New Drug Application

Nicox First Half 2021 Financial Results and Business Update

Monday, September 27, 2021 - 6:30am

Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, today reported the financial results for Nicox SA and its subsidiaries (the Nicox Group) for the six months ending June 30, 2021 and provided an update on recent events as well as progress on key programs.

Key Points: 
  • Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, today reported the financial results for Nicox SA and its subsidiaries (the Nicox Group) for the six months ending June 30, 2021 and provided an update on recent events as well as progress on key programs.
  • Net revenue1 for the first half of 2021 was 1.3 million (including 1.2 million in royalty revenue) versus 2.4 million (including 1.4 million in royalty revenue) for the first half of 2020.
  • Operating expenses for the first half of 2021 were 13.3 million compared to 10.2 million for the first half of 2020.
  • As of June 30, 2021, the Nicox Group had cash and cash equivalents of 36.5 million, as compared with 42.0 million at March 31, 2021 and 47.2 million at December 31, 2020.

ARDX FINAL DEADLINE TUESDAY: ROSEN, TRUSTED NATIONAL TRIAL COUNSEL, Encourages Ardelyx, Inc. Investors with Losses to Secure Counsel Before Important September 28 Deadline in Securities Class Action – ARDX

Sunday, September 26, 2021 - 8:15pm

WHAT TO DO NEXT: To join the Ardelyx class action, go to http://www.rosenlegal.com/cases-register-2134.html or call Phillip Kim, Esq.

Key Points: 
  • WHAT TO DO NEXT: To join the Ardelyx class action, go to http://www.rosenlegal.com/cases-register-2134.html or call Phillip Kim, Esq.
  • If you wish to serve as lead plaintiff, you must move the Court no later than September 28, 2021.
  • The Rosen Law Firm represents investors throughout the globe, concentrating its practice in securities class actions and shareholder derivative litigation.
  • 1 by ISS Securities Class Action Services for number of securities class action settlements in 2017.

Investor Deadline Approaching: Kessler Topaz Meltzer & Check, LLP Reminds Investors of Deadline in Securities Fraud Class Action Lawsuit Filed Against Ardelyx Inc. (ARDX)

Friday, September 24, 2021 - 2:58pm

Investor Deadline Reminder: Investors who purchased or acquired Ardelyx securities during the Class Period may, no later than September 28, 2021, seek to be appointed as a lead plaintiff representative of the class.

Key Points: 
  • Investor Deadline Reminder: Investors who purchased or acquired Ardelyx securities during the Class Period may, no later than September 28, 2021, seek to be appointed as a lead plaintiff representative of the class.
  • For additional information or to learn how to participate in this litigation please contact Kessler Topaz Meltzer & Check, LLP: James Maro, Esq.
  • Kessler Topaz Meltzer & Check, LLP prosecutes class actions in state and federal courts throughout the country involving securities fraud, breaches of fiduciary duties and other violations of state and federal law.
  • The complaint in this action was not filed by Kessler Topaz Meltzer & Check, LLP.

SHAREHOLDER ALERT: Pomerantz Law Firm Reminds Shareholders with Losses on their Investment in Iterum Therapeutics plc of Class Action Lawsuit and Upcoming Deadline – ITRM

Friday, September 24, 2021 - 12:23am

NEW YORK, Sept. 23, 2021 (GLOBE NEWSWIRE) -- Pomerantz LLP announces that a class action lawsuit has been filed against Iterum Therapeutics plc (Iterum or the Company) (NASDAQ: ITRM) and certain of its officers.

Key Points: 
  • NEW YORK, Sept. 23, 2021 (GLOBE NEWSWIRE) -- Pomerantz LLP announces that a class action lawsuit has been filed against Iterum Therapeutics plc (Iterum or the Company) (NASDAQ: ITRM) and certain of its officers.
  • To discuss this action, contact Robert S. Willoughby at newaction@pomlaw.com or 888.476.6529 (or 888.4-POMLAW), toll-free, Ext.
  • Iterum is a clinical-stage pharmaceutical company that engages in developing anti-infectives for multi-drug resistant pathogens in Ireland and the United States.
  • Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, Pomerantz pioneered the field of securities class actions.

ROSEN, A LEADING LAW FIRM, Encourages Iterum Therapeutics plc Investors to Secure Counsel Before Important October 4 Deadline in Securities Class Action – ITRM

Thursday, September 23, 2021 - 9:48pm

WHAT TO DO NEXT: To join the Iterum class action, go to http://www.rosenlegal.com/cases-register-2142.html or call Phillip Kim, Esq.

Key Points: 
  • WHAT TO DO NEXT: To join the Iterum class action, go to http://www.rosenlegal.com/cases-register-2142.html or call Phillip Kim, Esq.
  • WHY ROSEN LAW: We encourage investors to select qualified counsel with a track record of success in leadership roles.
  • The Rosen Law Firm represents investors throughout the globe, concentrating its practice in securities class actions and shareholder derivative litigation.
  • 1 by ISS Securities Class Action Services for number of securities class action settlements in 2017.

