Top Pick of the Day: VTGN

VistaGen (VTGN) stock shot up as the company announced the results  two Phase 1 studies of AV-101, a potential candidate for the non-opioid treatment of neuropathic pain. The data showed AV-101 was safe and well-tolerated.The company said that the data, along with positive results rom four preclinical models of pain associated with tissue inflammation and nerve injury, support future Phase 2 studies. The company said that they are optimistic about AV-101's potential as a new treatment alternative for major depressive disorder, without ketamine-like side effects.

The company stock shot up more than 14 percent after the announcement, trimming its Year to Date losses to 74 percent.

Focus Ticker: DMPI

DelMar Pharmaceuticals (DMPI) announced that it has received  Institutional Review Board approval to conduct a Phase 3 clinical trial assessing VAL-083 (dianhydrogalactitol) in patients with glioblastoma who failed to respond to treatment with a combination a temozolomide and Roche's Avastin (bevacizumab). The study is named STAR-3 and will enroll up to 180 subjects across 25 sites. The primary endpoint is overall survival. The company stock responded positively to the news and jumped over 19 percent,
DelMar has gained over 129 percent this year so far. The FDA regulations require the IRB review for all human subject research to ensure that the rights and welfare of human subjects are protected at all times.

Sector News

Pfizer (PFE) received a setback as the company received a Complete Response Letter (CRL) from the FDA in relation to market application for the approval of its biosimilar to Amgen’s Epogen. The company said that it is collaborating with the agency to address the issue.

Ionis Pharmaceuticals (IONS) announced hitting the enrollment target for a Phase 1/2 clinical trial assessing IONIS-HTTrx for the treatment of Huntington's disease. Patients who complete the initial phase of trial will be eligible to participate in an open-label extension study. The company is collaborating with Roche to develop antisense drugs to treat Huntington's disease.

Approvals

Roche (RHHBY) announced receiving the FDA approval to RITUXAN HYCELA (rituximab and hyaluronidase human) for subcutaneous injection for the treatment of three blood cancers. The company expects to commercially launch the product in the US in coming one to two weeks.

Qiagen (QGEN) received approval from France's Ministry of Health and Social Affairs for its QuantiFERON-TB Gold Plus to screen at-risk people for latent tuberculosis infection. The approval makes the company eligible for reimbursement by the national health insurance system.

Deals and Collaborations

Proteon Therapeutics (PRTO) announced a collaboration with a syndicate of institutional investors. The deals involves the direct sale of 22,000 shares of Series A A Convertible Preferred Stock at $1,000 per share. The gross proceeds are expected to be close to $22 million. Net proceeds will be used for funding the ongoing PATENCY-2 study and continued market access activities. 

Trovagene (TROV) announced inking a new deal with a global biopharma with regard to Trovera urine circulating tumor DNA (ctDNA) biomarker tests and services for use in its clinical trials. The company did not disclose the financial terms of the deal or the name of the firm.