Proposed acquisition strengthens Pharming’s late-stage pipeline with a potential first-in-disease asset Abliva’s lead product KL1333 is currently in a pivotal clinical trial, with a positive interim analysis achieved, in mitochondrial DNA-driven primary mitochondrial diseases Total transaction value of approximately US$66.1 million No external funding required to fund acquisition and KL1333 development costs Pharming to host a conference call on Monday, December 16, 2024 at 14:00 CET (8:00 am EST) Leiden, t ...

In 2022, Amazon introduced the Buy with Prime button, allowing premium subscribers to make purchases using their Amazon account even when shopping on other websites.Now the company is bringing a similar concept to its cloud-computing business.At its Reinvent conference in Las Vegas on Wednesday, Amazon Web Services said a new Buy with AWS button will be available for cloud software partners to embed on their sites as a way for customers to pay.AWS is the leading provider of cloud infrastructure, ahead of Mi ...

Billionaire hedge fund manager Ken Griffin just raised Citadel's position in global-consulting powerhouse Accenture.No other company has benefited more from the artificial intelligence (AI) revolution than Nvidia. The company's compute and networking products are connected to just about every single application in generative AI in some form or fashion.Given its influence on the generational opportunity AI presents, it's not shocking to learn that investors have been eagerly buying Nvidia stock in droves ove ...

Even as consumers have experienced some continued stress from the prior period of high inflation, Walmart (WMT -1.04%) continues to be one of the biggest winners in the retail space. The retail giant posted another strong quarter of sales and took a positive view on the upcoming holiday season.The stock is now up more than 60% year to date, as of this writing. The question for investors is, can the momentum in the stock continue? Let's take a closer look at its most recent results and guidance to help find ...

“Channel Therapeutics” reflects the Company’s focus on developing therapeutics to treat pain utilizing sodium channel blockade and modulationNew name is in advance of multiple near-term data readouts FREEHOLD, N.J., Nov. 21, 2024 (GLOBE NEWSWIRE) -- Chromocell Therapeutics Corporation, (NYSE American: CHRO), a pioneer in the development of non-opioid pain treatment therapeutics, today announced that on November 18, 2024 it had changed its name to Channel Therapeutics Corporation (“Channel” or the “Company”) ...

Core Insights - The Phase 2 data supports the proof-of-concept for efgartigimod SC in treating myositis, leading to the decision to continue development in the Phase 3 ALKIVIA study across all three myositis subtypes [1][2] - Efgartigimod SC has the potential to be the first targeted treatment for myositis patients with limited existing options [1][2] Study Design - The ALKIVIA study is a randomized, double-blind, placebo-controlled, multicenter Phase 2/3 trial involving 240 patients, focusing on idiopathic inflammatory myopathies (IIM) across three subtypes: IMNM, ASyS, and DM [3] - The primary endpoint is the mean total improvement score (TIS) at 24 weeks for Phase 2 and 52 weeks for Phase 3, with key secondary endpoints including response rates and quality of life measures [3] Efficacy and Safety - The Phase 2 portion of the ALKIVIA study met its primary endpoint, showing a statistically significant treatment effect in mean TIS at Week 24, with improvements across all six core set measures compared to placebo [2][3] - The safety and tolerability profile of efgartigimod SC was consistent with previous clinical trials [2] Background on Myositis - Idiopathic inflammatory myopathies (myositis) are rare autoimmune diseases that can severely impact muscle function and quality of life, affecting multiple organs [4] - The classification of myositis has evolved, with new subtypes like IMNM and ASyS emerging alongside traditional classifications [4][5] About Efgartigimod SC - Efgartigimod SC is a human IgG1 antibody fragment designed to reduce pathogenic IgG antibodies by blocking the IgG recycling process, currently evaluated in over 15 severe autoimmune diseases [6] - It is the first approved FcRn blocker globally, marketed under various names for conditions like generalized myasthenia gravis and chronic inflammatory demyelinating polyneuropathy [6] Company Overview - Argenx is a global immunology company focused on developing novel antibody-based medicines for severe autoimmune diseases, partnering with academic researchers to translate immunology breakthroughs into effective treatments [7]

