On December 5, 2019 The Board of Directors of Bristol-Myers Squibb Company (NYSE:BMY) reported an increase of 9.8% percent in the company’s quarterly dividend, beginning in the first quarter of 2020 (Press release, Bristol-Myers Squibb, DEC 5, 2019, View Source [SID1234551962]).

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The dividend increase will result in a quarterly dividend of forty-five cents ($0.45) per share on the $.10 par value Common Stock of the corporation. The next quarterly dividend will be payable on February 3, 2020, to stockholders of record at the close of business on January 3, 2020.

The directors also declared a quarterly dividend of fifty cents ($0.50) per share on the $2.00 Convertible Preferred Stock of the corporation, payable March 2, 2020 to stockholders of record at the close of business on February 4, 2020.

The directors indicated an expected dividend for the full year of 2020 of $1.80 per share on the $.10 par value Common Stock of the corporation, subject to the normal quarterly review by the Board.

On December 5, 2019 BioLineRx Ltd. (NASDAQ/TASE: BLRX), a clinical-stage biopharmaceutical company focused on oncology, reported preliminary data from the triple combination arm of the ongoing Phase 2a COMBAT/KEYNOTE-202 study showing that the combination of BL-8040 (a CXCR4 inhibitor), KEYTRUDA and chemotherapy shows high response and disease control rates in patients with metastatic pancreatic cancer (Press release, BioLineRx, DEC 5, 2019, View Source [SID1234551961]). The data, summarized in an abstract published today, entitled, "A Multi-Center Phase 2a Trial to Assess the Safety and Efficacy of BL-8040 (a CXCR4 inhibitor) in Combination with Pembrolizumab and Chemotherapy in Patients with Metastatic Pancreatic Adenocarcinoma (PDAC)," will be presented and discussed as a proffered paper (oral) presentation on Friday, December 13 at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Immuno-Oncology Congress (ESMO IO) 2019, which is being held December 11-14 at the Palexpo in Geneva, Switzerland.

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Manuel Hidalgo, MD, PhD, Chief of the Division of Hematology and Medical Oncology, Senior Member of the Meyer Cancer Center at Weill Cornell Medicine and New York-Presbyterian/Weill Cornell Medical Center, and principal investigator of this study, said, "Metastatic pancreatic cancer has the worst prognosis of all solid tumors, with five-year survival rates of 3%, and a very poor response to the currently available immunotherapy treatments that are transforming care in other cancer indications. Therefore, it is highly important to develop novel combination treatments that will increase the responsiveness and survival of pancreatic cancer patients to immunotherapy. We are encouraged by these preliminary results and look forward to sharing additional data from this important trial next week at ESMO (Free ESMO Whitepaper) IO."

Preliminary Data from Triple Combo Arm of the COMBAT/KEYNOTE-202 Study
As of September 30, 2019 (the data cutoff date for the abstract), 22 patients were dosed (out of ~40 planned), of which 15 were evaluable. All patients enrolled were originally diagnosed with stage IV metastatic pancreatic adenocarcinoma (PDAC) and had progressed following first-line treatment with gemcitabine-based chemotherapy.

Best response for the evaluable population of 15 patients showed 4 partial response (PR) and 8 stable disease (SD) patients – resulting in overall disease control in 12 out of 15 patients;

Study is ongoing and median progression free survival (PFS) and overall survival (OS) were not yet reached; survival data remain on track for mid-2020;

The combination was generally well tolerated, with a safety profile consistent with the individual safety profile of each component alone. Fifteen serious adverse events (SAEs) were reported by 10 patients and 2 patients discontinued the study due to SAEs.

"We are very excited by the preliminary data from this triple combination arm of our Phase 2a pancreatic study under our collaboration with Merck," stated Philip Serlin, Chief Executive Officer of BioLineRx. "These data appear to confirm our hypothesis relating to the synergistic effect of cytotoxic chemotherapy, together with the T-cell trafficking, tumor microenvironment modulation and T-cell infiltration effects of BL-8040 seen in PDAC patients from multiple Phase 2 trials in combination with checkpoint inhibitors. Despite metastatic PDAC being one of the toughest diseases to treat, with so many prior clinical failures, we believe this combination of BL-8040, KEYTRUDA and chemotherapy may provide real hope to pancreatic cancer patients. We look forward to the additional data to be shared next week, as well as the complete study results expected to be released in mid-2020."

Investor Breakfast Meeting Today in New York
The preliminary results will be discussed at an Investor/Analyst Breakfast Meeting being hosted by BioLineRx today, December 5, 2019, in New York, between 8:10 am and 9:30 am EST. A live webcast and replay of the event will be accessible here.

Design of Triple Combination Arm of COMBAT/KEYNOTE-202 Study
The triple combination arm focuses on second-line pancreatic cancer patients and is expected to include approximately 40 patients originally diagnosed with unresectable metastatic pancreatic adenocarcinoma who have progressed following first-line gemcitabine-based therapy. Patients receive BL-8040 monotherapy priming treatment for five days, followed by combination cycles of chemotherapy (Onivyde/5-fluorouracil/leucovorin), KEYTRUDA and BL-8040 until progression. The primary endpoint of the study is the objective response rate (ORR). Secondary endpoints include overall survival, progression free survival, and disease control rate.

The COMBAT/KEYNOTE-202 Study
The Phase 2a COMBAT/KEYNOTE-202 study was originally designed as an open-label, multicenter, single-arm trial to evaluate the safety and efficacy of the combination of BL-8040 and KEYTRUDA (pembrolizumab), an anti-PD-1 therapy marketed by Merck & Co., Inc., Kenilworth, N.J., USA (known as MSD outside the United States and Canada), in over 30 subjects with metastatic pancreatic adenocarcinoma. The study was primarily designed to evaluate the clinical response, safety and tolerability of the combination of these therapies, and was carried out in the US, Israel and additional territories. The study is being conducted by BioLineRx under a collaboration agreement signed in 2016 between BioLineRx and MSD, through a subsidiary.

In July 2018, the Company announced the expansion of its immuno-oncology collaboration with MSD to include the triple combination arm investigating the safety, tolerability and efficacy of BL-8040, KEYTRUDA and chemotherapy as part of the Phase 2a COMBAT/KEYNOTE-202 study.

About BL-8040 in Cancer Immunotherapy
BL-8040 is targeting CXCR4, a chemokine receptor and a well validated therapeutic target that is over-expressed in many human cancers including PDAC. CXCR4 plays a key role in tumor growth, invasion, angiogenesis, metastasis and therapeutic resistance, and CXCR4 overexpression has been shown to be correlated with poor prognosis.

BL-8040 is a short synthetic peptide used as a platform for cancer immunotherapy with unique features allowing it to function as a best-in-class antagonist of CXCR4. It shows high-affinity, long receptor occupancy and acts as an inverse agonist.

In a number of clinical and preclinical studies, BL-8040 has been shown to affect multiple modes of action in "cold" tumors, including immune cell trafficking, tumor infiltration by immune effector T cells, and reduction in immunosuppressive cells (such as MDSCs) within the tumor niche, turning "cold" tumors, such as pancreatic cancer, into "hot" (i.e., sensitizing them to immune checkpoint inhibitors and chemotherapy).

On December 5, 2019 Athenex, Inc. (Nasdaq: ATNX), a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer and related conditions, reported that it has directly entered into an agreement for the sale of its common stock in a private placement with a group of institutional investors (Press release, Athenex, DEC 5, 2019, View Source [SID1234551959]). The lead investor in the private placement is Kingdon Capital Management, LLC. The transaction is expected to result in gross proceeds to Athenex of approximately $60 million, before deducting offering expenses. Net proceeds from the transaction are expected to be used to fund clinical development and regulatory activities for oral paclitaxel and encequidar; regulatory activities for tirbanibulin ointment for the treatment of actinic keratosis; commercialization activities, including pre-launch activities for oral paclitaxel and encequidar; manufacturing infrastructure; and working capital and general corporate purposes.

