Quest Diagnostics To Release Second Quarter 2021 Financial Results On July 22

On July 6, 2021 Quest Diagnostics Incorporated (NYSE: DGX), the world’s leading provider of diagnostic information services, reported that it will report second quarter 2021 financial results on Thursday, July 22, 2021, before the market opens (Press release, Quest Diagnostics, JUL 6, 2021, View Source [SID1234584613]). It will hold its quarterly conference call to discuss the results beginning at 8:30 a.m. Eastern Time on that day.

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The conference call can be accessed by dialing 888-455-0391 within the U.S. and Canada, or 773-756-0467 internationally, using the passcode: "7895081." The earnings release and live webcast will be posted on www.QuestDiagnostics.com/investor. The company suggests participants dial in approximately 10 minutes before the call.

A replay of the call may be accessed online at www.QuestDiagnostics.com/investor or by phone at 866-360-3307 for domestic callers or 203-369-0162 for international callers; no passcode is required. Telephone replays will be available from approximately 10:30 a.m. Eastern Time on July 22, 2021 until midnight Eastern Time on August 5, 2021.

Anyone listening to the call is encouraged to read the company’s periodic reports on file with the Securities and Exchange Commission, including the discussion of risk factors and historical results of operations and financial condition in those reports.

Sirnaomics Receives FDA Approval of IND for Phase 1 Clinical Trial of Systemic RNAi Therapeutic STP707 for Solid Tumor Treatment

On July 6, 2021 Sirnaomics, Inc., a leading biopharmaceutical company in discovery and development of RNAi therapeutics, reported that the company’s IND application for a systemic siRNA (small interfering RNA) drug candidate STP707 received the U.S. Food and Drug Administration (FDA) acknowledgment "Study May Proceed", in patients with advanced solid tumors (Press release, Sirnaomics, JUL 6, 2021, View Source [SID1234584612]). This "Phase 1 Multicenter, Open-Label, Dose Escalation Study and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity of STP707 Administered Intravenously in Subjects with Advanced/Metastatic or Surgically Unresectable Solid Tumors Who Are Refractory to Standard Therapy" is expected to begin enrolling in coming months.

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Sirnaomics’ lead product candidate, STP707, is an anti-cancer siRNA (small interfering RNA) therapeutic. It takes advantage of a dual-targeted inhibitory property and a proprietary polypeptide nanoparticle (PNP)-enhanced targeted delivery to solid tumors and metastatic tumors via systemic administration. Initial preclinical study has demonstrated that knocking down TGF-β1 and COX-2 gene expression simultaneously in tumor microenvironment increases active T cell infiltration. A further combination study demonstrated a synergistic antitumor activity between STP707 and PD-L1 antibody using a mouse orthotopic liver cancer model.

"The IND green light from the US FDA for Sirnaomics’ first IV oncology drug, STP 707, represents another major milestone for the company’s mission in discovery and development of novel siRNA therapeutics for unmet clinical needs. Sirnaomics’ drug target selection and tumor targeting delivery should support a high rate of success for novel anticancer siRNA therapeutics, which have been verified in our clinical and preclinical studies" said the Founder and CEO of the company, Dr. Patrick Y. Lu. "Sirnaomics is currently in a strong position to lead the RNAi community in the development of novel oncology therapeutics."

"This IND approval represents a sentinel moment for the company as we can now expand our therapeutic reach in IV administration. This will allow more opportunities to target critical diseases with high unmet clinical need," stated Chief Medical Officer, Michael Molyneaux M.D. "We expect that our rigorous oncology basket clinical study design will enable us to gain great insights into the impact of STP707 on multiple solid tumor types. Our IND enabling non-clinical studies with STP707 demonstrated an excellent safety profile as well as very good efficacy in multiple tumor types."

