narrowed from 69 to 65 cents. Adaptive Biotechnologies' earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 21.38%. Shares of ADPT have surged 53% year to date. Agenus' loss per share estimate for 2025 has narrowed from $6.43 to $2.78 over the past 60 days, and the same for 2026 has improved from $6.57 to $5.26 during the same period. Agenus' earnings beat estimates in two of the trailing four quarters and missed the mark on the other two occasions, delivering an average negative surprise of 22.71%. Year to date, its shares have gained 10%. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report GSK PLC Sponsored ADR (GSK) : Free Stock Analysis Report Agenus Inc. (AGEN) : Free Stock Analysis Report Adaptive Biotechnologies Corporation (ADPT) : Free Stock Analysis Report Spero Therapeutics, Inc. (SPRO) : Free Stock Analysis Report This article originally published on Zacks Investment Research ( Zacks Investment Research Error while retrieving data Sign in to access your portfolio Error while retrieving data Error while retrieving data Error while retrieving data Error while retrieving data
Yahoo
29-05-2025
- Business
- Yahoo
Spero Therapeutics Jumps as Oral Carbapenem Hits Phase 3 Milestone
Spero Therapeutics, Inc. (NASDAQ:SPRO) saw its stock surge by 240% on May 28 following the company's announcement of the successful completion of the pivotal Phase 3 PIVOT-PO trial for tebipenem HBr, an investigational oral antibiotic intended for use in treating complicated urinary tract infections. The Phase 3 study, conducted in collaboration with development partner GSK plc, effectively achieved its primary goal, proving that tebipenem HBr is not inferior to the intravenous antibiotic imipenem-cilastatin in treating adult hospitalized patients with cUTI. According to a press statement issued by Spero on May 28, tebipenem HBr may be the first oral carbapenem antibiotic that patients in the U.S. can get, potentially addressing an estimated 2.9 million annual cases of cUTIs. The full trial results will be submitted to a peer-reviewed journal for publication and presentation at a later scientific convention, with Spero and GSK intending to submit the findings to the FDA in the second half of 2025. While we acknowledge the potential of SPRO to grow, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and have limited downside risk. If you are looking for an AI stock that is more promising than SPRO and that has 100x upside potential, check out our report about the cheapest AI stock. Read More: and . Disclosure: None. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
20-05-2025
- Business
- Yahoo
Shortfall of air travel system technicians aggravates technical issues
May 20 (UPI) -- The Newark airport task force is discussing solutions to communications issues that grounded multiple flights over the past month while the air traffic industry struggles with shortages. The Federal Aviation Administration's newly-formed task force with representatives from Verizon and L3Harris convened its first meeting last week. It is responding to at least three incidents in which air traffic controllers for Newark Liberty International Airport lost their primary communication lines with aircrafts in flight. The FAA reports that low staffing levels and low training success are contributing factors to congestion and flight delays at the airport. It held meetings with airlines from Wednesday through Friday. From the meeting, several solutions were proposed to address congestion and flight delays. The FAA proposed a maximum arrival and departure rate of 28 aircraft per hour until the construction of another runway is complete. When that is complete, it recommends a maximum arrival rate of 34 aircraft per hour until Oct. 25. The FAA is adding additional telecommunications connections between New York's Standard Terminal Automation Replacement System and Philadelphia Terminal Radar Approach Control Area C. It is also replacing copper telecommunications lines with fiberoptic lines which have greater bandwidth and speed. Newark Liberty International is operating under a unique configuration of air traffic control technology, according to Dave Spero, national president of the Professional Aviation Safety Specialists. He explained to UPI the transition it has undergone since last summer. PASS represents 11,000 FAA employees but it does not represent air traffic controllers. Philadelphia TRACON Area C has taken on the responsibility of directing aircraft at Newark Liberty International Airport since June. This transition involved moving automation equipment and staff to the Philadelphia location from the New York Terminal Radar Approach Control. "So to do that, they've got to sort of duplicate that environment," Spero told UPI. "You've got to send all the technology there to Philadelphia just as if it were in the same building it was in before. All the communications that they had, all of the automation equipment which produces the aircraft targets on their displays, the flight data that allows an aircraft controller to know the range and the air speed, everything that corresponds to air traffic control needs to be taken down to Philadelphia." "The problem that they've encountered is that the external communication lines that take all that information down to Philadelphia and put it on the displays have been failing," Spero continued. This equipment is handled by a third party under the purview of L3Harris, an aerospace and defense contractor based in Melbourne, Fla. On Monday, Philadelphia TRACON Area C reported that it lost radio frequencies for about two seconds at about 11:35 a.m. ET. The FAA is investigating the incident but all aircraft remained at a safe distance from each other. The task force is investigating the multiple potential reasons for the failures, with the involvement of Verizon and L3Harris in the task force indicating to Spero that the communication lines are the main suspect. "It's really not the equipment that's causing the failure. It's the communication in between," Spero said. "The equipment our folks maintain is working just as it should. Frankly, if something goes wrong with the communication line or something was wrong in New York, those technicians in Philadelphia can't do anything about it. Either the communication company or the technicians in New York have to get into the automation and see what's happening