Dermavant to Present New Data on Phase 3 PSOARING Program at 30th EADV Virtual Congress

Thursday, September 23, 2021 - 1:00pm

Dermavant Sciences, a clinical-stage biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology, will present data from its Phase 3 PSOARING long-term extension study at the 30th European Academy of Dermatology and Venerology (EADV) Virtual Congress, to be held September 29through October 2, 2021.

Key Points: 
  • Dermavant Sciences, a clinical-stage biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology, will present data from its Phase 3 PSOARING long-term extension study at the 30th European Academy of Dermatology and Venerology (EADV) Virtual Congress, to be held September 29through October 2, 2021.
  • Dermavants pivotal Phase 3 clinical program for tapinarof in adult plaque psoriasis consists of PSOARING 1 (NCT03956355) and PSOARING 2 (NCT03983980), as well as PSOARING 3 (NCT04053387), a long-term extension study.
  • Greater than 90% of eligible patients who completed PSOARING 1 and PSOARING 2 enrolled in PSOARING 3.
  • For more information, please visit www.dermavant.com , and follow us on Twitter ( @dermavant ) and LinkedIn ( Dermavant Sciences ).

BioXcel Therapeutics to Highlight Novel Approaches in AI-Based Drug Candidate Discovery and Development and Advances in Neuroscience Portfolio at Virtual R&D Day

Thursday, September 23, 2021 - 12:00pm

NEW HAVEN, Conn., Sept. 23, 2021 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology, today will host a virtual R&D Day beginning at 12:00 p.m., Eastern Time. The Company will discuss new applications of the artificial intelligence ecosystem to augment and accelerate its drug candidate discovery and development process for neuroscience disorders with large unmet medical need. BioXcel’s neuroscience leadership team will introduce BXCL502, an emerging program to bolster the Company’s novel neuroscience portfolio, and review the expansion of the Company’s most advanced clinical development program, BXCL501.

Key Points: 
  • The Company will discuss new applications of the artificial intelligence ecosystem to augment and accelerate its drug candidate discovery and development process for neuroscience disorders with large unmet medical need.
  • BioXcels neuroscience leadership team will introduce BXCL502, an emerging program to bolster the Companys novel neuroscience portfolio, and review the expansion of the Companys most advanced clinical development program, BXCL501.
  • A live webcast and accompanying presentation will be accessible through the Investors section of the Companys website or by clicking here .
  • BioXcel Therapeutics, Inc. is a clinical-stage biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology.

Bragar Eagel & Squire, P.C. Reminds Investors That Class Action Lawsuits Have Been Filed Against Ardelyx, SelectQuote, Katapult, and Waterdrop Sciences and Encourages Investors to Contact the Firm

Thursday, September 23, 2021 - 2:08am

On this news, the Companys share price declined, falling $9.71 per share, or nearly 74%, to close at $2.01 per share on July 20, 2021.

Key Points: 
  • On this news, the Companys share price declined, falling $9.71 per share, or nearly 74%, to close at $2.01 per share on July 20, 2021.
  • Furthermore, Waterdrop had suffered rapidly accelerating operating losses in the first quarter of 2021 which was completed weeksbeforethe IPO.
  • For more information on the Waterdrop class action go to: https://bespc.com/cases/WDH
    About Bragar Eagel & Squire, P.C.
  • The firm represents individual and institutional investors in commercial, securities, derivative, and other complex litigation in state and federal courts across the country.

ITRM SHAREHOLDER CLASS ACTION DEADLINE: Bernstein Liebhard LLP Reminds Investors of the Deadline to File a Lead Plaintiff Motion in a Securities Class Action Lawsuit Against Iterum Therapeutics plc

Wednesday, September 22, 2021 - 9:40pm

The lawsuit filed in the United States District Court for the Northern District of Illinois alleges violations of the Exchange Act of 1934.

Key Points: 
  • The lawsuit filed in the United States District Court for the Northern District of Illinois alleges violations of the Exchange Act of 1934.
  • If you wish to serve as lead plaintiff, you must move the Court no later than October 4, 2021.
  • A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation.
  • The law firm responsible for this advertisement is Bernstein Liebhard LLP, 10 East 40th Street, New York, New York 10016, (212) 779-1414.

SEPTEMBER 28, 2021 ARDX INVESTOR LAWSUIT FILING DEADLINE: Bernstein Liebhard LLP Reminds Investors of the Deadline to File a Lead Plaintiff Motion in a Securities Class Action Lawsuit Against Ardelyx, Inc.

Wednesday, September 22, 2021 - 5:10pm

The lawsuit filed in the United States District Court for the Northern District of California alleges violations of the Securities Act of 1934.

Key Points: 
  • The lawsuit filed in the United States District Court for the Northern District of California alleges violations of the Securities Act of 1934.
  • The FDA accepted the NDA in September 2020 ad set a Prescription Drug User Fee Act date for April 29, 2021.
  • If you wish to serve as lead plaintiff, you must move the Court no later than September 28, 2021.
  • A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation.