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BioWorld - Sunday, January 4, 2026
Home » Topics » Clinical

Clinical
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Solid phase IIb CVC data clear path for Sanifit phase III study

Nov. 12, 2019
By Nuala Moran
LONDON – Sanifit Therapeutics SA has delivered positive phase IIb data demonstrating SNF-472 significantly reduces progression of cardiovascular calcification (CVC) in patients with end-stage kidney disease who are on dialysis.
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Roche and PTC check off another SMA win, but the devil is in the details

Nov. 12, 2019
By Brian Orelli
Roche Holding AG and PTC Therapeutics Inc. together with their partner, the SMA Foundation, reported success in part two of the pivotal Sunfish study testing their survival motor neuron-2 splicing modifier risdiplam in patients with type 2 or 3 spinal muscular atrophy (SMA).
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Nextcure stock continues wild way, drops on updated data

Nov. 12, 2019
By Lee Landenberger
Shares of Nextcure Inc. (NASDAQ:NXTC) have alternately been up sharply lately or down dramatically. Following the weekend release of updated positive clinical data from its NC-318 phase I/II study, the share price nosed down 52.9% Monday.
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Gelesis-Plenity-11-11.png

Hydrogel weight-loss pill from Gelesis shows efficacy in overweight adults

Nov. 11, 2019
By Stacy Lawrence
Most weight loss interventions target obese or super-obese patients who have adjacent comorbidities, such as type 2 diabetes or sleep apnea. But Boston-based Gelesis aims to change that with its hydrogel pill Plenity.
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'Cataustrophe' makes AD the demon; AC Immune's effort detailed in webinar

Nov. 10, 2019
By Randy Osborne

Within the first few minutes of a key opinion leader webinar on Alzheimer's disease sponsored by AC Immune SA, CEO Andrea Pfeifer brought up the decision by Biogen Inc. to file for regulatory approval of amyloid beta targeter aducanumab in early AD, based on results from a subset of patients in the phase III study called Engage.


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Stock market crash illustration
Competitor Dermira enjoys boost

Shares sink as Anaptysbio study fails to hit the primary endpoint in AD trial

Nov. 10, 2019
By Lee Landenberger

In the wake of each dosing arms' failure to hit the primary endpoint in Anaptysbio Inc.'s phase IIb study of etokimab to treat moderate to severe atopic dermatitis (AD), the stock dropped steeply and the company postponed initiating its phase IIb etokimab trial in eosinophilic asthma until it analyzes the phase IIb result. 


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Penumbra's EXTRACT-PE study of Indigo Aspiration system hits primary endpoints

Nov. 8, 2019
By Meg Bryant
Penumbra Inc. reported final results from its IDE trial of the Indigo Aspiration system at the Vascular Interventional Advances (VIVA) annual meeting in Las Vegas. The Alameda, Calif.-based company said that the EXTRACT-PE trial met its primary endpoints in patients with acute pulmonary embolism (PE).
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Allena's shares plunge despite reloxaliase phase III hitting primary endpoint in EH study

Nov. 8, 2019
By Lee Landenberger
Allena Pharmaceuticals Inc.'s phase III URIROX-1 trial of reloxaliase hit its primary endpoint, with a statistically significant reduction in urinary oxalate (Uox) in patients with enteric hyperoxaluria (EH), while its phase II Study 206 trial showed reduced plasma oxalate reduction in patients with EH and advanced chronic kidney disease (CKD).
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In virtro fertilization

Obseva stock plunges on phase III miss, termination of in vitro fertilization program

Nov. 8, 2019
By Cormac Sheridan
DUBLIN – Obseva SA's stock plunged 65% Thursday on news that it was terminating development of its in vitro fertilization (IVF) drug, nolasiban, after it missed the primary endpoint of a confirmatory phase III trial. The result blindsided both Obseva and investors, as the outcome was at odds with that of a previous phase III study, Implant 2, which had demonstrated a statistically significant and clinically relevant improvement in the rate of successful pregnancy at 12 weeks.
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ASH abstracts move the market

Nov. 7, 2019
By Lee Landenberger
Emerging from the tsunami of abstracts from the nearly here American Society of Hematology (ASH) annual meeting in Orlando, Fla., were data that sent some stocks upward on Wednesday. Most notably, Constellation Pharmaceuticals Inc. (NASDAQ:CNST) was a huge winner as its shares nearly doubled in value as they closed at $28,10, up $13.33, for a gain of 90.25%.
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