Latest news with #Barth
Business Insider
22-07-2025
- Business
- Business Insider
Cathedral Energy Services (ACX) Gets a Buy from Raymond James
Raymond James analyst Michael Barth, CFA initiated coverage with a Buy rating on Cathedral Energy Services today and set a price target of C$9.00. The company's shares closed today at C$4.53. Elevate Your Investing Strategy: Take advantage of TipRanks Premium at 50% off! Unlock powerful investing tools, advanced data, and expert analyst insights to help you invest with confidence. Make smarter investment decisions with TipRanks' Smart Investor Picks, delivered to your inbox every week. According to TipRanks, Barth, CFA is a 4-star analyst with an average return of 8.2% and a 64.15% success rate. Barth, CFA covers the Energy sector, focusing on stocks such as Imperial Oil, Gibson Energy, and Keyera Corp.. Currently, the analyst consensus on Cathedral Energy Services is a Moderate Buy with an average price target of C$9.00. Based on Cathedral Energy Services' latest earnings release for the quarter ending March 31, the company reported a quarterly revenue of C$135.36 million and a net profit of C$7.25 million. In comparison, last year the company earned a revenue of C$164.96 million and had a net profit of C$11.58 million Based on the recent corporate insider activity of 37 insiders, corporate insider sentiment is negative on the stock. This means that over the past quarter there has been an increase of insiders selling their shares of ACX in relation to earlier this year.
Indianapolis Star
25-06-2025
- Sport
- Indianapolis Star
State champs, Division I recruits, draft hopefuls: Vote for IHSAA baseball player of the year
IndyStar has been recognizing the top baseball players in Indiana with our Players of the Week poll. With the season now complete, we've decided to run a Player of the Year poll. It's impossible to get every deserving player on here, but we did our best, compiling a list of 30 players from around the state. Voting is open until noon, EST, Wednesday. Lutheran runs its way to first title: 'I wanted to prove how good we were' Meet this season's top performers: The Notre Dame commit batted .643 with 50 runs scored, 27 RBIs, three home runs, five doubles, four triples and 37 stolen bases. On the mound, Barth pitched to a 1.56 ERA with 41 strikeouts over 28 innings. The IU commit batted .394 with 21 runs scored, 34 RBIs, six doubles, four home runs and three triples. On the mound, Bennett went 2-3 with a 3.37 ERA and 17 strikeouts over 18⅔ innings. The LSU commit batted .500 with 48 runs scored, 42 RBIs, 11 doubles, five home runs, three triples and 12 stolen bases. The Kentucky commit earned five wins with a 1.30 ERA and 103 strikeouts. At the plate, Coleman batted .378. Cope batted .446 with 39 runs scored, 20 RBI, three doubles, nine triples, four home runs and 37 stolen bases. The Notre Dame commit had a perfect 6-0 record with a miniscule 0.25 ERA and 97 strikeouts over 55 innings. At the plate, Crowell batted .375 with 32 runs scored, 24 RBIs, eight doubles, three triples, three home runs and four stolen bases. Denny batted .460 with 40 runs scored, 31 RBIs, 11 doubles, eight home runs, two triples and 36 stolen bases. The Alabama commit went 4-0 with a 2.26 ERA and 74 strikeouts over 43⅓ innings. At the plate, DeVaughan batted .227 with two home runs and one double. The Houston commit batted .362 with 24 runs scored, 18 RBIs, five home runs, four doubles, three triples and 20 stolen bases. On