Corporate Presentation

On November 30, 2022 Aura Biosciences presented its corporate presentation (Presentation, Aura Biosciences, NOV 30, 2022, View Source [SID1234624591]).

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argenx Enters Into Agreement To Acquire Priority Review Voucher

On November 30, 2022 Argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, reported an agreement to acquire a U.S. Food and Drug Administration (FDA) Priority Review Voucher (PRV) for $102 million (Press release, argenx, NOV 30, 2022, View Source [SID1234624589]). A PRV entitles the holder to FDA priority review of a single Biologics License Application (BLA), which reduces the target review period and may lead to an expedited approval.

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argenx expects to redeem the PRV for a future marketing application for efgartigimod, its first-in-class neonatal Fc receptor (FcRn) blocker.

"This purchase underscores our commitment to transform the way people living with chronic, autoimmune diseases are treated. We have demonstrated proof-of-concept in four autoimmune diseases with our first-in-class FcRn blocker, efgartigimod, and are planning to be active in fifteen disease targets by 2025. With a priority review voucher available, we hope to expedite the approval process for one of our current or future indications to more quickly reach the patients who are in serious need of a new treatment option," said Tim Van Hauwermeiren, Chief Executive Officer of argenx.

The closing of the acquisition of the PRV is subject to customary closing conditions, including clearance under the Hart-Scott Rodino (HSR) Antitrust Improvements Act.

About Efgartigimod

Efgartigimod is an antibody fragment designed to reduce pathogenic immunoglobulin G (IgG) antibodies by binding to the neonatal Fc receptor and blocking the IgG recycling process. Efgartigimod is being investigated in several autoimmune diseases known to be mediated by disease-causing IgG antibodies, including neuromuscular disorders, blood disorders, and skin blistering diseases, in both an intravenous and subcutaneous (SC) formulation. SC efgartigimod is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme’s ENHANZE drug delivery technology.

Alkermes to Participate in the BofA Securities 2022 Biotech SMID Cap Conference

On November 30, 2022 Alkermes plc (Nasdaq: ALKS) reported that management will participate in a fireside chat as part of the BofA Securities 2022 Biotech SMID Cap Conference on Wednesday, Dec. 7, 2022 at 8:00 a.m. ET (1:00 p.m. GMT) (Press release, Alkermes, NOV 30, 2022, View Source [SID1234624588]). The live webcast may be accessed under the Investors tab on www.alkermes.com and will be archived for 14 days.

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AnPac Announces regaining Compliance with Nasdaq Listing Requirement

On November 30, 2022 AnPac Bio-Medical Science Co., Ltd. (Nasdaq: ANPC) ("AnPac Bio" or the "Company"), a biotechnology company with operations in the United States and China focused on early cancer screening and detection, reported that the company has been notified by the Office of the General Counsel of The Nasdaq Stock Market LLC that the Company has regained compliance with the minimum $1 per share bid price requirement of Listed Securities required for continued listing as set forth in Listing Rule 5450(a)(1) (Press release, Anpac Bio, NOV 30, 2022, View Source [SID1234624585]). The Company will remain under the Mandatory Panel Monitor until June 9, 2023, imposed by a previous Hearings Panel’s decision on June 9, 2022.

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On June 9, 2022, AnPac Bio-Medical Science Co., Ltd. (the "Company") received the determination from The Nasdaq Stock Market LLC ("Nasdaq") that the Company has regained compliance with the requirements to remain listed in The Nasdaq Capital Market subject to a one-year Mandatory Panel Monitor of the Company’s ongoing compliance with such requirements as set force in Listing Rule 5815(d)(4)(B). If, within that one-year monitoring period, Listing Qualifications staff ("Staff") finds the Company again out of compliance with the requirement that was the subject of the exception, notwithstanding Rule 5810(c)(2), the Company will not be permitted to provide the Staff with a plan of compliance with respect to that deficiency and Staff will not be permitted to grant additional time for the Company to regain compliance with respect to that deficiency, nor will the company be afforded an applicable cure or compliance period pursuant to Rule 5810(c)(3). Instead, Staff will issue a Staff Delist Determination and the Company will have an opportunity to request a new hearing with the initial Hearings Panel or a newly convened Hearings Panel if the initial Hearings Panel is unavailable. The Company will have the opportunity to respond/present to the Hearings Panel as provided by Listing Rule 5815(d)(4)(C). If the hearing is unsuccessful, the Company’s securities may be at that time delisted from Nasdaq.

On September 9, 2022, the Company received a Staff determination letter (the "Letter") from the Listing Qualifications Department of The Nasdaq Stock Market LLC ("Nasdaq") notifying the Company of the Staff’s determination to delist the Company’s securities from The Nasdaq Capital Market due to its failure to regain compliance with the $1 Bid Rule within the 180 calendar day Compliance Period.

On September 16, 2022, the Company filed a request for a hearing before the NASDAQ Hearings Panel to present its financial data including Shareholders’ Equity and plan with the applicable listing requirements. This request was due to a Staff determination letter (the "Letter") on September 9, 2022 from the Listing Qualifications Department of The Nasdaq Stock Market LLC ("Nasdaq") notifying the Company of the Staff’s determination to delist the Company’s securities from The Nasdaq Capital Market due to the Company’s failure to regain compliance with the $1 per share bid price requirement of Listed Securities required for continued listing as set forth in Listing Rule 5450(a)(1) (the "$1 Bid Rule"), following the 180 calendar day compliance period set forth in Listing Rule 5810(c)(3)(A) (the "Compliance Period"). On September 16, 2022, Company received a letter from Nasdaq granting the appeal and scheduling the Nasdaq Hearings Panel for October 20, 2022.

During the hearing held on October 20, 2022, the Company presented its plan (including share reverse split) to regain compliance with $1 Bid Rule, and the Company’s request for continued listing on The Capital Market has been granted on the condition that before November 23, 2022, the Company shall demonstrate compliance with Listing Rule 5550(a)(2), the $1 Bid Price Rule.

Aileron Therapeutics Regains Compliance with Nasdaq Listing Requirements

On November 30, 2022 Aileron Therapeutics (Nasdaq: ALRN), a chemoprotection oncology company that aspires to make chemotherapy safer and thereby more effective to save more patients’ lives, reported that it received written notice on November 28, 2022 from The Nasdaq Stock Market noting that Aileron has regained compliance with the minimum bid price requirement under Listing Rule 5550(a)(2), which requires the company to maintain a minimum closing bid price of $1.00 per share, and the matter is now closed (Press release, Aileron Therapeutics, NOV 30, 2022, View Source [SID1234624583]). Nasdaq staff made this determination after Aileron’s closing bid price was above $1.00 per share for 10 consecutive business days from November 11, 2022 to November 25, 2022.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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