with the software, which is not what the errors have been." The issue in Newark highlights bigger issues facing the U.S. air travel infrastructure. The nationwide shortage of air traffic controllers has been reported to Congress but there is also a shortage of technicians -- specialists who maintain, repair, troubleshoot and certify the transportation systems used by air traffic controllers. There are about 4,800 transportation systems specialists in the United States. They are responsible for technical equipment across 400 airports and about 70,000 facilities, according to Spero. According to the FAA's "Transportation Operations staffing model" about 800 more technicians are needed. Meanwhile the average age of the current specialist workforce is in its mid-50s with 34% 55 years old or older. As a large portion of this workforce nears retirement, the government is preparing to take on a large-scale overhaul of its infrastructure. U.S. Transportation Secretary Sean Duffy announced earlier this month that he aims to replace the nation's air traffic control system. The FAA plans to increase controller staffing at Philadelphia TRACON Area C. It did not mention adding specialists in its readout of last week's meeting. Replacing the air traffic control system makes the need for more airway transportation systems specialists even more crucial, Spero said. "It's an enormous challenge," Spero said. "It's like changing tires on a vehicle when it's going 70 mph. You can't stop providing services while you're creating a new service. If we're going to start to rebuild this air traffic control system and start to put other new technologies out there and replace equipment then this workforce is going to be integral to that solution." A 2023 report from the Office of the Inspector General advised that it takes about a year and a half to promote a newly-hired maintenance technician to the level of journeyman. Prior to that, specialists undergo three years of training at the Mike Monroney Aeronautical Center in Oklahoma City. The Inspector General recommended that the FAA establish a maintenance technician workforce plan that acknowledges more than a year is needed to prepare for staffing turnover, as well as three other recommendations. That recommendation has not been adopted while the other three have. Having a workforce shortage also impacts the progress of new hires. "What's happening now is when someone retires, one of their coworkers has to take on the workload of that individual," Spero explained. "'So now I double my workload and also am going to have to train the new person that comes on.' Those are challenges that they have."
UPI
20-05-2025
- Business
- UPI
Shortfall of air travel system technicians aggravates technical issues
A United Airlines airplane comes in for a landing at Newark Liberty International Airport as seen through power lines on a street in Newark, N.J., on March 28. File Photo by John Angelillo/UPI | License Photo May 20 (UPI) -- The Newark airport task force is discussing solutions to communications issues that grounded multiple flights over the past month while the air traffic industry struggles with shortages. The Federal Aviation Administration's newly-formed task force with representatives from Verizon and L3Harris convened its first meeting last week. It is responding to at least three incidents in which air traffic controllers for Newark Liberty International Airport lost their primary communication lines with aircrafts in flight. The FAA reports that low staffing levels and low training success are contributing factors to congestion and flight delays at the airport. It held meetings with airlines from Wednesday through Friday. From the meeting, several solutions were proposed to address congestion and flight delays. The FAA proposed a maximum arrival and departure rate of 28 aircraft per hour until the construction of another runway is complete. When that is complete, it recommends a maximum arrival rate of 34 aircraft per hour until Oct. 25. The FAA is adding additional telecommunications connections between New York's Standard Terminal Automation Replacement System and Philadelphia Terminal Radar Approach Control Area C. It is also replacing copper telecommunications lines with fiberoptic lines which have greater bandwidth and speed. Newark Liberty International is operating under a unique configuration of air traffic control technology, according to Dave Spero, national president of the Professional Aviation Safety Specialists. He explained to UPI the transition it has undergone since last summer. PASS represents 11,000 FAA employees but it does not represent air traffic controllers. Philadelphia TRACON Area C has taken on the responsibility of directing aircraft at Newark Liberty International Airport since June. This transition involved moving automation equipment and staff to the Philadelphia location from the New York Terminal Radar Approach Control. "So to do that, they've got to sort of duplicate that environment," Spero told UPI. "You've got to send all the technology there to Philadelphia just as if it were in the same building it was in before. All the communications that they had, all of the automation equipment which produces the aircraft targets on their displays, the flight data that allows an aircraft controller to know the range and the air speed, everything that corresponds to air traffic control needs to be taken down to Philadelphia." "The problem that they've encountered is that the external communication lines that take all that information down to Philadelphia and put it on the displays have been failing," Spero continued. This equipment is handled by a third party under the purview of L3Harris, an aerospace and defense contractor based in Melbourne, Fla. On Monday, Philadelphia TRACON Area C reported that it lost radio frequencies for about two seconds at about 11:35 a.m. ET. The FAA is investigating the incident but all aircraft remained at a safe distance from each other. The task force is investigating the multiple potential reasons for the failures, with the involvement of Verizon and L3Harris in the task force indicating to Spero that the communication lines are the main suspect. "It's really not the equipment that's causing the failure. It's the communication in between," Spero said. "The equipment our folks maintain is working just as it should. Frankly, if