Healthcare Industry Developments | BioTuesdays by Kilmer Lucas IR

Developments

PharmaJet partner gets fast track for cancer vaccine

PharmaJet partner, Immunomic Therapeutics, received FDA fast track designation for a clinical study of its plasmid DNA vaccine, ITI-3000, in patients with Merkel cell carcinoma (MCC), a rare but aggressive form of skin...

December 13, 2022

Developments

MAIA Biotechnology expands Phase 2 THIO-101 trial to Europe

Regulatory authorities in three European countries, Hungary, Poland, and Bulgaria, have approved implementation of MAIA Biotechnology’s (NASDAQ:MAIA) THIO-101, the company’s Phase 2 clinical trial evaluating its lead...

December 13, 2022

Developments

Indaptus initiates Phase 1 trial of Decoy20 in advanced solid tumors

Indaptus Therapeutics (NASDAQ:INDP) initiated INDP-D101, its first-in-human, open label, dose escalation and expansion, multicenter Phase 1 clinical trial of its lead compound, Decoy20, in patients with...

December 13, 2022

Developments

UT Southwestern performs 100th procedure with Profound’s TULSA-PRO

UT Southwestern in Dallas, one of the nation’s premier academic medical centers, performed its 100th procedure with Profound Medical’s (NASDAQ:PROF; TSX:PRN) TULSA-PRO, an innovative MRI-guided minimally invasive...

December 9, 2022

Developments

Context posts encouraging preliminary Phase 2 data in breast cancer

Context Therapeutics (NASDAQ:CNTX) reported preliminary Phase 2 data from the ongoing SMILE trial of onapristone extended release (ONA-XR), the company’s orally administered progesterone receptor (PR) antagonist, in...

December 8, 2022

Developments

Rani posts positive repeat-dose results with RaniPill in osteoporosis

Rani Therapeutics (NASDAQ:RANI) reported topline results from the repeat-dose Part 2 of a Phase 1 study of RT-102, the RaniPill GO capsule containing a proprietary formulation of human parathyroid hormone being...

December 7, 2022

Developments

IntelGenx, UPEI collaborate on VetaFilm platform in dogs and cats

IntelGenx (TSX:IGX; OTCQB:IGXT) and the University of Prince Edward Island are collaborating on a research project to assess palatability, owner-perceived acceptability, and ease of administration of IntelGenx’s...

December 7, 2022

Developments

FDA fast tracks Vistagen’s PH10 for major depressive disorder

The FDA granted Vistagen (NASDAQ:VTGN) fast track designation for development of PH10, an investigational nasal sprays, for the treatment of major depressive disorder (MDD). The FDA decision aligns with “our belief in...

December 6, 2022

Developments

Hepion completes enrollment early in Phase 2 ALTITUDE-NASH liver function trial

Hepion Pharmaceuticals (NASDAQ:HEPA) completed enrollment of 60 non-alcoholic steatohepatitis (NASH) stage 3 (F3) subjects in the Phase 2 ALTITUDE-NASH clinical trial. The trial is being conducted in collaboration with...

December 5, 2022

Developments

iBio to showcase RubrYc discovery engine at antibody conference

iBio (NYSEA:IBIO) will present two posters about its intelligence-powered RubrYc discovery engine at the Antibody Engineering and Therapeutics Conference in San Diego on Dec. 4-8. The conference features the latest...

December 5, 2022

Developments

EF Hutton adds four analysts to healthcare research team

EF Hutton announced a series of strategic hires enhancing the company’s healthcare equity research department, including Tony Butler, Ph.D., senior managing director; Elemer Piros, Ph.D., managing director; Fozia Ahmed...

November 30, 2022

Developments

First Wave files IND for enhanced microgranule delivery of adrulipase

First Wave BioPharma (NASDAQ:FWBI) submitted an IND application seeking authorization from the FDA to evaluate an enhanced enteric microgranule delivery formulation of adrulipase as a treatment for exocrine pancreatic...

November 30, 2022

Developments

Context Therapeutics selects antibody for Claudin 6-positive solid tumors

Context Therapeutics (NASDAQ:CNTX) announced the selection of CTIM-76, a T-cell-engaging bispecific antibody, as its lead clinical development candidate to target Claudin 6 (CLDN6) positive cancers, resulting from its...

