PharmaShots Weekly Snapshots (November 14

Iveric Bio’s Zimura (avacincaptad pegol) Receives the US FDA’s Breakthrough Therapy Designation for Geographic Atrophy

Published: Nov 18, 2022 | Tags: Iveric Bio, Zimura, avacincaptad pegol, Geographic Atrophy, Regulatory, US, FDA, Breakthrough Therapy Designation

Evaxion Reports P-I/IIa Results of EVX-02 for the Treatment of Resected Melanoma

Published: Nov 18, 2022 | Tags: Evaxion, EVX-02, Resected Melanoma, Clinical Trial, P-I/IIa Trial

Immunic Reports P-II (EMPhASIS) Trial Results of IMU-838 (vidofludimus calcium) for the Treatment of Relapsing-Remitting Multiple Sclerosis
Published: Nov 18, 2022 | Tags: Immunic, IMU-838, vidofludimus calcium, Relapsing-Remitting Multiple Sclerosis, Clinical Trial, P-II EMPhASIS Trial

Attralus Entered into Option and License Agreement with Ossianix to Deliver AT-04 for the Treatment of Neurodegenerative Disorders

Published: Nov 18, 2022 | Tags: Attralus, AT-04, Neurodegenerative Disorders, VNAR antibody-based brain shuttle

BeiGene’s Brukinsa (zanubrutinib) Receives EC’s Approval for the Treatment Chronic Lymphocytic Leukemia

Published: Nov 18, 2022 | Tags: Beigene, Brukinsa, zanubrutinib, Chronic Lymphocytic Leukemia, Regulatory, EC, Approval

Regeneron Entered into a Research Collaboration with CytomX to Develop Conditional Bispecific Therapies for the Treatment of Cancer

Published: Nov 18, 2022 | Tags: Regeneron, Bispecific Therapies, Cancer, Probody therapeutic platform, Veloci-Bi bispecific Ab, Biotech

VISEN Pharmaceuticals Reports P-III Results of Lonapegsomatropin in Children with Growth Hormone Deficiency

Published: Nov 17, 2022 | Tags: Visen Pharmaceuticals, Lonapegsomatropin, Growth Hormone Deficiency, Clinical Trial, P-III, China

Ayala Pharmaceuticals Reports First Patient Dosing of AL102 in P-III (RINGSIDE) trial for the Treatment of Desmoid Tumors

Published: Nov 17, 2022 | Tags: Ayala Pharmaceuticals, AL102, Desmoid Tumors, Clinical Trial, P-III, RINGSIDE Trial

Horizon Entered into a Multi-Year Scientific Collaboration with Johns Hopkins University School of Medicine to Advance Research in Autoimmunity and Inflammation

Published: Nov 17, 2022 | Tags: Horizon, Autoimmunity, Inflammation, Pharma

Mineralys Therapeutics Reports P-II (Target-HTN) Trial Results of MLS-101 for Uncontrolled and Resistant Hypertension

Published: Nov 17, 2022 | Tags: Mineralys Therapeutics, MLS-101, Hypertension, Clinical Trial, P-II, Target-HTN Trial

Regeneron Entered into a Clinical Supply Agreement with Grey Wolf Therapeutics to Evaluate GRWD5769 + Libtayo (cemiplimab) for Solid Tumour

Published: Nov 17, 2022 | Tags: Regeneron, GRWD5769, Libtayo, cemiplimab, Solid Tumour, Pharma

Horizon Reports the Completion of Patients Enrollment of Tepezza (teprotumumab-trbw) in the P-III (OPTIC-J) Trial for the Treatment of Active Thyroid Eye Disease

Published: Nov 17, 2022 | Tags: Horizon, Tepezza, teprotumumab-trbw, Active Thyroid Eye Disease, Clinical Trial, P-III OPTIC-J Trial

NextCure Entered into a Collaboration and Co-Development Agreement with LegoChem Biosciences to Develop Antibody Drug Conjugates for Cancer

Published: Nov 16, 2022 | Tags: Nextcure, Antibody Drug Conjugates, Cancer, B7-H4 Ab, FIND-IO platform, ConjuAll ADC technology, Biotech

Antengene Reports P-I/II (TORCH-2) Study Results of ATG-008 for the Treatment of Relapsed/Metastatic Cervical Cancer

Published: Nov 16, 2022 | Tags: Antengene, ATG-008, Cervical Cancer, Clinical Trial, P-I/II, TORCH-2 Study

Reistone Biopharma’s Ivarmacitinib Meets its Primary Endpoint in P-III (QUARTZ3) Trial for the Treatment of Atopic Dermatitis

Published: Nov 16, 2022 | Tags: Reinston Biopharma, Ivarmacitinib, Atopic Dermatitis, Clinical Trial, P-III, QUARTZ3 Trial

