NDA

Opiant Pharmaceuticals Initiates Rolling Submission of New Drug Application to U.S. Food and Drug Administration for OPNT003, Nasal Nalmefene, for the Treatment of Opioid Overdose

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Wednesday, June 1, 2022
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The module was submitted pursuant to a rolling submission, as agreed with the U.S. Food and Drug Administration (FDA) during a pre-NDA meeting.

Key Points: 
  • The module was submitted pursuant to a rolling submission, as agreed with the U.S. Food and Drug Administration (FDA) during a pre-NDA meeting.
  • As communicated previously, the Company expects to complete the submission of the NDA using the 505(b)(2) pathway in the second half of 2022.
  • We look forward to working with the FDA to complete this rolling submission for OPNT003, nasal nalmefene, and we will provide an update when the NDA is completed.
  • Opiant Pharmaceuticals, Inc., the company that developed NARCAN Nasal Spray, is building a leadingfranchiseof new medicines to combat addictions and drug overdose.

Recardio and FDA Reach Agreement on Pivotal Phase 3 Trial Design

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Wednesday, June 1, 2022
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Along with data suggesting potential positive effects on cardiac function, it was concluded that a pivotal study of this therapeutic approach in a large, adequately powered NDA-enabling study is warranted.

Key Points: 
  • Along with data suggesting potential positive effects on cardiac function, it was concluded that a pivotal study of this therapeutic approach in a large, adequately powered NDA-enabling study is warranted.
  • Afterreviewing the Phase 2 trial results,the FDA agreed withtheproposedtrial design andsample size for thepivotal Phase 3 trial of Dutogliptin in co-adminstration with filgrastim in early recovery post-myocardial infarction.A comparable agreement was also reached with the EMA.
  • Recardio Inc. is a late clinical-stage life science company focusing on therapies for cardiovascular and other diseases.
  • Recardio is currently initiating its global pivotal Phase 3 clinical program in acute myocardial infarction for market authorization in major markets and will fully develop the therapeutic platform as a regenerative medication for patients with various cardiovascular diseases.

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. and Levena Biopharma, a Sorrento Company, are to Present Positive Clinical Progress of A166, an Anti-HER2 ADC, in Treating Locally Advanced or Metastatic HER2-Positive Breast Cancer Patients at the ASCO 20

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Wednesday, June 1, 2022
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Of 23 patients treated at 4.8 mg/kg cohort, one had a confirmed and sustained complete response (CR) lasting 7+ months.

Key Points: 
  • Of 23 patients treated at 4.8 mg/kg cohort, one had a confirmed and sustained complete response (CR) lasting 7+ months.
  • At the upcoming 2022 ASCO meeting, Kelun-Biotech will report updated data from this Phase 1 trial (Abstract #1037 and Poster #415).
  • Of 23 patients treated in the 4.8 mg/kg cohort, one had a confirmed and sustained CR lasting 7+ months.
  • ZTlido is a registered trademark owned by Scilex Pharmaceuticals Inc.
    All other trademarks are the property of their respective owners.

KemPharm Announces Research Affirming Serdexmethylphenidate’s Lower Potential for Abuse Featured in Peer-Reviewed Publication, Current Medical Research & Opinion

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Wednesday, June 1, 2022
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CELEBRATION, Fla., June 01, 2022 (GLOBE NEWSWIRE) -- KemPharm, Inc. (NasdaqGS: KMPH) (KemPharm, or the Company), a specialty pharmaceutical company focused on the discovery, development and commercialization of novel treatments for rare central nervous system (CNS), neurodegenerative and lysosomal storage diseases, today announced that a manuscript summarizing the results of three clinical studies involving serdexmethylphenidate (SDX), KemPharm’s prodrug of dexmethylphenidate (d-MPH), was published in the peer-reviewed journal, Current Medical Research & Opinion. The research concluded that SDX has significantly lower potential for abuse and minimal stimulant-like adverse events compared to d-MPH.

