Category - Developments

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

Developments

FDA clears Aerie Pharma’s Rocklatan in glaucoma or ocular hypertension

The FDA approved Aerie Pharmaceuticals’ (NASDAQ:AERI) Rocklatan ophthalmic solution to reduce elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. Aerie, which launched Rhopressa in...

March 13, 2019

Developments

Neurocrine Biosciences reports positive Phase 2 congenital adrenal hyperplasia data

Neurocrine Biosciences (NASDAQ:NBIX) announced positive interim results from its Phase 2 proof-of-concept study evaluating NBI-74788 in adult patients with classic congenital adrenal hyperplasia (CAH). Classic CAH is a...

March 12, 2019

Developments

Seres Therapeutics in microbiome immuno-oncology collaboration with AstraZeneca

Seres Therapeutics (NASDAQ:MCRB) entered a three-year research collaboration with AstraZeneca to focus on advancing the understanding of the microbiome in augmenting the efficacy of cancer immunotherapy, including...

March 11, 2019

Developments

Zafgen pulls IND application for Prader-Willi Syndrome candidate; CMO resigns

Zafgen (NASDAQ:ZFGN) has suspended plans to file an IND for its Prader-Willi Syndrome candidate after recently observing muscle degeneration and other anomalies in rodent toxicology studies. The effects were observed in...

March 11, 2019

Category - Developments

Karyopharm Therapeutics gets FDA extension of selinexor NDA review period

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

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

Akebia Therapeutics vadadustat meets primary endpoint in two Phase 3 trials

Akari Therapeutics announces successful pre-IND FDA meeting for Coversin

EyePoint Pharma launches DEXYCU intraocular suspension in U.S.

FDA clears Aerie Pharma’s Rocklatan in glaucoma or ocular hypertension

Neurocrine Biosciences reports positive Phase 2 congenital adrenal hyperplasia data

Seres Therapeutics in microbiome immuno-oncology collaboration with AstraZeneca

Zafgen pulls IND application for Prader-Willi Syndrome candidate; CMO resigns

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