The Week Ahead In Biotech (Oct. 10-16): Avadel FDA Decision, Conference Presentations And IPOs Take Center Stage

Biotech stocks retreated in the week ending Oct. 8, extending losses for the third straight week. Some of the selling in the space was due to money moving out of defensive stocks and into risky bets amid the broader market strength.

Vaccine stocks continued to experience selling pressure in the week. Data readouts and presentations at conferences also moved stocks in either direction.

Xenon Pharmaceuticals Inc. XENE was among the biggest gainers after it reported positive topline results from the Phase 2b study of XEN1101 in adult patients with focal epilepsy. On the other hand, Prelude Therapeutics Incorporated PRLD lost about one-half of its market-cap following its presentations at the AACR-NCI-EORTC conference.

Meanwhile, Allogene Therapeutics, Inc. ALLO lost over 100% after the Food and Drug Administration imposed a clinical hold on its CAR T-cell therapy studies following reporting of a chromosomal abnormality in a treated patient.

ChemoCentryx, Inc. CCXI shares benefitted from a positive FDA decision for its avacopan as a treatment for ANCA-associated vasculitis.

Three healthcare companies debuted on Wall Street, raising a combined $452 million.

Here are the key catalysts for the unfolding week:

Conferences

Trends In Medical Mycology Conference: Oct. 8-11 (Aberdeen, U.K.)

American Society of Retina Specialists, or ASRS, 2021 Annual Meeting: Oct. 8-12 (San Antonio, Texas)

Cell & Gene Meeting On The Mesa (hybrid conference): Oct. 12-15 (in Carlsbad, California)

Alliance Global Partners Biotech & Specialty Pharma Conference (virtual conference): Oct. 13

37th Congress of the European Committee for Treatment and Research In Multiple Sclerosis, or ECTRIMS (virtual meeting): Oct. 13-15

European Society for Medical Oncology, or ESMO, Virtual Plenary (virtual meeting): Oct. 14-15

PDUFA Dates

The FDA is scheduled to announce its decision on Avadel Pharmaceuticals plc AVDL's new drug application for FT218, an investigational, once-nightly formulation of sodium oxybate for the treatment of excessive daytime sleepiness and cataplexy in adults with narcolepsy. The decision is due by Friday, Oct. 15.

Clinical Readouts/Presentations

ASRS 2021 Annual Meeting Presentations

4D Molecular Therapeutics, Inc. FDMT: Phase 1/2 data of intravitreal 4D-125 AAV gene therapy in patients with advanced XLRP. (Sunday, Oct. 10, at 3:56 pm)

REGENXBIO Inc. RGNX: CLSD: results from the end-of-study Phase 1/2a study of subretinal delivery of RGX-314 for neovascular age-related macular degeneration (Monday, Oct. 11, at 9:38 am-9:44 am)

Regenxbio & Clearside Biomedical, Inc. CLSD: Phase 2 data for RGX-314 in wet AMD using suprachoroidal delivery (Monday, Oct. 11, at 9:44 am – 9:50 am)

Aerie Pharmaceuticals, Inc. AERI: Topline results from the AR-1105 (dexamethasone intravitreal implant) Phase 2 clinical trial in patients with macular edema due to retinal vein occlusion (Tuesday, Oct. 12, at 11:22 am)

Outlook Therapeutics, Inc. OTLK: data from supplemental safety study for ONS-5010/Lytenava, an investigational ophthalmic formulation of bevacizumab for use in retinal indications (Tuesday, Oct. 12, At 12:08 am to 12:14 am)

ECTRIMS Conference Presentations

Atara Biotherapeutics, Inc. ATRA: updated open-label extension clinical data and new magnetization transfer ratio imaging data from a Phase 1 study of ATA188 for progressive multiple sclerosis (Wednesday, Oct. 13, at 10:45 am)

ESMO Presentations

Eli Lilly and Company LLY: new data from the monarchE study for an investigational use of Verzenio, in combination with endocrine therapy, in patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative high risk early breast cancer (Thursday, Oct. 14, at 1:30 pm)

Standalone Presentations

CRISPR Therapeutics AG CRSP will host a virtual event on Tuesday, Oct. 12, at 4:30 p.m. to highlight clinical data from its ongoing Phase 1 study of CTX110 for the treatment of relapsed or refractory B-cell malignancies.

Earnings

Enzo Biochem, Inc. ENZ (Tuesday, Oct. 12, before the market open)
Theratechnologies Inc. THTX (Wednesday, Oct. 13, before the market open)

IPOs

IPO Pricing

Cingulate Inc CING, a clinical stage biopharma using its proprietary "Precision Timed Release" drug delivery platform technology, has filed for offering 4.55 million shares in an IPO at an estimated price range of $10-$12. The Kansas-based company has applied for listing its shares on the Nasdaq under the ticker symbol "CING."

Medical device maker PAVmed Inc. PAVM's spin-off unit Lucid Diagnostics Inc.LUCD has filed a preliminary prospectus with the SEC to offer 5 million shares in an IPO to be priced in the range of $14-$16. The New York-based company has applied for listing its shares on the Nasdaq under the ticker symbol "LUCD."

Lucid is a commercial-stage medical diagnostics technology company focused on treating patients with gastroesophageal reflux disease, also known as chronic heartburn, acid reflux or simply reflux, who are at risk of developing esophageal precancer and cancer, specifically highly lethal esophageal adenocarcinoma.
PAVmed currently owns approximately 72.6% of Lucid's outstanding common stock, and is its controlling stockholder.

Newport Beach, California-based Aeon Biopharma, Inc. AEON has filed to offer 5 million shares in an IPO, with the price estimated to be between $14 and $16 apiece.

Aeon is a clinical stage biopharma focused on developing its proprietary botulinum toxin complex, ABP-450 injection, or ABP-450, for debilitating medical conditions, with an initial focus on the neurology and gastroenterology markets. The company has applied for listing its shares on the Nasdaq under the ticker symbol "AEON."

IPO Quiet Period Expiry

DICE Therapeutics, Inc. DICE
Pasithea Therapeutics Corp. KTTA
Tyra Biosciences, Inc. TYRA