Major indices shrugged off a hotter than expected CPI number last week to reach all-time record highs. In tandem, the S&P Select Biotech Index rallied to test the 50-day moving average despite 10-year treasury yields hovering above 4%.
Fed funds futures markets are now pricing in less than two rate cuts for the remainder of the year leaving ample room for a surprise into year end.
M&A:
Lundbeck A/S announced the acquisition of Longboard Pharmaceuticals (LBPH) for $2.6 billion or $60 per share in cash. Lead asset Bexicaserin is a 5-HT2C receptor agonist being developed for seizures.
Regulatory:
Soleno therapeutics (SLNO) announced FDA does not expect to need an advisory panel to review the pending DCCR NDA in Prader-Willi Syndrome.
Zealand Pharma (ZEAL) received a Complete Response Letter (CRL) from the US FDA for dasiglucagon indicated for the prevention and treatment of hypoglycemia in pediatric patients with congenital hyperinsulinism. ZEAL cited third party manufacturing issues as the primary reason for the CRL.
Clinical:
Sage Therapeutics (SAGE) terminated development of dalzanemdor in Alzheimer’s following Ph2 miss.
Corporate Updates and Earnings:
GSK (GSK) announced a settlement of the vast majority of Zantac litigation claims for $2.2 billion. Shares rallied as this was at he low end of analyst expectations.
Eli Lilly (LLY) is sending cease-and-desist letters to hundreds telehealth companies, compounding pharmacies and medical spas, demanding that they stop making, selling and promoting products that mimic GLP1 drugs like Zepbound.
Teva Pharmaceuticals (TEVA) agreed to pay $450 million to settle kickback and price-fixing allegations.
10x Genomics (TXG) guided 3Q revenue below the street to ($151 v $162.2 million street) representing a 1% decline from the corresponding period last year. Shares were off ~25%, but still trade at >3x revenue.
Indivior PLC (INDV) lowered Q3 and FY 2024 Sublocade guidance based on a competitive entrant, but reaffirmed 25% year on year growth for the brand and >$1.5 billion of peak sales. 2024 operating profit is now guided to $260-280 million. INDV shares are trading at <1x revenue and <5x adjusted earnings.
Bayer AG (BAYN GY) shares fell on news Washington state's Supreme Court will review the decision by the lower appeals court to throw out a $185 million jury award to teachers allegedly harmed by toxic chemical exposure at the Sky Valle=y Education Center.
Culling the Herd:
Black Diamond Therapeutics (BDTX) announced they will turn down the difficulty level and focus efforts only on BDTX-1535 in EGFRm NSCLC. The workforce reduction extends the cash runway into 2Q 2026 and includes the CFO plus CPO.
Kezar Life Sciences (KZR) shares rallied after a shareholder offered to buy Kezar for $1.10 per share in cash. KZR shares have been trading at a negative EV with a <$50 million market cap and >$150 million in cash.
Gristone Bio (GRST) filed for Chapter 11 bankruptcy in Delaware.
Turnstone Biologics (TSBX) announced a 60% workforce reduction to extend the cash runway into 2Q 2026.
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