RCC

AVEO Oncology Announces Ficlatuzumab Granted Fast Track Designation by the U.S. FDA for the Treatment of Relapsed or Recurrent Head and Neck Squamous Cell Carcinoma

Monday, September 20, 2021 - 12:00pm

AVEO Oncology (Nasdaq: AVEO), a commercial stage, oncology-focused biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to ficlatuzumab for the treatment of patients with relapsed or recurrent head and neck squamous cell carcinoma (R/R HNSCC).

Key Points: 
  • AVEO Oncology (Nasdaq: AVEO), a commercial stage, oncology-focused biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to ficlatuzumab for the treatment of patients with relapsed or recurrent head and neck squamous cell carcinoma (R/R HNSCC).
  • The Company expects to continue to discuss potential ficlatuzumab pivotal study designs with the FDA and to continue ongoing partnership dialogues.
  • Clinical programs with Fast Track designation may benefit from early and frequent communication with the FDA throughout the regulatory review process.
  • Ficlatuzumab is currently being evaluated in squamous cell carcinoma of the head and neck (HNSCC) and metastatic pancreatic ductal cancer (PDAC).

Allarity Therapeutics Presents Dovitinib Survival Data from DRP® Screened RCC Patients at ESMO 2021 Virtual Congress

Thursday, September 16, 2021 - 9:00am

These results validate that the Dovitinib DRP companion diagnostic can identify RCC patients that benefit from treatment with dovitinib when compared to alternative treatment with sorafenib.

Key Points: 
  • These results validate that the Dovitinib DRP companion diagnostic can identify RCC patients that benefit from treatment with dovitinib when compared to alternative treatment with sorafenib.
  • The benefit of dovitinib therapy was also evident in progression-free survival data.
  • Allarity plans to file a new drug application (NDA) with the U.S. Food and Drug Administration (FDA) for the approval of dovitinib for the treatment of RCC during Q4 2021.
  • We remain committed to bringing novel oncology therapeutics to market, and to patients, together with their DRP companion diagnostics to improve patient outcomes.

Edison Investment Research Limited: Immunicum (IMMU): Primed for value appreciation

Wednesday, September 15, 2021 - 9:06am

Given the changes to the R&D pipeline and updated strategy, we have revised our forecasts and valuation and present a new investment thesis.

Key Points: 
  • Given the changes to the R&D pipeline and updated strategy, we have revised our forecasts and valuation and present a new investment thesis.
  • We value Immunicum at SEK1.95bn or SEK9.76 per share (rNPV using a 12.5% discount rate and SEK212m cash at end-Q221).
  • About Edison: Edison is a leading research and investor relations consultancy, connecting listed companies to the widest pool of global investors.
  • Having been the first in-market 17 years ago, Edison now has more than 100 analysts covering every economic sector.

Eisai to Present Abstracts on Oncology Products and Pipeline at ESMO Virtual Congress 2021

Tuesday, September 14, 2021 - 4:36am

In March 2018, Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A., through an affiliate, entered into a strategic collaboration for the worldwide co-development and co-commercialization of lenvatinib.

Key Points: 
  • In March 2018, Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A., through an affiliate, entered into a strategic collaboration for the worldwide co-development and co-commercialization of lenvatinib.
  • Eisai positions oncology as a key therapeutic area and is aiming to discover revolutionary new medicines with the potential to cure cancer.
  • This release discusses investigational compounds and investigational uses for FDA-approved products.
  • There is no guarantee that any investigational compounds or investigational uses of FDA-approved products will successfully complete clinical development or gain FDA approval.

Infinity to Participate in Oppenheimer’s Fall Healthcare Life Sciences and MedTech Summit and the 3rd Annual Macrophage-directed Therapies Summit

Monday, September 13, 2021 - 1:35pm

(NASDAQ: INFI), a clinical-stage biotechnology company developing eganelisib, a potentially first-in-class, oral, immuno-oncology macrophage reprogramming therapeutic which addresses a fundamental biologic mechanism of immune suppression in cancer, today announced that the Company will participate in Oppenheimers Fall Healthcare Life Sciences and MedTech Summit and at the 3rd Annual Macrophage-directed Therapies Summit.

Key Points: 
  • (NASDAQ: INFI), a clinical-stage biotechnology company developing eganelisib, a potentially first-in-class, oral, immuno-oncology macrophage reprogramming therapeutic which addresses a fundamental biologic mechanism of immune suppression in cancer, today announced that the Company will participate in Oppenheimers Fall Healthcare Life Sciences and MedTech Summit and at the 3rd Annual Macrophage-directed Therapies Summit.
  • MARIO-275 is a randomized, controlled combination study of eganelisib combined with Opdivo in I/O nave urothelial cancer.
  • With these studies Infinity is evaluating eganelisib in the anti-PD-1 refractory, I/O-nave, and front-line settings.
  • Avastin is a registered trademark of Genentech, Inc.
    Doxil is a registered trademark of Baxter Healthcare Corporation.

