On May 28, 2019 Onconova Therapeutics, Inc. (NASDAQ:ONTX), a Phase 3-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, with an initial focus on myelodysplastic syndromes (MDS), reported that it will be presenting at three upcoming conferences (Press release, Onconova, MAY 28, 2019, View Source [SID1234536608]):

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Acute Leukemia Forum China May 31 – Shanghai
Presentation: Fri, May 31 Steven Fruchtman, MD, President & CEO

BIO International Forum, Philadelphia June 3-6 – Philadelphia, PA
Presentation: Tues, June 4 3:15p EDT Steven Fruchtman, President & CEO
Webcast: http://www.veracast.com/webcasts/bio/internationalconvention2019/74119246905.cfm
Avi Oler, VP Corporate Development, will also attend and be available to meet with interested parties

9th Annual LD Micro Invitational June 4-5 – Bel Air, CA
Presentation: Tues, June 4 8:20a PDT Mark Guerin, CFO

On May 28, 2019 Galectin Therapeutics Inc. (NASDAQ: GALT), the leading developer of therapeutics that target galectin proteins, reported its Rights Offering has closed (Press release, Galectin Therapeutics, MAY 28, 2019, View Source [SID1234536626]).

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The Rights Offering resulted in the issuance of approximately 10.4 million shares of the Company’s common stock at a price of $4.28 per share, for total gross proceeds of $44.5 million to the Company. Investors in the Rights Offering also received warrants for the purchase of approximately 2.6 million shares of the Company’s common stock with an exercise price of $7.00 per share, which expire seven years after issuance. After giving effect to the rights offering, the Company has approximately 56 million shares of common stock issued and outstanding.

Richard E. Uihlein, Chairman of the Board of Directors, subscribed for $20,033,000 in the Rights Offering. Mr. Uihlein stated, "We are pleased with the results of the Rights Offering and are gratified that so many of our stockholders responded by making further investments in our Company. From the outset, we wanted to turn first to our stockholder base and give them the opportunity to continue supporting our company, its development program, and its clinical trials; we are proud that so many did so, with investments large and small. This capital raise positions us to proceed with plans to initiate a Phase 3 clinical trial this fall in patients with NASH cirrhosis."

Separately, Mr. Uihlein also exercised 500,000 common stock warrants at an exercise price of $5.00 per share for proceeds of $2,500,000.

A registration statement relating to the shares of common stock in the Rights Offering was previously filed with the Securities and Exchange Commission (the "SEC") and declared effective on April 12, 2019. Subscription rights that were not exercised by 5:00 p.m. Eastern Time on May 23, 2019, have expired.

On May 28, 2019 Prestige BioPharma (herein, Prestige) reported that European Medicines Agency (EMA) has validated and accepted for review the Marketing Authorization Application (MAA) for its trastuzumab biosimilar HD201 (Tuznue) on 23 May 2019 (Press release, Prestige BioPharma, MAY 28, 2019, View Source [SID1234593981]).

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HD201 is Prestige’s lead development candidate biosimilar to Herceptin (trastuzumab), which is indicated for the treatment of adult patients with HER2-overexpressing breast cancer as well as HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. Accordingly, if authorized by the EMA, HD201 (Prestige) would take part in the race along with Herzuma (Celltrion), Kanjinti (Amgen), Ontruzant (Samsung Bioepis), and Trazimera (Pfizer) to seize the EU market as one of the comparable biosimilars, which is currently dominated by Herceptin (Roche).

Furthermore, the positive top-line results from the Phase I / Phase III global clinical trial of HD201 confirm that HD201 is exceptionally biosimilar to Herceptin in terms of clinical response and PK, in addition to a comparable safety profile to the range previously observed in other trastuzumab biosimilar trials.

Dr Lisa S. Park, Chief Executive Officer of Prestige, commented: "We are very pleased that EMA has initiated the review of the HD201 Marketing Authorisation Application. It is a major step in our endeavor to become a global player focussing on biosimilars and innovative biologics. Our development approach has proven to be highly efficient with regard to trial performance, demonstrating exceptional similarity, and dossier filing."

HD201 will be Prestige’s first biosimilar to receive a positive Committee for Medicinal Products for Human Use (CHMP) opinion for marketing authorization from the EMA. Based on this achievement, Prestige will continue to move forward with other 8 biosimilars and innovative biologics in its portfolio, which are currently at different stages of development, from nonclinical development to advanced clinical stages.

On May 28, 2019 Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of drugs that treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of cortisol, reported that it will present data from the Phase 1/2 study of its proprietary, selective cortisol modulator, relacorilant, in combination with nab-paclitaxel (Abraxane) in patients with solid tumors, at the 2019 annual meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) in Chicago, Illinois (May 31 – June 4) (Press release, Corcept Therapeutics, MAY 28, 2019, https://ir.corcept.com/news-releases/news-release-details/corcept-therapeutics-present-data-phase-12-trial-relacorilant [SID1234536593]).

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"Our Phase 1/2 trial of relacorilant in combination with nab-paclitaxel has been productive," said Andreas Grauer, MD, Corcept’s Chief Medical Officer. "Encouraging results in patients with platinum-resistant ovarian cancer prompted us, after consultation with our investigators, to initiate a 180-patient, controlled Phase 2 trial of relacorilant plus nab-paclitaxel in that indication earlier this year. We look forward to sharing additional data in patients with a variety of solid tumors."

Monday, June 3rd
Relacorilant (RELA) with nab-paclitaxel (NP): Safety and
activity in patients with pancreatic ductal adenocarcinoma
(PDAC) and ovarian cancer (OvCA)

P. Munster; S. Shepard Gastrointestinal (Noncolorectal) Cancer
Poster Board: #235
Time: 8:00 – 11:00 am
Location: Hall A

Selective and nonselective GR antagonists in combination
with chemotherapy in ovarian cancer PDX models

J. Veneris; G. Fleming Gynecologic Cancer
Abstract No: e17039

About Relacorilant

Relacorilant is a non-steroidal, selective modulator of the glucocorticoid receptor, one of the two receptors to which cortisol binds. Relacorilant does not bind to the body’s other hormone receptors, including the progesterone receptor. Corcept is studying relacorilant as a potential treatment for a variety of serious disorders. Current trials include a 180-patient, controlled Phase 2 trial of relacorilant combined with nab-paclitaxel in patients with platinum-resistant ovarian cancer and a Phase 3 trial of relacorilant as monotherapy for patients with Cushing’s syndrome. Relacorilant is proprietary to Corcept and is protected by composition of matter and method of use patents through 2037. Relacorilant has received orphan designation in the United States for the treatment of both Cushing’s syndrome and pancreatic cancer.

On May 28, 2019 Pacira BioSciences, Inc. (NASDAQ: PCRX) reported that it will participate in an analyst-led fireside chat at the Jefferies 2019 Healthcare Conference at 10:00 AM ET on Tuesday, June 4, 2019 (Press release, Pacira Pharmaceuticals, MAY 28, 2019, View Source [SID1234536609]). Live audio of the event can be accessed by visiting the "Events" page of the company’s website at investor.pacira.com. A replay of the webcast will also be available for two weeks following the event.

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