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Athira Pharma (NasdaqGS:ATHA) Earnings Call Presentation
2025-12-18 13:30
Lasofoxifene (Metastatic Breast Cancer) - The global metastatic ER+/HER2- breast cancer market is expected to grow from approximately $10.9 billion in 2025 to roughly $15.9 billion by 2029[23] - Lasofoxifene, combined with abemaciclib, demonstrated a potential best-in-class median Progression-Free Survival (PFS) of 13 months in a heavily pre-treated mESR1 population in the Phase 2 ELAINE-2 trial[26, 27, 50] - In the ELAINE-1 Phase 2 study, lasofoxifene delivered a median PFS of 24.2 weeks compared to 16.2 weeks with fulvestrant in ESR1-mutant breast cancer[48] - Approximately 70% of all breast cancers are ER+/HER2- subtype[23, 32] - Lasofoxifene reduced new onset breast cancer by 83% in a large prevention trial[30] - The ELAINE-3 registrational Phase 3 trial is ongoing, with topline results expected in mid-2027 and over 50% enrollment[16, 17, 57, 138, 139] - Assuming approximately 10% market penetration, lasofoxifene has a peak market sale potential of over $1 billion in the US market[81] ATH-1105 (ALS) - Approximately 225,000 people globally are affected by ALS, with roughly 33,000 cases in the US[98] - ATH-1105 is a CNS-penetrant positive modulator of HGF as a potential treatment for ALS[103] - A Phase 2 POC study in ALS is planned to start in the first half of 2026, with topline results expected in 2027[18, 19, 140, 141] Financial - A PIPE financing of up to $236 million, including $90 million upfront, provides cash runway through data readout and into 2028[137]
Trump says Americans need to prepare for something the US ‘has never seen.’ How to get ready (and wealthy) in 2026
Yahoo Finance· 2025-12-18 13:13
Investment Announcements - Apple has announced a $600 billion investment in U.S. manufacturing and workforce training [1] - Johnson & Johnson plans to invest $55 billion in U.S. manufacturing, research and development, and new technologies [1] - Hyundai is investing $26 billion in the U.S. to enhance automotive production capacity and localize key components [1] - Toyota has announced plans to invest up to $10 billion in its U.S. operations over the next five years [4] Economic Outlook - Despite criticism of Trump's tariff policies, major companies continue to view the U.S. as a reliable place for investment, indicating strong confidence in the U.S. market [2] - The manufacturing sector has not yet seen a boom, with U.S. manufacturing activity contracting for the ninth consecutive month in November [3] - Trump claims that the return of factories from countries like Germany, Japan, and Canada is driven by companies wanting to avoid tariffs, leading to significant capital investments [3] Industry Trends - The auto industry is highlighted as a key sector experiencing a revival due to tariff policies, with companies returning to the U.S. for production [4][5] - Trump asserts that the U.S. is on the verge of unprecedented economic growth, attributing this to his tariff policy [5]
Revolution Medicines Announces First Patient Randomized in the RASolute 304 Clinical Trial of Daraxonrasib in Resectable Pancreatic Ductal Adenocarcinoma Following Adjuvant Chemotherapy
Globenewswire· 2025-12-18 13:00
REDWOOD CITY, Calif., Dec. 18, 2025 (GLOBE NEWSWIRE) -- Revolution Medicines, a late-stage clinical oncology company developing targeted therapies for patients with RAS-addicted cancers, today announced the first patient has been randomized in the RASolute 304 trial. RASolute 304 is a global, open-label, Phase 3 clinical trial evaluating the safety and efficacy of daraxonrasib, a RAS(ON) multi-selective inhibitor, in patients with resectable pancreatic ductal adenocarcinoma (PDAC) who have received surgery ...
Nutriband Inc. Signs Letter of Intent with Qvanta Group of Companies to Explore Advanced Technology Solutions for Abuse-Deterrent Pharmaceutical Innovation Strategic Exploration
Globenewswire· 2025-12-18 13:00
The LOI Aligns with Federal Priorities on Fentanyl Crisis, Artificial Intelligence, and Quantum TechnologyORLANDO, Fla., Dec. 18, 2025 (GLOBE NEWSWIRE) -- Nutriband Inc. (NASDAQ: NTRB) (NASDAQ: NTRBW) ("Nutriband" or the "Company"), a developer of transdermal pharmaceutical products including abuse-deterrent technologies, today announced the signing of a non-binding Letter of Intent ("LOI") with the Qvanta Group of Companies. The Qvanta Group comprises Qvanta LLC and its subsidiaries, Qvanta Foundry LLC and ...
Knight Therapeutics Announces Health Canada Approval for WYNZORA® to Treat Psoriasis Vulgaris
Globenewswire· 2025-12-18 12:30
MONTREAL, Dec. 18, 2025 (GLOBE NEWSWIRE) -- Knight Therapeutics Inc. (TSX: GUD) ("Knight"), a pan-American (ex-USA) specialty pharmaceutical company, announced today that Health Canada has approved WYNZORA®, a white uniform cream containing 0.05 mg/g of calcipotriol (CAL) and 0.5 mg/g of betamethasone dipropionate (BDP), indicated for the topical treatment of psoriasis vulgaris in adults and adolescents aged 12-17 years for up to 8 weeks.1 Knight obtained the Canadian rights to WYNZORA® through its June 202 ...
Eli Lilly Scores Another Major Win: Time to Buy?
