Here's a roundup of top developments in the biotech space over the last 24 hours. Scaling The Peaks (Biotech stocks hitting 52-week highs on Nov. 6) Agile Therapeutics Inc (NASDAQ: AGRX )(follow-on rally ...
70.6% of week 16 HiSCR responders maintain response throughout week 40 while 41.8% of non-responders become responders (total HiSCR rate = 56.3% at end of treatment) 78.2% of OLE patients complete extension ...
We can readily understand why investors are attracted to unprofitable companies. For example, although...
InflaRx has been on a bit of a cold streak lately.
End of Phase 2 FDA meeting scheduled to discuss the path forward for IFX-1 in Hidradenitis SuppurativaInitial promising results reported in Pyoderma GangraenosumPart 1 of.
End of Phase II meeting with the FDA scheduled to discuss the path forward for IFX-1 in Hidradenitis SuppurativaInitial promising results reported in Pyoderma GangraenosumPart 1.
JENA, Germany, Jan. 09, 2020 -- InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement.
There's no doubt that money can be made by owning shares of unprofitable businesses. For example, although Amazon.com...
Here's a roundup of top developments in the biotech space over the last 24 hours.Scaling The Peaks (Biotech Stocks Hitting 52-week Highs March 31) * Athersys Inc (NASDAQ: ATHX) * Forty Seven Inc (NASDAQ: FTSV) * Ra Pharmaceuticals Inc (NASDAQ: RARX) * Quidel Corporation (NASDAQ: QDEL)Down In The Dumps (Biotech Stocks Hitting 52-week Lows March 31) * Aikido Pharma Inc (NASDAQ: AIKI) * BIOLASE Inc (NASDAQ: BIOL) * Eloxx Pharmaceuticals Inc (NASDAQ: ELOX) * Gritstone Oncology Inc (NASDAQ: GRTS) * Neovasc Inc (NASDAQ: NVCN)(moved in reaction to its fourth quarter results) * Opko Health Inc. (NASDAQ: OPK) * Phio Pharmaceuticals Corp (NASDAQ: PHIO)(announced $4 million registered offering) * Second Sight Medical Products Inc (NASDAQ: EYES)Related Link: Amarin Analysts React To Vascepa Patent Loss, See Small Chance Of Overturning JudgmentStocks In Focus Inflarx Begins Human Testing Of Lead Drug For COVID-19-induced Pneumonia German biopharma Inflarx NV (NASDAQ: IFRX) said it has enrolled and dosed the first patient into a randomized clinical trial investigating the safety and efficacy of IFX-1, its monoclonal anti-C5a antibody in patients with severe COVID-19-induced pneumonia. The trial is being initiated in the Netherlands.The decision to initiate human testing follows initial positive human data from two patients suffering from COVID-19-induced pneumonia, who were treated with BDB-001, an anti-C5a antibody produced from BDB from the IFX-1 cell line, in China.The company said it plans to initiate additional centers in Germany and potentially other European countries.In pre-market trading Wednesday, InflaRx shares were jumping 114.66% to $8.20.Emergent Biosolutions To Provide CDMO Services For Novavax's Flu Vaccine Candidate Novavax, Inc. (NASDAQ: NVAX) and Emergent Biosolutions Inc (NYSE: EBS) announced an agreement, whereby the latter would provide molecule-to-market contract development and manufacturing to produce the former's recombinant quadrivalent seasonal influenza vaccine candidate with its proprietary Matrix-M adjuvant.Novavax recently announced positive results for the late-stage trial that evaluated the vaccine candidate.Novavax shares were adding 3.09% to $14 in pre-market trading.Benzinga is covering every angle of how the coronavirus affects the financial world. For daily updates, sign up for our coronavirus newsletter.Mesoblast's Regulatory Filing For Graft Vs. Host Disease Drug Accepted For Priority Review Mesoblast limited (NASDAQ: MESO) said the FDA has accepted for priority review its BLA for Ryoncil, its allogeneic cell therapy for the treatment of children with steroid-refractory acute graft versus host disease. The PDUFA date has been set for Sept. 30, the company noted.View more earnings on IFRXThe stock was advancing 8.45% to $4.75 in pre-market trading.Eisai To Co-develop And Commercialize Seikagaku's Osteoarthritis Drug In China Eisai Co., Ltd (OTC: ESALY) announced an agreement with Seikagaku for co-developing and marketing of SI-613 in China. SI-613 is a therapeutic agent for osteoarthritis discovered by Seikagaku.Chembio Launches Serological COVID-19 Detection Test In U.S. Chembio Diagnostics Inc (NASDAQ: CEMI) said it has launched in the U.S. the rapid DPP COVID-19 serological point-of-care test for the detection of IgM and IgG antibodies."These results can be obtained within 15 minutes from a simple finger stick utilizing Chembio's MicroReader 1 and MicroReader 2 analyzers which are produced by Chembio Germany," the company said.The stock was jumping 23.05% to $6.30 in after-hours trading.Becton Dickinson Releases COVID-19 Test Developed By BioMedomics Medtech company Becton Dickinson and Co (NYSE: BDX) and privately held diagnostics company BioMedomics announced the release of a new point-of-care test that can detect antibodies in blood to confirm current or past exposure to COVID-19 in as little as 15 minutes.The new test developed and manufactured by BioMedomics will be available through BD and distributed exclusively by Henry Schein, Inc. (NASDAQ: HSIC) to health care providers throughout the U.S.BD shares were adding 0.97% to $232 in pre-market trading.Ultragenyx Out-licenses Gene Therapy Platforms And In-licenses Gene