Regulation of food and dietary supplements by the U.S. Food and Drug Administration

Cybin Inc. Reports First Quarter Financial Results and Recent Business Highlights

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Cybin Inc. (NEO:CYBN) (NYSE American:CYBN) (Cybin or the Company), a biopharmaceutical company focused on progressing Psychedelics to TherapeuticsTM, today reported unaudited financial results for its first quarter ended June 30, 2022 and recent business highlights.

Key Points: 
  • Cybin Inc. (NEO:CYBN) (NYSE American:CYBN) (Cybin or the Company), a biopharmaceutical company focused on progressing Psychedelics to TherapeuticsTM, today reported unaudited financial results for its first quarter ended June 30, 2022 and recent business highlights.
  • Recent Business and Pipeline Highlights:
    Initiated enrollment for its first-in-human Phase 1/2a trial of CYB003 in major depressive disorder (MDD).
  • Based on preclinical data, CYB003 achieved less variability in plasma levels, faster onset of action, and shorter duration of effect.
  • If Cybin cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on Cybins performance and operations.

Biostage Announces Appointment of New Chief Financial Officer

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Monday, August 8, 2022 - 10:01pm
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Joe provides Biostage with considerable experience in raising capital and running operations for small-cap biotech companies.

Key Points: 
  • Joe provides Biostage with considerable experience in raising capital and running operations for small-cap biotech companies.
  • Recently his experience has included CFO, VP Finance and Controller roles at: Inhibikase Therapeutics, Cue Biopharma and Pressure Biosciences.
  • "I very much look forward to joining the highly motivated team at Biostage and contributing to future progress," said Mr. Damasio.
  • "Biostage is well positioned to achieve its strategic goals with the first-in-human clinical trial starting soon.

Merus Announces Financial Results for the Second Quarter and Provides Business Update

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Monday, August 8, 2022 - 9:17pm
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UTRECHT, The Netherlands and CAMBRIDGE, Mass., Aug. 08, 2022 (GLOBE NEWSWIRE) -- Merus N.V. (Nasdaq: MRUS) (“Merus”, the “Company,” “we”, or “our”), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics® and Triclonics®), today announced financial results for the second quarter that ended June 30, 2022 and provided a business update.

Key Points: 
  • We believe the favorable safety profile of Zeno may also allow for future, potential benefit in combination with other cancer therapies.
  • Details of the eNRGy trial can be found at www.ClinicalTrials.gov and Merus trial website at www.nrg1.com ,or by calling 1-833-NRG-1234.
  • As of June 30, 2022, Merus had $396.8 million cash and cash equivalents sufficient to fund company operations beyond 2024.
  • We ended the second quarter with cash, cash equivalents and marketable securities of $396.8 million compared to $430.7 million at December 31, 2021.

Clearside Biomedical Enters into Non-Dilutive Financing Agreement with HealthCare Royalty Partners for up to $65 Million

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Monday, August 8, 2022 - 9:30pm
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Under the terms of the agreement, Clearside will receive an initial payment of $32.5 million, less certain expenses.

Key Points: 
  • Under the terms of the agreement, Clearside will receive an initial payment of $32.5 million, less certain expenses.
  • The terms of the agreement also provide for an additional milestone payment of $20 million to Clearside upon attainment of a second pre-specified 2024 sales milestone for XIPERE.
  • The arrangement with HealthCare Royalty specifically excludes all Clearsides internal development programs, including CLS-AX, as well as any future in-licensed assets.
  • HEALTHCARE ROYALTY PARTNERS is a registered trademark of HealthCare Royalty Management, LLC in the U.S. and a trademark in other countries.

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

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Monday, August 8, 2022 - 9:05pm
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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.

Pfizer and Valneva Initiate Phase 3 Study of Lyme Disease Vaccine Candidate VLA15

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Monday, August 8, 2022 - 9:45pm
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The randomized, placebo-controlled, Phase 3 VALOR study is planned to enroll approximately 6,000 participants 5 years of age and older.

