Axitinib

Junshi Biosciences Announces Approval of the sNDA for Toripalimab for the 1st-Line Treatment of Renal Cancer

Retrieved on: 
Sunday, April 7, 2024
Diagnosis, OS, Nephrectomy, Immunotherapy, DCR, Oncology, Risk, Patient, Shanda, Malignancy, Death, IMDC, Carcinoma, Renal cell carcinoma, Trial of the century, RCC, National Medical Products Administration, ESMO, HKEX, IRC, PFS, Annals of Oncology, Axitinib, Independent Review Committee, Pharmaceutical industry

Renal carcinoma is the third most common malignancy of the urinary system globally, and RCC accounts for 80%~90% of all cases of renal carcinoma.

Key Points: 
  • Renal carcinoma is the third most common malignancy of the urinary system globally, and RCC accounts for 80%~90% of all cases of renal carcinoma.
  • There were approximately 77,000 new cases of and 46,000 deaths due to renal carcinoma in China in 2022.
  • Distant metastasis occurred in about one-third of renal carcinoma patients at initial diagnosis, and in 20%-50% of localized patients after nephrectomy.
  • “The approval of toripalimab combined with axitinib addresses the gap in first-line immunotherapy for renal cancer in China.

Junshi Biosciences Announces 2023 Full Year Financial Results and Provides Corporate Updates

Retrieved on: 
Friday, March 29, 2024
CPS, Patient, Lung cancer, IND, Infection, Cancer, Investment, Cisplatin, Paclitaxel, Melanoma, Marketing, RNA, New chemical entity, Gentlemen's agreement, NRDL, Food, Therapeutic Goods Administration, Biologics license application, Insurance, Research, Junshi, National Medical Products Administration, TGA, FDA, NMPA, Tablet, COVID-19, NPC, Spacecraft, DSM-IV codes, Dacarbazine, Axitinib, Total, Pharmaceutical industry

SHANGHAI, China, March 29, 2024 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences,” HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, announced its financial results for the full year of 2023 and provided corporate updates.

Key Points: 
  • SHANGHAI, China, March 29, 2024 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences,” HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, announced its financial results for the full year of 2023 and provided corporate updates.
  • Total research and development (“R&D”) expenses were approximately RMB1,937 million in 2023, representing a decrease of approximately 19% compared to 2022.
  • Loss attributable to owners was RMB2,282 million in 2023, representing a decrease of RMB104 million compared to the previous year.
  • This application was later approved for marketing in December 2023, marking the first and only approved perioperative therapy for lung cancer domestically.

Clearside Biomedical Announces Fourth Quarter and Full Year 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Tuesday, March 12, 2024
Patient, G&A, BioCryst Pharmaceuticals, Eye, Drug delivery, Clinical trial, AAO, Extension, Webcast, Pharming, CPT, Safety, Disease, SPA, American Academy of Ophthalmology, Compass, Insurance, Diabetic retinopathy, Conference call, Aura, AMD, TKI, CLS, FDA, Administration, Conference, SCS, DME, American Academy, OASIS, Injection, Research and development, Axitinib, Pharmaceutical industry

ALPHARETTA, Ga., March 12, 2024 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (Nasdaq: CLSD), a biopharmaceutical company revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS®), today reported financial results for the fourth quarter and year ended December 31, 2023, and provided a corporate update.

Key Points: 
  • License Revenue: License and other revenue for the fourth quarter of 2023 was $6.3 million, compared to $0.3 million for the fourth quarter of 2022.
  • Research and Development (R&D) Expenses: R&D expenses for the fourth quarter of 2023 were $6.3 million, compared to $5.0 million for the fourth quarter of 2022.
  • General and Administrative (G&A) Expenses: G&A expenses for the fourth quarter of 2023 were $2.9 million, compared to $3.2 million for the fourth quarter of 2022.
  • Other Expense: Non-cash interest expense for the fourth quarter of 2023 was $2.3 million, compared to $2.0 million for the fourth quarter of 2022.

