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Hot Stocks
Acasti Pharma announces voting results from Annual General, Special Meeting » 09:11
09/29/22
09/29
09:11
09/29/22
09:11
ACST

Acasti Pharma

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Acasti Pharma announced…

Acasti Pharma announced the voting results from its Annual General and Special Meeting of Shareholders which was held virtually on Wednesday September 28, 2022. All five nominees listed in the proxy statement dated August 31, 2022, being Jean Marie Canan, Jan D'Alvise, Donald Olds, Vimal Kavuru and Michael L. Derby were elected as directors of Acasti at the Meeting to serve for a term that expires at the 2023 annual meeting of Acasti shareholders or until their successors are duly elected or appointed, unless such office is earlier vacated in accordance with Acasti's by-laws. The Company thanks Dr. Roderick Carter for his board service and chairmanship over the last 7 years, and Dr. William Haseltine for his board service over the last year. At the Meeting, KPMG LLP was reappointed as the Company's independent auditor for the ensuing year and the directors of the Company were authorized to fix the auditor's remuneration. At the Meeting, shareholders passed an advisory resolution approving the compensation of Acasti's named executive officers. In August 2022, the board of directors of Acasti approved amendments to the existing limits of common shares reserved for issuance under the Company's equity incentive plan to set the total number of Common Shares reserved for issuance pursuant to awards granted under the Equity Incentive Plan to an aggregate number that shall not exceed 20% of the issued and outstanding Common Shares as of July 28, 2022, representing 8,898,838 Common Shares, which limit shall include Common Shares issuable pursuant to options issued under the Stock Option Plan. In August, 2022, the Board also approved amendments to the existing limits of Common Shares reserved for issuance under the Company's stock option plan to increase the number of Common Shares that may be issued upon the exercise of all options granted under the plan from 10% of the issued and outstanding Common Shares from time to time to 20% of the issued and outstanding Common Shares as of July 28, 2022, representing 8,898,838 Common Shares, which includes the 4,251,881 Common Shares currently reserved for outstanding options under the Stock Option Plan and which limit shall also include Common Shares issuable pursuant to any awards issued under the Equity Incentive Plan. At the Meeting, disinterested shareholders approved the amendments described above to the Stock Option Plan and the Equity Incentive Plan.

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ACST Acasti Pharma
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12/21/21 Oppenheimer
Oppenheimer starts Acasti Pharma with Outperform, $6 price target
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ACST Acasti Pharma
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Over a week ago
Hot Stocks
Acasti Pharma appoints Kohli as Chief Commercial Officer » 08:07
09/13/22
09/13
08:07
09/13/22
08:07
ACST

Acasti Pharma

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The Company announces…

The Company announces that Prashant Kohli has been named Chief Commercial Officer. Kohli previously served as Acasti's VP of Commercial Operations and held the same title at Grace Therapeutics, prior to its acquisition by Acasti in August 2021.

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ACST Acasti Pharma
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ACST Acasti Pharma
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12/21/21 Oppenheimer
Oppenheimer starts Acasti Pharma with Outperform, $6 price target
ACST Acasti Pharma
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ACST Acasti Pharma
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Hot Stocks
Acasti Pharma announces initiation of PK study for GTX-102 » 08:07
09/13/22
09/13
08:07
09/13/22
08:07
ACST