About STP707

STP707 is composed of two siRNA oligonucleotides, targeting TGF-β1 and COX-2 mRNA respectively, formulated in nanoparticles with a Histidine-Lysine Co-Polymer (HKP+H) peptide as the carrier. The specific carrier peptide is distinct from the carrier used in Sirnaomics’ STP705 product. Each individual siRNA was demonstrated to inhibit the expression of their target mRNAs, and combining the two siRNA’s produces a synergistic effect that diminishes pro-inflammatory factors. The drug substances in STP707 are two siRNA oligonucleotides, targeting TGF-β1 and COX-2 mRNA respectively. Over-expressions of TGF-β1 and COX-2 have been well-characterized in playing key regulatory roles in tumorigenesis. In preclinical studies with STP707, intravenous (IV) delivery resulted in knock-down of TGF-β1 and COX-2 gene expressions in various organs including liver and lung. In addition, in preclinical models STP707 had antitumor activity in various solid tumor types.

Y-mAbs Announces NMPA Submission of BLA for DANYELZA® (naxitamab-gqgk) in China

On July 6, 2021 Y-mAbs Therapeutics, Inc. ("Y-mAbs", NASDAQ: YMAB), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, reported that SciClone Pharmaceuticals (Holdings) Limited ("SciClone Pharmaceuticals") has submitted the Biologics License Application ("BLA") for DANYELZA (naxitamab-gqgk) for the treatment of patients with relapsed/refractory high-risk neuroblastoma to the National Medical Products Administration ("NMPA") of China (Press release, Y-mAbs Therapeutics, JUL 6, 2021, View Source [SID1234584611]).

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Zhao Hong, the Chief Executive Officer and president of SciClone Pharmaceuticals, said: "Thanks to NMPA’s reform to accelerate the launch of global innovative drugs in China, we are excited that within just seven months after FDA’s approval of DANYELZA, we have been able to submit our BLA to the NMPA in China. We are very pleased about the progress we are making and look forward to providing this innovative therapy to pediatric patients in China as quickly as possible."

"We are pleased with the development capabilities of SciClone Pharmaceuticals resulting in accelerated timelines for submitting the DANYELZA BLA in China. We believe this BLA submission marks another important milestone in our aim to make DANYELZA globally available and address a clear unmet medical need for families in China. We look forward to working closely with SciClone Pharmaceuticals on the production and logistic planning of DANYELZA, if approved by the NMPA, to make sure it will be in the market soon," commented Thomas Gad, founder, Chairman and President at Y-mAbs.

Researchers at MSK developed DANYELZA, which is exclusively licensed by MSK to Y-mAbs. As a result of this licensing arrangement, MSK has institutional financial interests in the product.

About DANYELZA (naxitamab-gqgk)

DANYELZA (naxitamab-gqgk) is indicated, in combination with granulocyte-macrophage colony-stimulating factor ("GM-CSF"), for the treatment of pediatric patients 1 year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy. This indication was approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefits in a confirmatory trial. DANYELZA includes a Boxed Warning for serious infusion-related reactions, such as cardiac arrest and anaphylaxis, and neurotoxicity, such as severe neuropathic pain and transverse myelitis. See full Prescribing Information for complete Boxed Warning and other important safety information.

Biofrontera reports preliminary revenue for the month of June 2021

On July 6, 2021 Biofrontera AG (NASDAQ: BFRA; Frankfurt Stock Exchange: B8F) (the "Company"), an international biopharmaceutical company, reported preliminary, unaudited revenue for the month of June 2021 (Press release, Biofrontera, JUL 6, 2021, View Source [SID1234584610]).

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The Company’s preliminary, unaudited revenue from product sales in June 2021 amounted to approximately EUR 2,626 thousand, compared to EUR 1,701 thousand in June 2020, an increase of 50%.

Preliminary revenues from product sales in the US were around EUR 1,375 thousand compared to EUR 1,235 thousand in June 2020, an increase of 11%. In Germany, revenues from product sales amounted to approximately EUR 417 thousand, compared to EUR 370 thousand in June 2020, an increase of 12%. In the rest of Europe, the Company generated product sales of around EUR 834 thousand, compared to EUR 96 thousand in June 2020, a plus of 770%. Sales in June this year include the first batch of Ameluz for reintroduction in the Scandinavian market by Galenica AB.

