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WOBURN, Mass., Nov. 21, 2024 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced that it has submitted a biologics license application (BLA) to the FDA for RP1 (vusolimogene oderparepvec) in combination with nivolumab for the treatment of adult patients with advanced melanoma who have previously received an anti-PD1 containing regimen. The submission was made under the Accelerated Approval pathway. The Company also announced that the FDA has granted Breakthrough Therapy designation to RP1 in combination with nivolumab in the same setting. Breakthrough Therapy designation is intended to expedite the development and review of therapies for serious diseases when preliminary clinical evidence indicates that the therapy may provide substantial improvement over existing available therapies on one or more clinically significant endpoints. This Breakthrough Therapy designation is based on the safety and clinical activity observed in the anti-PD1 failed melanoma cohort of the IGNYTE clinical trial. “Today is an important milestone for Replimune and for the melanoma community as we are one step closer to having another potential treatment available for patients who have limited options after progressing on anti-PD1 containing regimens,” said Sushil Patel, Ph.D., CEO of Replimune. The confirmatory Phase 3 IGNYTE-3 trial of RP1 in combination with nivolumab in advanced melanoma patients who have progressed on anti-PD1 and anti-CTLA-4 therapy, or who are not candidates for anti-CTLA-4 treatment is currently enrolling patients. For more information, visit https://replimune.com/clinical-trials/ignyte-3/ . About RP1 RP1 (vusolimogene oderparepvec) is Replimune’s lead product candidate and is based on a proprietary strain of herpes simplex virus engineered and genetically armed with a fusogenic protein (GALV-GP R-) and GM-CSF, intended to maximize tumor killing potency, the immunogenicity of tumor cell death, and the activation of a systemic anti-tumor immune response. About Replimune Replimune Group, Inc., headquartered in Woburn, MA, was founded in 2015 with the mission to transform cancer treatment by pioneering the development of novel oncolytic immunotherapies. Replimune’s proprietary RPx platform is based on a potent HSV-1 backbone intended to maximize immunogenic cell death and the induction of a systemic anti-tumor immune response. The RPx platform is designed to have unique dual local and systemic activity consisting of direct selective virus-mediated killing of the tumor resulting in the release of tumor derived antigens and altering of the tumor microenvironment to ignite a strong and durable systemic response. The RPx product candidates are expected to be synergistic with most established and experimental cancer treatment modalities, leading to the versatility to be developed alone or combined with a variety of other treatment options. For more information, please visit www.replimune.com . Forward Looking Statements This press release contains forward looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements regarding our belief regarding the effect that the breakthrough designation will have on the timing and development of RP1 and other statements identified by words such as “could,” “expects,” “intends,” “may,” “plans,” “potential,” “should,” “will,” “would,” or similar expressions and the negatives of those terms. Forward-looking statements are not promises or guarantees of future performance, and are subject to a variety of risks and uncertainties, many of which are beyond our control, and which could cause actual results to differ materially from those contemplated in such forward-looking statements. These factors include risks related to our limited operating history, our ability to generate positive clinical trial results for our product candidates, the costs and timing of operating our in-house manufacturing facility, the timing and scope of regulatory approvals, the availability of combination therapies needed to conduct our clinical trials, changes in laws and regulations to which we are subject, competitive pressures, our ability to identify additional product candidates, political and global macro factors including the impact of the coronavirus as a global pandemic and related public health issues and the Russian-Ukrainian and Israel-Hamas political and military conflicts, and other risks as may be detailed from time to time in our Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q and other reports we file with the Securities and Exchange Commission. Our actual results could differ materially from the results described in or implied by such forward-looking statements. Forward-looking statements speak only as of the date hereof, and, except as required by law, we undertake no obligation to update or revise these forward-looking statements. Investor Inquiries Chris Brinzey ICR Healthcare 339.970.2843 chris.brinzey@westwicke.com Media Inquiries Arleen Goldenberg Replimune 917.548.1582 media@replimune.comDenver Mayor Mike Johnston sets off firestorm with vows to resist Donald Trump’s mass deportation plans
The move by the PBOC to increase its gold holdings is part of a broader trend among central banks to reevaluate their reserve allocations in light of changing global economic dynamics. As the world becomes more interconnected and interdependent, central banks are becoming increasingly vigilant about the composition of their reserves and the potential risks they face in a rapidly changing environment.
