Category - Developments

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

Developments

Akebia Therapeutics vadadustat meets primary endpoint in two Phase 3 trials

Akebia Therapeutics (NASDAQ:AKBA) vadadustat met its primary endpoint in two pivotal Phase 3 clinical trials for anemia due to chronic kidney disease (CKD). The trials compared the safety and efficacy of vadadustat to...

March 13, 2019

Developments

Akari Therapeutics announces successful pre-IND FDA meeting for Coversin

Akari Therapeutics (NASDAQ:AKTX) had a positive pre-IND meeting with the FDA about its proposed pivotal clinical trial program for Coversin for the treatment of pediatric hematopoietic stem cell transplant-related...

March 13, 2019

Developments

EyePoint Pharma launches DEXYCU intraocular suspension in U.S.

EyePoint Pharmaceuticals (NASDAQ:EYPT) commercially launched DEXYCU in the U.S. as the first and only FDA-approved intraocular steroid for the treatment of postoperative inflammation. DEXYCU is administered as a single...

March 13, 2019

Category - Developments

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