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News Breaks
February 5, 2013
07:33 EDTOPXA, MKGAYOpexa Therapeutics, Merck Serono enter into license agreement for Tcelna
Opexa Therapeutics (OPXA) announced the execution of an agreement with Merck Serono, a division of Merck (MKGAY) for the development and commercialization of Tcelna, a potential first-in-class personalized T-cell therapy for patients suffering from multiple sclerosis. Tcelna is being developed by Opexa and currently is in a Phase IIb clinical trial in patients with Secondary Progressive MS. Potential payments to Opexa from the option and license agreement could total $225M based upon the successful development and commercialization of Tcelna for MS. Under the terms of the agreement, Opexa will receive an upfront payment of $5M for granting an option to Merck Serono for the exclusive license of the Tcelna program for the treatment of MS. The option may be exercised prior to or upon completion of Opexa’s ongoing Phase IIb clinical trial in patients with SPMS. Upon exercising this licensing option, Merck Serono would pay an upfront license fee of either $25M or $15M, and in return receive worldwide development and commercial rights to Tcelna in MS, excluding Japan. Additional financial considerations of the agreement include development and commercial milestone payments to Opexa of up to $195M and a tiered royalty rate from the high single digits to the mid-teens based on net sales payable to Opexa.
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September 16, 2014
08:34 EDTOPXAOpexa Therapeutics terminates public offering of common stock
Opexa Therapeutics announced that it has terminated the public offering of shares of its common stock previously announced on Monday, September 15. The termination results from an assessment by Opexa’s management that current market conditions are not conducive for an offering on terms that would be in the best interests of Opexa’s stockholders. As a result of such termination, no shares will be sold pursuant to the offering.
September 15, 2014
16:22 EDTOPXAOpexa Therapeutics files automatic common stock shelf
Aegis Capital Corp. is acting as sole book-running manager in this offering.
September 12, 2014
09:14 EDTMKGAYOn The Fly: Pre-market Movers
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08:39 EDTMKGAYOncothyreon says Merck KGaA discontinues development of tecemotide in NSCLC
Oncothyreon (ONTY) disclosed earlier in a regulatory filing that Merck KGaA (MKGAY), which has world-wide rights for the development and commercialization of tecemotide under a license agreement with Oncothyreon, announced that its biopharmaceutical division will discontinue the clinical development program of the investigational MUC1 antigen-specific cancer immunotherapy as a monotherapy in Stage III non-small cell lung cancer, or NSCLC. The decision to discontinue the current clinical program in NSCLC, which includes the Phase III START2 and INSPIRE studies, follows recent results from a planned analysis of EMR 63325-009, a randomized, double-blind, placebo-controlled Phase I/II study in Japanese patients. Merck Serono has made the decision to discontinue all other Merck Serono-sponsored clinical trials with tecemotide in NSCLC worldwide. Those patients on active treatment with tecemotide can undergo an individual assessment by their treating physician and apply to receive further treatment outside of the studies. Merck Serono will continue to supply tecemotide for ongoing investigator-sponsored trials in other indications in accordance with their agreements with the sponsors of these studies. Shares of Oncothyreon are down 12% in pre-market trading following the news from its partner.
September 8, 2014
07:30 EDTOPXAOpexa Therapeutics to target NMO as next development program
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