Category - Developments

Developments

Tiziana Life Sciences submits IND for oral Foralumab

Tiziana Life Sciences (NASDAQ:TLSA, AIM:TILS) submitted an IND to the FDA for its enteric-coated capsules of Foralumab, an anti-CD3 monoclonal antibody. Foralumab, believed to induce an anti-inflammatory response by...

March 20, 2019

Developments

Aptevo Therapeutics initiates Phase 1 trial for anti-inflammatory antibody

Aptevo Therapeutics (NASDAQ:APVO) began dosing subjects in its Phase 1 trial for APVO210, a targeted cytokine immunotherapy. APVO210 is a modified form of the cytokine, IL-10, that suppresses inflammation without...

March 20, 2019

Developments

GeoVax study suggests Ebola vaccine could provide 100% protection with single dose

GeoVax Labs (OTCQB:GOVX) published research showing that a single intramuscular dose of its Ebola vaccine, GEO-EM01, provided 100% protection in rhesus macaques challenged with a lethal dose of Ebola virus. GEO-EM01...

March 20, 2019

Developments

Puma Biotech anti-HER2 breast cancer drug approved in Australia

Puma Biotech (NASDAQ:PBYI) received approval to market neratinib in Australia via its licensing partner, Specialised Therapeutics Asia, who has also submitted an application for regulatory approval in Singapore...

March 19, 2019

Developments

Dare Bioscience publishes positive clinical findings for vaginally-administered tamoxifen

Dare Bioscience’s (NASDAQ:DARE) DARE-VVA1, a proprietary formulation of tamoxifen designed for vaginal delivery, showed significant improvements in reducing vaginal pH and dryness in patients with vulvar and vaginal...

March 19, 2019

Developments

Aerpio Pharma misses primary endpoint in Phase 2b diabetic retinopathy trial

Aerpio Pharmaceuticals (NASDAQ:ARPO) lead candidate, AKB-9778, failed to meet its primary endpoint in its Phase 2b trial for moderate-to-severe non-proliferative diabetic retinopathy (NPDR). Compared to placebo, twice...

March 19, 2019

Developments

Dermira atopic dermatitis drug meets primary endpoint in Phase 2b study

Dermira’s (NASDAQ:DERM) Phase 2b dose-ranging study of lebrikizumab in atopic dermatitis demonstrated that all three doses achieved greater improvements in the Eczema Area and Severity Index score, compared with placebo...

March 19, 2019

Developments

Karyopharm Therapeutics gets FDA extension of selinexor NDA review period

Karyopharm Therapeutics (NASDAQ:KPTI) announced that the FDA has extended its review of the company’s NDA for selinexor by three months. Selinexor’s NDA is currently under priority review for its use in combination with...

March 15, 2019

Developments

Soleno Therapeutics Phase 3 trial for Prader-Willi Syndrome gets positive DSMB recommendation

Soleno Therapeutics (NASDAQ:SLNO) reported that the Data Safety Monitoring Board (DSMB) recommended continuation of the company’s Phase 3 trial in Prader-Willi Syndrome (PWS) patients, without any changes. The...

March 15, 2019

Developments

Moleculin Biotech treats first patients in Phase 1/2 Annamycin trial, requests fast track designation

Moleculin Biotech (NASDAQ:MBRX) has treated the first patients in its European Phase 1/2 clinical trial of Annamycin for relapsed and refractory acute myeloid leukemia (AML). The company also submitted a request to the...

March 14, 2019

Category - Developments

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