On May 18, 2020 PDL BioPharma, Inc. ("PDL" or the "Company") (Nasdaq: PDLI) reported the final distribution ratio for the previously announced distribution of all of the Company’s 13,333,334 shares of common stock of Evofem Biosciences, Inc. ("Evofem") (Nasdaq: EVFM) to be made on May 21, 2020 (the "distribution date") (Press release, PDL BioPharma, MAY 18, 2020, View Source [SID1234558233]). Based on the shares of PDL common stock outstanding as of the close of business on May 15, 2020 (the "record date"), PDL stockholders of record as of the record date will be entitled to receive 0.11591985 shares of Evofem common stock for each share of PDL common stock held as of the close of business on the record date.

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Subject to certain conditions, the distribution by PDL will be made on the distribution date in the form of a pro rata common stock dividend to PDL stockholders of record as of the close of business on the record date. No fractional shares of Evofem common stock will be distributed. Instead, PDL stockholders will receive cash in lieu of any fraction of a share of Evofem common stock that they otherwise would have received. PDL stockholders should consult their tax advisors with respect to U.S. federal, state, local and non-U.S. tax consequences of the distribution. The distribution of Evofem common stock will be made in book entry form and no physical share certificates will be issued.

An information statement describing the distribution will be included as an exhibit to a Current Report on Form 8-K filed by PDL with the U.S. Securities and Exchange Commission (the "SEC"). PDL stockholders will not be required to pay cash or other consideration for the shares of Evofem common stock to be distributed to them or to surrender or exchange their shares of PDL common stock to receive Evofem common stock in the distribution.

Additional information on the distribution, including a copy of the information statement, will be posted to PDL’s website at View Source

On May 18, 2020 Clovis Oncology, Inc. (NASDAQ:CLVS) reported that it has commenced an underwritten public offering of common stock (Press release, Clovis Oncology, MAY 18, 2020, View Source [SID1234558232]).

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Clovis Oncology intends to offer, subject to market and other conditions, $85 million of shares of its common stock in an underwritten registered public offering. In connection with this offering, Clovis Oncology intends to grant to the underwriters a 30-day option to purchase up to an additional $12.75 million of shares of its common stock on the same terms and conditions. All shares of the common stock to be sold in the offering will be offered by Clovis Oncology.

Clovis Oncology intends to use the net proceeds of this offering for general corporate purposes, including repayment, repurchase or refinance of its debt obligations, sales and marketing expenses associated with Rubraca (rucaparib), funding of its development programs, payment of milestones pursuant to its license agreements, general and administrative expenses, acquisition or licensing of additional product candidates or businesses and working capital.

J. P. Morgan Securities LLC and BofA Securities are acting as joint book-running managers for the offering.

The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

The common stock is being offered pursuant to an effective shelf registration statement that Clovis Oncology has filed with the Securities and Exchange Commission ("SEC"). Before you invest, you should read the prospectus in that registration statement and other documents Clovis Oncology has filed with the SEC for more complete information about Clovis Oncology and this offering. The offering is being made only by means of a prospectus supplement and the related prospectus. Copies of the prospectus supplement and related prospectus may be obtained from J. P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by email to [email protected], or from BofA Securities, NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte NC 28255-0001, Attn: Prospectus Department, or by calling 1-800-294-1322 or by email to [email protected]. You may also obtain these documents free of charge when they are available by visiting EDGAR on the SEC’s website at www.sec.gov.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor will 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 May 18, 2020 Progenics Pharmaceuticals, Inc. (Nasdaq:PGNX), an oncology company developing innovative medicines and artificial intelligence to find, fight and follow cancer, reported that the results from the Phase 3 CONDOR trial evaluating the diagnostic performance and clinical impact of PyLTM (18F-DCFPyL) in men with biochemical recurrence of prostate cancer will be presented in an oral session at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2020 Virtual Scientific Program (Press release, Progenics Pharmaceuticals, MAY 18, 2020, View Source [SID1234558231]). PyL is the Company’s PSMA-targeted small molecule positron emission tomography (PET) imaging agent designed to visualize prostate cancer.

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"The vast majority of men dying of prostate cancer, the second most common cause of cancer-related death in men, succumb to metastatic disease. Due to the limitations of conventional imaging, early detection and accurate localization of metastatic lesions in patients with biochemical recurrence of prostate cancer represents an important medical need," said Peter R. Carroll, M.D., M.P.H., Distinguished Professor, Department of Urology, University of California, San Francisco. "New imaging agents, such as PyL, that enable early identification of metastatic disease, both at initial staging and at any point after definitive therapy, could have the potential to impact patient outcomes."

