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Hot Stocks
Aravive appoints Robert Geller as Chief Medical Officer » 09:09
07/05/22
07/05
09:09
07/05/22
09:09
ARAV

Aravive

/

+

Aravive announced the…

Aravive announced the appointment of Robert B. Geller as Chief Medical Officer. Geller is a medical oncologist with over 30 years of drug development experience leading all aspects of clinical and medical affairs, including commercialization preparedness and launch of novel therapeutics. Geller will play a critical role in progressing Aravive's portfolio of programs in ovarian, renal and pancreatic cancers. Geller started his academic career as the Director of the Stem Cell Transplant program at the University of Chicago and as the Director of the Leukemia Service and Director of the Unrelated Transplant Program, Emory University. He then transitioned to community practice where he focused on the development of clinical pathways for patients with hematologic malignancies and solid tumors, and the expansion of community-based clinical research programs. After over two decades in clinical practice, he then transitioned to the biopharmaceutical industry, where he held positions in medical affairs and clinical development at Alexion, Heron Therapeutics, and most recently as Senior Vice President at Coherus Biosciences where he was involved in the clinical development and successful commercialization of both their biosimilar franchise and their immune-oncology pipeline.

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ARAV Aravive
/

+

ARAV Aravive
/

+

06/03/22 Roth Capital
Aravive initiated with a Buy at Roth Capital
05/12/22 Piper Sandler
Aravive price target lowered to $6 from $9 at Piper Sandler
04/01/22 Piper Sandler
Aravive price target lowered to $9 from $14 at Piper Sandler
01/31/22 Piper Sandler
Aravive price target lowered to $14 from $18 at Piper Sandler
ARAV Aravive
/

+

Earnings
SAB Biotherapeutics hosts two congressmen for a tour of its facilities » 08:26
07/05/22
07/05
08:26
07/05/22
08:26
SABS

SAB Biotherapeutics

$1.44 /

+0.02 (+1.41%)

SAB Biotherapeutics…

SAB Biotherapeutics hosted U.S. Congressmen Dusty Johnson and Dean Phillips on Friday, July 1, for a tour of SAB's facilities and to learn about SAB's innovative immunotherapy platform that enables a scalable and reliable production of polyclonal antibodies. During their visit, Congressmen Johnson and Phillips toured SAB's Plasma Production Facility, featuring the company's transchromosomic Bovine which provide SAB's fully human polyclonal antibodies for therapeutics. The Congressmen also met with members of SAB's management team to discuss the company's history in COVID-19 treatment development and SAB's current pipeline in influenza, oncology, and type 1 diabetes.

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SABS SAB Biotherapeutics
$1.44 /

+0.02 (+1.41%)

SABS SAB Biotherapeutics
$1.44 /

+0.02 (+1.41%)

05/13/22 Chardan
SAB Biotherapeutics price target lowered to $7 from $10 at Chardan
04/01/22 Chardan
SAB Biotherapeutics price target lowered to $10 from $17 at Chardan
01/25/22 Northland
SAB Biotherapeutics weakness creates buying opportunity, says Northland
12/02/21 Northland
SAB Biotherapeutics price target raised to $21 from $18 at Northland
Hot Stocks
BioXcel Therapeutics appoints Michael Miller to board of directors » 07:08
07/05/22
07/05
07:08
07/05/22
07:08
BTAI

BioXcel Therapeutics

$14.29 /

+1.12 (+8.50%)

, JAZZ

Jazz Pharmaceuticals

$158.35 /

+2.43 (+1.56%)

BioXcel Therapeutics…

BioXcel Therapeutics (BTAI) announced the appointment of Michael Miller to its Board of Directors, effective July 1, 2022. Miller brings nearly 40 years of strategic leadership and commercial growth experience in the pharmaceutical industry, where he most recently served as Executive Vice President, U.S. Commercial at Jazz Pharmaceuticals (JAZZ).

