On December 17, 2019, Achieve Life Sciences, Inc., a Delaware corporation (the "Company"), reported that entered into an Underwriting Agreement (the "Underwriting Agreement") with Ladenburg Thalmann & Co. Inc. (the "Underwriter"), pursuant to which the Company agreed to issue and sell, in a registered public offering by the Company (the "Public Offering"), (a) 9,577,504 Class A Units (the "Class A Units"), with each Class A Unit consisting of one share of the Company’s common stock, par value $0.001 per share (the "Common Stock"), and a warrant to purchase one share of Common Stock (each warrant exercisable for one whole share of Common Stock, a "Warrant"), with each Class A Unit to be offered to the public at an offering price of $0.60 per Class A Unit and (b) 6,256 Class B Units (the "Class B Units", and collectively with the Class A Units, the "Units"), with each Class B Unit consisting of one share of Series B Preferred Stock, par value $0.001 per share (the "Series B Preferred Stock"), convertible into 1,666 shares of Common Stock and Warrants to purchase 1,666 shares of Common Stock, with each Class B Unit to be offered to the public at an offering price of $999.60 per Class B Unit (Filing, 8-K, OncoGenex Pharmaceuticals, DEC 17, 2019, View Source [SID1234552557]).

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In addition, pursuant to the Underwriting Agreement, the Company granted the Underwriter a 45 day option (the "Overallotment Option") to purchase up to 3,000,000 additional shares of Common Stock and/or Warrants to purchase up to 3,000,000 shares of Common Stock solely to cover over-allotments. The Overallotment Option was exercised in full on December 17, 2019. The Class A Units and Class B Units were not certificated and the shares of Common Stock, Series B Preferred Stock and Warrants comprising such Units were immediately separable and were issued separately in the Public Offering. The Units were offered by the Company pursuant to (i) the registration statement on Form S-1 (File No. 333-234530), and each amendment thereto, which was initially filed with the Securities and Exchange Commission (the "Commission") on November 6, 2019 and declared effective by the Commission on December 17, 2019 (the "Registration Statement").

On December 19, 2019, the Company issued and sold (i) 12,577,504 shares of Common Stock (which includes 3,000,000 shares of Common Stock sold pursuant to the exercise of the Overallotment Option), (ii) 6,256 shares of Series B Preferred Stock and (iii) 23,000,000 Warrants (which includes 3,000,000 Warrants sold pursuant to the exercise of the Overallotment Option) pursuant to the Registration Statement and the Underwriting Agreement. The net proceeds to the Company, after deducting the underwriting discounts and commissions and estimated offering expenses payable by the Company will be approximately $12.4 million.

Each Warrant is immediately exercisable, expires on the five (5) year anniversary of the date of issuance and is exercisable at a price per share of Common Stock of $0.60, subject to adjustment in the event of subsequent equity sales of common stock or securities convertible into common stock for an exercise price per share less than the exercise price per share of the warrants then in effect, provided, however, that the exercise price of the warrants cannot be reduced to an amount less than $0.06 per share of Common Stock. Additionally, subject to certain exceptions, if, after the closing date of the Public Offering, (i) the volume weighted average price of the Common Stock for each of 30 consecutive trading days (the "Measurement Period"), which Measurement Period commences on the closing date, exceeds 300% of the exercise price (subject to adjustments for stock splits, recapitalizations, stock dividends and similar transactions), (ii) the average daily trading volume for such Measurement Period exceeds $500,000 per trading day and (iii) certain other equity conditions are met, and subject to a beneficial ownership limitation, then the Company may call for cancellation of all or any portion of the Warrants then outstanding.

The foregoing summaries of the Underwriting Agreement and the Warrants do not purport to be complete and are subject to, and qualified in their entirety by, such documents attached as Exhibits 1.1 and 4.1, respectively, to this Current Report on Form 8-K, which are incorporated herein by reference.

On December 17, 2019 Biogen Inc. (Nasdaq: BIIB) reported that it will present at the 38th Annual J.P. Morgan Healthcare Conference (Press release, Biogen, DEC 17, 2019, View Source [SID1234552474]). The webcast will be live on Monday, January 13, 2020 at 3:30 p.m. PT, 6:30 p.m. ET. To access the live webcast, please visit Biogen’s Investors section at www.biogen.com/investors. An archived version of the webcast will be available following the presentation.

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On December 17, 2019, Ultragenyx Pharmaceutical Inc. (the "Company") reported that it has entered into a Royalty Purchase Agreement (the "Agreement") with RPI Finance Trust ("Royalty Pharma"), pursuant to which Royalty Pharma paid $320 million in cash to the Company in consideration for the right to receive future royalty payments (the "Royalties") due to the Company from Kyowa Kirin Co., Ltd. ("KKC") based on net sales of Crysvita in the European Union, the United Kingdom, and Switzerland under the terms of the Company’s Collaboration and License Agreement with KKC dated as of August 29, 2013, as amended. The Agreement will automatically expire, and the payment of Royalties to Royalty Pharma will cease, in the event aggregate royalty payments received by Royalty Pharma are equal to or greater than $608 million prior to December 31, 2030, or in the event aggregate royalty payments received by Royalty Pharma are less than $608 million prior to December 31, 2030, when aggregate royalty payments received by Royalty Pharma are equal to or greater than $800 million.

