Israel's Protalix Biotherapeutics Inc., the first company to gain FDA approval for a protein therapy produced by plant cell cultures in 2012, has moved one step closer to seeking FDA approval for a second such product with new phase III data supporting its experimental therapy for Fabry disease.

Eli Lilly and Co.'s $1.48 billion acquisition of Armo Biosciences Inc., intended to broadly bolster its immuno-oncology program, fell short of that goal in its first big test, a phase III trial in second-line pancreatic cancer called Sequoia.

BEIJING – Cell therapies specialist Nanjing Iaso Biotherapeutics Co. Ltd. became the latest Chinese biotech to enter the country's fierce CAR T race, after China regulators granted an IND approval to CT-103A, a fully-human BCMA CAR T for treating relapsed or refractory multiple myeloma.

HONG KONG – South Korea's Helixmith Co. Ltd. has announced the results of a phase III trial extension testing VM-202 (donaperminogene seltoplasmid), a regenerative plasmid DNA gene therapy candidate, in diabetic peripheral neuropathy (DPN). But, while the Seoul-based company, formerly known as Viromed, said VM-202 met the primary safety and secondary efficacy endpoints for a DPN therapy at 12 months, investors are doubting that the results are trustworthy.

Top-line data from Relmada Therapeutics Inc.'s phase II study of REL-1017 (dextromethadone) in patients with treatment-resistant depression caused the stock to more than double Tuesday, a great day on the market.

Reata Pharmaceuticals Inc.'s surprise victory in the pivotal, second part of the phase II study called Moxie with Nrf2 activator omaveloxolone in patients with Friedreich's ataxia (FA) energized Wall Street and sharpened appetites for data due shortly with another candidate in the class, bardoxolone methyl, in the works for Alport syndrome (AS).

PERTH, Australia – Following stunning interim clinical results for its Celgro nerve regeneration treatment in quadriplegic patients, regenerative medicine company Orthocell Ltd. will focus all its efforts on gaining early FDA approval based on the early results.

The first patients have been treated in Kodiak Sciences Inc.'s phase II DAZZLE trial of anti-VEGF antibody biopolymer conjugate KSI-301 in patients with treatment-naïve wet age-related macular degeneration. At least 368 patients worldwide are expected to enroll in the study. The primary endpoint will be assessed at one year and each patient will be treated and followed for two years.

Something of a duel may be shaping up between Menlo Park, Calif.-based Adverum Biotechnologies Inc. with ADVM-022, the phase I gene therapy candidate for wet age-related macular degeneration (AMD) and Regenxbio Inc., of Rockville, Md., with a similar candidate.