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Fennec announces new PEDMARK data at ASCO showing hearing loss reduction in pediatric/AYA patients
Phase 2/3 STS-J01 study met primary endpoint: hearing loss 16-24% vs 56-63% historical control.
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Fennec posts record FY2025 PEDMARK sales $44.6M (+50% YoY); Q4 $13.8M (+75%)
Full-year net product sales $44.6M vs $29.6M in 2024; Q4 $13.8M vs $7.9M in prior year.
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Fennec settles PEDMARK patent litigation; Cipla barred from generic until 2033
Lawsuit dismissed; each party bears its own costs.
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Fennec announces TGH Cancer Institute study of PEDMARK for ototoxicity in AYA and adult patients
Tampa General Hospital Cancer Institute initiates real-world study of PEDMARK (sodium thiosulfate) to reduce ototoxicity risk in AYA and adult patients receiving cisplatin.
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Fennec real-world data show PEDMARK safe in adults with head & neck cancers, no disruption to cisplatin therapy
Data from retrospective review of 15 adult HNC patients presented at 2026 MHNCS symposium (Feb 19-21).
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Fennec PEDMARK Phase 2/3 Japan trial meets endpoint; hearing loss reduced to 16-24% vs 56-63% historical
Primary endpoint met: hearing loss in 24% (ASHA) and 16% (Brock) of evaluable patients vs 56-63% historically.
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Fennec Pharmaceuticals redeems all convertible notes, now debt-free
Redeemed all remaining Petrichor convertible notes for $21.73M (principal $19.48M, accrued interest $305k, redemption fee $1.95M).
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Fennec raises $5.025M in Canadian private placement, redeems $21.7M Petrichor notes
Issued 670,000 common shares at US$7.50 per share for gross proceeds of $5,025,000 from existing institutional shareholders in Canada (excl. Quebec).
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Fennec prices $35M public offering of 4.7M shares at $7.50/share to repay debt
Offering of 4,666,667 common shares at $7.50 per share; gross proceeds ~$35M.
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Fennec Pharma reports FY2024 PEDMARK sales $29.6M (+40% YoY); Q4 EBITDA loss $0.6M, cash $26.6M
FY2024 net product sales $29.6M, up 40% from $21.3M in 2023; net loss narrowed to $0.07M from $16.0M.
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Fennec's partner Norgine launches PEDMARQSI in Germany for cisplatin-induced hearing loss prevention
PEDMARQSI (sodium thiosulfate injection) launched in Germany by Norgine for prevention of ototoxicity in pediatric patients.
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Fennec repays $13M convertible debt; eliminates $1.5M annual interest
Repurchased and redeemed $13M of convertible notes on Dec 18, 2024; fully retires First and Third Closing Notes.
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Fennec announces NICE recommends PEDMARQSI for cisplatin-induced hearing loss in children in England and Wales
NICE issued positive final draft guidance recommending PEDMARQSI for prevention of cisplatin-induced hearing loss in patients aged 1 month-17 years with localized solid tumors.
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Fennec Pharma appoints new CMO, CCO, CSO to accelerate growth
Pierre Sayad appointed CMO, Terry Evans CCO, Christiana Cioffi CSO, effective Oct. 28, 2024.
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Fennec appoints Jeffrey Hackman as CEO, succeeding Rostislav Raykov
Hackman named CEO and director effective August 16, 2024; Raykov steps down after 15 years, remains on board.
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Fennec COO Adrian Haigh departs; 66,667 options accelerated at $8.03
Adrian Haigh left COO role effective June 30, 2024; joined as COO Aug 2023 after nine years as independent director.
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Fennec Pharma FY2023 PEDMARK sales $21.3M, Q4 net loss $2.7M; $43M licensing deal bolsters cash
FY2023 PEDMARK net product sales $21.3M (vs $1.5M in 2022); Q4 net sales $9.7M.
