Streetwise Reports' Article Archives — December 2019 back to current month (37)

Neovasc Shares Climb 80% Upon FDA Premarket Approval Filing for Refractory Angina Device (12/31/2019)

Shares of specialty cardiovascular medical device company Neovasc Inc. opened more than 100% higher after the firm reported that it submitted a Premarket Approval application to the FDA for its Neovasc Reducer device for use in the treatment of refractory angina.

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Savara Shares Double After FDA Grants Breakthrough Therapy Status for aPAP Treatment (12/30/2019)

Shares of Savara opened nearly 140% higher today after the orphan lung disease company advised that the FDA has granted Breakthrough Therapy designation for the firm's Molgradex for treatment of Autoimmune Pulmonary Alveolar Proteinosis (aPAP).

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Biotech Advances Imaging Product to Functional Development Phase (12/27/2019)

The company aims to conduct pilot production testing in Q1/20.

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Iterum Therapeutics Shares Double After Completing Enrollment in Phase 3 Antibiotic Trial (12/27/2019)

Iterum Therapeutics shares traded more than 100% higher after the company reported that it has completed enrollment in its Phase 3 SURE 1 clinical study of oral sulopenem for treatment of uncomplicated urinary tract infections. The firm expects to receive topline data results in Q1/20.

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Biopharma Continues 'Positive Push Forward in Breast Cancer' (12/27/2019)

The latest clinical trial results and next step are reviewed in an H.C. Wainwright & Co. report.

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Microbot Shares Soar on Claims It Has Created the World's First Fully Disposable Endovascular Robotic System (12/24/2019)

Shares of Microbot Medical traded 70% higher after the company reported that in January 2020 it will unveil the world's first fully disposable robotic system for endovascular procedures. The firm claims that its breakthrough technology features compact design, remote operation capabilities and an integrated "One & Done" tool to democratize endovascular procedures.

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Coverage Initiated on Immunotherapies Developer with 'Catalyst Rich 2020' (12/23/2019)

The key business and investment points are presented in a ROTH Capital Partners report.

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Intra-Cellular Therapies Shares Rise 200% on FDA Approval of Adult Schizophrenia Drug (12/23/2019)

Shares of Intra-Cellular Therapies opened greater than 100% higher today after the company reported that the FDA approved its antipsychotic CAPLYTAŽ (lumateperone) drug for the treatment of schizophrenia in adults.

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Healthcare Innovator to Acquire Canadian Telehealth Firm (12/21/2019)

The purchase price for the company is 4.5 million shares.

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Telehealth Firm Starts Pilot with Australian Aeromedical Agency (12/21/2019)

The program goal is to improve care access and health outcomes among residents of Australia's remote and rural areas.

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NewLink Genetics Shares Shoot Higher after FDA Ebola Vaccine Approval (12/20/2019)

Shares of NewLink Genetics got a boost today after the firm reported that the FDA approved its ERVEBO V920 vaccine used in the treatment of Zaire Ebola virus. The company's shares set a new 52-week high price in mid-morning trading.

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Paratek Pharma Awarded $285 Million BARDA Contract to Combat Anthrax (12/19/2019)

Shares of Paratek Pharmaceuticals traded 40% higher today after the firm announced it was awarded a BARDA BioShield program contract valued at up to $285 million for NUZYRA used to treat anthrax.

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Agreement Sets Stage to Secure Chinese Approval of Non-Antibiotic Livestock Feed Supplement (12/18/2019)

The requirements include, among others, trials of the company's livestock feed additive.

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Syros Pharma Teams Up with Global Blood Therapeutics to Fight Sickle Cell Disease (12/18/2019)

Syros Pharmaceuticals' shares rose 20% today after the firm reported that it entered into a collaboration agreement with Global Blood Therapeutics for development of therapies for sickle cell disease and beta thalassemia that could result in payments to Syros as high as $315 million over three years.

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Biopharma to Test Immunity Activator in Advanced Solid Cancers (12/17/2019)

The company's plans for and approach to one of its most advanced drug candidates are discussed in an H.C. Wainwright & Co. report.

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Biopharma 'Keeps Executing and Securing Milestones' (12/17/2019)

The company's latest achievement and partnership potential are addressed in a ROTH Capital Partners report.

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Feed Additive Developer Signs MOU with Philippine Distributor (12/17/2019)

This is the first step toward a binding, definitive agreement between the two companies.

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Axsome Therapeutics Shares Open 82% Higher on Phase 3 MDD Trial Outcome (12/16/2019)

Axsome Therapeutics shares reached a new 52-week high price today after the company reported that its AXS-05 drug achieved primary endpoint in the GEMINI Phase 3 trial in Major Depressive Disorder. The firm indicated that the positive results support a New Drug Application filing in H2/20.

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Animal Health Product Developer Lands First Sale in Malaysia (12/15/2019)

The maiden order comes on the heels of the country approving use of the product there.

