Diffusion Pharmaceuticals Achieves Drug Production Milestone For Planned Phase 3 Clinical Trial In Inoperable GBM Brain Cancer

CHARLOTTESVILLE, Va., July 20, 2017 -- Diffusion Pharmaceuticals Inc. (NASDAQ:DFFN), a clinical stage biotechnology company developing novel small molecule therapeutics for cancer and other hypoxia-related diseases, today reported the completion of a major production run of its lead drug candidate trans sodium crocetinate (TSC). This drug supply will be used in its planned Phase 3 trial which will test TSC in the treatment of newly diagnosed inoperable glioblastoma (GBM) brain cancer patients and is of sufficient quantity to support the entire trial. Diffusion plans to initiate this clinical trial by the end of 2017.
 
“Diffusion has reached an important milestone for initiating the Phase 3 trial with this successful manufacture of Phase 3-ready TSC,” said David Kalergis, Diffusion’s Chairman and CEO. “In its End-of-Phase-2-Meeting response, the FDA required that any TSC used in upcoming Phase 3 studies must be made using commercially-ready processes, both for the active pharmaceutical ingredient (API) and formulated drug product. The necessary advanced production and formulation processes were implemented over the last eighteen months and were cleared with the FDA in June, immediately prior to the successful clinical trial supply production run earlier this month.”
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Daré © Bioscience, Inc. trading on The NASDAQ Capital Market under the symbol “DARE ”

Company focused on the development and commercialization of women’s reproductive health products
Daré to Host Conference Call on Monday, July 24, 2017, at 
4:30 p.m. Eastern Time / 1:30 p.m. Pacific Time to Discuss Business Opportunity
 
SAN DIEGO, July 20, 2017  -- Daré Bioscience, Inc. (NASDAQ:DARE) (formerly known as Cerulean Pharma Inc., and formerly traded under NASDAQ:CERU) announced today the outcomes of three important transactions: (i) approval by Cerulean stockholders of the purchase of all of the outstanding common shares and options of Daré Bioscience (which has been renamed Daré Bioscience Operations, Inc. to avoid confusion with the renamed Cerulean), (ii) approval by Cerulean stockholders of the sale of all rights related to the Dynamic Tumor Targeting™ Platform to Novartis for $6 million in cash, and (iii) approval by Cerulean stockholders and authorization by the Cerulean board of directors of a 10 to 1 reverse stock split. 
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Arcadia Biosciences ’ Water Use Efficiency Trait Completes US Food and Drug Administration Early Food Safety Evaluation

-- FDA Accepts Conclusion That Trait Protein Is Safe for Humans and Animals --
 
DAVIS, Calif. --  Arcadia Biosciences, Inc. (Nasdaq: RKDA), an agricultural technology company that develops and commercializes plant traits and products that improve farm economics and benefit the environment and human health, announced that the U.S. Food and Drug Administration (FDA) has accepted an Early Food Safety Evaluation (EFSE) for the company’s water use efficiency (WUE) trait. The EFSE is now applicable to all plant species that feature this trait.
 
The EFSE concluded that the functional protein for the WUE trait, isopentenyl transferase (IPT), is safe for humans and animals and would not raise food safety concerns if present in the food supply. 
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Moleculin Signs Agreement with MD Anderson Cancer Center for Leukemia Drug, Annamycin

HOUSTON, TX--(July 18, 2017) - Moleculin Biotech, Inc., (NASDAQ: MBRX) ("Moleculin" or the "Company"), a preclinical pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center, today announced it has signed a new technology license agreement with MD Anderson Cancer Center based on new patent applications it intends to file relating to its drug Annamycin for the treatment of relapsed or refractory acute myeloid leukemia (AML).
 
"In anticipation of beginning our planned clinical trials for Annamycin," commented Walter Klemp, CEO of Moleculin, "one of our priorities has been to ensure the best possible protection for our intellectual property. Some key patent applications had yet to be filed and signing a new license agreement with MD Anderson clears the way for those patents."
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Capricor Receives Rare Pediatric Disease Designation from FDA for CAP-1002 for Patients with Duchenne Muscular Dystrophy

Designation Covers Broad Treatment of Duchenne Muscular Dystrophy (DMD)
 
LOS ANGELES, July 18, 2017 -- Capricor Therapeutics, Inc. (NASDAQ: CAPR), a biotechnology company developing biological therapies for Duchenne muscular dystrophy and other rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation to CAP-1002, Capricor's development candidate for the treatment of Duchenne muscular dystrophy, a debilitating genetic disorder characterized by progressive weakness and chronic inflammation of skeletal, heart, and respiratory muscles. The Rare Pediatric Disease Designation, as well as the Orphan Drug Designation previously granted to CAP-1002 by the FDA, covers the broad treatment of DMD. Upon receiving market approval for CAP-1002 by the FDA, Capricor would be eligible to receive a Priority Review Voucher.
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