Keytruda (pembrolizumab)
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Pfizer, Astellas Report Positive Phase 3 Trial Results for PADCEV Combination in Bladder Cancer Treatment
Yahoo Finance· 2026-01-08 14:13
Pfizer Inc. (NYSE:PFE) is one of the most buzzing stocks to invest in according to hedge funds. Earlier on December 17, Astellas Pharma and Pfizer Inc. (NYSE:PFE) announced positive topline results from the Phase 3 EV-304 clinical trial (also called KEYNOTE-B15). This study showed that the combination of PADCEV (enfortumab vedotin) and Keytruda (pembrolizumab) improves survival outcomes for patients with muscle-invasive bladder cancer/MIBC who are eligible for cisplatin-based chemotherapy. Used as a peri ...
Revamping best-selling drugs to combat patent cliff has limits
Yahoo Finance· 2025-12-29 11:00
As the looming patent cliff approaches, some major blockbuster drugs are set to lose their exclusivity, with pharma companies making moves to try and reduce the impact. Patent expiry is a phenomenon that haunts every pharmaceutical company, with the loss of market exclusivity often causing a dramatic dip in a company’s profits. This can be particularly challenging for companies whose drug is one of their best-sellers – having the potential to wipe billions from revenue figures. With a particularly large ...
BofA Trims Pfizer (PFE) PT as COVID-19 Sales Slide and Obesity Focus Shifts to Metsera
Yahoo Finance· 2025-12-25 08:11
Pfizer Inc. (NYSE:PFE) is one of the best high volume stocks to buy right now. On December 16, Bank of America analyst Jason Gerberry lowered the firm’s price target on Pfizer to $27 from $28 while keeping a Neutral rating on the shares. Pfizer’s 2026 guidance revealed a steeper erosion of its COVID-19 franchise than previously projected, leading the firm to trim its near-term financial forecasts. The focus has now shifted to the company’s obesity strategy; investors are awaiting trial results from the rec ...
Analysts Sound Alarm On Pyxis Oncology's Tiny Trial
Benzinga· 2025-12-19 14:07
Pyxis Oncology Inc. (NASDAQ:PYXS) on Thursday released preliminary data from its ongoing Phase 1 studies of micvotabart pelidotin (MICVO) for recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC).The update includes preliminary data from both the Phase 1 monotherapy study in second line (2L+) R/M HNSCC and the Phase 1/2 study evaluating MICVO in combination with Merck & Co. Inc.’s (NYSE:MRK) Keytruda (pembrolizumab), in (first and second line) 1L/2L+ R/M HNSCC.The data reported below reflec ...
FDA Grants Fast Track Designation to ADAG's Colorectal Cancer Drug
ZACKS· 2025-12-17 14:46
Core Insights - Adagene Inc. (ADAG) received Fast Track designation from the FDA for its lead immuno-oncology candidate, muzastotug (ADG126), in combination with Merck's Keytruda for treating adult patients with microsatellite-stable metastatic colorectal cancer (MSS mCRC) without active liver metastases [1][6] - Following the announcement, ADAG shares increased by 13.8% [1][7] - The Fast Track designation aims to expedite the development and review of therapies for serious diseases with unmet medical needs [2] Company Overview - Muzastotug is a next-generation anti-CTLA-4 antibody developed using proprietary SAFEbody masking technology, which may improve survival and quality of life compared to conventional therapies [5][7] - The ongoing phase II study has primary and secondary endpoints focused on overall response rate, duration of response, progression-free survival, and overall survival [6][8] - A phase III study is planned to start in 2027, contingent on continued positive clinical results [8] Market Performance - Over the past year, ADAG's shares have declined by 6.9%, contrasting with a 16.3% rise in the industry [4] - The Fast Track designation allows for more frequent interactions with the FDA and potential rolling reviews of future marketing applications [8]
Inhibrx Biosciences Provides Progress Updates on the INBRX-106 Program and the Expansion Cohorts of the ozekibart (INBRX-109) Program
Prnewswire· 2025-12-16 22:00
® SAN DIEGO, Dec. 16, 2025 /PRNewswire/ -- Inhibrx Biosciences, Inc. (Nasdaq: INBX) ("Inhibrx" or the "Company"), a clinical-stage biopharmaceutical company focused on developing therapeutics for oncology today announced an update on the INBRX-106 Phase 2/3 clinical trial in combination with Keytruda (pembrolizumab) as a first-line treatment for patients with locally advanced unresectable or metastatic head and neck squamous cell carcinoma (HNSCC) and the Phase 1/2 trial evaluating patients with checkpoint ...
Pliant Cancer Drug Boosts Responses When Paired With Merck's Blockbuster Keytruda In Tough-To-Treat Tumors
Benzinga· 2025-12-04 18:53
Core Viewpoint - Pliant Therapeutics is gaining attention due to promising interim trial results for its cancer therapy, PLN-101095, despite a significant decline in its stock price [1][8]. Group 1: Trial Results - Pliant Therapeutics released interim data from its Phase 1 dose escalation trial of PLN-101095, which was evaluated in combination with Merck's Keytruda for patients with immune checkpoint inhibitor-refractory advanced or metastatic solid tumors [2]. - In a heavily pretreated patient population, PLN-101095 demonstrated antitumor activity, with four responders identified, including one confirmed complete response and three partial responses [3][4]. - Clinical responses were observed in various cancer types, including cholangiocarcinoma, melanoma, head and neck squamous cell carcinoma, and non-small cell lung cancer [4]. Group 2: Patient Outcomes - The median time on treatment for patients was 15 months, with 60% of secondary refractory patients showing stable disease or tumor reduction [5]. - All responding patients exhibited significant increases in plasma interferon gamma (IFN-γ) levels after a 14-day monotherapy run-in period, while non-responders did not show meaningful increases [5]. Group 3: Safety and Future Plans - PLN-101095 was generally well tolerated across all tested doses and exhibited a dose-dependent pharmacokinetic profile [6]. - Pliant plans to accelerate the development of PLN-101095 with a Phase 1b indication expansion trial set to begin in 2026, focusing on non-small cell lung cancer and other tumor types [7].
