Rejection

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Stop Chasing, Start Attracting: How Desperation Kills Deals
Garry Tan· 2025-07-09 15:01
Key Principles for Founders - Desperation repels investors and others, signaling risk [5] - Contentment attracts capital and opportunities, as founders building independently signal confidence [6] - Handling rejection with resilience demonstrates potential for success [6] Strategies for Success - Focus on building something undeniable to attract helpers and funding organically [9][10] - Detachment, not as passivity but as inward power, allows opportunities to arise [11] - Embrace the present and stop chasing future outcomes to create space for opportunities [12] - Believe in a real chance of success, even if not 100% certain [8] Mindset and Action - Avoid performative actions and focus on real calm and progress [7] - Turn dreams into tangible code or hardware [14] - Look inward for design space, code, character, and conviction [13]
You Have To Risk Rejection
20VC with Harry Stebbings· 2025-07-08 14:01
If you want to score above your weight class economically and romantically, get out a big spoon, get ready to eat endure rejection, and if you ask someone for money or a job and you don't get the money or the job, or you ask someone out on a date and you don't get the date, you're all going to be just fine. You're all going to end up dead. But the person who is unafraid and asks for all of those things every day ends up wealthier and with a higher character mate than their peers. ...
Press Release: Riliprubart earns orphan drug designation in the US for antibody-mediated rejection in solid organ transplantation
GlobeNewswire News Room· 2025-06-25 05:00
Core Insights - The FDA has granted orphan drug designation to riliprubart for treating antibody-mediated rejection (AMR) in solid organ transplantation, highlighting a significant unmet need in transplant medicine [1][2] - Riliprubart is a first-in-class IgG4 humanized monoclonal antibody that selectively inhibits activated C1s in the classical complement pathway [3] - Sanofi is conducting multiple clinical studies for riliprubart, including a phase 2 study for kidney transplant recipients and two phase 3 studies for chronic inflammatory demyelinating polyneuropathy (CIPD) [2][6] Company Overview - Sanofi is an R&D driven biopharma company focused on improving lives through innovative medicines and vaccines, leveraging deep understanding of the immune system [5] - The company is committed to addressing urgent healthcare challenges and has a robust pipeline aimed at high unmet medical needs [5] Industry Context - Antibody-mediated rejection is a serious complication post-organ transplantation, where the recipient's immune system attacks the transplanted organ, leading to potential organ failure if untreated [4] - The orphan drug designation reflects the rarity of conditions like AMR, affecting fewer than 200,000 people in the US, and underscores the need for effective treatments in this area [1]
Don't self-reject: The Overthinker's Antidote | Neha Lagoo Ratnakar | TEDxUWCMaastricht
TEDx Talks· 2025-06-12 15:31
It was the year 2016 and I found myself in a situation that felt like an oxymoron. Feeling completely lost yet about to discover a life-changing secret. I was in Moscow, Russia, and I was desperately looking for an English speaking activity.And that's how one fine evening I stumbled into an improv class. Now, I knew nothing about improv. When I entered, the teacher asked for two volunteers, for two people to step up on stage.I was there to learn something new. So, I went up and the only instruction that the ...
Tonix Pharmaceuticals Announces Presentation at the 2025 BIO International Convention
Globenewswire· 2025-06-10 11:00
* Tonix's product development candidates are investigational new drugs or biologics; their efficacy and safety have not been established and have not been approved for any indication. Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. All other marks are property of their respective owners. This press release and further information about Tonix can be found at www.tonixpharma.com. CHATHAM, N.J., June 10, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (To ...
