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Recommendations
Medexus Pharmaceuticals price target lowered to C$2.75 from C$3.50 at Canaccord » 12:05
09/22/22
09/22
12:05
09/22/22
12:05
MEDXF

Medexus Pharmaceuticals

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+

Canaccord analyst Tania…

Canaccord analyst Tania Gonsalves lowered the firm's price target on Medexus Pharmaceuticals to C$2.75 from C$3.50 and keeps a Speculative Buy rating on the shares.

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MEDXF Medexus Pharmaceuticals
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MEDXF Medexus Pharmaceuticals
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09/20/22 Raymond James
Medexus Pharmaceuticals downgraded to Market Perform from Outperform at Raymond James
08/10/22 Canaccord
Medexus Pharmaceuticals price target raised to C$3.50 from C$3.25 at Canaccord
08/10/22 Stifel
Medexus Pharmaceuticals price target lowered to C$11 from C$14.25 at Stifel
07/26/22 Raymond James
Medexus Pharmaceuticals resumed with an Outperform at Raymond James
Downgrade
Medexus Pharmaceuticals downgraded to Market Perform from Outperform at Raymond James » 08:44
09/20/22
09/20
08:44
09/20/22
08:44
MEDXF

Medexus Pharmaceuticals

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Raymond James analyst…

Raymond James analyst Rahul Sarugaser downgraded Medexus Pharmaceuticals to Market Perform from Outperform with a price target of C$2.00, down from C$4.50. On Monday, the FDA issued medac a second notice of incomplete response relating to its NDA submission for treosulfan, further delaying the review process, Sarugaser tells investors in a research note. The analyst expects turnaround on this resubmission will be measured in months rather than years.

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MEDXF Medexus Pharmaceuticals
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MEDXF Medexus Pharmaceuticals
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08/10/22 Canaccord
Medexus Pharmaceuticals price target raised to C$3.50 from C$3.25 at Canaccord
08/10/22 Stifel
Medexus Pharmaceuticals price target lowered to C$11 from C$14.25 at Stifel
07/26/22 Raymond James
Medexus Pharmaceuticals resumed with an Outperform at Raymond James
03/02/22 Raymond James
Medexus price target raised to C$5.75 from C$5.50 at Raymond James
Hot Stocks
Medexus assumes full responsibility for commercializing Gleolan in the U.S. » 08:17
09/19/22
09/19
08:17
09/19/22
08:17
MEDXF

Medexus Pharmaceuticals

$1.44 /

+0.01 (+0.70%)

Medexus has now assumed…

Medexus has now assumed full responsibility for commercializing Gleolan in the United States and has begun shipping Medexus-labeled product to customers across the country. Gleolan sales since March 2022, when Medexus acquired exclusive U.S. commercialization rights, have been in line with Medexus's expectations, and the company expects to continue that strong performance over the coming months. Medexus previously estimated that Gleolan had generated US$3 million to US$4 million in revenue in the last full quarter before Medexus acquired the exclusive right to commercialize Gleolan in the United States. During the now-completed transition period, Medexus had recognized a portion of total net sales in its revenue, net of an estimated royalty amount. September 2022 will be the first full month in which Medexus recognizes 100% of Gleolan net sales, on which Medexus will pay a tiered annual royalty. Michael Adelman, General Manager-U.S. Operations, commented: "Completing this seamless transition to full commercialization responsibility is an important accomplishment for patients and customers. We and our partners have worked hard to ensure uninterrupted access to Gleolan and related support programs, and we remain focused on realizing Gleolan's full potential to improve neurosurgeons' ability to help high grade glioma patients across the United States and Canada, where Medexus launched Gleolan in February 2021. The institutional sales infrastructure we have built in our U.S. business will serve as a foundation for additional products with similar target accounts."