Summary of opinion: Keytruda, 22/02/2024 Positive

Retrieved on: 
Sunday, March 10, 2024
Carboplatin, GEJ, Hodgkin lymphoma, Patient, HNSCC, Cervical cancer, Ageing, CHL, Colorectal cancer, ALK, BTC, Head, Large intestine, Neck, Committee, Recurrence, IIC, Marketing, RCC, Renal cell carcinoma, Cancer, TPS, CHMP, Trastuzumab, TNBC, Paclitaxel, ASCT, Axitinib, Transitional epithelium, NSCLC, Lung cancer, European Commission, EGFR, Cholangiocarcinoma, Medication package insert, CRC, Neoplasm, Radiation, Cisplatin, Civil service commission, Pembrolizumab, Endometrial cancer, Nephrectomy, Platinum, MSI-H, Pemetrexed, Bevacizumab, Risk, Transitional cell carcinoma, CPS, PD-L1

Summary of opinion: Keytruda, 22/02/2024 Positive

Key Points: 


Summary of opinion: Keytruda, 22/02/2024 Positive

Ocular Therapeutix™ Announces First Subjects Screened in Phase 3 Pivotal Clinical Trial of AXPAXLI™ in Wet AMD

Retrieved on: 
Tuesday, February 13, 2024
Injection, FDA, Consultant, Eye, Diabetic retinopathy, Macular degeneration, AMD, Patient, SPA, Clinical trial, Axitinib, SOL, Research, Pharmaceutical industry

The Company previously announced FDA agreement on its Special Protocol Assessment (SPA) Agreement Modification on January 25th.

Key Points: 
  • The Company previously announced FDA agreement on its Special Protocol Assessment (SPA) Agreement Modification on January 25th.
  • “The screening of these subjects in the pivotal Phase 3 SOL-1 trial of AXPAXLI marks an exciting milestone for Ocular Therapeutix,” said Antony Mattessich, CEO of Ocular Therapeutix.
  • We believe that AXPAXLI could set a new standard in wet AMD therapy by significantly extending time between treatments.
  • “Clinical trials like the SOL-1 study for AXPAXLI represent a critical step forward in our pursuit of more patient-centric treatments for wet AMD.

Ocular Therapeutix™ Announces FDA Agreement to Amend Special Protocol Assessment (SPA) for Pivotal Clinical Trial of AXPAXLI™ in Wet AMD

Retrieved on: 
Thursday, January 25, 2024
Eye, Injection, SOL, Axitinib, Food, AMD, SPA, FDA, Clinical trial, Visual acuity, Pharmaceutical industry

BEDFORD, Mass., Jan. 25, 2024 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced that the U.S. Food and Drug Administration (FDA) has agreed to a Special Protocol Assessment (SPA) Agreement Modification for the Company’s pivotal Phase 3 SOL clinical trial of AXPAXLI™ (axitinib intravitreal implant, also known as OTX-TKI) for the treatment of wet age-related macular degeneration (wet AMD).

Key Points: 
  • The SPA Agreement Modification enables the trial to include treatment-naïve wet AMD subjects with visual acuity of approximately 20/80 or better at the initial screening visit.
  • The SPA Agreement Modification also allows the pivotal trial to move forward, evaluating AXPAXLI with a single optimized implant with a drug load of 450 µg of a more soluble form of axitinib.
  • “With the changes reflected in the SPA Agreement Modification agreed to by the FDA, we believe we can accelerate the enrollment process for the SOL trial,” said Antony Mattessich, CEO of Ocular Therapeutix.
  • “We have worked closely with the FDA to ensure that the SOL trial meets the agency’s updated guidance for wet AMD clinical trials, and we are eager to advance our engagement with clinical sites to enroll this trial under these new criteria."

Clearside Biomedical Reports Significant Progress in ODYSSEY Phase 2b Trial of CLS-AX in Wet AMD

Retrieved on: 
Thursday, December 14, 2023
Axitinib, AMD, Injection, VEGF, Pharming, Eye, TKI, OASIS, Patient, Pharmaceutical industry

ALPHARETTA, Ga., Dec. 14, 2023 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (Nasdaq: CLSD), a biopharmaceutical company revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS®), announced today that it has completed randomization in its ODYSSEY Phase 2b clinical trial of CLS-AX (axitinib injectable suspension) in neovascular age-related macular degeneration (wet AMD). Topline data results are expected in the third quarter of 2024.

Key Points: 
  • ALPHARETTA, Ga., Dec. 14, 2023 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (Nasdaq: CLSD), a biopharmaceutical company revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS®), announced today that it has completed randomization in its ODYSSEY Phase 2b clinical trial of CLS-AX (axitinib injectable suspension) in neovascular age-related macular degeneration (wet AMD).
  • Topline data results are expected in the third quarter of 2024.
  • “As we continue to make significant progress in our ODYSSEY trial, we are optimistic about the potential benefits of CLS-AX, our proprietary suspension of axitinib for suprachoroidal injection,” said George Lasezkay, Pharm.D., J.D., President and Chief Executive Officer.
  • “Axitinib is a highly-potent tyrosine kinase inhibitor (TKI) that achieves pan-VEGF blockade, directly inhibiting VEGF receptors-1, -2, and -3 with high potency and specificity.