the mound, Dickens had a 2-2 record with 47 strikeouts over 27⅔ innings. The Mississippi State commit had a 4-4 record with 68 strikeouts over 38⅓ innings. The Tennessee commit batted .429 with 36 runs scored, 35 RBIs, nine doubles, three triples, six home runs and 15 stolen bases. The Kentucky commit had a 7-0 record with a 2.76 ERA and 70 strikeouts over 38 innings. The Indiana commit and Indiana Gatorade Player of the Year earned six wins with a 0.76 ERA and 61 strikeouts. The Notre Dame commit batted .404 with 23 runs scored, 15 RBIs, two doubles, two triples, 21 walks to just nine strikeouts and 25 stolen bases. On the mound, Francis had a 2.19 ERA and 45 strikeouts over 38⅓ innings. The Marion County Player of the Year batted .413 with 21 runs scored, 20 RBIs, seven doubles, one triple, one home run and eight stolen bases. On the mound, Godsey went 5-1 with a 2.79 ERA and 102 strikeouts over 52⅔ innings. The Tennessee commit had an 8-0 record with a 2.02 ERA and 58 strikeouts over 55⅓ innings. At the plate, Grant batted .376 with 21 runs scored, 26 RBIs, three doubles, one home run and three stolen bases. The junior batted .342 with 42 runs scored, 20 RBIs, six doubles, one triple, one home run and 34 stolen bases. On the mound, Levin went 5-2 with two saves, a 1.67 ERA and 56 strikeouts over 46 innings. Logan is committed to play baseball and football at Notre Dame. Logan batted .389 with 57 runs scored, 31 RBIs, six doubles, two triples, seven home runs and 44 stolen bases. The Olney Central commit had a 9-2 record with a 1.46 ERA and 89 strikeouts over 67⅓ innings. At the plate, Mahurin batted .352 with 29 runs scored, 13 RBIs, six doubles, one triple, one home run and five stolen bases. The IU commit batted .320 with 44 runs scored, 18 RBIs, seven doubles, four triples, two home runs and 12 stolen bases. The Wabash Valley commit batted .437 with 21 runs scored, 20 RBIs, five doubles, five home runs, three triples and one stolen base. The freshman batted .514 with 54 runs scored, 45 RBIs, 12 doubles, five home runs, four triples and 20 stolen bases. On the mound, Miller went 2-0 with a 0.61 ERA and 99 strikeouts over 57 innings. The Evansville commit batted .330 with 30 runs scored, 21 RBIs, eight doubles, three home runs, two doubles and nine stolen bases. On the mound, Pennington went 1-0 with a 3.32 ERA and 38 strikeouts over 25⅓ innings. The Valparaiso commit batted .484 with 52 runs scored, 29 RBIs, seven doubles, three triples, two home runs and 33 stolen bases. On the mound, Pitcock went 9-1 with a 0.74 ERA and 101 strikeouts over 66 innings. Redding went 4-1 with a 2.10 ERA and 70 strikeouts over 53⅓ innings. He earned the win for Lutheran's first ever baseball state title against Kouts. The Mississippi State commit went 4-2 with a 1.24 ERA and 88 strikeouts over 45 innings. The Kentucky commit went 5-1 with a 2.39 ERA and 55 strikeouts over 44 innings. At the plate, Smith batted .413 with 31 runs scored, 24 RBIs, seven doubles, seven home runs, one triple and nine stolen bases. The Wake Forest commit batted .333 with 36 runs scored, 20 stolen bases, 12 RBIs, two doubles, one triple and one home run. The Alabama commit had a 1.00 ERA and 100 strikeouts over 56 innings. At the plate, Troxell batted .250 with seven runs scored, 11 RBIs, two doubles and one home run. The Vincennes commit went 7-0 with a 0.90 ERA and 77 strikeouts over 62 innings. At the plate, Watson batted .309 with 15 runs scored, 20 RBIs, seven doubles and one triple.