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MEDXF Medexus Pharmaceuticals
$1.44 /

+0.01 (+0.70%)

MEDXF Medexus Pharmaceuticals
$1.44 /

+0.01 (+0.70%)

08/10/22 Canaccord
Medexus Pharmaceuticals price target raised to C$3.50 from C$3.25 at Canaccord
08/10/22 Stifel
Medexus Pharmaceuticals price target lowered to C$11 from C$14.25 at Stifel
07/26/22 Raymond James
Medexus Pharmaceuticals resumed with an Outperform at Raymond James
03/02/22 Raymond James
Medexus price target raised to C$5.75 from C$5.50 at Raymond James
Hot Stocks
Medexus says FDA delivers medac second notice of incomplete response » 08:16
09/19/22
09/19
08:16
09/19/22
08:16
MEDXF

Medexus Pharmaceuticals

$1.44 /

+0.01 (+0.70%)

On Friday, September 16,…

On Friday, September 16, Medexus Pharmaceuticals was informed by medac, licensor of Medexus's commercialization rights to treosulfan, that the U.S. Food and Drug Administration has delivered to medac a second notice of incomplete response regarding medac's new drug application resubmission for treosulfan. The FDA's notice requests further supporting information from medac to complete medac's NDA resubmission but does not require submission of new clinical data. Medexus will provide an update to its shareholders and stakeholders once management knows whether the resubmission has been accepted and is better able to assess the impact of this delay. "While we recognize that the FDA's response timeline has proven longer than anticipated, we are encouraged to see that the Agency remains engaged with medac to find a path towards resubmission," commented Ken d'Entremont, CEO of Medexus. "We continue to seek opportunities to collaborate with medac to the extent permitted by our license agreement in order to support medac in satisfying the FDA's requests and in upholding their responsibility for treosulfan regulatory matters. We are evaluating the potential impact of this delay, including on the timing of a commercial launch in the United States, and we are working with our regulatory and legal advisors to plan accordingly. We firmly believe that treosulfan would make a substantial difference for U.S. patients, as it has in Europe and Canada, and we remain optimistic about the prospect of a treosulfan approval in the United States. We remain focused on delivering strong revenue growth and improved overall performance in our current portfolio of products in both the United States and Canada. We were pleased to announce the strongest fiscal Q1 in our company's history by delivering a record US$23.0 million of revenue and improved operating performance. Overall, our monthly results so far suggest that we are heading towards another strong quarter."

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MEDXF Medexus Pharmaceuticals
$1.44 /

+0.01 (+0.70%)

MEDXF Medexus Pharmaceuticals
$1.44 /

+0.01 (+0.70%)

08/10/22 Canaccord
Medexus Pharmaceuticals price target raised to C$3.50 from C$3.25 at Canaccord
08/10/22 Stifel
Medexus Pharmaceuticals price target lowered to C$11 from C$14.25 at Stifel
07/26/22 Raymond James
Medexus Pharmaceuticals resumed with an Outperform at Raymond James
03/02/22 Raymond James
Medexus price target raised to C$5.75 from C$5.50 at Raymond James
Over a month ago
Recommendations
Medexus Pharmaceuticals price target raised to C$3.50 from C$3.25 at Canaccord » 11:50
08/10/22
08/10
11:50
08/10/22
11:50
MEDXF

Medexus Pharmaceuticals

$2.24 /

+0.29 (+14.87%)

Canaccord analyst Tania…

Canaccord analyst Tania Gonsalves raised the firm's price target on Medexus Pharmaceuticals to C$3.50 from C$3.25 and keeps a Speculative Buy rating on the shares.

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MEDXF Medexus Pharmaceuticals
$2.24 /

+0.29 (+14.87%)

MEDXF Medexus Pharmaceuticals
$2.24 /

+0.29 (+14.87%)

08/10/22 Stifel
Medexus Pharmaceuticals price target lowered to C$11 from C$14.25 at Stifel
07/26/22 Raymond James
Medexus Pharmaceuticals resumed with an Outperform at Raymond James
03/02/22 Raymond James
Medexus price target raised to C$5.75 from C$5.50 at Raymond James
02/22/22 Raymond James
Medexus Pharmaceuticals initiated with an Outperform at Raymond James
Recommendations
Medexus Pharmaceuticals price target lowered to C$11 from C$14.25 at Stifel » 11:33
08/10/22
08/10
11:33
08/10/22
11:33
MEDXF

Medexus Pharmaceuticals

$2.24 /

+0.29 (+14.87%)

Stifel analyst Justin…

Stifel analyst Justin Keywood lowered the firm's price target on Medexus Pharmaceuticals to C$11 from C$14.25 and keeps a Buy rating on the shares.

