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Marker Therapeutics Secures $13.1M Grant To Support MultiTAA Cell Therapy Trial
Friday, August 20, 2021 - 6:32am | 159Marker Therapeutics Inc (NASDAQ: MRKR) received notice of a Product Development Research award of approximately $13.1 million from Texas's Cancer Prevention and Research Institute (CPRIT). The CPRIT award is intended to support the adjuvant arm Phase 2 trial of its MultiTAA-...
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Paratek's Antibiotic Gets FDA Orphan Drug Tag For Lung Infection
Thursday, August 19, 2021 - 6:36am | 333The FDA has granted Orphan Drug Designation to Paratek Pharmaceuticals Inc's (NASDAQ: PRTK), Nuzyra (omadacycline) for infections caused by Nontuberculous Mycobacteria (NTM). The orphan drug designation includes NTM pulmonary disease caused by Mycobacterium...
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Galecto Starts Dosing In Mid-Stage Myelofibrosis Trial
Wednesday, August 18, 2021 - 9:25am | 192Galecto Inc (NASDAQ: GLTO) has announced the treatment of the first patient in a Phase 2a trial of its oral LOXL2 inhibitor GB2064 in myelofibrosis. Myelofibrosis, a form of chronic leukemia, is a rare type of blood cancer in which the normal bone marrow is destroyed by...
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DMC Recommends Biophytis Continue Sarconeos COVID-19 Study
Monday, August 16, 2021 - 8:36am | 214The Data Monitoring Committee (DMC) has recommended Biophytis SA (NASDAQ: BPTS) to continue patient recruitment into part 2 of Phase 2-3 COVA Study in COVID-19, with the protocol unmodified after reviewing of safety data. The COVA clinical program is assessing Sarconeos (BIO101...
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Frequency Therapeutics Stock Craters After FX-322's Four Weekly Regime Shows No Benefit In Sensorineural Hearing Loss
Tuesday, March 23, 2021 - 7:54am | 441Frequency Therapeutics Inc (NASDAQ: FREQ) stock plunges in the premarket after reporting topline day-90 data from its Phase 2a study (FX-322-202) evaluating the company's lead product candidate FX-322 in sensorineural hearing loss (SNHL). What Happened: Final results...
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AnaptysBio's Imsidolimab Fails To Separate From Placebo In Skin Blistering Disorder Study
Monday, March 8, 2021 - 9:28am | 320AnaptysBio Inc (NASDAQ: ANAB) reports disappointing top-line data from its Phase 2 (POPLAR) trial of imsidolimab for palmoplantar pustulosis (PPP). The study failed to meet its primary endpoint of improvement on disease severity index from baseline at week 16,...
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Chimerix's DSTAT Shows Promising Results In First Cohort Of COVID-19 Study
Thursday, February 25, 2021 - 9:50am | 250Chimerix Inc (NASDAQ: CMRX) reports topline results from the first cohort (n=12) of its Phase 2/3 study evaluating DSTAT in hospitalized patients with Acute Lung Injury (ALI) and COVID-19 infection. The primary endpoint of the study is survival without the need for mechanical...
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Revance Therapeutics' DaxibotulinumtoxinA For Injection Improves Muscle Tone In Mid-Stage Upper Limb Spasticity
Tuesday, February 23, 2021 - 6:58am | 472Revance Therapeutics Inc (NASDAQ: RVNC) has reported topline data from JUNIPER Phase 2 study evaluating DaxibotulinumtoxinA for Injection to treat adults with moderate to severe upper limb spasticity. It is a neurological condition that affects the ability to move the...
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Nektar Therapeutics Secures $150M From SFJ Pharma For New Study With BEMPEG/Pembrolizumab Combo In Head & Neck Cancer
Wednesday, February 17, 2021 - 10:25am | 361Nektar Therapeutics (NASDAQ: NKTR) announces a financing and co-development collaboration with privately-held SFJ Pharmaceuticals to develop Bempegaldesleukin (BEMPEG) CD122-preferential IL-2–pathway agonist. The collaboration between SFJ and Nektar will support a new...
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Clene To Start Testing CNM-ZnAg In COVID-19 Patients In Brazil
Tuesday, February 16, 2021 - 2:29pm | 153Regulatory authorities in Brazil signed off Clene Inc's (NASDAQ: CLNN) Phase 2 study evaluating CNM-ZnAg liquid solution in acutely symptomatic, non-hospitalized COVID-19 patients. CNM-ZnAg is a proprietary zinc-silver ionic solution. The 276-subject trial's...
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Windtree Therapeutics' AEROSURF Drug Delivery Device Secures US Patent
Tuesday, February 16, 2021 - 1:16pm | 202United States Patent and Trademark Office (USPTO) has issued U.S. Patent No. 10,874,818 to Windtree Therapeutics Inc (NASDAQ: WINT), covering features of the aerosol delivery system for AEROSURF drug delivery device. The new aerosol delivery system also implements...
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Exelixis' Cabozantinib Data Shows Clinically Significant Benefit Versus Pfizer's Sutent, In A Type Of Kidney Cancer
Tuesday, February 16, 2021 - 10:01am | 386Exelixis Inc (NASDAQ: EXEL) has reported new data from the Phase 2 (PAPMET) study evaluating CABOMETYX (cabozantinib) compared with Pfizer Inc's (NYSE: PFE) Sutent (sunitinib) in patients with metastatic papillary renal cell carcinoma (PRCC), a form of...
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Cortexyme Stops Enrollment In Mid-Stage Atuzaginstat Study In Alzheimer's Disease
Tuesday, February 16, 2021 - 9:52am | 239Following the review of hepatic adverse events, the FDA has instituted a partial clinical hold impacting the open-label extension (OLE) phase of Phase 2/3 GAIN trial of Cortexyme Inc (NASDAQ: CRTX) evaluating atuzaginstat (COR388) in patients with mild to...
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Heat Biologics Cell Therapy Shows Survival Benefit In Mid-Stage Lung Cancer Study, Shares Rally
Tuesday, February 9, 2021 - 9:23am | 320Heat Biologics Inc (NASDAQ: HTBX) soars in premarket on the heels of encouraging interim data from the Phase 2 trial evaluating HS-110, in combination with Bristol-Myers Squibb's (NYSE: BMY) Opdivo (nivolumab) in advanced non-small-cell lung cancer (NSCLC). Median...
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Innate Pharma To Test Lacutamab In Relapsed/Refractory Peripheral T-Cell Lymphoma Patients
Tuesday, February 9, 2021 - 8:19am | 269Innate Pharma SA's (NASDAQ: IPHA) ongoing TELLOMAK Phase 2 trial, evaluating lacutamab has reached the pre-determined number of responses needed to advance to stage 2, thus allowing Innate to recruit additional patients. The company expects to present the preliminary data from...