Missing teen believed to be with 'unknown male' she met on SnapchatThe was rated as a strong one last spring, a bunch of potential game-changers. And now that the fantasy football season is all but complete, we can emphatically give the final conclusion. The kids are alright. Rookies splashed all over TV screens in the fantasy football finals, intent on delivering championships to managers who believed in youth over experience. as the early Sunday window closed, with 12 games in the books. Malik Nabers (7-171-2 good for 32.6 fantasy points) ranked as the WR2 for the week, Ladd McConkey (9-84-2 for 25.4 points) the WR7. Jalen McMillan (5-51-2 for 20.5 points), Brian Thomas Jr. (7-91-1 for 20.4 points) and Xavier Worthy (8-79-1 for 18.9 points) were all in a row, holding down the 10-11-12 spots, respectively. Heck, even Marvin Harrison Jr. (6-96-0) had a solid game from Saturday, while Keon Coleman (3-27-1) . Thomas and Nabers were college teammates at LSU (along with another super rookie, QB Jayden Daniels), and the Thomas vs. Nabers fantasy draft debate should be a fun one next year. Thomas has been remarkably productive and consistent this year despite mediocre quarterback play from Trevor Lawrence and Mac Jones (to be fair, the touchdown Thomas caught on Sunday ). The New York quarterback situation has held Nabers down at times, although Drew Lock had his good stuff in Sunday's upset of Indianapolis. The Giants are sure to draft a signature quarterback next year. Nabers and Thomas could push into Round 1 of 2025 drafts Nabers, of course, went . But it was Thomas who was the . Given what Thomas overcame this year, I give him the slight edge over Nabers in 2025, but it's a tiny difference. They might go back-to-back in a lot of leagues. For now, I figure they'll land somewhere around the Pick 12-13 turn, but I wouldn't be shocked if they become even pricier than that. Forget landing them in Round 3, that's not going to happen. McConkey will be a fantasy building block in Year 2 McConkey's was doubly stinging for the Patriots, who traded the pick that became McConkey to the Chargers back in April, then shortly after selected one of the rookie flops of the year, WR Ja'Lynn Polk. McConkey's true upside was likely shielded at Georgia, where he and TE Brock Bowers didn't get to play in weekly shootouts. Does McConkey have potential Cooper Kupp upside down the road? It sure seems like the rookie is constantly open. He feels like a perfect Round 3 pick next year. Worthy's stock on the rise The flow of Worthy's rookie season was similar to how the Chiefs handled Rashee Rice last year — soft-pedal things early, then turn it on late. Of course, Worthy and Rice play much different roles, but the cadence of their seasons was similar. I suspect Worthy probably lands around Round 5 in 2025 drafts. Bucs' offseason decisions will impact McMillan McMillan was slow to earn fantasy trust from managers, as he finally climbed over the 50% rostered tag late this week. But with two touchdowns Sunday, that gives him six spikes in his last four games, part of the reliable Tampa Bay carnival. It will be interesting to see how Tampa Bay handles Chris Godwin, a pending free agent, after the season. If Godwin doesn't return, McMillan probably makes sense around Rounds 5-6. With Godwin back, it's a trickier call. The Buccaneers might also lose OC Liam Coen, who's been brilliant with the play sheet. Harrison, you ask? I suspect Harrison is a third-round pick next year — a bet on the talent, even if you don't trust the infrastructure. Kyler Murray and Harrison never completely worked out the kinks. Two other non-quarterback rookies deserve a Week 17 nod as we complete this look-ahead. Bucky Irving, star in the making Bucky Irving grabbed the RB3 slot in championship week on the strength of 190 total yards against the Carolina sieve. He basically threw Rachaad White out of the way in the Tampa backfield — Irving collected 20 carries and 24 touches compared to six and seven, respectively, for White. I don't think White is a bad player but Irving sure looks like a special one. Sounds like Irving might be a second-round pick next year, no later than Round 3. Brock Bowers is the new TE1 Bowers, of course, rewrote all those rookie tight end rules that Sam LaPorta worked on a year ago. Bowers came on late in Sunday's win over the Saints, securing all of his targets for a solid 7-77-0 line. His touchdown count of four is a little light, but consider the limited quarterbacks he's been playing with. And let's also acknowledge on the all-time rookie TE yardage chart, albeit Bowers had the benefit of a thicker schedule. Kyle Pitts once challenged that Ditka yardage record, falling just short. Pitts has been a maddening fantasy player since, but Bowers looks like something that will last. Maybe the Raiders upgrade at QB, maybe not, but I don't think it matters. Bowers should be the first tight end selected next year, figuring that will be Round 2-3 in pretty much every league.