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MEDXF Medexus Pharmaceuticals
$2.24 /

+0.29 (+14.87%)

MEDXF Medexus Pharmaceuticals
$2.24 /

+0.29 (+14.87%)

07/26/22 Raymond James
Medexus Pharmaceuticals resumed with an Outperform at Raymond James
03/02/22 Raymond James
Medexus price target raised to C$5.75 from C$5.50 at Raymond James
02/22/22 Raymond James
Medexus Pharmaceuticals initiated with an Outperform at Raymond James
08/18/21 Canaccord
Medexus Pharmaceuticals downgraded to Hold from Speculative Buy at Canaccord
Initiation
Medexus Pharmaceuticals resumed with an Outperform at Raymond James » 07:23
07/26/22
07/26
07:23
07/26/22
07:23
MEDXF

Medexus Pharmaceuticals

$1.88 /

+0.415 (+28.33%)

Raymond James analyst…

Raymond James analyst Rahul Sarugaser resumed coverage of Medexus Pharmaceuticals with an Outperform rating and C$4.50 price target. With its solid platform of growth-stage and mature assets that effectively cover the operations of the company, Sarugaser expects that ~60% of the revenue from Medexus's newest assets -- Treosulfan and Gleolan -- should drop straight to the bottom line, driving a material escalation in EBITDA beginning in 2H23, and into 2024, the analyst tells investors in a research note.

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MEDXF Medexus Pharmaceuticals
$1.88 /

+0.415 (+28.33%)

MEDXF Medexus Pharmaceuticals
$1.88 /

+0.415 (+28.33%)

03/02/22 Raymond James
Medexus price target raised to C$5.75 from C$5.50 at Raymond James
02/22/22 Raymond James
Medexus Pharmaceuticals initiated with an Outperform at Raymond James
08/18/21 Canaccord
Medexus Pharmaceuticals downgraded to Hold from Speculative Buy at Canaccord
08/09/21 Canaccord
Medexus Pharmaceuticals downgraded to Speculative Buy from Buy at Canaccord
Hot Stocks
Medexus Pharmaceuticals announces resubmission of Treosulfan NDA » 07:02
07/25/22
07/25
07:02
07/25/22
07:02
MEDXF

Medexus Pharmaceuticals

$1.47 /

+ (+0.00%)

Medexus Pharmaceuticals…

Medexus Pharmaceuticals and medac announces that medac has resubmitted its New Drug Application for treosulfan with the U.S. Food and Drug Administration. The current submission was a response to the FDA request to submit information to complete medac's April 2022 NDA resubmission and initiate FDA review. The NDA requests approval of treosulfan in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation. The current submission includes updates to data files and supporting information in response to the FDA's information request received with the FDA's acknowledgment of receipt of the NDA resubmission in May 2022. If the response is considered complete by the FDA, the review clock for the NDA resubmission will then start as of the date of submission of a complete response. "We remain excited about the prospect of a treosulfan approval in the United States and about treosulfan's significant potential in the U.S. market," commented Ken d'Entremont, Medexus's CEO. "We are encouraged by the recent publication of the final study results and analysis of the pivotal phase 3 clinical trial of treosulfan conducted by medac, which met its primary endpoint and key secondary endpoints. An FDA approval within a two- to six-month period from the acceptance date would then pave the way for a commercial launch of treosulfan in the United States in the first half of calendar year 2023."

