Talk to us about opioids that the FDA failed. The FDA did fail. There were many parts of our health care system that failed.Look, I feel terrible about the opioid epidemic. I personally prescribed opioids with misinformation. It was taught to me by my chief resident in my surgical residency, and we sort of woke up to this problem around 2014, 2015 and thought, Oh my God, what have we done.What information did we not have, I think was regulatory capture at the agency. Now we can't prove that. But when the re ...

With Varda Space, leading Silicon Valley players make big bet on making drugs in space | TechCrunch https://t.co/cl8BrIaOJ2 ...

Summary of Processa Pharmaceuticals (PCSA) Update / Briefing July 09, 2025 Company Overview - **Company**: Processa Pharmaceuticals - **Ticker**: PCSA - **Industry**: Pharmaceuticals, specifically oncology drug development Core Points and Arguments 1. **Derisked Approach**: Processa Pharmaceuticals adopts a derisked approach to drug development, focusing on improving existing cancer therapies rather than creating entirely new drugs. This strategy aims to enhance efficacy and safety of current treatments [15][29][40] 2. **Regulatory Science**: The company has a proprietary regulatory science approach that has led to 30 regulatory approvals, aligning with FDA's new project optimist requirements for oncology drugs [15][16][30] 3. **Pipeline Overview**: - **PCS 6422**: A combination therapy with capecitabine, showing a 67% response rate in a phase 1b trial, significantly higher than the 20-40% response rate for capecitabine alone. The drug also demonstrated better safety, with only 6% of patients experiencing hand and foot syndrome compared to 50% for capecitabine alone [18][19][34] - **PCS 11T**: An altered version of SN-38, aiming to reduce off-target effects and improve safety by preferentially drawing the drug into tumor cells. The goal is to potentially remove black box warnings associated with existing drugs [22][35] - **PCS 12852**: Recently partnered with Intact Therapeutics, with a deal valued at approximately $454 million, including milestone payments and royalties [24][25] - **PCS 499**: Pivoting back to renal and nephropathy space, with plans for a phase 3 adaptive study, potentially being the only drug in its category without a black box warning [26][27][45] Market Position and Competitive Advantage 1. **High Unmet Need**: Despite advancements in oncology, cancer remains the second leading cause of death, indicating a significant market opportunity for better therapies [16] 2. **Competitive Differentiation**: Processa's derisked approach allows it to focus on enhancing existing therapies, which is seen as a lower bar compared to developing new drugs from scratch. This strategy is supported by a seasoned management team with extensive experience in public companies and regulatory approvals [30][40][48] 3. **Strategic Partnerships**: The company is actively seeking partnerships to accelerate drug development, particularly for PCS 499 and oncology assets, with ongoing discussions with major players in the renal space [44][46] Upcoming Catalysts 1. **Phase 2 Preliminary Analysis**: Expected results for PCS 6422 in the second half of the year, which could provide significant data for future partnerships [31][49] 2. **FDA Interactions**: Ongoing engagement with the FDA regarding study protocols and potential approvals, particularly for PCS 499 and the phase 2 study for PCS 6422 [41][43] Additional Important Information 1. **Market Potential**: The ability to make capecitabine safer and more effective could expand the patient population, particularly among those who are currently not prescribed the drug due to its side effects [34][38] 2. **Investor Sentiment**: The CEO expressed confidence in the company's undervaluation and the potential for significant returns due to the derisked approach and multiple drug candidates in the pipeline [47][48] This summary encapsulates the key points from the Processa Pharmaceuticals update, highlighting the company's strategic focus, pipeline developments, and market positioning within the oncology sector.

RADNOR, Pa., July 09, 2025 (GLOBE NEWSWIRE) -- Certara, Inc. (Nasdaq: CERT), a global leader in model-informed drug development, today announced that it will release financial results for the second quarter of 2025 after the market close on Wednesday, August 6th, 2025. Company management will host a conference call to discuss financial results at 5:00PM ET. Investors interested in listening to the conference call are required to register online. It is recommended to register at least one day in advance. A l ...