In conclusion, while Lautaro Martinez's exclusion from the Double Crown and Golden Boot candidacy may be disappointing for his fans and supporters, it is essential to recognize the various factors at play in determining award recipients in football. Martinez's talent and potential are undeniable, and his time to shine on the big stage may come in the future. For now, he can take pride in his contributions to Inter Milan and continue to strive for excellence on the pitch. Who knows, with the right timing, form, and continued dedication, Lautaro Martinez may soon find himself among the elite contenders for individual awards in the world of football.What does 2025 have in store for your star sign?
Moreover, building trust and credibility with customers and regulators is paramount for Ant Group's success. Transparency, integrity, and regulatory compliance are non-negotiable values that must be ingrained in the company's culture. By prioritizing customer satisfaction, data privacy, and risk management, Ant Group can build long-term relationships and loyalty with its stakeholders.
Palo Alto Networks, Inc. ( NASDAQ:PANW – Get Free Report ) traded down 2.4% during mid-day trading on Friday . The stock traded as low as $183.20 and last traded at $183.97. 774,961 shares changed hands during trading, a decline of 90% from the average session volume of 7,478,080 shares. The stock had previously closed at $188.50. Wall Street Analysts Forecast Growth Several analysts have commented on PANW shares. Susquehanna raised their price objective on shares of Palo Alto Networks from $210.00 to $217.50 and gave the stock a “positive” rating in a report on Thursday, November 21st. TD Cowen lifted their price target on Palo Alto Networks from $200.00 to $210.00 and gave the company a “buy” rating in a research report on Thursday, November 21st. Truist Financial upped their price target on Palo Alto Networks from $200.00 to $212.50 and gave the stock a “buy” rating in a research note on Monday, November 18th. Stifel Nicolaus boosted their target price on shares of Palo Alto Networks from $192.50 to $220.00 and gave the company a “buy” rating in a report on Thursday, November 14th. Finally, Jefferies Financial Group increased their price target on shares of Palo Alto Networks from $225.00 to $240.00 and gave the stock a “buy” rating in a research note on Thursday, December 19th. Two research analysts have rated the stock with a sell rating, ten have issued a hold rating, thirty-one have issued a buy rating and one has given a strong buy rating to the company. According to MarketBeat, Palo Alto Networks has an average rating of “Moderate Buy” and a consensus target price of $201.40. Read Our Latest Stock Analysis on Palo Alto Networks Palo Alto Networks Stock Down 1.2 % Palo Alto Networks ( NASDAQ:PANW – Get Free Report ) last released its earnings results on Wednesday, November 20th. The network technology company reported $0.78 EPS for the quarter, topping analysts’ consensus estimates of $0.74 by $0.04. The company had revenue of $2.14 billion for the quarter, compared to analysts’ expectations of $2.12 billion. Palo Alto Networks had a net margin of 32.99% and a return on equity of 23.36%. The firm’s revenue was up 13.9% compared to the same quarter last year. During the same quarter last year, the business earned $0.32 EPS. As a group, research analysts forecast that Palo Alto Networks, Inc. will post 3.49 EPS for the current year. Insiders Place Their Bets In other Palo Alto Networks news, CEO Nikesh Arora sold 163,172 shares of the stock in a transaction that occurred on Thursday, October 10th. The shares were sold at an average price of $184.00, for a total transaction of $30,022,832.14. Following the completion of the sale, the chief executive officer now directly owns 1,237,430 shares of the company’s stock, valued at $227,680,932.85. This trade represents a 11.65 % decrease in their position. The sale was disclosed in a filing with the SEC, which is available through the SEC website . Also, EVP Nir Zuk sold 336,000 shares of the business’s stock in a transaction on Monday, November 25th. The stock was sold at an average price of $193.70, for a total transaction of $65,081,520.00. Following the completion of the transaction, the executive vice president now directly owns 3,643,516 shares in the company, valued at $705,730,831.62. This trade represents a 8.44 % decrease in their position. The disclosure for this sale can be found here . In the last quarter, insiders sold 571,172 shares of company stock worth $107,074,352. Corporate insiders own 2.50% of the company’s stock. Institutional Investors Weigh In On Palo Alto Networks Several large investors have recently made changes to their positions in PANW. Geode Capital Management LLC grew its holdings in Palo Alto Networks by 3.0% during the 3rd quarter. Geode Capital Management LLC now owns 7,656,968 shares of the network technology company’s stock valued at $2,609,486,000 after buying an additional 220,900 shares in the last quarter. International Assets Investment Management LLC grew its holdings in shares of Palo Alto Networks by 34,318.2% in the third quarter. International Assets Investment Management LLC now owns 3,259,063 shares of the network technology company’s stock valued at $1,113,948,000 after purchasing an additional 3,249,594 shares in the last quarter. Legal & General Group