something goes wrong with the communication line or something was wrong in New York, those technicians in Philadelphia can't do anything about it. Either the communication company or the technicians in New York have to get into the automation and see what's happening with the software, which is not what the errors have been." The issue in Newark highlights bigger issues facing the U.S. air travel infrastructure. The nationwide shortage of air traffic controllers has been reported to Congress but there is also a shortage of technicians -- specialists who maintain, repair, troubleshoot and certify the transportation systems used by air traffic controllers. There are about 4,800 transportation systems specialists in the United States. They are responsible for technical equipment across 400 airports and about 70,000 facilities, according to Spero. According to the FAA's "Transportation Operations staffing model" about 800 more technicians are needed. Meanwhile the average age of the current specialist workforce is in its mid-50s with 34% 55 years old or older. As a large portion of this workforce nears retirement, the government is preparing to take on a large-scale overhaul of its infrastructure. U.S. Transportation Secretary Sean Duffy announced earlier this month that he aims to replace the nation's air traffic control system. The FAA plans to increase controller staffing at Philadelphia TRACON Area C. It did not mention adding specialists in its readout of last week's meeting. Replacing the air traffic control system makes the need for more airway transportation systems specialists even more crucial, Spero said. "It's an enormous challenge," Spero said. "It's like changing tires on a vehicle when it's going 70 mph. You can't stop providing services while you're creating a new service. If we're going to start to rebuild this air traffic control system and start to put other new technologies out there and replace equipment then this workforce is going to be integral to that solution." A 2023 report from the Office of the Inspector General advised that it takes about a year and a half to promote a newly-hired maintenance technician to the level of journeyman. Prior to that, specialists undergo three years of training at the Mike Monroney Aeronautical Center in Oklahoma City. The Inspector General recommended that the FAA establish a maintenance technician workforce plan that acknowledges more than a year is needed to prepare for staffing turnover, as well as three other recommendations. That recommendation has not been adopted while the other three have. Having a workforce shortage also impacts the progress of new hires. "What's happening now is when someone retires, one of their coworkers has to take on the workload of that individual," Spero explained. "'So now I double my workload and also am going to have to train the new person that comes on.' Those are challenges that they have."
Yahoo
07-04-2025
- Politics
- Yahoo
Presidential executive order halts new arrivals of refugees to Oklahoma
OKLAHOMA CITY (KFOR) — A local non-profit called the Spero Project is helping refugees who make it to the Sooner State adjust and thrive. However, now they're facing a new challenge, due to recent executive orders by President Donald Trump. 'There is war in my country, it's been [going on] many, many years,' said Sang Rem, the executive director of resettlement at the Spero Project. Rem was born in Burma. She turned her emotional refugee journey into a children's book. When she was a teenager, Rem and her family crossed over into Malaysia. 'Because of the war. Because of the starvation,' said Sang. 'We walk, we run, we cross rivers and fields. We were on the boat. We had to lay down and they put tarp on top of us.' Rem and her family are forever grateful to have landed on U.S. soil when she was 15. When they eventually arrived in Oklahoma, the Spero Project was there. 'They supported me throughout my college years,' said Rem. At 31, she's now Spero's executive director of resettlement. The non-profit has been around for about 17 years, but recently became affiliated with agencies contracted with the federal government, to help refugees find homes in Oklahoma. They've helped 2,700 refugees from countries from all over the world with housing, to the language, culture, and jobs. 'We give families and individuals a chance to dream again,' said Rem. 'Nothing was held back': Former state forester speaks out after firing To put it into perspective, consider that the average refugee, who makes it to another country, spends an average of 26 years in a refugee camp. Less than half of 1% actually make it out of a refugee camp and into a country that accepts refugees. However, an executive order from the Trump Administration is halting the future arrivals or refugees—crushing news for those about to arrive. 'They are ready to fly to the US. A few weeks after the inauguration, and they already sell everything that they own,' said Rem. 'They get to know that they're not going to fly any more.' Kaitlyn Ritchie, Executive Director of Programs, said a promised 90-day review of refugee programs was instead cut-short by the White House. That leaves Spero without federal funding. 'Those ten national resettlement agencies that are contracted to the federal government, of which we are a affiliate of, they have since received termination letters,' said Ritchie. 'Starting October of 2025, 86% of our funding is going to get cut. So we don't know what we're going to do,' said Rem. According to the Realigning The United States Refugee Admissions Program executive order, 'The United States lacks the ability to absorb large numbers of migrants, and in particular, refugees, into its communities in a manner that does not compromise the availability of resources for Americans, that protects their safety and security, and that ensures the appropriate assimilation of refugees. This order suspends the USRAP until such time as the further entry into the United States of refugees aligns with the interests of the United States.' 'We made that commitment to neighbors. I think the United States made that commitment to neighbors. And so we want to honor it too,' said Ritchie. For now, the Spero Project is hoping grants and private donors can help them find a path forward. Copyright 2025 Nexstar Media, Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
