Accurexa Inc (ACXA) 0.3500 $ACXA FDA Grants Accurexa

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Accurexa Inc (ACXA) 0.3500 $ACXA

FDA Grants Accurexa Pre-IND Meeting for its ACX-31 Program in the Treatment of Brain Cancer
ACCESSWIRE - Tue Jul 05, 7:01AM CDT
NEWARK, DE / ACCESSWIRE / July 5, 2016 / Accurexa Inc. (the "Company" (OTCQB: ACXA), a biotechnology company focused on the development of novel neurological therapies to be directly delivered into the brain, announced today that the U.S. FDA (Food and Drug Administration) has granted Accurexa a pre-IND (Investigational New Drug) meeting requested to discuss the CMC (Chemistry, Manufacturing and Controls), nonclinical and clinical development of its ACX-31 program, and to confirm the acceptability of a 505b2 application pathway. The FDA's stated goal date for providing its written response is August 19, 2016, provided that the background information submitted to the FDA by Accurexa is adequate. Accurexa is developing its ACX-31 program for the local delivery of temozolomide as adjunctive therapy to BCNU, both chemotherapeutics, in the treatment of brain tumors.

Accurexa Submits Pre-IND Meeting Request to the U.S. FDA for Its ACX-31 Program
ACCESSWIRE - Wed Jun 22, 8:00AM CDT
NEWARK, DE / ACCESSWIRE / June 22, 2016 / Accurexa Inc. (the "Company" (OTCQB: ACXA), a biotechnology company focused on the development of novel neurological therapies to be directly delivered into the brain, announced today that it has submitted a request for a pre-IND (Investigational New Drug) meeting to the U.S. FDA (Food and Drug Administration) for its ACX-31 program for the local delivery of temozolomide as adjunctive therapy to BCNU, both chemotherapeutics, in the treatment of brain tumors in conjunction with surgery and radiation. A pre-IND meeting typically occurs within 60 days of the FDA receipt of the written meeting request per FDA's own guidance.

UCSF and Accurexa Receive Response From FDA to Pre-IND Meeting Request
ACCESSWIRE - Thu Mar 24, 7:00AM CDT
NEWARK, DE / ACCESSWIRE / March 24, 2016 / the "Company" or "Accurexa" (OTCQB: ACXA), a biotechnology company focused on the development of novel neurological therapies to be directly delivered into the brain, announced today that the University of California, San Francisco ("UCSF" received a written response from the FDA (U.S. Food and Drug Administration) regarding a pre-IND meeting request to discuss a collaborative program between UCSF and Accurexa to evaluate a combined stem cell/gene transfer candidate therapeutic CNS10-NPC GDNF for the treatment of Parkinson's Disease using Accurexa's BranchPoint delivery device. CNS10-NPC are human fetal neural stem cells that express Glial-Derived Neurotrophic Factor (GDNF) in the treatment of Parkinson's Disease, and are expected to be supplied by the Cedars-Sinai Regenerative Medicine Institute in support of IND (Investigational New Drug) enabling studies.

Accurexa Initiates Preparation of Pre-IND Meeting for its ACX-31 Program
ACCESSWIRE - Thu Mar 17, 7:00AM CDT
NEWARK, DE / ACCESSWIRE / March 17, 2016 / Accurexa Inc. (the "Company" (OTCQB: ACXA), a biotechnology company focused on the development of novel neurological therapies to be directly delivered into the brain, announced today that it has initiated the preparation of a pre-IND meeting for its ACX-31 program for the local delivery of temozolomide in combination with BCNU, both chemotherapeutics, in the treatment of brain tumors.

Accurexa Engages PharmaLex to Advance its ACX-31 Program towards a Regulatory Path
ACCESSWIRE - Wed Feb 10, 7:03AM CST
NEWARK, DE / ACCESSWIRE / February 10, 2016 / Accurexa Inc. (the "Company" (OTCQB: ACXA), a biotechnology company focused on the development of novel neurological therapies to be directly delivered into the brain, announced today that it has engaged PharmaLex Development Services, LLC ("PharmaLex" to advise the Company in the development of its ACX-31 program for the local delivery of temozolomide in combination with BCNU, both chemotherapeutics, in the treatment of brain tumors.

