Amgen Inc. is paying $3.7 billion in cash to buy Chemocentryx Inc. The deal, with Amgen paying $52 per share for Chemocentryx stock, brings Amgen Tavneos (avacopan), a first-in-class medicine for treating antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis, which destroys small blood vessels. The deal comes less than a year after Tavneos was approved by the U.S. FDA. Tavneos is the first new therapy approved for ANCA-associated vasculitis in more than a decade and it was Chemocentryx’s first-ever approval. The agency cleared the oral, small-molecule C5aR antagonist in October 2021 as an adjunct therapy for adults with the two main forms of the rare autoimmune renal disease, granulomatosis with polyangiitis and microscopic polyangiitis in combination with standard therapy. The acquisition prompted San Carlos, Calif.-based Chemocentryx’s stock (NASDAQ:CCXI) to more than double during midday trading. Shares were up 109% to about $50.40 each.

Gilead buys UK immunology biotech Mirobio for $405M

Gilead Sciences Inc. has bought the privately owned U.K. biotech Mirobio Ltd., paying $405 million for the Oxford-based firm and its checkpoint agonists to treat autoimmune diseases. Gilead, of Foster City, Calif., will acquire Mirobio’s discovery platform and entire portfolio of immune inhibitory receptor agonists. Mirobio’s lead investigational antibody, MB-272, is a selective agonist of immune inhibitory receptor B- and T-Lymphocyte Attenuator (BTLA) and has entered phase I trials, with the first patient dosed earlier this week.

F2G pads coffers with $70M as novel antifungal approaches finish line

F2G Ltd. has raised a further $70 million in venture capital as it continues preparations to submit a new drug application to the U.S. FDA for its novel antifungal drug, olorofim, before the end of 2022. The fresh injection of capital comes less than three months after Manchester, U.K.-based F2G reached an agreement with Shionogi & Co. Ltd. for the development and commercialization of the treatment for invasive aspergillosis in Asia and Europe. The Japanese pharma paid $100 million up front as part of the $480 million deal.

Sironax raises $200M in series B for RIPK1 inhibitors

Sironax Ltd. has raised $200 million in a series B financing round to support the development of its receptor-interacting serine/threonine-protein kinase 1 (RIPK1) inhibitors. The latest financing has brought the capital raised by the Beijing and Shanghai-based company to more than $300 million to date. Participation in the round comes from a mix of new and existing investors.

Blueprint, others busy in EGFR exon 20 NSCLC; phase II Pioneer data due soon in ISM

With data due this summer from the phase II Pioneer trial testing Blueprint Medicines Corp.’s approved Ayvakit (avapritinib), many investor eyes are on the potential label expansion into indolent systemic mastocytosis (ISM) – but the company has another potential ace in the hole with BLU-451, which targets EGFR exon 20 insertion mutations in non-small-cell lung cancer. Blueprint in June 2021 won the U.S. FDA’s nod for KIT inhibitor Ayvakit to treat advanced SM. For the first time, patients had available a targeted therapy designed to block D816V mutant KIT, the main driver of the disease. Cambridge, Mass.-based Blueprint first won approval in January 2020 for the drug, a tyrosine kinase inhibitor that targets PDGFRA and PDGFRA D842 mutants as well as multiple KIT exon 11 and 17 mutants, to treat PDGFR-alpha exon 18 mutant gastrointestinal stromal tumors. If the Pioneer effort achieves its goals, Ayvakit’s label may widen even further, into the potentially highly bankable ISM. Meanwhile, the exon 20 space, though, has been steadily heating up.

Positive news for Amylyx as it prepares for adcom redux

Amylyx Pharmaceuticals Inc. got good news today when the Institute for Clinical and Economic Review (ICER) posted a revised evidence report assessing the comparative clinical effectiveness and value of the company’s AMX-0035 and Mitsubishi Tanabe Pharma America Inc.’s Radicava (edaravone) in treating amyotrophic lateral sclerosis (ALS). Unlike current ALS treatments approved in the U.S. that largely focus on supportive treatment, ICER found that AMX-0035 “appears to extend life and modestly slow disease progression,” providing a small to substantial benefit. However, ICER noted the regulatory uncertainty that overhangs the drug as it faces a second U.S. FDA advisory committee meeting next month, after getting a negative 6-4 vote at its first adcom in March.

Biopharma financings return to pre-pandemic levels

The amount of money raised by biopharma companies so far this year is down by 59% in comparison with last year, and there are 42% fewer transactions. The $33.3 billion brought in through 589 financings in 2022 is much more in line with the pre-pandemic year of 2019 when $34.8 billion through 639 financings were completed through the end of July. But it is way down from the $80.8 billion (1,023 financings) in the first seven months of 2021 and the $80.4 billion (930 financings) during the same timeframe in 2020. Both are record-breaking years for biopharma financings.

Tillis takes another crack at patent subject matter impasse

Makers of biotech therapies and in vitro diagnostics may be understandably weary of hearing about patent subject matter eligibility under Section 101 of the Patent Act, but Sen. Thom Tillis (R-N.C.) is prepared to take another swipe at the problem. Tillis announced Aug. 3 that the Patent Eligibility Restoration Act of 2022 is intended to reverse some of the deleterious effects of Supreme Court jurisprudence on Section 101 questions, a proposal that may be the last, best chance to address what many believe is a fundamentally broken judicial understanding of subject matter eligibility.

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AC Immune, Acurx, Aerie, Alnylam, Ampio, Amylyx, Anheart, Antengene, Ascletis, Avenge, Cardiol, Cassava, Coherus, Cornerstone, Eisai, Eureka, Helixmith, Innocare, Kazia, Kintor, Landos, Lynk, Maia, Marius, Mediwound, Merck, Merrimack, Mymd, Olix, Pfizer, Poseida, Profoundbio, Regeneron, Regenxbio, Renovion, Sciwind, Sinovac, Sorrento, ST Pharm, Sumitomo, Tevogen, Tikomed, Timber, TME, Vaxess, Volitionrx, Xenetic, Zyversa