Zealand Pharma A/S, of Glostrup, Denmark, filed with the SEC to raise up to $86 million in a U.S. IPO. The number of American depositary shares and share price have not yet been disclosed.
Emmaus Medical Inc.'s pharmaceutical-grade L-glutamine cleared the FDA on its July 7 PDUFA date, becoming the first new treatment for sickle cell disease (SCD) in the U.S. since chemotherapeutic agent hydroxyurea gained approval in 1998, and the first treatment indicated for pediatric patients.
An international research collaboration has found a means to improve the effect of mimetics of the second mitochondrial-derived activator of caspase (Smac), a novel class of targeted cancer drugs that act by inducing apoptotic cancer cell death and inhibiting pro-survival signaling.
An antithrombin-targeting RNAi therapy for hemophilia, fitusiran, developed by Alnylam Pharmaceuticals Inc. with Sanofi Genzyme, is entering phase III territory. The three-part Atlas trial program, in hemophilia A and B, is expected to yield top-line data in mid to late 2019. Its start, just days before results of an ongoing phase II study are scheduled to be detailed at a Berlin medical meeting, triggers a $25 million milestone payment for Alnylam and marks the kick-off of the last leg in a race to approval with Roche Holding AG's bispecific monoclonal antibody emicizumab.
In previous antibiotic drug development, "you would always look for the one molecule and the one dose that you could use for everything," Entasis Therapeutics Inc. CEO Manos Perros told BioWorld. "Maybe that approach has reached its limit."
The sun has been shining on the biopharmaceutical sector of late as investors have returned to the sector big time. As a result, the BioWorld Biopharmaceutical index grew a healthy 6.6 percent in the second quarter, well ahead of the general markets, thanks to a late June spurt in valuations, causing the index to grow 5.8 percent last month.
Although global private biopharmaceutical companies kept up the first-quarter momentum by raising more than $1.8 billion in the second quarter, both deal volume and deal flow dipped. The total was approximately 15 percent less than the Q1 volume and, according to BioWorld data, 70 companies completed transactions in the period compared to 92 that were inked in the first quarter of this year. U.S. biotech companies were involved in 42 of the total transactions and collectively they raised approximately $980 million, compared to $1.4 billion from 46 deals that disclosed financial terms in the first quarter.