Shares in Ardelyx Inc. have crashed after its tenapanor, under FDA review for managing phosphate levels in chronic kidney disease (CKD), ran into trouble with the regulator. The company said that the FDA has identified “deficiencies” in the data package, which prevent discussions about labeling and postmarketing commitments. Shares in the biotech were down more than 73% in premarket trading on the Nasdaq to $2.13 following the announcement late July 19 and continued ticking down when trading resumed July 20.
$135M series C fuels Amylyx work with late-stage ALS prospect
Amylyx Pharmaceuticals Inc. pulled down an oversubscribed, $135 million series C financing led by Viking Global Investors to support development and potential launch plans for lead candidate AMX-0035 for amyotrophic lateral sclerosis (ALS). The Cambridge, Mass.-based company filed a new drug submission with Health Canada in June and aims to submit for approval by the end of this year in the EU. In the U.S., plans are in the works for a phase III trial with AMX-0035, made of sodium phenylbutyrate and taurursodiol. The compound targets endoplasmic reticulum and mitochondrial-dependent neuronal degeneration pathways in ALS and other neurodegenerative diseases.
Panakès Partners banks $177M at first close of second fund
DUBLIN – Panakès Partners SGR SpA has raised €150 million (US$177 million) in a first close of its second fund and is looking to secure a final tally of €180 million by year-end. That would represent more than twice the size of its first fund of €80 million and reflects its move into therapeutics investing.
Rivus Pharmaceuticals raises $35M to pursue mitochondrial uncoupling for cardiometabolic disease
Rivus Pharmaceuticals Inc. has emerged from stealth and disclosed a $35 million series A round to fund development of its pipeline of “controlled metabolic accelerators,” or CMAs, for treating cardiometabolic diseases. The Charlottesville, Va.-based firm already has a lead program in the clinic and is planning to move that asset, HU-6, into a range of large-scale indications in the near future and to bring forward additional molecules from its discovery platform as well. “We have identified close to 100 other CMAs with our platform,” CEO and co-founder Allen Cunningham told BioWorld.
Cyber threats: Enough is enough, nations tell China
Following the 2010 theft of $60 million worth of pharmaceuticals from an Eli Lilly and Co. warehouse in Connecticut, biopharma companies ramped up their security measures with several of them hiring experts from Interpol and other international law enforcement agencies. A decade later, large biopharma and med-tech companies are having to fend off a more pervasive kind of thief who can cripple their global operations or stealthily steal valuable research and trade secrets with a few clicks on a computer located thousands of miles away. Responding to the growing risk of cyber threats to health care and other key sectors, the EU, U.K., U.S. and other NATO allies issued statements July 19 laying out expectations and markers for how responsible nations behave in cyberspace and calling out China’s “malicious cyber activity.”
Junshi and Immorna launch JV to develop mRNA therapeutics and vaccines
Junshi Biosciences Co. Ltd. entered an agreement with Immorna Biotechnology Co. Ltd. to establish a joint venture (JV) as part of its efforts to expand into the mRNA sector. “The JV company will mainly engage in the R&D, clinical research, application for approval, production and commercialization of product development projects in the fields of cancer, infectious diseases, rare diseases and other diseases agreed by both parties on the mRNA technology platform in the JV territory,” which involves global coverage, a Junshi Biosciences spokesperson told BioWorld. Under the terms of the agreement, Shanghai-based Junshi Biosciences will invest no more than ¥799 million (US$123.2 million) in cash into the joint venture, named Shanghai Junshi Xihai Biotechnology Co. Ltd. The initial investment is ¥200 million, of which ¥50 million will be used to subscribe to 50% of the registered capital of the JV, while the subsequent milestone contribution is no more than ¥599 million.
Preclinical data: Immunome’s cocktail holds delta variant at bay
Preclinical pseudovirus testing from Immunome Inc. showed that its three-antibody cocktail demonstrated neutralizing activity against the SARS-CoV-2 Delta variant. The cocktail, IMM-BCP-01, also demonstrated in vitro activity through non-neutralizing mechanisms, the company added, including complement fixation. IMM-BCP-01 contains three monoclonal antibodies that bind to non-overlapping regions of the spike protein with picomolar affinity. Immunome received $17.6 million technology from the U.S. Department of Defense's Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense and the Defense Health Agency to bolster Immunome’s COVID program. The Exton, Pa.-based company’s stock (NASDAQ:IMNM) jumped 17% on the data at midday.
Eluminex brings in late-stage biosynthetic cornea from Fibrogen in $108M deal
In a deal worth up to $108 million, ophthalmic startup Eluminex Biosciences Ltd. has licensed the global rights to Fibrogen Inc.’s biosynthetic cornea derived from recombinant human collagen (RHC) type III intended to tackle corneal blindness. Eluminex will pay $8 million up front to Fibrogen, which may also receive up to $64 million in future manufacturing, clinical, regulatory and commercial milestone payments, plus $36 million in commercial milestones for the first recombinant collagen III product that is not the biosynthetic cornea. With global rights under its belt, Eluminex plans to move the RHC-based biosynthetic cornea, known as EB-301 in its pipeline, to a clinical market authorization registration study in China in the second half of 2022.
Cellares launches Cell Shuttle partnership
Cellares Corp. added Poseida Therapeutics Inc. to its expanding early access partnership program (EAPP) for the company's Cell Shuttle, a highly specialized "factory in a box" solution for development of cell therapies. Poseida brings two autologous CAR T product candidates to the program and joins Pact Pharma and Fred Hutchinson Cancer Research Center in the EAPP.
U.S. drug distributors settle opioid suit for $1.2B
Three of the largest biopharma distributors in the U.S. agreed to a settlement of nearly $1.2 billion with New York, bowing out of the state’s ongoing opioid lawsuit. Under the settlement announced July 20, Amerisource Bergen Drug Corp., Cardinal Health Inc. and McKesson Corp. will pay a total of $1.179 billion, with more than $1 billion to go toward the state’s opioid abatements costs. Beginning in two months, the payments will be extended over 17 years, according to the New York Attorney General’s Office. The agreement leaves Endo Health Solutions, Teva Pharmaceuticals USA and Allergan Finance as the only defendants still in the lawsuit.
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