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Sera Prognostics: PreTRM Labor Test Should Represent Advance In Risk Assessment
Seeking Alpha· 2025-06-30 15:57
Preterm birth is defined as occurring before 37 weeks of gestation, and it has a US prevalence of 10% . Three percent of preterm births are early preterm, between 20-34 weeks gestation. As shown below, preterm births are associatedAnalyst’s Disclosure:I/we have a beneficial long position in the shares of SERA either through stock ownership, options, or other derivatives. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I h ...
Alzheimer's Setback Hits INmune Bio Stock, But FDA Hopes Remain
Benzinga· 2025-06-30 15:52
Core Insights - INmune Bio Inc. is experiencing a significant decline in stock price, trading down 59% at $2.14, with a session volume of 23.2 million shares compared to an average of 1.45 million shares [1][5] - The company announced results from its Phase 2 MINDFuL trial for XPro, a selective soluble TNF inhibitor aimed at early Alzheimer's Disease, which showed cognitive benefits in a specific subpopulation despite not meeting the primary endpoint in the modified intent-to-treat population [2][4] Trial Results - The MINDFuL trial enrolled 208 participants, with the primary endpoint being the change in cognition over 6 months measured by the Early Mild Alzheimer's Cognitive Composite (EMACC) [3] - Although the primary endpoint was not met in the mITT group, significant benefits were observed in a subpopulation of patients with two or more biomarkers of inflammation [4] - Key findings indicated a cognitive benefit for XPro over placebo on the primary endpoint EMACC (effect size: 0.27) and a behavioral benefit on the Neuropsychiatric Inventory (effect size: -0.24) [5] Future Plans - The company plans to file for Breakthrough Therapy Designation with the FDA and schedule an End-of-Phase 2 meeting in Q4 2025 to discuss the path for a pivotal trial to support XPro's approval in early Alzheimer's Disease [5] - INmune Bio announced a registered direct offering of 3 million shares at $6.30 per share, aiming for approximately $19 million in gross proceeds to be used for working capital and general corporate purposes [4][5]
Are Investors Undervaluing Catalyst Pharmaceuticals (CPRX) Right Now?
ZACKS· 2025-06-30 14:40
The proven Zacks Rank system focuses on earnings estimates and estimate revisions to find winning stocks. Nevertheless, we know that our readers all have their own perspectives, so we are always looking at the latest trends in value, growth, and momentum to find strong picks.Looking at the history of these trends, perhaps none is more beloved than value investing. This strategy simply looks to identify companies that are being undervalued by the broader market. Value investors use tried-and-true metrics and ...
嘉和生物-B(06998.HK):被许可人于其许可引入的新型T细胞衔接器用于自身免疫性疾病临床评估方面取得进展
Ge Long Hui· 2025-06-30 14:19
Core Insights - Candid Therapeutics, Inc. has made progress in clinical evaluation of GB261, a novel T cell engager for autoimmune diseases, with the first patients receiving treatment and showing good tolerance [1] - The subcutaneous formulation of GB261 has been established, which is a bispecific antibody targeting CD20 on B cells and CD3 on T cells, designed to mediate T cell cytotoxicity against CD20-expressing B cells [1] - GB261 has a low affinity for CD3, reducing the risk of T cell overactivation while maintaining effective and selective B cell clearance [1] Company Overview - Candid Therapeutics, Inc. is a clinical-stage biotechnology company focused on transforming treatment methods for autoimmune and inflammatory diseases through its novel T cell engager platform [2] - The company has granted a global exclusive license to TRC 2004, Inc. for the development and commercialization of GB261, excluding mainland China, Hong Kong, Macau, and Taiwan [2] - Following the merger of Candid Therapeutics, Inc. and TRC 2004, Inc. in August 2024, the rights will be transferred to Candid Therapeutics, which is led by an experienced management team including CEO Dr. Ken Song [2]
Bio-Techne's New USP Deal on mAb and Gene Therapy May Boost Its Stock
