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Prometic Life Sciences Inc (PLI.TO)

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Latest Key Developments (Source: Significant Developments)

Prometic reports positive interim clinical data from IVIG phase 3 trial
Wednesday, 22 Nov 2017 07:00am EST 

Nov 22 (Reuters) - Prometic Life Sciences Inc :Prometic reports positive interim clinical data from ongoing intravenous immunoglobulin (IVIG) pivotal phase 3 trial.Prometic Life Sciences Inc - ‍interim clinical data shows non inferiority to commercially-approved products for primary immunodeficiencies​.Prometic Life Sciences - ‍clinical data confirmed no significant safety issues, efficacy appeared to be comparable to existing commercial IVIG products​.  Full Article

Prometic Q3 revenue C$24 million versus C$3.7 million
Monday, 13 Nov 2017 08:24pm EST 

Nov 13 (Reuters) - Prometic Life Sciences Inc :Prometic reports 2017 third quarter highlights and financial results.Q3 revenue C$24 million versus C$3.7 million.Q3 revenue view c$6.9 million -- Thomson Reuters I/B/E/S.Prometic Life Sciences - ‍incurred a net loss of $17.8 million for quarter ended sept 30, compared to net loss of $28.0 million for quarter ended Sept 30, 2016​.  Full Article

Prometic receives clearance from the Swedish Medical Products Agency to initiate plasminogen clinical trial
Wednesday, 1 Nov 2017 07:00am EDT 

Nov 1 (Reuters) - Prometic Life Sciences Inc ::Prometic receives clearance from the Swedish Medical Products Agency to initiate plasminogen clinical trial in chronic tympanic membrane perforation.Prometic Life Sciences Inc - ‍up to 33 adult patients are expected to be enrolled in clinical trial​.  Full Article

Prometic enters LOI for $80 mln line of credit from Structured Alpha LP
Monday, 23 Oct 2017 05:30am EDT 

Oct 23 (Reuters) - Prometic Life Sciences Inc ::Prometic enters into binding letter of intent to secure usd $80 million (CAD $100 million) line of credit from Structured Alpha LP, an affiliate of Thomvest Asset Management Inc.Company to grant Structured Alpha LP an initial 10 million warrants with an exercise price of CAD $1.70 per common share​.Company to also grant Structured Alpha LP additional 44 million warrants at exercise price of CAD $1.70 per common share​.  Full Article

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