EMD Serono to Present Latest Highlights From Oncology Portfolio at WCLC and ESMO 2021

Sunday, September 12, 2021 - 11:05pm

EMD Serono is a science-led organization dedicated to delivering transformative medicines with the goal of making a meaningful difference in the lives of people affected by cancer.

Key Points: 
  • EMD Serono is a science-led organization dedicated to delivering transformative medicines with the goal of making a meaningful difference in the lives of people affected by cancer.
  • Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month.
  • Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroid therapy.
  • The only exceptions are the United States and Canada, where the business sectors of Merck KGaA, Darmstadt, Germany operate as EMD Serono in healthcare, MilliporeSigma in life science, and EMD Electronics.

Herbers & Company Academy Appoints Heath Jackson to Role of Senior Consultant

Thursday, September 9, 2021 - 3:08pm

Herbers & Company , an independent, full-service business management consultancy serving independent financial advisory firms, has hired a new Senior Consultant at Herbers & Company with 20 years of financial services experience -- Heath Jackson, CFP, AEP.

Key Points: 
  • Herbers & Company , an independent, full-service business management consultancy serving independent financial advisory firms, has hired a new Senior Consultant at Herbers & Company with 20 years of financial services experience -- Heath Jackson, CFP, AEP.
  • When we make new hires at Herbers & Company, we consider not only a persons background but their values as well.
  • As such, I am thrilled to have Heath driving data and analytics for our clients at Herbers and Company, said Angie Herbers , Managing Partner.
  • In his previous role as Director of Operations at USAA Federal Savings Bank, Mr. Jackson led teams in fulfillment, compliance, and risk management.

Bristol Myers Squibb Research at ESMO 2021 Demonstrates Clinical Benefits of Immunotherapies in Multiple Hard-to-Treat Advanced or Metastatic Cancers and Reinforces the Benefit of Opdivo in Earlier-Stage Cancers

Wednesday, September 8, 2021 - 11:59am

By harnessing the bodys own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers.

Key Points: 
  • By harnessing the bodys own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers.
  • OPDIVO (nivolumab), in combination with cabozantinib, is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC).
  • OPDIVO (nivolumab) is indicated for the treatment of patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy.
  • Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Infinity to Participate in Wells Fargo and H.C. Wainwright Investor Conferences

Thursday, September 2, 2021 - 1:35pm

Infinity Pharmaceuticals, Inc. (Infinity or the Company), is a clinical-stage biotechnology company developing eganelisib (IPI-549), a potentially first-in-class, oral, immuno-oncology macrophage reprogramming therapeutic which addresses a fundamental biologic mechanism of immune suppression in cancer in multiple clinical studies.

Key Points: 
  • Infinity Pharmaceuticals, Inc. (Infinity or the Company), is a clinical-stage biotechnology company developing eganelisib (IPI-549), a potentially first-in-class, oral, immuno-oncology macrophage reprogramming therapeutic which addresses a fundamental biologic mechanism of immune suppression in cancer in multiple clinical studies.
  • MARIO-275 is a randomized, controlled combination study of eganelisib combined with Opdivo in I/O nave urothelial cancer.
  • With these studies Infinity is evaluating eganelisib in the anti-PD-1 refractory, I/O-nave, and front-line settings.
  • For more information on Infinity, please refer to Infinity's website at www.infi.com .

BELLUS Health to Present at the H.C. Wainwright Global Investment Conference

Thursday, September 2, 2021 - 12:00pm

BELLUS Health Inc. (Nasdaq:BLU; TSX:BLU) (BELLUS Health or the Company), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of refractory chronic cough (RCC) and other hypersensitization-related disorders, today announced that Roberto Bellini, BELLUS Health's President and Chief Executive Officer, will present a corporate overview of the Company at the H.C. Wainwright Global Investment Conference.

Key Points: 
  • BELLUS Health Inc. (Nasdaq:BLU; TSX:BLU) (BELLUS Health or the Company), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of refractory chronic cough (RCC) and other hypersensitization-related disorders, today announced that Roberto Bellini, BELLUS Health's President and Chief Executive Officer, will present a corporate overview of the Company at the H.C. Wainwright Global Investment Conference.
  • A webcast of the presentation may be accessed on the Events & Presentations page under the Investors & Media section of BELLUS Health's website at www.bellushealth.com .
  • BELLUS Health is a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of RCC and other hypersensitization-related disorders.
  • The Company's product candidate, BLU-5937, is being developed for the treatment of RCC and chronic pruritus associated with AD.