USA Today
21-06-2025
- Sport
- USA Today
Notre Dame pledge Mason Barth wins state baseball title
Notre Dame baseball commit Mason Barth is once again a state champion. The Andrean (Merrillville, IN) right-handed pitcher/shortstop struck out Jasper's A.J. Huelsman with the bases loaded for the final out Friday night to help his team capture the IHSAA Class 3A State Championship in Indianapolis. No. 1 Andrean scored two runs in the 6th inning and two more in the 7th before holding off Jasper in a 4-3 win at Victory Field in Indy. It is the ninth state title in program history for the 59ers. The powerhouse is 9-2 all-time in state championship games, with all nine titles coming within the last 20 years. The nine championships put the program in a tie with Lafayette Central Catholic for most all time. Andrean finished with a 31-3 record. The 5-foot-9, 195-pound Barth committed to Notre Dame in October 2022. Andrean head coach Dave Pishkur stated a few years back that Barth was the second-best freshman he's ever coached. Contact/Follow us @IrishWireND on X (Formerly Twitter), and like our page on Facebook to follow ongoing coverage of Notre Dame news, notes, and opinions. Follow Dave on X: Miller_Dave
Politico
30-05-2025
- Business
- Politico
FDA denies ultra-rare drug but offers path to ‘yes'
Presented by With help from Chelsea Cirruzzo Driving The Day ANOTHER BLOW TO BARTH'S TREATMENT — The FDA rejected Stealth BioTherapeutics' latest bid to market its proposed treatment for an ultra-rare genetic condition, though regulators have suggested a 'path' toward accelerated approval, the company said Thursday. Stealth said the agency's complete response letter, which came four months after the FDA was initially scheduled to make a decision, didn't raise concerns with clinical safety data for the drug, known as elamipretide, to treat Barth syndrome by targeting underlying dysfunction in mitochondria, which are small energy-producing structures in cells. CEO Reenie McCarthy told Prescription Pulse that agency requests for additional data in late 2024 led the biotech to expect approval, and the biotech believes they should have gotten accelerated approval based on what the FDA conveyed in the letter. 'They have all the information they need to make that decision,' she said. HHS didn't respond to a request for comment. Background: Barth syndrome — which can cause an enlarged and weakened heart, muscle weakness, recurrent infections and delayed growth — typically affects males and shortens their life expectancy by decades. About 150 Americans have the condition. Stealth had suggested two ways the FDA could consider approving elamipretide — granting full approval based on the company's natural history study of disease progression absent medical intervention or endorsing accelerated approval based on a trial suggesting long-term improvements in muscle function. The FDA has agreed to consider muscle strength around the knees as a potential intermediate marker by which it could support accelerated approval and has asked Stealth to resubmit its application based on that endpoint, McCarthy said. External FDA advisers voted last year to recommend approval for elamipretide despite persistent questions about its effectiveness. Stealth, rare disease advocates and patients with Barth syndrome and their caregivers have advocated for years for FDA approval, highlighting the difficulties in conducting trials for potential rare disease treatments that can't be studied in large populations. Thursday's rejection seems 'inconsistent' with FDA Commissioner Marty Makary's recent comments about approving rare disease therapies based on plausible mechanisms and patient demand, McCarthy said. 'There's a bit of a disconnect' between those statements and the FDA's feedback, she said. What's next: Stealth expects to meet with the FDA next month to discuss a postmarketing study it proposed in 2022 and 'gauge how serious they are,' McCarthy said. The company laid off 30 percent of its staff to save money for a potential FDA resubmission and to maintain elamipretide access for critically ill patients under the agency's compassionate use pathway. McCarthy also raised concern about the FDA's stance that an accelerated approval would make the drug inappropriate to administer to newborns in acute cardiac distress, a population she said makes up two-thirds of Stealth's expanded access program. Half of early Barth syndrome deaths occur by age 1, per the company. IT'S FRIDAY. WELCOME BACK TO PRESCRIPTION PULSE. Do you work at HHS? We want to learn more about the decision to cancel Moderna's bird flu vaccine funding. Send your tips to David Lim (dlim@ @davidalim or davidalim.49 on Signal) and Lauren Gardner (lgardner@ @Gardner_LM or gardnerlm.01 on Signal). Eye on the FDA REPLACING COLOR ADDITIVES IN MEDS — The FDA quietly released draft recommendations for drugmakers that want to replace color additives in their approved drugs — potentially hinting at where the Trump administration will next focus HHS Secretary Robert F. Kennedy Jr.'s Make America Healthy Again energies. The agency acknowledged that changing the formulation of a drug — including its inactive ingredients — is generally considered a major change. But the agency said replacing a color additive with another already listed in the FDA's color-additive regulations in many cases 'is unlikely to have an adverse effect on the identity, strength, quality, purity, or potency of the drug product.' Replacing a color additive can 'generally be considered a moderate change' that can be requested via a 30-day supplement known as a CBE-30, according to the draft guidance published Thursday. 