Biondvax Pharmaceuticals Ltd., of Ness Ziona, Israel, said the Israel Innovation Authority agreed to fund up to 40 percent of a NIS2.7 million (US$750,000) budget toward ongoing development of M-001, the company's universal flu vaccine candidate. In six previously completed human trials, including the recently finished phase IIb experiment in Europe, M-001 was shown to be safe and immunogenic toward multiple flu strains. Including today's grant approval, since 2006 the authority has granted over US$6 million in funding to Biondvax. The non-dilutive grants will become repayable from royalties generated from sales of Biondvax's vaccine, once commercially available, the company said.

Biotime Inc., of Alameda, Calif., said it has received a grant of about $2 million for 2017 from the Israel Innovation Authority. The funding will support the development program for Opregen for dry age-related macular degeneration; the agency has awarded about $12 million in annual funding to date. Opregen is in a phase I/IIa dose-optimization trial and the data safety monitoring board has granted authorization for the company to move forward to enroll participants in cohort 3. Sites will be located in the U.S. and Israel. Biotime said it anticipates sharing data at a meeting of the American Academy of Ophthalmology later this year.

Crescita Therapeutics Inc., of Mississauga, Ontario, signed an amended loan agreement with Knight Therapeutics Inc., of Montreal. On Sept. 1, 2016, Crescita acquired 100 percent of the equity of Intega Skin Sciences Inc., of Laval, Quebec, and assumed about $6.8 million (currently $6.6 million of principal outstanding) of an Intega loan from Knight, which was secured by a letter of credit issued by a Canadian chartered bank on the company's behalf. The letter of credit was secured by cash held in the company's account with the bank. Under the terms of the amended loan agreement, Crescita will immediately repay $2.5 million of the loan (reducing the principal amount to $4.1 million) and Knight has agreed to release the letter of credit in exchange for a general security interest over all of Crescita's assets. As a result, the company now has access to $6 million more (after the repayment), money that was previously restricted under the terms of the letter of credit. The loan continues to bear interest at 9 percent per annum and matures on Jan. 22, 2022.

Emisphere Technologies Inc., of Roseland, N.J., reported that it plans to file a form 15 with the SEC, on Aug. 14, to voluntarily terminate any obligations to report under Securities Exchange Act of 1934. The company's obligations will be suspended immediately, and after 90 days, Emisphere will not have to follow SEC filing rules as long as the company has fewer than 500 holders of record. In addition, the Sarbanes-Oxley Act of 2002 will no longer apply to the company.

Fortress Biotech Inc., of New York, said it launched a new subsidiary, Aevitas Therapeutics Inc. The new company's goal is to develop gene therapy approaches for complement-mediated diseases using a technology that has been licensed from a leading university. The technology uses adeno-associated virus-based gene therapy to restore production of functional complement regulatory proteins, providing a potentially curative treatment.

H3 Biomedicine Inc., a Cambridge, Mass.-based subsidiary of Eisai Inc., gained FDA orphan status for H3B-8800 for the treatment of patients with acute myelogenous leukemia and chronic myelomonocytic leukemia. The company is testing the oral, small-molecule modulator of wild-type and mutant SF3b complexes in phase I trials.

Lipocine Inc., of Salt Lake City, said the FDA acknowledged receipt of its NDA resubmission for Tlando to be used as a testosterone replacement therapy in adult males for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism. The resubmission includes data from Lipocine's Dosing Validation study to address deficiencies related to the dosing algorithm raised in a June 2016 complete response letter from the agency. The FDA gave the application a Prescription Drug User Fee Act goal date of Feb. 8, 2018.

Prometic Life Sciences Inc., of Laval, Quebec, finalized a joint venture with affiliates of Shenzhen Royal Asset Management Co. Ltd. (SRAM) that will earmark $33 million to fund ongoing clinical development of PBI-4050, PBI-4547 and PBI-4425, products for which Prometic has licensed Chinese development and commercialization to an SRAM affiliate. Prometic is also licensing development, manufacturing and commercialization rights for the same products for pulmonary and liver fibrosis to a new subsidiary. The subsidiary will receive $23 million of the committed funds on Prometic's behalf before the end of this year. Follow-on tranches are expected in 2018. SRAM's ownership in Prometic Chinaco, the temporary name for the subsidiary, would increase up to 25 percent when all funds are received. Prometic Chinaco controls the bulk manufacturing of the products which it will exclusively supply to sublicensees in China. It also stands to receive royalties for the net sales of the products in the future.

Saniona AB, of Copenhagen, Denmark, and Cambridge, Mass.-based Luc Therapeutics Inc. have started preclinical development for CAD-1883, a potential treatment for ataxia with the aim of initiating phase I trials in 2018. Luc will be responsible for further development of compounds identified under the ataxia program. Should it choose to commercialize any, Saniona, a Luc shareholder, has rights to royalties on any resulting products.

Sinovac Biotech Ltd., of Beijing, reported that Nasdaq has granted the company an exemption from a listing rule to allow it extra time to file its 2016 annual report on form 20-F while it conducts an internal investigation into complaints lodged against the company and its sales practices and policies. The market extended the deadline for complying with the rule until Oct. 30.

Soligenix Inc., of Princeton, N.J., said the National Institute of Allergy and Infectious Diseases, part of the NIH, exercised an option to fund good manufacturing practices-compliant Rivax (ricin toxin vaccine) bulk drug substance and finished drug product manufacturing, which is required for the conduct of future preclinical and clinical safety and efficacy studies. The overall objectives of the contract are to advance the development of Soligenix's thermostabilization technology, Thermovax, in combination with Rivax, as a medical countermeasure to prevent the effects of ricin exposure. The exercised option provides about $2.5 million in additional non-dilutive funding, bringing the total amount awarded to date under this contract to $21.2 million. If all contract options are exercised, the total award of up to $24.7 million will support the preclinical, manufacturing, and clinical development activities necessary to advance heat stable Rivax with the FDA, Soligenix said.