Therapy Vectors Ultragenyx Pharmaceutical Inc (NASDAQ: RARE) announced a strategic partnership and non-exclusive license and technology access agreement with DAIICHI SANKYO/S ADR (OTC: DSNKY) for its AAV-based gene therapy manufacturing technologies, namely its HeLa PCL and HEK293 transient transfection manufacturing technology platforms.The agreement provides for Daiichi Sankyo making an upfront payment of $125 million and an equity investment amounting to $75 million at about $60 per share in Ultragenyx. Daiichi Sankyo will pay an additional $25 million upon completion of the technology transfer of the HeLa PCL and HEK293 platforms as well as single-digit royalties on net sales of products manufactured in either system.Separately, Ultragenyx and Regenxbio Inc (NASDAQ: RGNX) announced a new exclusive, worldwide license agreement, extending the companies' existing gene therapy partnership. Under the agreement, REGENXBIO has granted Ultragenyx an exclusive, worldwide license, with rights to sublicense, to its NAV AAV8 and AAV9 vectors for the development and commercialization of gene therapy treatments for a rare metabolic disorder. Regenxbio will be compensated with an upfront payment of $7 million, ongoing fees, milestone payments, and royalties on net sales of products incorporating the licensed intellectual property.On The Radar Earnings Ascendis Pharma A/S (NASDAQ: ASND) (after the market close)See more from Benzinga * The Daily Biotech Pulse: Milestone Pharma Flunks Late-Stage Study, CytomX Strikes Cancer Drug Collaboration, BARDA Grant For GenMark's COVID-19 Test * 10 Small-To-Mid-Cap Biotech Ideas For When The Coronavirus Fades(C) 2020 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Recently announced results of open label extension part of SHINE Phase IIb study confirm potential of IFX-1 in Hidradenitis Suppurativa and warrant evaluation of future development Company announces updated ...
It seems that the masses and most of the financial media hate hedge funds and what they do, but why is this hatred of hedge funds so prominent? At the end of the day, these asset management firms do not gamble the hard-earned money of the people who are on the edge of poverty. Truth […]
Shares of InflaRx and BioNTech diverged Wednesday after the biotech companies unveiled updates for their coronavirus treatment and vaccine, respectively. InflaRx rocketed as BioNTech fell.
JENA, Germany, Feb. 19, 2020 -- InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement.
Does InflaRx N.V. (NASDAQ:IFRX) represent a good buying opportunity at the moment? Let’s quickly check the hedge fund interest towards the company. Hedge fund firms constantly search out bright intellectuals and highly-experienced employees and throw away millions of dollars on satellite photos and other research activities, so it is no wonder why they tend to […]
InflaRx to present initial data at the SVB Leerink Global Healthcare Conference today at 9:00 am EST (3:00 pm CET). JENA, Germany, Feb. 26, 2020 (GLOBE NEWSWIRE) -- InflaRx N.V. (IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, announces positive initial data from the first 5 patients in the Phase IIa open label study with IFX-1 in patients suffering from Pyoderma Gangraenosum (PG). PG is a rare and debilitating neutrophil-driven, autoinflammatory skin disease, characterized by an acute, destructive ulcerating process of the skin, primarily occurring on the legs but also other regions of the body.
IFX-1 in Hidradenitis Suppurativa did not meet the primary endpoint; trial ongoing - multiple efficacy signals for high-dose group identifiedFirst patient treated in Pyoderma.
InflaRx (IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, today reported additional in-depth analysis of the completed double blind, placebo controlled part of the ongoing international SHINE Phase IIb study to supplement InflaRx’s top line disclosure of results reported on June 5, 2019. The purpose of this study is to investigate the safety and efficacy of IFX-1, a first-in-class anti-human complement factor C5a monoclonal antibody, in patients suffering from moderate to severe Hidradenitis Suppurativa (HS), a painful and debilitating chronic inflammatory skin disease with limited treatment options. Prof. Niels C. Riedemann, CEO and Founder of InflaRx, commented: “While we were very disappointed about missing our primary endpoint in the SHINE study, our in depth post-hoc data analysis suggests a robust anti-inflammatory activity in the high dose IFX-1 treatment group across numerous efficacy measures which were not reflected by the HiSCR.
InflaRx N.V. (IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, today announced the enrollment of the first patient into a randomized clinical trial investigating the safety and efficacy of IFX-1, the company´s monoclonal anti-C5a antibody, in patients with severe COVID-19-induced pneumonia. The company has received initial positive human data from two initial patients suffering from COVID-19-induced severe pneumonia who were treated with BDB-001, an anti-C5a antibody produced by BDB from the IFX-1 cell line, in China.
“A volatile, risk-off environment could make these relative outperformers,” writes Jeffries’ Michael Yee.
If you want to know who really controls InflaRx N.V. (NASDAQ:IFRX), then you'll have to look at the makeup of its...