Biopharmaceutical

Search documents
Ipsen receives positive CHMP opinion for Cabometyx® in previously treated advanced neuroendocrine tumors
Globenewswire· 2025-06-20 10:19
Core Viewpoint - Ipsen has received a positive opinion from the CHMP of the EMA for Cabometyx® (cabozantinib) for adult patients with unresectable or metastatic neuroendocrine tumors, based on the CABINET Phase III trial results, with a final decision expected soon [1][6]. Company Summary - Ipsen is a global biopharmaceutical company focused on oncology, rare diseases, and neuroscience, with nearly 100 years of development experience [11]. - The company has exclusive rights for the commercialization and clinical development of Cabometyx outside the U.S. and Japan, while Exelixis retains rights in the U.S. [8]. Industry Summary - The incidence of neuroendocrine tumors (NETs) is increasing, with a higher prevalence than pancreatic or bladder cancer, and treatment options are often limited upon disease progression [2]. - The CABINET Phase III trial demonstrated significant efficacy for Cabometyx, showing median progression-free survival (PFS) of 13.8 months for pNET patients compared to 4.4 months for placebo [7]. - For advanced gastrointestinal and lung NETs, the five-year survival rates are 68% and 55%, respectively, while advanced pNET has a poor prognosis with a five-year survival rate of only 23% [3].
Despite Fast-paced Momentum, Fortress Biotech (FBIO) Is Still a Bargain Stock
ZACKS· 2025-06-19 13:51
Group 1: Momentum Investing Overview - Momentum investing deviates from the traditional strategy of "buying low and selling high," focusing instead on "buying high and selling higher" for quicker profits [1] - Fast-moving trending stocks can be challenging to enter at the right time, as they may lose momentum if future growth does not justify their high valuations [2] Group 2: Investment Strategy - A safer investment approach involves targeting bargain stocks that exhibit recent price momentum, utilizing tools like the Zacks Momentum Style Score to identify promising candidates [3] - Fortress Biotech (FBIO) is highlighted as a strong candidate, showing a price increase of 6.5% over the past four weeks, indicating growing investor interest [4] Group 3: Fortress Biotech (FBIO) Performance - FBIO has demonstrated a 7.7% price gain over the past 12 weeks, with a beta of 1.76, suggesting it moves 76% more than the market [5] - The stock has a Momentum Score of A, indicating a favorable entry point for investors looking to capitalize on its momentum [6] Group 4: Earnings Estimates and Valuation - FBIO's upward trend in earnings estimate revisions has earned it a Zacks Rank 2 (Buy), which is associated with strong momentum effects [7] - The stock is currently trading at a Price-to-Sales ratio of 0.93, suggesting it is undervalued, as investors pay only 93 cents for each dollar of sales [7] Group 5: Additional Opportunities - Besides FBIO, there are other stocks that meet the criteria of the 'Fast-Paced Momentum at a Bargain' screen, presenting further investment opportunities [8] - Investors can explore over 45 Zacks Premium Screens tailored to different investing styles to identify potential winning stocks [9]
AlloVir (ALVR) Earnings Call Presentation
2025-06-19 13:33
Company Overview June 2025 1 Forward-Looking Statements & Disclaimer This presentation contains "forward-looking statements" within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and Section 21E of the Securities Exchange Act of 1934, as amended, that involve substantial risk and uncertainties. All statements, other than statements of historical fact, contained in this presentation, including statements regarding the strategy, future operations, future financial position, projected ...
BridgeBio Pharma (BBIO) Earnings Call Presentation
2025-06-19 13:29
Corporate Presentation April 29th, 2025 Forward Looking Statements and Disclaimer The presentation contains forward-looking statements. Statements made or presented may include statements that are not historical facts and are considered forward-looking 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. Words such as "believe," "anticipate," "plan," "expect," "intend," "will," "may," "goal," "potential," "should," " ...
