With an FDA approval fresh in their pocket, Sanofi SA and Astrazeneca plc said they plan to launch their respiratory syncytial virus (RSV) drug, Beyfortus (nirsevimab), in the U.S. ahead of the upcoming 2023-2024 RSV season. The FDA approved the prophylactic today, making it the first monoclonal antibody to prevent RSV lower respiratory tract disease in all infants through their first RSV season. It also is indicated in children up to 24 months of age who are vulnerable to severe RSV disease through their second RSV season. Although Beyfortus is not a vaccine, the FDA told its Antimicrobial Drugs Advisory Committee last month that the CDC and its Advisory Committee on Immunization Practices would develop the guidelines for using nirsevimab if it were approved.

Bridgebio’s acoramidis wows in phase III; NDA expected by year-end

Shares of Bridgebio Pharma Inc. (NASDAQ:BBIO) were trading up more than 80% at midday on 30-month data from its phase III Attribute-CM study testing acoramidis in transthyretin amyloid cardiomyopathy, which met the primary endpoint, defined as a hierarchical analysis prioritizing all-cause mortality, frequency of cardiovascular-related hospitalization, change from baseline in NT-proBNP and six-minute walk test, with a win ratio assessment of 1.8. The company, which anticipates filing an NDA with the U.S. FDA by year-end 2023, is banking on the totality of the data as it goes up against Pfizer Inc.’s approved tafamidis drugs, with another potential competitor, Alnylam Pharmaceuticals Inc.’s patisiran, under FDA review.

Handsome deals inked by Sangamo/Lilly ($1.19B), Mirum/Travere ($445M)

Sangamo Biosciences Inc. signed a global, potential $1.19 billion pact with Eli Lilly and Co. subsidiary Prevail Therapeutics Inc. whereby Prevail gains rights to evaluate adeno-associated virus capsids and may exercise options to license them for multiple undisclosed neurological targets. If Prevail pulls the trigger on its option for all targets, and if a product is approved in the U.S. as well as Europe for each target, Sangamo would bank fees and development milestone payments of about $415 million, plus as much as about $775 million if commercial goals are met, along with royalties. Separately, Mirum Pharmaceuticals Inc. and Travere Therapeutics Inc. sealed an arrangement whereby the former is buying for $445 million the latter’s bile-acid product portfolio, including rare-disease medicines Cholbam (cholic acid) and Chenodal (chenodiol).

Dtx brings siRNA candidates to Novartis in deal worth up to $1B

Novartis AG just added muscle to its siRNA development effort by buying Dtx Pharma Inc. in a deal that could total $1 billion. Novartis is getting a preclinical asset, DTx-1252, which just received the U.S. FDA’s orphan drug designation on June 8. Dtx is developing the siRNA candidate for treating the neuromuscular disease Charcot-Marie-Tooth disease type 1A. Novartis will pay Dtx $500 million up front and make payments of up to $500 million in milestones completions. Novartis is also getting two other early-stage programs in neuromuscular and CNS indications. The deal closely follows Novartis’ June deal to buy precision medicines drug developer Chinook Therapeutics Inc., for up to $3.5 billion.

Newco news: Glycocore seeking €10M to advance Hylach technology

Newco Glycocore Pharma Srl is setting out to raise €10 million (US$11.2 million) in a series A round to take a novel approach to treating inflammatory respiratory diseases into the clinic, starting with a phase I/Ib trial in idiopathic pulmonary fibrosis. The underlying technology, called Hylach, involves the modification of the biopolymer hyaluronic acid by conjugating a galactose moiety to the amino group of the polymer chain. The galactose binds galectin-3, a proinflammatory lectin with diverse functions in different tissues that is thought to maintain the fibrotic state in respiratory disorders including IPF and chronic obstructive pulmonary disease.

Camurus’ acromegaly drug’s appeal grows on strong phase III readout

Camurus AB’s subcutaneous octreotide hydrochloride injection pen, CAM-2029, yielded statistically significant improvements in “multiple endpoints” in a 52-week phase III extension trial in patients with acromegaly, moving it closer to providing a more convenient treatment option for patients with the rare, chronic growth disorder than currently available therapies. The study enrolled 135 adults with the disease, 54 of whom had been rolled over from the company’s previous, 24-week randomized trial, Acroinnova 1, which incorporated 72 patients who had been receiving one of two first-line somatostatin analog injectable depots, Novartis AG’s Sandostatin (octreotide acetate) or Ipsen SA’s Somatuline (lanreotide), when they entered the study.

After FDA rejection, GC Biopharma refiles Alyglo’s BLA

GC Biopharma Corp., formerly Green Cross Corp., said July 17 that it refiled the BLA for its intravenous immune globulin agent Alyglo (GC-5107B; IVIG-SN 10%) to the U.S. FDA – nearly a year and a half after the regulator’s initial rejection. The BLA was filed on July 14, Yongin, South Korea-based GC Biopharma said, marking its second attempt after the first application on Feb. 26, 2021. The FDA’s complete response letter was issued one year later, on Feb. 26, 2022, and related primarily to a delay in conducting an on-site inspection for GC Biopharma’s blood product manufacturing facility in Ochang, North Chungcheong Province.

June values soar with four $1B+ M&As; biopharma deal values plunge

The biopharma industry experienced a notable decline in deal values and activity in June 2023, with a 48.5% decrease in deal values and a 43.6% decrease in the number of deals completed compared to the previous June. M&As, however, showed a remarkable 824.6% increase in value year over year in June, thanks to several billion-dollar M&A transactions.

Also in the news

60 Degrees, Aatec, Alphyn, Astellas, Brainstorm Cell, Calliditas, Caeregen, Caribou, Cel-Sci, Eleven, Emmaus, Evogene, Gilead, Infinity, Ionis, Janux, Kuros, Ligand, Lyndra, Medipacific, MEI, Neural, Novan, Novo Nordisk, Pardes, Petros, Psycheceutical, Scipher, Scisparc, Theseus, Turnstone