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The Agreement contains other customary terms and conditions, including representations and warranties, covenants and indemnification obligations in favor of each party. The above description of the Agreement is a summary of the material terms, does not purport to be complete and is qualified in its entirety by reference to the Agreement, which will filed as an exhibit to the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2019.

On December 17, 2019 CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) ("CNS" or the "Company"), a biotechnology company specializing in the development of novel treatments for brain tumors, reported the completed good manufacturing practice (GMP) reprocessing of its lead drug candidate, Berubicin, with partner Anthem Biosciences Pvt. Ltd. of Banglaore, India, ("Anthem") an internationally recognized Contract Research and Innovation Service Provider specializing in complex medicinal chemistry (Press release, CNS Pharmaceuticals, DEC 17, 2019, View Source [SID1234552453]).

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This critical manufacturing step was undertaken pursuant to previously announced positive feedback from the U.S. Food and Drug Administration (FDA) for the Company’s Pre-IND (Investigational New Drug) meeting proposal to use a lyophilized drug product, Berubicin, in Phase II clinical trials.

In its response to the Company’s Pre-IND request, the FDA agreed that CNS’ proposal to use a lyophilized drug product, that was developed previously but not used clinically, is acceptable. The FDA further stated that the Company’s proposal to utilize its existing supply of Berubicin in its proposed Phase 2 clinical trial was reasonable if the Berubicin was reprocessed by batch GMP recrystallization and released under GMP specifications. In response to the FDA’s guidance, CNS contracted with Anthem and completed the GMP reprocessing of CNS’ existing supply of Berubicin.

"We are thankful to have such an experienced partner, Anthem, assist us in completing the critical reprocessing work of our existing Berubicin supply," stated CEO of CNS, John M. Climaco. "The GMP reprocessing was a significant milestone in our continued efforts to prepare a new IND in accordance with the FDA guidance we received. We look forward to our upcoming potential Phase II trial evaluating the efficacy of Berubicin in subjects who have glioblastoma that has recurred or progressed following radiation therapy and temozolomide, as we believe in Berubicin’s potential to demonstrate in clinical trials that it can become the only effective anthracycline against brain cancer."

About Berubicin
Berubicin is an anthracycline, a class of drugs among the most powerful chemotherapy drugs and effective against more types of cancer than any other class of chemotherapeutic agents. Anthracyclines are designed to damage the DNA of targeted cancer cells by interfering with the action of the topoisomerase II, a critical enzyme enabling cell proliferation. Berubicin was developed at the MD Anderson Cancer Center (MDACC), the world’s largest cancer research facility. Berubicin appeared to demonstrate one Durable Complete Response in a Phase I human clinical trial conducted by a prior developer.

On December 17, 2019 Prime Therapeutics LLC (Prime), a leading pharmacy benefit manager (PBM) serving more than 28 million members nationally, reported that it has entered into a value-based agreement with Pfizer Inc., a global biopharmaceutical company, intended to help improve outcomes for patients being treated for cancer (Press release, Prime Therapeutics, DEC 17, 2019, View Source [SID1234552452]).

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"An essential part of Prime’s total drug management strategy is identifying drug therapies that, with the right measures and monitoring, can lead to enhanced member outcomes and yield the best value for patients and insurers," said Kelly Pokuta, vice president, pharmaceutical trade relations for Prime. "Intentionally teaming up with biopharmaceutical companies is one of the many ways we control health plan costs and deliver customer-centered value. Prime’s next-generation analytics and rich drug value assessment experience, combined with Pfizer’s deep expertise in oncology and research, make this agreement a win for patients."

Prime will utilize real-world patient pharmacy data to support a value-based agreement related to patients’ adherence to their cancer treatment. Interruptions in oncology therapy can not only have a negative impact on patient outcomes but can also drive up associated health care costs.

"We are pleased to work with Prime on this agreement using real-world data with the aim to improve patient outcomes and ultimately lower health care costs," said Justin McCarthy, senior vice president, patient and health impact group, Pfizer. "As we move from a volume- to a value-based health care system, this collaboration is a great example of the partnerships we are creating across the health care sector to help patients access innovative medicines."

As a pioneer in value-based contracting since 2010, Prime’s manufacturer contracts analyze the value of a selected medicine when taken appropriately, with the goal of improving outcomes and lowering total cost of care. As an integral part of its value and health outcomes strategy, Prime is transforming value-based contracting through analysis of integrated pharmacy and medical data, showing members’ total health picture and providing actionable information to design high-touch interventions. Prime continues to leverage value-based contracts to help ensure emerging and high-cost therapies are priced according to the member value they deliver.