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BioWorld - Saturday, April 17, 2021
Home » Topics » Clinical

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

Nov. 8, 2019
By Meg Bryant
No Comments
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
No Comments
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
No Comments
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
No Comments
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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Supernus' non-superlative ADHD try vexing investors, still promise in SPN-812

Nov. 7, 2019
By Randy Osborne
No Comments
Supernus Pharmaceuticals Inc. CEO Jack Khattar said the phase III failure in the study called P301 with SPN-810 (molindone hydrochloride) was "very puzzling" to the Rockville, Md.-based firm, which will be "digging very deep into the data" with hopes of figuring out what went wrong. Shares (NASDAQ:SUPN) closed Wednesday at $19.93, down $9.20, or 31.6%. 
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Centering itself: Epicentrx launches a phase III in SCLC

Nov. 6, 2019
By Lee Landenberger
No Comments
Corey Carter, whose company Epicentrx Inc. just dosed its first patient in a phase III trial for treating third-line and beyond small-cell lung cancer (SCLC), has made studying the disease a life goal. "With my military background, I noticed that smoking rates are higher there," Carter, the company's president and CEO, told BioWorld. "That's when it became important to me. Then, also, my dad had small-cell lung cancer."
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Amgen says it wants the Revolution for its phase Ib

Nov. 5, 2019
By Lee Landenberger
No Comments
Amgen Inc. and Revolution Medicines Inc. will collaborate on a clinical trial evaluating the combination of RMC-4630, Revolution's SHP2 inhibitor, and Amgen's AMG-510, a KRAS-G12C inhibitor. Amgen will conduct the phase Ib trial to treat patients with advanced solid tumors harboring the KRAS G12C mutation and Revolution will provide Amgen with RMC-4630.
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Listen up: Otonomy effort with Otividex could mean 'turnaround' in Meniere's

Nov. 4, 2019
By Randy Osborne
No Comments
San Diego-based Otonomy Inc.'s launch of the phase I/II trial for OTO-413, a sustained-exposure formulation of brain-derived neurotrophic factor (BDNF), in patients with hearing loss brought renewed investor attention to the company, consigned to the back burner after a late-stage failure.
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Nyxoah reports positive results for its Genio, implantable neurostimulation device

Nov. 4, 2019
By Nuala Moran
No Comments
LONDON – Nyxoah SA reported positive clinical results for Genio, its lead-free, battery-less implantable neurostimulation device, showing it resulted in a significant reduction of the severity of obstructive sleep apnea (OSA), the world's most common sleeping disorder.
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Cyclerion reorganizes in wake of two phase II troubles forsGC stimulator praliciguat

Oct. 31, 2019
By Lee Landenberger
No Comments
Two phase II stumbles for startup Cyclerion Therapeutics Inc., an Ironwood Pharmaceuticals Inc. spinout, crushed the stock (NADAQ:CYCN), which closed down a steep 79.5% on Wednesday.
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