Breaking News

Over a week ago
Show Full Stories

X

To view all stories in expanded form, please subscribe.
Send Info
Hot Stocks
Urovant Sciences enters co-promotion agreement with Sunovion for vibegron » 08:10
10/07/20
10/07
08:10
10/07/20
08:10
UROV

Urovant Sciences

$9.59 /

-0.37 (-3.71%)

Urovant Sciences…

Urovant Sciences announced it has entered into a five-year U.S. co-promotion agreement with Sunovion Pharmaceuticals to promote vibegron in the primary care segment upon receiving FDA approval for the drug. In March, the FDA accepted the new drug application, or NDA, for vibegron in overactive bladder, or OAB, and assigned a Prescription Drug User Fee Act, or PDUFA, goal date of December 26. Under the terms of the agreement, Sunovion will deploy its multi-specialty sales force to bring vibegron to primary care physicians, or PCP. In support of this effort, Sunovion will provide sales and marketing activities targeting the PCP segment through March 31, 2026. In compensation for its sales and marketing activities during the period of this agreement, Sunovion will receive a mid-single digit repayment fee based on the net sales of vibegron beginning on April 1, 2023. The co-promotion agreement is in addition to the exclusive three-year agreement Urovant entered into with Sunovion in June for services related to wholesale trade and retail distribution, contract operations, and select account management activities for vibegron. Sunovion Pharmaceuticals is a subsidiary of Sumitomo Dainippon which is the majority shareholder of Urovant.

ShowHide Related Items >><<
UROV Urovant Sciences
$9.59 /

-0.37 (-3.71%)

UROV Urovant Sciences
$9.59 /

-0.37 (-3.71%)

06/19/20 H.C. Wainwright
Urovant Sciences price target lowered to $28 from $33 at H.C. Wainwright
12/31/19 H.C. Wainwright
Urovant Sciences price target raised to $33 from $28 at H.C. Wainwright
Over a quarter ago
Recommendations
Urovant Sciences price target lowered to $28 from $33 at H.C. Wainwright » 06:11
06/19/20
06/19
06:11
06/19/20
06:11
UROV

Urovant Sciences

$11.48 /

+0.44 (+3.99%)

H.C. Wainwright analyst…

H.C. Wainwright analyst Raghuram Selvaraju lowered the firm's price target on Urovant Sciences to $28 from $33 and keeps a Buy rating on the shares following the company's fiscal 2019 results.

ShowHide Related Items >><<
UROV Urovant Sciences
$11.48 /

+0.44 (+3.99%)

UROV Urovant Sciences
$11.48 /

+0.44 (+3.99%)

12/31/19 H.C. Wainwright
Urovant Sciences price target raised to $33 from $28 at H.C. Wainwright
UROV Urovant Sciences
$11.48 /

+0.44 (+3.99%)

Hot Stocks
Urovant Sciences announces collaboration with Sunovion Pharmaceuticals » 08:06
06/18/20
06/18
08:06
06/18/20
08:06
UROV

Urovant Sciences

$11.04 /

+ (+0.00%)

Urovant Sciences…

Urovant Sciences announced it has entered into an exclusive three-year distribution agreement with Sunovion Pharmaceuticals for services to support the commercialization of vibegron, an investigational agent for the treatment of overactive bladder. Both companies are subsidiaries of Sumitomo Dainippon Pharma. Urovant said in a release, "The co-promotion agreement will enable Urovant to leverage Sunovion's commercial infrastructure to increase efficiency of the planned launch of vibegron. The agreement covers services such as account management, contract operations, third party logistics, and trade and retail distribution."

ShowHide Related Items >><<
UROV Urovant Sciences
$11.04 /

+ (+0.00%)

UROV Urovant Sciences
$11.04 /

+ (+0.00%)

12/31/19 H.C. Wainwright
Urovant Sciences price target raised to $33 from $28 at H.C. Wainwright
UROV Urovant Sciences
$11.04 /

+ (+0.00%)

Hot Stocks
Urovant Sciences names James Robinson president, CEO » 16:05
03/23/20
03/23
16:05
03/23/20
16:05
UROV

Urovant Sciences

$9.10 /

+1.35 (+17.42%)

Urovant Sciences…

Urovant Sciences announced the appointment of accomplished industry veteran Jim Robinson to the position of President and Chief Executive Officer. Mr. Robinson will continue his service as a member of the Urovant Board of Directors. Mr. Robinson is succeeding Urovant's founding CEO Keith Katkin, who will transition to the role of advisor to the Urovant Board for the next five years. "Since the founding of Urovant, our intention has been to evolve to the point where we would identify a highly-talented and capable CEO with the right commercial and biotech leadership experience who could lead Urovant through its next growth phase as a commercial company. With our vibegron new drug application on file with the FDA and the strong financial support of Sumitomo Dainippon Pharma, now is the perfect time to transition the leadership of Urovant to Jim Robinson," said Mr. Katkin. "Having worked closely with Jim on the Urovant Board, I know he is the right leader at this stage of the Company's growth, and I look forward to working with Jim and the rest of the Urovant Board to deliver on the commercial promise of vibegron, as well as our entire clinical pipeline. Jim has the background, experience and entrepreneurial spirit to drive near-term shareholder value creation as well as long-term success."

