Second Sight Receives Full FDA Approval to Begin First Orion Human Clinical Study

--Second Sight has completed additional device testing and addressed outstanding questions previously requested by the FDA--

Second Sight Medical Products, Inc. (NASDAQ:EYES) ("Second Sight" or "the Company"), a developer, manufacturer and marketer of implantable visual prosthetics that are intended to create an artificial form of useful vision to blind patients, today announced that the Company has received full approval from the U.S. Food and Drug Administration (FDA) to begin the Orion™ Cortical Visual Prosthesis System (Orion) feasibility clinical study. The approval allows two U.S. sites, the University of California at Los Angeles (UCLA) and Baylor College of Medicine (Baylor) in Houston, to enroll up to five total patients. Second Sight has also completed the additional device testing and addressed the remaining outstanding questions requested by the FDA in their prior conditional approval announced by the Company on August 28, 2017.

Published: 02 November 2017

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Citius Pharmaceuticals, Inc. Receives "Fast Track" Designation By FDA For Mino-Lok ™ Investigational Trial

CRANFORD, N.J., Oct. 31, 2017 -- Citius Pharmaceuticals, Inc. ("Citius") ("Company") (NASDAQ: CTXR), a specialty pharmaceutical company focused on adjunctive cancer care and critical care drug products, announced today it has received official notice from the U. S. Food and Drug Administration ("FDA") that the investigational program for Mino-Lok™ is designated "Fast Track". Mino-Lok is a catheter lock solution that has entered phase 3 trials for an adjunctive treatment for catheter related blood stream infection ("CRBSI"). Fast Track is a designation by the FDA of an investigational drug to expedite review to facilitate development of drugs which treat a serious or life-threatening condition and fill an unmet medical need.

Published: 31 October 2017

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Nasdaq FDA HC Decision Up on News

Incyte and MacroGenics Announce Global Collaboration and Licensing Agreement for Anti-PD-1 Monoclonal Antibody MGA012

Incyte gains exclusive, worldwide development and commercialization rights to MGA012 in all indications

MacroGenics to receive an upfront cash payment of $150 million plus potential milestone paymentsand royalties, and retains right to develop its pipeline assets in combination with MGA012

WILMINGTON, Del. & ROCKVILLE, Md. -- Incyte Corporation (NASDAQ:INCY) and MacroGenics, Inc. (NASDAQ:MGNX) announced today that the companies have entered into an exclusive global collaboration and license agreement for MacroGenics’ MGA012, an investigational monoclonal antibody that inhibits programmed cell death protein 1 (PD-1). Incyte has obtained exclusive worldwide rights for the development and commercialization of MGA012 in all indications, while MacroGenics retains the right to develop its pipeline assets in combination with MGA012.

Published: 25 October 2017

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Nasdaq Up on News Project Update

Cellect Announces a Major Breakthrough of its ApoGraft ™ Technology: Reporting Today Positive Results from a 20 Patients Trial With Tel-Aviv Ichilov Medical Center

ApoGraft™ significantly improved stem cells derived from fat tissues

Dr. Shai Yarkoni: "This breakthrough finding is increasing our addressable market by an order of magnitude. We can now actively seek strategic alliances for the commercialization of ApoGraft™" in aesthetic medicine as well as orthopedic indications.

TEL AVIV, Israel, Oct 25, 2017 -- Cellect Biotechnology Ltd. (Nasdaq: APOP), a developer of stem cell selection technology, announced today that it has achieved a major milestone with the conclusion of a large study on the use ApoGraft™ on stem cells derived from fat tissues.

Published: 25 October 2017

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Nasdaq Up on News Project Update

Pain Therapeutics Announces Successful Phase I Clinical Study for PTI-125

AUSTIN, Texas, Oct. 24, 2017 -- Pain Therapeutics, Inc. (Nasdaq:PTIE) announced today the completion of a Phase I clinical study for PTI-125, a new experimental drug therapy to treat Alzheimer’s Disease. This study investigated for the first time the safety, dosing and pharmacokinetic profile of PTI-125 in healthy human volunteers.

Summary of Key Findings

PTI-125 was safe and well-tolerated at all doses studied

PTI-125 demonstrated favorable pharmacokinetics for further drug development

"The clinical data are encouraging,” said Remi Barbier, President & CEO of Pain Therapeutics. “Given the absence of dose-limiting effects in healthy adults, an excellent non-clinical safety database, a strong scientific rationale, and multiple peer-reviewed publications and research grant awards, we are eager to move this drug program to the next level of development.”

Published: 24 October 2017

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Nasdaq Up on News Project Update

Second Sight Medical Products ( EYES )

Second Sight Receives Full FDA Approval to Begin First Orion Human Clinical Study

Citius Pharmaceuticals ( CTXR )

Citius Pharmaceuticals, Inc. Receives "Fast Track" Designation By FDA For Mino-Lok ™ Investigational Trial

MacroGenics ( MGNX )

Incyte and MacroGenics Announce Global Collaboration and Licensing Agreement for Anti-PD-1 Monoclonal Antibody MGA012

Cellect Biotechnology ( APOP )

Cellect Announces a Major Breakthrough of its ApoGraft ™ Technology: Reporting Today Positive Results from a 20 Patients Trial With Tel-Aviv Ichilov Medical Center

Pain Therapeutics ( PTIE )

Pain Therapeutics Announces Successful Phase I Clinical Study for PTI-125