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JAZZ Jazz Pharmaceuticals
$158.35 /

+2.43 (+1.56%)

BTAI BioXcel Therapeutics
$14.29 /

+1.12 (+8.50%)

BTAI BioXcel Therapeutics
$14.29 /

+1.12 (+8.50%)

05/23/22 H.C. Wainwright
BioXcel Therapeutics price target lowered to $110 from $134 at H.C. Wainwright
05/13/22 Canaccord
BioXcel Therapeutics price target lowered to $75 from $84 at Canaccord
05/10/22 Truist
BioXcel Therapeutics price target lowered to $71 from $125 at Truist
04/20/22 Canaccord
BioXcel Therapeutics shares remain significantly undervalued, says Canaccord
JAZZ Jazz Pharmaceuticals
$158.35 /

+2.43 (+1.56%)

06/13/22 UBS
Jazz Pharmaceuticals initiated with a Buy at UBS
06/13/22 UBS
Jazz Pharmaceuticals initiated with a Buy at UBS
06/03/22 Piper Sandler
Piper keeps $193 target on Jazz after surveying 25 physicians
05/27/22 Craig-Hallum
Avadel Pharmaceuticals price target lowered to $15.50 from $20 at Craig-Hallum
JAZZ Jazz Pharmaceuticals
$158.35 /

+2.43 (+1.56%)

BTAI BioXcel Therapeutics
$14.29 /

+1.12 (+8.50%)

JAZZ Jazz Pharmaceuticals
$158.35 /

+2.43 (+1.56%)

BTAI BioXcel Therapeutics
$14.29 /

+1.12 (+8.50%)

Hot Stocks
Lyra Therapeutics appoints Nieman as Chief Medical Officer » 07:04
07/05/22
07/05
07:04
07/05/22
07:04
LYRA

Lyra Therapeutics

$5.39 /

-0.14 (-2.53%)

, BMY

Bristol-Myers

$76.87 /

-0.19 (-0.25%)

, TEVA

Teva

$7.88 /

+0.355 (+4.72%)

, BAYRY

Bayer

$15.02 /

+0.15 (+1.01%)

Lyra Therapeutics (LYRA)…

Lyra Therapeutics (LYRA) announced that Richard Nieman, MD, has been appointed Chief Medical Officer, effective July 11, 2022. Dr. Nieman brings more than 25 years of experience in drug development and medical affairs. Dr. Nieman has had prior leadership roles as SVP & Worldwide Medical Head of Immunology at Bristol Myers Squibb (BMY), Head of R&D China at BMS, Global Medical Officer & Head of Medical at Teva (TEVA), and Head of Asia Pacific Medical at Bayer (BAYRY).

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TEVA Teva
$7.88 /

+0.355 (+4.72%)

LYRA Lyra Therapeutics
$5.39 /

-0.14 (-2.53%)

BMY Bristol-Myers
$76.87 /

-0.19 (-0.25%)

BAYRY Bayer
$15.02 /

+0.15 (+1.01%)

LYRA Lyra Therapeutics
$5.39 /

-0.14 (-2.53%)

05/24/22 Cantor Fitzgerald
Lyra Therapeutics initiated with an Overweight at Cantor Fitzgerald
05/24/22 Cantor Fitzgerald
Lyra Therapeutics initiated with an Overweight at Cantor Fitzgerald
BMY Bristol-Myers
$76.87 /

-0.19 (-0.25%)

06/23/22 BMO Capital
Nuvalent initiated with an Outperform at BMO Capital
06/06/22 H.C. Wainwright
Turning Point Therapeutics downgraded to Neutral from Buy at H.C. Wainwright
06/05/22 BofA
BofA keeps Buy on Bristol-Myers, raises price target to $80
06/03/22 Oppenheimer
Turning Point Therapeutics downgraded to Perform from Outperform at Oppenheimer
TEVA Teva
$7.88 /

+0.355 (+4.72%)

06/13/22 UBS
Teva initiated with a Neutral at UBS
06/13/22 UBS
Teva initiated with a Neutral at UBS
05/17/22 BofA
Teva upgraded to Neutral at BofA on potential opioid deal upside
05/17/22 BofA
Teva upgraded to Neutral from Underperform at BofA
BAYRY Bayer
$15.02 /

+0.15 (+1.01%)