Company Overview - Incyte has faced a setback in its mid-stage study of MRGPRX2 (INCB000262) for chronic spontaneous urticaria (CSU), leading to a pause in enrollment due to preclinical toxicology findings [1][4] - The company is collaborating with the FDA to determine the next steps following the data sharing [4] Stock Performance - Shares of Incyte declined by 9% in after-market trading on November 18 [2] - Year-to-date, Incyte's shares have increased by 5.4%, contrasting with an 11.1% decline in the industry [3] Product Pipeline - Enrollment in other proof-of-concept studies for INCB000262 is complete, and data from these studies will inform future development and potential growth of backup molecules [5] - Data from the phase II study of MRGPRX4 in cholestatic pruritus does not support further development [4] Dependence on Jakafi - Jakafi, Incyte's lead drug, is a JAK1/JAK2 inhibitor approved for multiple indications, including polycythemia vera and myelofibrosis [6] - Sales of Jakafi remain strong, but the company is heavily reliant on this drug for top-line growth [7] Competitive Landscape - Increased competition for Jakafi's indications is evident, particularly with the FDA's approval of GSK's Ojjaara for similar conditions [8] - Jakafi is expected to lose patent protection in the coming years, making the successful development of new drugs critical for Incyte [8] Market Position - Incyte currently holds a Zacks Rank of 3 (Hold) [9] - Comparatively, Immunocore Holdings and Castle Biosciences are better-ranked stocks in the biotech sector, both holding a Zacks Rank of 1 (Strong Buy) [9]

Stellantis' Ram 1500 Revolution battery-electric concept pickup truck is introduced during a keynote address by Stellantis CEO Carlos Tavaras during CES 2023 at The Venetian Resort Las Vegas on January 05, 2023 in Las Vegas, Nevada.DETROIT — Stellantis is delaying the launch of its Ram electric pickup trucks from this year until the first half of 2025, as the transatlantic automaker continues testing the vehicles.CEO Carlos Tavares on Tuesday declined to disclose details regarding what caused the delays as ...

Core Insights - Actinium Pharmaceuticals is advancing its clinical programs for Actimab-A, Iomab-ACT, and Iomab-B, with significant regulatory updates and financial results reported for Q3 2024 [1][2][6] Regulatory and Development Updates - Actinium has aligned with the FDA on a seamless Phase 2/3 trial for Actimab-A combined with CLAG-M for relapsed/refractory acute myeloid leukemia (r/r AML) [1][3] - Actimab-A has been selected for the National Cancer Institute's myeloMATCH precision medicine program targeting AML and myelodysplastic syndromes [1][4] - The FDA has cleared two IND applications for Iomab-ACT, including a commercial CAR-T trial and a sickle cell transplant trial, with proof-of-concept data expected in 2025 [1][4] - Actinium is seeking a U.S. strategic partner for Iomab-B to conduct a Phase 3 trial based on FDA guidance [1][5] Financial Performance - As of September 30, 2024, Actinium reported cash and cash equivalents of approximately $78.6 million, expected to fund operations into 2027 [1][6] - Research and development expenses decreased to $9.8 million in Q3 2024 from $11.6 million in Q3 2023, primarily due to lower CMC expenses [7] - General and administrative expenses increased slightly to $2.8 million in Q3 2024, attributed to higher non-cash stock compensation [8] - The net loss for Q3 2024 was $11.6 million, a decrease from $13.3 million in Q3 2023, due to lower R&D expenses [11]

Core Insights - Lipocine Inc. announced the publication of a Phase 2 trial manuscript for LPCN 1148, which shows promise in treating sarcopenia and hepatic encephalopathy in male patients with cirrhosis [1][2][5] Company Overview - Lipocine Inc. is a biopharmaceutical company focused on developing therapeutics through effective oral delivery, with a proprietary technology platform [1][12] - The company has multiple drug candidates in development, including LPCN 1148, which targets liver cirrhosis and its complications [12][13] Clinical Trial Details - The Phase 2 trial (LPCN 1148-21-001) was conducted in two stages: a double-blind, placebo-controlled stage followed by a single-arm open-label extension [2] - The trial specifically evaluated LPCN 1148 in men with cirrhosis and sarcopenia awaiting liver transplantation [2] Key Findings - At 24 weeks, LPCN 1148 therapy significantly improved sarcopenia compared to placebo, and participants experienced fewer episodes of overt hepatic encephalopathy [3] - Additional benefits included improvements in muscle quality, hemoglobin levels, and patient-reported symptoms [3] Industry Context - Cirrhosis is a severe liver disease with limited treatment options, affecting over 382,000 patients in the US, many of whom are awaiting liver transplants [6][7] - Overt hepatic encephalopathy is a common and debilitating complication of liver disease, with a high recurrence rate and significant impact on patient quality of life [8][9][10]