Streetwise Reports' Article Archives — December 2019 back to current month (37)
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.
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).
The company aims to conduct pilot production testing in Q1/20.
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.
The latest clinical trial results and next step are reviewed in an H.C. Wainwright & Co. report.
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.
The key business and investment points are presented in a ROTH Capital Partners report.
Shares of Intra-Cellular Therapies opened greater than 100% higher today after the company reported that the FDA approved its antipsychotic CAPLYTA® (lumateperone) drug for the treatment of schizophrenia in adults.
The purchase price for the company is 4.5 million shares.
The program goal is to improve care access and health outcomes among residents of Australia's remote and rural areas.
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.
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.
The requirements include, among others, trials of the company's livestock feed additive.
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.
The company's plans for and approach to one of its most advanced drug candidates are discussed in an H.C. Wainwright & Co. report.
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.
This is the first step toward a binding, definitive agreement between the two companies.
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.
The maiden order comes on the heels of the country approving use of the product there.
The Vancouver-based company debuts its premium brand dried flower in Alberta.
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.
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.
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.
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.
How this company's Alzheimer's therapeutic compares to an advanced-stage competitor is outlined in a Dawson James Securities note.
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.
Now, the company has the green light to sell this product in eight countries.
A new advancement in bladder-related endoscopic surgery is endorsed and de-risked.
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.
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.
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.
Company Vies for New Brunswick Cannabis Contract (12/04/2019)
The opportunity is one of the largest in retail cannabis in Canada.
To start, the company will introduce its premium brand of dried flower there.
Daniel Carlson of Tailwinds Research initiates coverage on this clinical-stage biotech whose drug candidate works to strengthen the innate immune system.
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.
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.
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.