NDA

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

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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.

Bragar Eagel & Squire, P.C. Reminds Investors That Class Action Lawsuits Have Been Filed Against Iterum, View, and Spectrum and Encourages Investors to Contact the Firm

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Thursday, September 23, 2021 - 2:07am

On this news, Iterums ordinary share price fell $0.87 per share, or 37.99%, to close at $1.42 per share on July 2, 2021.

Key Points: 
  • On this news, Iterums ordinary share price fell $0.87 per share, or 37.99%, to close at $1.42 per share on July 2, 2021.
  • On this news, Iterums ordinary share price fell $0.499 per share, or 44.16%, to close at $0.631 per share on July 26, 2021.
  • For more information on the Spectrum class action go to: https://bespc.com/cases/SPPI
    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

Endpoint security, News, LLP, Review, Advertising, NDA, Securities Exchange Act of 1934, Urinary tract infection, NASDAQ, FDA, ITRM, Adult, Court, Letter, New Drug Application, Company, District court, Woman, The Legal 500, Labour government, Connecticut, GLOBE, Lists of schools in England, Security (finance), Pharmaceutical industry, Cryptocurrency
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.

News, Securities Act of 1933, LLP, Advertising, NDA, Annual report, NASDAQ, FDA, Patient, Dialysis, Adult, Court, Letter, New Drug Application, District court, The Legal 500, Labour government, Connecticut, Time, Company, Chronic kidney disease, GLOBE, Lists of schools in England, Security (finance), Pharmaceutical industry
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.

SCYNEXIS Announces U.S. Availability of BREXAFEMME® (ibrexafungerp tablets), the First New Antifungal Class of Therapy Approved by the U.S. FDA for Vaginal Yeast Infections in More Than 20 Years

Vomiting, CQD, Biotechnology, Tablet, Food, Candida albicans, Dizziness, Vaginal yeast infection, Compte rendu, Risk, NDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Infection, Annual report, Security (finance), Most, Private Securities Litigation Reform Act, NASDAQ, Depression, U.S. Securities and Exchange Commission, FDA, Abdominal pain, Patient, Administration, Pregnancy, Physician, Nausea, Birth, New Drug Application, Life, Growth, Woman, Pain, Fungus, Candidiasis, Embarrassment, Candida glabrata, Incidence, Vaginitis, QIDP, CYP3A, Anxiety, GLOBE, Diarrhea, Pharmaceutical industry, Birth control, Dietary supplement
Wednesday, September 22, 2021 - 1:30pm

BREXAFEMME is a truly new, first-in-class fungicidal triterpenoid antifungal, designed to kill the yeast causing the infection, including azole-resistant strains.

Key Points: 
  • BREXAFEMME is a truly new, first-in-class fungicidal triterpenoid antifungal, designed to kill the yeast causing the infection, including azole-resistant strains.
  • As part of its commitment to ensuring patient access, SCYNEXIS has implemented programs to remove potential barriers and help patients receive treatment.
  • Vulvovaginal Candidiasis (VVC), commonly known as a vaginal yeast infection due to Candida, is the second most common cause of vaginitis.
  • All forward-looking statements contained in this press release speak only as of the date on which they were made.

Endeavor BioMedicines Doses First Patient in Phase 2 Clinical Trial of Taladegib (ENV-101) for Idiopathic Pulmonary Fibrosis; Appoints Chief Medical Officer

Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Publication, Degenerative disease, Idiopathic pulmonary fibrosis, Patient, NDA, University of Illinois at Chicago College of Dentistry, FVC, Cancer, Precision medicine, Pathology, Siberian State Medical University, Endeavour, Hedgehog, FEV1, CEO, Merck, IPF, University, Growth, Tufts University School of Medicine, Pharmacology, Apoptosis, Entrepreneurship, Disease, Johns Hopkins University, HIV disease progression rates, Technology, Drug development, Myofibroblast, Safety, Fibrosis, Pulmonology, Lung, Pharmaceutical industry
Wednesday, September 22, 2021 - 1:02pm

Endeavor also announced today that Srikanth Pendyala, M.D., has been appointed as the companys first Chief Medical Officer.

Key Points: 
  • Endeavor also announced today that Srikanth Pendyala, M.D., has been appointed as the companys first Chief Medical Officer.
  • Hood added, We are also pleased to welcome Srikanth Pendyala as our chief medical officer.
  • Endeavors forward-thinking approach to precision therapies used to treat pulmonary disease and cancer has already exhibited immense potential since the company launched, said Srikanth Pendyala, M.D., Chief Medical Officer, Endeavor BioMedicines.
  • Endeavor BioMedicines is a clinical-stage precision medicine company targeting the core drivers of multiple terminal diseases, including oncology and fibrosis.

