Biotech stocks extended their gains in the week ending Sept. 3, partly aided by the broader market strength. The news flow was fairly light ahead of the Labor Day holiday weekend.
Clinical readouts swung stocks wildly during the week. Forte Biosciences, Inc. (NASDAQ:FBRX) plunged over 80% in reaction to its announcement that the Phase 2 clinical study of its investigational asset FB-401 for the treatment of atopic dermatitis failed to meet its primary endpoint with statistical significance.
On the regulatory front, Impel NeuroPharma, Inc. (NASDAQ:IMPL) received the Food and Drug Administration's approval for Trudhesa, its lead candidate, for the treatment of acute migraine. On a not-so-positive note, a Wall Street Journal report suggested that the FDA is in no hurry to approve Pfizer, Inc. (NYSE:PFE)-BioNTech SE (NASDAQ:BNTX)'s COVID-19 vaccine booster shot.
Here are the key catalytic events for the unfolding week:
Conferences
- International Liver Conference Association, or ILCA, Annual Conference (virtual): Sept. 2-5
- European Respiratory Society, or ERS, International Conference 2021 (virtual): Sept. 5-8
- Goldman Sachs Eleventh Annual Biotech Symposium: Sept. 7-10
- Citi's 16th Annual BioPharma Conference (virtual): Sept. 8-10
- 2021 Wells Fargo Virtual Healthcare Conference (virtual): Sept. 9-10
- Morgan Stanley 19th Annual Global Healthcare Conference (virtual): Sept. 9-15
- American Urological Association, AUA, Conference (virtual): Sept. 10-13
- Heart Failure Society of America, or HFSA, Annual Scientific Meeting (both virtual and in-person, hybrid format): Sept. 10-13
- International Association of the Study of Lung Cancer, or IASLC, 2021 World Conference on Lung Cancer (virtual): Sept. 11-14
Related Link: Attention Biotech Investors: Mark Your Calendar For September PDUFA Dates
Clinical Readouts/Presentations
Pliant Therapeutics, Inc. (NASDAQ:PLRX) will release Tuesday, Sept. 7, interim clinical data from an ongoing Phase 2a positron emission tomography imaging trial of PLN-74809 in patients with idiopathic pulmonary fibrosis.
INmune Bio, Inc. (NASDAQ:INMB) is due to present additional Phase 1b data on XPro, its selective DN-TNF inhibitor candidate for the treatment of Alzheimer's disease, treatment resistant depression, and other neurological diseases where neuroinflammation is implicated. The presentation is scheduled for Tuesday, Sept. 7, at 4:30 pm.
Valneva SE (NASDAQ:VALN) said, at the Goldman Sachs Biotech Symposium, it will present an update on its late stage vaccine candidate VLA-15 against Lyme disease. The company is partnering with Pfizer for this program. Valneva will also present updates on its two more late-stage vaccine candidates - VLA2001 against COVID-19 and VLA 1553 against chikungunya. VLA2001 is being evaluated in combination with Dynavax Technologies Corporation (NASDAQ:DVAX)'s vaccine adjuvant and alum. The presentations are scheduled for Tuesday, Sept. 7.
Cardiff Oncology, Inc. (NASDAQ:CRDF) will present new data from its Phase 1b/2 clinical trial evaluating onvansertib in combination with standard-of-care FOLFIRI/Bristol-Mysrs Squibb Company (NYSE:BMY)'s Avastin in KRAS-mutated metastatic colorectal cancer. The presentation is organized as a virtual KOL event for analysts, investors, and the scientific community on Wednesday, Sept. 8, between 4 pm and 5 pm.
ImmunityBio, Inc. (NASDAQ:IBRX) will present at the AUA conference Phase 2/3 clinical results of IL-15 Superagonist N-803 with BCG in BCG-unresponsive bladder cancer. The presentation is scheduled for Friday, Sept. 10.
Mersana Therapeutics, Inc. (NASDAQ:MRSN) will host a webcast to discuss progress of its clinical development strategy for upifitamab rilsodotin and report updated interim data from the ovarian cancer expansion cohort of the UpRi Phase 1 study. The webcast is scheduled for Friday, Sept. 10, at 8 am.
Earnings
- Centogene N.V. (NASDAQ:CNTG) (Tuesday, before the market open)
- Affimed N.V. (NASDAQ:AFMD) (Wednesday, before the market open)
- Trinity Biotech plc (NASDAQ:TRIB) (Thursday, before the market open)
IPOs
IPO Quiet Period Expiry
Dermata Therapeutics, Inc. (NASDAQ:DRMA)
Related Link: Why Cassava Sciences Stock Investors Are Pulling Back