AIM ImmunoTech to Participate in Live ‘Fireside' Chat on Virtual Investor Closing Bell Series
Globenewswire· 2025-12-01 13:55
Core Insights - AIM ImmunoTech will participate in the Virtual Investor Closing Bell Series on December 4, 2025, featuring CEO Thomas K. Equels [1] - The discussion will focus on AIM's clinical and regulatory strategy for its lead drug Ampligen, particularly the DURIPANC clinical trial in collaboration with AstraZeneca for metastatic pancreatic cancer [2] - The importance of a completed Phase 2 clinical trial with Merck, showing the combination of Ampligen and Keytruda was well-tolerated and beneficial for advanced recurrent ovarian cancer, will also be highlighted [2] Company Overview - AIM ImmunoTech Inc. is an immuno-pharma company dedicated to developing therapeutics for various cancers, immune disorders, and viral diseases, including COVID-19 [4] - The company's lead product, Ampligen (rintatolimod), is a first-in-class investigational drug that acts as a dsRNA and highly selective TLR3 agonist immuno-modulator [4]
Eli Lilly flies the pharma flag in tech-heavy $1tn market cap club
Yahoo Finance· 2025-11-24 16:59
Core Insights - Eli Lilly has achieved a market capitalisation of $1 trillion, becoming the first healthcare company to reach this milestone, previously dominated by technology firms [1][2] - The surge in Eli Lilly's market value is primarily driven by the unprecedented demand for its weight loss drugs, particularly tirzepatide [1][4] Financial Performance - Eli Lilly's share price closed at $1,059.70 on November 21, reflecting a 27% increase since January 2025, although it slightly retreated to $1,056.77 by November 24 [2] - The S&P 500 pharmaceutical index has risen by 19% since the beginning of September, indicating a growing investor interest in pharmaceutical stocks [3] Product Success - Tirzepatide, marketed as Zepbound and Mounjaro, has significantly contributed to Eli Lilly's success, with Mounjaro generating $6.5 billion in Q3 2025, a 109% increase from Q3 2024, and Zepbound achieving $3.6 billion, up 185% from the same period [4][5] - GlobalData forecasts that the combined sales of Zepbound and Mounjaro will reach $64 billion by 2031 [5] Competitive Landscape - Tirzepatide's growth has positioned Eli Lilly ahead of its main competitor, Novo Nordisk, which has seen a decline in share prices despite being first to market with semaglutide [6] - Tirzepatide's dual-action mechanism offers better efficacy compared to semaglutide, contributing to its market success [6] - The sales performance of tirzepatide has surpassed that of MSD's Keytruda, which has been the top-selling drug globally in recent years [7]
PDS Biotech Reports Third Quarter 2025 Financial Results and Provides Clinical Programs Update
Globenewswire· 2025-11-13 12:30
Core Viewpoint - PDS Biotechnology Corporation has completed the VERSATILE-002 Phase 2 trial for PDS0101 in combination with pembrolizumab, showing promising results that lead the company to seek an expedited approval pathway in the ongoing VERSATILE-003 Phase 3 trial [1][2][3]. Clinical Update - The VERSATILE-002 trial demonstrated a median overall survival (mOS) of 39.3 months for patients with CPS ≥ 1, with a 95% confidence interval lower limit of 23.9 months [4]. - Progression-free survival (PFS) was reported at 6.3 months for the same patient group [4]. - The company plans to amend the ongoing VERSATILE-003 trial to potentially reduce its size while maintaining statistical power, with mOS remaining the primary endpoint for full FDA approval [4][3]. Financial Results - For Q3 2025, the company reported a net loss of $9.0 million, or $0.19 per share, a decrease from a net loss of $10.7 million, or $0.29 per share, in Q3 2024 [5][16]. - Research and development expenses were $4.6 million, down from $6.8 million in the same quarter of the previous year, attributed to lower manufacturing and clinical expenses [6][16]. - General and administrative expenses increased to $3.6 million from $3.4 million year-over-year, primarily due to higher professional fees [7][16]. Cash Position - As of September 30, 2025, the company's cash balance was $26.2 million, a decrease from $41.7 million as of December 31, 2024 [8][15]. - The company raised approximately $5.3 million by selling 5,800,000 shares and accompanying warrants on November 12, 2025 [9]. Additional Clinical Developments - The National Cancer Institute presented new clinical data at the 2025 Society for Immunotherapy of Cancer Annual Meeting, highlighting the immunological properties of PDS0101 and PDS01ADC [4]. - Preliminary results from the colorectal cancer cohort of the Phase 2 clinical trial with PDS01ADC met the criteria for expansion to Stage 2, confirming at least 6 of 9 objective responses [4].