ZACKS· 2025-06-30 13:50
Company Overview - Bio-Techne Corp. (TECH) has entered into a distribution agreement with the U.S. Pharmacopeia (USP) to sell USP monoclonal antibody (mAb) and recombinant adeno-associated virus (AAV) reference standards alongside its analytical solutions, including the Maurice system, to support global monoclonal antibody and gene therapy development [1][8] - The company has a market capitalization of $8.13 billion and an earnings yield of 3.6%, which is significantly better than the industry's -28.4% yield [4] Recent Developments - The partnership with USP is seen as a significant milestone in advancing Bio-Techne's efforts to provide innovative tools and solutions to the scientific community [2] - Bio-Techne's tools enable efficient and integrated analysis of complex biologics from development to product release, addressing analytical challenges in mAb and gene therapy development [8][6] Market Context - The global monoclonal antibody therapeutics market was valued at $222.6 billion in 2023 and is expected to grow at a compound annual growth rate of 14.5% through 2029, driven by advancements in biotechnology and genetic engineering [10] - The need for consistent mAb quality is increasing as patent protections expire and biosimilar versions become available, necessitating thorough testing of critical quality attributes throughout the development and manufacturing processes [5] Stock Performance - Following the announcement of the partnership, Bio-Techne shares dipped 0.1%, closing at $51.84, but the collaboration is expected to positively influence market sentiment towards TECH stock [3] - Over the past three months, TECH shares have declined 11.6%, while the industry has seen a smaller decline of 2.7% [12]
今年已有9家公司以“18C”规则递表,数量超此前总和
Mei Ri Jing Ji Xin Wen· 2025-06-30 13:41
Core Viewpoint - The implementation of innovative IPO policies and the strengthening of the Hong Kong stock market have accelerated the process for unprofitable companies to go public under the "18A" and "18C" listing rules since 2025 [1][2]. Group 1: IPO Trends - Since 2025, a total of 9 companies have submitted applications to the Hong Kong Stock Exchange under the "18C" listing rule, with 5 of these companies applying after the launch of the "Special Line for Science and Technology Companies" in May 2025 [1][2]. - A total of 18 companies have submitted applications under the "18A" listing rule since 2025, with the number for the entire year expected to surpass the 20 companies that applied in 2024 [1][2]. Group 2: Company Characteristics - The 9 companies applying under the "18C" rule are primarily from the fields of artificial intelligence and robotics, each with unique characteristics [3]. - For instance, Chengtai Technology is the largest supplier of forward-looking millimeter-wave radar in China, while Yunjike Technology is a leading provider of robotic service agents in the hotel sector [3]. Group 3: Market Environment - The Hong Kong market is noted for its strong inclusivity and maturity, which contrasts with the A-share market's previously unpredictable stance on unprofitable companies [4]. - The A-share IPO market is gradually increasing its tolerance for unprofitable companies, as indicated by recent policy changes from the China Securities Regulatory Commission [4]. Group 4: Impact of Policy Innovations - The recent IPO policy innovations in Hong Kong have created a more flexible and diverse listing environment, particularly benefiting innovative pharmaceutical companies that are still in the R&D phase [6]. - The introduction of the "Special Line for Science and Technology Companies" allows companies to submit listing applications confidentially, protecting their commercial secrets and facilitating the listing preparation process [6]. Group 5: Market Performance - As of June 25, 2025, the Hang Seng Index has risen approximately 20% since the beginning of the year, with over 80% of the 72 listed "18A" companies experiencing an increase in their stock prices [7]. - The positive performance in the secondary market has boosted investor confidence, attracting overseas capital into the Hong Kong stock market [7].
