→ Another round of leadership changes is taking place at Intrexon $XON: retired lieutenant general Thomas Bostick is slated to replace COO Andrew Last; Teva vet Nir Nimrodi has been promoted as chief business officer; and Helen Sabzevari is taking the helm of Precigen as president of the subsidiary. This marks the latest move by hands-on billionaire backer and CEO Randal “RJ” Kirk, after the high profile departure of then-president Gene Germano in March. “A more streamlined senior management structure is in line with our transition to a group of related and increasingly commercially oriented enterprises,” Kirk said in a statement.
→ Denali is eyeing a price between $17 and $19 per share for its IPO, bumping the maximum take to $182 million for a total of 8,333,333 shares that they are selling. That’s up from the $100 million the startup had pencilled in earlier this month, though they are estimating a more modest $136 million, according to the amended S-1. As previously announced, the neurodegeneration-focused biotech will list on NASDAQ as $DNLI. At the end of September, it had $190.8 million in cash, cash equivalents and marketable securities. The extra cash will help move Denali’s six core and five seed programs forward, the most advanced of which is still in Phase I development.
→ Bayer said over the holiday weekend that its global Phase III clinical study of Amikacin Inhale — in addition to standard of care in intubated and mechanically ventilated patients with Gram-negative pneumonia — flopped in comparison to standard of care and aerosolized placebo. Amikacin Inhale is the development name of an integrated drug-device combination, consisting of a specially formulated Amikacin Inhalation Solution and a proprietary Synchronized Inhalation System with a vibrating mesh nebulizer.
→ In a label update for its hemophilia B drug Alprolix, Bioverativ $BIVV is highlighting data that shows the treatment to be effective in bleed protection among children as well as adults. The new label, based on interim data from the Phase III B-YOND trial and final data from Kids B-LONG study, reflects the results of prophylactic treatment of 93 subjects for more than 104 weeks. Said EVP and chief global therapeutics operations officer Rogerio Vivaldi: “Alprolix has the most clinical trial experience of any hemophilia B extended half-life therapy on the market, and in the three years since approval, we have continued to observe low overall bleed rates, as well as low spontaneous and joint bleeds with extended prophylactic dosing across all populations,” It’s not all rosy, though; among the updates is also obstructive uropathy as a common adverse reaction to the drug.
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