OPGN News

Total Revenue for Q1 2020 was approximately $617,000 (excluding Curetis Revenue)Curetis and Ares revenue was approximately $900,000 for the first quarter generating a pro forma.

OpGen, Inc. (Nasdaq: OPGN, “OpGen”), a precision medicine company harnessing the power of molecular diagnostics and informatics to help combat infectious disease, announced today that total revenue for the first quarter of 2020 was approximately $617,000 down from $1.0 million in the first quarter of 2019, excluding revenues from the Curetis businesses, which was acquired upon closing of the business combination on April 1, 2020. OpGen expects that its submission to the U.S. Food and Drug Administration (“FDA”) for clearance of the Acuitas® AMR Gene Panel (Isolates) for the detection of antimicrobial resistance genes in bacterial isolates is nearing completion.

OpGen, Inc. (OPGN) announced today that shareholders of Curetis N.V. have voted to approve the business combination of Curetis GmbH and OpGen. The successful completion of the Curetis vote at their Extraordinary General Meeting is an essential milestone for the planned business combination.

GAITHERSBURG, Md., March 23, 2020 -- OpGen, Inc. (Nasdaq: OPGN) announced today that its Acuitas Lighthouse® was used in a study conducted by the Mayo Clinic to predict.

OpGen, Inc. (Nasdaq: OPGN, “OpGen”), a precision medicine company harnessing the power of molecular diagnostics and informatics to help combat infectious disease, announced today an update on shareholder proxy voting in relation to the business combination with Curetis. As of March 23, 2020, a quorum has been achieved for the Company’s upcoming Special Meeting of Shareholders to be held on March 30, 2020 at which shareholders will vote on the approval of the business combination transaction.

Peer-reviewed study evaluated performance of AI-powered bioinformatics cloud platform, ares-genetics.cloud, for NGS-based antibiotic susceptibility testing on 12 pathogenic.

OpGen, Inc. (OPGN) reported an update on the business of Curetis GmbH (“Curetis”), the other party to the planned business combination with OpGen. Today, Curetis announced preliminary, unaudited 2019 condensed combined key financials and provided a business update. Revenue growth in 2019 was primarily driven by partnering projects of Curetis Group Company Ares Genetics as well as increasing uptake of Curetis’ Unyvero product line.

OpGen, Inc. (Nasdaq: OPGN, “OpGen”), a precision medicine company harnessing the power of molecular diagnostics and informatics to help combat infectious disease, announced today that, following its Special Meeting of Shareholders held March 30, 2020, OpGen shareholders overwhelmingly voted to approve the proposed business combination with Curetis N.V. OpGen reported that 95% of the votes cast were voted to approve the business combination. The business combination is expected to close in the coming days.

Q1 2020 OpGen Inc Earnings Call

OpGen, Inc. (Nasdaq: OPGN, “OpGen”), a precision medicine company harnessing the power of molecular diagnostics and informatics to help combat infectious disease, announced today that the business combination between Curetis and OpGen has successfully closed on April 1, 2020. At the closing, William E. Rhodes III, the former chairman of the Supervisory Board of Curetis N.V., was appointed chairman of the board of OpGen, and Oliver Schacht, PhD, the former Chief Executive Officer of Curetis N.V., was appointed the President and Chief Executive Officer of OpGen and to the board of directors.

GAITHERSBURG, Md., April 27, 2020 -- OpGen, Inc. (NASDAQ: OPGN) (“OpGen” or “the Company”) announced today that the Company will provide a business update and report its first.

