JNJ reports third-quarter results on Tuesday, and Koyfin analysts expect modest revenue growth and lower earnings.
- TRAX plans to release top-line data from the first ANB033 celiac-disease study cohort on Monday.
- CYTK will present additional Aficamten analyses at HFSA, while EPRX presents previously disclosed EP-104GI data at ACG.
- ARWR and VSTM have clinical updates scheduled for Wednesday on Alzheimer’s research and the cancer drug VS-7375.
Biotech investors face a packed week, with First Tracks set to report early data on a celiac-disease drug, Verastem preparing an update on a cancer treatment, and the FDA approaching decisions on two eye therapies.
The Health Care Select Sector SPDR Fund (XLV) gained 2.8% last week, outperforming SPDR S&P 500 ETF Trust (SPY), up 1.2%, and Invesco QQQ Trust (QQQ), up 0.2%. The iShares Biotechnology ETF (IBB) rose 0.6%, trailing SPY but beating QQQ, while the SPDR S&P Biotech ETF (XBI) fell 0.4%.
| Date | Ticker/Event | Development |
| Oct.12 | TRAX | First Tracks plans to report Cohort 1 top-line data for ANB033 in celiac disease; investor call at 8:30 a.m. ET |
| Oct.12 | CYTK / HFSA | Two late-breaking analyses of Aficamten in nonobstructive hypertrophic cardiomyopathy at the HFSA meeting |
| Oct.12 | EPRX / ACG | Poster on EP-104GI and dysphagia improvements through 52 weeks in the RESOLVE study |
| Oct.13 | JNJ | Third-quarter results; investor call at 8:30 a.m. ET |
| Oct.14 | ARWR | Webinar with interim clinical data from the ARO-MAPT study in Alzheimer’s disease and other tauopathies |
| Oct.14 | VSTM | Investor event with initial efficacy and updated safety data for VS-7375 |
| Oct.14-Oct.17 | PHAR / ESID | Late-breaking presentation of Phase 2 Leniolisib data in primary immunodeficiencies with immune dysregulation |
| Oct.15 | RHHBY | FDA target action date for Roche’s Enspryng in thyroid eye disease |
| Oct.17 | VTRS / IRD | FDA target action date for phentolamine ophthalmic solution 0.75% in presbyopia |
| Oct.17-Oct.20 | UEG Week | Gastroenterology conference in Barcelona, with presentations from EPRX, ABVX, Agomab and PALI |
Monday: TRAX, CYTK and EPRX
First Tracks Biotherapeutics plans to report top-line data on Monday from Cohort 1 of its Phase 1b study of ANB033, a drug that blocks the immune target CD122. The gluten-challenge study is testing whether the drug can protect the intestinal lining from damage in people with celiac disease.
Cytokinetics (CYTK) will present two late-breaking analyses of Aficamten on Monday at the Heart Failure Society of America’s meeting in Phoenix. The ACACIA-HCM analyses examine the drug’s overall effectiveness and impact on exercise performance in nonobstructive hypertrophic cardiomyopathy, where a thickened heart muscle does not block blood flow. The company plans to submit a supplemental new drug application in the fourth quarter.
Eupraxia Pharmaceuticals (EPRX) will present a poster on Monday at the American College of Gastroenterology meeting on EP-104GI in eosinophilic esophagitis, an inflammatory condition of the esophagus. It will examine improvements in difficulty swallowing that lasted up to 52 weeks in the Phase 1b/2 Resolve study. Eupraxia reported the 52-week results from its highest-dose group late last month.
Midweek: JNJ, ARWR And VSTM
Johnson & Johnson (JNJ) will report its third-quarter results on Tuesday. According to Koyfin, analysts expect revenue of $25.38 billion, up 0.3%. They forecast earnings before interest, taxes, depreciation and amortization (EBITDA) at $8.24 billion, down 8%, and earnings before interest and taxes (EBIT) at $7.42 billion, down 10%. GAAP earnings per share (EPS) are projected at $2.07, down 9%.
On Wednesday, Arrowhead Pharmaceuticals (ARWR) will share interim results from an early-stage study of ARO-MAPT, its treatment for Alzheimer’s disease and other disorders linked to abnormal tau protein. A webinar on the same day will also include an update on the company’s central nervous system pipeline.
Verastem Oncology (VSTM) will host an investor event on Wednesday to present initial efficacy results and updated safety data for VS-7375. The oral drug targets KRAS G12D, a cancer-driving mutation, and is being studied in pancreatic, lung and colorectal cancers as part of the Target-D program.
FDA Target Dates Loom For 2 Eye Treatments
Roche (RHHBY) is awaiting an FDA decision by Thursday on its application to use Enspryng (Satralizumab) to treat thyroid eye disease. The application received Priority Review. If approved, Roche says Enspryng could become the first at-home, under-the-skin treatment for the condition. The Phase 3 SatraGO results were presented last year.
Viatris (VTRS) and Opus Genetics (IRD) face an Oct.17 FDA target date for phentolamine eye drops, also known as MR-141, as a treatment for presbyopia — the age-related difficulty focusing on nearby objects. The FDA accepted the application seeking approval for this new use.
GI Conferences Bring More Data Presentations
Pharming (PHAR) will present previously announced Phase 2 results for Leniolisib at the European Society for Immunodeficiencies meeting, running Oct.14-Oct.17 in the Netherlands. The study involved patients with rare, genetically defined immune disorders. Pharming released the top-line findings last month.
Meanwhile, the United European Gastroenterology Week runs from Oct.17-Oct.20 in Barcelona. Abivax (ABVX) will present seven Obefazimod abstracts, including results from a Phase 3 maintenance study and patient subgroup analyses, longer-term Phase 2 findings and a preclinical study.
Agomab will present long-term data from an extension of its STENOVA Phase 2a study, in which patients continued Ontunisertib treatment for up to 60 weeks. The study focuses on fibrostenosing Crohn’s disease, which can cause narrowing of the bowel. Palisade Bio (PALI) will make four presentations on PALI-2108, including Phase 1b findings on early clinical improvements and evidence that the drug affects PDE4, a protein involved in inflammation. Three additional posters will cover gut-targeted delivery, safety and potential biomarkers that could help predict treatment response.
Separately, Filana Therapeutics (FLNA) said it will attend the Maxim Growth Summit, running Oct.12-Oct.14, for one-on-one meetings.
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