Group 1 - Rezolute, Inc. shares experienced a significant decline of approximately 85-90% following disappointing topline results from its Phase 3 sunRIZE clinical trial for the drug candidate ersodetug, which failed to meet primary and key secondary endpoints [4][5] - The highest dose in the clinical trial showed reductions in hypoglycemia events that were not statistically significant compared to placebo, leading to investor concerns [4] - Following the news, trading of Rezolute's stock was halted under Nasdaq's volatility controls after it dropped from around $10.94 to an intraday low near $0.90 [5] Group 2 - Faruqi & Faruqi, LLP, a national securities law firm, is investigating potential claims against Rezolute, Inc. for investors who suffered significant losses [2] - The firm has a history of recovering hundreds of millions of dollars for investors since its establishment in 1995 [3] - Investors who experienced losses in Rezolute stock or options are encouraged to contact the firm to discuss their legal rights [1]

Core Insights - Rezolute, Inc. experienced a significant decline in share price following disappointing results from its Phase 3 sunRIZE clinical trial for ersodetug, which is aimed at treating congenital hyperinsulinism [1] - The clinical trial did not meet its primary and key secondary endpoints, with the highest dose showing reductions in hypoglycemia events that were not statistically significant compared to placebo [1] Market Reaction - During intraday trading, Rezolute's shares plummeted from approximately $10.94 to an intraday low of around $0.90, reflecting an approximate 85–90% drop as trading was halted under Nasdaq's volatility controls [2]

On Monday, October 13, 2025, Tvardi Therapeutics, Inc. saw its shares plummet over 80% after disappointing preliminary data from the Phase 2 REVERT clinical trial of TTI-101 in idiopathic pulmonary fibrosis. The study was designed to assess safety, pharmacokinetics, and exploratory outcomes related to lung function. After reviewing the preliminary safety data and exploratory efficacy results, including changes in Forced Vital Capacity (FVC), the Company concluded that the study did not meet its goals. Prel ...

Core Insights - Rezolute, Inc. is facing potential legal claims following a significant drop in its stock price due to disappointing results from its Phase 3 clinical trial for its lead drug candidate, ersodetug [2][3] Group 1: Company Performance - On December 11, 2025, Rezolute, Inc. shares fell sharply, with a decline from approximately $10.94 to an intraday low of around $0.90, representing an approximate 85-90% drop [2][3] - The Phase 3 sunRIZE clinical trial for ersodetug did not meet its primary and key secondary endpoints, with the highest dose showing reductions in hypoglycemia events that were not statistically significant compared to placebo [2] Group 2: Legal Investigation - Faruqil & Faruqil, LLP is investigating potential claims against Rezolute, indicating that the firm has a history of recovering hundreds of millions of dollars for investors since its founding in 1995 [1]

Core Viewpoint - MannKind Corporation has announced the discontinuation of its Phase 3 ICoN-1 clinical trial for MNKD-101, a nebulized clofazimine inhalation suspension, due to a lack of efficacy in treating refractory nontuberculous mycobacterial (NTM) lung disease [1][8]. Group 1: Clinical Trial Details - The ICoN-1 trial was a multi-national, randomized, double-blind, placebo-controlled Phase 3 study aimed at evaluating the efficacy and safety of clofazimine inhalation suspension in adults with refractory NTM lung disease caused by mycobacterium avium complex (MAC) [5]. - An analysis of sputum culture conversion data from the first 46 participants showed no conversions, leading to concerns about meeting the study's primary endpoint [2]. - The independent Data Safety Monitoring Board (DSMB) reviewed the data and agreed to discontinue the trial due to futility, although no safety concerns were identified during the study [2][8]. Group 2: Future Developments - Despite the discontinuation of MNKD-101, the company remains optimistic about MNKD-102, a dry powder inhalation (DPI) formulation of clofazimine, which is progressing toward Phase 1 development [3][8]. - The company is committed to understanding the factors that led to the failure of the nebulized formulation and intends to apply these insights to future development efforts [3]. Group 3: NTM Disease Context - NTM lung disease is a rare but significant global health concern, with rising prevalence and associated morbidity, particularly affecting individuals with underlying conditions such as COPD, asthma, and bronchiectasis [6][7]. - The most common type of NTM is MAC, which accounts for approximately 80% of NTM lung disease cases in the U.S., with an estimated prevalence of over 100,000 cases in the U.S. and over 150,000 in Japan as of 2022 [7].