Here's a roundup of top developments in the biotech space over the last 24 hours.On a day when the three major averages shed over 4% in reaction to bleak forecasts concerning the COVID-19 pandemic's impact, none of the Nasdaq- or NYSE-listed biotech stocks hit 52-week highs or lows.Stocks In Focus InVitae Withdraws FY20 Guidance Due To Pandemic, Plans Offering InVitae Corp (NYSE: NVTA), a medical genetics company, pre-announced first-quarter results and said it expects revenue of more than $63 million, up 55% year-over-year, billable tests of 147,000, up 65%, and non-GAAP cash burn of less than $100 million. Analysts expect revenue of $60.3 million.Citing the unknown duration and extent of COVID-19's impact on its business and the health care system in general, the company said it is withdrawing its guidance for 2020.Separately, the company announced an underwritten public offering of 17.78 million shares priced at $9 per share. All the shares are being sold by the company. The company expects the offering to close April 6 and to raise gross proceeds of about $16 million.The stock was down 11.96% at $10.31 in Thursday's premarket session. Benzinga is covering every angle of how the coronavirus affects the financial world. For daily updates, sign up for our coronavirus newsletter.Novartis Terminates Agreement To Sell Sandoz US Assets To Aurobindo Novartis AG (NYSE: NVS) said it has mutually agreed with Aurobindo Pharma to terminate a previously announced deal to sell the Sandoz U.S. generic oral solids and dermatology businesses to Aurobindo. The decision follows a lack of FTC approval for the transaction within anticipated timelines.Novartis shares were adding 1.57% to $82.20 in premarket trading Thursday.Nevro Forecasts Q1 Revenue Shortfall, Withdraws 2020 Guidance Nevro Corp (NYSE: NVRO) announced preliminary unaudited worldwide revenue for the first quarter of $86.4 million to $86.9 million, up from $82.1 million a year ago. This compares to the $94.96-million consensus estimate. The company attributed the potential shortfall to a rapid deceleration in March due to COVID-19 shelter-in-place policies and restrictions on elective surgical procedures.The company also withdrew its 2020 guidance issued in late February due to the rapidly evolving environment and continued uncertainties related to COVID-19.Separately, the company announced a public offering of 1.625 million shares of common stock and $165 million in aggregate principal amount of convertible senior notes due 2025.The stock fell 3.86% to $86 in after-hours trading.OpGen Closes On Curetis Purchase OpGen Inc (NASDAQ: OPGN) announced the consummation of its proposed acquisition of Dutch molecular diagnostics company Curetis N.V. OpGen shares paid as consideration for the sale will be distributed to Curetis, which will be dissolved and delisted from the Euronext exchange.OpGen shares were trading 5.44% higher at $2.52 in Thursday's premarket session. See also: The Week Ahead In Biotech: Clinical Readouts, COVID-19 News Flow In Focus Amid Continuing Uncertainty Eiger's HDV Study To Be Delayed, Company To Support Studies Of Peginterferon Lambda In COVID-19 Issuing an update on clinical development activity and business operations, Eiger Biopharmaceuticals Inc (NASDAQ: EIGR) said it has taken appropriate steps to ensure the safety of patients and integrity of the HDV Phase 3 D-LIVR trial. The trial is evaluating lonafarnib and ritonavir with or without PEGylated interferon-alfa-2a in patients with chronic hepatitis D virus infection.It now expects the COVID-19 pandemic to lead to the shifting of the completion of enrollment in the study to 2021.The company also said it has begun supporting multiple investigator-sponsored studies of peginterferon lambda in COVID-19."These studies will assess a 180 mcg, once-weekly, subcutaneous dose of Lambda, and will enroll at academic centers across the U.S., as well as international sites," the company said.The shares advanced 6.27% to $6.27 in after-hours trading.Affimed's Lead Drug Gets Orphan Drug Designation In T-Cell Lymphoma Affimed NV (NASDAQ: AFMD) said the FDA has granted orphan drug designation to AFM13, its lead CD30- and CD16A-binding innate cell engager, for the treatment of patients with T-cell lymphoma.Affimed shares were up 6.92% to $1.70 in the premarket session. BioCryst Names Anthony Doyle As CFO BioCryst Pharmaceuticals, Inc. (NASDAQ: BCRX) announced the appointment of Anthony Doyle as CFO. Doyle previously served as a global contract research organization's CFO.In premarket trading Thursday, BioCryst shares were adding 0.26% to $1.90.Boston Scientific Lowers Q1 Revenue Guidance Due To COVID-19 Impact Boston Scientific Corporation (NYSE: BSX) lowered its first-quarter revenue growth guidance to flat to slightly up from its previous estimate for 10-12% growth. The company attributed the predicament to a significant decline in procedural volumes in March due to COVID-19 impact.Humanigen's Lenzilumab Gets FDA Nod For Compassionate Use In COVID-19 Patients Humanigen Inc (OTC: HGEN) said the FDA approved the administration of its lenzilumab for COVID-19 patients under individual patient emergency IND applications to patients under its compassionate use program.The company said it is advancing plans to conduct a multi-center, Phase 3 study of lenzilumab for the prevention of acute respiratory distress syndrome, ARDS and/or death in hospitalized patients with pneumonia associated with coronavirus 2 infection.Applied Therapeutics Opens IND With FDA For AT-001 To Treat COVID-19-Related Lung Inflammation, Cardiomyopathy Applied Therapeutics Inc (NASDAQ: APLT) said it has opened an INDA with the FDA for AT-001 to treat acute lung inflammation and cardiomyopathy in critical COVID-19 patients. The company noted that multiple AT-001 investigator-initiated trials are now underway to address these two issues.Vir, Alnylam Expand Existing Collaboration To Include Additional Targets In COVID-19 Treatment Vir Biotechnology Inc (NASDAQ: VIR) and Alnylam Pharmaceuticals, Inc. (NASDAQ: ALNY) announced an expansion of their existing collaboration for RNAi therapeutics for infectious diseases. The expansion includes up to three additional targets focused on host factors for SARS-CoV-2, including ACE2 and TMPRSS2, both of which are considered critical for viral entry.Vir shares were gaining 2.45% to $30.50 in premarket trading Thursday.Related Link: Attention Biotech Investors: Mark Your Calendar For These April PDUFA Dates See more from Benzinga * 10 Biotech Winners And Losers In Q1 * The Daily Biotech Pulse: InflaRx Begins Human Testing For COVID-induced Pneumonia, Chembio, Becton Dickinson Launch Coronavirus Tests(C) 2020 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

