NDA

Verona Pharma Announces Ensifentrine Meets Primary Endpoint in Phase 3 ENHANCE-2 Trial for COPD

Retrieved on: 
Tuesday, August 9, 2022 - 7:00am

LONDON and RALEIGH, N.C., Aug. 09, 2022 (GLOBE NEWSWIRE) -- Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma” or the “Company”), today announces its top-line Phase 3 ENHANCE-2 (“Ensifentrine as a Novel inHAled Nebulized COPD thErapy”) trial results evaluating nebulized ensifentrine for the maintenance treatment of chronic obstructive pulmonary disease (“COPD”). The ENHANCE-2 trial has successfully met its primary endpoint, as well as secondary endpoints demonstrating improvements in lung function, and significantly reduced the rate and risk of COPD exacerbations.

Key Points: 
  • The Company is evaluating nebulized ensifentrine in its Phase 3 clinical program ENHANCE (Ensifentrine as a Novel inHAled Nebulized COPD thErapy) for COPD maintenance treatment.
  • Ensifentrine met the primary endpoint in ENHANCE-2 demonstrating a statistically significant and clinically meaningful improvement in lung function.
  • In addition, ensifentrine significantly reduced the rate of COPD exacerbations in the ENHANCE-2 trial.
  • Verona Pharma is conducting ENHANCE-1 at a number of clinical trial sites in Russia and Europe (but not including Ukraine).

Medexus Announces Record Fiscal Q1 2023 Revenue of US$23.0 Million, a 33% Increase versus Fiscal Q1 2022

Retrieved on: 
Monday, August 8, 2022 - 10:00pm

TORONTO and CHICAGO, Aug. 08, 2022 (GLOBE NEWSWIRE) -- Medexus Pharmaceuticals (Medexus) (TSX: MDP) (OTCQX: MEDXF) today announced its operating and financial results and provided a business update for the company’s first fiscal quarter ended June 30, 2022. All dollar amounts in this press release are in United States dollars unless specified otherwise.

Key Points: 
  • Delivered record total revenue of $23.0 million in fiscalQ12023, an increase of 33% compared to $17.3million in fiscalQ12022 and an increase of 13% compared to $20.3million in fiscalQ42022.
  • Achieved Adjusted EBITDA* of $1.9million in fiscalQ12023 compared to $(4.9)million in fiscalQ12022 and $1.1 million in fiscal Q4 2022.
  • Medexus achieved this Adjusted EBITDA increase while continuing to maintain appropriate investments in preparations for a commercial launch of treosulfan in the United States.
  • In addition, in August 2022, Medexus and medac signed an amendment to their February 2021 license agreement for treosulfan.

CorMedix Inc. Announces Regulatory and Manufacturing Updates

Retrieved on: 
Monday, August 8, 2022 - 9:05pm

The Company understands that the inspectional deficiencies at these manufacturing facilities could not be resolved prior to the PDUFA date.

Key Points: 
  • The Company understands that the inspectional deficiencies at these manufacturing facilities could not be resolved prior to the PDUFA date.
  • As part of the technology transfer and validation of the manufacturing process at Alcami, CorMedix will also qualify an alternate source of heparin API from a major US supplier.
  • CorMedix may not actually achieve the goals or plans described in its forward-looking statements, and investors should not place undue reliance on these statements.
  • CorMedix assumes no obligation and does not intend to update these forward-looking statements, except as required by law.

Turning Point Therapeutics Reports Second-Quarter 2022 Financial Results, Provides Operational Updates

Retrieved on: 
Monday, August 8, 2022 - 9:17pm

Announced a definitive merger agreement with Bristol Myers Squibb to acquire Turning Point Therapeutics for $76.00 per share.

