On November 8, 2021 Bayer Pharmaceuticals, working with The Life Raft Group (LRG), reported that they have extended a research collaboration to broaden access to comprehensive genomic testing for Gastrointestinal Stromal Tumor (GIST) patients (Press release, Bayer, NOV 8, 2021, View Source [SID1234594768]). This collaboration aims to advance precision medicine in oncology and use comprehensive genomic testing to identify patients in the United States (U.S.) who may benefit from personalized care.

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Comprehensive genomic testing, also known as biomarker testing or molecular testing, is a crucial step in understanding the genomic factors that play a role in establishing a GIST diagnosis. There are different types of comprehensive genomic testing: the most common tests are basic mutational testing and advanced next-generation sequencing. These tests may help identify alterations, or changes, within DNA and/or RNA of cancer cells that determine how a tumor behaves or why it grows. Basic mutational testing focuses on testing specific genes like c-KIT, PDGFRA, and BRAF. Advanced next-generation sequencing may test a broader range of genes, usually between 5 – 500+ genes, including neurotrophic receptor tyrosine kinase (NTRK) gene fusions. The results can help healthcare providers match patients with available treatment options or clinical trials. Finding the right therapeutic can be a turning point in the treatment journey of a GIST patient.

GISTs are a type of soft tissue sarcoma – cancers that develop in connective or supporting tissues – that affect an estimated 3,000 to 5,000 people in the U.S. each year.1 One genomic alteration that can drive the growth and spread of GIST is called an NTRK gene fusion. There are currently treatments for GIST driven by NTRK gene fusions approved in the U.S.

Criteria for patients to participate in this program include: be a U.S. resident, be or become a part of The Life Raft Group GIST Patient Registry, have a treating oncologist, must not have had any type of prior comprehensive genomic testing (basic mutational testing or next-generation sequencing), or have previously been identified with wildtype c-KIT or PDGFRA results from basic mutational testing.

The Life Raft Group, based in Wayne, New Jersey, is a global leader in GIST, focused on educating patients, providing resources, and launching initiatives for the community for better patient outcomes. This collaboration is an example of the vital role patient advocacy groups play in bridging the gap between researchers and motivated patient populations willing to be part of innovative studies.

"As part of our commitment to precision oncology, we believe identifying NTRK patients early through comprehensive genomic testing is a critical step in the cancer diagnosis of oncology patients experiencing metastatic disease, as it helps physicians understand the underlying drivers of tumor growth and can inform the treatment approach," said Iain Webb, M.D., Vice President, U.S. Medical Affairs, Oncology at Bayer. "That is why we are pleased to collaborate with The Life Raft Group to increase the availability of comprehensive genomic testing for GIST patients to potentially uncover NTRK gene fusions and provide options for those who may benefit from precision oncology treatments."

This collaboration builds on Bayer’s existing commitment to advance precision oncology, which includes research to find targets and pathways that drive cancer growth, and how these findings can impact the way cancer is treated.

"We are excited to be a part of this groundbreaking opportunity to work with great organizations to pave the road towards precision medicine and to help us to reach our goal of increasing the testing rate among GIST patients," said Denisse Montoya, Patient Registry Director at The Life Raft Group. "By offering comprehensive genomic testing with no charge, many patients will have the opportunity to know what genes are driving their GIST and benefit from genetic-informed care. Results from this testing collaboration will help us understand more traits and patterns within GIST that will help us with our aim of accelerating GIST cancer research."

Healthcare professionals with eligible patients can find additional information here.

On November 8, 2021 Merck (NYSE: MRK), known as MSD outside the United States and Canada, reported that its pending acquisition of Acceleron Pharma Inc. (Nasdaq: XLRN) has been cleared by the competition authorities in Germany and Austria (Press release, Merck & Co, NOV 8, 2021, View Source [SID1234594755]).

