Breaking News

Friday
Show Full Stories

X

To view all stories in expanded form, please subscribe.
Send Info
Hot Stocks
Aquestive Therapeutics gets FDA CRL for Libervant in seizure cluster management » 17:41
09/25/20
09/25
17:41
09/25/20
17:41
AQST

Aquestive Therapeutics

$7.59 /

-0.2 (-2.57%)

The company states:…

The company states: "Aquestive Therapeutics announced that the FDA has issued a complete response letter, or CRL, regarding the New Drug Application for Libervant, or diazepam, Buccal Film for management of seizure clusters. The FDA issues a CRL to indicate that the review cycle for an application is complete but the application cannot be approved in its current form. In the CRL, the FDA cited that, in a study submitted by the company with the NDA, certain weight groups showed a lower drug exposure level than desired. The company intends to provide to the FDA additional information on PK modeling to demonstrate that dose adjustments will obtain the desired exposure levels. There were no other safety, clinical pharmacology/biopharmaceutics or CMC issues identified in the CRL. The FDA did cite a small number of protocol deviations in blood draws in one of the studies in the NDA. The company believes, based on discussions with the FDA, that the company will not need to conduct any further clinical studies in order to cure the items cited in the CRL, and will confirm that view in its upcoming follow-up meeting with the FDA. Based on interactions with the Agency, the company believes that this CRL will not be a barrier to ultimate approval, as the CRL was limited to providing additional information on PK modeling for an adjusted dosing regimen for a limited subset of patient weight categories. The company plans to request a Type A meeting with the FDA in the coming weeks and to resubmit the NDA prior to the end of 2020 with the adjusted dosage regimen for the identified weight groups at issue. A submission before the end of the year should result in a PDUFA Action Date in the 1st half of 2021. The Agency did not include any indication regarding approval of U.S. market access for Libervant at this time."

ShowHide Related Items >><<
AQST Aquestive Therapeutics
$7.59 /

-0.2 (-2.57%)

AQST Aquestive Therapeutics
$7.59 /

-0.2 (-2.57%)

09/24/20 Lake Street
Lake Street says FDA decision on Aquestive's Libervant may come Friday or Monday
05/22/20 H.C. Wainwright
Aquestive Therapeutics price target raised to $15 from $13 at H.C. Wainwright
03/16/20 Wedbush
Aquestive Therapeutics price target lowered to $31 from $36 at Wedbush
02/10/20 Wedbush
Wedbush delays launch estimates for Libervant, ups Aquestive Therapeutics target
AQST Aquestive Therapeutics
$7.59 /

-0.2 (-2.57%)

  • 13
    Dec
AQST Aquestive Therapeutics
$7.59 /

-0.2 (-2.57%)

Conference/Events
Applied Genetic management to meet virtually with Roth Capital » 11:25
09/25/20
09/25
11:25
09/25/20
11:25
AGTC

Applied Genetic

$4.77 /

+0.04 (+0.85%)

Virtual Meeting to be…

Virtual Meeting to be held on September 25 at 12 pm hosted by Roth Capital.

ShowHide Related Items >><<
AGTC Applied Genetic
$4.77 /

+0.04 (+0.85%)

AGTC Applied Genetic
$4.77 /

+0.04 (+0.85%)

09/09/20 Roth Capital
Roth bumps up Applied Genetic price target to $26 after earnings, XLRP updates
09/03/20 Cantor Fitzgerald
Cantor sees positive risk/reward for Applied Genetic ahead of XLRP update
07/17/20 H.C. Wainwright
H.C. Wainwright says Applied Genetic still in 'pole position' in XLRP
07/01/20 Roth Capital
Applied Genetic may attract Sanofi takeover interest, says Roth Capital
AGTC Applied Genetic
$4.77 /

+0.04 (+0.85%)

  • 07
    Feb
Hot Stocks
Graybug appoints Christina Ackermann, Erik Bjerkholt, Julie Eastland to board » 08:10
09/25/20
09/25
08:10
09/25/20
08:10
GRAY

Graybug Vision

$0.00 /

+ (+0.00%)

, BHC

Bausch Health

$15.22 /

-0.53 (-3.37%)