Yahoo Finance· 2025-12-18 12:13
Key Points Eli Lilly's next-gen anti-obesity candidate hit it out of the park in a phase 3 study. This should help solidify the company's lead in this niche of the industry. Even after their strong run, Lilly's shares remain attractive at current levels. 10 stocks we like better than Eli Lilly › Can anyone stop Eli Lilly (NYSE: LLY)? The pharmaceutical leader has established itself as the leader in the fast-growing weight loss market. And although many other drugmakers are hot on its tail, Lilly ...
Better Buy in 2026: Novo Nordisk or Intuitive Surgical?
Yahoo Finance· 2025-12-18 12:05
Key Points Novo Nordisk's new indications for semaglutide and its attractive pipeline could allow it to bounce back. Intuitive Surgical should remain the leader in its niche despite increased competition. Both stocks could be long-term winners, and the choice today might depend on risk tolerance. 10 stocks we like better than Novo Nordisk › Novo Nordisk (NYSE: NVO) and Intuitive Surgical (NASDAQ: ISRG) are both healthcare leaders, but they operate in different corners of this vast sector. The for ...
Nutriband Differentiates Prescription Fentanyl from Illicit Fentanyl in Response to United States Executive Order Designating Fentanyl as a Weapon of Mass Destruction
Globenewswire· 2025-12-18 12:00
Prescription pharmaceutical transdermal fentanyl is a valuable treatment for management of pain in opioid-tolerant patients, severe enough to require daily, around-the-clock, long-term opioid treatment for which alternate treatment options are inadequate. Illicit fentanyl and its core precursor chemicals have been designated as weapons of mass destruction to enable the US government to combat the manufacture and distribution by cartels and foreign networks that have flooded the US with illegal fentanyl. Nut ...
Viatris Provides Pipeline Update on Four Regulatory Milestones
Prnewswire· 2025-12-18 11:59
Core Insights - Viatris Inc. has announced four significant regulatory milestones in its global pipeline, highlighting advancements in research and development throughout 2025 [1][6][14] Group 1: Regulatory Approvals - The U.S. FDA has approved the company's octreotide acetate for injectable suspension, a generic version of Sandostatin LAR Depot, for treating acromegaly and certain cancer-related symptoms [6][14] - This approval marks the fourth injectable FDA approval for Viatris in 2025, alongside iron sucrose, paclitaxel, and liposomal amphotericin B, showcasing the company's ability to navigate complex regulatory pathways [3][14] - The FDA has accepted the New Drug Application (NDA) for a low dose estrogen weekly patch for contraception, with a target action date of July 30, 2026 [6][14] Group 2: Pipeline Developments - The investigational low dose estrogen weekly patch is designed for women with a BMI below 30 kg/m², delivering approximately 150 mcg of norelgestromin and 17.5 mcg of ethinyl estradiol per day [4][7] - The planned 505(b)(2) NDA for the patch is supported by positive results from the Phase 3 Luminous Study, demonstrating a favorable efficacy and safety profile [5][14] - The U.S. FDA has cleared the Investigational New Drug (IND) application for MR-146, a gene therapy candidate for neurotrophic keratopathy, with plans to initiate a Phase 1/2 clinical trial in the first half of 2026 [6][9][14] Group 3: International Developments - The Japan Pharmaceuticals and Medical Devices Agency has accepted the Japanese New Drug Application (J-NDA) for pitolisant in obstructive sleep apnea syndrome, supported by positive Phase 3 data [6][11][14] - The Phase 3 trial for pitolisant showed statistically significant improvements in excessive daytime sleepiness compared to placebo, indicating its potential effectiveness [11][14]
Pfizer Plays Catchup In Obesity Market, Licenses Weight-loss Drug From Fosun
Benzinga· 2025-12-18 11:58
Core Insights - Pfizer has acquired global rights to an oral weight-loss drug from Fosun Pharma, aiming to enhance its position in the competitive weight management market [1][4] - The collaboration is potentially valued at over $2 billion, highlighting the growing interest in innovative medications developed in China, particularly GLP-1 drugs [5][12] Group 1: Licensing Deal Details - Fosun Pharma's subsidiary, Yao Pharma, has granted Pfizer an exclusive worldwide license for the oral GLP-1 receptor agonist YP05002, which is still in early-stage development [6][8] - The deal includes an upfront payment of $150 million, with additional potential payments of up to $350 million tied to clinical and commercial milestones, and sales-related payments that could total $1.59 billion, leading to a maximum deal value of approximately $2.09 billion [7][12] Group 2: Market Context and Competition - GLP-1 therapies have become a significant focus for global pharmaceutical companies, with Novo Nordisk's semaglutide generating $25.46 billion in sales and Eli Lilly's tirzepatide achieving $24.84 billion in sales in the first three quarters of 2025 [10] - The oral version of GLP-1 drugs, like YP05002, could offer advantages over injectables, potentially improving patient compliance due to convenience [11] Group 3: Fosun Pharma's Performance - Fosun Pharma reported an 18.09% increase in revenue from innovative drugs in the first three quarters, despite an overall revenue decline of 4.91% to 29.39 billion yuan ($4.17 billion) due to price pressures in China's drug procurement [14] - The partnership with Pfizer is seen as a significant milestone in Fosun Pharma's strategy for innovation and internationalization, potentially enhancing its global market presence [15] Group 4: Future Outlook - Fosun Pharma's focus on innovative drugs is expected to drive growth, as it continues to divest non-core assets and allocate resources to research and development [16] - The company's current price-to-earnings ratio of around 17 times suggests potential for multiple expansion compared to other established Chinese drugmakers [16]