Evolving macro data and outlook drove the 2-year Treasury rate below the 10 for the first time since July of 2022. This coupled with continued mild inflation appear poised to become tailwinds for speculative sectors such as biotech.
Trading desks are calling out signs that generalists are looking at pre-commercial biotech stocks again suggesting the long-awaited rotation out of “Big Tech” may be around the corner. M&A headlines remain quiet as medical meeting headlines pick up for the sector with good data continuing to be rewarded.
Clinical:
Summit Therapeutics (SMMT) released full Ph3 HARMONi-2 data showing a mPFS benefit in NSCLC compared to Keytruda ( HR=0.51) with bispecific VEGF-PD1 antibody ivonescimab. This China-only trial is the first data set to show head-to-head benefit over Keytruda, but gold standard overall survival (OS) data has yet to be shared and the bispecific also showed higher rates of adverse events. It is expected this data would not enable filing in the US and data from the international Ph3 HARMONi-3 trial of ivonescimab combined with chemotherapy versus pembrolizumab combined with chemotherapy for the first-line treatment of metastatic squamous NSCLC (primary endpoint OS; estimated completion in 2027) will be required.
Relay Therapeutics (RLAY) rallied >50% on interim data of pan mutant and isoform selective PI3Ka inhibitor RLY-2608 in combination with fulvestrant that showed 9.2m PFS in pre-treated PI3Ka-mutated HR+/HER2- metastatic breast cancer patients. Pivotal trial planning suggests it could start in 2025.
Bicycle Therapeutics (BCYC) rallied >25% on ESMO abstract that BT8009 may have a superior profile to market leading ADC Padcev.
C4 Therapeutics (CCCC) reported Ph1 data for CFT1946 monotherapy that missed investor expectations, sending shares down ~20%.
Nuvalent (NUVL) released positive updated Ph1 data for NVL-655 in ALK+ NSCLC with ORR of 38% in all patients and 37% in 4L+ patients. DOR of 7.7 months in the late line patients appears sufficient to support FDA approval with an expanded data set.
Terns Pharmaceuticals (TERN) released initial phase 1 data for daily oral GLP-1 pill showing 4.9% placebo adjusted weight loss at the highest dose after 28 days. No patients discontinued given the inpatient trial design, but nausea and vomiting were observed in nearly all patients suggesting additional dose exploration / titration will be examined in phase 2.
Corporate Updates and Earnings:
BioMarin Pharmaceuticals (BMRN) announced long term revenue goal of $4 billion in 2027 (13% CAGR 2023-2027) an investor day and an operating margin of >40% ahead of consensus ($3.8 billion and 38%).
Ascendis Pharma (ASND) reported a top and bottom line miss driven by increased sales deductions for Skytrofa. 2024 Skytrofa revenue guidance was revised to EU 220-240 million (from EU320-340 million) below the street at EU350 million.
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