"New To The Street" to Air New Interviews on FOX Business Network
Marketwired - Tue Dec 01, 2:09PM CST
"New To The Street" will be broadcasting its latest show nationwide on FOX Business, Sunday, December 13, 2015 at 4:30 pm, potentially reaching 83.1 million households.
TWTR: 18.08 (+0.71)

UCSF and Accurexa Request Pre-IND Meeting with FDA
ACCESSWIRE - Wed Nov 04, 7:01AM CST
NEWARK, DE / ACCESSWIRE / November 4, 2015 / Accurexa Inc. (the "Company" or "Accurexa" (OTCQB: ACXA), a biotechnology company focused on the development of novel neurological therapies to be directly delivered into the brain, announced today that the University of California, San Francisco ("UCSF" requested a pre-IND meeting with the FDA to discuss a collaborative program between UCSF and Accurexa to evaluate a combined stem cell/gene transfer candidate therapeutic CNS10-NPC GDNF for the treatment of Parkinson's Disease using Accurexa's BranchPoint delivery device. CNS10-NPC are human fetal neural stem cells that express Glial-Derived Neurotrophic Factor (GDNF) in the treatment of Parkinson's Disease, and are expected to be supplied by the Cedars-Sinai Regenerative Medicine Institute in support of IND (Investigational New Drug) enabling studies.

Accurexa Enters into Collaboration with The Hebrew University of Jerusalem
ACCESSWIRE - Mon Nov 02, 7:02AM CST
NEWWARK, DE / ACCESSWIRE / November 2, 2015 / Accurexa Inc. (the "Company" (OTCQB: ACXA), a biotechnology company focused on the development of novel neurological therapies to be directly delivered into the brain, announced today that it entered into an agreement with the Yissum Research Development Company of The Hebrew University of Jerusalem Ltd. ("Yissum" to develop and supply a polymeric formulation of a combination of carmustine and temozolomide for sustained local administration to a solid tumor (the "Services". The Services will be provided by Yissum under a service agreement under which the Company will retain ownership of all intellectual property rights that are discovered or developed during the course of the provision of the Services. Professor Avi Domb of The Hebrew University of Jerusalem will lead the development efforts provided by Yissum.

"New To The Street" Heads to Florida for Press Conference With Governor Rick Scott and Oakridge Global Energy Solutions, Inc. -- OTCQB: OGES
Marketwired - Tue Oct 06, 12:05PM CDT
"New To The Street" announces with great excitement that it taped Florida's Governor Rick Scott's press conference at the headquarters of one of their feature companies, Oakridge Global Energy Solution, Inc. (OTCQB: OGES). This interview featured Governor Scott speaking about the importance of manufacturing in the USA, and Oakridge Global's commitment to "Made in America." "New To The Street's" Executive Producer, Joyce Glicker, together with Anchor, Erica Ferrari, attended this important press conference.
TWTR: 18.08 (+0.71)

Accurexa to Present at 2015 Stem Cell Meeting on the Mesa
ACCESSWIRE - Mon Sep 28, 7:01AM CDT
NEWARK, DE / ACCESSWIRE / September 28, 2015 / Accurexa Inc. (the "Company" (OTCQB: ACXA), a biotechnology company focused on the development of novel neurological therapies to be directly delivered into the brain, announced today that George Yu, MD, President & CEO, will present at the annual Partnering Forum, part of the Stem Cell Meeting on the Mesa to be held October 7-9 in La Jolla, California.

"New To The Street" Announces Upcoming Interviews With New Clients & Recurring Clients
Marketwired - Wed Sep 23, 2:10PM CDT
"New To The Street" is excited to announce its current line-up for the taping of their newest T.V. series, set for October 22, 2015 at their state of the art studios in New York City, New York.
TWTR: 18.08 (+0.71)

Professor Robert Langer Advises Accurexa in the Development of its ACX-31 Program
ACCESSWIRE - Thu Sep 03, 7:47AM CDT
NEWARK, DE / ACCESSWIRE / September 3, 2015 / Accurexa Inc. (the "Company" (OTCQB: ACXA), a biotechnology company focused on the development of novel neurological therapies that can deliver therapeutics directly into the brain, announced today that Professor Robert Langer agreed to advise the Company in the development of its ACX-31 Program for the local delivery of temozolomide in combination with BCNU, both chemotherapeutics, in the treatment of brain tumors.