Quorum achieved for OpGen stockholder vote on Curetis business combination with 99% of votes supporting transactionTransaction close anticipated by early April 2020Combined.

OpGen, Inc. (Nasdaq: OPGN, “OpGen”), a precision medicine company harnessing the power of molecular diagnostics and bioinformatics to help combat infectious disease, announced today the start of an investigator initiated collaboration with Karolinska Institutet, Sweden, to identify bacterial co-infections in patients admitted to the ICU for COVID-19 pneumonia using the Unyvero HPN panel. High-risk COVID-19 patients, especially in intensive care units and on ventilation, many of whom may be elderly or have preexisting conditions that compromise their immune system, are at a higher risk of acquiring bacterial co-infections that pose severe life-threatening complications.

OpGen, Inc. (OPGN) reported an update on the business of Curetis GmbH (“Curetis”), the other party to the planned business combination with OpGen. Today, Curetis announced that it started offering a CE-IVD certified real-time PCR test kit for SARS-CoV2 (also known as 2019-nCov), the causal pathogen of Corona Virus Disease 2019 (Covid-19).

Q4 2019 OpGen Inc Earnings Call

OpGen, Inc. (Nasdaq: OPGN, “OpGen”), a precision medicine company harnessing the power of molecular diagnostics and informatics to help combat infectious disease, to issued two letters to stockholders from new OpGen CEO Oliver Schacht and Chairman of the Board William Rhodes. As the newly appointed president and CEO of OpGen I want to take a moment to formally introduce myself and share the vision our new management team has for the company with regards to our business outlook, product pipeline and growth strategy for this year and beyond. This is an exciting time for OpGen, and I very much look forward to working with the entire team through the next phase of its growth.

OpGen, Inc. (Nasdaq: OPGN, “OpGen”), a precision medicine company harnessing the power of molecular diagnostics and informatics to help combat infectious disease, announced today an update on shareholder proxy voting in relation to the business combination with Curetis. Of those OpGen shareholders who have voted on the business combination proposal, more than 95% have voted in support of the transaction.

OpGen Inc (NASDAQ: OPGN) shares were ripping higher Monday in reaction to an announcement regarding a COVID-19 test kit from German molecular diagnostics company Curetis, which OpGen has agreed to merge with.Curetis said it has begun offering a CE-IVD-certified real-time PCR test kit for SARS-CoV-2, the virus causing COVID-19, OpGen said.The test kit, developed and manufactured by Curetis' Chinese strategic partner BGI, was cleared by the Chinese authorities in January. It was CE-IVD certified on Feb. 28. CE certification indicates the product is in conformity with health, safety and environmental protection standards for products sold in the European Economic Area.The BGI COVID-19 test kit allows labs to perform testing of nasopharyngeal swabs and bronchoalveolar lavage fluid. It has all necessary reagents and controls to test up to 48 patients in just a few hours, according to OpGen. The test is to be made available to labs in Europe through Curetis' network of distribution partners as well as directly by Curetis in countries where its distribution partners are not equipped to supply the test at short notices."We commend both Curetis and BGI Group for swiftly bringing this important product to market in a time of greatest need. As Covid-19 spreads across the globe, rapid testing technologies will be critical to the containment and ultimate treatment of the outbreak in Europe and beyond," OpGen CEO Evan Jones said in a statement. The stock was rallying 105.96% higher to $4.14 at the time of publication Monday. Related Links:The Week Ahead In Biotech: COVID-19 Updates, Tapering Earnings Flow, Eton's Seizure Drug Review 8 Biotechs With Coronavirus Vaccines In Development See more from Benzinga * 5 Reasons Why Amazon Is Morgan Stanley's Top Pick * 8 Biotechs With Coronavirus Vaccines In Development * BioNTech Says Coronavirus Vaccine Testing Begins Next Month In 'Project Lightspeed'(C) 2020 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

GAITHERSBURG, Md., March 12, 2020 -- OpGen, Inc. (NASDAQ: OPGN) (“OpGen” or “the Company”) announced today that the Company will report its fourth quarter and full year 2019.