'If a manufacturer or an applicant intends to use a color additive that is not already listed in FDA's color additive regulations for the particular use, a petition must be sent to the Human Foods Program,' the draft guidance says. 'If FDA finds the color additive safe and suitable for such use, the additive will be listed in the color additive regulations.' What's next: The FDA is taking comments on the draft guidance for 60 days. AROUND THE AGENCIES LAYOFFS ON HOLD — CDC layoffs planned for early June are being paused in the wake of a preliminary injunction, two employees at the agency, granted anonymity for fear of retribution, confirmed to POLITICO's Sophie Gardner. CDC employees who were sent termination notices in April received an email from the agency's Office of Human Resources on Thursday, informing them that, because of a preliminary injunction, HHS 'is staying further action on any existing Reduction in Force (RIF) notices, including final separation of employees, at this time.' The laid-off employees will remain on paid administrative leave 'or in their current employment status' until further notice, the email said. An HHS spokesperson did not immediately respond to a request for comment. Background: On April 1, amid a massive restructuring of HHS, around 18 percent of the CDC's workforce received termination notices. But legal challenges have complicated the reduction in force and the HHS reorganization, meaning the vast majority of those employees are still technically employed at the CDC, with most remaining on administrative leave. Key context: On May 22, Judge Susan Illston of the federal district court in San Francisco issued a preliminary injunction that bars the administration from carrying out the reduction in force across 22 agencies — including HHS — that are defendants in the case. Federal employee unions, nonprofits and local governments are the plaintiffs. The email sent to CDC employees cites Illston's injunction as the reason for the decision. PROOFREADER WANTED — The White House blamed 'formatting issues' for errors in the citations of the recently released Make America Healthy Again report after a media report found studies in it that do not exist. 'We have complete confidence in [Secretary Robert F. Kennedy Jr.] and his team at HHS. I understand there were some formatting issues with the MAHA report,' White House press secretary Karoline Leavitt said Thursday. Her remarks came after NOTUS reported that seven of the sources cited in the report, which said children's health is in crisis and blamed chemicals, lack of exercise and ultraprocessed foods, don't exist. The report now lists five of its citations as 'corrected' or 'updated,' though that doesn't include the citations NOTUS reported as false. 'Some of the hundreds of citations in the report were formatted incorrectly or mistakenly referenced something other than what was actually intended,' a White House spokesperson told Pulse. 'That said, the content of the report is fully substantiated, and there is nothing in there that cannot be backed up; we did not conjure up any facts. Report has been corrected now.' Pharma Moves Laura Akowuah has joined Cooley as special counsel. She previously worked at the FDA for more than a decade in enforcement roles. Document Drawer The FDA approved Eton Pharmaceuticals' hydrocortisone oral solution Wednesday as a replacement therapy in patients ages 5 and older with adrenocortical insufficiency. WHAT WE'RE READING POLITICO's Erin Schumaker spoke with Dr. Wafik El-Deiry, a Brown University cancer researcher, about his campaign to lead the National Cancer Institute amid NIH funding cuts. Two pharmacy benefit managers filed lawsuits Thursday challenging a recently passed Arkansas law they say would force pharmacies across the state to close, Modern Healthcare's Hayley DeSilva writes. Texas lawmakers have sent legislation to Republican Gov. Greg Abbott's desk that would make it easier for parents to start the process of exempting their children from school vaccine mandates, The Associated Press' Jim Vertuno reports. Several House Republicans are raising concerns about broad pharmaceutical tariffs potentially being placed on the industry, POLITICO's Ari Hawkins reports.