Key Points: 
  • The research concluded that SDX has significantly lower potential for abuse and minimal stimulant-like adverse events compared to d-MPH.
  • KemPharm is developing KP1077 as a treatment for idiopathic hypersomnia, a rare neurological sleep disorder, and narcolepsy.
  • We are very pleased that this important research demonstrating SDXs significantly lower abuse potential in comparison to d-MPH was published in the peer-reviewed journal, Current Medical Research & Opinion, stated Travis C. Mickle, Ph.D., President and CEO of KemPharm.
  • This data involves a number of assumptions and limitations, and you are cautioned not to give undue weight to such estimates.

AXSOME THERAPEUTICS, INC. (NASDAQ: AXSM) SHAREHOLDER CLASS ACTION ALERT: Bernstein Liebhard LLP Reminds Investors of the Deadline to File a Lead Plaintiff Motion in a Securities Class Action Lawsuit Against Axsome Therapeutics, Inc. (NASDAQ: AXSM)

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Wednesday, June 1, 2022
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NEW YORK, June 01, 2022 (GLOBE NEWSWIRE) -- Bernstein Liebhard LLP, a nationally acclaimed investor rights law firm, reminds investors of the deadline to file a lead plaintiff motion in a securities class action lawsuit that has been filed on behalf of investors who purchased or acquired the securities of Axsome Therapeutics, Inc. (“Axsome” or the “Company”) (NASDAQ: AXSM) between December 30, 2019 and April 22, 2022, inclusive (the “Class Period”). The lawsuit was filed in the United States District Court for the Southern District of New York and alleges violations of the Securities Exchange Act of 1934.

Key Points: 
  • Shareholder Class Action Lawsuit or contact Peter Allocco at (212) 951-2030 or [email protected] to discuss your rights.
  • Axsome is a biopharmaceutical company that engages in the development of novel therapies for central nervous system (CNS) disorders in the U.S.
  • On April 25, 2022, during pre-market hours, Axsome disclosed in an SEC filing that [o]n April 22, 2022, Axsome .
  • The law firm responsible for this advertisement is Bernstein Liebhard LLP, 10 East 40th Street, New York, New York 10016, (212) 779-1414.

Eagle Pharmaceuticals Announces Submission of New Drug Application to U.S. Food and Drug Administration for Landiolol, a Beta-1 Adrenergic Blocker

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Wednesday, June 1, 2022
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WOODCLIFF LAKE, N.J., June 01, 2022 (GLOBE NEWSWIRE) -- Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle” or the “Company”) today announced that AOP Orphan Pharmaceuticals GmbH, a member of the AOP Health Group (“AOP Health”), with whom Eagle entered into a licensing agreement in August 2021, submitted a new drug application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) for landiolol, a short-acting, intravenous (“IV”), cardio-selective beta-1 adrenergic blocker. The submission seeks approval for landiolol for the short-term reduction of ventricular rate in patients with supraventricular tachycardia (“SVT”), including atrial fibrillation and atrial flutter.

Key Points: 
  • The submission seeks approval for landiolol for the short-term reduction of ventricular rate in patients with supraventricular tachycardia (SVT), including atrial fibrillation and atrial flutter.
  • We believe that landiolol has the potential to become a cornerstone therapy in the management of tachycardia in critically ill patients.
  • Landiolol is an ultra-short-acting, cardio-selective, beta-1 adrenoceptor blocker, which reduces heart rate and has a minimal effect over cardiac contractility (inotropy).
  • All forward-looking statements contained in this press release speak only as of the date on which they were made.

Apellis Announces Submission of New Drug Application to the FDA for Pegcetacoplan for Geographic Atrophy

Retrieved on: 
Wednesday, June 1, 2022
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The NDA submission is based on results from the Phase 3 DERBY and OAKS studies at 12 and 18 months and the Phase 2 FILLY study at 12 months.