Arcutis Reports P-III (INTEGUMENT-1) Trial Results of Roflumilast Cream for Atopic Dermatitis in Adults and Children Aged ≥6 Years

Published: Nov 16, 2022 | Tags: Arcutis, Roflumilast Cream, Atopic Dermatitis, Clinical Trial, P-III, INTEGUMENT-1 Trial

Simcere Entered into an Exclusive License Agreement with Idorsia for Daridorexant in China

Published: Nov 16, 2022 | Tags: Simcere, Idorsia, Daridorexant, Pharma, License Agreement, China

Jnana Therapeutics Entered into a Second Collaboration and License Agreement with Roche to Discover Small Molecule Drugs

Published: Nov 16, 2022 | Tags: Roche, Jnana Therapeutics, Small Molecule Drugs, License Agreement, RAPID chemoproteomics platform, biotech

Junshi Reports MAA Submission of Toripalimab to the EMA for Nasopharyngeal Carcinoma and Esophageal Squamous Cell Carcinoma

Published: Nov 15, 2022 | Tags: Junshi, Toripalimab, Nasopharyngeal Carcinoma, Esophageal Squamous Cell Carcinoma, Regulatory, MAA, EMA

UCB Reports the US FDA Acceptance of NDA and EMA’s Validation of MAA for Zilucoplan to Treat Generalized Myasthenia Gravis

Published: Nov 15, 2022 | Tags: UCB, Zilucoplan, Generalized Myasthenia Gravis, Regulatory, MAA, US, FDA, NDA, EMA

Biotheus Entered into a License and Collaboration Agreement with Hansoh Pharma for PM1080

Published: Nov 15, 2022 | Tags: Hansoh Pharma, Biotheus, PM1080, non-small cell lung cancer, Pharma

Ono Collaborated with Captor Therapeutics to Develop Small Molecule Protein Degraders for the Treatment of Neurodegenerative Diseases

Published: Nov 15, 2022 | Tags: Ono, Captor Therapeutics, Protein Degraders, Neurodegenerative Diseases, OptigradeTM TPD platform, Pharma

Innovent Reports First Participant Dosing of Mazdutide (IBI362) in the P-III (GLORY-1) Trial for the Treatment of Overweight or Obesity

Published: Nov 15, 2022 | Tags: Innovent, Mazdutide, IBI362, Overweight, Obesity, Clinical Trial, P-III GLORY-1 Trial

Lantheus Entered into an Exclusive License Agreements with POINT Biopharma to Commercialize PNT2002 and PNT2003

Published: Nov 15, 2022 | Tags: lantheus, Point BiopharmaPNT2002, PNT2003, metastatic castration-resistant prostate cancer, gastroenteropancreatic neuroendocrine tumors, Pharma

Akeso's Ivonescimab Receives the NMPA’s Breakthrough Therapy Designation for the Treatment of Non-Small-Cell Lung Carcinoma

Published: Nov 14, 2022 | Tags: Akeso, Ivonescimab, Non-Small-Cell Lung Carcinoma, Regulatory, NMPA, Breakthrough Therapy Designation

Genentech's Gantenerumab Missed Primary Endpoints in P-III (GRADUATE I & II) Studies for Early Alzheimer’s Disease

Published: Nov 14, 2022 | Tags: Genentech, Gantenerumab, Early Alzheimer’s Disease, Clinical Trials, P-III (GRADUATE I & II) Studies

Indivior to Acquire Opiant Pharmaceuticals for ~$145M

Published: Nov 14, 2022 | Tags: Indivior, Opiant Pharmaceuticals, OPNT003, Acquire ~$145M, M&A

OncoSec Reports P-II (KEYNOTE-695) Trial Results of TAVO-EP + Keytruda (pembrolizumab) for Advanced Melanoma

Published: Nov 14, 2022 | Tags: OncoSec, TAVO-EP, Keytruda, pembrolizumab, Advanced Melanoma, Clinical Trial, P-II KEYNOTE-695 Trial

AstraZeneca’s Imfinzi (durvalumab) + Imjudo (tremelimumab) Receive the US FDA’s Approval for Metastatic Non-Small Cell Lung Cancer

Published: Nov 14, 2022 | Tags: AstraZeneca, Imfinzi, durvalumab, Imjudo, tremelimumab, Non-Small Cell Lung Cancer, Regulatory, US, FDA, Approval

Regeneron Receives EMA’s CHMP Positive Opinion of Dupixent (dupilumab) for the Treatment of Prurigo Nodularis

Published: Nov 14, 2022 | Tags: Regeneron, Dupixent, dupilumab, Prurigo Nodularis, Regulatory, EMA, CHMP, Positive Opinion