HUTCHMED Announces that it has Completed Enrollment of a Phase II/III Trial of Fruquintinib in Combination with Sintilimab for Advanced Renal Cell Carcinoma in China

Retrieved on: 
Wednesday, December 13, 2023
Quality of life, Axitinib, Shanghai Cancer Center, Everolimus, RECIST, HKEX, Fudan University, Sintilimab, RCC, TTR, Patient, Safety, Pharmaceutical industry

HONG KONG, Shanghai and FLORHAM Park, N.J., Dec. 12, 2023 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (Nasdaq/AIM:​HCM, HKEX:​13) (“ HUTCHMED ”) today announces that it has completed enrollment of its Phase II/III trial of fruquintinib in combination with sintilimab as second-line treatment for locally advanced or metastatic renal cell carcinoma (“RCC”) in China.

Key Points: 
  • HONG KONG, Shanghai and FLORHAM Park, N.J., Dec. 12, 2023 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (Nasdaq/AIM:​HCM, HKEX:​13) (“ HUTCHMED ”) today announces that it has completed enrollment of its Phase II/III trial of fruquintinib in combination with sintilimab as second-line treatment for locally advanced or metastatic renal cell carcinoma (“RCC”) in China.
  • The study is a randomized, open-label, active-controlled study to evaluate the efficacy and safety of fruquintinib in combination with sintilimab versus axitinib or everolimus monotherapy for the second-line treatment of advanced RCC.
  • The primary endpoint is progression free survival (“PFS”) per RECIST 1.1 as assessed by blinded independent central review (BICR).
  • If favorable, the results would enable a New Drug Application submission to China’s National Medical Products Administration (“NMPA”).

AiViva Biopharma Completes Phase 1/2 Clinical Trial of AIV001 Administration in Patients with Nonmelanoma Skin Cancer

Retrieved on: 
Monday, December 11, 2023
Axitinib, MD, Doctor of Philosophy, Cancer, COSA, Neoplasm, Ageing, Scar, BCC, Patient, Carcinoma, Safety, University, Skin, Pharmaceutical industry

COSA MESA, Calif., Dec. 11, 2023 (GLOBE NEWSWIRE) -- AiViva Biopharma Inc., a clinical-stage biotechnology company, announced completion of their first trial administering AIV001 (axitinib) to patients diagnosed with basal cell carcinoma (BCC) tumors.

Key Points: 
  • COSA MESA, Calif., Dec. 11, 2023 (GLOBE NEWSWIRE) -- AiViva Biopharma Inc., a clinical-stage biotechnology company, announced completion of their first trial administering AIV001 (axitinib) to patients diagnosed with basal cell carcinoma (BCC) tumors.
  • AIV001 is AiViva’s novel intradermally administered product designed for local, prolonged treatment effect for dermatological conditions.
  • The phase 1/2 multicenter, open-label clinical trial evaluated AIV001 in patients with superficial, nodular or mixed BCC tumors.
  • The most common cancer worldwide is nonmelanoma skin cancer with the BCC subtype being the most prevalent that occurs in the skin.

Clearside Biomedical Announces Third Quarter 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Monday, November 13, 2023
Potential, Visual acuity, Patient, Research, American Medical Association, Targeted drug delivery, Conference, American Academy of Ophthalmology, R, Diabetes, Diabetic retinopathy, Webcast, Literature, American Academy, Administration, DME, G&A, Research and development, Physician, Paratriathlon, Retina, Drug delivery, Pharming, Eye, Intravitreal injection, BioCryst Pharmaceuticals, SCS, Edema, AAO, Melanoma, AURA, Solubility, Partnership, AMD, Clearside, Bausch & Lomb, OASIS, Axitinib, Plasma, Clinical trial, CLS, CPT, Conference call, UME, Injection, HIV disease progression rates, Pharmaceutical industry, Nursing, Video game

ALPHARETTA, Ga., Nov. 13, 2023 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (Nasdaq: CLSD), a biopharmaceutical company revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS®), today reported financial results for the third quarter ended September 30, 2023, and provided a corporate update.

Key Points: 
  • ET -
    ALPHARETTA, Ga., Nov. 13, 2023 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (Nasdaq: CLSD), a biopharmaceutical company revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS®), today reported financial results for the third quarter ended September 30, 2023, and provided a corporate update.
  • Other Income: Other income for the third quarter of 2023 was $0.4 million, compared to $0.2 million for the third quarter of 2022.
  • Other Expense: Non-cash interest expense for the third quarter of 2023 was $2.6 million, compared to $1.3 million in the third quarter of 2022.
  • Clearside’s management will host a webcast and conference call today at 4:30 p.m. Eastern Time to discuss the financial results and provide a corporate update.