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MEDXF Medexus Pharmaceuticals
$1.47 /

+ (+0.00%)

MEDXF Medexus Pharmaceuticals
$1.47 /

+ (+0.00%)

03/02/22 Raymond James
Medexus price target raised to C$5.75 from C$5.50 at Raymond James
02/22/22 Raymond James
Medexus Pharmaceuticals initiated with an Outperform at Raymond James
08/18/21 Canaccord
Medexus Pharmaceuticals downgraded to Hold from Speculative Buy at Canaccord
08/09/21 Canaccord
Medexus Pharmaceuticals downgraded to Speculative Buy from Buy at Canaccord
Over a quarter ago
Hot Stocks
Medexus Pharmaceuticals announces publication of study results on treosulfan » 08:50
06/06/22
06/06
08:50
06/06/22
08:50
MEDXF

Medexus Pharmaceuticals

$1.66 /

-0.055 (-3.21%)

Medexus Pharmaceuticals…

Medexus Pharmaceuticals announced that the American Journal of Hematology has accepted for publication the final study results and analysis of the pivotal phase 3 clinical trial of treosulfan conducted by medac, a strategic partner of Medexus. The publication has undergone full peer review and has already been published online. The open-label, multicenter, randomized parallel study was designed to compare event-free survival after treosulfan-based conditioning with a widely applied reduced-intensity conditioning busulfan regimen in older or comorbid patients with acute myeloid leukemia or myelodysplastic syndrome undergoing allogeneic hematopoietic stem cell transplantation. The primary endpoint of the study was EFS of patients with disease recurrence, graft failure, or death from any cause as events. Secondary endpoints were overall survival, cumulative incidence of relapse or progression, cumulative incidence of graft failure, and non-relapse mortality. The study was performed in 31 clinical institutions across five European countries and enrolled 570 patients between June 2013 and December 2016. The publication concludes that the study demonstrates clinically relevant superiority of treosulfan over RIC busulfan with regard to its primary endpoint, EFS. The study found that EFS of patients in the study was superior after treosulfan compared to RIC busulfan. The publication also includes favorable conclusions on two key secondary endpoints, finding that overall survival with treosulfan was superior compared to busulfan and that non-relapse mortality for patients in the treosulfan arm was lower than for patients in the busulfan arm. The authors conclude that a treosulfan regimen appears particularly suitable for older AML and MDS patients. Frequencies of treatment-emergent adverse events of all grades and serious AEs were equally distributed between the study arms. Further, frequencies of patients with treatment-emergent serious AEs categorized by organ class and term were comparably low and no unknown safety risks were identified.

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MEDXF Medexus Pharmaceuticals
$1.66 /

-0.055 (-3.21%)

MEDXF Medexus Pharmaceuticals
$1.66 /

-0.055 (-3.21%)

03/02/22 Raymond James
Medexus price target raised to C$5.75 from C$5.50 at Raymond James
02/22/22 Raymond James
Medexus Pharmaceuticals initiated with an Outperform at Raymond James
08/18/21 Canaccord
Medexus Pharmaceuticals downgraded to Hold from Speculative Buy at Canaccord
08/09/21 Canaccord
Medexus Pharmaceuticals downgraded to Speculative Buy from Buy at Canaccord
Hot Stocks
Medexus Pharmaceuticals announces resubmission of Treosulfan NDA » 08:32
04/22/22
04/22
08:32
04/22/22
08:32
MEDXF

Medexus Pharmaceuticals

$2.37 /

-0.075 (-3.07%)

Medexus Pharmaceuticals…

Medexus Pharmaceuticals and medac are pleased to announce that medac has resubmitted its New Drug Application for Treosulfan with the U.S. Food and Drug Administration. The NDA requests approval of Treosulfan in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation. The resubmission includes additional clinical data and statistical analysis relating to the previously-completed phase 3 clinical trial of Treosulfan as well as an update of the integrated summary of safety, which the FDA had requested in their July 2021 Complete Response Letter to medac.

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MEDXF Medexus Pharmaceuticals
$2.37 /

-0.075 (-3.07%)

MEDXF Medexus Pharmaceuticals
$2.37 /

-0.075 (-3.07%)

03/02/22 Raymond James
Medexus price target raised to C$5.75 from C$5.50 at Raymond James
02/22/22 Raymond James
Medexus Pharmaceuticals initiated with an Outperform at Raymond James
08/18/21 Canaccord
Medexus Pharmaceuticals downgraded to Hold from Speculative Buy at Canaccord
08/09/21 Canaccord
Medexus Pharmaceuticals downgraded to Speculative Buy from Buy at Canaccord

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