Acasti Pharma

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Acasti Pharma announces…

Acasti Pharma announces the initiation of its planned pharmacokinetic, PK, bridging study to evaluate the comparative bioavailability, pharmacokinetics, and safety of its oral betamethasone spray, GTX-102, compared to an intramuscular injection of betamethasone and to an oral solution of betamethasone, in 48 healthy subjects. The First Subject, First Dose was administered on September 13th. This PK study is the next step in the proposed 505(b)(2) regulatory pathway for GTX-102 and is expected to be completed with top line results reported before year end. Jan D'Alvise, Chief Executive Officer of Acasti, stated, "The initiation of this PK study is yet another important milestone in the advancement of our GTX-102 program designed to provide a novel therapy for treating the chronic symptoms of Ataxia Telangiectasia in children with this rare genetic disorder. GTX-102 is now the third program to advance into the clinic this year as we continue to leverage our novel drug delivery technologies that have the potential to improve the performance of currently marketed drugs by achieving faster onset of action, enhanced efficacy, reduced side effects, and more convenient drug delivery. We look forward to the completion of this PK study later this year, and assuming positive results, we expect to move rapidly into Phase 3 in the second half of 2023. Currently there are no drugs approved for A-T, and we are very motivated to potentially bring this exciting novel treatment to children who suffer from A-T." The primary objective of the study is to evaluate and characterize the PK profile of GTX-102 as an oral spray.

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ACST Acasti Pharma
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ACST Acasti Pharma
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12/21/21 Oppenheimer
Oppenheimer starts Acasti Pharma with Outperform, $6 price target
ACST Acasti Pharma
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ACST Acasti Pharma
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Over a month ago
Hot Stocks
Acasti Pharma expects cash to fund GTX-104 through NDA submission » 07:15
08/11/22
08/11
07:15
08/11/22
07:15
ACST

Acasti Pharma

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Cash, cash equivalents…

Cash, cash equivalents and short-term investments totaled $38.4 million as of June 31, 2022, compared to $43.7 million in cash, cash equivalents and short-term investments as of March 31, 2022. Based on management's current projections, current cash is expected to fund our lead asset GTX-104 through to NDA submission, and GTX-102 and GTX-101 to additional important milestones.

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ACST Acasti Pharma
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ACST Acasti Pharma
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12/21/21 Oppenheimer
Oppenheimer starts Acasti Pharma with Outperform, $6 price target
ACST Acasti Pharma
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ACST Acasti Pharma
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Earnings
Acasti Pharma reports Q2 EPS (10c) vs. (12c) last year » 07:14
08/11/22
08/11
07:14
08/11/22
07:14
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Acasti Pharma

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Jan D'Alvise, Chief…

Jan D'Alvise, Chief Executive Officer of Acasti said, "We are making excellent progress on all three of our clinical programs, each of which have important clinical trials underway or to be initiated this fiscal year. All of our drug candidates have already received Orphan Drug Designation from the FDA, and each has the potential to be considered for fast-track review and approval. We are currently planning the Phase 3 safety trial for our lead drug candidate, GTX-104, a novel IV formulation of nimodipine designed to treat patients with subarachnoid hemorrhage. We also recently initiated a single dose study for GTX-101, a novel topical spray form of the analgesic bupivacaine, which is designed to treat Postherpetic Neuralgia the severe and often debilitating nerve pain that can persist following a shingles infection. Very shortly in calendar Q3, we expect to initiate a PK bridging study for GTX-102, a concentrated oral mucosal spray form of betamethasone, designed to improve the neurological symptoms of patients with Ataxia Telangiectasia. We are excited about the progress we are making to deliver innovative new treatments to thousands of patients who currently lack effective therapies. We look forward to reporting on the progress and results of these studies."

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ACST Acasti Pharma
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ACST Acasti Pharma
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12/21/21 Oppenheimer
Oppenheimer starts Acasti Pharma with Outperform, $6 price target
ACST Acasti Pharma
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ACST Acasti Pharma
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Hot Stocks
Acasti Pharma announces initiation of PK study for GTX-101 » 08:13
07/27/22
07/27
08:13
07/27/22
08:13
ACST

