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. 
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Catalyst Pharmaceuticals Announces Positive Data from Investigator-Sponsored Trial of Firdapse ® in treating MuSK Antibody Positive Myasthenia Gravis

Catalyst intends to proceed to U.S. multi-center pivotal trial
Expects additional data to be presented at upcoming medical congresses in 2017
 
CORAL GABLES, Fla., March 15, 2017 -- Catalyst Pharmaceuticals, Inc. (Catalyst) (Nasdaq:CPRX), a biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare neuromuscular and neurological diseases, today announced positive top-line results from the investigator-sponsored trial evaluating Firdapse® (Amifampridine Phosphate) as a treatment for myasthenia gravis patients with anti-MuSK antibodies (MuSK-MG).
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Adaptimmune Reports Fourth Quarter and Full Year 2016 Financial Results

– Opened two new INDs for wholly-owned SPEAR® T-cell therapies; Company now has four open INDs in 11 indications –
– Received orphan designation, PRIME regulatory support and Breakthrough Therapy designation for NY-ESO SPEAR T-cell –
– Received FDA notification of permission to proceed with new cell manufacturing process –
– Conference call to be held today at 8:00 a.m. EDT (12:00 p.m. GMT) –
 
PHILADELPHIA and OXFORD, United Kingdom, March 13, 2017 -- Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in T-cell therapy to treat cancer, today reported financial results for the fourth quarter and year ended December 31, 2016.
 
“2016 was an important year for Adaptimmune during which we established substantial clinical momentum and significantly advanced our commercial-ready cell manufacturing process,” commented James Noble, Adaptimmune’s Chief Executive Officer.
Read more: Adaptimmune Therapeutics ( ADAP )

Kitov Announces License Agreement for KIT-302 in South Korea

TEL AVIV, Israel, March 8, 2017 -- Definitive agreement grants KuhnilPharmaceutical Co. Ltd.an exclusive license tomanufactureand marketKIT-302 in South Korea 
 
TransactionisKitov's FirstLicenseAgreement for KIT-302 
Celecoxibis the leadingNSAIDproduct in South Koreawithreportedsales of over $55 Million in 2015 
 
Kitov Pharmaceuticals Holdings Ltd. (NASDAQ: KTOV; TASE: KTOV), an innovative biopharmaceutical company, announced today that the Company has signed a definitive License Agreement for its lead product candidate, KIT-302, which was developed to simultaneously treat pain caused by osteoarthritis and to treat hypertension, for the territory of South Korea with Kuhnil Pharmaceutical Co. Ltd., a leading South Korea-based pharmaceutical company.  Upon receipt of marketing authorization in South Korea, Kuhnil will have the exclusive right and license to manufacture, distribute and sell KIT-302 in South Korea.  Kuhnil will be responsible for seeking regulatory approval for KIT-302 in South Korea.
Read more: Kitov Pharmaceuticals Holdings ( KTOV )

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