Sol-Gel Technologies to Present at Upcoming Cantor Virtual Global Healthcare Conference

Rosacea, NDA, FDA, Patient, Skin, Psoriasis, COVID-19, PDUFA, Dermatology, Acne, Travel, Pharmaceutical industry
Wednesday, September 22, 2021 - 12:30pm

Discussion available on demand beginning Thursday, September 30th 10:40 a.m.

Key Points: 
  • Discussion available on demand beginning Thursday, September 30th 10:40 a.m.
  • ET (TRACK 3)
    To listen to the discussion, click here .
  • A replay will be archived for 30 days at this link (or go to www.sol-gel.com to access within the Investors/Events and Presentations section).
  • Sol-Gelis a dermatology company focused on identifying, developing and commercializing branded and generic topical drug products for the treatment of skin diseases.

Deliver Third-Party Risk Updates Straight to Customer Inboxes with SafeBase!

Knowledge, NDA, Interview, Workflow, Multimedia, CEO, SAN, Split, Information, Jamf, Automation, Subscription business model, Beam (structure), Knowledge base, CISO, Online shopping
Wednesday, September 22, 2021 - 12:00pm

On top of the already robust portal, which includes the Security Status Page , NDA automation, and Knowledge Base, SafeBase is now the go-to place when communicating important updates about your company's security posture.

Key Points: 
  • On top of the already robust portal, which includes the Security Status Page , NDA automation, and Knowledge Base, SafeBase is now the go-to place when communicating important updates about your company's security posture.
  • Companies can subscribe to a Security Status Page to be automatically alerted when there are updates.
  • On top of these benefits, Matt Roeckel has seen Split's volume of security questionnaires decrease by 50% since implementing SafeBase.
  • Gaining customer trust begins with the SafeBase Security Status Page.

Mirum Pharmaceuticals and Takeda Enter into Exclusive Licensing Agreement to Develop and Commercialize Maralixibat for Rare Pediatric Liver Diseases in Japan

Health, General Health, Research, Pharmaceutical, Science, Biotechnology, Cholestasis, Food, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Marketing, Liver disease, NDA, Primary sclerosing cholangitis, Biliary atresia, Hematology, Health, European Medicines Agency, TSE, Takeda Pharmaceutical Company, Private Securities Litigation Reform Act, U.S. Securities and Exchange Commission, FDA, Alagille syndrome, Multimedia, Patient, Cholestatic pruritus, Abdominal pain, Feces, Pregnancy, Primary biliary cholangitis, Medication, TAK, Itch, BA, BSEP, Security (finance), COVID-19, Vaccine, PDUFA, Genetics, R, Institute of Liver and Biliary Sciences, Investment, PFIC, Quality of life, Nasdaq, Database, Diarrhea, Pharmaceutical industry, Medical device
Tuesday, September 21, 2021 - 1:00pm

View the full release here: https://www.businesswire.com/news/home/20210921005502/en/

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20210921005502/en/
    Under the terms of the agreement, Takeda will be responsible for regulatory approval and commercialization of maralixibat in Japan.
  • We are excited for Takeda to engage in the development of maralixibat and collaborate in our effort to advance this potentially life-changing therapy.
  • This agreement reinforces Takedas commitment to developing highly differentiated medicines to improve the health and quality of life of patients.
  • Maralixibat is a novel, minimally absorbed, orally administered investigational drug being evaluated in several rare cholestatic liver diseases.

Aerie Pharmaceuticals, Inc. Announces the Appointment of Interim Executive Chair and Departure of Chairman and CEO

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Tuesday, September 21, 2021 - 11:30am

no longer serves as the Companys Chairman and Chief Executive Officer or as a director of the Company.

Key Points: 
  • no longer serves as the Companys Chairman and Chief Executive Officer or as a director of the Company.
  • as its Interim Executive Chairman of the Board of Directors of the Company and commenced a search for a new Chief Executive Officer.
  • Upon the appointment of a new Chief Executive Officer, the Company intends to separate the roles of Chairman and Chief Executive Officer.
  • Under his leadership, Aerie now has two clearly differentiated products on the market and we believe we have a very good portfolio of products in development.