NEW YORK, Dec. 08, 2025 (GLOBE NEWSWIRE) -- The Gross Law Firm issues the following notice to shareholders of MoonLake Immunotherapeutics (NASDAQ: MLTX). Shareholders who purchased shares of MLTX during the class period listed are encouraged to contact the firm regarding possible lead plaintiff appointment. Appointment as lead plaintiff is not required to partake in any recovery. CONTACT US HERE: https://securitiesclasslaw.com/securities/moonlake-loss-submission-form/?id=179740&from=3 CLASS PERIOD: March 10 ...

Core Viewpoint - The Gross Law Firm is notifying shareholders of Skye Bioscience, Inc. regarding a class action lawsuit due to alleged misleading statements about the company's lead product candidate, nimacimab [1][3]. Group 1: Allegations - The complaint alleges that during the class period from November 4, 2024, to October 3, 2025, the defendants issued materially false and misleading statements regarding nimacimab's effectiveness [3]. - It is claimed that the clinical, regulatory, and commercial prospects of nimacimab were overstated, leading to inflated public statements by the defendants [3]. Group 2: Shareholder Actions - Shareholders who purchased shares of SKYE during the specified class period are encouraged to register for the class action, with a deadline set for January 16, 2026 [4]. - Once registered, shareholders will receive updates through a portfolio monitoring software regarding the status of the case [4]. Group 3: Law Firm's Mission - The Gross Law Firm aims to protect the rights of investors who have suffered due to deceit and illegal business practices, emphasizing the importance of responsible corporate behavior [5].

Core Viewpoint - Dyne Therapeutics reported significant progress with its investigational drug zeleciment rostudirsen for Duchenne muscular dystrophy (DMD), achieving primary and secondary endpoints in a clinical trial, leading to a notable increase in share price [1][2][4]. Group 1: Clinical Trial Results - The drug zeleciment rostudirsen met its primary endpoint in a phase 1/2 clinical trial involving 86 patients [2]. - It also achieved secondary endpoints, demonstrating a statistically significant increase in dystrophin production, a crucial protein for muscle protection [4]. Group 2: Regulatory Outlook - Dyne Therapeutics plans to submit zeleciment rostudirsen for accelerated approval by the U.S. Food and Drug Administration (FDA) in the second quarter of next year [4]. Group 3: Market Performance - Following the announcement, Dyne's shares increased by 9.57%, with the current price at $22.22 and a market capitalization of $3 billion [5][6]. - The stock's 52-week range is between $6.36 and $29.71, indicating significant volatility [5].

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Summary of Catalyst Pharmaceuticals Conference Call Company Overview - **Company**: Catalyst Pharmaceuticals (NasdaqCM: CPRX) - **Key Products**: Agamree and Firdapse - **Focus**: Rare diseases and orphan drug development Key Points Business Development and Licensing - Catalyst Pharmaceuticals is focused on business development (BD) and licensing as core components of its strategy, particularly concerning Firdapse's intellectual property (IP) resolution before significant capital deployment [4][5][18] - The company has assessed over 100 opportunities since the beginning of the year, indicating a proactive approach to identifying potential acquisitions [6][7] Financial Position - Catalyst has approximately $689 million in cash and no funded debt, positioning it as a strong bidder in the market [9] - The company is cautious about entering bidding wars with larger players and aims to focus on opportunities that are immediately accretive or nearly so [5][9] Product Performance and Market Potential - Firdapse has the potential to exceed $500 million in revenue, with a focus on lifecycle management to optimize patient engagement and product usage [11][12] - Agamree is showing promising patient sourcing, with 45% from Emflaza, 45% from Prednisone, and 10% naive patients, indicating strong market acceptance [29][30] - The addressable market for steroids is estimated to be above $1 billion, with the potential for significant growth if the product proves effective in clinical trials [33][34] Clinical Trials and Research - The SUMMIT trial is critical for validating the efficacy of Agamree, with expectations of positive outcomes based on previous trials [35][36] - The company is conducting a phase one study to determine the immunosuppressive dose of Agamree, which could open new therapeutic avenues [15][17] Intellectual Property and Litigation - Catalyst is actively defending its IP for Firdapse, having settled with three out of four defendants in ongoing litigation [18][50] - The company believes its patent estate is robust, which is crucial for maintaining market exclusivity [50][69] Market Dynamics and Competitive Landscape - The company is facing generic competition for Fycompa, but brand stickiness is reportedly holding up better than expected [63][64] - The introduction of generics has not significantly dented Firdapse's business, indicating strong market positioning and patient loyalty [70] Future Outlook and Strategic Focus - Catalyst aims to expand its portfolio into other rare conditions requiring long-term steroid use, focusing on patient populations that can benefit most from its products [46][48] - The company is also exploring opportunities in the oncology space, particularly for cancer-associated LEMS patients, which could enhance its market reach [55][76] Capital Allocation - A $200 million share repurchase program has been authorized, signaling confidence in the company's financial health while maintaining flexibility for business development [66][67] - The company is committed to balancing capital allocation between share buybacks and potential acquisitions [67] Payer Coverage and Market Access - Payer coverage for Agamree is improving, with nearly 90% of prescriptions being approved, indicating growing acceptance among insurers [39][40] - The company is working to streamline the process for patients to access its therapies, which is critical for maintaining market share [39][40] Conclusion Catalyst Pharmaceuticals is strategically positioned in the rare disease market with a strong financial foundation and a focus on innovative product development. The company is actively managing its IP, exploring new market opportunities, and optimizing its existing product lines to drive growth and enhance shareholder value.