Key Takeaways COGT soared after its SUMMIT study met all endpoints in non-advanced systemic mastocytosis. Bezuclastinib showed strong symptom reduction and biomarker response versus placebo. The drug was well-tolerated, and an FDA submission is targeted for the end of 2025.Shares of Cogent Biosciences (COGT) soared 23.4% on Monday after the company reported positive top-line data from a late-stage study of its investigational candidate, bezuclastinib, for treating non-advanced systemic mastocytosis (SM) p ...

Seasoned Leader Brings Deep Experience in Oncology Drug Development as Company Advances Portfolio of Next Generation Therapeutics for Solid Tumors WALTHAM, Mass., July 08, 2025 (GLOBE NEWSWIRE) -- Crescent Biopharma, Inc. (“Crescent” or the “Company”) (Nasdaq: CBIO), a biotechnology company dedicated to rapidly advancing the next wave of therapies for cancer patients, today announced the appointment of Jan Pinkas, Ph.D., as chief scientific officer. Dr. Pinkas brings more than two decades of experience in o ...

Corporate Presentation June 2025 Forward-looking Statement This presentation contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended, including without limitation, statements regarding, among other things, the potential number of patients who could be treated by tebipenem HBr and market demand for tebipenem HBr generally; the potential regulatory path forward for tebipenem HBr, the potential approval of tebipenem HBr by the U.S. Food and Drug Admini ...

Key Takeaways RXRX dropped REC-994, REC-2282 and REC-3964 due to poor mid-stage study results and low efficacy. The company is now focused on REC-4881, which showed a 43% polyp reduction in early phase II data. RXRX is advancing REC-1245, REC-617, and REC-3565 as it refines its AI-driven drug development pipeline.Recursion Pharmaceuticals (RXRX) faced a massive setback in May 2025 after announcing the discontinuation of three key drug candidates — REC-994, REC-2282 and REC-3964 — due to disappointing resu ...

CRB-701 (Nectin-4 Targeting ADC) - Clinical data readouts are expected for CRB-701 in the second half of 2025, with complete dose optimization and RP2D determination expected in Q4 2025[5] - CRB-701 is designed to address unmet needs of PADCEV® by extending ADC half-life to reduce dosing frequency and enabling higher doses due to lower DAR and longer half-life[10] - Phase 1 dose escalation studies are ongoing, with continued expansion at 2 doses and dose optimization planned for HNSCC, cervical, and bladder tumors[17, 18] - In Phase 1 dose escalation studies, ocular toxicity was reduced from 66% in CSPC cohorts to 38% in Corbus cohorts through the use of prophylaxis and baseline selection[32] - Emerging combined safety profile of CRB-701 shows a Grade 3 or higher AE rate of 20% (n=15/75), compared to 58% for PADCEV® (n=179 of 310)[33] - Phase 1 data shows an ORR of 27% and DCR of 77% in Corbus patients (n=26), and an ORR of 28% and DCR of 68% in CSPC patients (n=25)[38] - In mUC patients, CRB-701 showed an ORR of 44% (4 out of 9) and a DCR of 78% (7 out of 9)[48] - In cervical cancer patients, CRB-701 showed an ORR of 43% (3 out of 7) and a DCR of 86% (6 out of 7)[52] - In HNSCC patients, CRB-701 showed an ORR of 4 out of 7 patients and a DCR of 6 out of 7 patients[57] Financials - As of March 31, 2025, the company had $133 million in cash, cash equivalents, and investments, with approximately 122 million common shares outstanding (~140 million fully-diluted shares)[5]

Corporate Presentation April 2025 1 Forward-Looking Statements 2 • This presentation, including any oral presentation accompanying it, contains "forward-looking statements," including statements about Lexicon's strategy and operating performance and events or developments that we expect or anticipate will occur in the future, such as projections of our future results of operations or of our financial condition, the potential therapeutic and commercial potential of pilavapadin (LX9211), LX9851, sotagliflozin ...