06/13/22 Redburn
FMC downgraded to Neutral on cost inflation at Redburn
05/19/22 UBS
Bayer price target raised to EUR 96 from EUR 90 at UBS
05/11/22 Barclays
Bayer price target raised to EUR 90 from EUR 85 at Barclays
05/11/22 Credit Suisse
Bayer price target raised to EUR 62 from EUR 56 at Credit Suisse
TEVA Teva
$7.88 /

+0.355 (+4.72%)

BMY Bristol-Myers
$76.87 /

-0.19 (-0.25%)

BAYRY Bayer
$15.02 /

+0.15 (+1.01%)

TEVA Teva
$7.88 /

+0.355 (+4.72%)

BMY Bristol-Myers
$76.87 /

-0.19 (-0.25%)

BAYRY Bayer
$15.02 /

+0.15 (+1.01%)

TEVA Teva
$7.88 /

+0.355 (+4.72%)

LYRA Lyra Therapeutics
$5.39 /

-0.14 (-2.53%)

BMY Bristol-Myers
$76.87 /

-0.19 (-0.25%)

BAYRY Bayer
$15.02 /

+0.15 (+1.01%)

TEVA Teva
$7.88 /

+0.355 (+4.72%)

LYRA Lyra Therapeutics
$5.39 /

-0.14 (-2.53%)

BMY Bristol-Myers
$76.87 /

-0.19 (-0.25%)

Thursday
Hot Stocks
Titan Medical appoints Cary Vance as CEO » 16:03
06/30/22
06/30
16:03
06/30/22
16:03
TMDI

Titan Medical

/

+

Titan Medical announced…

Titan Medical announced that Cary Vance has been appointed as the company's president and CEO effective July 1. Vance will succeed Paul Cataford, Titan's chair of the board of directors, who has served as interim president and CEO since December 2021. Vance previously served as president and CEO at Xcath Incorporated, a privately held neurovascular robotics company.

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TMDI Titan Medical
/

+

TMDI Titan Medical
/

+

03/25/22 Oppenheimer
Titan Medical downgraded to Perform from Outperform at Oppenheimer
03/25/22 Oppenheimer
Titan Medical downgraded to Perform from Outperform at Oppenheimer
TMDI Titan Medical
/

+

Periodicals
New analysis of Amarin's Vascepa resurrects effectiveness questions, STAT says » 13:09
06/30/22
06/30
13:09
06/30/22
13:09
AMRN

Amarin

$1.73 /

-0.1 (-5.48%)

A new analysis of…

A new analysis of Amarin's Vascepa, a medicine derived from fish oil and used to prevent heart attacks in a select group of patients, raises big questions about the evidence that the medicine is effective, STAT News' Matthew Herper writes. Several experts say the questions require a new clinical trial to be conducted, and some even say the Food and Drug Administration should reconsider the product's approval, the author adds. The new data comes from an analysis funded by Amarin itself. Reference Link

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AMRN Amarin
$1.73 /

-0.1 (-5.48%)

AMRN Amarin
$1.73 /

-0.1 (-5.48%)

05/06/22 JPMorgan
JPMorgan downgrades Amarin to sell on headwinds in U.S., Europe
05/06/22 JPMorgan
Amarin downgraded to Underweight from Neutral at JPMorgan
05/05/22 H.C. Wainwright
Amarin downgraded to Neutral from Buy at H.C. Wainwright
05/05/22 SVB Securities
Amarin downgraded to Market Perform from Outperform at SVB Leerink
AMRN Amarin
$1.73 /

-0.1 (-5.48%)

AMRN Amarin
$1.73 /

-0.1 (-5.48%)

AMRN Amarin
$1.73 /

-0.1 (-5.48%)

Conference/Events
iKena Oncology management to meet with Jefferies » 12:17
06/30/22
06/30
12:17
06/30/22
12:17
IKNA

iKena Oncology

$4.38 /

-0.11 (-2.45%)

Biotech Analyst Shi holds…

Biotech Analyst Shi holds a meeting with CEO Manfredi and CMO Santillana and CFO Marango on the West Coast on June 30 hosted by Jefferies.