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The Company will issue 3,945,750 shares of common stock for a purchase price of $15.30 per share, for aggregate gross proceeds of approximately $60 million. The closing of the private placement is expected to occur on or about December 9, 2019, subject to customary closing conditions.

SunTrust Robinson Humphrey has acted as an exclusive placement agent to the Company in this private placement.

The offering of shares of common stock has not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or applicable state securities laws, and the shares are being offered pursuant to an exemption from the registration requirements of the Securities Act and similar exemptions under applicable state securities laws. At the closing of the offering, the Company will enter into a registration rights agreement with the investors, pursuant to which the Company will agree to file a registration statement with the Securities and Exchange Commission registering for resale the shares issued in this private placement.

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

On December 5, 2019 Applied DNA Sciences, Inc. (NASDAQ: APDN), reported it plans to release financial results for its fiscal 2019 fourth quarter ended September 30, 2019 after market close on Thursday, December 12, 2019 (Press release, Applied DNA Sciences, DEC 5, 2019, View Source [SID1234551955]). In conjunction with the release, the Company has scheduled a conference call at 4:30 p.m. Eastern Time that will also be broadcast live over the Internet.

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What: Applied DNA’s Fiscal 2019 Fourth Quarter Financial Results Conference Call
When: Thursday, December 12, 2019, at 4:30 p.m. Eastern Time
Where: Via phone by dialing +1 844-887-9402 or +1 412-317-6798 and ask to join the Applied DNA call; via webcast.

A telephonic replay of the conference call will be available for one day and may be accessed by calling +1 877-344-7529 or +1 412-317-0088 with the passcode 10136194. The webcast will be archived within the ‘Events and Presentations’ portion of the ‘Investors’ page to the company’s website.

On December 5, 2019 Novartis AG (NYSE: NVS) ("Novartis") reported that its indirect wholly-owned subsidiary, Medusa Merger Corporation, a Delaware corporation ("Purchaser"), has commenced a cash tender offer to purchase all of the outstanding shares of common stock, par value USD 0.001 per share, of The Medicines Company (NASDAQ: MDCO) for a price of USD 85.00 per share, net to the seller in cash, without interest and subject to any tax withholding (the "Offer") (Press release, Novartis, DEC 5, 2019, View Source [SID1234551952]). The Offer is being made upon the terms and subject to the conditions set forth in the Offer to Purchase, dated December 5, 2019, and the related Letter of Transmittal and pursuant to the terms of the previously announced Agreement and Plan of Merger, dated as of November 23, 2019 (the "Merger Agreement"), among Novartis, Purchaser and The Medicines Company.

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The Offer will expire at 12:00 midnight, New York City time, at the end of the day on January 3, 2020, unless extended (the latest time and date at which the Offer will expire, the "Expiration Date"). Any extension of the Offer will be followed by public announcement of the extension by press release or other public announcement before 9:00 a.m., New York City time, on the next business day after the Expiration Date.

Novartis will file today a Tender Offer Statement on Schedule TO with the United States Securities and Exchange Commission (the "SEC"). The Offer to Purchase contained within the Schedule TO sets out the full terms and conditions of the Offer.

The Medicines Company will file today a Solicitation/Recommendation Statement on Schedule 14D-9 with the SEC, which includes, among other things, the recommendation of The Medicines Company board of directors that The Medicines Company’s stockholders accept the Offer and tender their shares of The Medicines Company common stock pursuant to the Offer.

The Offer is subject to customary closing conditions, including the tender of at least a majority of the outstanding shares of The Medicines Company common stock and the expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. The Offer is subject to other important conditions set forth in the Offer to Purchase. The Offer is not subject to a financing condition.

Innisfree M&A Incorporated is acting as information agent for Purchaser in the Offer. American Stock Transfer & Trust Company, LLC is acting as the depositary and paying agent in the Offer. Requests for documents and questions by stockholders relating to the Offer may be directed to Innisfree M&A Incorporated by telephone at 1 (888) 750-5834 (toll free).