Core Viewpoint - aTyr Pharma, Inc. experienced a dramatic decline in share price, dropping over 80% after failing to meet the primary endpoint in its late-stage study of efzofitimod for pulmonary sarcoidosis treatment [1][7]. Company Summary - On September 15, 2025, aTyr announced that its EFZO-FIT trial did not achieve statistical significance in steroid reduction after a year of tapering, leading to a significant market reaction [7]. - The company had previously assured investors that its Phase 2 data was among the best seen by experts and highlighted a multi-billion-dollar market opportunity for efzofitimod [6]. Investigation Summary - Following the market reaction, Hagens Berman, a national shareholders rights firm, initiated an investigation into whether aTyr misled investors regarding its Phase 2 data and Phase 3 trial design [2][5]. - The investigation is focused on the accuracy of aTyr's disclosures about the quality of its Phase 2 data and the design of the EFZO-FIT trial [5]. Market Reaction - The announcement of the topline results led to a flood of analyst downgrades and a catastrophic drop in aTyr's share price, reflecting investor disappointment and loss of confidence [7].

Core Insights - Class actions have been initiated for stockholders of Altimmune, Inc. and SelectQuote, Inc. with deadlines for lead plaintiff petitions approaching [1] Altimmune, Inc. (NASDAQ:ALT) - The class period for Altimmune is from August 10, 2023, to June 25, 2025, with a lead plaintiff deadline of October 6, 2025 [2] - On June 26, 2025, Altimmune announced disappointing results from the IMPACT Phase 2b MASH trial of Pemvidutide, failing to achieve statistical significance in the primary endpoint of fibrosis reduction due to a higher-than-expected placebo response [2] - Following the announcement, Altimmune's stock price plummeted from $7.71 to $3.61 per share, marking a decline of 53.2% in one day [3] SelectQuote, Inc. (NYSE:SLQT) - The class period for SelectQuote is from September 9, 2020, to May 1, 2025, with a lead plaintiff deadline of October 10, 2025 [3] - On May 1, 2025, the U.S. Department of Justice filed a complaint against SelectQuote, alleging the company received "tens of millions of dollars" in illegal kickbacks from health insurance companies from 2016 to 2021 [3] - The complaint claims SelectQuote misled Medicare beneficiaries by stating it offered unbiased coverage comparisons while actually directing them to plans that paid SelectQuote the most, resulting in a stock price drop of $0.61, or 19.2%, to close at $2.56 per share on the same day [3][4]

Core Viewpoint - Rocket Pharmaceuticals, Inc. is facing a class action lawsuit due to allegations of providing misleading statements regarding the safety and clinical trial protocol of its RP-A501 treatment, which resulted in significant stock price decline after the FDA placed a clinical hold on the study following a Serious Adverse Event [2][3]. Summary by Sections Allegations - The complaint alleges that Rocket Pharmaceuticals made overwhelmingly positive statements while concealing material adverse facts about RP-A501's safety and clinical trial protocol, including the risk of Serious Adverse Events (SAEs) and participant deaths [2]. - The company amended the trial protocol to include a new immunomodulatory agent without informing shareholders, leading to artificially inflated stock prices [2]. - Following the announcement of the FDA's clinical hold on May 27, 2025, due to a patient's death linked to the trial, Rocket's stock price plummeted from $6.27 to $2.33, a decline of approximately 37% in one trading day [2]. Class Action Details - The class period for the lawsuit is from February 27, 2025, to May 26, 2025, with a deadline for shareholders to register as lead plaintiffs by August 11, 2025 [3]. - Shareholders who register will receive updates on the case's progress through portfolio monitoring software [3]. Law Firm Information - The Gross Law Firm is a nationally recognized class action law firm dedicated to protecting investors' rights against deceit and fraud, seeking recovery for losses incurred due to misleading statements or omissions by companies [4].