, AIMT

Aimmune

$34.30 /

+0.01 (+0.03%)

Graybug Vision (GRAY)…

Graybug Vision (GRAY) announced the appointment of three new members to the company's Board of Directors with immediate effect. Christina Ackermann will chair Graybug's Nominating and Corporate Governance Committee and serve as a member of its Compensation Committee. Eric Bjerkholt, MBA, will chair the company's Compensation Committee and serve as a member of the Audit Committee. Julie Eastland, MBA, will chair the Audit Committee. Ms. Ackermann, Mr. Bjerkholt and Ms. Eastland replace Emmett Cunningham, Jr., MD, PhD, Managing Director at Blackstone Lifesciences Group, Chau Q. Khuong, MPH, Partner at OrbiMed, and Cameron Wheeler, PhD, Partner at Deerfield, all of whom served on Graybug's Board of Directors representing three of Graybug's long-term private investors. Christina currently serves as Executive Vice President, General Counsel and Head of Commercial Operations at Bausch Health Companies (BHC). Eric Bjerkholt is the Chief Financial Officer of Aimmune Therapeutics (AIMT). Julie Eastland served as Chief Financial Officer and Chief Business Officer of Rainier Therapeutics, a private biotechnology company focused on bladder cancer.

ShowHide Related Items >><<
BHC Bausch Health
$15.22 /

-0.53 (-3.37%)

AIMT Aimmune
$34.30 /

+0.01 (+0.03%)

GRAY Graybug Vision
$0.00 /

+ (+0.00%)

BHC Bausch Health
$15.22 /

-0.53 (-3.37%)

09/17/20
Fly Intel: Top five analyst upgrades
09/17/20 BofA
Bausch Health upgraded to Neutral from Underperform at BofA
08/24/20 JPMorgan
Bausch Health shares can double into separation, says JPMorgan
08/24/20 H.C. Wainwright
Bausch Health price target lowered to $50 from $64 at H.C. Wainwright
AIMT Aimmune
$34.30 /

+0.01 (+0.03%)

09/01/20 Credit Suisse
Aimmune price target raised to $34.50 from $14 at Credit Suisse
09/01/20 Cantor Fitzgerald
Aimmune downgraded to Neutral from Overweight at Cantor Fitzgerald
08/31/20 Wedbush
Aimmune downgraded to Neutral from Outperform at Wedbush
08/31/20 Roth Capital
Nestle acquisition of Aimmune could be good for shareholders, says Roth Capital
BHC Bausch Health
$15.22 /

-0.53 (-3.37%)

AIMT Aimmune
$34.30 /

+0.01 (+0.03%)

  • 25
    Sep
GRAY Graybug Vision
$0.00 /

+ (+0.00%)

BHC Bausch Health
$15.22 /

-0.53 (-3.37%)

AIMT Aimmune
$34.30 /

+0.01 (+0.03%)

BHC Bausch Health
$15.22 /

-0.53 (-3.37%)

Conference/Events
Applied Genetic management to meet virtually with Roth Capital » 04:55
09/25/20
09/25
04:55
09/25/20
04:55
AGTC

Applied Genetic

$4.72 /

-0.16 (-3.28%)

Virtual Meeting to be…

Virtual Meeting to be held on September 25 at 12 pm hosted by Roth Capital.

ShowHide Related Items >><<
AGTC Applied Genetic
$4.72 /

-0.16 (-3.28%)

AGTC Applied Genetic
$4.72 /

-0.16 (-3.28%)

09/09/20 Roth Capital
Roth bumps up Applied Genetic price target to $26 after earnings, XLRP updates
09/03/20 Cantor Fitzgerald
Cantor sees positive risk/reward for Applied Genetic ahead of XLRP update
07/17/20 H.C. Wainwright
H.C. Wainwright says Applied Genetic still in 'pole position' in XLRP
07/01/20 Roth Capital
Applied Genetic may attract Sanofi takeover interest, says Roth Capital
AGTC Applied Genetic
$4.72 /

-0.16 (-3.28%)

  • 07
    Feb
Thursday
Hot Stocks
IGM Biosciences enters research collaboration with AbCellera for IgM antibodies » 16:03
09/24/20
09/24
16:03
09/24/20
16:03
IGMS

