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Will RXRX's Shift in Pipeline Focus Help Restore Investor Faith?
ZACKS· 2025-07-07 15:26
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 ...
Corbus Pharmaceuticals Holdings (CRBP) Earnings Call Presentation
2025-07-04 12:22
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]
Lexicon Pharmaceuticals (LXRX) Earnings Call Presentation
2025-07-04 11:20
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 ...
X @Forbes
Forbes· 2025-07-04 04:00
New drugs take too long to get to market because of clinical trial bottlenecks. Two cancer doctors built AI-enabled tech to speed up the process. (Photo: Maria Ponce) https://t.co/wWD1GG2CwU https://t.co/OfdTG5b3B9 ...
Novartis' Cosentyx Misses Primary Goal in Arteritis Phase III Study
ZACKS· 2025-07-03 15:35
Key Takeaways NVS reported that Cosentyx missed the primary endpoint in a phase III study for giant cell arteritis. Cosentyx plus a 26-week steroid taper showed no significant remission benefit over placebo and 52-week taper. While endpoints were missed, Cosentyx showed lower steroid exposure and consistent safety in the GCA study.Novartis (NVS) announced that a late-stage study of its interleukin-17A inhibitor, Cosentyx (secukinumab), has failed to meet the primary endpoint of sustained remission at week ...
BioNTech (BNTX) Earnings Call Presentation
2025-07-03 14:26
Oncology Pipeline & Strategy - BioNTech has a multiplatform oncology portfolio with over 20 ongoing Phase 2 or 3 trials[7] - BNT327, a PD-L1/VEGF-A antibody, is a priority program with potential as a next-generation IO-backbone, with clinical activity observed across multiple indications in over 750 patients enrolled in 20+ clinical trials[7, 19, 20] - BNT327 combined with chemo in 1L TNBC showed an objective response rate (ORR) of 769% in PD-L1 negative, 563% in PD-L1 low, and 100% in PD-L1 high patients[25] - FixVac and iNeST are novel mRNA cancer immunotherapies targeting tumor-associated antigens and cancer mutations[7, 37] COVID-19 Vaccine & Financials - BioNTech anticipates maintaining a high market share in the U S, EU, and Japan for its COVID-19 vaccine[49] - The company expects total revenues between €1700 million and €2200 million for the financial year 2025[51] - R&D expenses for FY 2025 are projected to be between €2600 million and €2800 million[51] - SG&A expenses are estimated to be between €650 million and €750 million, with capital expenditure for operating activities between €250 million and €350 million[51] Financial Position - As of December 31, 2024, BioNTech's total cash plus security investments amounted to €174 billion, including €97619 million in cash and cash equivalents, €65362 million in current security investments, and €10611 million in non-current security investments[7, 8]
FDA Grants Accelerated Approval to Regeneron's Blood Cancer Drug
ZACKS· 2025-07-03 14:20
Key Takeaways REGN gained FDA approval for Lynozyfic to treat relapsed or refractory multiple myeloma. Lynozyfic showed a 70% response rate and 45% complete response rate in the LINKER-MM1 trial. The approval makes Lynozyfic the first FDA-cleared BCMAxCD3 bispecific with biweekly or monthly dosing.Regeneron Pharmaceuticals, Inc. (REGN) obtained FDA approval for linvoseltamab-gcpt for the treatment of relapsed or refractory (R/R) multiple myeloma (MM).The regulatory body granted accelerated approval to lin ...
高盛:全球医疗保-2025 年第三季度值得关注的生物制药催化因素
Goldman Sachs· 2025-07-03 02:41
Global Healthcare Biopharma catalysts to watch in 3Q25 With macroeconomic volatility and healthcare policy uncertainty persisting likely into the back half of the year, we continue to advocate for and highlight idiosyncratic catalysts with attractive risk/reward setups to drive alpha generation. Herein, we highlight and preview key catalysts in 3Q25 across the GS biotechnology coverage universe from pivotal studies: BMY's Cobenfy ADEPT-2 in Alzheimer's disease psychosis; LLY's orforglipron ATTAIN-1 in obesi ...
X @Forbes
Forbes· 2025-07-02 12:00
New drugs take too long to get to market because of clinical trial bottlenecks. Two cancer doctors built AI-enabled tech to speed up the process. (Photo: Maria Ponce) https://t.co/h2z5abwqHe https://t.co/7k3mmUwhfT ...
Esperion Appoints Craig Thompson to Board of Directors
Globenewswire· 2025-07-01 12:06
Brings More Than Twenty Years of Biopharmaceutical Leadership ExperienceANN ARBOR, Mich., July 01, 2025 (GLOBE NEWSWIRE) -- Esperion (NASDAQ: ESPR) today announced it has appointed Craig Thompson, Chief Executive Officer of Cerevance, to its Board of Directors. Mr. Thompson will serve as an independent director. With Mr. Thompson’s appointment, Esperion’s Board of Directors now comprises eight members. “We are thrilled to welcome Craig to our Board of Directors. With more than two decades of biopharmaceutic ...