CAMBRIDGE, MASSACHUSETTS--(Aug. 30, 2017) -

Sci-B-Vac® is a third-generation hepatitis B vaccine, approved for use in Israel and 14 other countries

VBI expects to initiate enrollment in a Phase 3 clinical program later in the second half of 2017 in the U.S., Europe and Canada

VBI Vaccines Inc. (NASDAQ:VBIV)(TSX:VBV) (VBI) today announced that the U.S. Food and Drug Administration (FDA) has accepted the company's Investigational New Drug Application (IND) for a Phase 3 clinical program evaluating Sci-B-Vac®, VBI's third-generation hepatitis B vaccine. The company had previously received a No Objection Letter (NOL) from Health Canada in response to its Clinical Trial Application (CTA) as well. Acceptance of the IND and CTA enable the company to initiate the Phase 3 clinical study in both the U.S. and Canada.

HOUSTON, TX--(August 29, 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 filed with the Food and Drug Administration (FDA) an Investigational New Drug (IND) application to study Annamycin in the treatment of relapsed or refractory acute myeloid leukemia (AML).

 

Submitting this revised IND marks a significant milestone for Moleculin. FDA allowing the IND to go into effect -- which is the anticipated next step and normally would occur within 30 days -- will allow the Company to begin additional clinical trials as part of demonstrating the safety and effectiveness of Annamycin. The current plan is to seek approval for treating relapsed or refractory acute myeloid leukemia. If the IND goes into effect as planned, the Company expects to begin clinical trials during the fourth quarter of this year. There can be no assurance, however, that the IND will go into effect within in expected time frame, or at all.

Strengthens Jazz hematology/oncology portfolio with options for innovative development candidates IMGN779 and IMGN632

 

ImmunoGen to receive a $75 million upfront payment, up to $100 million in research support, a co-commercialization option, and potential future opt-in fees, milestones and royalties ----- ImmunoGen conference call to be held today at 8:00 AM EDT; Jazz conference call to be held today at 4:30 PM EDT

 

DUBLIN & WALTHAM, Mass. --  Jazz Pharmaceuticals plc (Nasdaq: JAZZ) and ImmunoGen, Inc. (Nasdaq: IMGN) today announced that the companies have entered into a collaboration and option agreement granting Jazz Pharmaceuticals exclusive, worldwide rights to opt into development and commercialization of two early-stage, hematology-related antibody-drug conjugate (ADC) programs, as well as an additional program to be designated during the term of the agreement. The programs covered under the agreement include IMGN779, a CD33-targeted ADC for the treatment of acute myeloid leukemia (AML) in Phase 1 testing, and IMGN632, a CD123-targeted ADC for hematological malignancies expected to enter clinical testing before the end of the year.

-- Immediately Positions Gilead as a Leader in Cell Therapy --

-- Kite’s Lead CAR T Therapy Candidate, Axicabtagene Ciloleucel, Under Priority Review in the U.S. and Expedited Review in the EU --

-- Provides Broad Pipeline in Hematologic Malignances and Solid Tumors and Robust Platform for Continued Innovation --

-- Leverages Gilead’s Expertise in Rapidly Advancing Therapies to Address Unmet Patient Needs --

 

FOSTER CITY, Calif. & SANTA MONICA, Calif. -- Gilead Sciences, Inc. (Nasdaq: GILD) and Kite Pharma, Inc. (Nasdaq: KITE) announced today that the companies have entered into a definitive agreement pursuant to which Gilead will acquire Kite for $180.00 per share in cash. The transaction, which values Kite at approximately $11.9 billion, was unanimously approved by both the Gilead and Kite Boards of Directors and is anticipated to close in the fourth quarter of 2017. The transaction will provide opportunities for diversification of revenues, and is expected to be neutral to earnings by year three and accretive thereafter.