The Phase 3 CONDOR trial is a prospective, multi-center, open label pivotal trial in which 208 patients with biochemical recurrence of prostate cancer and uninformative baseline imaging based on conventional modalities, including Axumin, Choline PET, CT/MR and/or bone scan, were dosed and imaged with PyL at 14 sites in the United States and Canada. The trial achieved its primary endpoint, with a correct localization rate (CLR) of 84.8% to 87.0% among the three blinded independent readers (the lower bound of the 95% confidence intervals ranging from 77.8% to 80.4%). CLR is based on positive predictive value (PPV), defined as the percentage of patients with a one-to-one correspondence between localization of at least one lesion identified on PyL and a composite truth standard comprised of histopathology, conventional imaging and/or a ≥ 50% decline in PSA levels following radiation therapy. Median CLR in patients with baseline PSA <0.5 ng/mL, 0.5 to <1.0 ng/mL, and 1.0 to <2.0 ng/mL were 73.3%, 75.0%, and 83.3%, respectively, which are promising results in a patient population with non-informative baseline findings based on available approved imaging modalities.

63.9% of patients in the CONDOR trial had a change in intended disease management plans due to PyL imaging results, a key secondary endpoint of the trial. The most frequent changes to treatment management plans due to the PyL results included salvage local therapy to systemic therapy, observation to initiating therapy, noncurative systemic therapy to salvage local therapy, and planned treatment to observation.

"In addition to the robust diagnostic performance, the clinician’s high change in management rate based on PyL scans is a particularly significant finding of CONDOR. The subjects in this study represent a true clinical dilemma as there is residual disease present as demonstrated by the detectable PSA, but standard scans are uninformative. CONDOR demonstrates that clinicians trust the information on the PyL scan and use it." said Michael J. Morris, M.D., Clinical Director, Genitourinary Medical Oncology Service & Prostate Cancer Section Head, Division of Solid Tumor Oncology, Memorial Sloan Kettering Cancer Center, and lead author of the ASCO (Free ASCO Whitepaper) presentation. "These positive results further underscore the diagnostic potential for PSMA targeted imaging and open up future opportunities to examine how the results of PyL imaging can be used to deliver new, improved patterns of care."

Progenics ASCO (Free ASCO Whitepaper) Data Release Page 2

Consistent with the Phase 2 OSPREY trial results, safety results showed that PyL was well tolerated. There was one serious adverse event of hypersensitivity reported as related to the study drug in a patient with significant allergic history.

"The full positive results of our Phase 3 CONDOR trial continue to validate our beliefs in PyL to potentially alter the way physicians treat prostate cancer. The CONDOR results, together with previously presented data from OSPREY, collectively demonstrated strong diagnostic performance of PyL in multiple stages of the prostate cancer disease continuum," said David Mims, Interim Chief Executive Officer of Progenics. "We remain on track to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for PyL early in the third quarter of 2020."

Details for the ASCO (Free ASCO Whitepaper) 2020 Virtual Scientific Program presentation are as follows:

Title: Impact of PSMA-targeted imaging with 18F-DCFPyL-PET/CT on clinical management of patients (pts) with biochemically recurrent (BCR) prostate cancer (PCa): Results from a phase III, prospective, multicenter study (CONDOR)

Presenter: Michael J. Morris, M.D., Clinical Director, Genitourinary Medical Oncology Service & Prostate Cancer Section Head, Division of Solid Tumor Oncology, Memorial Sloan Kettering Cancer Center

Abstract #: 5501

Session: Genitourinary Cancer—Prostate, Testicular, and Penile

Date and Time: May 29, 2020 at 8 AM ET on an "on demand" basis

About PyL for PET Imaging of Prostate Cancer

PyL (also known as 18F-DCFPyL) is a fluorinated PSMA-targeted positron emission tomography (PET) imaging agent that enables visualization of both bone and soft tissue metastases to determine the presence or absence of recurrent and/or metastatic prostate cancer.

About Prostate Cancer

Prostate cancer is the second most common form of cancer affecting men in the United States: an estimated one in nine men will be diagnosed with prostate cancer in his lifetime. The American Cancer Society estimates that each year approximately 174,650 new cases of prostate cancer will be diagnosed and about 31,620 men will die of the disease. Approximately 2.9 million men in the U.S. currently count themselves among prostate cancer survivors.

