Core Viewpoint - The article highlights a pending securities class action lawsuit against Telix Pharmaceuticals Ltd. due to alleged misstatements regarding the company's therapeutic candidates and supply chain reliability, leading to significant investor losses [1][2][3]. Regulatory Issues - The lawsuit follows regulatory setbacks, including an SEC subpoena and a Complete Response Letter (CRL) from the FDA, which resulted in a 21% decline in Telix's stock price [2][7]. - The SEC is investigating Telix's disclosures related to the development of its prostate cancer therapeutic candidates, suggesting misleading statements about their advancement [7]. - The FDA rejected Telix's Zircaix application, citing severe deficiencies in Chemistry, Manufacturing, and Controls (CMC), and issued Form 483 notices to two third-party supply chain partners, revealing foundational weaknesses that were allegedly concealed [7]. Allegations of Misrepresentation - The complaint alleges that Telix and its executives materially overstated the developmental progress of its therapeutic candidates and misrepresented the reliability and regulatory compliance of its third-party supply chain and manufacturing partners [2][3]. - The complaint claims that these documented failures were material and concealed, making the company's claims of "great progress" and "truly global manufacturing capability" materially false [3]. Investor Impact - The cumulative effect of the regulatory disclosures allegedly caused Telix ADSs to fall sharply, leading to damages for investors who purchased TLX ADSs during the Class Period from February 21, 2025, to August 28, 2025 [7]. - The firm Hagens Berman is urging Telix investors who suffered substantial losses to contact them to discuss their rights [4][5].

The company has billed this drug as a potential treatment for hypoglycemia caused by hyperinsulinism ("HI"). The news, analyst moves, and severe market reaction have prompted national shareholders rights firm Hagens Berman to open an investigation into whether Rezolute may have previously misled investors about erso's efficacy and commercial prospects. SAN FRANCISCO, Dec. 15, 2025 /PRNewswire/ -- On December 11, 2025, investors in Rezolute, Inc. (NASDAQ: RZLT) saw the price of their shares crater as much as ...

Core Viewpoint - Telix Pharmaceuticals Ltd. is facing a securities class action lawsuit due to alleged misstatements regarding the development of its prostate cancer drug TLX591 and deficiencies in its third-party manufacturing processes, leading to significant investor losses [2][3][6]. Regulatory Issues - The lawsuit follows regulatory setbacks, including an SEC subpoena and a Complete Response Letter (CRL) from the FDA, which resulted in a 21% decline in Telix's stock price [2][6]. - The SEC is reportedly questioning the accuracy of Telix's development disclosures, while the FDA rejected a Biologics License Application (BLA) due to serious deficiencies in Chemistry, Manufacturing, and Controls (CMC) [3][6]. Allegations of Misrepresentation - The complaint claims that Telix and its executives materially overstated the progress of their therapeutic candidates and misrepresented the reliability of their supply chain and manufacturing partners [2][3]. - Documented failures in regulatory compliance were allegedly concealed, contradicting the company's claims of significant progress and global manufacturing capabilities [3][6]. Investor Impact - The cumulative effect of the regulatory disclosures has led to substantial financial losses for investors who purchased Telix's American Depositary Shares (ADSs) during the class period from February 21, 2025, to August 28, 2025 [6]. - Following the final regulatory news, Telix's ADSs experienced a sharp decline, highlighting the impact of the alleged misstatements on investor confidence [2][6].

SAN FRANCISCO, Nov. 24, 2025 (GLOBE NEWSWIRE) -- Medical device manufacturer Inspire Medical Systems, Inc. (NYSE: INSP) is the subject of a securities class action lawsuit following a sharp decline in its stock price, with shareholders alleging the company misled investors about the launch of its latest product, the Inspire V device for obstructive sleep apnea. Hagens Berman is investigating the allegations. The firm urges investors in Inspire who suffered significant losses to submit your losses now. Class ...