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IKNA iKena Oncology
$4.38 /

-0.11 (-2.45%)

IKNA iKena Oncology
$4.38 /

-0.11 (-2.45%)

04/13/22 H.C. Wainwright
iKena Oncology price target raised to $26 from $25 at H.C. Wainwright
03/17/22 Credit Suisse
iKena Oncology price target lowered to $24 from $27 at Credit Suisse
12/23/21 H.C. Wainwright
iKena Oncology initiated with a Buy at H.C. Wainwright
IKNA iKena Oncology
$4.38 /

-0.11 (-2.45%)

Hot Stocks
Cara Therapeutics announces results from Phase 2 trial of difelikefalin » 07:20
06/30/22
06/30
07:20
06/30/22
07:20
CARA

Cara Therapeutics

$9.60 /

+0.33 (+3.56%)

Cara Therapeutics…

Cara Therapeutics announced positive topline results from its Phase 2 proof-of-concept clinical trial evaluating oral difelikefalin for the treatment of moderate-to-severe pruritus in patients with notalgia paresthetica, a nerve disorder characterized by chronic pruritus of the upper to middle back. "We are pleased to have demonstrated clinical proof of concept for oral difelikefalin in the treatment of pruritus associated with notalgia paresthetica," said Joana Goncalves, M.D., Chief Medical Officer at Cara Therapeutics. "These topline results coupled with the results from our other programs support the broad development of oral difelikefalin across disease areas regardless of the underlying cause of pruritus. We look forward to completing our data analyses and discussing next steps with the U.S. Food and Drug Administration." The Phase 2 8-week study was designed to evaluate the efficacy and safety of oral difelikefalin for moderate-to-severe pruritus in approximately 120 patients with NP. Patients were randomized to oral difelikefalin 2 mg taken twice daily versus placebo for 8 weeks, followed by a 4-week active extension period. The primary efficacy endpoint was the change from baseline in the weekly mean of the daily 24-hour Worst Itch-Numeric Rating Scale score at Week 8. Other endpoints included the greater than or equal to4-point responder analysis, itch-related quality of life scores, and safety assessments. Patients treated with oral difelikefalin achieved the primary endpoint with significant improvement observed as early as Week 1 and sustained through Week 8. In addition, a statistically significantly greater proportion of patients treated with oral difelikefalin achieved a greater than or equal to4-point improvement in WI-NRS score at Week 8 vs. placebo. Oral difelikefalin was generally well tolerated with a safety profile consistent with that seen in earlier clinical trials.

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CARA Cara Therapeutics
$9.60 /

+0.33 (+3.56%)

CARA Cara Therapeutics
$9.60 /

+0.33 (+3.56%)

05/10/22 H.C. Wainwright
H.C. Wainwright sees 'major valuation disconnect' at Cara Therapeutics
03/14/22 Canaccord
Cara Therapeutics price target lowered to $29 from $33 at Canaccord
03/08/22 JPMorgan
Cara Therapeutics upgraded to Overweight from Neutral at JPMorgan
11/01/21 Canaccord
Cara Therapeutics assumed with a Buy at Canaccord
CARA Cara Therapeutics
$9.60 /

+0.33 (+3.56%)

Over a week ago
On The Fly
Fly Intel: After-Hours Movers » 18:48
06/29/22
06/29
18:48
06/29/22
18:48
POWW

AMMO

$4.08 /

-0.01 (-0.24%)

, MLKN

MillerKnoll

$27.98 /

-0.445 (-1.57%)

, FC

Franklin Covey

$37.91 /

-0.88 (-2.27%)

, CDMO

Avid Bioservices

$15.19 /

-0.34 (-2.19%)

, ADAG

Adagene

$2.11 /

+ (+0.00%)

, AVDL

Avadel Pharmaceuticals

$2.36 /

+0.02 (+0.85%)

, FIGS

Figs

$8.29 /

+0.205 (+2.54%)

, SGH

SGH

$20.28 /

-0.205 (-1.00%)

, DCT

Duck Creek Technologies

$18.43 /

-0.32 (-1.71%)

, CULP

Culp, Inc.

