Latest news with #Alligator
Yahoo
5 days ago
- Business
- Yahoo
Alligator Bioscience Announces European Orphan Drug Designation for HLX22 in Gastric Cancer
LUND, SE / / May 26, 2025 / Alligator Bioscience (STO:ATORX) - Lund, Sweden - 26 May 2025 - Alligator Bioscience (Nasdaq Stockholm: ATORX) today announces that the European Commission has granted orphan drug designation (ODD) to HLX22, an anti-HER2 monoclonal antibody, for the treatment of gastric cancer. HLX22 is being developed by Shanghai Henlius Biotech, Inc. under a sublicense from AbClon, Inc., which had previously licensed the antibody from Alligator. This designation follows the ODD granted by the U.S. Food and Drug Administration (FDA) in March 2025, further highlighting HLX22's potential as a treatment for HER2-positive gastric cancer. Henlius is conducting a global Phase 3 clinical trial (NCT06532006) to evaluate HLX22 in combination with trastuzumab and chemotherapy as a first-line treatment for HER2-positive metastatic gastric and gastroesophageal junction (GEJ) cancer. Søren Bregenholt, CEO of Alligator Bioscience, commented:"The orphan designation to HLX22 in Europe represents another important regulatory milestone for this program. Following the earlier FDA designation, this reinforces the potential clinical and commercial value of the antibody. While Alligator is not directly involved in the development, we look forward to following its progress as it may contribute future revenue to Alligator." Under the terms of the license agreement, Alligator is entitled to 35% of AbClon's revenue from its sublicense agreement with Henlius. For further information, please contact: Søren Bregenholt, CEOE-mail: +46 (0) 46 540 82 00 The information was submitted for publication, through the agency of the contact person set out above, at 3:00 p.m. CEST on 26 May 2025. About Alligator Bioscience Alligator is a clinical-stage biotechnology company developing tumor-directed immuno-oncology antibody drugs focused on the CD40 receptor. This validated approach promotes priming of tumor-specific T cells and reversing the immunosuppressive nature of the tumor microenvironment, with significant potential benefits for cancer patients across multiple types of cancer. The Company's lead drug candidate mitazalimab, is currently in preparation for Phase 3 development, and has previously presented unprecedented survival data at 24-months follow up in first-line metastatic pancreatic cancer patients in the Phase 2 trial OPTIMIZE-1. Alligator is listed on Nasdaq Stockholm (ATORX) and headquartered in Lund, Sweden. For more information, please visit About the European Orphan Drug Designation The European Orphan Drug Designation is granted to medicines intended for the treatment, prevention or diagnosis of life-threatening or chronically debilitating conditions affecting no more than five in 10,000 people in the EU. The designation provides a range of incentives, including protocol assistance, fee reductions, and ten years of market exclusivity following regulatory approval. Attachments Alligator Bioscience announces European orphan drug designation for HLX22 in gastric cancer SOURCE: Alligator Bioscience View the original press release on ACCESS Newswire Sign in to access your portfolio
Yahoo
20-05-2025
- Business
- Yahoo
Alligator Bioscience Announces Paediatric Study Waiver for Mitazalimab Granted by the European Medicines Agency
LUND, SE / / May 20, 2025 / Alligator Bioscience (Nasdaq Stockholm:ATORX), a clinical stage biotechnology company pioneering immuno-oncology therapeutics, today announced that the European Medicines Agency (EMA) has granted a waiver from conducting paediatric clinical trials for Alligator's lead asset mitazalimab. The waiver, issued as part of the Paediatric Investigation Plan (PIP) regulatory process, exempts Alligator from the obligation to conduct pediatric studies with mitazalimab in the treatment of pancreatic cancer. This regulatory milestone removes a key requirement ahead of potential future marketing authorization submissions in the European Union. Mitazalimab, a CD40 agonist antibody, is currently being evaluated in the OPTIMIZE-1 Phase 2 clinical trial in combination with chemotherapy for patients with previously untreated metastatic pancreatic cancer. Recent 24-month follow-up data demonstrate a survival rate of 29.4% for patients treated with mitazalimab in combination with mFOLFIRINOX, which is more than triple the estimated 8% survival rate for FOLFIRINOX alone. The median overall survival was reported at 14.9 months, and the median duration of response was 12.6 months, both indicating a favorable safety profile and encouraging survival outcomes. "This decision by the EMA allows us to continue advancing mitazalimab through late-stage development with a clear regulatory path to approval," said Søren Bregenholt, CEO of Alligator Bioscience. "While we remain committed to the highest standards of patient safety, this waiver recognizes that pancreatic cancer is extremely rare in