NEW YORK--(BUSINESS WIRE)--Faruqi & Faruqi, LLP, a leading national securities law firm, is investigating potential claims against aTyr Pharma, Inc. ("aTyr†or the "Company†) (NASDAQ: ATYR) and reminds investors of the December 8, 2025 deadline to seek the role of lead plaintiff in a federal securities class action that has been filed against the Company. The complaint alleges that the Company and its executives violated federal securities laws by making false and/or misleading statements After aTyr Pharma ...

Kura Oncology ASH 2025 Update Summary Company Overview - **Company**: Kura Oncology (NasdaqGS: KURA) - **Event**: ASH 2025 update call - **Key Product**: Ziftomenib (branded as Comzifti) Industry Context - **Focus**: Acute Myeloid Leukemia (AML) treatment, specifically targeting NPM1 mutant and KMT2A rearranged AML - **Significance**: First ASH conference where ziftomenib is approved, highlighting its potential in AML treatment Core Points and Arguments 1. **Ziftomenib Approval**: Ziftomenib is now approved and available as 200 mg capsules, marking a significant milestone for Kura Oncology and its partners [4][5][6] 2. **Combination Therapy**: The combination of ziftomenib with azacitidine and venetoclax shows promising results in both newly diagnosed and relapsed/refractory AML settings [3][17] 3. **Efficacy Data**: - In newly diagnosed NPM1 mutant AML, the complete response (CR) rate was 73%, with an overall response rate of 89% [11][12] - In relapsed/refractory settings, CR rates were 27% for NPM1 mutant patients and 6% for KMT2A rearranged patients, with overall response rates of 66% and 41% respectively [22][26] 4. **Safety Profile**: The safety profile of ziftomenib in combination with azacitidine and venetoclax was favorable, with low rates of myelosuppression and adverse events such as differentiation syndrome and QTc prolongation [16][20][25] 5. **MRD Negativity**: The minimal residual disease (MRD) negativity rates were 68% at a threshold of 0.1% and 44% at 0.01% in newly diagnosed patients, indicating deepening responses over time [12][61] 6. **Clinical Development Plans**: Kura Oncology is committed to further developing ziftomenib in combination therapies and has a robust clinical development plan, including the ongoing COMET-017 trial [28][29] Additional Important Insights 1. **Patient Demographics**: The median age of patients in the studies was around 75 years, with a significant portion being older and unfit for intensive therapies [8][19] 2. **Long-term Treatment**: The combination therapy allows for prolonged treatment without significant dose reductions, which is crucial for maintaining response and preventing relapse [72][78] 3. **Comparative Efficacy**: The data suggests that ziftomenib may offer enhanced efficacy compared to other menin inhibitors, particularly in terms of MRD negativity and durability of response [40][61] 4. **Future Directions**: Kura Oncology aims to be the first approved menin inhibitor in the newly diagnosed setting, with ongoing trials designed to evaluate the effectiveness of ziftomenib in various patient populations [30][29] Conclusion Kura Oncology's ziftomenib demonstrates significant promise in treating AML, particularly in combination with established therapies. The favorable safety profile and high response rates position it as a potential leader in the evolving landscape of AML treatment. The company is focused on advancing its clinical trials to solidify its role in frontline therapy for AML patients.