Yahoo
29-05-2025
- Business
- Yahoo
Barth Syndrome Foundation Responds to FDA's Proposed 'Path Forward' for Elamipretide
Families face more delay despite dire need, strong data and years and years of effort BOSTON, May 29, 2025--(BUSINESS WIRE)--The Barth Syndrome Foundation (BSF) today responded to new developments from the U.S. Food and Drug Administration (FDA) regarding elamipretide, a potential treatment for the ultra-rare and life-threatening condition. Despite an already lengthy review and a 10-6 favorable FDA Cardiovascular and Renal Drugs Advisory Committee vote last October, the FDA now has indicated to Stealth BioTherapeutics that the agency will not approve the current application for this drug. However, for the first time, the agency issued a written recommendation outlining a potential path to accelerated approval based on previously submitted data showing more than 45 percent improvement in muscle strength and its correlation with increased physical function. "It's unconscionable that it now will take even longer for the FDA to rule on this drug for our very small population with no other specific therapies," said Emily Milligan, executive director, Barth Syndrome Foundation. "This administration has sent strong signals it's serious about defining a process that works for rare disease families. Now is the time to deliver. We need FDA leadership to take strong, decisive action and put an end to the hemming and hawing. This literally translates into life, death and better lives for our children." Barth syndrome is an ultra-rare, life-threatening genetic disorder primarily affecting males. There are no FDA-approved treatments and no other therapies in late-stage clinical development. Clinical studies show elamipretide can improve mitochondrial function and boost muscle strength by 45 percent and heart function by 40 percent in patients with Barth syndrome. Most patients from the original trial continue to take and benefit from this therapy more than eight years after initiating treatment. Many more individuals, mostly infants, in acute cardiac distress have received elamipretide through emergency access requests approved by the FDA. Despite the extensive safety record and strong vote of the advisory committee, the FDA has not granted approval. Nearly 20 percent of U.S. patients with Barth syndrome are currently receiving elamipretide through an expanded access program. The FDA's current proposed path, unfortunately, excludes the sickest babies, who make up a majority of those currently receiving the drug through emergency access. Over half of deaths in Barth syndrome occur in the first few years of life. Yet the FDA has declined to include these patients in the potential approval path, citing a lack of feasibility for pre-approval studies. "No safety concerns have been raised, and the agency acknowledged the difficulty of conducting traditional trials in a disease this rare," Milligan said. "Still, families are left in limbo, waiting on a treatment that medical experts, patient experiences and common sense overwhelmingly support." More than 50 clinicians and nearly 20,000 people from across the globe have signed letters and petitions over the last few years urging the FDA to approve elamipretide without further delay. Their views echo the lived experience of families and patients who have endured years of uncertainty. "With no approved therapies and limited access to treatment, every day of inaction carries a devastating cost," Milligan said. "The FDA made a promise to our community—to conduct a fair, thorough and equitable review of elamipretide through the advisory committee process. That promise remains unfulfilled." Stories Behind the Science Families from across the country continue to fight for access to a treatment that could mean survival. Their stories offer a powerful reminder of what is at stake: In Mississippi, a mother describes her desperate effort to keep her son alive with no other options: "Mississippi's Heartbeat" In California, one physician's 3 a.m. call from the ICU leads to a life-saving intervention: "In the ICU at 3 a.m." In Ohio, a family spanning two generations shares what this drug means to them: "Two Generations, One Drug" In Texas, a newborn's life is saved just in time by emergency access: "A Life Saved in the Nick of Time" In Georgia, one family measures survival in milligrams and urgency: "A Life Measured in Milligrams" In New York, a 13-year fight shows what resilience in rare disease looks like: "Too Rare to Care" And in Oklahoma, one young man explains why elamipretide is the drug that gave him his life back: "Walker Burger's Fight" Each of these families speaks with one voice: the time to approve this treatment is now. About Barth Syndrome Foundation (BSF) Barth Syndrome Foundation and our international affiliates comprise the only global network of families, health care providers, and researchers solely driven by the mission to save lives through education, advances in treatments, and finding a cure for Barth syndrome. Considered a role model in rare disease advocacy, BSF has funded $7 million and catalyzed more than $41.4 million in funding from other sources to advance global scientific discoveries. BSF also provides a lifeline to families around the world through individualized support, educational conferences, a patient registry, and collaborations with expert providers to define standards of care, treatment, and rapid diagnosis. View source version on Contacts BSF Media Contact: Matt Burnsmatt@ 518-423-5907