Acasti Pharma

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Acasti Pharma announces…

Acasti Pharma announces the initiation of its planned pharmacokinetic, PK, bridging study to evaluate the relative bioavailability of GTX-101 compared to the reference listed drug bupivacaine in 48 healthy subjects. Feedback from FDA was obtained on the study protocol, and the non-objection letter was received on July 12th from Health Canada. The First-Subject, First-Dose was administered on July 26th. The PK study is the next step in the proposed 505(b)(2) regulatory pathway for GTX-101. This study is expected to be completed by the end of calendar 2022 as planned and will provide important information on the dose and dosing frequency in humans. Based on market research with more than 250 physicians, the Company believes that a significant unmet need exists for treating these patients with PHN. Approximately 40% of patients that are prescribed the standard of care experience insufficient pain relief. The PK study is a Phase 1, Randomized, Single-Dose, 4-Cohort, Parallel study to evaluate the pharmacokinetics, dose proportionality, safety and tolerability of GTX-101 and subcutaneous injectable bupivacaine in healthy subjects. The primary objective is to assess the pharmacokinetics of 3 dose levels of GTX-101 given as a single-dose topical application.

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ACST Acasti Pharma
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ACST Acasti Pharma
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12/21/21 Oppenheimer
Oppenheimer starts Acasti Pharma with Outperform, $6 price target
ACST Acasti Pharma
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ACST Acasti Pharma
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Over a quarter ago
On The Fly
Fly Intel: Pre-market Movers » 08:58
06/21/22
06/21
08:58
06/21/22
08:58
K

Kellogg

$67.55 /

-0.12 (-0.18%)

, TSLA

Tesla

$650.06 /

+10.73 (+1.68%)

, SAVE

Spirit Airlines

$21.28 /

+0.44 (+2.11%)

, MDLZ

Mondelez

$58.81 /

+0.205 (+0.35%)

, VALN

Valneva

$16.26 /

+0.37 (+2.33%)

, PFE

Pfizer

$46.51 /

-1.01 (-2.13%)

, LEN

Lennar

$64.60 /

+0.21 (+0.33%)

, RSVR

Reservoir Media

$6.57 /

+0.1 (+1.55%)

, ACST

Acasti Pharma

/

+

, ACAD

Acadia Pharmaceuticals

$19.51 /

+ (+0.00%)

, IP

International Paper

$42.36 /

-0.36 (-0.84%)

, WRK

WestRock

$41.08 /

-0.19 (-0.46%)

, JBLU

JetBlue

$8.54 /

+0.43 (+5.30%)

Check out this morning's…

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WRK WestRock
$41.08 /

-0.19 (-0.46%)

VALN Valneva
$16.26 /

+0.37 (+2.33%)

TSLA Tesla
$650.06 /

+10.73 (+1.68%)

SAVE Spirit Airlines
$21.28 /

+0.44 (+2.11%)

RSVR Reservoir Media
$6.57 /

+0.1 (+1.55%)

PFE Pfizer
$46.51 /

-1.01 (-2.13%)

MDLZ Mondelez
$58.81 /

+0.205 (+0.35%)

LEN Lennar
$64.60 /

+0.21 (+0.33%)

K Kellogg
$67.55 /

-0.12 (-0.18%)

JBLU JetBlue
$8.54 /

+0.43 (+5.30%)

IP International Paper
$42.36 /

-0.36 (-0.84%)

ACST Acasti Pharma
/

+

ACAD Acadia Pharmaceuticals
$19.51 /

+ (+0.00%)

K Kellogg
$67.55 /

-0.12 (-0.18%)

05/09/22 Credit Suisse
Kellogg price target raised to $69 from $62 at Credit Suisse
05/06/22 Citi
Kellogg price target raised to $83 from $74 at Citi
05/03/22 Piper Sandler
Kellogg downgraded to Underweight from Neutral at Piper Sandler
04/25/22 Deutsche Bank
Kellogg downgraded to Hold from Buy at Deutsche Bank
TSLA Tesla
$650.06 /

+10.73 (+1.68%)

06/15/22 Mizuho
Mizuho likes three electric vehicle stocks into second half rebound
06/14/22 Morgan Stanley
Morgan Stanley says 'very prudent' to shift some Tesla production to Q3 from Q2
06/13/22 RBC Capital
RBC Capital upgrades Tesla to Outperform on near-term improvement, positioning
06/13/22 RBC Capital
Tesla upgraded to Outperform from Sector Perform at RBC Capital
SAVE Spirit Airlines
$21.28 /

