Dr. Reddy’s Laboratories enters into exclusive sales and distribution agreement with Novartis India Limited for select India brands

On February 11, 2022 Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY, hereafter referred to as "Dr. Reddy’s") reported that it has entered into an exclusive sales and distribution agreement with Novartis India Limited ("NIL") for the Voveran range, the Calcium range and Methergine in India (Press release, Dr Reddy’s, FEB 11, 2022, View Source [SID1234608025]).

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Under the arrangement, Dr. Reddy’s will have exclusive rights to promote and distribute the well-established Voveran range, the Calcium range and Methergine in India. The company will use its strengths in promotion and distribution to considerably expand its engagement with healthcare professionals with the aim of enabling access to patients in need.

Leidos Holdings, Inc. Declares Quarterly Cash Dividend

On February 11, 2022 Leidos Holdings, Inc. (NYSE: LDOS) reported that its Board of Directors has declared a quarterly cash dividend of $0.36 per outstanding share of common stock of Leidos Holdings, Inc (Press release, Leidos, FEB 11, 2022, View Source [SID1234608023]). The cash dividend is payable on March 31, 2022 to stockholders of record as of the close of business on March 15, 2022

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Iovance Biotherapeutics to Host Fourth Quarter and Full Year Financial Results Conference Call and Webcast on Thursday, February 24, 2022

On February 11, 2022 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies, reported that it will report its fourth quarter and full year financial results on Thursday, February 24, 2022 (Press release, Iovance Biotherapeutics, FEB 11, 2022, View Source [SID1234608022]). Management will host a conference call and live audio webcast to discuss these results and provide a corporate update at 4:30 p.m. ET.

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To participate in the conference call, please dial 1-844-646-4465 (domestic) or 1-615-247-0257 (international) and reference the access code 2877242. The live webcast can be accessed in the Investors section of the Company’s website at www.iovance.com. The archived webcast will also be available for one year in the Investors section at www.iovance.com.

Y-mAbs Announces Completion of Pre-BLA Meeting with FDA for Omburtamab

On February 11, 2022 Y-mAbs Therapeutics, Inc. (the "Company" or "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 it recently completed a Pre-Biologics License Application ("pre-BLA") meeting with the U.S. Food and Drug Administration ("FDA") regarding a potential pathway for FDA approval of omburtamab for the treatment of patients with CNS/leptomeningeal metastases from neuroblastoma (Press release, Y-mAbs Therapeutics, FEB 11, 2022, View Source [SID1234608021]). The Company expects to resubmit the BLA for omburtamab by the end of the first quarter 2022.

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A data readout from a single-center clinical study (Study 03-133) of omburtamab conducted at Memorial Sloan Kettering ("MSK"), where 107 evaluable patients with CNS/leptomeningeal metastases from neuroblastoma received up to two doses of radiolabeled omburtamab, showed that patients had a median survival of 50.0 months, with the final median not yet being reached. The Company intends to submit the complete clinical data package in the BLA and announce the data later this year.

"We are pleased with the outcome of the pre-BLA meeting for omburtamab providing a clear regulatory path forward for the resubmission of the BLA. We believe omburtamab has the potential to make a meaningful impact in addressing a substantial unmet medical need for children suffering from high-risk neuroblastoma brain tumors and may potentially add an important treatment option to doctors and families facing this diagnosis," said Thomas Gad, founder, Chairman and President.

Dr. Claus Moller, Chief Executive Officer further notes, "We believe that we can resubmit the omburtamab BLA by the end of the first quarter 2022. We have been working closely with the agency to get to this point, and we will be applying for full approval. I am very grateful to the FDA and my team for the high-level constructive collaboration that has been exercised to get to this pivotal point."

Researchers at MSK developed omburtamab, which is exclusively licensed by MSK to Y-mAbs. As a result of the licensing arrangement, MSK has institutional financial interest related to the compound.

Enveric Biosciences Announces Pricing of $10 Million Public Offering

On February 11, 2022 Enveric Biosciences (NASDAQ: ENVB) ("Enveric" or the "Company"), a neuroscience company developing next-generation, psychedelic-inspired mental health and oncology treatments, reported the pricing of its previously announced underwritten public offering of 20,000,000 shares of its common stock and warrants to purchase up to 20,000,000 shares of its common stock (Press release, Enveric Biosciences, FEB 11, 2022, View Source [SID1234608020]). Each share of common stock is being sold together with one warrant to purchase one share of common stock at an effective combined public offering price of $0.50 per share of common stock and accompanying warrant, less underwriting discounts and commissions. The warrants have an exercise price of $0.55 per share, are exercisable immediately, and will expire five years following the date of issuance.

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A.G.P./Alliance Global Partners is acting as sole book-running manager for the offering.

In addition, Enveric has granted the underwriter a 45-day option to purchase up to an additional 3,000,000 shares of common stock and/or warrants to purchase up to an additional 3,000,000 shares of common stock at the public offering price, less the underwriting discounts and commissions.

All the securities being sold in the offering are being offered by Enveric. The offering is expected to close on or about February 15, 2022, subject to satisfaction of customary closing conditions.

The gross proceeds from the offering to Enveric, before deducting underwriting discounts and commissions and other offering expenses, excluding any proceeds that may be received upon the exercise of the option to purchase additional securities and any exercise of the warrants to purchase common stock, are expected to be $10 million. The Company intends to use the net proceeds from this offering for working capital and to fund other general corporate purposes.

This offering is being made pursuant to an effective shelf registration statement on Form S-3 (No. 333-257690) previously filed with the U.S. Securities and Exchange Commission (the "SEC") that was declared effective by the SEC on July 9, 2021. The offering will be made only by means of a prospectus supplement and accompanying base prospectus, as may be further supplemented by any free writing prospectus and/or pricing supplement that Enveric may file with the SEC. The preliminary prospectus supplement and accompanying prospectus relating to the offering were filed with the SEC and are available on the SEC’s website located at View Source." target="_blank" title="View Source." rel="nofollow">View Source The final prospectus supplement will be filed with the SEC and, once filed, will be available on the SEC website located at View Source, and electronic copies may be also obtained from A.G.P./Alliance Global Partners, 590 Madison Avenue, 28th Floor, New York, NY 10022 or via telephone at 212-624-2060 or email: [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy 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.