Trading volumes remain near lowest levels of the year as indices rally Back following the volatility spike a couple of weeks back.
The VIX drop from 65 to below 15 was the fastest decline ever recorded.
The market is waiting for the Fed chair's comments this Friday for potential further confirmation that rate cuts will be coming in September. Companies are taking advantage of the updraft in markets to seek new issuance before potential election induced volatility kicks in.
M&A:
Surmodics (SRDX) disclosed the FTC requested additional information regarding merger with GTCR (private).
Regulatory:
CMS released the IRA associated price controls for the first 10 drugs on the list. The headline discounts appear large~40-80%, but they reference the discount from the gross list price. Actual discounts from the current net price are generally much lower (4-30%) and are in line with prior guidance from management teams. For example, Bristol Myers Squibb (BMY) announced Eliquis guidance for 2026 and 2027 that bracketed current consensus estimates. The next 15 drugs will be selected in February 2025
Liquidia Corp (LQDA) fell ~40% as FDA granted regulatory exclusivity to competitor United Therapeutics (UTHR), thereby blocking entry for LQDA's Yutrepia until May 23, 2025.
Gilead Sciences (GILD) announced FDA granted accelerated approval for Livdelzi in PBC. Livdelzi is the first primary biliary cholangitis (PBC) treatment to have clinical improvement of pruritis included in the label. The asset was obtained in the acquisition of CymaBay for $4.3B.
Clinical:
Jasper Therapeutics (JSPR) announced to date there have been no cases of anaphylaxis, hospitalizations, or serious reportable events to date in the ongoing dose escalation trial of c-kit antibody briquilimab.
Siga Technologies (SIGA) fell >40% on announcing experimental therapy to treat Monkeypox did not meet its primary endpoint.
Syros Pharmaceuticals (SYRS) fell >50% after announced it will discontinue enrollment in the SELECT-AML-1 trial evaluating RARA agonist tamibarotene in combination with venetoclax and azacitidine in AML patients with RARA gene overexpression as the control arm demonstrated a higher CR / Cri rate at the interim analysis.
Culling the Herd:
Grail (GRAL) announced it will cut 30% of staff to focus resources on Galleri, reducing FY25 burn to $325 million (cash runway extended from 2H26 into 2028).
Acelyrin (SLRN) announced a strategic shift to focus on Ophthalmology and will cut headcount by 33% (cash runway extended to mid 2027).
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