Biotech Archives - Page 717 of 795

2 minute read

Spero Therapeutics Provides Tebipenem HBr Program Update Following Type A Meeting With FDA; Announces ‘Alignment with the FDA on a regulatory path forward for the continued development of tebipenem Hbr’

September 6, 8:10 AM

Alignment with the FDA on a regulatory path forward for the continued development of tebipenem Hbr FDA feedback indicates positive results from a single additional Phase 3 clinical trial in patients with

SPRO

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Applied DNA Launches Monkeypox Testing Service

By Benzinga Newsdesk

September 6, 8:06 AM

Applied DNA Sciences, Inc. (NASDAQ:APDN) (“Applied DNA” or the “Company”), a leader in PCR-based DNA technologies, announced today that its wholly-owned clinical laboratory subsidiary, Applied DNA

APDN

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FDA
News

Soligenix Announces FDA Awards $2.6M Orphan Products Development Grant For Expanded Study Of HyBryte In The Treatment Of Cutaneous T-Cell Lymphoma

By Bill Haddad

September 6, 7:31 AM

Grant supports study of expanded HyBryte™ treatment, including in the Home Use Setting PRINCETON, N.J., Sept. 6, 2022 /PRNewswire/ -- Soligenix, Inc. (NASDAQ:SNGX) (Soligenix or the Company), a late-stage

SNGX

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Dyne Therapeutics Announces First Patient Dosed In Phase 1/2 DELIVER Clinical Trial Of DYNE-251 For The Treatment Of Duchenne Muscular Dystrophy

By Bill Haddad

September 6, 7:13 AM

Data from Global, Multiple Ascending Dose DELIVER Trial Anticipated in the Second Half of 2023 - - Dyne to Host “Spotlight on the Clinic” Virtual Event on September 12 - WALTHAM, Mass., Sept. 06, 2022

DYN

1 minute read

Tonix Pharmaceuticals Announces Oral Presentations Involving TNX-1500 At International Congress Of The Transplantation Society

By Bill Haddad

September 6, 7:12 AM

Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced three oral presentations by academic collaborators at the 29th International Congress

TNXP

1 minute read

Sanofi-Regeneron’s Flagship Drug Shows Consistent Efficacy, Safety Profile At Two Years For Asthma In Kids

By Vandana Singh

September 6, 7:10 AM

Regeneron Pharmaceuticals Inc (NASDAQ:REGN) and Sanofi SA (NASDAQ:SNY) announced results from a Phase 3 open-label extension trial of Dupixent (dupilumab) as maintenance therapy…

REGN

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Avalo Advances BTLA Agonist Fusion Protein (AVTX-008) To IND-enabling Stage

By Bill Haddad

September 6, 7:09 AM

Avalo Therapeutics, Inc. (NASDAQ:AVTX) announced today that its human B and T Lymphocyte Attenuator (BTLA) agonist fusion protein, AVTX-008, has now entered IND-enabling studies, with a target IND submission date of

AVTX

1 minute read

Allena Pharmaceuticals Shares Fall After Filing For Bankruptcy

By Vandana Singh

September 6, 7:06 AM

In its SEC filing, Allena Pharmaceuticals Inc (NASDAQ:ALNA) filed for chapter 11 bankruptcy protection and terminated the employment of substantially…

ALNA

4 minute read

Ironwood Pharmaceuticals Reports Positive Topline Data From Phase III Trial Of LINZESS (linaclotide) In Pediatric Patients Aged 6-17 With Functional Constipation; Study Met Primary And Secondary Endpoints

By Bill Haddad

September 6, 7:04 AM

– Study met primary and secondary endpoints – – Results add to body of data supporting the safety of linaclotide for this patient population – – There are currently no FDA approved

IRWD

3 minute read

Mannkind Completes Phase 1 Study of Inhaled Clofazimine; Says ‘Study supports the dosing regimen that will be pursued in further clinical programs’

By Bill Haddad

September 6, 6:15 AM

Study supports the dosing regimen that will be pursued in further clinical programs No serious adverse events or QT prolongation identified Planning underway to discuss results and the ongoing clinical

MNKD