Accurexa to Present at the Rodman & Renshaw 17th Annual Global Investment Conference
ACCESSWIRE - Tue Sep 01, 7:00AM CDT
NEWARK, DE / ACCESSWIRE / September 1, 2015 / Accurexa Inc. (the "Company" (OTCQB: ACXA), a biotechnology company focused on the development of novel neurological therapies that can deliver therapeutics directly into the brain, announced today that it will present at the 17th Annual Rodman & Renshaw Global Investment Conference taking place from September 8-10, 2015 at the St. Regis Hotel in New York City.

"New To The Street" Begins Working With Twitter to Promote Clients Videos on Twitter's Beta Video Platform
Marketwired - Tue Aug 25, 3:15PM CDT
"New To The Street" has just started sharing their clients' videos, marketing with key words to specific demographics on Twitter's (NYSE: TWTR) beta platform.
TWTR: 18.08 (+0.71)

Accurexa Licenses Combination of Local Temozolomide with Local BCNU Patent
ACCESSWIRE - Wed Aug 12, 7:00AM CDT
NEWARK, DE / ACCESSWIRE / August 12, 2015 / Accurexa Inc. (the "Company" (OTCQB: ACXA), a biotechnology company focused on developing and commercializing novel neurological therapies, announced today that it has entered into an exclusive license agreement ("ACL License" with Accelerating Combination Therapies LLC ("ACL" in regards to the exclusive licensing of the issued U.S. Patent No. 8,895,597 B2 Combination of Local Temozolomide with Local BCNU ("Patent Rights". ACL is beneficially owned by the original Patent Rights holders and Inventors Henry Brem et al. ("Inventors" who assigned the Patent Rights to ACL. Henry Brem is the Harvey Cushing Professor of Neurosurgery, Director of the Department of Neurosurgery, and Neurosurgeon-in-Chief at The Johns Hopkins University, and invented and developed Gliadel(R) wafers to deliver local chemotherapy to brain tumors.

Accurexa Appoints William Callahan to Its Board of Directors
ACCESSWIRE - Thu Jul 02, 7:00AM CDT
NEWARK, DE / ACCESSWIRE / July 2, 2015 / Accurexa Inc. (the "Company" (OTCQB: ACXA), a biotechnology company focused on developing and commercializing novel neurological therapies, announced today that William Callahan has been appointed to its Board of Directors, effective July 1, 2015.
DEPO: 18.77 (+0.01)

"New To The Street" Introduces Five Companies on the Next Two Shows
Marketwired - Thu Jun 25, 8:02AM CDT
"New To The Street" just completed shooting two shows in their state of the art NYC studios.

Accurexa Announces Equity Financing of $2.25 Million
ACCESSWIRE - Wed Jun 17, 7:01AM CDT
SAN FRANCISCO, CA / ACCESSWIRE / June 17, 2015 / Accurexa Inc. ("Accurexa" or the "Company", (OTCQB: ACXA), a biotechnology company focused on developing and commercializing novel neurological therapies, today announced that it has entered into definitive agreements with institutional investors, led by a healthcare dedicated fund, for the private placement of 2,250 shares of the Company's convertible preferred stock for gross proceeds to the Company of $2,250,000.

Accurexa Files 501(k) with FDA; Share Skyrocket to 2015 Highs - Analyst Brief by BrokerBank Securities
PR Newswire - Wed Jun 17, 6:00AM CDT
Accurexa Inc. (OTCQB: ACXA) a biotechnology company focused on developing and commercializing novel neurological therapies, announced on Monday that it has filed a submission with the U.S. FDA for 510(k) clearance to market its BranchPoint device. The Company's BranchPoint device was invented to deliver therapeutics, such as stem cells, through the radial deployment of a flexible catheter to specific brain target areas through a single brain penetration. The current standard of care is the use of straight, rigid needles which increase the risk of bleeding, stroke or reflux of therapeutics. Accurexa's system helps minimize this risk.

Accurexa Submits its BranchPoint Device to FDA for 510(k) Clearance
ACCESSWIRE - Mon Jun 15, 7:00AM CDT
SAN FRANCISCO, CA / ACCESSWIRE / June 15, 2015 / Accurexa Inc. (the "Company" (OTCQB: ACXA), a biotechnology company focused on developing and commercializing novel neurological therapies, announced today that it has filed a submission with the U.S. Food and Drug Administration (FDA) for 510(k) clearance to market its BranchPoint device.

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