Plc increased its position in Palo Alto Networks by 8.5% in the second quarter. Legal & General Group Plc now owns 3,243,457 shares of the network technology company’s stock worth $1,099,564,000 after purchasing an additional 255,060 shares during the last quarter. Jennison Associates LLC raised its stake in Palo Alto Networks by 50.1% during the third quarter. Jennison Associates LLC now owns 3,147,215 shares of the network technology company’s stock valued at $1,075,718,000 after purchasing an additional 1,050,173 shares in the last quarter. Finally, Canada Pension Plan Investment Board lifted its position in Palo Alto Networks by 5.4% during the second quarter. Canada Pension Plan Investment Board now owns 2,233,918 shares of the network technology company’s stock valued at $757,321,000 after purchasing an additional 114,742 shares during the last quarter. 79.82% of the stock is owned by institutional investors. Palo Alto Networks Company Profile ( Get Free Report ) Palo Alto Networks, Inc provides cybersecurity solutions worldwide. The company offers firewall appliances and software; and Panorama, a security management solution for the global control of network security platform as a virtual or a physical appliance. It also provides subscription services covering the areas of threat prevention, malware and persistent threat, URL filtering, laptop and mobile device protection, DNS security, Internet of Things security, SaaS security API, and SaaS security inline, as well as threat intelligence, and data loss prevention. Recommended Stories Receive News & Ratings for Palo Alto Networks Daily - Enter your email address below to receive a concise daily summary of the latest news and analysts' ratings for Palo Alto Networks and related companies with MarketBeat.com's FREE daily email newsletter .
A long-withheld investigation into a 2019 hacking at LifeLabs Inc. that compromised millions of Canadians' health data has finally been made public after an Ontario court dismissed the company's appeal to prevent its release. Read this article for free: Already have an account? To continue reading, please subscribe: * A long-withheld investigation into a 2019 hacking at LifeLabs Inc. that compromised millions of Canadians' health data has finally been made public after an Ontario court dismissed the company's appeal to prevent its release. Read unlimited articles for free today: Already have an account? A long-withheld investigation into a 2019 hacking at LifeLabs Inc. that compromised millions of Canadians’ health data has finally been made public after an Ontario court dismissed the company’s appeal to prevent its release. A statement from the privacy commissioners of both Ontario and British Columbia says their joint report, completed in June 2020, found that LifeLabs “failed to take reasonable steps” to protect clients’ data while collecting more personal health information than was “reasonably necessary.” The report ordered LifeLabs to address a number of issues such as appropriately staffing its security team, and the commissioners’ statement says the company complied with all of the orders and recommendations. LifeLabs had cited litigation and solicitor-client privilege to prevent the document’s publication, but this was opposed by the commissioners’ offices. The company then sought a judicial review in Divisional Court in Ontario before the case made its way to the Ontario Court of Appeal, where LifeLabs’ appeal was dismissed. B.C. Information and Privacy Commissioner Michael Harvey says in a statement that “the road to accountability and transparency has been too long” for the victims of the data breach. “LifeLabs’ failure to put in place adequate safeguards to protect against this attack violated patients’ trust, and the risk it exposed them to was unacceptable,” Harvey says. “When this happens, it is important to learn from past mistakes so others can prevent future breaches from happening. Winnipeg Jets Game Days On Winnipeg Jets game days, hockey writers Mike McIntyre and Ken Wiebe send news, notes and quotes from the morning skate, as well as injury updates and lineup decisions. Arrives a few hours prior to puck drop. “But to learn from lessons, we need to share them.” Ontario Information and Privacy Commissioner Patricia Kosseim says in the statement that she is pleased with the court’s decision to uphold the decision by her office “to help restore public trust in the oversight mechanisms designed to hold organizations accountable.” In May, Canadians who applied to be part of a class-action lawsuit against LifeLabs began receiving cheques and e-transfers, with administrator KPMG saying more than 900,000 valid claims were received. An Ontario court had approved a total Canada-wide settlement of up to $9.8 million in the data breach, which allowed hackers to access the personal information of up to 15 million customers. This report by The Canadian Press was first published Nov. 25, 2024. Advertisement AdvertisementIn conclusion, let us unite in sending thoughts of healing and support to the young singer as she embarks on a challenging journey of recovery. May her courage and resilience inspire us all to prioritize health, safety, and well-being in our pursuit of holistic wellness.
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Column: Brady Corbet’s epic movie ‘The Brutalist’ came close to crashing down more than once