Core Insights - Arcellx Inc. presented new data from its pivotal Phase 2 iMMagine-1 study of anitocabtagene autoleucel (anito-cel) for relapsed or refractory multiple myeloma at the 2025 ASH Annual Meeting [1][2] Data Summary - The study included 117 patients with a median follow-up of 15.9 months, all receiving a single infusion of anito-cel at a target dose of 115×10^6 CAR+ viable T cells [2] - The overall response rate (ORR) was 96% (112/117), with a complete response/stringent complete response (CR/sCR) rate of 74% (86/117) and a very good partial response or higher (≥VGPR) rate of 88% (103/117) [3] - Among those evaluable for minimal residual disease (MRD) testing, 95% (91/96) achieved overall MRD negativity, and 83% (54/65) sustained MRD negativity for over 6 months [3] Survival Rates - Six-month progression-free survival (PFS) and overall survival (OS) rates were 93.1% and 95.7%, respectively, with median PFS and OS not yet reached [4] - Twelve-month PFS and OS rates were 82.1% and 94.0%, while 18-month rates were 67.4% and 88.0%, and 24-month rates were 61.7% and 83.0% [7] Safety Profile - No delayed or non-ICANS neurotoxicities have been observed in patients dosed more than 12 months ago, including no cases of Parkinsonism or Guillain-Barré syndrome [4] Commercial Outlook - The company anticipates the commercial launch of anito-cel in 2026 [4] Analyst Commentary - Analysts from William Blair and Needham expressed confidence in anito-cel's best-in-class profile and reiterated a Buy rating for Arcellx, maintaining a price target of $105 [5] - Arcellx shares increased by 10.12% to $76.59 at the time of publication [5]

Core Viewpoint - Fulcrum Therapeutics Inc. is experiencing a significant stock surge following the release of promising initial results from the 20 mg dose cohort of the Phase 1b PIONEER trial for pociredir in treating sickle cell disease [1][2]. Group 1: Trial Results - The mean absolute fetal hemoglobin (HbF) increased by 9.9% at six weeks of treatment with pociredir, rising from a baseline of 7.1% to 16.9% [3]. - At the data cutoff on November 11, 2025, 58% of patients (7 out of 12) achieved absolute HbF levels of ≥20% at week six, with all patients showing a robust increase in HbF [3][4]. - A clear dose-response was observed, with a >3.75-fold mean induction of HbF at week 12 among patients in the 20 mg cohort, compared to a 2.4-fold mean induction in the 12 mg cohort [5]. Group 2: Safety and Efficacy - The proportion of F-cells (HbF-containing red blood cells) increased from a mean of 31% at baseline to 58% at week six, indicating early progression toward pan-cellular HbF induction [6]. - The safety profile in the 20 mg dose cohort remained consistent with previously reported safety data from the 12 mg cohort [6]. Group 3: Analyst Ratings and Stock Performance - HC Wainwright maintains a Buy rating and raises the price forecast from $18 to $25, while Piper Sandler reiterates an Overweight rating and raises the forecast from $16 to $23 [7]. - Cantor Fitzgerald also maintains an Overweight rating, increasing the price forecast from $15 to $24, and RBC Capital raises its forecast from $7 to $10 while maintaining a Sector Perform rating [7]. - Fulcrum Therapeutics stock is up 9.66% at $14.21 at the time of publication [7].

SAN FRANCISCO, Dec. 08, 2025 (GLOBE NEWSWIRE) -- Global plaintiffs’ rights law firm Hagens Berman reminds investors of the December 8, 2025, deadline to move the Court for appointment as lead plaintiff in the securities class action lawsuit filed against aTyr Pharma, Inc. (NASDAQ: ATYR). The litigation follows a catastrophic 83% single-day stock collapse after the company’s flagship drug trial failed to meet its primary endpoint. The lawsuit alleges that aTyr and its executives provided materially false and ...