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Home » Drug & Device Pipeline News

Drug & Device Pipeline News

December 5, 2022
Company Drug/Device Medical Condition Status
Trials Authorized
Ananda Scientific Nantheia A1002N5S Social anxiety disorder IND approved by the FDA
Ascletis ASC11 COVID-19 treatment IND approved by the FDA
Immorna JCXH-221 mRNA-based COVID vaccine IND approved by the FDA for phase 1/2 trial
Mabwell 9MW3011 Polycythemia vera IND approved by the FDA
Marker Therapeutics MT-601 Pancreatic cancer IND approved by the FDA
Triastek T21 Ulcerative colitis IND approved by the FDA
Praxis Precision Medicines PRAX-562 Pediatric patients with developmental and epileptic encephalopathies IND approved by the FDA for phase 2 trial
SOFIE Biosciences [18F]FAPI-74 Gastric cancer, cholangiocarcinoma, hepatocellular carcinoma, pancreatic cancer and colorectal cancer IND approved by the FDA for phase 2 trial
AB Science Masitinib Mild-to-moderate Alzheimer’s disease IND approved by the FDA for phase 3 trial
Vistagen PH10 Major depressive disorder Study May Proceed letter issued by the FDA
Exscientia EXS-21546 Advanced solid tumors CTA approved by the EU for phase 1/2 trial
Trials Initiated
Autobahn Therapeutics ABX-002 Major depressive disorder Initiation of phase 1 trial
Dianthus Therapeutics DNTH103 Severe autoimmune diseases Initiation of phase 1 trial
Gate Neurosciences Apimostinel Acute depressive disorders Initiation of phase 1 trial
Imago Biosciences Bomedemstat plus venetoclax Relapsed/refractory acute myeloid leukemia Initiation of phase 1 trial
Spirita Oncology E6201 plus dabrafenib Patients with central nervous system metastases from BRAF V600 mutated metastatic melanoma Initiation of phase 1 trial
VYNE Therapeutics VYN201 Vitiligo Initiation of phase 1a/b trial
Kiora Pharmaceuticals KIO-301 Retinitis pigmentosa Initiation of phase 1b trial in Australia
Clarametyx Biosciences CMTX-101 Community-acquired bacterial pneumonia Initiation of phase 1a trial
Compass Therapeutics CTX-471 plus Keytruda Advanced solid tumors Initiation of phase 1b trial
ImmunoMet Therapeutics IM156 Pancreatic cancer Initiation of phase 1b trial
AstraZeneca AZD2936 Stage III unresectable or stage IV non-small cell lung cancer Initiation of phase 2 trial
BioSight Aspacytarabine (BST-236) in combination with venetoclax Acute myeloid leukemia Initiation of phase 1/2 trial
Immuneering IMM-1-104 Advanced solid tumors with RAS mutations Initiation of phase 1/2a trial
TRACON Pharmaceuticals YH001 plus envafolimab and doxorubicin Sarcoma Initiation of phase 1/2 trial
Tyra Biosciences TYRA-300 Metastatic urothelial carcinoma Initiation of phase 1/2 trial
Genentech RG6501 (OpRegen) Geographic atrophy secondary to age-related macular degeneration Initiation of phase 2a trial
EmbarkNeuro ANC-501 Major depressive disorder Initiation of phase 2 trial
Escient Pharmaceuticals EP547 Cholestatic pruritus Initiation of phase 2 trial
India Globalization Capital IGC-AD1 Agitation in dementia from Alzheimer’s disease Initiation of phase 2 trial
Inversago Pharma INV-202 Diabetic kidney disease Initiation of phase 2 trial
Kinevant Sciences Namilumab Pulmonary sarcoidosis Initiation of phase 2 trial
NETRIS Pharma NP137 Advanced/metastatic solid tumors Initiation of phase 2 trial
Telix Pharmaceuticals TLX101 Recurrent high-grade gliomas Initiation of phase 2 trial
Morphic Therapeutics MORF-057 Moderate-to-severe ulcerative colitis Initiation of phase 2b trial
TC Biopharm OmnImmune Acute myeloid leukemia Initiation of phase 2b trial
Atea Pharmaceuticals Bemnifosbuvir (AT-527) Treatment of COVID-19 in non-hospitalized patients at high risk for disease progression Initiation of phase 3 trial
Biofrontera Bioscience Ameluz and BF-RhodoLED XL Actinic keratosis on the extremities, neck and trunk Initiation of phase 3 trial
Approvals
CSL Hemgenix (etranacogene dezaparvovec-drlb) Hemophilia B Approved by the FDA
Ferring Pharmaceuticals Rebyota (fecal microbiota, live-jslm) Prevention of recurrence of Clostridioides difficile infection (CDI) in adults following antibiotic treatment for recurrent CDI Approved by the FDA
Jazz Pharmaceuticals Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn) Acute lymphoblastic leukemia or lymphoblastic lymphoma Approved by the FDA for new dosing formulation
Provention Bio Tzield (teplizumab-mzwv) To delay the onset of stage 3 type 1 diabetes in patients 8 years and older who currently have stage 2 type 1 diabetes Approved by the FDA
InnoCare Pharma Hibruka (orelabrutinib) Mantle cell lymphoma Approved in Singapore
Rhythm Pharmaceuticals Imcivree (setmelanotide) Treatment of obesity and control of hunger in patients 6 years and older with Bardet-Biedl syndrome Approved in UK
Roche Polivy (polatuzumab vedotin for injection) Large B-cell lymphoma Approved in Canada

 

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