Key Points: 
  • Announced a definitive merger agreement with Bristol Myers Squibb to acquire Turning Point Therapeutics for $76.00 per share.
  • The transaction was unanimously approved by both the Bristol Myers Squibb and Turning Point Therapeutics Boards of Directors and is anticipated to close during the third quarter of 2022.
  • The company is driven to develop therapies that mark a turning point for patients in their cancer treatment.
  • These forward-looking statements are based upon Turning Point Therapeutics current expectations and involve assumptions that may never materialize or may prove to be incorrect.

Opiant Pharmaceuticals Announces Additional $2.1 Million Funding Under BARDA Contract for OPNT003, Nasal Nalmefene

Retrieved on: 
Monday, August 8, 2022 - 9:05pm

SANTA MONICA, Calif., Aug. 08, 2022 (GLOBE NEWSWIRE) -- Opiant Pharmaceuticals, Inc.(Opiant) (NASDAQ: OPNT) today announced that theBiomedical Advanced Research and Development Authority(BARDA) has awarded an additional approximately $2.1 millionto support OPNT003, nasal nalmefene, for the treatment of opioid overdose.

Key Points: 
  • SANTA MONICA, Calif., Aug. 08, 2022 (GLOBE NEWSWIRE) -- Opiant Pharmaceuticals, Inc.(Opiant) (NASDAQ: OPNT) today announced that theBiomedical Advanced Research and Development Authority(BARDA) has awarded an additional approximately $2.1 millionto support OPNT003, nasal nalmefene, for the treatment of opioid overdose.
  • We greatly appreciate BARDAs support for OPNT003, saidRoger Crystal, M.D., President and Chief Executive Officer of Opiant.
  • Earlier awards from BARDA for $8.7 million, combined with a$7.4 milliongrant Opiant received from theNational Institute on Drug Abuse, have also supported the clinical development and U.S. regulatory submission of OPNT003.
  • Opiant Pharmaceuticals, Inc., the company that developed NARCAN Nasal Spray, is building a leadingfranchiseof new medicines to combat addictions and drug overdose.

Pliant Therapeutics Provides Corporate Update and Reports Second Quarter 2022 Financial Results

Retrieved on: 
Monday, August 8, 2022 - 9:05pm

SOUTH SAN FRANCISCO, Calif., Aug. 08, 2022 (GLOBE NEWSWIRE) -- Pliant Therapeutics, Inc. (Nasdaq: PLRX), a clinical stage biotechnology company focused on discovering and developing novel therapeutics for the treatment of fibrosis, today provided a corporate update and reported second quarter 2022 financial results.

Key Points: 
  • SOUTH SAN FRANCISCO, Calif., Aug. 08, 2022 (GLOBE NEWSWIRE) -- Pliant Therapeutics, Inc. (Nasdaq: PLRX), a clinical stage biotechnology company focused on discovering and developing novel therapeutics for the treatment of fibrosis, today provided a corporate update and reported second quarter 2022 financial results.
  • A highlight to our teams progress in 2022 is the positive safety and efficacy data from the INTEGRIS-IPF Phase 2a trial.
  • Pliant Therapeutics is a clinical stage biopharmaceutical company focused on discovering and developing novel therapies for the treatment of fibrosis.
  • For additional information about Pliant Therapeutics, visit www.pliantrx.com and follow us on Twitter, LinkedIn, Facebook and YouTube.

Acadia Pharmaceuticals Reports Second Quarter 2022 Financial Results

Retrieved on: 
Monday, August 8, 2022 - 9:05pm

Acadia Pharmaceuticals Inc. (Nasdaq: ACAD), today announced its financial results for the second quarter ended June 30, 2022.

Key Points: 
  • Acadia Pharmaceuticals Inc. (Nasdaq: ACAD), today announced its financial results for the second quarter ended June 30, 2022.
  • In the second quarter of 2022, NUPLAZID net sales increased 17% year-over-year, said Steve Davis, Chief Executive Officer.
  • For the six months ended June 30, 2022 and 2021, Acadia reported net product sales of $250.0 million and $221.8 million, respectively.
  • For the six months ended June 30, 2022 and 2021, research and development expenses were $204.5 million and $113.9 million.

