Raising $15.6 billion through 276 transactions, the biopharma industry has experienced a respectable first quarter (Q1) in terms of financings, with a 14% jump over last year and higher amounts than the first quarters of many pre-pandemic years. The financings compare with $13.7 billion raised through 253 transactions in 2022’s Q1. Private money remains the strongest source of capital in 2023, with venture capital bringing nearly 45% to the table and private investors in public companies bringing another 20%.
At least 64 biopharma companies have announced workforce reductions so far in 2023, resulting in 6,000 jobs lost in the industry. It is a clear indication of a continuing trend begun last year in which executives needed to rein in spending to keep innovative programs afloat.
Pharming Group NV’s stock skyrocketed March 24 on news that the U.S. FDA approved Joenja (leniolisib) to treat activated phosphoinositide 3-kinase delta syndrome (APDS) for those ages 12 and older. The nod, which came a few days ahead of the March 29 PDUFA date, sent shares (NASDAQ:PHAR) up 33%, or $3.69, to end the day at $14.96.
Incyte Corp.’s retifanlimab-dlwr received its first regulatory nod on March 22, with the U.S. FDA granting accelerated approval for the PD-1 inhibitor to treat adults with a rare form of skin cancer, advanced Merkel cell carcinoma.
A deal worth $745 million for two small-molecule programs, with a lucrative option to expand into other modalities, brings together the diabetes and metabolic disease expertise of Novo Nordisk A/S with an artificial intelligence technology platform from Dewpoint Therapeutics Inc. Boston-based Dewpoint signed on with Bagsvaerd, Denmark-based Novo Nordisk to use the former’s biomolecular condensates discovery engine to find new drugs for diabetic complications. The drugs will target condensates that contribute to the mechanisms of insulin sensitivity and insulin resistance, a key driver of type 2 diabetes and metabolic syndrome.
Marking the latest Alzheimer’s disease (AD) disappointment, Eli Lilly and Co.’s solanezumab failed in a phase III trial to slow progression of cognitive decline in patients at the preclinical stage of the disease – those with amyloid plaque but no clinical symptoms – prompting the company to terminate development. The Indianapolis-based company is turning its attention instead to phase III AD products donanemab and remternetug.
U.S. Sen. Bernie Sanders (I-Vt.) sent letters to Sanofi SA and Novo Nordisk A/S executives on March 1, urging them to follow Eli Lilly and Co.’s example in cutting prices for their insulin products, offering more affordable access for Americans with diabetes. Industry leaders, however, have long argued that the problem goes far beyond list price, as pharmacy benefit managers and health plans have simply not passed their rebates onto consumers.
As several key revenue-driving products fall off patent in coming years, pharmaceutical companies are increasingly focused on mechanisms by which they can draw innovation to them. What launched as the Partner of Choice organization, for example, has now become the newly named Pfizer Ignite model – an end-to-end engine designed to bring innovation to the pharmaceutical company in return for services.
With a $200 million oversubscribed and upsized series A round completed, Cargo Therapeutics Inc. will advance its autologous CD22 chimeric antigen receptor (CAR) T-cell therapy, CRG-022, which has breakthrough therapy designation in the U.S. “The proceeds are critical for us,” said Gina Chapman, CEO of San Mateo, Calif.-based Cargo. “We will demonstrate manufacturability this year and kick off the pivotal phase II.”
As broader markets struggled throughout 2022, the biopharma industry’s largest and most lucrative companies ended the year in a strong position, according to BioWorld’s Biopharmaceutical Index (BBI), which showed the 22 component stocks climbed by 17.3% throughout the year. Neither the Nasdaq Biotechnology Index (NBI) nor the Dow Jones Industrial Average (DJIA) demonstrated such gains. They were down by 10.9% and 8.8%, respectively. All three indices, however, are following the same path in 2023, shooting up throughout the month of January and back down in recent weeks.