Medicare Boosts Reimbursement for Oncocyte's Flagship Technology
GlobeNewswire News Room· 2025-05-19 20:05
Core Insights - Oncocyte Corp. has announced a positive update regarding the pricing of its next-generation lab-developed test (LDT), GraftAssureCore, which enhances its position in the transplant rejection testing market and indicates potential growth in its estimated $1 billion total addressable market [1][6] Pricing and Reimbursement - The Centers for Medicare & Medicaid Services (CMS) has increased the reimbursement rate for GraftAssureCore to $2,753 per result, up from $2,222 for first-time testing and $1,029 for subsequent tests [2] - This new pricing aligns with existing competitive technologies and expands market appeal for future FDA-cleared kitted products at transplant centers [6] Company Strategy and Future Prospects - Oncocyte has invested significantly in improving the scalability and manufacturability of its workflow, which supports its kitted test program [3] - The new reimbursement rate establishes a benchmark for future kitted tests, such as GraftAssureDx, which is expected to be submitted for FDA review by the end of the year [3] - The company anticipates that receiving FDA authorization will enable broader adoption of its technology, allowing transplant centers to access high-quality, FDA-cleared kits with established reimbursement [4] Clinical Trials and Market Engagement - Oncocyte has received approval from a Central Institutional Review Board for its clinical trial, with final preparations underway at participating transplant centers [4] - The company expects participation from three of the top 10 U.S. transplant centers, representing nearly 10% of annual U.S. transplant volume [4] Technology and Market Position - Oncocyte's technology quantifies donor-derived cell-free DNA (dd-cfDNA), which has been established as a trusted biomarker for transplant rejection [5] - The company is rebranding its test portfolio under the GraftAssure brand, with GraftAssureCore being the new name for its previously marketed VitaGraft assay [5]
Eledon: A Company With Good Early Data In Kidney Transplant Rejection And A Full Balance Sheet
Seeking Alpha· 2025-05-03 12:15
Group 1 - Eledon Pharmaceuticals is a small cap, development-stage biotech company focused on its lead candidate, tegoprubart, which inhibits CD40 ligand binding of T-cells with CD40 receptors on B-cells and dendritic cells [1] - The mechanism of action for tegoprubart serves to reduce T-cell mediated immune responses, indicating potential therapeutic applications [1]
Oncocyte Provides Positive Update on Clinical Trial Progress
GlobeNewswire News Room· 2025-04-30 12:30
Core Viewpoint - Oncocyte Corp. is making significant progress towards initiating a clinical trial for an organ transplant rejection monitoring test kit, which is essential for obtaining regulatory authorization to market the product [1][6]. Company Progress - Oncocyte has completed the clinical trial design and received approval from a central institutional review board (IRB) [2]. - The company expects to include three of the top 10 transplant centers in the U.S. as participants in the clinical trial, representing nearly 10% of the U.S. transplanted organ volume [3]. - Oncocyte estimates that transplant rejection testing generates approximately $500 million in annual revenue in the U.S., with a global addressable market exceeding $1 billion [4]. Market Engagement - The transplant community is enthusiastic about the opportunity to conduct testing in-house, with major transplant centers supporting Oncocyte's efforts [5]. - Oncocyte plans to announce its National Principal Investigator (NPI) soon and will host a conference call to introduce this key opinion leader [5]. Regulatory Pathway - The upcoming clinical trial is the only requirement for FDA authorization of Oncocyte's test kit, which is being pursued through a Class II de novo pathway [6]. - Oncocyte is preparing for its second and final Q-Submission (Q-Sub) meeting with the FDA, following productive discussions in previous meetings [7][8].
Oncocyte's Proprietary Assay Demonstrates Long-Term Clinical Validity
GlobeNewswire News Room· 2025-04-29 12:30
Core Viewpoint - Oncocyte Corp. has published new data on its blood-based transplant rejection assay, indicating significant advancements in understanding organ rejection and potential market expansion opportunities for monitoring high-risk patients [1][4]. Scientific Significance - The study demonstrates a correlation between microvascular and vascular inflammation and elevated donor-derived cell-free DNA (dd-cfDNA) levels in blood plasma, enhancing the understanding of organ rejection biology [2]. - Two novel observations were made: T-cell mediated rejection (TCMR) is linked to high dd-cfDNA levels in the presence of vascular inflammation, while calcineurin inhibitor toxicity does not elevate dd-cfDNA levels [7][8]. Strategic Significance - The research supports the long-term management of high-risk transplant patients using Oncocyte's proprietary test, which is positioned to disrupt the market with more affordable and faster testing options [4][5]. - The study's findings validate the clinical utility of dd-cfDNA testing over a decade post-transplant, indicating its relevance in ongoing patient management [5]. - A significant portion of patients with organ rejection also exhibited de novo donor-specific antibodies, aligning with Oncocyte's previous clinical trial findings that led to expanded Medicare reimbursement [6]. Market Expansion - Oncocyte is developing a kitted version of its assay for local lab use, aiming to enhance accessibility and affordability of transplant monitoring tests [3]. - The collaboration with Charité University in Berlin has been instrumental in advancing scientific knowledge in transplantation, further solidifying Oncocyte's position in the market [4].