TG THERAPEUTICS, INC. (NASDAQ: TGTX) 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 TG Therapeutics, Inc. (NASDAQ: TGTX)

Retrieved on: 
Monday, August 8, 2022 - 9:00pm

NEW YORK, Aug. 08, 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 TG Therapeutics, Inc. (“TG Therapeutics” or the “Company”) (NASDAQ: TGTX) between January 15, 2020 and May 31, 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 pallocco@bernlieb.com to discuss your rights.
  • 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.
  • If you purchased TG Therapeutics securities, and/or would like to discuss your legal rights and options please visit TG Therapeutics, Inc.
  • The law firm responsible for this advertisement is Bernstein Liebhard LLP, 10 East 40th Street, New York, New York 10016, (212) 779-1414.

Enanta Pharmaceuticals Appoints Scott T. Rottinghaus, M.D., as Senior Vice President and Chief Medical Officer

Retrieved on: 
Monday, August 8, 2022 - 9:00pm

Enanta Pharmaceuticals, Inc. (NASDAQ: ENTA), a clinical-stage biotechnology company dedicated to creating novel, small molecule drugs for viral infections and liver diseases, today announced the appointment of Scott T. Rottinghaus, M.D., as Senior Vice President and Chief Medical Officer, effective today, August 8, 2022.

Key Points: 
  • Enanta Pharmaceuticals, Inc. (NASDAQ: ENTA), a clinical-stage biotechnology company dedicated to creating novel, small molecule drugs for viral infections and liver diseases, today announced the appointment of Scott T. Rottinghaus, M.D., as Senior Vice President and Chief Medical Officer, effective today, August 8, 2022.
  • View the full release here: https://www.businesswire.com/news/home/20220808005491/en/
    Scott T. Rottinghaus, M.D., Senior Vice President and Chief Medical Officer, Enanta Pharmaceuticals (Photo: Business Wire)
    We are delighted to welcome Scott Rottinghaus to our senior management team.
  • Earlier in his Pfizer career, he worked as a clinician on early stage clinical trials for influenza vaccine development.
  • Enanta cautions investors not to place undue reliance on the forward-looking statements contained in this release.

Ironclad Taps Former Twilio Executive as Chief Marketing Officer

Retrieved on: 
Monday, August 8, 2022 - 8:01pm

SAN FRANCISCO, Aug. 8, 2022 /PRNewswire/ -- Ironclad, the leading digital contracting platform, today announced the hiring of Leslie Henthorn, former SVP of Corporate Marketing and Interim CMO of Twilio, as its new Chief Marketing Officer. Henthorn will focus on the company's top-line marketing strategy as the company enters its next stage of growth.

Key Points: 
  • Leslie Henthorn, former SVP of Corporate Marketing and interim CMO of Twilio, joins Ironclad to lead and grow its marketing organization
    SAN FRANCISCO, Aug. 8, 2022 /PRNewswire/ -- Ironclad , the leading digital contracting platform, today announced the hiring of Leslie Henthorn, former SVP of Corporate Marketing and Interim CMO of Twilio, as its new Chief Marketing Officer.
  • Henthorn joins the fast-growing leadership team, which has added Leyla Seka as Chief Operating Officer, Helen Wang as Chief Financial Officer, and Ambrosia Vertesi as Chief People Officer, all within the past year.
  • "We have been incredibly intentional with our executive team's growth, ensuring that we consciously develop our Chief operating team in line with our overall vision, at the right moments," said Jason Boehmig, CEO and co-founder of Ironclad.
  • During Henthorn's tenure at Twilio, she helped grow the marketing team from less than 50 people to more than 300, led the Partner Marketing and Campaigns teams, and eventually built and scaled its first Worldwide Field Marketing Organization.