RT Thomas Brewster (@iblametom)🚨NEW🚨 A couple made millions from an anti-choking device that sucked objects out of throats, claiming it was FDA-approved.But the FDA had told them to stop selling it.Meanwhile, similar devices were on Amazon up until this week when I flagged them.https://t.co/3yuenho1sV ...

Company Overview - Kura Oncology is preparing for the FDA approval of ziftomenib, with a PDUFA date set for November 30, indicating confidence in obtaining a competitive label for relapsed/refractory NPM1-mutant AML [3]. Product Development - The company has received positive feedback from key opinion leaders (KOLs) regarding the efficacy, simplicity, compatibility, and safety of ziftomenib compared to competitors [3]. - Kura's commercial team is fully established and ready for market access and preapproval information exchanges [3]. Future Prospects - Kura Oncology is also advancing ziftomenib in combination with standard treatments for frontline indications, indicating a strategic focus on expanding its therapeutic applications [4].

Technology & Procedure - Hystotripsy, utilizing targeted ultrasound waves, offers a non-invasive method for tumor destruction [2] - The Edison system by HystoSonics is currently the only commercially available hystotripsy machine for human use [2] - Hystotripsy mechanically destroys tumor cells by rapidly expanding and contracting gases within them, liquefying the tissue instantly [7] - The procedure typically takes 1 to 3 hours, depending on the number of tumors targeted [18] Clinical Trials & Applications - Hystotripsy received FDA approval in October 2023 and is expanding availability [20] - While primarily focused on liver tumors, hystotripsy has potential applications for tumors in other organs [13] - Trials are underway for kidney and pancreatic tumors, with US availability for pancreatic tumor treatment expected in 2026 [15][16] - Future trials may explore applications for prostate (BPH and cancer), uterine fibroids, breast tumors, thyroid nodules, and even brain tumors [17] Post-Procedure & Immune Response - Most patients can return home a few hours after the procedure [19] - The body's immune system naturally absorbs the liquefied tumor [11] - Animal studies suggest hystotripsy may offer a systemic immunologic benefit by exposing hidden tumor antigens to the immune system [11][12]

Core Insights - Arquitos Capital Management reported a net return of 13.1% for Q2 2025, with year-to-date gains reaching 28.8% as of June 30, 2025 [1] Company Overview - Liquidia Corporation (NASDAQ:LQDA) is a biopharmaceutical company focused on developing, manufacturing, and commercializing products for unmet patient needs in the U.S. [2] - As of September 22, 2025, Liquidia's shares closed at $22.90, with a market capitalization of $1.922 billion [2] Stock Performance - Liquidia's stock experienced a decline of 19.40% over the past month, but it gained 120.85% over the last 12 months [2] - Following the FDA approval and launch of its flagship drug Yutrepia, Liquidia's stock price fell from over $19 in early June to $12.46 by the end of Q2 2025, attributed to investor concerns regarding the commercial rollout and potential competition [3] Product Launch and Market Position - The launch of Yutrepia is critical for Liquidia, as it aims to penetrate a previously monopolistic market [3] - Despite challenges such as patent disputes and FDA approval delays, Liquidia's shares have increased by 200% compared to the original purchase price over three years [3]

Clinical Trial Results & FDA Approval - Lilly's oral pill data for obesity and Type 2 diabetes initially caused significant market disappointment [1][2] - The recent data is viewed as the final step before submitting plans to the FDA for approval of the pill [2] - FDA approval is anticipated no earlier than 2026 [4] Market Expectations & Potential - Long-term expectations for the pill have decreased due to weight loss percentage and gastrointestinal side effects [3] - Despite lowered expectations, the pill is still projected to become a multi-billion dollar product in the US market [3] Side Effects & Advantages - The pill's side effects include diarrhea, nausea, and gastrointestinal issues, comparable to other medications like Wegovy [5] - The primary advantage of the pill is its convenience as a once-daily oral medication compared to weekly injections [6]

What if dogs could live longer? Celine Halioua has raised $135 million from top investors to develop canine longevity pills—and expects to get her first conditional approval from the FDA next year. https://t.co/XPMe2lfUUh (Photo: Ethan Pines For Forbes) #BillionDollarStartups https://t.co/QMtkigu7m7 ...

Core Insights - InspireMD, Inc. has made significant progress in 2024, particularly with the CGuard Prime carotid stent system, which is on track for potential U.S. approval in the first half of 2025 [3][10] - The company reported a revenue increase of 10.7% in Q4 2024 compared to Q4 2023, driven by growth in both new and existing markets [4][11] - Despite revenue growth, gross profit decreased due to rising costs, leading to a net loss of $9.17 million in Q4 2024, compared to a net loss of $5.41 million in Q4 2023 [5][7][16] Recent Business Highlights - The CEO highlighted the advancement of CGuard Prime towards FDA approval and the initiation of the CGUARDIANS II pivotal study for the TCAR market [3][10] - The company established its headquarters in Miami, Florida, to support the anticipated U.S. commercial launch of CGuard Prime [10] Financial Results for Q4 2024 - Total revenue for Q4 2024 was $1.95 million, up from $1.76 million in Q4 2023 [4][23] - Gross profit for Q4 2024 was $469,000, down from $505,000 in Q4 2023, reflecting increased costs of goods sold [5][23] - Operating expenses rose to $9.84 million in Q4 2024, a 55.8% increase from $6.31 million in Q4 2023, primarily due to higher salaries and clinical expenses [6][23] Financial Results for Full Year 2024 - For the full year 2024, revenue increased by 13.0% to $7.01 million from $6.21 million in 2023 [11][23] - Gross profit for the full year decreased by 16.7% to $1.51 million, with a gross margin decline to 21.5% from 29.1% in 2023 [12][13][23] - The net loss for the full year totaled $32.01 million, compared to a net loss of $19.92 million in 2023 [16][23] Cash Position - As of December 31, 2024, cash and cash equivalents and marketable securities totaled $34.64 million, down from $39.02 million a year earlier [8][23]