Core Viewpoint - A class-action lawsuit has been filed against KBR, Inc. alleging misleading statements made by the company prior to the cancellation of a significant military contract, which adversely affected its business outlook [1][2]. Summary by Sections Legal Action - The lawsuit seeks to represent investors who acquired KBR securities between May 6, 2025, and June 19, 2025, with a deadline for lead plaintiffs set for November 18, 2025 [2]. - The legal action claims that KBR executives provided an overly optimistic outlook on a crucial partnership just before its collapse [2]. Contract Cancellation - The litigation arises from the U.S. Department of Defense's cancellation of its global household goods contract with HomeSafe Alliance LLC, a joint venture led by KBR, announced on June 20, 2025 [3]. - This cancellation resulted in a more than 7% drop in KBR's share price, reflecting investor concerns over the loss of a contract potentially worth up to $20 billion over nine years [3]. Misrepresentation Allegations - On May 6, 2025, during its Q1 earnings call, KBR assured investors that the HomeSafe partnership was "strong" and projected a revenue contribution of approximately $400 million for 2025 [4]. - However, on June 19, 2025, HomeSafe revealed that TRANSCOM had terminated the contract due to operational issues, which KBR allegedly knew about but did not disclose to investors [5]. Financial Impact - Following the contract termination, KBR revised its low-end 2025 revenue guidance downward by about $900 million, a decrease of 9%, primarily due to the removal of the HomeSafe JV revenue contribution [5]. - KBR management acknowledged operational challenges during the Q2 2025 earnings call, indicating a shift in the company's financial outlook [5].

Core Viewpoint - Inspire Medical Systems, Inc. is facing a proposed class-action lawsuit for allegedly misleading investors regarding the commercial readiness and demand for its Inspire V sleep apnea device, leading to a significant stock decline [1][6]. Company Overview - Inspire Medical Systems, Inc. is under investigation by prominent investor rights law firm Hagens Berman for claims related to investor losses during the class period from August 6, 2024, to August 4, 2025 [2][3]. Allegations and Claims - The lawsuit asserts that Inspire provided repeated assurances about meeting all regulatory and commercial prerequisites for the Inspire V launch, while claiming high demand and successful commercial proceedings [3]. - Contrary to these assurances, the lawsuit claims that the Inspire V launch was a failure, with minimal initial demand due to customers being overstocked with the older Inspire IV devices [4]. - The complaint indicates that Inspire neglected essential steps to facilitate the new device's adoption by clinicians and payors [4]. Impact of the Launch - On August 4, 2025, Inspire disclosed that the launch faced an "elongated timeframe" due to undisclosed challenges, including incomplete training and onboarding at many centers [5]. - The company noted that while the CPT code for Inspire V was approved for Medicare patients, necessary software updates for claims processing were delayed until July 1, affecting billing capabilities [5]. - Demand for Inspire V was further hindered by the need for customers to deplete existing Inspire IV inventory, which is expected to continue impacting demand [6]. Financial Consequences - Following the disastrous launch, Inspire slashed its 2025 earnings guidance by 80%, projecting earnings of only $0.40 to $0.50 per share [6]. - The announcement led to a significant drop in Inspire's stock price, with shares falling by approximately 32%, or $42.04, the day after the news [6].

Core Viewpoint - Inspire Medical Systems, Inc. is facing a proposed class-action lawsuit for allegedly misleading investors regarding the commercial readiness and demand for its Inspire V sleep apnea device, leading to a significant stock decline [1][6]. Company Overview - Inspire Medical Systems, Inc. is under investigation by prominent investor rights law firm Hagens Berman for claims related to investor losses during the class period from August 6, 2024, to August 4, 2025 [2][3]. Allegations of Misleading Information - The lawsuit claims that Inspire provided repeated assurances about meeting all regulatory and commercial prerequisites for the Inspire V launch while promoting high demand, which was later revealed to be untrue [3][4]. - The complaint highlights that the actual launch of Inspire V was disastrous, with minimal initial demand attributed to customers being overstocked with the older Inspire IV devices [4][5]. Impact of the Launch - On August 4, 2025, Inspire disclosed that the launch faced an "elongated timeframe" due to undisclosed challenges, including incomplete training and onboarding at implanting centers [5][6]. - The company noted that although the CPT code for Medicare patients was approved, software updates for claims processing did not take effect until July 1, delaying billing for procedures and leading centers to continue using the older Inspire IV [5][6]. Financial Consequences - As a result of the poor launch performance, Inspire slashed its 2025 earnings guidance by 80%, projecting earnings of only $0.40 to $0.50 per share [6]. - Following this announcement, Inspire's stock price plummeted by approximately 32%, dropping $42.04 the next day [6].