Key Points: 
  • The NDA submission is based on results from the Phase 3 DERBY and OAKS studies at 12 and 18 months and the Phase 2 FILLY study at 12 months.
  • Apellis also plans to submit a marketing authorization application to the European Medicines Agency in the second half of 2022.
  • Pegcetacoplanwas granted Fast Track designation by the U.S. Food and Drug Administration (FDA) forthe treatment of geographic atrophy.
  • Apellis Pharmaceuticals, Inc. is a global biopharmaceutical company that is committed to leveraging courageous science, creativity, and compassion to deliver life-changing therapies.

INVESTOR ALERT: Law Offices of Howard G. Smith Announces the Filing of a Securities Class Action on Behalf of Verrica Pharmaceuticals Inc. (VRCA) Investors

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Tuesday, June 7, 2022
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Law Offices of Howard G. Smith announces that a class action lawsuit has been filed on behalf of investors who purchased Verrica Pharmaceuticals Inc. (Verrica or the Company) (NASDAQ: VRCA ) securities between May 28, 2021 and May 24, 2022, inclusive (the Class Period).

Key Points: 
  • Law Offices of Howard G. Smith announces that a class action lawsuit has been filed on behalf of investors who purchased Verrica Pharmaceuticals Inc. (Verrica or the Company) (NASDAQ: VRCA ) securities between May 28, 2021 and May 24, 2022, inclusive (the Class Period).
  • Verrica investors have until August 5, 2022 to file a lead plaintiff motion.
  • Investors suffering losses on their Verrica investments are encouraged to contact the Law Offices of Howard G. Smith to discuss their legal rights in this class action at 888-638-4847 or by email to [email protected] .
  • In November 2021, Verrica resubmitted the NDA for VP-102, claiming [t]he resubmission addresses the successful resolution of inspection deficiencies at the manufacturing facility.

VRCA CLASS ACTION NOTICE: Glancy Prongay & Murray LLP Files Securities Fraud Lawsuit Against Verrica Pharmaceuticals Inc.

Retrieved on: 
Tuesday, June 7, 2022
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Glancy Prongay & Murray LLP (GPM) announces that it has filed a class action lawsuit in the United States District Court for the Eastern District of Pennsylvania captioned Gorlamari v. Verrica Pharmaceuticals, Inc., et al., Case No.

Key Points: 
  • Glancy Prongay & Murray LLP (GPM) announces that it has filed a class action lawsuit in the United States District Court for the Eastern District of Pennsylvania captioned Gorlamari v. Verrica Pharmaceuticals, Inc., et al., Case No.
  • 22-cv-2226, on behalf of persons and entities that purchased or otherwise acquired Verrica Pharmaceuticals Inc. (Verrica or the Company) (NASDAQ: VRCA ) securities between May 28, 2021 and May 24, 2022, inclusive (the Class Period).
  • Plaintiff pursues claims under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 (the Exchange Act).
  • Investors are hereby notified that they have 60 days from this notice to move the Court to serve as lead plaintiff in this action.

The Law Offices of Frank R. Cruz Announces the Filing of a Securities Class Action on Behalf of Spero Therapeutics, Inc. (SPRO) Investors

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Monday, June 6, 2022
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The Law Offices of Frank R. Cruz announces that a class action lawsuit has been filed on behalf of persons and entities that purchased or otherwise acquired Spero Therapeutics, Inc. (Spero or the Company) (NASDAQ: SPRO ) securities between October 28, 2021 and May 2, 2022, inclusive (the Class Period).

Key Points: 
  • The Law Offices of Frank R. Cruz announces that a class action lawsuit has been filed on behalf of persons and entities that purchased or otherwise acquired Spero Therapeutics, Inc. (Spero or the Company) (NASDAQ: SPRO ) securities between October 28, 2021 and May 2, 2022, inclusive (the Class Period).
  • Spero investors have until July 25, 2022 to file a lead plaintiff motion.
  • On this news, Speros stock fell $1.59, or 18.27%, to close at $7.11 per share on April 1, 2022.
  • This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules.