Biotech stocks are high-risk, high-return opportunities that are under the mercy of several make-or-break catalysts, most of which are binary events. It pays to remain cognizant of the timing of these catalysts and which way they will likely pan out.
Benzinga brings to investors a weekly feature focusing on five key catalysts that could impact the stock prices of the respective companies in an appreciable manner.
1. Arrowhead Pharmaceuticals, Inc. ARWR
- Date: Tuesday, June 25
- Catalyst: Discussion of Phase 3 PALISADE study of investigational plozasiran in patients with genetically confirmed or clinically diagnosed familial chylomicronemia syndrome
On June 3, the company released Phase 3 topline results, which showed the study met the primary endpoint, and key secondary endpoints and demonstrated statistical significance versus placebo. The stock rose over 7% on the day. The company is scheduled to discuss the data at the Cardiometabolic event on Tuesday as part of its 2024 Summer Series of R&D Webinars.
The company expects to file an NDA for plozasiran in FCS around year-end, with a potential launch in 2025.
Arrowhead ended Friday’s session up 7.19% at $25.50, according to Benzinga Pro data. Chardan has a Buy rating on Arrowhead and a $60 price target: “We expect 2024 to be a data rich year for Arrowhead,” said Chardan analyst Keay Nakae in a June 3 note.
“We believe that at the current price, the balance of risk/reward is highly favorable for the stock going forward,” he said.
2. Intellia Therapeutics, Inc. NTLA
- Date: Tuesday, June 25
- Catalyst: redosing data from the Phase 1 study of NTLA-2001, which is based on CRISPR/Cas9 gene-editing technology,
The data, which is to be presented at the Peripheral Nerve Society Annual Meeting being held in Montreal, Canada, will offer insight into the safety and pharmacodynamics of redosing patients. NTLA-2001 is being evaluated for Transthyretin amyloidosis, or ATTR amyloidosis, a rare, progressive and fatal disease. Interim Phase 1 clinical data showed the administration of NTLA-2001 led to consistent, deep and long-lasting TTR reduction. The gene-editing candidate is being jointly developed with Regeneron Pharmaceuticals, Inc. REGN.
The stock added 0.74% on Friday before closing at $24.22.
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3. Merck & Co., Inc. MRK
- Date: Wednesday, June 26
- Catalyst: PDUFA date for antibody-drug conjugate patritumab deruxtecan as a treatment option for a certain type of non-small cell lung cancer.
The ADC candidate is being tested in patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) previously treated with two or more systemic therapies.
Lung cancer is the second most common cancer and the leading cause of cancer-related deaths worldwide, with non-small cell lung cancers accounting for approximately 85% of all lung cancers. EGFR mutations occur in 14%-38% of all NSCLC tumors worldwide.
Patritumab deruxtecan is one of the three drugs Merck acquired from Japan’s Daiichi Sankyo Company, Limited DSKYF last year.
Merck settled Friday’s session 0.81% higher at $130.72.
4. Verona Pharma plc VRNA
- Date: Wednesday, June 26
- Catalyst: PDUFA date for ensifentrine that is being evaluated as maintenance treatment of patients with Chronic obstructive pulmonary disease
Raleigh, North Carolina-based Verona Pharma is a clinical-stage biopharma working on therapies for respiratory diseases. If ensifentrine gets the nod, it has the potential to become the first inhaled non-steroidal therapy for the treatment of respiratory diseases that combines bronchodilator and anti-inflammatory activities in one molecule, the company said. It is prepping for the commercial launch of ensifentrine in the third quarter.
Verona added 2.11% on Friday and ended at $15.
5. X4 Pharmaceuticals, Inc. XFOR
- Date: Thursday, June 27 (8 a.m. EDT)
- Catalyst: new interim Phase 2 data for mavorixafor in severe congenital neutropenia, which results from very low levels of neutrophils – a type of white blood cells that are used to treat several infections, especially bacterial.
The data will be presented at a virtual investor event hosted by the company. X4 Pharma rallied over 5% to $1.01.
The SPDR S&P Biotech ETF XBI, an exchange-traded fund that tracks the S&P Biotechnology Select Industry Index, ended Friday at $92.38, up 2.77%. For the year, the EFF has gained 3.46%, underperforming the broader S&P 500 Index.
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