A return to growth of M2 may be the invisible hand helping major indices ratchet to all-time highs. At the same time, net interest expense and entitlements are consuming a breathtaking ~100% of total government receipts over the last 12 months. The S&P Select Biotech Index seems poised to retest the 100-day moving average as investors stare down Q3 earnings season and the upcoming election.
Regulatory:
Wave Life Sciences (WVE) rallied to 2020 highs on data from thePhase 1b RestorAATion-2 trial that showed notable RNA editing in In the first two ZZ-Alpha-1 antitrypsin deficiency (AATD) patients. Specifically, circulating levels of total AAT reached a mean of 10.8 uM by day 15 after a single dose from an undetectable baseline and ~60% were WT M-AAT.
Novavax (NVAX) announced FDA placed a clinical hold on COVID-19-Influenza Combination due to a spontaneous report of a serious adverse event (“SAE”) of motor neuropathy in a single CIC Phase 2 trial participant.
Urogen Pharma (URGN) disclosed FDA accepted the NDA submission for UGN-102 under standard review (PDUFA 6/13/25).
Clinical:
Jazz Pharmaceuticals (JAZZ) released positive topline results from their Ph 3 IMforte trial of Zepzelca SCLC that showed improvement in OS and PFS.
Jasper Therapeutics (JSPR) reported preliminary data from the SPOTLIGHT Ph1b/2a study of briquilimab that showed 14 of 15 CIndU patients achieving clinical response across two dose cohorts within the 6-week analysis period. Tolerability profile appeared favorable with no Grade ≥3 AEs observed.
Corporate Updates and Earnings:
Johnson & Johnson (JNJ) raised FY24 sales guidance to $88.4B-$88.8B from $88B-$88.4B. 3Q top/bottom-line beat driven by Innovative Medicine offset by MedTech miss.
Bright Minds Bio (DRUG) rallied ~1500% while trading 25x of the float on speculation of its prospects following the Longboard Pharmaceuticals (LBPH) acquisition announcement. DRUG went from ~$10m market cap to over $170 million.
Culling the Herd:
Sage Therapeutics (SAGE) announced strategic reorganization plans to prioritize the ongoing Zurzuvae PPD launch to extend cash runway. Headcount will be reduced by ~33%.
October M&A:
Lundbeck acquired Longboard Pharmaceuticals for $2.6B or $60/share
September M&A:
Organon acquired Dermavant for $175M
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