Weekly FDA Drug Pipeline Calendar (Dec 12 - Dec 17)

$Amgen (AMGN.US)$ Inc. is in advanced talks to buy drug company $Horizon Therapeutics (HZNP.US)$, according to people familiar with the matter, in a takeover likely to be valued at well over $20 billion and mark the largest healthcare merger of the year.

$ROCHESTER RESOURCES LTD (RCTFF.US)$Holding AG presented new data from a Phase 3 study showing that its Polivy antibody-drug can significantly reduce the risk of disease deterioration or death for people with untreated diffuse large B-cell lymphoma.

Danish biotechnology companies $NOVONESIS (NOVOZYMES) B UNSP ADR EACH REP 1 SER'B' DKK10 (NVZMY.US)$and $CHR. HANSEN HOLDING A/S SPON ADS EACH REP 0.25 ORD SHS (CHYHY.US)$ said Monday they have agreed to merge, creating a biological solutions provider with combined annual revenue of around 3.5 billion euros ($3.69 billion).

$Ambrx Biopharma (AMAM.US)$ shares closed up higher this week after it released Phase 2 ACE Breast-03 study of ARX788 to treat HER2-positive mBC patients who are resistant or refractory to T-DM1. The data reported a 51.7% overall response rate (ORR) by RECIST v1.1 and a 100% disease control rate (DCR). Shares closed the week up 735% at $4.26.

$Pharvaris (PHVS.US)$ shares soared this week after it announced that its Phase 2 RAPIDe-1 trial of PHVS416 as a treatment for hereditary angioedema (HAE) attacks met its primary endpoint. Shares closed the week up 339% at $8.78.

$Summit Therapeutics (SMMT.US)$ entered into a licensing agreement with Akeso Inc. for the commercialization of ivonescimab (PD-1/VEGF). Akeso Inc will receive $500 million upfront with the deal totalling $5 billion including milestones. Shares closed the week up 400% at $3.90.

$Prometheus Biosciences (RXDX.US)$ had a busy week with the release of data from two PRA023 trials, the Phase 2 ARTEMIS-UC and Phase 2a APOLLO-CD trials. Both reported positive data sending the shares higher. Later in the week Prometheus

Tuesday, December 13, 2022
Advisory Committee $Cytokinetics (CYTK.US)$ Omecamtiv Mecarbil
4Q $NeuroOne Medical (NMTC.US)$ Earnings
Nov. Consumer Price Index 8:30 am ET

Wednesday, December 14, 2022
PDUFA $Zai Lab (ZLAB.US)$ Adagrasib for NSCLC

Friday, December 16, 2022
Initial Public Offering (IPO) for $Cadrenal Therapeutics (CVKD.US)$