Nicox Announces Senior Management Change
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Nicox Announces Senior Management Change
Helsinn Group and Italfarmaco announce oral presentation of NEPA (netupitant and palonosetron) data at ESMO Virtual Congress 2020
SEATTLE, Sept. 17, 2020 (GLOBE NEWSWIRE) -- Athira Pharma, Inc., (Nasdaq: ATHA) (“Athira”), a late clinical-stage biopharmaceutical company focused on developing small molecules to restore neuronal health and stop neurodegeneration, today announced the pricing of its initial public offering of 12,000,000 shares of its common stock at a price to the public of $17.00 per share. All of the shares of common stock are being offered by Athira. The gross proceeds from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Athira, are expected to be $204.0 million. Athira’s common stock is expected to begin trading on the Nasdaq Global Select Market under the ticker symbol “ATHA” on September 18, 2020. The offering is expected to close on September 22, 2020, subject to satisfaction of customary closing conditions. In addition, Athira has granted the underwriters a 30-day option to purchase up to an additional 1,800,000 shares of Athira’s common stock at the initial public offering price less the underwriting discounts and commissions.
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Athira Pharma Announces Pricing of Initial Public Offering
Basel, 18 September 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the launch of its Elecsys® Anti-SARS-CoV-2 S antibody test for markets accepting the CE Mark. Roche has filed for Emergency Use Authorisation (EUA) from the U.S. Food and Drug Administration (FDA). The Elecsys Anti-SARS-CoV-2 serology test can be used to quantitatively measure antibodies in people who have been exposed to the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) and can play an important part in characterising a vaccine-induced immune response.1 Specifically, the test targets antibodies which are directed against the particular region of the viral spike protein responsible for binding to the host cell receptor, which is required for the virus to enter the host cell. The majority of current candidate vaccines aim to induce an antibody response against the spike protein. “As the possibility of an effective SARS-CoV-2 vaccine becomes a reality, quantitative measurement of antibodies will be crucial in the evaluation of any potential vaccine. The new quantitative Elecsys antibody test can play a pivotal role in vaccine clinical trials as well as helping clinicians assess patients immune response.This will be instrumental in protecting people most vulnerable to the virus, as well as in overcoming COVID-19 for society in general.” said Thomas Schinecker, CEO Roche Diagnostics. "This new test, the twelfth in the Roche SARS-CoV-2 testing portfolio, is another essential addition to support healthcare systems and patients as we jointly fight COVID-19.” Before a vaccine is administered it is important to know the starting level of antibodies a person has, in order to evaluate any change in antibody levels that the vaccine induces, especially the development of antibodies directed against the SARS-CoV-2 spike protein. These antibodies have been shown to have potent antiviral activity and correlate to potential immunity.2 Measuring antibody levels could also be vital in establishing vaccine efficacy in the prevention of infection and/or the development of severe COVID-19.1 Alongside its importance to vaccine design and efficacy evaluations, the Elecsys Anti-SARS-CoV-2 S serology test can be used to determine antibody levels in plasmapheresis donations. Performing a combination of the Elecsys Anti-SARS-CoV-2 S and Elecsys Anti-SARS-CoV-2 tests can also help to more effectively define what percentage of a given population has developed antibodies (seroprevalence) against SARS-COV-2, especially in low to moderate seroprevalence settings.3 Knowing a given population’s seroprevalence is important in understanding how to contain the spread of the virus, as well as how to safely ease lockdown restrictions. The test is the latest addition to the comprehensive Roche diagnostic portfolio to help healthcare systems combat COVID-19 through testing in the laboratory and at the point of care. Currently, this portfolio includes molecular, serology and digital solutions which help diagnose and manage COVID-19 during the initial stages of infection, during the recovery phase, as well as following the resolution of infection. About SARS-CoV-2 Coronaviruses (CoV) are a large family of viruses that cause illness ranging from the common cold to more severe diseases such as Middle East Respiratory Syndrome (MERS-CoV) and Severe Acute Respiratory Syndrome (SARS-CoV). The novel coronavirus (SARS-CoV-2) is a new strain which has not previously been identified in humans. Signs of infection include respiratory symptoms such as cough, shortness of breath, difficulty breathing, and fever. In more severe cases, pneumonia, severe acute respiratory syndrome, kidney failure and death can occur.4 About potential SARS-COV-2 vaccines As of 3 September 2020, 47 candidate vaccines are in clinical evaluation and 3 vaccines have been approved for early or limited use, while at least 91 preclinical vaccines are under active investigation.1,5 All candidate vaccines in Phase III or approved for limited / early use aim to induce an antibody response against the SARS-CoV-2 spike protein. Any potential vaccine for SARS-CoV-2 would work (amongst other mechanisms) by triggering the immune response to develop neutralising antibodies, in the person receiving the vaccine. In doing so, the vaccine trains the body’s immune system to recognize and fight an exposure to SARS-CoV-2, in a controlled way, without being exposed to the actual virus.1 About Elecsys Anti-SARS-CoV-2 S and Elecsys Anti-SARS-CoV-2 serology tests The Elecsys® Anti-SARS-CoV-2 S is an immunoassay for the quantitative, in vitro determination