Key Points: 
  • The randomized, placebo-controlled, Phase 3 VALOR study is planned to enroll approximately 6,000 participants 5 years of age and older.
  • As per the terms of the collaboration agreement between Pfizer and Valneva, Pfizer will make a $25 million milestone payment to Valneva upon initiation of the Phase 3 study.
  • VLA15 is the only Lyme disease vaccine candidate currently in clinical development.
  • This investigational multivalent protein subunit vaccine uses an established mechanism of action for a Lyme disease vaccine that targets the outer surface protein A (OspA) of Borrelia burgdorferi, the bacteria that cause Lyme disease.

Acadia Pharmaceuticals Reports Second Quarter 2022 Financial Results

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Monday, August 8, 2022 - 9:05pm
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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.

MacroGenics Provides Update on Corporate Progress and Second Quarter 2022 Financial Results

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Monday, August 8, 2022 - 9:01pm
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ROCKVILLE, Md., Aug. 08, 2022 (GLOBE NEWSWIRE) -- MacroGenics, Inc. (NASDAQ: MGNX), a biopharmaceutical company focused on developing and commercializing innovative antibody-based therapeutics for the treatment of cancer, today provided an update on its recent corporate progress and reported financial results for the quarter ended June30, 2022.

Key Points: 
  • ROCKVILLE, Md., Aug. 08, 2022 (GLOBE NEWSWIRE) -- MacroGenics, Inc. (NASDAQ: MGNX), a biopharmaceutical company focused on developing and commercializing innovative antibody-based therapeutics for the treatment of cancer, today provided an update on its recent corporate progress and reported financial results for the quarter ended June30, 2022.
  • We made important progress in the second quarter, during which we completed enrollment in a Phase 1/2 dose expansion study of lorigerlimab, a PD-1 CTLA-4 DART molecule.
  • Recent progress and anticipated events in 2022 related to MacroGenics investigational product candidates in clinical development are highlighted below.
  • Revenue for the quarter ended June30, 2022 included MARGENZA net sales of $4.7 million, compared to $3.2million for the quarter ended June30, 2021.

Annexon Biosciences Highlights Business and Portfolio Progress and Key Anticipated Milestones and Reports Second Quarter 2022 Financial Results

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Monday, August 8, 2022 - 9:01pm
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BRISBANE, Calif., Aug. 08, 2022 (GLOBE NEWSWIRE) -- Annexon, Inc. (Nasdaq: ANNX), a clinical-stage biopharmaceutical company developing a new class of complement medicines for patients with classical complement-mediated autoimmune, neurodegenerative and ophthalmic disorders, today outlined progress across its broad pipeline of fit-for-purpose product candidates and anticipated clinical milestones, and reported second quarter 2022 financial results.

Key Points: 
  • Annexon was founded with an ambitious goal: deliver game-changing treatments to patients suffering from complement-mediated diseases by stopping the classical complement cascade at its start.
  • With the proceeds from our recent financing, we are well-positioned to execute our milestones with a multi-year runway into the second half of 2025.
  • Overall, were invigorated by the promise of our platform and pipeline to make a meaningful difference in the treatment landscape for patients.
  • Annexon is rigorously developing a pipeline of diversified product candidates across multiple mid- to late- stage clinical trials, with clinical data anticipated throughout 2022 and 2023.

MOLECULAR PARTNERS AG (NASDAQ: MOLN) 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 Molecular Partners AG (NASDAQ: MOLN)

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Monday, August 8, 2022 - 9:00pm
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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 otherwise acquired: (a) Molecular Partners AG (“Molecular Partners” or the “Company”) American Depositary Shares (“ADSs”) pursuant and/or traceable to the Offering Documents issued in connection with the Company’s initial public offering conducted on or about June 16, 2021 (the “IPO”); and/or (b) Molecular Partners securities between June 16, 2021 and April 26, 2022, both dates 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 Act of 1933 and Securities Exchange Act of 1934.

Key Points: 
  • If so, please visit Molecular Partners AG Shareholder Class Action Lawsuit or contact Peter Allocco at (212) 951-2030 or pallocco@bernlieb.com to discuss your rights.
  • Molecular Partners operates as a clinical-stage biopharmaceutical company that focuses on the discovery, development, and commercialization of therapeutic proteins.
  • Among other product candidates, Molecular Partners is developing ensovibep as a treatment for COVID-19 in collaboration with Novartis AG (Novartis).
  • The law firm responsible for this advertisement is Bernstein Liebhard LLP, 10 East 40th Street, New York, New York 10016, (212) 779-1414.