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Fennec licenses PEDMARQSI to Norgine for EU/AU/NZ; €40M upfront, up to €210M milestones
Exclusive license covers Europe (incl. UK), Australia, New Zealand; Norgine to commercialize.
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Fennec prelim Q4 2023 net revenue $9.2-9.7M (+41-49% QoQ); FY 2023 $20.7-21.2M
Q4 2023 net revenue expected $9.2-9.7M, up 41-49% from Q3 2023.
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Fennec Q3 2023: PEDMARK revenue $6.5M (+96% QoQ); UK approval for PEDMARQSI
PEDMARK net product revenue $6.5M in Q3 2023, up 96% from $3.3M in Q2 2023.
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Fennec Q2 revenue $3.3M (+98% QoQ); appoints Adrian Haigh as COO
Net product revenue $3.3M in Q2 2023, up 98% from $1.7M in Q1 2023.
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Fennec Q2 PEDMARK revenue $3.3M, up 98% QoQ; appoints Adrian Haigh as COO
Net product sales of PEDMARK $3.3M, a 98% sequential increase from Q1 2023.
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Fennec Q2 revenue $3.3M (up 98% QoQ); appoints Adrian Haigh as COO
Net product sales of $3.3M for Q2 2023, up 98% from Q1 2023; gross profit $3.2M.
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Fennec gets EU approval for Pedmarqsi to prevent cisplatin-induced hearing loss in children
European Commission granted marketing authorization for Pedmarqsi (sodium thiosulfate) for pediatric localized solid tumors.
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Fennec receives positive CHMP opinion for Pedmarqsi to prevent cisplatin-induced hearing loss in pediatric patients
CHMP recommends EU marketing authorization for Pedmarqsi (sodium thiosulfate) to prevent ototoxicity in pediatric patients aged 1 month to <18 years with localized solid tumors.
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Fennec receives FDA Orphan Drug Exclusivity for PEDMARK; 7-year market exclusivity until 2029
FDA granted Orphan Drug Exclusivity to PEDMARK, providing 7-year market exclusivity from Sept. 20, 2022 to Sept. 20, 2029.
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NCCN guidelines updated to recommend PEDMARK for reducing cisplatin-induced hearing loss in pediatric AYA patients.
NCCN AYA Oncology guidelines now recommend PEDMARK to reduce cisplatin-induced hearing loss in pediatric patients with localized, non-metastatic solid tumors.
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Fennec launches PEDMARK in US for cisplatin-induced hearing loss in pediatric patients
PEDMARK is the first and only FDA-approved therapy to reduce cisplatin-induced ototoxicity in pediatric patients aged 1 month+ with localized solid tumors.
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Fennec closes $20M second tranche of Petrichor notes triggered by FDA approval of PEDMARK
Second closing of $20M senior secured convertible notes funded after FDA approved PEDMARK on Sept 20, 2022.
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Fennec Pharma gets FDA approval for PEDMARK to reduce cisplatin-induced hearing loss in pediatric patients
FDA approved PEDMARK (sodium thiosulfate) for reducing ototoxicity in children aged 1 month+ with localized, non-metastatic solid tumors.
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Fennec closes $5M initial tranche of $45M senior secured note; $20M on FDA approval of PEDMARK
First closing $5M senior secured note; $20M upon FDA approval of PEDMARK; up to $20M additional.
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Fennec secures up to $45M from Petrichor; $5M now, $20M on FDA approval of PEDMARK
Petrichor invests $5M in convertible notes at $8.11/share; $20M additional due upon FDA approval of PEDMARK by Sep 30, 2022.
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Fennec resubmits NDA to FDA for PEDMARK to prevent pediatric ototoxicity
Resubmitted New Drug Application (NDA) for PEDMARK (sodium thiosulfate anhydrous injection).
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Fennec receives FDA Complete Response Letter for PEDMARK NDA citing manufacturing deficiencies
FDA issued CRL on Nov 29, 2021, after PDUFA date of Nov 27, citing manufacturing deficiencies for PEDMARK NDA.