Chair Powell's comment that additional rate hikes were unlikely led to a violent rally in the S&P Select Biotech Index as the 10-year yield retreated back down below 450 bps.
The Fed provided an additional dovish surprise by reducing the cap for balance sheet treasury runoff to $25 billion (vs >$30 billion expected), from $60 billion seemingly in recognition of increasing treasury supply to financing the growing deficit. The S&P Select Biotech Index rallied back to the 50-day moving average and started the week largely holding those gains despite a slew of negative SMID cap clinical data updates highlighting the strong influence of macro considerations.
M&A:
Novartis (NVS) to acquire Mariana Oncology (private) for $1 billion upfront and up to $750 million in potential milestone payments
Clinical:
Urogen Pharmaceuticals (URGN) announced positive Ph3 durability data for UGN-102 in new/recurrent LG-IR-NMIBC with DOR at 12mo after achieving CR at 3mo of 87.5% and 69.1% in new and recurrent patients, respectively
Lyra Therapeutics (LYRA) crashed ~90% on news the Phase 3 ENLIGHTEN trial for long acting steroid treatment LYR-210 failed to meet the primary endpoint in chronic rhinosinusitis patients (CRS). LYRA plans a workforce reduction in the near term
Glycomimetics (GLYC) fell ~75% on announcing the Phase 3 pivotal trial of E-selectin antagonist Uproleselan in AML did not meet the primary endpoint. The drug had previously received Breakthrough therapy Designation from FDA
Eyepoint Pharmaceuticals (EYPT) fell ~40% after announcing a Phase 2 trial of Duravyu in diabetic retinopathy failed to meet the primary endpoint
Corporate Updates & Earnings:
Pfizer (PFE) reported a 1Q beat on both revenue ($14.9 billion vs street $13.9 billion) and adjusted EPS ($0.82 vs street $0.51). 2024 adjusted EPS guidance was raised to $2.15-$2.35 from $2.05-$2.25. Non-Covid operating revenue grew 11% from the year earlier
Biocryst Pharmaceuticals (BCRX) reported 1Q ahead of estimates. Orladeyo Q1 revenue grew 30% y-o-y to $89 million (vs $82 million street) and 2024 revenue was guided up to $390-400 million. Shares rallied 18% to trade at ~2.5x current revenue
GSK (GSK) reported a 1Q beat on both revenue (7.4 vs street 7.1 billion pounds) and adjusted EPS (0.43 vs 0.36 pounds). 2024 guidance was raised for revenue (+7%) and adjusted EPS (+8-10% from +6-9%)
United Therapeutics (UTHR) reported a 1Q beat on both revenue ($677 vs street $624 million) and adjusted earnings ($6.17 vs street $5.78)
Amgen (AMGN) reported an in line Q and raised FY 2024 guidance range by a dime. The CEO announced plans to move AMG 133 into a Ph3 study following an unblinded interim analysis of the 6-mos data from the ongoing Ph2 obesity study
Novo Norsidk (NOVOB DC) raised FY24 sales guidance to +19%-27% vs +18-26% prior following 1Q top/bottom-line beat on Ozempic strength, offset by Wegovy weakness due to supply constraints
Blueprint Medicines (BPMC) reported a 1Q revenue beat ($96 vs street $80 million) and raised Ayvakit revenue guidance for 2024 ($390-410 vs prior $360-390 million)
Neurocrine Biosciences (NBIX) reported 1Q revenue beat ($515 vs street $512 million) with 23% year on year growth for flagship franchise Ingrezza and reaffirmed 2024 guidance
Aurinia Pharmaceuticals (AUPH) reported a 1Q revenue beat ($50.3 vs street $47 million) and expects to be cash flow positive in 2Q 2024
Regeneron (REGN) reported a 1Q top (-2%) and bottom line(-6%) miss citing seasonality
Inari Medical (NARI) reported a 1Q revenue beat ($143 vs street $138 million) and raised 2024 revenue guidance ($592.5-$602.5 million from prior $580-$595 million), reflecting growth of >20%
Harmony Biosciences (HRMY) reported a 1Q beat with ~30% revenue growth year on year and maintained 2024 guidance (revenue $700-720 million)
Eli Lilly (LLY) 1Q revenue missed ($8.7B vs street $8.9B) as Mounjaro and Trulicity were ~$400 million light. Adjusted EPS beat ($2.58 vs street $2.44) on a lower tax rate and 2024 revenue guidance was raised to ($42.4-$43.6B up from $40.4-$41.6B) and earnings ($13.50-$14 vs prior $12.20-$12.70). LLY trades at a record ~3x the multiple of the peer group
Axsome therapeutics (AXSM) reported 1Q revenue ahead ($75 vs street $73.2 million). Expenses were ahead by 14%, but the company continues to project funding is sufficient through CFBE
Krysatal Biotech (KRYS) reported 1Q revenue for newly approved gene therapy Vyjuvek for DEB wounds below the street ($45.3 vs $47.4 million)
Incyte Pharmaceuticals (INCY) reported a top (~3.9%) and bottom line (~$21%) miss as lead franchise Jakafi came in light due in part to destocking
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