+0.44 (+2.11%)

06/10/22 JPMorgan
Spirit Airlines upgraded to Overweight from Neutral at JPMorgan
05/05/22 Deutsche Bank
Spirit Airlines price target lowered to $27 from $38 at Deutsche Bank
04/11/22 MKM Partners
JetBlue upgraded to Neutral at MKM Partners on valuation
04/06/22 MKM Partners
MKM Partners expects to see 'heavy regulatory pushback' to JetBlue-Spirit deal
MDLZ Mondelez
$58.81 /

+0.205 (+0.35%)

05/19/22 Mizuho
Mizuho recommends buying three food stocks on recent selloff
04/27/22 Mizuho
Mondelez price target lowered to $75 from $77 at Mizuho
04/12/22 Credit Suisse
Mondelez reinstated with an Outperform at Credit Suisse
03/30/22 UBS
Mondelez initiated with a Buy at UBS
VALN Valneva
$16.26 /

+0.37 (+2.33%)

12/22/21 Kempen
Valneva downgraded to Sell from Neutral at Kempen
09/15/21 Bryan Garnier
Valneva upgraded to Buy from Neutral at Bryan Garnier
09/13/21 Bryan Garnier
Valneva downgraded to Neutral from Buy at Bryan Garnier
08/05/21 Goldman Sachs
Dynavax initiated with a Buy at Goldman Sachs
PFE Pfizer
$46.51 /

-1.01 (-2.13%)

06/13/22 Morgan Stanley
Moderna pediatric EUA vaccine briefing docs 'clean,' says Morgan Stanley
06/03/22 Oppenheimer
Turning Point Therapeutics downgraded to Perform from Outperform at Oppenheimer
05/31/22 Evercore ISI
Enanta upgraded to In Line from Underperform at Evercore ISI
05/25/22 Piper Sandler
Piper Sandler says Ventyx Biosciences' VTX002 could produce superior efficacy
LEN Lennar
$64.60 /

+0.21 (+0.33%)

06/16/22 UBS
Lennar price target lowered to $108 from $154 at UBS
06/06/22 BTIG
Lennar price target lowered to $92 from $118 at BTIG
04/13/22 JPMorgan
Lennar price target lowered to $89 from $108 at JPMorgan
04/05/22 Credit Suisse
Lennar initiated with a Neutral at Credit Suisse
RSVR Reservoir Media
$6.57 /

+0.1 (+1.55%)

08/23/21 Craig-Hallum
Craig-Hallum bullish on Reservoir Media, initiates with a Buy
08/23/21 Craig-Hallum
Reservoir Media initiated with a Buy at Craig-Hallum
08/23/21 Roth Capital
Reservoir Media initiated with a Buy at Roth Capital
ACST Acasti Pharma
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+

12/21/21 Oppenheimer
Oppenheimer starts Acasti Pharma with Outperform, $6 price target
ACAD Acadia Pharmaceuticals
$19.51 /

+ (+0.00%)

06/21/22 Canaccord
Odds of Acadia's Nuplazid approval for ADP in August 'very slim,' says Canaccord
06/21/22 Cantor Fitzgerald
Acadia Pharmaceuticals price target lowered to $26 from $37 at Cantor Fitzgerald
06/21/22 H.C. Wainwright
Acadia Pharmaceuticals price target lowered to $20 from $36 at H.C. Wainwright
06/20/22 Stifel
Stifel says negative AdComm vote likely closes door on pimavanserin ADP approval
IP International Paper
$42.36 /

-0.36 (-0.84%)

06/21/22 Citi
International Paper downgraded to Neutral from Buy at Citi
04/18/22 Deutsche Bank
International Paper price target raised to $48 from $47 at Deutsche Bank
04/08/22 Citi
International Paper price target lowered to $53 from $54 at Citi
02/14/22 Jefferies
International Paper, WestRock increasing box prices, says Jefferies
WRK WestRock
$41.08 /

