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Fennec's PEDMARK hits primary endpoint in Japan Phase 2, 24% hearing loss vs 56.4%
Phase 2 STS-J01 met primary endpoint: ASHA-defined hearing loss 24.0% (6/25) vs 56.4% historical benchmark (P=0.001).
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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).