of antibodies to SARS-CoV-2 in human serum and plasma. Through a blood sample, the test can measure the quantity of antibodies to the spike protein of the coronavirus, which could signal whether a person has been already infected and potentially developed immunity to the virus. This can also be used to determine antibody levels in plasmapheresis donations. Plasmapheresis is a procedure which separates and removes the plasma from a patient’s blood. This plasma is then replaced with plasma from a donor. It is assumed that plasma from a donor who has already had SARS-CoV-2 will have direct antiviral properties for the donor recipient.6 This is being explored as an adjunctive treatment for the management of COVID-19.6 The test has both a high clinical specificity of 99.98% (N=5991) and sensitivity of 98.8% (N=1423), 14 days or later after diagnosis with PCR. Additionally, across panels of potentially cross-reactive samples (N=1100) from endemic human coronaviruses, infectious respiratory diseases, other infectious diseases, auto-immune and liver related diseases, the test demonstrated zero cross-reactivity. Hospitals and reference laboratories can run the test on Roche’s cobas e analyzers which are widely available around the world. These fully-automated systems can provide SARS-CoV-2 test results in approximately 18 minutes, with a test throughput of up to 300 tests/hour, depending on the analyzer.3 *The Elecsys Anti-SARS-CoV-2 is an immunoassay for the qualitative, in vitro detection of antibodies (including IgG) to SARS-CoV-2. The test can detect antibodies to the coronavirus, which could signal whether a person has been already infected and potentially developed immunity to the virus. This test can also help in the determination of seroprevalence (i.e. the frequency of individuals with antibody to the virus), in a given population, as well as a complement test to Nucleic Acid Amplification Tests (NAAT) for the diagnosis of SARS-CoV-2 infection. The test runs on Roche’s cobas e analyzers which are widely available around the world.3 About Roche response to COVID-19 section The COVID-19 pandemic continues to evolve globally with varying developments from country to country and we are partnering with healthcare providers, laboratories, authorities and organisations to help make sure that patients receive the tests, treatment and care they need. This new test is an additional step in Roche’s fight against the COVID-19 pandemic, which has already included:
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Roche launches new quantitative antibody test to measure SARS-CoV-2 antibodies, to support the evaluation of vaccines
LEXINGTON, Mass., Sept. 18, 2020 (GLOBE NEWSWIRE) -- Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with an extensive pipeline of checkpoint antibodies, cell therapy, adjuvants, and vaccines designed to activate immune response to cancers and infections, today presented preliminary results from two large clinical trials of more than 150 patients each at the European Society for Medical Oncology (ESMO) Virtual Congress 2020. Both trials were conducted in patients with recurrent/metastatic cervical cancer which has limited effective treatment options and disproportionately affects younger women.
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Agenus Presents Results from Two Large Cervical Cancer Trials at ESMO
WATERTOWN, Mass., Sept. 21, 2020 (GLOBE NEWSWIRE) -- Aileron Therapeutics, Inc. (NASDAQ: ALRN), today announced it has entered into a common stock purchase agreement (“Purchase Agreement”) for up to $15 million with Lincoln Park Capital Fund, LLC (“LPC”), a Chicago-based institutional investor and current shareholder.
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Aileron Therapeutics Announces Common Stock Purchase Agreement for up to $15 Million with Lincoln Park Capital
3rd Orphan Drug designation for Toripalimab 3rd Orphan Drug designation for Toripalimab
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Junshi Biosciences Receives Orphan Drug Designation from the U.S. FDA for Toripalimab for the Treatment of Soft Tissue Sarcoma
LA JOLLA, Calif., Sept. 17, 2020 (GLOBE NEWSWIRE) -- Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company developing itolizumab to treat severe autoimmune and inflammatory disorders, today announced that data supporting the CD6-ALCAM pathway as a relevant target for therapeutic intervention in patients with uncontrolled asthma was presented in an oral presentation and two posters at the virtual European Respiratory Society (ERS) International Congress 2020 held September 7-9, 2020.
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Equillium Presented New Data and Insights on the CD6-ALCAM Pathway in Uncontrolled Asthma at the European Respiratory Society International Congress...
Conference call and webcast on Tuesday, September 22 at 2:30 pm CET/8:30 am ET Conference call and webcast on Tuesday, September 22 at 2:30 pm CET/8:30 am ET
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ERYTECH Provides Business Update and Reports Financial Results for the First Half of 2020
WALTHAM, Mass., Sept. 21, 2020 (GLOBE NEWSWIRE) -- Dyne Therapeutics, Inc. (Nasdaq: DYN), a muscle disease company focused on advancing innovative life-transforming therapeutics for patients with genetically driven diseases, today announced the closing of its initial public offering of 14,089,314 shares of its common stock at an initial public offering price of $19.00 per share, including 1,837,736 additional shares of common stock issued upon the exercise in full by the underwriters of their option to purchase additional shares. All of the shares in the offering were sold by Dyne. The gross proceeds of the offering, before deducting the underwriting discount and commissions and other offering expenses payable by Dyne, were approximately $268 million.
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Dyne Therapeutics Announces Closing of Initial Public Offering