Aimmune Therapeutics announced that the New England Journal of Medicine has published the full results of the landmark phase 3 PALISADE clinical trial of AR101, Aimmune's investigational biologic oral immunotherapy for desensitization of patients with peanut allergy. PALISADE is the largest and first successful phase 3 peanut allergy immunotherapy trial to date. As reported in the NEJM article, "AR101 Oral Immunotherapy for Peanut Allergy,"1 PALISADE met its primary endpoint and key secondary endpoints. In the trial's primary analysis of peanut-allergic children and adolescents ages 4-17, AR101 treatment resulted in a significant increase in the amount of peanut protein tolerated, compared to placebo. The increase, which was measured through a series of doses in an exit food challenge, suggests that AR101-treated patients could expect to have protection against reactions to accidental peanut exposures. In a real-world translation of the amounts of peanut protein tolerated, 67% of AR101 patients tolerated a single dose of at least 2 peanuts; among AR101 patients who completed the trial, 85% tolerated this level, which is equivalent to 3-4 peanuts of total exposure. Also, 50% of AR101 patients tolerated the highest challenge level, a single dose equivalent to 3-4 peanuts. AR101 treatment also resulted in a reduction in the number and severity of reactions in the exit food challenge, compared to placebo. In the exit challenge,10% of AR101 patients received epinephrine, and the median dose at which it was given was 1,000 mg of peanut protein, compared to 53% of placebo patients at a median dose of 100 mg. This corresponds to an overall 81% reduction in epinephrine use in AR101 patients across all levels of the exit challenge, with a 99% reduction at the 300-mg level and a 94% reduction at the 600-mg level. AR101 demonstrated a favorable safety profile in the highly atopic patient population enrolled in PALISADE. Treatment-emergent adverse events occurred in more than 95% of patients in both trial groups, and nearly all were mild or moderate in severity. In AR101 patients who experienced treatment-related adverse events, 2.4% experienced severe adverse events and 1.1% experienced serious adverse events. Epinephrine was used for severe adverse events in two patients, one of which was the single case of anaphylaxis in the trial.

Sonoma Pharmaceuticals announced the pricing of a "best efforts" public offering of units consisting of one share of common stock, together with one half of one warrant to purchase one share of common stock at an exercise price equal to $1 per whole share. The public offering price was $1 per unit. The offering is expected to close on or about November 21, 2018, subject to customary closing conditions. Certain investors, who would beneficially own, together with its affiliates and certain related parties, more than 4.99% of the outstanding common stock as a result of the public offering, can purchase series C convertible preferred stock convertible into shares of common stock, in lieu of purchasing common stock.

Motorola Solutions announced that the U.S. International Trade Commission has issued a Notice of Final Determination confirming that certain Hytera Communications products are infringing four Motorola Solutions patents. The ITC has also issued exclusion and cease-and-desist orders for Motorola Solutions' U.S. Patent Nos. 7,369,869, 7,729,701 and 8,279,991, prohibiting Hytera from importing products into the United States and selling or marketing those products. The ITC also rejected Hytera's request to allow it to import infringing products or components into the U.S. to repair or replace those in the field. The ruling also affirms Administrative Law Judge McNamara's finding that Hytera "unquestionably copied certain of Motorola patented technologies." A mandatory 60-day presidential review period has now begun, during which the U.S. President may modify the ITC's Final Determination. The ITC's exclusion and cease-and-desist orders will take effect on approximately Jan. 15, 2019, when all Hytera products infringing Motorola Solutions' '869, '701 and '991 patents would be excluded from the U.S. market. In addition to the ITC victory, Motorola Solutions recently prevailed against Hytera in the Regional Court of Mannheim in Germany in a similar patent infringement case. Motorola Solutions will also continue to vigorously pursue its patent infringement, copyright infringement and trade secret theft lawsuits against Hytera in the U.S. District Court for the Northern District of Illinois, the Regional Court of Dusseldorf in Germany, the Federal Court of Australia and other jurisdictions around the world.