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Supplier Enters Canadian Recreational Cannabis Market (12/13/2019)

The Vancouver-based company debuts its premium brand dried flower in Alberta.

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Sarepta Shares Get a 35% Boost from FDA Approval of 2nd DMD Drug (12/13/2019)

Sarepta Therapeutics shares traded 35% higher after the firm reported that the FDA approved its second RNA exon-skipping treatment drug VYONDYS 53 injection for the treatment of Duchenne's Muscular Dystrophy in patients amenable to skipping Exon 53.

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Assertio Therapeutics' Shares Jump 50% on Sale of Shingles Pain Drug to Alvogen (12/12/2019)

Assertio Therapeutics' shares rose 50% today after the firm reported that it has agreed to sell all rights to its Gralise drug used in the treatment of pain from shingles to Alvogen for $127.5 million. The transaction is expected to close in January 2020.

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Proteostasis Therapeutics Reports Positive Results from European Cystic Fibrosis Research (12/11/2019)

Proteostasis Therapeutics' shares traded higher today after the company reported positive results in its European Cystic Fibrosis study of organoids grown from human stem cells. The firm believes the ongoing ex-vivo study supports initiation of a human clinical trial in mid-2020, and potential for a Marketing Authorization Application in 2021.

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Avid Bioservices' Shares Rise on Q2/20 Earnings and Confirmed Outlook (12/10/2019)

Shares of Avid Bioservices traded higher today, reaching a new 52-week high, after the firm reported Q2/20 earnings and reaffirmed its revenue guidance for Full-Year 2020.

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Analyst Believes Biopharma's Alzheimer's Treatment Could Be Superior to Biogen's (12/10/2019)

How this company's Alzheimer's therapeutic compares to an advanced-stage competitor is outlined in a Dawson James Securities note.

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ArQule Shares Double on Proposed $2.7 Billion Tender Offer from Merck (12/09/2019)

ArQule Inc. shares traded more than 100% higher today after the company entered into definitive agreement to be acquired by a Merck subsidiary company for $20 per share. The deal is valued at $2.7 billion and is expected to close in the early part of Q1/20.

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Antibiotic Alternative for Livestock Feed Approved for Malaysia (12/07/2019)

Now, the company has the green light to sell this product in eight countries.

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Imagin Medical Poised for Breakout with Bladder Cancer Detection Device (12/06/2019)

A new advancement in bladder-related endoscopic surgery is endorsed and de-risked.

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Cassava Sciences' Shares Trade Up 20% on Updated Phase 2a Alzheimer's Data (12/06/2019)

Shares of Cassava Sciences traded 20% higher after the firm presented additional data from the Phase 2a study of its investigational drug candidate PTI-125 for Alzheimer's disease to the Clinical Trials on Alzheimer's Disease conference in San Diego, Calif.

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Aurinia Pharma Shares Open 100% Higher on Phase 3 Lupus Data (12/05/2019)

Shares of Aurinia Pharmaceuticals traded much higher today after it reported positive results from its Phase 3 AURORA trial of Voclosporin for treatment of lupus nephritis. The company plans to submit a New Drug Application to the FDA in H1/20.

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Immuno-Oncology Firm Expands Agreement with AbbVie (12/04/2019)

The revisions to the existing arrangement between the two U.S. firms are discussed in a ROTH Capital Partners report.

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Company Vies for New Brunswick Cannabis Contract (12/04/2019)

The opportunity is one of the largest in retail cannabis in Canada.

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Cannabis Producer Signs Supply Contract with Province of Alberta (12/04/2019)

To start, the company will introduce its premium brand of dried flower there.

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INmune Bio Targeting Cancer, Alzheimer's and NASH Simultaneously (12/04/2019)

Daniel Carlson of Tailwinds Research initiates coverage on this clinical-stage biotech whose drug candidate works to strengthen the innate immune system.

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Protagonist Therapeutics Shares Trade Up 70% on Phase 2 Transfusion Trial Results (12/04/2019)

Newark, Calif.-based Protagonist Therapeutics' shares traded 70% higher today after the firm reported preliminary Phase 2 results for Hepcidin Mimetic PTG-300 in the treatment of transfusion dependent beta-thalassemia.

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Axsome Therapeutics Investors Awaken to Positive Outcome in Phase 2 Narcolepsy Trial (12/03/2019)

Axsome Therapeutics shares traded 14% higher today after the company reported that its narcolepsy drug candidate AXS-12 achieved its primary endpoint in the Phase 2 CONCERT Study.

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Kodiak Shares Soar on $225 Million Royalty Deal for Retinal Drug (12/02/2019)

Shares of Kodiak Sciences traded more than 100% higher at times after the company reported that it entered into a $225 million royalty agreement for the firm's KSI-301 used in the treatment of retinal vascular diseases including age-related macular degeneration and diabetic eye diseases.

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