大阪世博会“广东活动周”6月下旬举办,聚焦产业投资推介
2 1 Shi Ji Jing Ji Bao Dao· 2025-06-19 10:45
据悉,广东活动周开幕式、粤港澳大湾区投资环境推介暨中日大健康产业对接会两场大型活动将在"广 东活动周"举行。在对接会上,将有300多名中日企业代表与会共商合作,就大健康、智能制造等领域进 行对接交流。会上还将举办广州、韶关、中山、阳江等重点城市专题推介活动,面向日本工商界代表, 介绍当地营商环境、优惠政策和重点园区,促进产业对接和投资合作,推动共赢发展。 2025年日本大阪世博会中国馆广东活动周将于6月27至29日在日本大阪世博会中国馆举行。 南方财经记者谭海燕 广州报道 6月19日,在"2025年日本大阪世博会中国馆广东活动周"新闻发布会上,广东省贸促会副会长谢惠蓉介 绍,为期三天的"广东活动周"将突出岭南地方特色和文化特点,围绕"绿美广东,智创未来"主题,举办 一系列经贸、文化、科技交流活动。 另一方面,开展"南粤之窗"国际文化交流系列活动,英歌舞、粤剧、广东音乐、醒狮等广东的非遗民俗 精品将到世博舞台进行全方位展示。通过舞蹈、武术、音乐等形式,创新结合多种表演方式,全面呈现 广东民俗文化的内涵和价值,向世界展示展现传统与现代交融的岭南文化新活力。 南方财经记者了解到,广东共有11个地市组织经贸代表团参加 ...
Addex Therapeutics Reports Q1 2025 Financial Results and Provides Corporate Update
Globenewswire· 2025-06-19 05:00
Core Viewpoint - Addex Therapeutics reported a strong start to 2025 with significant progress in product development and business milestones, particularly in their GABAB PAM drug candidate for chronic cough and regained rights to their Phase 2 mGlu2 PAM asset, ADX71149 [2][5]. Financial Summary - Income for Q1 2025 was CHF 71,000, a decrease of CHF 164,000 from CHF 235,000 in Q1 2024 [4]. - R&D expenses decreased to CHF 156,000 from CHF 245,000, a reduction of CHF 89,000 [4][8]. - G&A expenses decreased to CHF 521,000 from CHF 778,000, a reduction of CHF 257,000 [4][8]. - Total operating loss improved to CHF 606,000 from CHF 788,000, an improvement of CHF 182,000 [4]. - Net loss from continuing operations was CHF 1,473,000, compared to CHF 735,000 in Q1 2024, an increase of CHF 738,000 [4]. - Net loss for the period decreased to CHF 1,473,000 from CHF 3,087,000, a reduction of CHF 1,614,000 [4][9]. - Basic and diluted net loss per share was CHF 0.01, down from CHF 0.03 in the same period last year [4][10]. - Cash and cash equivalents increased to CHF 2.8 million from CHF 1.6 million, an increase of CHF 1.2 million [4][11]. - Shareholders' equity improved significantly to CHF 8.3 million from a negative CHF 1.4 million [4]. Operational Highlights - The GABAB PAM chronic cough candidate demonstrated robust anti-tussive activity in multiple disease models [5][6]. - The company regained rights to its Phase 2 mGlu2 PAM asset, ADX71149 [5][6]. - Indivior successfully advanced their GABAB PAM program for substance use disorders through IND enabling studies [5][6]. - An option agreement was entered with Sinntaxis for exclusive licensing of intellectual property related to mGlu5 NAM in brain injury recovery [5][6].
Nuvalent Appoints Christy Oliger to Board of Directors
Prnewswire· 2025-06-18 20:30
CAMBRIDGE, Mass., June 18, 2025 /PRNewswire/ -- Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced the appointment of Christy Oliger to its Board of Directors."Christy's proven success in delivering new therapies to patients living with cancer strengthens our Board as we evolve from a development-stage company toward potential commercialization," said James Porter, Ph.D., C ...
