Life Sciences News | BioTuesdays by Kilmer Lucas IR

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

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

JMP sees Phase 1 results for Roche’s antibody encouraging for iBio’s IBIO-101

JMP Securities, in a new report, writes that the promising mechanistic and clinical activity for Roche’s drug candidate, RG6292, should support advancement of iBio’s (NYSEA:IBIO) IBIO-101. IBIO-101 is an anti-CD25...

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

Executive Moves

IntelGenx makes organizational changes to support global growth strategy

IntelGenx Technologies (TSX:IGX; OTCQB:IGXT) appointed Dwight Gorham as CEO, effective immediately, succeeding the company’s founder, Horst Zerbe, Ph.D., who has retired as CEO, but will continue as chairman. The CEO...

April 13, 2023

Developments

FDA clears Candesant’s Brella to reduce excessive underarm sweating

The FDA cleared closely-held Candesant Biomedical’s Brella, the first and only three-minute SweatControl Patch for the reduction of excessive underarm sweating in adults with primary axillary hyperhidrosis. Brella uses...

April 13, 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

MAIA Biotechnology reports preliminary Phase 2 survival data for NSCLC

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

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

SAB Biotherapeutics nabs FDA breakthrough status for Influenza immunotherapy

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

Kiora initiates Phase 2 Trial for ocular presentation of autoimmune diseases

JMP sees Phase 1 results for Roche’s antibody encouraging for iBio’s IBIO-101

FDA approves IntelGenx’s RIZAFILM for acute migraine

MindMed collaborators post positive Phase 2 data with LSD in MDD

IntelGenx makes organizational changes to support global growth strategy

FDA clears Candesant’s Brella to reduce excessive underarm sweating

Tonix expedites fibromyalgia and chronic migraine programs

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