On May 18, 2020 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, reported that pending the receipt of additional information from the Company, Nasdaq has halted the trading in the Company’s common stock (Press release, Moleculin, MAY 18, 2020, View Source [SID1234558230]). The Company is actively working with the staff of Nasdaq to provide it with all requested information, and hopes to begin trading as soon as possible.

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The May 1st, 2020 temporary suspension by the Securities and Exchange Commission in the trading of Moleculin securities expired at 11:59 p.m. ET on May 15th, 2020.

On May 18, 2020 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of cancer, autoimmune, metabolic and other major diseases, and The University of Texas MD Anderson Cancer Center reported a strategic collaboration agreement to co-develop TYVYT (sintilimab injection), Innovent’s anti-PD-1 monoclonal antibody, in rare cancers in the U. S. (Press release, Innovent Biologics, MAY 18, 2020, View Source [SID1234558229]).

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The joint development will focus on advancing sintilimab as an effective immune checkpoint inhibitor for patients with rare cancer types. This research will be enabled by MD Anderson’s experience in conducting clinical trials for even the rarest cancers not often seen by other centers. These studies will provide opportunities for Innovent to pursue approval of sintilimab by the U.S. Food and Drug Administration for multiple rare cancer indications in addition to larger cancer indications for sintilimab that Innovent is independently pursuing for approval as well.

"TYVYT (sintilimab injection) was approved in 2018 by the National Medical Products Association (NMPA) in China for the treatment of relapsed or refractory classic Hodgkin’s lymphoma after second-line or later systemic chemotherapy, where it is currently being evaluated in additional clinical trials for solid tumors" said Dr. Michael Yu, Founder, Chairman and CEO of Innovent. "We believe TYVYT has great potential in various tumor types, both as a single agent and in combination with other inhibiting agents, and currently we are conducting more than 20 related clinical trials including over 10 registration clinical trials. Through this new co-development collaboration, we will work to advance TYVYT into rare tumors, where we hope it will continue to demonstrate its efficacy across multiple tumor types."

"We look forward to working with Innovent and utilizing our unique expertise in treating rare cancers to advance sintilimab toward potential FDA approval," said Ferran Prat, Ph.D., J.D., senior vice president for Research Administration and Industry Relations at MD Anderson. "The introduction of sintilimab to the U.S. would broaden the treatment options available to patients with rare cancer types, many of whom do not currently have an effective standard of care available."

Under the agreement, Innovent and MD Anderson will co-fund the development activities for sintilimab, which may include multiple clinical research studies to be conducted by MD Anderson. MD Anderson plans to develop an approach, upon commercialization in rare diseases, to allow royalty payments it receives on sales of the product in the U.S. to be used to fund care for uninsured patients.

About TYVYT (Sintilimab Injection)

TYVYT (sintilimab injection), an innovative drug developed with global quality standards jointly developed by Innovent and Lilly in China, has been granted marketing approval by the NMPA for relapsed or refractory classic Hodgkin’s lymphoma after second-line or later systemic chemotherapy, and included in the 2019 Guidelines of Chinese Society of Clinical Oncology for Lymphoid Malignancies. TYVYT is the only PD-1 inhibitor that has been included in the new Catalogue of the National Reimbursement Drug List (NRDL), in November 2019. In April 2020, the NMPA accepted the supplemental new drug application for TYVYT in combination with ALIMTA (pemetrexed) and platinum as first-line therapy in non-squamous non-small cell lung cancer (NSCLC). In May 2020, TYVYT combined with Gemzar (gemcitabine for injection) and platinum chemotherapy met the predefined primary endpoint in the Phase 3 ORIENT-12 study as first-line therapy in patients with locally advanced or metastatic squamous NSCLC, TYVYT monotherapy met the primary endpoint in the ORIENT-2 study as second-line therapy in patients with advanced or metastatic esophageal squamous cell carcinoma as well.

TYVYT is a type of immunoglobulin G4 monoclonal antibody, which binds to PD-1 molecules on the surface of T-cells, blocks the PD-1/ PD-Ligand 1 (PD-L1) pathway and reactivates T-cells to kill cancer cells. Innovent is currently conducting more than 20 clinical studies with TYVYT to evaluate its safety and efficacy in a wide variety of cancer indications, including more than 10 registration or pivotal clinical trials.