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  • Jonathan Poyer

Biotech Index Hovers Around 50-Day Moving Average Despite Low Trade Volume. J&J Acquires Proteologix for $850M, Novartis Acquires MorphoSys





The S&P 500 notched four straight up weeks culminating with a fresh all-time high following an in-line CPI report that helped investors look past a hot PPI number (0.5% vs street expectations for a 0.3% increase).



Investors continue to raise expectations for rate cuts this year despite more cautious "fedspeak". The S&P Select Biotech continues to hover above the 50-day moving average, albeit on low volume in the post earnings news vacuum.



M&A:


  • JNJ agreed to buy Proteologix (private) for $850 million in cash with the potential for additional milestone payments. The lead asset is a phase 1 ready bispecific antibody targeting IL-13 and TSLP

  • Novartis (NVS) met all tender offer conditions to acquire MorphoSys (MOR) by securing 79.6% acceptance during the initial acceptance period, exceeding the 65% threshold. The tender is expected to complete by May 30th



Regulatory:


  • Dynavax (DVAX) received a CRL from FDA on an sBLA for use of Heplisav-B in patients on dialysis. FDA stated the application did not provide sufficient data due to destruction of data sources by third party vendors. The application was approved by the European Commission in October 2023

  • Ascendis Pharma (ASND) announced that the FDA issued a 3-month extension of the TransCon PTH NDA to review a major data amendment. The new PDUFA date is August 14

  • PTC Therapeutics (PTCT) disclosed EMA has decided to keep Translarna on the market for the moment while CHMP for re-evaluates the totality of data



Clinical:


  • Roche (RHHBY) reported 18.8% placebo adjusted weight loss at week 24 for its weekly GIP/GIP-1 candidate CT-388, roughly similar to VK2735 & numerically higher compared to market leader Eli Lily's (LLY) Mounjaro. Full safety, dose titration and other data will be presented at an upcoming meeting

  • Cabaletta Bio (CABA) disclosed the first patients dosed with CABA-201 had no CRS or ICANS of any grade during the 28-day DLT observation window following administration. Initial clinical activity data will be presented at EULAR



Corporate Updates & Earnings:


  • Biocryst (BCRX) senior management voted with their feet and purchased ~150k shares in the open market following an upbeat Q1 earnings report



Culling the Herd:


  • Bolt Biotherapeutics (BOLT) announced it would cease development of trastuzumab imbotolimod (BDC-1001), appoint a new CEO / COO and reduce the work force by 50%.



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