Key Developments: Zeltia SA (ZEL.MC)

ZEL.MC on Madrid SE C.A.T.S.

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19 Dec 2014
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Latest Key Developments (Source: Significant Developments)

Zeltia to start pivotal Phase III with PM1183 in platinum-resistant ovarian cancer patients
Thursday, 4 Dec 2014 02:16am EST 

Zeltia SA:Says to start a pivotal Phase III with PM1183 in patients with ovarian cancer resistant to platinum in H1 2015.Says patients with ovarian cancer resistant to platinum treated with PM1183 reach median overall survival of 18.1 months versus 8.5 months with topotecan in Phase IIb.  Full Article

Zeltia considers merger with its unit PharmaMar and listing in US
Tuesday, 2 Dec 2014 02:13am EST 

Zeltia SA:Says considers merger with its unit PharmaMar SA.Says after merger oncology business to trade directly in the market.Says after merger company to apply for listing in the United States.  Full Article

Zeltia SA's partner submits New Drug Application for Yondelis to US Food and Drug Administration for advanced soft tissue sarcoma treatment
Monday, 24 Nov 2014 05:33pm EST 

Zeltia SA:Says Janssen Research & Development LLC submitted New Drug Application (NDA) for Yondelis to US Food and Drug Administration for the treatment of patients with advanced soft tissue sarcoma (STS).Janssen has the rights to develop and sell Yondelis globally except in Europe and Japan.  Full Article

Zeltia SA’s PharmaMar initiates phase I study with Aplidin in combination with bortezomib and dexamethasone
Wednesday, 23 Jul 2014 02:23am EDT 

Zeltia SA:Says its subsidiary, PharmaMar SA, has initiated phase I clinical trial with Aplidin (plitidepsin) in combination with bortezomib and dexamethasone in patients with relapsed and/or refractory multiple myeloma.Trial is to determine recommended dose of Aplidin in combination with bortezomib and dexamethasone and to evaluate efficacy of combination in patients with multiple myeloma.Trial to be conducted in six centres in Spain and France and 30 patients to be recruited.  Full Article

Zeltia SA's Sylentis receives authorisation to commence Phase IIb clinical trial with bamosiran
Thursday, 17 Jul 2014 02:47am EDT 

Zeltia SA:Sylentis has been authorised by Estonian authorities to commence Phase IIb trial with bamosiran (SYL040012) for treatment of glaucoma and ocular hypertension.Trial, named SYLTAG, is dose-finding parallel randomized, investigator-masked trial involving four groups receiving bamosiran and fifth group receiving active control (timolol).It will be conducted at 21 centres in Spain, Estonia, Germany and the United States and will recruit 180 patients.  Full Article

Zeltia SA's PharmaMar and Chugai Pharmaceutical Co's Chugai Pharma Marketing sign license agreement for Aplidin
Monday, 14 Jul 2014 05:31am EDT 

Zeltia SA:Says its subsidiary, PharmaMar SA, and Chugai Pharma Marketing Ltd, subsidiary of Chugai Pharmaceutical Co Ltd, signed license agreement.Under term of agreement, Chugai Pharma Marketing to market Aplidin in eight european countries (France, Germany, UK, Benelux, Ireland and Austria).Aplidin is PharmaMar product for treatment of multiple myeloma.PharmaMar to receive initial payment of 5 million euros and additional payments are also considered and could reach total number of more than 30 million euros.  Full Article

Zeltia Pharma Mar SRL signs license agreement with GP Pharm to distribute Politrate in Italy
Tuesday, 1 Jul 2014 02:30am EDT 

Zeltia SA:Grupo Zeltia says that Pharma Mar SRL, Italian subsidiary of Pharma Mar SA, has signed license agreement with GP Pharm.Under terms of agreement Pharma Mar SRL to distribute Politrate of GP Pharm in Italy.Politrate is marketed in other countries under brand of Lutrate.Politrate is drug approved in 23 countries of European Union for treatment of prostate cancer.Pharma Mar expects to start distribution of Politrate as of Oct. 2014.  Full Article

Zeltia PharmaMar presents positive trial results of PM1183 at ASCO annual meeting
Monday, 2 Jun 2014 02:38am EDT 

Zeltia SA:Says its subsidiary, PharmaMar, has presented positive trial results of PM01183 at meeting of American Society of Clinical Oncology (ASCO).Presentation on Lurbinectedin (PM01183), PFS and OS results in phase II study in platinum-resistant/refractory ovarian cancer (PRROC) patients.Phase II multicentre trial with PM1183 as monotherapy to treat patients with PRROC, compared with standard treatment with Topotecan.PharmaMar plans to initiate phase III trial for this indication with PM1183.  Full Article

Zeltia French subsidiary initiates its commercial activity
Monday, 26 May 2014 02:31am EDT 

Zeltia SA:French subsidiary of PharmaMar SA initiates its commercial activity.  Full Article

Zeltia Japanese partner to request marketing for Yondelis-Reuters
Tuesday, 22 Apr 2014 02:49am EDT 

Zeltia SA:Taiho, Japanese partner of Zeltia, has carried out positive trials with the group's cancer drug Yondelis-Reuters.Taiho expects to request marketing authorisation in Japan.Yondelis is already sold in 75 countries.  Full Article

BRIEF-Zeltia to start pivotal Phase III with PM1183 in platinum-resistant ovarian cancer patients

* Says to start a pivotal Phase III with PM1183 in patients with ovarian cancer resistant to platinum in H1 2015

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