Preliminary unaudited revenues

Due to commercial rounding, rounding differences may occur in tables.

Due to the pandemic, the monthly and quarterly sales development is compared with sales in 2019 for increased transparency. As such, an increase of 19% in June 2021 total product sales was achieved in all markets compared to June 2019. In more detail, June 2021 sales were up by 35% in Germany and by 131% in the remaining European markets compared to June 2019. In the USA, product sales decreased by 10%. The decline was mainly caused by no or lower sales of Aktipak and Xepi, respectively, while sales of Ameluz were at a comparable level.

In Q2 2021, product sales in all markets were up by around 10% compared to Q2 2019. Sales in Q2 2021 increased by around 19% in Germany and by almost 83% in the rest of the European market compared to Q2 2019. Revenue in the US market was down 4%, mainly due to the lack of or lower sales of Aktipak and Xepi, while sales of Ameluz showed a slight increase compared to Q2 2019.

AstraZeneca receives clearance from the European Commission for the proposed acquisition of Alexion

On July 6, 2021 AstraZeneca reported it’s proposed acquisition of Alexion Pharmaceuticals, Inc. (Alexion) has achieved an important step towards completion by having cleared the European Commission review (Press release, AstraZeneca, JUL 6, 2021, View Source [SID1234584609]).

The clearance follows competition clearances in the United States, Japan and other countries globally, with a complete list available on astrazeneca.com. Regulatory clearance in the UK is pending and remains a requirement to complete the deal.

Marc Dunoyer, Executive Director and Chief Financial Officer, said: "We are pleased to have secured clearance from the European Commission for the proposed acquisition of Alexion, a pioneer in the discovery and development of medicines for rare diseases. We are now another step closer to closing the acquisition and combining the two companies to create a leader in immunology and precision medicines. We continue to progress towards the completion of the acquisition during this quarter."

The proposed acquisition, first announced in December 2020, would enhance the Company’s scientific presence in immunology by adding Alexion’s innovative complement-technology platform and an extensive pipeline. Rare diseases represent a high-growth disease area with rapid innovation and significant unmet medical needs. Shareholders of both companies overwhelmingly supported the acquisition by their votes on 11 May 2021.

Subject to completing the acquisition, a group focusing on rare diseases will be created. This group will be named ‘Alexion, AstraZeneca Rare Disease’, and will be headquartered in Boston, US.

Rare diseases
Over 7,000 rare diseases are known today, and only approximately 5% have treatments approved by the US Food and Drug Administration.1 Demand in medicines for rare diseases is forecasted to grow by a low double-digit percentage in the future.2

Important additional information
In connection with AstraZeneca’s proposed acquisition of Alexion (the Acquisition), AstraZeneca filed a registration statement on Form F-4 with the SEC on 12 April 2021 (the Registration Statement), which has been declared effective by the United States Securities and Exchange Commission, and which includes a document that serves as a prospectus of AstraZeneca and a proxy statement of Alexion (the proxy statement/prospectus), Alexion filed a proxy statement with the SEC (the proxy statement) on 12 April 2021, and each party will file other documents regarding the Acquisition with the SEC. Investors and security holders of Alexion are urged to carefully read the entire Registration Statement and proxy statement/prospectus or proxy statement and other relevant documents filed with the SEC when they become available, because they will contain important information. Investors and security holders may obtain the Registration Statement and the proxy statement/prospectus or the proxy statement free of charge from the SEC’s website or from AstraZeneca or Alexion as described in the paragraphs below.

The documents filed by AstraZeneca with the SEC may be obtained free of charge at the SEC’s website at www.sec.gov. These documents may also be obtained free of charge on AstraZeneca’s website at View Source under the tab "Investors". The documents filed by Alexion with the SEC may be obtained free of charge at the SEC’s website at www.sec.gov. These documents may also be obtained free of charge on Alexion’s internet website at View Source under the tab, "Investors" and under the heading "SEC Filings" or by contacting Alexion’s Investor Relations Department at [email protected].

