Strategy
Public Company Edition: Uncertainty about the US FDA’s direction earlier in the year caused biotech stocks to sag, but recent leadership upheaval has not sunk the XBI. Also, Belite raised $350m, Capricor grossed $150m and Immatics brought in $125m in follow-on offerings.
A submission to the FDA in the coming months for essential tremor drug ulixacaltamide could be swiftly followed by a filing of relutrigine for two rare forms of epilepsy.
Roughly four months after raising its 2025 revenue forecast, UCB has done it again, helped by strong performance of its IL-17A and IL-17F inhibitor.
Plus deals involving Simcere/Vigonvita, Formosa/Rxilient, Shionogi/Japan Tobacco, Taiho/NEC/JFCR, Toray/Sanodyne, SK Biopharmaceuticals/WARF, BioCorteX/CD Biopharma, ToolGen/GenEditBio and Actimed/Mankind.
Vertex, Bristol Myers and Regeneron updated investors on launches underway, while Sanofi CEO Paul Hudson assured investors on the late-stage pipeline.
The company says that clascoterone presents the first potential innovation in over 30 years in male hair loss.
Sun launches tildrakizumab, its star psoriasis therapy in India seven years after US FDA approval at what’s seen as a carefully calibrated price point. Can it ruffle entrenched products like secukinumab?
Pharvaris’s oral bradykinin B2 antagonist hit all endpoints in a Phase III study in hereditary angioedema attacks, meaning the drug could be competing soon with Kalvista’s Ekterly.
AstraZeneca quietly acquires Six Peaks, plus deals involving Bayer/Dare, Tempest/Factor, XenoTherapeutics/Repare, DayOne/Mersana and more.
The pivotal Phase III trial met the primary and secondary endpoints, showing skeletal and cardiac benefits and supporting deramiocel as a treatment for Duchenne cardiomyopathy.
If approved, VER-01 would be the first cannabinoid-based therapy for chronic low back pain.
At the Clinical Trials On Alzheimer’s Disease meeting, Novo explained why it tested semaglutide in AD a day before the company’s Phase III EVOKE/EVOKE+ presentation, Roche updated Phase Ib/IIa results for its anti-amyloid trontinemab and UCB’s bepranemab remains in limbo.
After AI’s magic wand status, it's now come to Google and Open AI CEOs talking of the likelihood of a bubble burst. In this interview, Parexel’s India head discusses how to view returns on such investments, the CRO’s own use cases and the US FDA’s keenness on transparency and open dialogue.
Private Company Edition: Protego’s series B round comes four years after its $51m series A. Also, Aspen Neuroscience reveals a $115m series C round, Profluent raises $106m to fund AI-enabled protein design and Phrontline brings in $60m in pre-series A+ financing.
Tessera, which claims its gene-writing technology offers functionality beyond gene-editing, hopes Regeneron can accelerate development of its preclinical alpha-1 antitrypsin deficiency drug.
The €150m agreement is music to the ears of biotechs battling to find cash.
The Paris-headquartered giant has put the spotlight on its extensive investments at home.
With Gilead reporting that both of its approved CAR-Ts saw sales declines as other products saw growth, a mixture of different competitive headwinds seems to be behind the disparities.
Public Company Edition: Lilly’s obesity franchise makes it the highest-valued health care company in the US. Also, Genmab accesses $4.5bn to fund its $8bn Merus buy, Moderna locks in a $1.5bn credit facility and Ionis sells $700m worth of notes.
Following US approval of its first-in-class drug for IgAN sibeprelimab, Otsuka is planning an sNDA for an autoinjector in 2026 and is in talks with regulatory authorities in Japan and Europe.