Cellectar Biosciences Announces One-for-Thirty Reverse Stock Split
GlobeNewswire News Room· 2025-06-18 20:30
Core Viewpoint - Cellectar Biosciences, Inc. announced a one-for-thirty reverse stock split effective June 24, 2025, aimed at consolidating shares to potentially enhance stock performance and meet listing requirements on Nasdaq [1][2]. Company Overview - Cellectar Biosciences is a late-stage clinical biopharmaceutical company focused on developing drugs for cancer treatment, utilizing its proprietary Phospholipid Drug Conjugate™ (PDC) delivery platform [7]. Reverse Stock Split Details - The reverse stock split was approved by stockholders on June 13, 2025, reducing the number of shares from approximately 54.36 million to about 1.81 million [2]. - Each stockholder's percentage ownership will remain unchanged, except for fractional shares, which will be compensated in cash [3]. - The reverse stock split will proportionately affect the number of shares available under equity incentive plans and adjust the terms of outstanding stock options and warrants accordingly [4]. Administrative Aspects - Equiniti Trust Company, LLC will act as the transfer agent for the reverse stock split, managing the issuance of post-split shares without requiring action from stockholders [5]. - Additional information regarding the reverse stock split is available in the company's definitive proxy statement filed with the SEC [6]. Product Pipeline - Cellectar's product pipeline includes iopofosine I 131, which has received Breakthrough Therapy Designation from the FDA, and other programs targeting various solid tumors [8][10]. - The company is also developing CLR 121225 and CLR 121125, targeting significant unmet needs in cancer treatment [8][9].
Annexon Bolsters Ophthalmology Expertise with Appointment of Retina Specialist Lloyd Clark, M.D., as Pivotal ANX007 Program Advances in Dry Age-Related Macular Degeneration (AMD) with Geographic Atrophy (GA)
Globenewswire· 2025-06-18 20:05
Core Insights - Annexon, Inc. has appointed Dr. Lloyd Clark as senior vice president of ophthalmology strategy and innovation, bringing over 25 years of experience in retina diseases and drug development [1][3] - The investigational therapy ANX007 is the only treatment shown to significantly preserve vision and central retinal photoreceptors in patients with dry age-related macular degeneration (AMD) with geographic atrophy (GA) [2][3] - The Phase 3 ARCHER II trial for ANX007 is expected to complete enrollment by Q3 2025, with topline data anticipated in the second half of 2026 [2][6] Company Overview - Annexon, Inc. focuses on developing novel therapies for neuroinflammatory diseases, targeting the classical complement pathway to prevent tissue damage [7] - The company aims to address significant unmet needs in the treatment of neurodegenerative and ophthalmic diseases, with a pipeline that includes investigational drug candidates for over 8 million patients globally [7] Product Details - ANX007 is designed to block C1q locally in the eye and is currently being evaluated in the pivotal Phase 3 ARCHER II trial, which will enroll approximately 630 patients [2][6] - The primary endpoint of the ARCHER II trial is to prevent a ≥15-letter loss in best corrected visual acuity (BCVA), a well-established functional endpoint for ophthalmology drug approvals [6] Market Context - Dry AMD with GA is a leading cause of blindness affecting over 8 million patients worldwide, with no approved therapies currently available to preserve vision [2][4] - The addition of Dr. Clark to the Annexon team is seen as a strategic move to enhance the company's position in the retina community and improve treatment options for patients with dry AMD [3]
Why Scholar Rock Shares Are Soaring Today
The Motley Fool· 2025-06-18 17:41
Shares of Scholar Rock Holding (SRRK 14.77%) are soaring today, up 13.7% as of 1:14 p.m. ET. The move comes as the S&P 500 and Nasdaq Composite were up modestly.Scholar Rock, a biopharma company, reported positive results from a phase 2 trial of its muscle-preserving weight-loss therapy.Significant resultsThe study evaluated Scholar Rock's apitegromab in combination with Eli Lilly's blockbuster weight-loss drug tirzepatide (sold as Mounjaro and Zepbound). The combo showed a significant reduction in lean mas ...