Michelle Carr, Author at BioTuesdays

Developments

Lyra restarts Phase 3 trial in chronic rhinosinusitis

Lyra Therapeutics (NASDAQ:LYRA) resumed screening and enrollment in ENLIGHTEN II, its second Phase 3 clinical trial of LYR-210 in patients with chronic rhinosinusitis (CRS). LYR-210 is a bioresorbable nasal implant...

April 25, 2023

Developments

Lantheus, POINT get FDA fast track for mCRPC

The FDA granted Lantheus Holdings (NASDAQ:LNTH) and POINT Biopharma (NASDAQ:PNT) fast track designation for 177Lu-PNT2002 for the treatment of metastatic castration resistant prostate cancer (mCRPC). PNT2002 is an...

April 24, 2023

Developments

MAIA Biotechnology reports preliminary Phase 2 survival data for NSCLC

MAIA Biotechnology (NYSEA:MAIA) announced preliminary survival data in the Part A safety lead-in of its ongoing Phase 2 trial, THIO-101, evaluating THIO in patients with advanced non-small cell lung cancer (NSCLC). The...

April 20, 2023

Developments

Cali initiates Phase 3 studies to decrease post-operative pain; cut opioid use

Cali Biosciences initiated Phase 3 studies of its core product, CPL-01, a long-acting ropivacaine, with dosing in hernia patients already begun and dosing in bunion patients scheduled to start next month. CPL-01 is an...

April 19, 2023

Developments

SAB Biotherapeutics nabs FDA breakthrough status for Influenza immunotherapy

The FDA granted breakthrough therapy designation for SAB Biotherapeutics’ (NASDAQ:SABS) SAB-176, an investigational therapeutic, for post-exposure prophylaxis for Type A and Type B influenza illness in high-risk...

April 18, 2023

Developments

Kiora initiates Phase 2 Trial for ocular presentation of autoimmune diseases

Kiora Pharmaceuticals (NASDAQ:KPRX) enrolled the first patient in its Phase 2 trial of KIO-101 in the treatment of the ocular presentations of rheumatoid arthritis and other autoimmune diseases. The multi-center...

April 17, 2023

Developments

FDA approves IntelGenx’s RIZAFILM for acute migraine

The FDA has approved IntelGenx’s (TSX:IGX; OTCQB:IGXT) RIZAFILM VersaFilm 505(b)(2) new drug application for the treatment of acute migraine. RIZAFILM is a proprietary oral thin film formulation of rizatriptan benzoate...

April 17, 2023

Developments

MindMed collaborators post positive Phase 2 data with LSD in MDD

Prof. Matthias Liechti and Dr. Felix Mueller, Mind Medicine’s (NASDAQ:MNMD) collaborators at University Hospital Basel and the University Hospital of Psychiatry, released positive topline data from a double-blind...

April 14, 2023

Developments

Tonix expedites fibromyalgia and chronic migraine programs

Tonix Pharmaceuticals (NASDAQ:TNXP) is eliminating the interim analyses in its registration-enabling, confirmatory Phase 3 RESILIENT study of TNX-102 SL for fibromyalgia and its Phase 2 PREVENTION study of TNX-1900 for...

April 13, 2023

Developments

Cantor eyes next NASH readout for Hepion’s rencofilstat

Cantor Fitzgerald is eagerly awaiting data from Hepion Pharmaceuticals’ (NASDAQ:HEPA) Phase 2 ALTITUDE-NASH liver function trial with its cyclophilin inhibitor, rencofilstat, guided for the second quarter of 2023. “We...

April 11, 2023

Author - Michelle Carr

Lyra restarts Phase 3 trial in chronic rhinosinusitis

Lantheus, POINT get FDA fast track for mCRPC

MAIA Biotechnology reports preliminary Phase 2 survival data for NSCLC

Cali initiates Phase 3 studies to decrease post-operative pain; cut opioid use

SAB Biotherapeutics nabs FDA breakthrough status for Influenza immunotherapy

Kiora initiates Phase 2 Trial for ocular presentation of autoimmune diseases

FDA approves IntelGenx’s RIZAFILM for acute migraine

MindMed collaborators post positive Phase 2 data with LSD in MDD

Tonix expedites fibromyalgia and chronic migraine programs

Cantor eyes next NASH readout for Hepion’s rencofilstat

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