ShowHide Related Items >><<
UROV Urovant Sciences
$9.10 /

+1.35 (+17.42%)

12/31/19 H.C. Wainwright
Urovant Sciences price target raised to $33 from $28 at H.C. Wainwright
06/14/19 JPMorgan
Urovant Sciences continued share weakness unwarranted, says JPMorgan
Hot Stocks
Urovant Sciences announces FDA acceptance of vibegron NDA for review » 08:08
03/05/20
03/05
08:08
03/05/20
08:08
UROV

Urovant Sciences

$13.46 /

+0.66 (+5.16%)

Urovant Sciences…

Urovant Sciences announced that the FDA has accepted for review the company's new drug application, or NDA, for once-daily 75 mg vibegron for the treatment of patients with overactive bladder, or OAB, with symptoms of urge urinary incontinence, urgency and urinary frequency. The NDA has been assigned a Prescription Drug User Fee Act goal date of December 26. In addition, the FDA has communicated that they are not currently planning to hold an advisory committee meeting to discuss the application.

ShowHide Related Items >><<
UROV Urovant Sciences
$13.46 /

+0.66 (+5.16%)

12/31/19 H.C. Wainwright
Urovant Sciences price target raised to $33 from $28 at H.C. Wainwright
06/14/19 JPMorgan
Urovant Sciences continued share weakness unwarranted, says JPMorgan
03/20/19 Cowen
Urovant's vibegron data present clear path to approval, says Cowen
03/20/19 JPMorgan
JPMorgan boosts Urovant target to $24, calls selloff yesterday unfounded
Hot Stocks
Urovant Sciences announces publication of safety, efficacy results of EMPOWUR » 09:10
03/02/20
03/02
09:10
03/02/20
09:10
UROV

Urovant Sciences

$12.38 /

+0.38 (+3.17%)

Urovant Sciences…

Urovant Sciences announced the publication of the efficacy and safety results of vibegron in patients with overactive bladder, or OAB, from the international Phase 3 EMPOWUR trial. The peer-reviewed publication is currently available online and the print article is scheduled to be published in the August issue of Journal of Urology. The double-blind, placebo-controlled 12-week trial, in patients with OAB, studied vibegron 75 mg once-daily compared to placebo and included an active control. In the trial, vibegron achieved rapid onset of action at two weeks in both co-primary endpoints and daily urgency episodes and statistically significant efficacy was maintained at all timepoints measured through the end of the study. Vibegron also achieved statistical significance over placebo on all seven key secondary endpoints, including the most important secondary endpoint of reduction in urgency episodes. Vibegron demonstrated consistent efficacy, a favorable safety profile, and was well tolerated. The frequency of serious adverse events was similar across treatment arms and the incidence of the reported adverse event of hypertension for vibegron was equal to placebo.

ShowHide Related Items >><<
UROV Urovant Sciences
$12.38 /

+0.38 (+3.17%)

12/31/19 H.C. Wainwright
Urovant Sciences price target raised to $33 from $28 at H.C. Wainwright
06/14/19 JPMorgan
Urovant Sciences continued share weakness unwarranted, says JPMorgan
03/20/19 Cowen
Urovant's vibegron data present clear path to approval, says Cowen
03/20/19 JPMorgan
JPMorgan boosts Urovant target to $24, calls selloff yesterday unfounded
Earnings
Urovant Sciences reports Q3 EPS ($1.36), consensus (98c) » 16:17
02/13/20
02/13
16:17
02/13/20
16:17
UROV

Urovant Sciences

$11.12 /

+0.03 (+0.27%)

Q4 cash used in…

Q4 cash used in operations was $23.6M. As of December 31, 2019, total cash and cash equivalents was $131.9M. "This has been an exciting and transformational quarter for our company, marked by key milestones across all aspects of our business," said Keith A. Katkin, CEO of Urovant Sciences. "We submitted our New Drug Application for vibegron for the treatment of patients with overactive bladder to the FDA ahead of schedule, initiated a Phase 2a study of our novel gene therapy product, URO-902 and entered into a transformative relationship with Sumitomo Dainippon Pharma. We now look forward to our interactions with the FDA as we prepare to bring to market a potentially best in class therapeutic option for the treatment of patients suffering from overactive bladder."