-0.19 (-0.46%)

06/21/22 Citi
WestRock downgraded to Neutral from Buy at Citi
05/26/22 Wells Fargo
WestRock price target lowered to $59 from $66 at Wells Fargo
04/18/22 Deutsche Bank
WestRock price target raised to $59 from $52 at Deutsche Bank
JBLU JetBlue
$8.54 /

+0.43 (+5.30%)

04/26/22 JPMorgan
JetBlue double downgraded to Underweight from Overweight at JPMorgan
04/22/22 Deutsche Bank
JetBlue downgraded to Hold on headwinds at Deutsche Bank
04/22/22 Deutsche Bank
JetBlue downgraded to Hold from Buy at Deutsche Bank
WRK WestRock
$41.08 /

-0.19 (-0.46%)

TSLA Tesla
$650.06 /

+10.73 (+1.68%)

SAVE Spirit Airlines
$21.28 /

+0.44 (+2.11%)

RSVR Reservoir Media
$6.57 /

+0.1 (+1.55%)

PFE Pfizer
$46.51 /

-1.01 (-2.13%)

MDLZ Mondelez
$58.81 /

+0.205 (+0.35%)

LEN Lennar
$64.60 /

+0.21 (+0.33%)

K Kellogg
$67.55 /

-0.12 (-0.18%)

JBLU JetBlue
$8.54 /

+0.43 (+5.30%)

IP International Paper
$42.36 /

-0.36 (-0.84%)

ACST Acasti Pharma
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ACAD Acadia Pharmaceuticals
$19.51 /

+ (+0.00%)

  • 29
    Oct
TSLA Tesla
$650.06 /

+10.73 (+1.68%)

SAVE Spirit Airlines
$21.28 /

+0.44 (+2.11%)

PFE Pfizer
$46.51 /

-1.01 (-2.13%)

MDLZ Mondelez
$58.81 /

+0.205 (+0.35%)

LEN Lennar
$64.60 /

+0.21 (+0.33%)

K Kellogg
$67.55 /

-0.12 (-0.18%)

TSLA Tesla
$650.06 /

+10.73 (+1.68%)

SAVE Spirit Airlines
$21.28 /

+0.44 (+2.11%)

RSVR Reservoir Media
$6.57 /

+0.1 (+1.55%)

PFE Pfizer
$46.51 /

-1.01 (-2.13%)

MDLZ Mondelez
$58.81 /

+0.205 (+0.35%)

LEN Lennar
$64.60 /

+0.21 (+0.33%)

K Kellogg
$67.55 /

-0.12 (-0.18%)

JBLU JetBlue
$8.54 /

+0.43 (+5.30%)

IP International Paper
$42.36 /

-0.36 (-0.84%)

ACST Acasti Pharma
/

+

ACAD Acadia Pharmaceuticals
$19.51 /

+ (+0.00%)

TSLA Tesla
$650.06 /

+10.73 (+1.68%)

SAVE Spirit Airlines
$21.28 /

+0.44 (+2.11%)

PFE Pfizer
$46.51 /

-1.01 (-2.13%)

MDLZ Mondelez
$58.81 /

+0.205 (+0.35%)

LEN Lennar
$64.60 /

+0.21 (+0.33%)

K Kellogg
$67.55 /

-0.12 (-0.18%)

JBLU JetBlue
$8.54 /

+0.43 (+5.30%)

ACAD Acadia Pharmaceuticals
$19.51 /

+ (+0.00%)

Hot Stocks
Acasti Pharma expects cash to fund GTX-104 through NDA submission » 08:03
06/21/22
06/21
08:03
06/21/22
08:03
ACST

Acasti Pharma

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Cash, cash equivalents…

Cash, cash equivalents and short-term investments totaled $43.7 million as of March 31, 2022 compared to $60.7 million in cash, cash equivalents and short-term investments as of March 31, 2021. Based on management's current projections, current cash is expected to fund our lead asset GTX-104 through to NDA submission, and GTX-102 and GTX-101 to additional key milestones.