IGM Biosciences

$71.81 /

-4.13 (-5.44%)

AbCellera and IGM…

AbCellera and IGM Biosciences announced that they have entered into a multi-year, multi-target strategic research collaboration and license agreement to facilitate the discovery and development of novel IgM antibodies. AbCellera will generate panels of antibodies for multiple therapeutic targets identified by IGM using its full-stack, AI-powered antibody discovery technology, and IGM will have the rights to develop and commercialize the novel antibodies resulting from this collaboration. Financial terms of the collaboration were not disclosed. AbCellera sources, searches, decodes and analyzes natural immune responses to identify antibodies for next-generation therapeutics.

ShowHide Related Items >><<
IGMS IGM Biosciences
$71.81 /

-4.13 (-5.44%)

IGMS IGM Biosciences
$71.81 /

-4.13 (-5.44%)

09/18/20 Piper Sandler
Piper Sandler lays out next potential takeover targets in oncology
09/14/20 Jefferies
Inhibrx initiated with a Buy at Jefferies
09/09/20 Jefferies
ASH data could prompt 40% rise, or 70% drop, for IGM Biosciences, says Jefferies
07/17/20
Fly Intel: Top five analyst initiations
IGMS IGM Biosciences
$71.81 /

-4.13 (-5.44%)

IGMS IGM Biosciences
$71.81 /

-4.13 (-5.44%)

IGMS IGM Biosciences
$71.81 /

-4.13 (-5.44%)

Conference/Events
Aptinyx management to meet virtually with Wedbush » 11:44
09/24/20
09/24
11:44
09/24/20
11:44
APTX

Aptinyx

$3.19 /

-0.04 (-1.24%)

Virtual Meeting to be…

Virtual Meeting to be held on September 28 hosted by Wedbush.

ShowHide Related Items >><<
APTX Aptinyx
$3.19 /

-0.04 (-1.24%)

APTX Aptinyx
$3.19 /

-0.04 (-1.24%)

07/01/20 Truist
Aptinyx initiated with a Buy at SunTrust
07/01/20 Truist
Aptinyx initiated with a Buy at SunTrust
05/08/20
Fly Intel: Top analyst initiations
05/08/20 William Blair
William Blair starts Aptinyx with Outperform, $10 fair value estimate
APTX Aptinyx
$3.19 /

-0.04 (-1.24%)

  • 10
    Jan
Hot Stocks
BioMarin doses first patient in PHEARLESS Phase 1/2 study with BMN 307 » 09:09
09/24/20
09/24
09:09
09/24/20
09:09
BMRN

BioMarin

$78.41 /

-1.07 (-1.35%)

BioMarin announced that…

BioMarin announced that it has dosed the first participant in the global PHEARLESS Phase 1/2 study with BMN 307, an investigational gene therapy for the treatment of individuals with PKU. BMN 307 is an AAV5-phenylalanine hydroxylase gene therapy designed to normalize blood phenylalanine concentration levels in patients with PKU by inserting a correct copy of the PAH gene into liver cells. BMN 307 will be evaluated to determine safety and whether a single dose of treatment can restore natural Phe metabolism, normalize plasma Phe levels, and enable a normal diet in patients with PKU. BioMarin will conduct this study with material manufactured with a commercial-ready process to facilitate rapid clinical development and potentially support approval. BMN 307 represents a potential third PKU treatment option in BioMarin's PKU franchise and a second gene therapy development program.

ShowHide Related Items >><<
BMRN BioMarin
$78.41 /

-1.07 (-1.35%)

BMRN BioMarin
$78.41 /

-1.07 (-1.35%)

09/10/20 Truist
BioMarin price target lowered to $125 from $130 at Truist
08/25/20 JPMorgan
Sarepta added to Analyst Focus List, named a Top Idea at JPMorgan
08/20/20 RBC Capital
Sarepta selloff on BioMarin CRL overdone ,says RBC Capital
08/20/20
Fly Intel: Top five analyst downgrades
BMRN BioMarin
$78.41 /

-1.07 (-1.35%)

BMRN BioMarin
$78.41 /

-1.07 (-1.35%)