pediatric populations and supports our focused efforts to address the significant unmet medical need in adults." Alligator will continue to engage with regulatory authorities in Europe and the United States as it prepares for potential registrational steps for mitazalimab. For further information, please contact: Søren Bregenholt, CEOE-mail: +46 (0) 46 540 82 00 The information was submitted for publication, through the agency of the contact person set out above, at 2:30 p.m. CEST on 20 May 2025. About Alligator Bioscience Alligator is a clinical-stage biotechnology company developing tumor-directed immuno-oncology antibody drugs focused on the CD40 receptor. This validated approach promotes priming of tumor-specific T cells and reversing the immunosuppressive nature of the tumor microenvironment, with significant potential benefits for cancer patients across multiple types of cancer. The Company's lead drug candidate mitazalimab, is currently in preparation for Phase 3 development, and has previously presented unprecedented survival data at 24-months follow up in first-line metastatic pancreatic cancer patients in the Phase 2 trial OPTIMIZE-1. Alligator is listed on Nasdaq Stockholm (ATORX) and headquartered in Lund, Sweden. For more information, please visit Attachments Alligator Bioscience announces paediatric study waiver for mitazalimab granted by the European Medicines Agency SOURCE: Alligator Bioscience View the original press release on ACCESS Newswire Sign in to access your portfolio
Newsweek
17-05-2025
- Politics
- Newsweek
Ukraine Destroys $16M Russian 'Alligator' Helicopter in Drone Strike
Based on facts, either observed and verified firsthand by the reporter, or reported and verified from knowledgeable sources. Newsweek AI is in beta. Translations may contain inaccuracies—please refer to the original content. A Russian attack helicopter was downed by a Ukrainian drone, according to Kyiv's military. Ukraine's Special Operations Forces said it had successfully targeted the Russian Ka-52 "Alligator" helicopter, worth an estimated $16 million, over Ukrainian territory, posting video of what it said showed the strike. Newsweek has been unable to verify the footage and has contacted the Russian Defense Ministry for comment. A Russian Kamov Ka-52 "Alligator" military attack helicopter is pictured at the Dubai Airshow on November 13, 2023. A Russian Kamov Ka-52 "Alligator" military attack helicopter is pictured at the Dubai Airshow on November 13, 2023. GIUSEPPE CACACE//Getty Images Why It Matters Ukraine has used drones to considerable effect on the front line, causing Russia to face high losses of troops and equipment. The strike on a Russian helicopter further demonstrates these capabilities. What To Know Ukraine's Special Operations Forces' Bombus Balista unit said it had conducted a successful strike on a Russian Ka-52 "Alligator" attack helicopter using an FPV (first person view) drone. A video posted on social media appears to show the drone targeting the helicopter as it is on combat patrol over Ukrainian territory. No date or specific location was given for the operation. The post described it as a calculated strike that added to the further attrition of Russian aerial assets. ❗️A Ukrainian FPV drone hit a Russian Ka-52 Alligator helicopter. The helicopter is worth about $16 million. Glory! — Anton Gerashchenko (@Gerashchenko_en) May 16, 2025 In May 2024, Ukrainian forces shot down a Russian Ka-52 "Alligator" helicopter. On February 7 this year, another Ka-52 with its crew was taken down by a shoulder-launched MANPADS (Man Portable Air Defense System) near Avdiivka in the Donetsk region, according to Ukraine's United24 Media. Missiles and drones launched by Ukrainian Special Operations Forces have struck other high-value Russian military assets, according to reports, including a $45 million Russian Buk-M3 surface-to-air missile system in May and a rare Uragan multiple launch rocket system, United 24 Media reported. On Saturday, Ukrainian security service drones struck an ammunition depot used by Russia's 126th Coastal Defense Brigade in the southern Crimean Peninsula, causing a large explosion and fire, according to the Kyiv Independent citing an unnamed security official. The depot, located near a key highway between Simferopol and Alushta on the occupied peninsula, housed military equipment, ammunition and fuel storage facilities. What People Are Saying Ukraine's Special Operations Forces' Bombus Balista unit: "The Ka-52 attempted a combat patrol over Ukrainian fields, but did not anticipate the presence of our tactical drone group 'Bombus.'" What Happens Next President Volodymyr Zelensky announced in April that his country would step up production of long-range drones and ground-based robotic systems. Ukraine's drone campaign targeting Russian military facilities continues apace and following the strike on Crimea, Ukraine's Security Service told the Kyiv Independent "efforts to degrade (Russia's) military capabilities will continue."
