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Kamada Ltd (KMDA.TA)

KMDA.TA on Tel Aviv Stock Exchange

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Latest Key Developments (Source: Significant Developments)

Kamada to withdraw European Marketing Authorization application for inhaled ALPHA-1 antitrypsin
Thursday, 22 Jun 2017 07:00am EDT 

June 22 (Reuters) - Kamada Ltd :Kamada announces withdrawal of European Marketing Authorization application for inhaled ALPHA-1 antitrypsin for treatment of ALPHA-1 antitrypsin deficiency disease.Kamada Ltd -following discussions with EMA, Kamada concluded that EMA does not view data submitted to date as sufficient for approval of MAA.Says Kamada intends to utilize data to be obtained from pivotal study to resubmit MAA to EMA.Kamada - is currently in advanced discussions with U.S. FDA to secure approval of IND this year to conduct U.S. phase 3 pivotal study of inhaled AAT for treatment of AATD that would begin in 2018.  Full Article

Kamada receives additional milestone payment from Shire PLC
Monday, 12 Jun 2017 07:00am EDT 

June 12 (Reuters) - Kamada Ltd :Kamada receives additional milestone payment under Glassia exclusive supply and distribution agreement with Shire.Kamada Ltd - announced receipt of an undisclosed additional milestone payment under supply and distribution agreement with shire for Glassia.Kamada Ltd - milestone payment was triggered by shire achieving a sales milestone for Glassia in U.S..Kamada Ltd - recently shipped all of proprietary products-related revenues, totaling approximately $11.5 million, which were previously delayed from Q1.Kamada Ltd - as detailed by Kamada in its Q1 financial results, revenues from shipment were shifted from Q1 and will be recorded in Q2.  Full Article

Kamada receives additional milestone payment under Glassia exclusive supply and distribution agreement with Shire
Monday, 12 Jun 2017 07:00am EDT 

June 12 (Reuters) - Kamada Ltd :Kamada receives additional milestone payment under glassia® exclusive supply and distribution agreement with shire.Kamada receives additional milestone payment under glassia® exclusive supply and distribution agreement with shire.Kamada Ltd - milestone payment was triggered by shire achieving a sales milestone for glassia in u.s.Kamada Ltd - recently shipped all of proprietary products-related revenues, totaling approximately $11.5 million, which were previously delayed from q1.Kamada Ltd - as detailed by kamada in its q1 financial results, revenues from shipment were shifted from q1 and will be recorded in q2.Kamada Ltd - announced receipt of an undisclosed additional milestone payment under supply and distribution agreement with shire for glassia.  Full Article

Kamada provides update on clinical program for alpha-1 antitrypsin IV treatment
Wednesday, 7 Jun 2017 07:00am EDT 

June 7 (Reuters) - Kamada Ltd :Provides update on clinical program for alpha-1 antitrypsin IV for treatment of graft-versus-host disease.Kamada, Shire agreed INDA approved by U.S. FDA for phase 2/3 study evaluating alpha-1 antitrypsin for treatment of GVHD will be transferred to Kamada.Kamada will take full ownership and responsibility for clinical development of g1-aat iv in this indication.Kamada Ltd says Shire decided to transfer INDA to Kamada due to pipeline prioritization and slow recruitment rate in its current u.s. Study.Kamada will assume control of, and onward funding for full G1-AAT iv program.Kamada Ltd says intends to conduct an integrated clinical development program across both territories - u.s. And eu.Kamada Ltd says as result of this decision, current part 1 of phase 2/3 study conducted in u.s. Is being halted by shire.  Full Article

Kamada Q1 loss per share $0.11
Tuesday, 16 May 2017 07:00am EDT 

May 16 (Reuters) - Kamada Ltd :Kamada reports 2017 first quarter financial results.Q1 loss per share $0.11.Q1 revenue fell 21 percent to $11.6 million.Sees fy 2017 revenue $100 million.Kamada ltd says for 2017, continues to expect proprietary products revenues between $76 to $78 million and distributed products revenues between $22 to $24 million.  Full Article

Kamada announces collaboration with Massachusetts General Hospital
Tuesday, 21 Feb 2017 06:30am EST 

Kamada Ltd : Kamada Ltd - announced a collaboration with Massachusetts General Hospital . Kamada Ltd - a collaboration to conduct a proof of concept study evaluating potential benefit of co's liquid Alpha-1 antitrypsin on liver preservation .Kamada - purpose of study is to evaluate effect of Kamada's liquid AAT on graft quality and viability, assess graft for markers of IRI caused to liver.  Full Article

Kamada Q4 loss per share $0.05
Monday, 6 Feb 2017 06:30am EST 

Kamada Ltd : Kamada Ltd - reaffirms revenue guidance of $100 million for 2017 . Kamada reports financial results for the fourth quarter and full-year 2016 . Q4 loss per share $0.05 . Q4 revenue fell 5.5 percent to $24.3 million . Sees FY 2017 revenue $100 million .Kamada Ltd - as of December 31, 2016, Kamada had cash, cash equivalents and short-term investments of $28.6 million.  Full Article

Kamada announces positive scientific advice response from the European Medicines Agency
Monday, 23 Jan 2017 06:30am EST 

Kamada Ltd : Kamada announces positive scientific advice response from the European Medicines Agency focused on Alpha-1 antitrypsin IV for treatment of acute graft-versus-host disease . In process of reviewing guidance received and, following discussions with company's European Scientific Advisory Board . Kamada Ltd- Intends to submit a clinical trial authorization (CTA) application to EMA in 2017 in order to conduct phase 2/3 study .Kamada Ltd- Intends to conduct European Study in parallel with U.S. Study.  Full Article

Kamada announces collaboration agreement with Yissum for Development of a Recombinant Human Alpha 1 Antitrypsin
Tuesday, 15 Nov 2016 07:00am EST 

Kamada Ltd :Press release - Kamada announces collaboration agreement with Yissum for development of a recombinant human Alpha 1 Antitrypsin.  Full Article

Kedrion Biopharma, Kamada- FDA accepts rabies immunoglobulin review
Monday, 7 Nov 2016 07:00am EST 

Kamada Ltd : Kamada ltd- pdufa goal date of august 29, 2017 .Kedrion biopharma and kamada announce fda acceptance of bla submission for human rabies immunoglobulin as a post-exposure treatment.  Full Article

BRIEF-Kamada to withdraw European Marketing Authorization application for inhaled ALPHA-1 antitrypsin

* Kamada announces withdrawal of European Marketing Authorization application for inhaled ALPHA-1 antitrypsin for treatment of ALPHA-1 antitrypsin deficiency disease