BMRN BioMarin
$78.41 /

-1.07 (-1.35%)

Recommendations
Lake Street says FDA decision on Aquestive's Libervant may come Friday or Monday » 09:08
09/24/20
09/24
09:08
09/24/20
09:08
AQST

Aquestive Therapeutics

$8.02 /

-0.51 (-5.98%)

Lake Street analyst…

Lake Street analyst Thomas Flaten noted that the FDA's PDUFA date for Aquestive's Libervant decision is September 27, which means "we might more reasonably expect FDA action on Friday or Monday" given that date is a Sunday. He believes "the odds favor, by a small margin," that the FDA approves Libervant and grants it access to the market upon approval. Flaten, who points out that that FDA has previously approved products of the same molecular entity when another previously-approved and orphan drug exclusivity-designated product has been on the market, is currently estimating a commercial launch of Libervant in the first quarter of 2021. He keeps a Buy rating and $10 price target on Aquestive Therapeutics shares.

ShowHide Related Items >><<
AQST Aquestive Therapeutics
$8.02 /

-0.51 (-5.98%)

AQST Aquestive Therapeutics
$8.02 /

-0.51 (-5.98%)

05/22/20 H.C. Wainwright
Aquestive Therapeutics price target raised to $15 from $13 at H.C. Wainwright
03/16/20 Wedbush
Aquestive Therapeutics price target lowered to $31 from $36 at Wedbush
02/10/20 Wedbush
Wedbush delays launch estimates for Libervant, ups Aquestive Therapeutics target
02/10/20 Wedbush
Aquestive price target raised to $36 at Wedbush after FDA accepts NDA
AQST Aquestive Therapeutics
$8.02 /

-0.51 (-5.98%)

  • 13
    Dec
AQST Aquestive Therapeutics
$8.02 /

-0.51 (-5.98%)

Hot Stocks
Millendo Therapeutics initiates dosing in MLE-301 trial » 08:35
09/24/20
09/24
08:35
09/24/20
08:35
MLND

Millendo Therapeutics

$1.54 /

-0.07 (-4.35%)

Millendo Therapeutics…

Millendo Therapeutics announced dosing of the first subject in a Phase 1 clinical trial evaluating the safety, pharmacokinetics and preliminary efficacy of MLE-301, a selective neurokinin 3 receptor, or NK3R, antagonist that is being developed for the treatment of VMS, commonly known as hot flashes and night sweats, in menopausal women. The first-in-human trial is designed to evaluate the safety and tolerability of MLE-301. The single ascending dose portion of the study will be conducted in healthy male volunteers, to determine the pharmacokinetics of MLE-301 and its pharmacodynamic profile as measured by reductions of biomarkers. The Phase 1 multiple ascending dose portion will enroll post-menopausal women, allowing measurement of reductions in VMS frequency and severity, and establishment of initial clinical proof of concept. The Phase 1 clinical trial is supported by strong preclinical data that showed potency and selectivity for the NK3R receptor, the potential for once-daily dosing, and testosterone lowering effects consistent with the expected activity of an NK3R antagonist. Based on its demonstrated in vitro and in vivo activity, Millendo believes MLE-301 may have meaningful clinical impact in an area of unmet medical need.

ShowHide Related Items >><<
MLND Millendo Therapeutics
$1.54 /

-0.07 (-4.35%)

MLND Millendo Therapeutics
$1.54 /

-0.07 (-4.35%)

06/23/20 Wedbush
Wedbush keeps Neutral rating on Millendo after nevanimibe development halt
05/29/20 Citi
Millendo Therapeutics resumed with a Buy at Citi
04/07/20 Craig-Hallum
Millendo failure in PWS doesn't add risk to Soleno readout, says Craig-Hallum
04/07/20 Roth Capital
Millendo Therapeutics price target lowered to $6 from $35 at Roth Capital
MLND Millendo Therapeutics
$1.54 /

-0.07 (-4.35%)

  • 05
    Dec
Hot Stocks
Ideaya, Pfizer expand collaboration for IDE196 and crizotinib study » 06:07
09/24/20
09/24
06:07
09/24/20
06:07
IDYA

Ideaya Biosciences

$11.86 /

+0.15 (+1.28%)