ShowHide Related Items >><<
ACST Acasti Pharma
/

+

ACST Acasti Pharma
/

+

12/21/21 Oppenheimer
Oppenheimer starts Acasti Pharma with Outperform, $6 price target
ACST Acasti Pharma
/

+

ACST Acasti Pharma
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+

Earnings
Acasti Pharma reports 2022 EPS (27c) vs. ($1.33) last year » 08:02
06/21/22
06/21
08:02
06/21/22
08:02
ACST

Acasti Pharma

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Jan D'Alvise, CEO of…

Jan D'Alvise, CEO of Acasti said, "Fiscal year 2022 was a truly transformative year for Acasti, and I am extremely pleased with all our team has accomplished over the last 12 months. In FY'22, we pivoted as a company, and acquired Grace Therapeutics in August 2021. This gave us a new mission of leveraging Grace's proprietary drug delivery technologies to reformulate and repurpose marketed medicines for indications in rare and orphan diseases, where significant unmet medical needs exist. We now have three drug candidates advancing in clinical development, and all three have already received Orphan Drug Designation by the FDA, which could grant us 7 years of market exclusivity in the US. Just a few weeks ago we announced that GTX-104, a novel IV formulation of nimodipine, met all its PK Bridging Study endpoints, and we are now working with the FDA to commence a Phase 3 study, which we expect to be the final step required to seek regulatory approval. We also advanced our other drug candidates, GTX-102 and GTX-101, into the clinic with significant potential milestones expected later this calendar year. We are confident that our strong balance sheet, which shows $43.7 million of cash and short-term investments as of March 31, 2022, will allow us to advance GTX-104 through Phase 3 and to potential FDA submission, while similarly advancing GTX-102 and GTX-101 to key value inflection points. We look forward to the coming fiscal year with tremendous excitement."

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ACST Acasti Pharma
/

+

ACST Acasti Pharma
/

+

12/21/21 Oppenheimer
Oppenheimer starts Acasti Pharma with Outperform, $6 price target
ACST Acasti Pharma
/

+

ACST Acasti Pharma
/

+

Hot Stocks
Acasti Pharma announces issuance of additional patents for GTX-104, GTX-101 » 08:06
06/14/22
06/14
08:06
06/14/22
08:06
ACST

Acasti Pharma

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Acasti Pharma announced…

Acasti Pharma announced that three composition of matter patents for GTX-104 were issued by The United States Patent and Trademark Office, the Japanese Patent Office, and the Australian Patent Office. Additionally, one new patent for GTX-104 was awarded by the Indian Patent Office. These granted patents are all valid until 2037. GTX-104 is a novel formulation of nimodipine for IV infusion to treat patients suffering from Subarachnoid Hemorrhage, which is caused by a ruptured aneurysm and is estimated to affect about 110,000 patients per year, in the US and Europe. In addition, the Canadian Intellectual Property Office has issued a notice of allowance for a composition of matter patent for GTX-101, a topical spray of bupivacaine targeting Postherpetic Neuralgia, PHN. The granted patent is valid until 2036. Jan D'Alvise, Chief Executive Officer of Acasti, stated, "We are pleased to report that our progress in the clinic is being matched by our progress protecting our intellectual property, both in North America and internationally. We are happy to highlight that we now hold 5 U.S. patents for GTX-104. GTX-101 could provide significant benefits over the current standard of care including greater convenience, faster onset of action and longer duration of pain relief and we are pleased to see that we have additional IP coverage in Canada. We expect that a single-dose clinical trial will be launched soon to study the PK profile of GTX-101 in healthy volunteers," D'Alvise concluded.

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ACST Acasti Pharma
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ACST Acasti Pharma
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12/21/21 Oppenheimer
Oppenheimer starts Acasti Pharma with Outperform, $6 price target
ACST Acasti Pharma
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ACST Acasti Pharma
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