ShowHide Related Items >><<
UROV Urovant Sciences
$11.12 /

+0.03 (+0.27%)

12/31/19 H.C. Wainwright
Urovant Sciences price target raised to $33 from $28 at H.C. Wainwright
06/14/19 JPMorgan
Urovant Sciences continued share weakness unwarranted, says JPMorgan
03/20/19 Cowen
Urovant's vibegron data present clear path to approval, says Cowen
03/20/19 JPMorgan
JPMorgan boosts Urovant target to $24, calls selloff yesterday unfounded
Hot Stocks
Urovant Sciences announces publication of safety, efficacy results of URO-902 » 08:04
02/04/20
02/04
08:04
02/04/20
08:04
UROV

Urovant Sciences

$12.90 /

-0.65 (-4.80%)

Urovant Sciences…

Urovant Sciences announced the publication of the safety and efficacy results of URO-902 in female patients with overactive bladder, or OAB, from two double-blind, placebo-controlled randomized Phase 1 trials. The first trial was conducted with instillation therapy and the second trial with direct injections into the bladder wall under local anesthesia. The peer-reviewed publication was published online in Neurology and Urodynamics. URO-902, a naked DNA plasmid-based gene therapy administered via injection directly into the bladder, is currently being evaluated as a potential treatment for OAB in an ongoing Phase 2a study in the United States. In the trials, URO-902 was well tolerated and the administration via direct injection procedure demonstrated statistically significant improvement in OAB symptoms. Two double-blind, placebo-controlled, multicenter Phase 1 trials were performed in female patients with OAB and urodynamically demonstrated detrusor overactivity, or DO. The aim of the trials was to demonstrate the safety and potential efficacy of URO-902, which comprises a gene therapy plasmid vector expressing the human big potassium channel a subunit. Among the safety outcomes, there were no clinically relevant or dose-limiting adverse events, or AEs, preventing dose escalation during either trial, and no participants withdrew due to AEs. For efficacy, a significant reduction versus placebo in urgency episodes and number of voids were observed as early as one week after injection. These improvements over placebo were statistically significant and observed over 24 weeks.

ShowHide Related Items >><<
UROV Urovant Sciences
$12.90 /

-0.65 (-4.80%)

12/31/19 H.C. Wainwright
Urovant Sciences price target raised to $33 from $28 at H.C. Wainwright
06/14/19 JPMorgan
Urovant Sciences continued share weakness unwarranted, says JPMorgan
03/20/19 Cowen
Urovant's vibegron data present clear path to approval, says Cowen
03/20/19 JPMorgan
JPMorgan boosts Urovant target to $24, calls selloff yesterday unfounded
Recommendations
Urovant Sciences price target raised to $33 from $28 at H.C. Wainwright » 07:24
12/31/19
12/31
07:24
12/31/19
07:24
UROV

Urovant Sciences

$13.27 /

-0.18 (-1.34%)

H.C. Wainwright analyst…

H.C. Wainwright analyst Raghuram Selvaraju raised his price target on Urovant Sciences to $33 from $28 to reflect the elimination of near-term equity dilution given that Sumitomo Dainippon has agreed to extend a $300M term loan facility to Urovant as part of its deal to acquire stakes in multiple Roivant-established companies and take an 11% stake in Roivant for $3B. In that deal, Sumitomo Dainippon has acquired the 75% stake in Urovant Sciences that Roivant originally owned, Selvaraju noted. He keeps a Buy rating on Urovant shares.

ShowHide Related Items >><<
UROV Urovant Sciences
$13.27 /

-0.18 (-1.34%)

06/14/19 JPMorgan
Urovant Sciences continued share weakness unwarranted, says JPMorgan
03/20/19 Cowen
Urovant's vibegron data present clear path to approval, says Cowen
03/20/19 JPMorgan
JPMorgan boosts Urovant target to $24, calls selloff yesterday unfounded
03/15/19
Fly Intel: Top five analyst initiations
Hot Stocks
Urovant Sciences submits vibegron NDA to FDA » 16:18
12/30/19
12/30
16:18
12/30/19
16:18
UROV

Urovant Sciences

$13.20 /

-0.25 (-1.86%)

Urovant Sciences…

Urovant Sciences announced that it has submitted a new drug application, or NDA, to the FDA seeking approval of once-daily 75mg vibegron for the treatment of patients with overactive bladder, or OAB, with symptoms of urge urinary incontinence, urgency and urinary frequency. The NDA for vibegron is supported by a clinical development program, which included over 4,000 patients with OAB. In a pivotal efficacy and safety study, once-daily 75mg vibegron met all primary and key secondary efficacy endpoints, and demonstrated a favorable safety profile.

ShowHide Related Items >><<
UROV Urovant Sciences
$13.20 /

-0.25 (-1.86%)

06/14/19 JPMorgan
Urovant Sciences continued share weakness unwarranted, says JPMorgan
03/20/19 Cowen
Urovant's vibegron data present clear path to approval, says Cowen
03/20/19 JPMorgan
JPMorgan boosts Urovant target to $24, calls selloff yesterday unfounded
03/15/19
Fly Intel: Top five analyst initiations

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.