, PFE

Pfizer

$36.01 /

-0.25 (-0.69%)

Ideaya Biosciences (IDYA)…

Ideaya Biosciences (IDYA) announced that it has expanded its clinical trial collaboration and supply agreement with Pfizer (PFE) for an Ideaya sponsored clinical combination study of IDE196, a Protein Kinase C, or PKC, inhibitor, and crizotinib, a cMET inhibitor to which Pfizer has exclusive worldwide rights. The study will evaluate IDE196 and crizotinib combination therapy in patients with solid tumors having GNAQ or GNA11 mutations, including metastatic uveal melanoma, or MUM, skin melanoma, lung cancer and colorectal cancer. Evaluating MUM patient clinical samples, Ideaya identified cMET expression or activation as a potentially valuable biomarker that may guide IDE196 clinical treatment in this indication. Ideaya also demonstrated preclinical synergy in MUM with the combination of IDE196 and crizotinib, which further supports the potential biomarker on cMET expression. Ideaya's clinical development plan in MUM for IDE196 is based on combination therapies, including with binimetinib, a MEK inhibitor, and crizotinib, a cMET inhibitor, enabled through its clinical trial collaboration and drug supply agreement with Pfizer. The company announced first-patient-in, or FPI, for the IDE196 and binimetinib clinical combination in June and is targeting FPI for the crizotinib clinical trial combination in late 2020 to early 2021. Ideaya is also evaluating IDE196 as monotherapy in an ongoing GNAQ/11 non-MUM basket trial in additional solid tumor types, including in skin melanoma, where the company announced Phase 2 expansion. Ideaya and Pfizer have established a Joint Development Committee, or JDC, and there will be joint decision making and data sharing of the clinical trial results between the parties. Ideaya will sponsor the study and Pfizer will provide the crizotinib drug supply. If there is clinical data from the collaboration studies that could be used to obtain regulatory approvals or label changes, Ideaya and Pfizer will enter into good faith negotiations to determine a regulatory submission strategy.

ShowHide Related Items >><<
PFE Pfizer
$36.01 /

-0.25 (-0.69%)

IDYA Ideaya Biosciences
$11.86 /

+0.15 (+1.28%)

IDYA Ideaya Biosciences
$11.86 /

+0.15 (+1.28%)

09/01/20 Northland
Ideaya Biosciences initiated with an Outperform at Northland
07/30/20 Roth Capital
Roth Capital bullish on Ideaya as GSK highlights synthetic lethality pipeline
07/13/20 JPMorgan
Ideaya upgraded to Overweight on recent pullback at JPMorgan
07/13/20 JPMorgan
Ideaya Biosciences upgraded to Overweight from Neutral at JPMorgan
PFE Pfizer
$36.01 /

-0.25 (-0.69%)

09/21/20 Morgan Stanley
Eli Lilly's Verzenio 'clear winner' over Pfizer's Ibrance, says Morgan Stanley
09/16/20 Baird
uniQure weakness a buying opportunity, says Baird
09/15/20 Citi
Sarepta price target raised to $190 from $177 at Citi
09/09/20 SVB Leerink
AstraZeneca pause 'a mixed blessing for Moderna, others, says SVB Leerink
PFE Pfizer
$36.01 /

-0.25 (-0.69%)

IDYA Ideaya Biosciences
$11.86 /

+0.15 (+1.28%)

  • 18
    Jun
PFE Pfizer
$36.01 /

-0.25 (-0.69%)

PFE Pfizer
$36.01 /

-0.25 (-0.69%)

IDYA Ideaya Biosciences
$11.86 /

+0.15 (+1.28%)

PFE Pfizer
$36.01 /

-0.25 (-0.69%)

IDYA Ideaya Biosciences
$11.86 /

+0.15 (+1.28%)

Get Full Fly Access

Breaking market intelligence sent straight to you
Our team of experts analyze every news story and filter out the noise to deliver real-time market moving news.
Up-to-date information on important industry events
Get real-time updates on events that are moving the market—from conferences and calls to syndicate announcements.
News focused on the companies in your portfolio
Create up to 12 portfolios with 150 stocks each, and see how active they are in market news.