Articles written by Ragothaman Srinivasan - Benzinga

Important Biotech Catalysts For September 15, 2022 - End Of The Day Summary

Candel Secures European Medicines Agency Orphan Drug Status For Brain Tumour Candidate

|The European Medicines Agency (EMA) Committee for Orphan Medical Products (COMP) has issued a positive opinion on Candel Therapeutics’ (NASDAQ: CADL) application for orphan drug designation for CAN-2409 for the treatment of glioma.

Jasper Shares Climb As FDA Grants Fast Track Status To Immunodeficiency Disease Candidate

|Jasper Therapeutics (NASDAQ: JSPR) announced that its lead asset JSP191 has received fast track designation from the U.S. Food and Drug Administration (FDA) for the treatment of patients with severe combined immunodeficiency (SCID) undergoing allogeneic hematopoietic stem cell transplant.

Kymera Gets Orphan Drug Status For Rare Blood Cancer Candidate

|The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to Kymera Therapeutics’ (NASDAQ: KYMR) product candidate KT-333 for the treatment of Cutaneous T-cell Lymphoma (CTCL).

Important Biotech Catalysts For September 14, 2022 - End Of The Day Summary

Eloxx Shares Plummet As Mid-Stage Cystic Fibrosis Study Results Miss Efficacy Endpoints

|Eloxx Pharmaceuticals (NASDAQ: ELOX) announced topline results from the Phase 2 clinical trial of ELX-02 in combination with ivacaftor in Class 1 cystic fibrosis (CF) patients with at least one nonsense mutation.

Adverum Commences Mid-Stage Chronic Eye Disorder Candidate Study

|Adverum Biotechnologies (NASDAQ: ADVM) dosed first subject in the LUNA Phase 2 trial evaluating ixoberogene soroparvovec (Ixo-vec, formerly referred to as ADVM-022) for the treatment of wet age-related macular degeneration (wet AMD).

FDA Grants Orphan Drug Status To Centessa's Hemophilia B Candidate

|Centessa Pharmaceuticals (NASDAQ: CNTA) announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to SerpinPC for the treatment of hemophilia B. A Phase 2a proof-of-concept study evaluated SerpinPC in severe hemophilia A and B patients not on prophylaxis.

TRACON Shares Ascend On FDA Fast Track Status To Soft Tissue Cancer Candidate

Important Biotech Catalysts For September 13, 2022 - End Of The Day Summary

GENFIT Gets FDA Orphan Drug Status For Liver Disease Candidate

|The U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to GENFIT’s (NASDAQ: GNFT) drug candidate GNS5611 (ezurpimtrostat) for the treatment of cholangiocarcinoma.

Conformis Shares Shoot Higher Following FDA Clearance For Actera Hip System

|Conformis (NASDAQ: CFMS) has received 510(k) clearance from the U.S. Food and Drug Administration for its Actera Hip System. Actera utilizes an advanced tri-taper femur stem design that facilitates direct anterior approach total hip arthroplasties, and provides an additional stem option to orthopedic surgeons.

Syros Shares Soar As FDA Grants Orphan Drug Status To Pancreatic Cancer Candidate

|The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to Syros Pharmaceuticals (NASDAQ: SYRS) lead candidate SY-5609 for the treatment of pancreatic cancer.

Merck Secures Canadian Regulatory Nod For KEYTRUDA In Skin Cancer After Resection

|Health Canada has granted approval for Merck’s (NYSE: MRK) KEYTRUDA (pembrolizumab) for the adjuvant treatment of adult and pediatric (12 years and older) patients with stage IIB or IIC melanoma following complete resection.

Lyra's Mid-Stage Chronic Rhinosinusitis Candidate Study Progressed, Shares Fall

|Lyra Therapeutics (NASDAQ: LYRA) advanced into its Part 2 of the Phase 2 BEACON clinical trial of LYR-220 in adults with chronic rhinosinusitis (CRS) who have had a prior sinus surgery.

aTyr Pharma Gets FDA Fast Track Status For Systemic Sclerosis Candidate

|The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for aTyr Pharma’s (NASDAQ: LIFE) lead therapeutic candidate, efzofitimod, for the treatment of systemic sclerosis (SSc)-associated, interstitial lung disease (ILD).

Important Biotech Catalysts For September 12, 2022 - End Of The Day Summary

AVITA Shares Climb Following Positive Results From RECELL System Study In Stable Vitiligo Lesions

|AVITA Medical (NASDAQ: RCEL) reveals positive top-line results from a pivotal trial evaluating the safety and effectiveness of the RECELL System for repigmentation of stable vitiligo lesions.

Adamis Achieves Enrolment Target In Mid-Stage Covid-19 Study, Awaits Data Safety Monitoring Board Review Later This Month

|Adamis Pharmaceuticals (NASDAQ: ADMP) announced that it has reached the initial planned enrollment target in the ongoing U.S. Phase 2/3 clinical trial investigating Tempol as a treatment for COVID-19.

Agenus Begins Mid-Stage Global Studies On Colorectal And Skin Cancer Candidate

|Agenus (NASDAQ: AGEN) has initiated Phase 2 ACTIVATE trials of botensilimab to advance globally in metastatic patients who have progressed on available therapies. This global Phase 2 program include clinical trials of ACTIVATE-Colorectal and ACTIVATE-Melanoma studies.