Important notices relating to financial advisors
Evercore Partners International LLP (Evercore), which is authorised and regulated by the Financial Conduct Authority (FCA) in the United Kingdom, is acting exclusively for AstraZeneca and no one else in connection with the Acquisition and the matters referred to in this announcement and will not regard any other person as a client in relation to the matters set out in this announcement (whether or not a recipient of this announcement) and will not be responsible to anyone other than AstraZeneca for providing the protections afforded to its clients, nor for providing advice in relation to the Acquisition or any other matter referred to in this announcement. Neither Evercore nor any of its subsidiaries, holding companies, branches or affiliates owes or accepts any duty, liability, or responsibility whatsoever (whether direct or indirect, whether in contract, in tort, under statute or otherwise) to any person who is not a client in connection with the Acquisition or any statement contained in this announcement or otherwise. Apart from the responsibilities and liabilities, if any, which may be imposed on Evercore by the Financial Services and Markets Act 2000 (FSMA), or the regulatory regime established thereunder, or under the regulatory regime of any jurisdiction where exclusion of liability under the relevant regulatory regime would be illegal, void or unenforceable, neither Evercore nor any of its affiliates accepts any responsibility or liability whatsoever for the contents of this announcement, and no representation, express or implied, is made by it, or purported to be made on its behalf, in relation to the contents of this announcement, including their accuracy, fairness, sufficiency, completeness or verification of any statement contained in this announcement or any other statement made or purported to be made by it, or on its behalf, in connection with AstraZeneca or the matters described in announcement, and nothing in this announcement is, or shall be relied upon as, a promise or representation in this respect, whether as to the past or the future. To the fullest extent permitted by applicable law, each of Evercore and its affiliates accordingly disclaim all and any responsibility or liability whether arising in tort, contract or otherwise (save as referred to above) which they might otherwise have in respect of this announcement, or any statement contained in this announcement.

Centerview Partners UK LLP (Centerview Partners), which is authorised and regulated by the FCA in the United Kingdom, is acting exclusively for AstraZeneca and no one else in connection with the Acquisition and the matters referred to in this announcement and will not regard any other person as a client in relation to the matters set out in this announcement (whether or not a recipient of this announcement) and will not be responsible to anyone other than AstraZeneca for providing the protections afforded to its clients, nor for providing advice in relation to the Acquisition or any other matter referred to in this announcement. Neither Centerview Partners nor any of its subsidiaries, holding companies, branches or affiliates owes or accepts any duty, liability, or responsibility whatsoever (whether direct or indirect, whether in contract, in tort, under statute or otherwise) to any person who is not a client in connection with the Acquisition or any statement contained in this announcement or otherwise. Apart from the responsibilities and liabilities, if any, which may be imposed on Centerview Partners by the FSMA, or the regulatory regime established thereunder, or under the regulatory regime of any jurisdiction where exclusion of liability under the relevant regulatory regime would be illegal, void or unenforceable, neither Centerview Partners nor any of its affiliates accepts any responsibility or liability whatsoever for the contents of this announcement, and no representation, express or implied, is made by it, or purported to be made on its behalf, in relation to the contents of this announcement, including their accuracy, fairness, sufficiency, completeness or verification of any statement contained in this announcement or any other statement made or purported to be made by it, or on its behalf, in connection with AstraZeneca or the matters described in this announcement, and nothing in this announcement is, or shall be relied upon as, a promise or representation in this respect, whether as to the past or the future. To the fullest extent permitted by applicable law, each of Centerview Partners and its affiliates accordingly disclaim all and any responsibility or liability whether arising in tort, contract or otherwise (save as referred to above) which they might otherwise have in respect of this announcement, or any statement contained in this announcement.

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