Category - Developments

Developments

Morphic posts positive cohort data in ulcerative colitis

Morphic Therapeutic (NASDAQ:MORF) reported positive topline data from the main cohort of the open-label EMERALD-1 Phase 2a study of MORF-057, an oral small molecule inhibitor of the α4β7 integrin, in adults with...

April 25, 2023

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

Blue Water Vaccines changes name to Blue Water Biotech

Blue Water Vaccines changed its corporate name to Blue Water Biotech, following its recent acquisition of ENTADFI, an FDA-approved treatment for benign prostatic hyperplasia, which has begun Blue Water’s transition into...

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

Visus posts positive Phase 3 data to treat presbyopia

Visus Therapeutics reported positive topline results from its Phase 3 pivotal BRIO-I trial, demonstrating highly statistically significant improvements in near and distance binocular visual acuity at multiple...

April 20, 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

Zucara receives IND clearance for Phase 2 trial of ZT-01 for prevention of night-time hypoglycemia

The FDA has cleared Zucara Therapeutics’ IND application for a Phase 2a study of ZT-01 for the prevention of nocturnal hypoglycemia in patients with Type 1 Diabetes (T1D), with first patient dosing set in the third...

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

Hepion to present data on synergistic effects of rencofilstat with anti-PD1 at AACR

Daren Ure, Ph.D., CSO of Hepion Pharmaceuticals (NASDAQ:HEPA) will present an abstract on April 18 highlighting the company’s lead drug candidate, rencofilstat, at the American Association for Cancer Research annual...

April 18, 2023

Category - Developments

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