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As previously announced on October 12, 2021, Merck commenced, through a subsidiary, a cash tender offer to purchase all outstanding shares of common stock of Acceleron, for $180 in cash, without interest and less any required tax withholding. The receipt of antitrust clearance from the competition authorities in Germany and Austria satisfies one of the conditions necessary for the consummation of the tender offer. Consummation of the tender offer remains subject to other conditions described in the tender offer statement on Schedule TO filed with the U.S. Securities and Exchange Commission (the "SEC") on October 12, 2021, including the termination or expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended ("HSR") and the tender of shares representing at least a majority of the total number of Acceleron’s outstanding shares. As previously announced on October 29, 2021, the tender offer will expire at 5:00 p.m., Eastern Time, on November 18, 2021, unless further extended in accordance with the merger agreement and the applicable rules and regulations of the SEC. The acquisition is expected to close in the fourth quarter of 2021.

The Depositary for the tender offer is Computershare Trust Company, N.A., c/o Voluntary Corporate Actions, P.O. Box 43011, Providence, RI 02940-3011. The Information Agent for the tender offer is Innisfree M&A Incorporated, 501 Madison Avenue, 20th floor, New York, NY 10022. The tender offer materials may be obtained at no charge by directing a request by mail to Innisfree M&A Incorporated or by calling toll free at (877) 800-5195, and may also be obtained at no charge at the website maintained by the SEC at www.sec.gov.

On November 8, 2021 Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, reported that management will participate in three upcoming investor conferences (Press release, Zymeworks, NOV 8, 2021, View Source [SID1234594754]).

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Stifel 2021 Virtual Healthcare Conference, November 16th – 17th. Zymeworks is participating in a fireside chat on November 17th at 1:20 p.m. ET.
Jefferies London Healthcare Conference, November 18th – 19th. Zymeworks’ pre-recorded presentation will be available on the Zymeworks’ website listed below on November 18th.
Evercore ISI 4th Annual HEALTHCONx Virtual Conference, November 30th – December 1st. Zymeworks is participating in a fireside chat on November 30th at 3:05 p.m. ET.
The Stifel and Evercore fireside chats will be webcast live and available for replay on Zymeworks’ website at View Source

On November 8, 2021 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported the company will be participating virtually in the upcoming 2021 Stifel Healthcare Conference (Press release, Guardant Health, NOV 8, 2021, View Source [SID1234594753]).

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Guardant Health’s management is scheduled to participate in a fireside chat on Monday, November 15 at 11:40 a.m. Pacific Time / 2:40 p.m. Eastern Time. Interested parties may access a live and archived webcast of the presentation on the "Investors" section of the company website at: www.guardanthealth.com.

On November 8, 2021 ANI Pharmaceuticals, Inc. (NASDAQ: ANIP) (ANI or the Company) reported the closing of its previously announced underwritten public offering (Press release, ANI Pharmaceuticals, NOV 8, 2021, View Source [SID1234594752]). A total of 1,500,000 shares of its common stock were sold at a public offering price of $50.00 per share. The gross proceeds of the offering to the Company are $75 million, before deducting the underwriting discounts and commissions and offering expenses. In addition, ANI granted the underwriters a 30-day option to purchase up to an additional 225,000 shares of common stock at the public offering price, less underwriting discounts and commissions.

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Guggenheim Securities acted as lead book-running manager for the offering. Raymond James also acted as book-running manager for the offering. H.C. Wainwright & Co. acted as lead manager for the offering.

The securities described above were offered by ANI pursuant to a shelf registration statement on Form S-3 (File No. 333-239771), which was filed by the Company with the Securities and Exchange Commission (SEC) on July 9, 2020 and was declared effective by the SEC on July 17, 2020.

A preliminary prospectus supplement relating to the offering was filed with the SEC on November 3, 2021 and is available on the SEC’s website at View Source A final prospectus supplement relating to and describing the terms of the offering was also filed with the SEC and is available on the SEC’s website at View Source Copies of the final prospectus supplement and accompanying prospectus relating to the offering may be obtained from Guggenheim Securities, LLC Attention: Equity Syndicate Department, 330 Madison Avenue, New York, NY 10017 or by telephone at (212) 518-9544, or by email at [email protected], and from Raymond James & Associates, Inc. Attention: Equity Syndicate, 880 Carillon Parkway, St. Petersburg, Florida 33716, by telephone at (800) 248-8863 or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.