The widely expected approval of Sage Therapeutics Inc.'s 60-hour intravenous (I.V.) Zulresso (brexanolone) in postpartum depression (PPD) opens the marketing door to the first therapy approved in the indication and raised investor hopes for Marinus Therapeutics Inc., developing a similar PPD therapy in I.V.-to-oral form as well as an all-oral version.

Urovant Sciences Ltd.'s favorable top-line data from the phase III study called Empowur with vibegron in adults with overactive bladder (OAB) did not bring the stock-boosting effect that some might have expected, as doubters fretted that the once-daily beta-3 adrenergic receptor agonist did not perform well enough relative to generic tolterodine, even though – as J.P. Morgan analyst Eric Joseph pointed out – the latter was not meant for a head-to-head comparison.

Aerpio Pharmaceuticals Inc.'s phase IIb data with AKB-9778 in moderate to severe nonproliferative diabetic retinopathy (NPDR) failed to provide betterment relative to the phase IIa experiment in diabetic macular edema (DME), but CEO Stephen Hoffman noted that the findings were "hot off the press" and the company needs to conduct an internal review, with more detail to come at a scientific meeting.

The prospects of an oral taxane chemotherapy – providing similar efficacy to intravenous (I.V.) with a better toxicity profile – have drawn players to the field that include Odonate Therapeutics Inc. and Athenex Inc., the latter with a phase III trial fully enrolled and the former with a late-stage experiment expected to finish sign-ups in the second half of this year.

As the Philippine Department of Justice (PDOJ) said it found probable cause to indict Sanofi SA and government officials over deaths caused by the Paris-based pharma giant's dengue vaccine, the FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) reviewed the BLA for the product in an uneventful session.

Zafgen Inc. CEO Jeffrey Hatfield said the firm has backup compounds for ZGN-1258 to treat Prader-Willi syndrome (PWS) and "remains committed" to the condition. "We're going to evaluate all of our options to try and unlock potential value we see in methionine aminopeptidase 2 [MetAP2] inhibition for this terrible disease."

Snipr Biome ApS was "flying a little bit under the radar" until the company had "something worth listening to," CEO Christian Grondahl told BioWorld, and the day for talking arrived with the Copenhagen-based company raising $50 million in series A cash.

Cerebral Therapeutics Inc. CEO Dan Abrams told BioWorld that his firm's closing of the $7.8 million extension to its series A financing by Granite Point Capital Management LP and Vivo Capital LLC should "allow us to do a substantial phase II trial" that will bring an epilepsy drug-device combo therapy to the next level.

As the Philippine Department of Justice (PDOJ) said it found probable cause to indict Sanofi SA and government officials over deaths caused by the Paris-based pharma giant's dengue vaccine, the FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) reviewed the BLA for the product in an uneventful session.