Yahoo
16-05-2025
- Entertainment
- Yahoo
Adam Sandler Pays Tribute to ‘Happy Gilmore' Gator Morris, Who Died at Age 80-Ish: ‘We Are All Gonna Miss You'
Adam Sandler is giving a tongue in cheek tribute to the late 'Happy Gilmore' alligator Morris, who died at an estimated age of 80. In the iconic 1996 comedy, Morris infamously is confronted by Sandler's golfing character Happy; Morris grabs a golf ball on the green, leading Happy to realize that it is the same gator who chomped on the hand of his mentor, Chubbs (Carl Weathers). 'Goodbye, Morris. We are all gonna miss you,' Sandler tweeted after the news of Morris' passing was made public Monday, May 12. 'You could be hard on directors, make-up artists, costumers — really anyone with arms or legs — but I know you did it for the ultimate good of the film.' More from IndieWire 'Sirât' Review: Oliver Laxe's Spectacular Film Could Be Cinema's First Rave Tragedy 'Bring Her Back' Review: Sally Hawkins Is Psychotically Good in Yet Another Horror Movie About Grief Sandler continued, 'The day you wouldn't come out of your trailer unless we sent in 40 heads of lettuce taught me a powerful lesson: Never compromise your art. I will never forget at craft service that time when we split the Three Musketeers bar and you let me have the bigger half. But that's who you were.' While Morris was not going to star in the upcoming 'Happy Gilmore 2,' which will be released on Netflix July 25, Sandler still recalled how much the animal actor was missed on set. 'I know your character's decapitation in the first movie precluded your participation in the sequel, but we all appreciated the fruit basket and the hilarious note,' he quipped. 'I will miss the sound of your tail sliding through the tall grass, your cold, bumpy skin, but, most of all, I will miss your infectious laugh. Thanks to Mr. Young for taking care of you all these years, and vaya con dios, old friend.' Morris even landed a NYT obituary. The 640-pound, 11-foot alligator worked in Hollywood from 1975 to 2006, with roles in the 'Alligator' films, 'Dr. Doolittle 2,' 'Interview With the Vampire' (1994), and 'Blues Brothers 2000.' He also appeared on 'The Jay Leno Show' with late animal wrangler Steve Irwin. His career first started after being discovered in a private residential Los Angeles backyard, where he was kept as an illegal pet. Morris retired to the Colorado Gator Farm in Mosca, CO. The alligator died of old age, as a representative for the Colorado Gator Farm said. 'His exact age was unknown, but he was nine feet long in 1975, and by his growth rate and tooth loss, we can estimate his age at over 80 years,' the farm said. 'We have decided to get Morris taxidermied so that he can continue to scare children for years to come. It's what he would have wanted.' Best of IndieWire Guillermo del Toro's Favorite Movies: 56 Films the Director Wants You to See 'Song of the South': 14 Things to Know About Disney's Most Controversial Movie The 55 Best LGBTQ Movies and TV Shows Streaming on Netflix Right Now
Miami Herald
16-05-2025
- Entertainment
- Miami Herald
5-foot gator ‘just chillin' in sewer stares back at camera, Florida video shows
A camera sent into the sewers of Oviedo, Florida, found a 5-foot alligator lounging in the dark and it's suspected the reptile may live in the subterranean pipes that crisscross the city. That's because a gator of about the same size was recorded during a camera survey in 2023. 'He's back! We did a routine check of the pipe under Lockwood Blvd and discovered our friend was back, just chillin',' the city wrote in a May 15 Facebook post. 'We aren't sure if this is the same alligator from a few years ago, but it's just as fun to watch!' The camera entered the concrete pipes to inspect for damage and video shows it encountered the alligator about 90 feet in, sitting in a puddle. The alligator responded by waddling about 250 feet deeper into the pipe, in search of deeper water. It was last seen with just its head exposed, giving the camera serious side-eye treatment. Four thousand people had watched the video within a day, including some who suggested the city start a live-streaming service from the sewer for subscribers. Names for the alligator have also been suggested, including the Pipe Puppy and the Oviedo Pipe Gator. 'I wish there was 24 hour Sewer Alligator Cam …. I'd watch it,' Leigh-Ann Tepper posted on the city's Facebook page. 'What's Gators (yess!)?' Eileen Morse wrote. Concerns for the alligator's safety were also expressed, and city officials assured commenters it doesn't need to be rescued. Storm drains allow alligators to come and go, the city said. 'The alligators can easily navigate in and out of the storm water pipes without issue,' city officials told McClatchy News in an email. 'We have many lakes and the Econlockhatchee River in the area and the pipes are pretty big so they wouldn't get stuck.' Alligators are native to Florida's waterways, and can top 14 feet and 1,000 pounds, the Florida Fish and Wildlife Conservation Commission reports. May and June are mating season for the reptiles. Oviedo is about a 20-mile drive northeast from Orlando.
