On September 28, 2021 Onconova Therapeutics, Inc. (NASDAQ: ONTX) ("Onconova"), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, reported the closing of its previously announced underwritten public offering (Press release, Onconova, SEP 28, 2021, View Source [SID1234590469]). A total of 5,000,000 shares of its common stock were sold at a public offering price of $4.20 per share. The gross proceeds of the offering to the Company are $21 million, before deducting the underwriting discounts and commissions and other estimated offering expenses. In addition, Onconova granted the underwriters a thirty-day option to purchase up to an additional 750,000 shares of common stock at the public offering price, less underwriting discounts and commissions.

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Guggenheim Securities is acting as sole book-running manager. Ladenburg Thalmann & Co. Inc. and Noble Capital Markets, Inc. are acting as co-managers for the offering.

The securities described above were offered by Onconova pursuant to a shelf registration statement on Form S-3 (File No. 333-237844) which was initially filed by the Company with the Securities and Exchange Commission ("SEC") on April 24, 2020, amended on Form S-3/A that was filed with the SEC on May 15, 2020, and was declared effective by the SEC on May 18, 2020.

A preliminary prospectus supplement relating to the offering was filed with the SEC on September 23, 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 filed with the SEC and is also 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, by telephone at (212) 518-9544, 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.

On September 28, 2021 Novartis reported that the US Food and Drug Administration (FDA) has accepted and granted Priority Review to the company’s New Drug Application (NDA) for 177Lu-PSMA-617, an investigational targeted radioligand therapy for the treatment of metastatic castration-resistant prostate cancer (mCRPC) in the post androgen receptor pathway inhibition, post taxane-based chemotherapy setting (Press release, Novartis, SEP 28, 2021, View Source [SID1234590375]). With Priority Review, the Prescription Drug User Fee Act (PDUFA) date is anticipated in the first half of 2022. Priority Review is granted to therapies that have the potential to provide significant improvements in the treatment, diagnosis or prevention of serious conditions, as determined by the FDA1.

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Priority Review is based on positive data from the pivotal, Phase III VISION study showing 177Lu-PSMA-617 plus standard of care (SOC), significantly improved overall survival and radiographic progression-free survival for men with progressive PSMA-positive mCRPC compared to SOC alone2
Two additional studies with 177Lu-PSMA-617 in earlier lines of treatment for metastatic prostate cancer are ongoing, investigating clinical utility in the pre-taxane setting (PSMAfore) and in the metastatic hormone-sensitive setting (PSMAddition)3,4
The FDA previously granted Breakthrough Therapy designation for 177Lu-PSMA-617 for the treatment of mCRPC. Data from the VISION study were published in The New England Journal of Medicine (NEJM)2. Novartis is also evaluating additional opportunities to investigate 177Lu-PSMA-617 in earlier stages of prostate cancer.

On September 28, 2021 CRISPR Therapeutics (Nasdaq: CRSP), a biopharmaceutical company focused on creating transformative gene-based medicines for serious diseases, reported that members of its senior management team are scheduled to participate in the Chardan’s 5th Annual Genetic Medicines Conference on Monday, October 4, 2021 at 2:00 p.m. ET (Press release, CRISPR Therapeutics, SEP 28, 2021, View Source [SID1234590399]).

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A live webcast of the event will be available on the "Events & Presentations" page in the Investors section of the Company’s website at View Source A replay of the webcast will be archived on the Company’s website for 14 days following each presentation.

On September 28, 2021 AmerisourceBergen (NYSE: ABC), Cardinal Health (NYSE: CAH) and McKesson (NYSE: MCK) reported that they have reached an agreement with the Cherokee Nation to pay approximately $75 million over 6.5 years to resolve opioid-related claims (Press release, Cardinal Health, SEP 28, 2021, View Source [SID1234590418]). This settlement was negotiated in connection with ongoing negotiations toward a broad resolution of opioid-related claims brought by Native American tribes that, as previously disclosed by the companies, are not covered by the ongoing settlement process involving state and local governmental entities. The companies view today’s settlement as an important step toward reaching a broader settlement with all federally recognized Native American tribes across the country.

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This settlement reflects an agreement of the Cherokee Nation to dismiss its ongoing lawsuit in exchange for the companies’ agreement that the Cherokee Nation will receive a settlement amount consistent with its anticipated allocation under a broader agreement with Native American tribes.

While the companies strongly dispute the allegations against them, they believe this resolution will allow the companies to focus their attention and resources on the safe and secure delivery of medications and therapies while delivering meaningful relief to affected communities, and will also support efforts to achieve a broad resolution with the remaining Native American tribes.

The companies remain deeply concerned about the impact the opioid epidemic is having on communities across the nation and remain committed to being part of the solution.

On September 28, 2021 Admera Health, a precision-medicine company and genetics laboratory, reported that it has engaged Back Bay Life Science Advisors, a strategic advisory and investment banking firm, to explore strategic alternatives for its pharmacogenomics and clinical services business as part of a company-wide strategic review (Press release, Admera Health, SEP 28, 2021, View Source [SID1234590542]). Admera offers the most comprehensive clinical PGx test in the industry, covering 62 genes, over 270 medications, and over 20 therapeutic areas, including: psychiatry, cardiology, pain management, and oncology. Admera Health’s clinical services portfolio is built on a strong foundation of next-generation sequencing (NGS) and data analysis capabilities.

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The company’s current PGx and clinical services product portfolio consists of:

PGxOne Plus is a 62-gene pharmacogenomics test that provides insight into how patients may respond to certain medications based on DNA variants that affect pharmacokinetics and pharmacodynamics
RxVision is a secure, online digital platform that delivers PGx test results to providers and offers a complete PGx assessment with the gene-drug interactions aligning with the FDA sources and guidelines from professional organizations. The product is accessible on web-based browsers, as well as iOS and Android mobile devices, obviating the need for complicated integration with electronic medical record systems
OncoGxOneis a comprehensive 364-gene Next Generation Sequencing assay for profiling all solid tumor types. Input includes both DNA and RNA for optimal fusion detection. The product compliments Admera Health’s suite of NGS tests, spanning the continuum of cancer patient care
The company has also capitalized on its infrastructure by partnering with other domain experts to expand its product offering, notably with its Cardiovascular Test Portfolio.

"We are proud of the significant commercial value we have built in our pharmacogenomics products and are looking to select a strategic partner with additional scale and resources to realize their full potential," said Jeffrey Mitchell, interim CEO of Admera Health.

The company will continue to own and operate its biopharma services business, providing genomics and bioinformatics services in a CAP-accredited CLIA certified laboratory for researchers working on projects ranging from exploratory to clinical.