Clearmind Medicine Announces First Participant Ever Dosed with its CMND-100 Treatment in Groundbreaking Clinical Trial for Alcohol Use Disorder
Globenewswire· 2025-06-30 13:16
Vancouver, Canada, June 30, 2025 (GLOBE NEWSWIRE) -- Clearmind Medicine Inc. (Nasdaq: CMND), (FSE: CWY0) (“Clearmind” or the "Company"), a clinical-stage biotech company focused on discovery and development of novel psychedelic-derived therapeutics to solve major under-treated health problems, today announced a historic milestone: the first participant has been dosed with CMND-100, its proprietary MEAI-based oral drug candidate, in its Phase I/IIa clinical trial for the treatment of Alcohol Use Disorder (AU ...
Senti Bio Participates in Nasdaq Amplify Spotlight Series
Globenewswire· 2025-06-30 13:15
Core Insights - Senti Biosciences, Inc. is a clinical-stage biotechnology company focused on developing next-generation cell and gene therapies using its proprietary Gene Circuit platform [2][3] - The company's lead program, SENTI-202, is a first-in-class CAR NK cell therapy targeting hematologic malignancies, currently in a Phase 1 clinical trial with positive preliminary data [3] - SENTI-202 has received Orphan Drug Designation from the FDA for treating relapsed/refractory hematologic malignancies, including AML [3] Company Overview - Senti Bio aims to create new medicines for patients with incurable diseases by engineering Gene Circuits that can precisely target and kill cancer cells while sparing healthy cells [5] - The company's pipeline includes cell therapies designed to address challenging liquid and solid tumor indications, with Gene Circuits shown to work in both NK and T cells [5] - Senti Bio is also exploring the application of Gene Circuits in other diseases beyond oncology through partnerships [5]
July 14, 2025 Deadline: Contact The Gross Law Firm to Join Class Action Suit Against IOVA
Prnewswire· 2025-06-30 13:00
NEW YORK, June 30, 2025 /PRNewswire/ -- The Gross Law Firm issues the following notice to shareholders of Iovance Biotherapeutics, Inc. (NASDAQ: IOVA).Shareholders who purchased shares of IOVA 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/iovance-biotherapeutics-inc-loss-submission-form/?id=154634&from=4 CLASS PE ...
TuHURA Biosciences Completes Acquisition of Kineta
Prnewswire· 2025-06-30 12:50
Acquisition Overview - TuHURA Biosciences has successfully completed the acquisition of Kineta, Inc., which includes a novel VISTA inhibiting monoclonal antibody (mAb) now named TBS-2025, enhancing TuHURA's late-stage immuno-oncology pipeline [1][2] - The acquisition allows TuHURA to initiate a Phase 2 randomized trial for TBS-2025 in the second half of 2025 [1] Financial Details - The completion of the acquisition unlocks the fourth tranche of funds from a $12.5 million aggregate PIPE financing announced on June 3, 2025 [1] - Each share of Kineta common stock was converted into the right to receive 0.185298 shares of TuHURA common stock, totaling 2,868,169 shares [3] Product Development - TBS-2025 is positioned to overcome acquired resistance to cancer immunotherapy, particularly in patients with NPM1 mutated acute myeloid leukemia (AML) [2] - The drug is being investigated in combination with a menin inhibitor, aiming to improve response rates and reduce relapse in AML patients [2] Mechanism of Action - VISTA is a significant immune checkpoint expressed on myeloid cells, contributing to immunosuppression in the tumor microenvironment [5] - TBS-2025 is designed to block VISTA, potentially enhancing T cell function and improving treatment outcomes in cancer therapy [5][6] Clinical Trials - TBS-2025 has shown promising results in a Phase 1/2 trial, demonstrating good tolerance and over 90% receptor occupancy [7] - The drug is administered intravenously every two weeks and has been tested both as a monotherapy and in combination with pembrolizumab [6][7] Company Background - TuHURA Biosciences focuses on developing technologies to address primary and acquired resistance to cancer immunotherapy [8] - The company is also working on bi-specific antibody drug conjugates targeting myeloid derived suppressor cells to enhance immune response [10]