Sage Therapeutics Advances SAGE-217 into Placebo-Controlled Phase 2 Clinical Trial in Major Depressive Disorder

Open-label Pilot Study of Once Daily, Orally Administered Molecule Demonstrates Positive Signal of Activity and Tolerability
 
CAMBRIDGE, Mass. --  Sage Therapeutics (NASDAQ:SAGE), a clinical-stage biopharmaceutical company developing novel medicines to treat life-altering central nervous system (CNS) disorders, today announced encouraging top-line results from its Phase 2 clinical trial of orally-administered SAGE-217 for the treatment of major depressive disorder (MDD). The primary endpoint of the 13 patient Part A open-label trial was to evaluate safety and tolerability. SAGE-217 was found to be generally well-tolerated with no serious adverse events or discontinuations reported. 
Read more: Sage Therapeutics ( SAGE )

Zosano Pharma Announces 3.8mg Dose of M207, its Novel Transdermal Therapeutic, Meets  Both Co-primary Endpoints in the ZOTRIP Pivotal Efficacy Trial in Migraine

41.5% of patients experienced freedom from pain at 2 hours vs. 14.3% for placebo (p < 0.0001)
68.3% of patients experienced freedom from most bothersome symptom at 2 hours vs. 42.9% for placebo (p < 0.0009)
26.8% of patients experienced freedom from pain at 1 hour vs. 10.4% for placebo (p < 0.0084)
 
FREMONT, Calif., Feb. 13, 2017  -- Zosano Pharma Corporation (NASDAQ:ZSAN) announces that its lead product candidate, M207, achieved both co-primary endpoints of pain freedom and most bothersome symptom freedom at 2 hours in the recently completed ZOTRIP trial. The ZOTRIP pivotal efficacy study was a multicenter, double-blind, randomized, placebo-controlled, dose-ranging trial comparing three doses (1.0mg, 1.9mg and 3.8mg) of M207, a novel transdermal therapeutic, to placebo for a single migraine attack. A total of 589 subjects were enrolled at 36 sites across the US. The 3.8mg dose achieved significance in the secondary endpoints of pain freedom at 45 minutes and 1 hour and showed durability of effect on pain freedom at 24 and 48 hours. Additionally, M207 was not associated with any Serious Adverse Events (SAEs).
Read more: Zosano Pharma Corporation ( ZSAN )

Immunomedics Enters into Exclusive Global Licensing Agreement with Seattle Genetics for Sacituzumab Govitecan (IMMU-132) with Potential Payments of up to Approximately $2 Billion, Plus Royalties

2017-02-10 06:50 ET - News Release - Immunomedics to Receive $250 Million in Upfront Cash Payment; Plus Among Other Milestone Payments, an Additional $50 Million or Negotiated Economic Splits Relating to Rights Outside US, Canada and EU
Agreement Provides for Seattle Genetics to Develop, Manufacture and Commercialize IMMU-132 in Multiple Indications; Immunomedics Retains Rights to Co-Promote in the United States
Seattle Genetics to Make up to $57 Million Equity Investment for up to 9.9% Stake in Immunomedics Via an Immediate Purchase of Common Stock and a Three-Year Warrant, Each Priced at a 10% Premium to the Company's 15-Day VWAP
Read more: Immunomedics Inc ( IMMU )

Pulse Biosciences Announces Healthcare Executives and Entrepreneurs Robert Duggan and Dr. Maky Zanganeh Have Acquired a Combined Interest of 17.1% of the Company

Company Appoints Dr. Maky Zanganeh to Company Board of Directors
 
BURLINGAME, Calif. --  Pulse Biosciences, Inc. (Nasdaq:PLSE), a medical technology company developing a proprietary therapeutic tissue treatment platform based on Nano-Pulse Stimulation (NPS), today announced that Robert “Bob” Duggan and Maky Zanganeh, the former CEO and COO of Pharmacyclics Inc. (now Pharmacyclics LLC, a wholly owned subsidiary of AbbVie Inc.), respectively, have purchased a combined interest of 17.1% of Pulse Biosciences’ outstanding common stock of which $10 million of the stock was purchased in transactions this week. The transactions included $5 million, or 819,673 shares, purchased from the Company and $5 million, or 819,672 shares, purchased from existing shareholders that have been released from a one year lock-up restriction from the date of the Company’s initial public offering. These shares are in addition to 771,799 shares purchased on the open market prior to these transactions. Dr. Zanganeh has also been appointed to the Company’s Board of Directors.
Read more: Pulse Biosciences Inc ( PLSE )

Acorda Announces Positive Phase 3 Clinical Trial Results for CVT-301

SPAN-PD trial met primary endpoint: CVT-301 showed statistically significant improvement of motor function compared to placebo
New Drug Application (NDA) submission planned for Q2 2017
Data from two long-term safety studies expected in Q1 2017
 
ARDSLEY, N.Y. --  Acorda Therapeutics, Inc. (Nasdaq:ACOR) today announced Phase 3 clinical data of CVT-301, showing a statistically significant improvement in motor function in people with Parkinson’s disease experiencing OFF periods. CVT-301 is an investigational, inhalable formulation of levodopa (L-dopa). It is being studied as a treatment for OFF periods in people with Parkinson’s disease taking an oral carbidopa / levodopa regimen. OFF periods refer to the re-emergence of Parkinson’s symptoms.
Read more: Acorda Therapeutics Inc ( ACOR )