NKTR-181 Meets Primary and Secondary Endpoints in Phase 3 SUMMIT-07 Study in Chronic Pain

NKTR-181 Significantly Reduced Pain in Patients with Moderate to Severe Chronic Low Back Pain
Primary Efficacy Endpoint Achieved (p=0.0019)
Analyst Conference Call and Webcast Today at 5:45 a.m. PDT/8:45 a.m. EDT
 
SAN FRANCISCO, March 20, 2017 / -- Nektar Therapeutics (Nasdaq: NKTR) today announced positive results from the SUMMIT-07 Phase 3 efficacy study of NKTR-181, a first-in-class opioid analgesic.  NKTR-181 is a new chemical entity (NCE) that is the first full mu-opioid agonist molecule designed to provide potent pain relief without the high levels of euphoria that can lead to abuse and addiction with standard opioids.1  The U.S. Food and Drug Administration (FDA) has granted the investigational medicine NKTR-181 Fast Track designation for the treatment of moderate to severe chronic pain.
Read more: Nektar Therapeutics ( NKTR )

Esperion Announces FDA Confirmation Regarding Regulatory Pathway to Approval for an LDL-C Lowering Indication for Bempedoic Acid

- Global Pivotal Phase 3 Program Design Can Support Approval for an LDL-C Lowering Indication - 
- Proposed LDL-C Lowering Indication Will Include Patients with High CVD Risk, Specifically Those with ASCVD and/or HeFH - 
- On Track to Submit NDA for an LDL-C Lowering Indication by 1H 2019 - 
- Conference Call and Webcast on Monday, March 20, 2017 at 8:00 a.m. Eastern Time -
 
ANN ARBOR, Mich., March 20, 2017 -- Esperion Therapeutics, Inc. (NASDAQ:ESPR), the lipid management company focused on developing and commercializing convenient, complementary, cost-effective, once-daily, oral therapies for the treatment of patients with elevated low density lipoprotein cholesterol (LDL-C), today announced the U.S. Food and Drug Administration (FDA) recently confirmed that Esperion’s LDL-C lowering program is adequate to support approval of an LDL-C lowering indication for bempedoic acid.
Read more: Esperion Therapeutics ( ESPR )

Threshold Pharmaceuticals and Molecular Templates Agree to Combine

-- Transaction to result in Nasdaq-listed company focused on developing novel treatments for cancer --
-- Molecular Templates lead drug candidate being developed to treat non-Hodgkin’s Lymphoma (NHL); engineered toxin body (ETB) platform has applications in multiple oncology indications --
-- Combined company will be capitalized to support advancement of MT-3724 through pivotal trial in NHL and evofosfamide through Phase 1b trial at MD Anderson Cancer Center --
-- $20 million investment by leading U.S. venture capital firm at the close of the transaction --
-- Conference call on March 17, 2017 at 8:30 a.m. ET --
 
SOUTH SAN FRANCISCO, Calif. and AUSTIN, Texas, March 17, 2017 -- Threshold Pharmaceuticals, Inc. (Nasdaq:THLD), a clinical-stage biopharmaceutical company developing novel therapies for cancer, and Molecular Templates, Inc., a privately held biopharmaceutical company, today jointly announced that they have entered into a definitive agreement under which Molecular Templates will merge with a wholly owned subsidiary of Threshold in an all-stock transaction. The transaction will result in a combined company focused on the development of novel treatments for cancer.
Read more: Threshold Pharmaceuticals ( THLD )

Seres Therapeutics to Initiate New SER-109 Clinical Study

– Positive SER-109 Type B FDA meeting –
– Seres and FDA reach agreement on key design elements of a new SER-109 Phase 2 study in patients with multiply recurrent C. difficile infection –
– New trial may qualify as a Pivotal Study with achievement of a persuasive clinical effect and addressing FDA requirements –
– Conference call at 8 a.m. ET today –
 
Seres Therapeutics Inc., (NASDAQ:MCRB), a leading microbiome therapeutics platform company, today announced plans to initiate a new SER-109 Phase 2 clinical study (ECOSPOR III) in patients with multiply recurrent Clostridium difficile (C. difficile) infection. The ECOSPOR III study design was finalized following a positive Type B meeting with the U.S. Food and Drug Administration (FDA). In a separate announcement today, Seres reported fourth quarter and full year 2016 financial results and provided an update on multiple ongoing microbiome clinical programs.
Read more: Seres Therapeutics ( MCRB )

Innocoll Holdings Announces Statement re: Possible Offer

ATHLONE, Ireland, March 16, 2017 -- The Board of Innocoll Holdings plc (“Innocoll” or the “Company”) (NASDAQ:INNL) notes anomalous movements in Innocoll’s share price this week and confirms that it is in discussions which may or may not lead to an offer for the entire issued share capital of the Company.
 
Management has been investigating and continues to investigate strategic options for the Company to maximise shareholder value. There can be no certainty that this will lead to an offer for Innocoll or any of its share capital nor as to the terms on which an offer, if any, might be made. The Company has participated in a Type A meeting with the United States Food and Drug Administration ("FDA") regarding the re-submission to the FDA for approval of XARACOLL. It expects to receive the minutes of the Type A meeting before the end of March and will make a further announcement at that time. 
Read more: Innocoll Holdings plc ( INNL )

Videos / Webinars

View all videos

Pepperstone | Metatrader 4 Forex Broker