November 29, 2022

Developments

PharmaJet receives NIH grant for HPV needle-free immunization study

Closely-held PharmaJet received an $800,000-plus direct to Phase 2 grant from the NIH to evaluate the immunogenicity of intradermal administration of human papilloma virus (HPV) vaccine using the company’s Tropis...

November 29, 2022

Developments

Enrollment tops 25% in Femasys FemaSeed de novo trial

Femasys (NASDAQ:FEMY) completed more than 25% of its targeted enrollment of 214 patient fertility cycles in its FemaSeed de novo trial. FemaSeed is the first and only first-line approach in development designed to...

November 29, 2022

Developments

FDA grants fast tract to Aravive’s batiraxcept for ccRCC

The FDA granted fast track designation to Aravive’s (NASDAQ:ARAV) lead program, batiraxcept, for the treatment of patients with advanced or metastatic clear cell renal cell carcinoma (ccRCC) who have progressed after...

November 29, 2022

Developments

TC BioPharm begins dosing Phase 2b AML study

TC BioPharm (NASDAQ:TCBP) began dosing the first three patients in its Phase 2b ACHIEVE clinical trial of OmnImmune, an allogeneic unmodified cell therapy focused on treating acute myeloid leukemia (AML). The initial...

November 22, 2022

Developments

Palisade Bio gets FDA fast track for return of bowel function after GI surgery

The FDA granted fast tract designation to Palisade Bio’s (NASDAQ:PALI) LB1148 for the acceleration of time to return of bowel function following surgery. By inhibiting the activity of digestive proteases, the company...

November 22, 2022

Developments

IntelGenx receives FDA PDUFA date for RIZAFILM

The FDA accepted for review IntelGenx’s (TSX:IGX; OTCQB:IGXT) Class 2 response to a 2020 complete response letter for the company’s 505(b)(2) NDA for RIZAFILM VersaFilm for the treatment of acute migraine. The FDA has...

November 22, 2022

Developments

Kiora doses first patient in Phase 1b retinitis pigmentosa trial

Kiora Pharmaceuticals (NASDAQ:KPRX) dosed the first patient in a first-in-human open-label clinical trial for KIO-301, intended to restore vision loss in patients with retinitis pigmentosa, a rare, inherited genetic eye...

November 17, 2022

Developments

Azura posts positive Phase 2b results in meibomian gland dysfunction

Azura Ophthalmics reported positive 3-month efficacy and safety results from its Phase 2b study of AZR-MD-001 0.5% in meibomian gland dysfunction (MGD), a leading cause of dry eye disease and contact lens discomfort...

November 17, 2022

Developments

NeuroSense receives IND clearance for Phase 2b ALS study

The FDA cleared NeuroSense Therapeutics’ (NASDAQ:NRSN) IND for its Phase 2b PARADIGM study with its lead drug candidate, PrimeC, in the treatment of amyotrophic lateral sclerosis (ALS). PARADIGM is currently enrolling...

November 15, 2022

PharmaJet partner gets fast track for cancer vaccine

MAIA Biotechnology expands Phase 2 THIO-101 trial to Europe

Indaptus initiates Phase 1 trial of Decoy20 in advanced solid tumors

UT Southwestern performs 100th procedure with Profound’s TULSA-PRO

Context posts encouraging preliminary Phase 2 data in breast cancer

Rani posts positive repeat-dose results with RaniPill in osteoporosis

IntelGenx, UPEI collaborate on VetaFilm platform in dogs and cats

FDA fast tracks Vistagen’s PH10 for major depressive disorder

Hepion completes enrollment early in Phase 2 ALTITUDE-NASH liver function trial

iBio to showcase RubrYc discovery engine at antibody conference

EF Hutton adds four analysts to healthcare research team

First Wave files IND for enhanced microgranule delivery of adrulipase

Context Therapeutics selects antibody for Claudin 6-positive solid tumors

PharmaJet receives NIH grant for HPV needle-free immunization study

Enrollment tops 25% in Femasys FemaSeed de novo trial

FDA grants fast tract to Aravive’s batiraxcept for ccRCC

TC BioPharm begins dosing Phase 2b AML study

Palisade Bio gets FDA fast track for return of bowel function after GI surgery

IntelGenx receives FDA PDUFA date for RIZAFILM

Kiora doses first patient in Phase 1b retinitis pigmentosa trial

Azura posts positive Phase 2b results in meibomian gland dysfunction

NeuroSense receives IND clearance for Phase 2b ALS study

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