Less than two weeks after getting a thumbs-up from the EMA’s Committee for Medicinal Products for Human Use, Santhera Pharmaceutical AG’s vamorolone secured U.S. FDA approval for use in patients, 2 and older, with Duchenne muscular dystrophy (DMD). A first-in-class drug, vamorolone, branded Agamree, is expected to offer a safer alternative to the steroid therapy, which the company has said will remain a foundational treatment of DMD, even with the introduction of gene therapies.
The public markets have hammered biopharma companies conducting IPOs in the past four years, with the number of debuts dwindling and the amounts raised falling dramatically as well. But one of the more telling measures is price performance, which is significantly down for all IPOs completed since 2020. The stock prices of 13 firms that entered the U.S. markets in 2023 are currently at a decline of 26.8% on average, with only two companies trading above their offering price.
With one of the higher series A rounds for 2023, the newly launched Aiolos Bio Inc. pulled in $245 million to advance its lead product, AIO-001, an anti-thymic stromal lymphopoietin monoclonal antibody set to enter a phase II trial for moderate to severe asthma.
While biopharma dealmaking remains active, a strong third quarter (Q3) was not enough to bring it to the same level seen during each of the last three years, although values are coming close. At the same time, M&As appear to be rising above 2022, but even with the increase, they still lag behind other years. If the Pfizer Inc./Seagen Inc. merger, worth $43 billion, closes before the end of 2023, for example, M&As will still not come close to the overall value seen in 2019 and 2020.
Royalty monetization is a financing tactic that is becoming increasingly popular during challenging times, and PTC Therapeutics Inc. is the latest firm to leverage a marketed drug to pay off debt and fuel its development pipeline. The South Plainfield, N.J.-based company agreed to sell up to $1.5 billion of its Evrysdi (risdiplam) royalty stream to Royalty Pharma plc, of New York. Evrysdi is a survival motor neuron 2 RNA splicing modifier approved by the U.S. FDA in 2020 to treat spinal muscular atrophy.
While biopharma dealmaking remains active, a strong third quarter (Q3) was not enough to bring it to the same level seen during each of the last three years, although values are coming close. At the same time, M&As appear to be rising above 2022, but even with the increase, they still lag behind other years. If the Pfizer Inc./Seagen Inc. merger, worth $43 billion, closes before the end of 2023, for example, M&As will still not come close to the overall value seen in 2019 and 2020.
Biopharma financings in 2023 – at $49.3 billion raised through the third quarter (Q3) – are tracking ahead of, or only slightly behind, several years since 2011, except for the two outlier years of 2020 and 2021 when there was a flurry of investments in response to the COVID-19 pandemic.
With shares dropping again, this time more than 15% on Oct. 13, Cassava Sciences Inc. has found itself entangled in a mess involving short-sellers, data that were allegedly mishandled involving its oral Alzheimer’s disease (AD) candidate simufilam, and a leaked investigation report from the City University of New York (CUNY).
Biopharma financings in 2023 – at $49.3 billion raised through the third quarter (Q3) – are tracking ahead of, or only slightly behind, several years since 2011, except for the two outlier years of 2020 and 2021 when there was a flurry of investments in response to the COVID-19 pandemic.
Biopharma financings in 2023 – at $49.3 billion raised through the third quarter (Q3) – are tracking ahead of, or only slightly behind, several years since 2011, except for the two outlier years of 2020 and 2021 when there was a flurry of investments in response to the COVID-19 pandemic.
