Category - Developments

Developments

Allena Pharma completes enrollment in first of two Phase 3 enteric hyperoxaluria trials

Allena Pharmaceuticals (NASDAQ:ALNA) has completed enrollment in the first of two Phase 3 clinical trials of reloxaliase for the treatment of enteric hyperoxaluria. Enteric hyperoxaluria occurs when an underlying...

September 16, 2019

Developments

FDA AdCom votes to approve Aimmune’s PALFORZIA for peanut allergy

An advisory committee of the FDA voted to support the use of Aimmune Therapeutics’ (NASDAQ:AIMT) PALFORZIA in children and teens with peanut allergy. The committee voted seven-to-two that the efficacy data and eight-to...

September 16, 2019

Developments

Bellerophon gets FDA orphan drug designation for IPF therapy

Bellerophon Therapeutics (NASDAQ:BLPH) received FDA orphan drug designation for the treatment of idiopathic pulmonary fibrosis (IPF) with nitric oxide. IPF is a progressive and fatal lung disease caused by the...

September 16, 2019

Developments

Verrica Pharma submits NDA for molluscum contagiosum drug

Verrica Pharmaceuticals (NASDAQ:VRCA) submitted an NDA to the FDA for its molluscum contagiosum drug candidate, VP-102. Molluscum contagiosum is a viral skin infection that currently has no FDA-approved therapies. VP...

September 16, 2019

Developments

Wave Life Sciences gets FDA fast track designation for suvodirsen

Wave Life Sciences (NASDAQ:WVE) received FDA fast track designation for suvodirsen for the treatment of Duchenne muscular dystrophy (DMD). DMD is a genetic disorder caused by the absence of dystrophin – a protein that...

September 16, 2019

Developments

TG Therapeutics presents new data from Phase 2 and 3 trials of ublituximab

TG Therapeutics (NASDAQ:TGTX) presented initial Phase 3 and updated Phase 2 data for ublituximab, an anti-CD20 monoclonal antibody, for the treatment of relapsing forms of multiple sclerosis (RMS). At the 35th Annual...

September 13, 2019

Developments

Akari’s nomacopan gets FDA orphan drug designation for bullous pemphigoid

Akari Therapeutics (NASDAQ:AKTX) received FDA orphan drug designation for nomacopan for the treatment of bullous pemphigoid (BP). BP is a severe orphan inflammatory skin disease characterized by chronic blistering of...

September 13, 2019

Developments

Helius Medical adds new PoNS clinic in Quebec City

Helius Medical Technologies (NASDAQ:HSDT; TSX:HSM) is opening a new PoNS clinic in Quebec City, Canada to be operated by Clinique Cortex. The PoNS device is authorized in Canada for the acute treatment of chronic...

September 13, 2019

Developments

Tocagen fails Phase 3 trial in recurrent brain cancer

Tocagen’s (NASDAQ:TOCA) Phase 3 Toca 5 clinical trial, evaluating Toca 511 and Toca FC, in patients with recurrent high grade glioma, undergoing resection, missed the primary endpoint of overall survival, compared with...

September 12, 2019

Developments

INmune Bio receives USPTO allowance for DN-TNF-alpha platform

The U.S. Patent and Trademark Office (USPTO) gave INmune Bio (NASDAQ: INMB) notice of allowance for a patent, which covers the company’s INB03 program utilizing its dominant negative tumor necrosis factor–alpha (DN-TNF...

September 12, 2019

Category - Developments

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