Analysts voiced no little skepticism in 2014 when Celgene Corp. acquired privately held Nogra Pharma Ltd. to get its hands on GED-0301 (mongersen), a phase III-ready, oral antisense DNA oligonucleotide targeting the Smad7 protein to treat moderate to severe Crohn’s disease (CD) and related indications.
A month ahead of schedule, Yescarta (axicabtagene ciloleucel, previously KTE-C19) gained a nod from the FDA, representing the second chimeric antigen receptor (CAR) T-cell therapy approved by the agency and the first for certain types of non-Hodgkin lymphoma (NHL).
Privately held Vir Biotechnology Inc. left no doubt about its intent to take a starring role in infectious diseases by initiating broad deals in the space with Alnylam Pharmaceuticals Inc. and Visterra Inc. Both partners are set to receive undisclosed up-front payments along with more than $1 billion apiece in potential milestone payments.
Immune Design Corp. said the FDA blessed its plans to initiate a pivotal phase III of CMB-305, its prime-boost vaccine approach against NY-ESO-1-expressing tumors, in individuals with locally advanced unresectable or metastatic synovial sarcoma, a subtype of soft tissue sarcoma.
Privately held Hemoshear Therapeutics LLC signaled its intention to compete both with small peers and big biopharma in the race to develop therapies for liver diseases, especially nonalcoholic steatohepatitis (NASH), by luring Takeda Pharmaceutical Co. Ltd. to a funded three-year discovery and development pact.
Symbiomix Therapeutics LLC, which saw its single asset, Solosec (secnidazole, previously SYM-1219), approved by the FDA last month to treat bacterial vaginosis (BV), agreed to a buyout by Lupin Inc., the U.S. subsidiary of Mumbai-based Lupin Ltd., for $150 million, including $50 million up front. Lupin, which has a global presence but focuses largely on generics, earlier this year took an option to acquire privately held Symbiomix, which specialized in therapies to treat gynecologic infections.
Considering that Chicago isn’t exactly a breeding ground for biopharma, Exicure Inc. already had defied expectations by raising more than $42 million since its inception in 2011 as Aurasense Therapeutics LLC and attracting the attention of tech and business notables such as Microsoft Corp. co-founder and philanthropist Bill Gates.
Spruce Biosciences Inc. landed a $20 million series A last year but kept the financing under wraps, waiting for its only asset, SPR-001, to achieve its first clinical milestone. With a phase II study now testing the small molecule in adults with congenital adrenal hyperplasia (CAH), the San Francisco-based company opted to shed a bit of light on its strategy.
Symbiomix Therapeutics LLC, which saw its single asset, Solosec (secnidazole, previously SYM-1219), approved by the FDA last month to treat bacterial vaginosis (BV), agreed to a buyout by Lupin Inc., the U.S. subsidiary of Mumbai-based Lupin Ltd., for $150 million, including $50 million up front. Lupin, which has a global presence but focuses largely on generics, earlier this year took an option to acquire privately held Symbiomix, which specialized in therapies to treat gynecologic infections.
Shares of Kalvista Pharmaceuticals Inc. (NASDAQ:KALV) soared to $15.80 – the high water mark since the company's reverse merger last year with Carbylan Therapeutics Inc. – and closed at $10.19 for a gain of $2.81 after Merck & Co. Inc. agreed to pay a $37 million nonrefundable up-front fee and up to $715 million in milestone payments as part of a collaboration to advance KVD-001, an intravitreal (IVT) injection candidate to treat diabetic macular edema (DME).