Core Viewpoint - Soleno Therapeutics, Inc. experienced a significant drop in share price by $18.78 (-28%) following disappointing news regarding its drug VYKAT™ XR, which is intended to treat hyperphagia associated with Prader-Willi syndrome [1][2]. Company Performance - The company had previously assured investors of a successful launch of VYKAT™ XR after receiving FDA approval, stating that the launch "has been going really well" and "definitely exceeded our expectations" [2]. - However, during the Q3 2025 earnings call, Soleno disclosed a disruption in the launch trajectory, citing a lower number of start forms and increased discontinuations due to non-serious adverse events [2]. Market Reaction - Following the negative news, Soleno's share price fell nearly 40% from August 14, 2025, to November 5, 2025 [4]. - The market reaction was influenced by concerns raised by short seller Scorpion Capital, which highlighted potential risks associated with VYKAT™ XR, including reports of children hospitalized for heart failure after using the drug [3][4]. Investigations and Allegations - Hagens Berman, a national shareholders rights firm, is investigating whether Soleno misled investors regarding the commercial prospects of VYKAT™ XR [5]. - Scorpion Capital characterized Soleno as a "one-trick pony" with no other significant assets or pipeline, raising doubts about the company's future if VYKAT™ XR fails [3][4]. - Allegations were made regarding the integrity of clinical trial data and the influence of a controversial physician involved in key trials, suggesting potential irregularities in the company's disclosures [4].

Core Viewpoint - CarMax, Inc. has experienced a significant decline in share price following the announcement of CEO Bill Nash's termination and disappointing preliminary financial results for Q3 2026, indicating potential issues with the company's business model and growth prospects [1][2]. Financial Performance - CarMax forecasts a comparable store unit decrease of 8% - 12% and net EPS in the range of $0.18 - $0.36, which is below analysts' expectations of $0.69 [2]. - The company reported a year-over-year net EPS decline of 24%, with retail used unit sales falling by 5.4% and comparable store used unit sales decreasing by 6.3% [5]. - CarMax Auto Finance (CAF) revenue declined by 11.02% year-over-year, attributed to a $142 million loan loss provision, marking a nearly 40% sequential increase and approximately 24% year-over-year jump [6]. Legal Issues - A securities class action has been filed against CarMax, focusing on allegations that the company misled investors regarding its business model and growth prospects during the class period from June 20, 2025, to September 24, 2025 [3][4]. - The complaint claims that CarMax's positive Q1 2026 results were misleading, as they were influenced by consumers pulling forward car purchases to avoid tariffs [4]. - The investigation by Hagens Berman is centered on whether CarMax intentionally misled investors about the strength of its business model and the quality of its CAF portfolio [7].

Core Viewpoint - A class-action lawsuit has been filed against KBR, Inc. alleging misleading statements to investors prior to the cancellation of a significant military contract, which adversely affected the company's business outlook [1][5]. Group 1: Lawsuit Details - The lawsuit seeks to represent investors who acquired KBR securities between May 6, 2025, and June 19, 2025 [1][2]. - The legal action claims that KBR executives provided an overly optimistic outlook on a crucial partnership just before its collapse [2][5]. Group 2: Contract Cancellation Impact - The lawsuit is linked to the Department of Defense's cancellation of a global household goods contract with HomeSafe Alliance LLC, a joint venture led by KBR, announced on June 20, 2025 [3]. - Following the contract termination, KBR shares dropped over 7% due to the loss of a contract valued at up to $20 billion over a potential nine-year term [3][5]. Group 3: Misrepresentation Allegations - On May 6, 2025, during its Q1 earnings call, KBR assured investors that the HomeSafe partnership was "strong" and projected a mid-point revenue contribution of about $400 million for 2025 [4]. - Just weeks later, on June 19, 2025, HomeSafe disclosed the termination of the contract due to operational issues, which KBR allegedly knew about but did not disclose to investors [5]. Group 4: Financial Revisions - After the class period, KBR revised its low-end 2025 revenue guidance downward by approximately $900 million (-9%) due to the removal of the HomeSafe JV revenue contribution [6]. - KBR management acknowledged operational challenges during the Q2 2025 earnings call, raising questions about whether the company misled investors regarding the contract's status [6].