$5.02 /

-0.105 (-2.05%)

, RH

RH

$237.19 /

-6.87 (-2.81%)

, WSM

Williams-Sonoma

$116.07 /

-2.46 (-2.08%)

, FIZZ

National Beverage

$48.08 /

-0.12 (-0.25%)

, CYTK

Cytokinetics

$48.65 /

+1.275 (+2.69%)

, ANGN

Angion Biomedica

$1.73 /

-0.11 (-5.98%)

Check out this evening's…

ShowHide Related Items >><<
WSM Williams-Sonoma
$116.07 /

-2.46 (-2.08%)

SGH SGH
$20.28 /

-0.205 (-1.00%)

RH RH
$237.19 /

-6.87 (-2.81%)

POWW AMMO
$4.08 /

-0.01 (-0.24%)

MLKN MillerKnoll
$27.98 /

-0.445 (-1.57%)

FIGS Figs
$8.29 /

+0.205 (+2.54%)

FC Franklin Covey
$37.91 /

-0.88 (-2.27%)

DCT Duck Creek Technologies
$18.43 /

-0.32 (-1.71%)

CYTK Cytokinetics
$48.65 /

+1.275 (+2.69%)

CULP Culp, Inc.
$5.02 /

-0.105 (-2.05%)

CDMO Avid Bioservices
$15.19 /

-0.34 (-2.19%)

AVDL Avadel Pharmaceuticals
$2.36 /

+0.02 (+0.85%)

ANGN Angion Biomedica
$1.73 /

-0.11 (-5.98%)

ADAG Adagene
$2.11 /

+ (+0.00%)

POWW AMMO
$4.08 /

-0.01 (-0.24%)

08/17/21 Lake Street
AMMO price target raised to $12 at Lake Street after beat and raise report
06/30/21 Lake Street
AMMO price target raised to $11 from $9 at Lake Street
MLKN MillerKnoll
$27.98 /

-0.445 (-1.57%)

FC Franklin Covey
$37.91 /

-0.88 (-2.27%)

01/07/22 Barrington
Franklin Covey price target raised to $60 from $55 at Barrington
11/11/21 Roth Capital
Franklin Covey price target raised to $53 from $45 at Roth Capital
11/10/21 Barrington
Franklin Covey price target raised to $55 from $45 at Barrington
08/19/21 Barrington
Franklin Covey price target raised to $45 from $40 at Barrington
CDMO Avid Bioservices
$15.19 /

-0.34 (-2.19%)

03/09/22 Craig-Hallum
Avid Bioservices price target lowered to $30 from $35 at Craig-Hallum
12/08/21 RBC Capital
Avid Bioservices price target raised to $32 from $27 at RBC Capital
12/08/21 Craig-Hallum
Avid Bioservices price target raised to $35 from $29 at Craig-Hallum
12/08/21 KeyBanc
Avid Bioservices downgraded to Sector Weight from Overweight at KeyBanc
ADAG Adagene
$2.11 /

+ (+0.00%)

02/01/22 Morgan Stanley
Adagene price target lowered to $15 from $27 at Morgan Stanley
AVDL Avadel Pharmaceuticals
$2.36 /

+0.02 (+0.85%)

05/27/22 Craig-Hallum
Avadel Pharmaceuticals price target lowered to $15.50 from $20 at Craig-Hallum
05/27/22 H.C. Wainwright
Avadel selloff yesterday 'extremely overdone', says H.C. Wainwright
05/26/22 Stifel
Stifel downgrades Avadel despite 59% selloff on launch delay
05/26/22 Stifel
Avadel Pharmaceuticals downgraded to Hold from Buy at Stifel
FIGS Figs
$8.29 /

+0.205 (+2.54%)

06/29/22 Raymond James
Figs initiated with a Strong Buy at Raymond James
05/16/22 Barclays
Figs price target lowered to $13 from $34 at Barclays
05/16/22 Oppenheimer
Figs price target lowered to $22 from $45 at Oppenheimer
05/16/22 BofA
Figs downgraded to Neutral from Buy at BofA
SGH SGH
$20.28 /

-0.205 (-1.00%)

