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Prometic Life Sciences Inc (PLI.TO)

PLI.TO on Toronto Stock Exchange

1.63CAD
16 Oct 2017
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Latest Key Developments (Source: Significant Developments)

FDA accepts Prometic's Biologics License Application for Plasminogen
Friday, 13 Oct 2017 06:30am EDT 

Oct 13 (Reuters) - Prometic Life Sciences Inc :Prometic announces FDA acceptance of its Biologics License Application for Plasminogen (Ryplazim™).Prometic Life Sciences Inc - ‍prescription Drug User Fee Act (PDUFA) action date is set for April 14, 2018​.  Full Article

Prometic receives FDA clearance of its IND to initiate PBI-4050 phase 2/3 trial in patients with idiopathic pulmonary fibrosis
Monday, 25 Sep 2017 06:30am EDT 

Sept 25 (Reuters) - Prometic Life Sciences Inc :Prometic receives FDA clearance of its IND to initiate pivotal PBI-4050 phase 2/3 trial in patients with idiopathic pulmonary fibrosis.Prometic Life Sciences Inc - ‍Prometic plans to supplement IND with a protocol for a study of PBI-4050 monotherapy in IPF patients in October 2017​.Prometic Life Sciences Inc - ‍U.S. IND to be followed by clinical trial applications in Canada, Europe, Australia and Japan throughout Q4 2017​.Prometic Life Sciences- ‍Phase 3 stage would randomize an additional up to 450 subjects to receive nintedanib plus either placebo or chosen PBI-4050 dose​.  Full Article

Prometic receives Rare Pediatric Disease Designation from U.S. FDA for its plasminogen replacement therapy
Tuesday, 29 Aug 2017 06:30am EDT 

Aug 29 (Reuters) - Prometic Life Sciences Inc :Prometic receives Rare Pediatric Disease Designation from U.S. FDA for its plasminogen replacement therapy.Prometic life sciences - ‍U.S. FDA granted Rare Pediatric Disease Designation to Prometic's Ryplazimä, a plasminogen replacement therapy.  Full Article

Prometic reports 2017 second quarter highlights and financial results
Monday, 14 Aug 2017 07:18pm EDT 

Aug 14 (Reuters) - Prometic Life Sciences Inc :Prometic reports 2017 second quarter highlights and financial results.Q2 revenue C$3.6 million versus C$3.3 million.Q2 revenue view C$4.8 million -- Thomson Reuters I/B/E/S.  Full Article

Prometic Life Sciences says ‍executed joint venture agreements with affiliates of Shenzhen Royal Asset Management​
Monday, 14 Aug 2017 06:30am EDT 

Aug 14 (Reuters) - Prometic Life Sciences Inc :Prometic Life Sciences - ‍executed agreements in relation to previously announced joint venture with affiliates of Shenzhen Royal Asset Management​.Prometic Life Sciences Inc says SRAM's initial funding of $33 million is earmarked for clinical development of product.Prometic Life Sciences Inc - ‍Prometic Chinaco is to receive royalties for net sales of products from sub-licensees​.Prometic Life Sciences Inc - ‍Prometic Chinaco controls bulk manufacturing of products which it will exclusively supply to sub-licensees in China​.Prometic Life Sciences - co is licensing development, manufacturing, commercialization rights for PBI-4050, PBI-4547 and PBI-4425 for Chinese market​.  Full Article

Prometic announces positive long term clinical data on Ryplazy in plasminogen congenital deficiency
Tuesday, 11 Jul 2017 06:30am EDT 

July 11 (Reuters) - Prometic Life Sciences Inc :Prometic announces positive long term clinical data on Ryplazym™ in plasminogen congenital deficiency and provides regulatory update.Prometic Life Sciences Inc - ‍RYPLAZYM (plasminogen iv) long-term treatment shown to prevent recurrence of lesions at 48 weeks​.Prometic Life Sciences - ‍FDA inspection of ryplazym(TM) manufacturing facility, as part of ongoing bla evaluation, currently scheduled for summer 2017​.Prometic Life Sciences Inc - ‍ryplazym (plasminogen iv) maintains same safety, tolerability profile without any serious adverse events at 48 weeks​.Prometic - ‍48-week clinical data will be submitted as a supplement to bla filing, after ryplazym gets its expected accelerated approval in q4 of 2017​.Prometic Life Sciences Inc - ‍there was no recurrence of lesions and no safety or tolerability issues observed related to longer-term dosing in study​.Prometic Life Sciences - responding diligently to all fda requests which to date are not related to underlying clinical data for ryplazym​.Prometic Life Sciences-in talks with european medicines agency regarding clinical information required to secure regulatory approval of ryplazym in europe.  Full Article

Prometic reports $53 mln bought deal offering
Thursday, 15 Jun 2017 04:55pm EDT 

June 15 (Reuters) - Prometic Life Sciences Inc ::Prometic announces $53 million bought deal offering.Says offering priced at c$1.70per share.Prometic Life Sciences Inc - underwriters have agreed to buy on a bought deal basis, 31.25 million common shares.Prometic Life Sciences -proceeds to be used for completion of sales, marketing infrastructure necessary for commercialization of Plasminogen, IVIG.  Full Article

Fda confirms Prometic's PBI-4050 IPF clinical trial design
Tuesday, 18 Apr 2017 07:00am EDT 

April 18 (Reuters) - Prometic Life Sciences Inc :FDA confirms Prometic's PBI-4050 IPF clinical trial design.Prometic Life Sciences Inc - Prometic to also conduct placebo controlled phase 2/3 PBI-4050 monotherapy clinical trial.Prometic Life Sciences Inc - FDA concurs with add-on placebo controlled phase 2/3 clinical trial for PBI-4050 in combination with Nintedanib.  Full Article

Prometic Life Sciences has received a $9.5 mln purchase order for supply of affinity resin to an existing client
Friday, 7 Apr 2017 07:00am EDT 

Prometic Life Sciences Inc : Has received a $9.5 million purchase order for supply of affinity resin to an existing client . The purchase order is part of an ongoing license and long-term supply agreement already secured with the client .Affinity resin will be supplied to the client starting in second half of 2017 and continuing throughout 2018.  Full Article

Prometic completes filing of its plasminogen Biologics license application with U.S. FDA
Wednesday, 5 Apr 2017 06:00am EDT 

Prometic Life Sciences Inc : Prometic completes the filing of its plasminogen Biologics license application ("BLA") with the U.S. FDA .Prometic Life Sciences Inc - "we look forward to launching Plasminogen in USA in Q4 2017".  Full Article