04/06/22 Needham
SGH price target raised to $45 from $42.50 at Needham
04/06/22 Barclays
SGH price target lowered to $30 from $35 at Barclays
02/08/22 Barclays
SGH price target lowered to $35 from $82 at Barclays
01/10/22 Stifel
Stifel sees 'material boost' to SGH consensus earnings from PADIS extension
DCT Duck Creek Technologies
$18.43 /

-0.32 (-1.71%)

04/04/22 Wolfe Research
Duck Creek Technologies downgraded to Peer Perform at Wolfe Research
04/01/22 Needham
Duck Creek Technologies price target lowered to $27 from $40 at Needham
04/01/22 DA Davidson
Duck Creek Technologies price target lowered to $34 from $38 at DA Davidson
04/01/22 Raymond James
Duck Creek Technologies price target lowered to $24 from $36 at Raymond James
CULP Culp, Inc.
$5.02 /

-0.105 (-2.05%)

RH RH
$237.19 /

-6.87 (-2.81%)

06/06/22 Loop Capital
RH price target lowered to $500 from $700 at Loop Capital
06/06/22 Barclays
RH price target lowered to $400 from $528 at Barclays
06/03/22 Jefferies
RH price target lowered to $520 from $560 at Jefferies
06/03/22 Morgan Stanley
RH price target lowered to $385 from $400 at Morgan Stanley
WSM Williams-Sonoma
$116.07 /

-2.46 (-2.08%)

05/27/22 Barclays
Williams-Sonoma price target lowered to $173 from $186 at Barclays
05/26/22 RBC Capital
Williams-Sonoma price target lowered to $185 from $220 at RBC Capital
05/26/22 Morgan Stanley
Williams-Sonoma price target lowered to $160 from $170 at Morgan Stanley
05/26/22 Wells Fargo
Williams-Sonoma price target lowered to $135 from $140 at Wells Fargo
FIZZ National Beverage
$48.08 /

-0.12 (-0.25%)

CYTK Cytokinetics
$48.65 /

+1.275 (+2.69%)

06/17/22 H.C. Wainwright
H.C. Wainwright says confidence in approval of Cytokinetics' omecamtiv unchanged
06/17/22 Piper Sandler
Cytokinetics PDUDA extension 'not a big deal,' says Piper Sandler
06/09/22 Piper Sandler
Cytokinetics price target raised to $72 from $50 at Piper Sandler
05/17/22 Piper Sandler
Piper 'surprised' AdComm called to review Cytokinetics' omecamtiv mecarbil
ANGN Angion Biomedica
$1.73 /

-0.11 (-5.98%)

05/23/22 H.C. Wainwright
Angion Biomedica price target lowered to $28 from $32 at H.C. Wainwright
04/18/22 H.C. Wainwright
Angion Biomedica price target lowered to $32 from $50 at H.C. Wainwright
12/10/21 Oppenheimer
Angion Biomedica price target lowered to $8 from $15 at Oppenheimer
11/09/21 H.C. Wainwright
Angion Biomedica price target lowered to $50 from $100 at H.C. Wainwright
WSM Williams-Sonoma
$116.07 /

-2.46 (-2.08%)

SGH SGH
$20.28 /

-0.205 (-1.00%)

RH RH
$237.19 /

-6.87 (-2.81%)

POWW AMMO
$4.08 /

-0.01 (-0.24%)

MLKN MillerKnoll
$27.98 /

-0.445 (-1.57%)

FIZZ National Beverage
$48.08 /

-0.12 (-0.25%)

FIGS Figs
$8.29 /

+0.205 (+2.54%)

FC Franklin Covey
$37.91 /

-0.88 (-2.27%)

DCT Duck Creek Technologies
$18.43 /

-0.32 (-1.71%)

CYTK Cytokinetics
$48.65 /

+1.275 (+2.69%)

CULP Culp, Inc.
$5.02 /

-0.105 (-2.05%)

CDMO Avid Bioservices
$15.19 /

-0.34 (-2.19%)

AVDL Avadel Pharmaceuticals
$2.36 /

+0.02 (+0.85%)

ADAG Adagene
$2.11 /

+ (+0.00%)

  • 16
    Sep
  • 21
    Jul
RH RH
$237.19 /

-6.87 (-2.81%)

FIGS Figs
$8.29 /

+0.205 (+2.54%)

WSM Williams-Sonoma
$116.07 /

-2.46 (-2.08%)

SGH SGH
$20.28 /

-0.205 (-1.00%)

RH RH
$237.19 /

-6.87 (-2.81%)

MLKN MillerKnoll
$27.98 /

-0.445 (-1.57%)

FIZZ National Beverage
$48.08 /

-0.12 (-0.25%)

FIGS Figs
$8.29 /

+0.205 (+2.54%)

FC Franklin Covey
$37.91 /

-0.88 (-2.27%)

DCT Duck Creek Technologies
$18.43 /

-0.32 (-1.71%)

CYTK Cytokinetics
$48.65 /

+1.275 (+2.69%)

WSM Williams-Sonoma
$116.07 /

-2.46 (-2.08%)

SGH SGH
$20.28 /

-0.205 (-1.00%)

RH RH
$237.19 /

-6.87 (-2.81%)

POWW AMMO
$4.08 /

-0.01 (-0.24%)

FIGS Figs
$8.29 /

+0.205 (+2.54%)

FC Franklin Covey
$37.91 /

-0.88 (-2.27%)

DCT Duck Creek Technologies
$18.43 /

-0.32 (-1.71%)

AVDL Avadel Pharmaceuticals
$2.36 /

+0.02 (+0.85%)

Hot Stocks
Avadel Pharmaceuticals announces steps taken to accelerate FDA approval of FT218 » 16:23
06/29/22
06/29
16:23
06/29/22
16:23
AVDL

Avadel Pharmaceuticals

$2.36 /

+0.02 (+0.85%)

Avadel Pharmaceuticals…

Avadel Pharmaceuticals announced the steps it is taking to explore every available pathway to accelerate the decision by FDA to grant final approval of its lead drug candidate, FT218, prior to June 2023. Concurrent with this strategy, Avadel has received and agreed upon what is expected to be a final label and is completing the last edits of the Risk Evaluation and Mitigation Strategy, or REMS, with FDA and expects to receive tentative approval of FT218. Avadel is taking the following actions, including those that can potentially accelerate FDA's final approval decision and shorten the timeline between approval and launch of FT218: submitted a Paragraph IV patent certification and expects to receive a tentative approval; filed a motion in the U.S. District Court of Delaware to delist US Patent No. 8,731,963 from FDA's Orange Book; a court order requiring the patent holder to delist the REMS patent from the Orange Book could provide a pathway for a final approval of FT218 prior to June 2023; preparing for a claim construction hearing in the existing patent litigation in the U.S. District Court of Delaware which is scheduled for August 31; the Court has previously stated this claim construction hearing needs to take place prior to ruling on the motion to delist the REMS patent from the Orange Book; investing in patient and physician education including the company's disease state program, which has resulted in over 5,000 narcolepsy patient enrollments in the first half of 2022; continuing key activities in anticipation of a final approval on or before June 2023, including planning for the final preparation of the FT218 REMS program and the continued manufacturing of commercial supply; optimizing the cost structure to reduce total quarterly cash operating expenses to $12M to $14M, excluding inventory purchases. A restructuring charge of between $3M-$4M, comprised primarily of severance related costs associated with a nearly 50% reduction in workforce, is expected to be recorded in the second quarter of 2022. The company expects to report greater than $100M of cash, cash equivalents and marketable securities as of June 30. Based on extensive market research and comprehensive claims data analytics, Avadel estimates the total patient population could be in the range of approximately 30,000-35,000 and expects FT218, if approved, to be the treatment of choice for patients suffering from narcolepsy-related excessive daytime sleepiness or cataplexy. In addition, Avadel estimates that in the last three years, 10,000-15,000 patients have discontinued their twice-nightly oxybate use, many due to the complications associated with the middle of the night dosing. Furthermore, based on an analysis of U.S. claims data, the company believes that each year approximately 3,000 patients initiate oxybate treatment for the first time and expects this to grow by 25%-50% over time with the introduction of FT218.

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AVDL Avadel Pharmaceuticals
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