The Week Ahead In Biotech: Incyte, Ascendis FDA Decisions, Liver Congress Presentations And 4 IPOs

Biotech stocks came under pressure in the week ended June 18, dragged by the negative sentiment that prevailed in the broader market due to macroeconomic worries.

The U.S. Federal Reserve's monetary policy setting arm — the FOMC — met this week and the key takeaway from the meeting is that after being at a very accommodative level of 0-0.25% ever since the onset of the pandemic, the fed funds target could be hiked as early as 2023.

Several stock-specific catalysts also panned out negatively. After Aduhelm approval, Biogen, Inc. BIIB faced multiple clinical trial disappointments, including a failed gene therapy study in choroideremia and stalling of an Alzheimer's trial.

High-flying meme stock Orphazyme A S ADR ORPH came crashing down after the Food and Drug Administration slapped a complete response letter for its new drug application for an investigational drug to treat Niemann-Pick disease type C, a rare, progressive, neurodegenerative disease.

Among the other FDA decisions due for the week, Eton Pharmaceuticals, Inc. ETON and Blueprint Medicines Corp BPMC secured nods for treatments for low blood pressure and advanced systemic mastocytosis, respectively. Takeda Pharmaceutical Co Ltd TAK is yet to hear from the FDA on its eosinophilic esophagitis treatment.

German vaccine developer CureVac BV CVAC, backed by the Gates Foundation, reported disappointing Phase 2/3 results for its vaccine candidate, sending its shares down by over 40% in a single session.

The week, however, started with some positive tidings from Novavax, Inc. NVAX. The Maryland-based biopharma reported encouraging data from the U.S. leg of the Phase 3 study of its vaccine candidate against the wild coronavirus and variants.

The week also witnessed a host of an initial public offering, as IPO news flow resumed after a lull.

Here are the key catalytic events for the unfolding week:

Conferences

16th International Conference on Malignant Lymphoma, or ICML, Virtual Edition: June 18-22
Raymond James Human Health Innovation 2021 Virtual Conference: June 21-23
LifeSci Genetics Medicine Conference: June 22
BMO Biopharma Day: Spotlight on Rare Disease and Ophthalmology: June 22
Prader-Willi Syndrome Association, or PWSA, USA National Convention: June 22-26
The Piper Sandler SynBio Day: June 23
Parent Project Muscular Dystrophy, or PPMD, Annual Conference (Virtual Edition): June 23-26
The International Liver Congress 2021 - The Annual Meeting of the European Association for the Study of the Liver, or EASL: June 23-26
Facioscapulohumeral Muscular Dystrophy, or FSHD, Society's International Research Congress: June 24
Polycystic Kidney Disease, or PKD, Connect Conference: June 25-26
2021 Peripheral Nerve Society, or PNS, Annual Meeting: June 25-27

PDUFA Dates

The FDA is scheduled to rule on Incyte Corporation's INCY NDA for ruxolitinib cream, a selective JAK1/JAK2 inhibitor designed for topical application, as a treatment for atopic dermatitis. The PDUFA date is fixed for Monday, June 21.

Incyte also awaits the decision on its supplemental NDA for ruxolitinib, which goes by the trade name Jakafi, as a treatment option for steroid-refractory chronic graft-versus-host disease in adult and pediatric patients 12 years and older. The PDUFA date for the sNDA is Tuesday, June 22.

The regulator will also announce by Friday, June 25, its decision on the Ascendis Pharma A/S ASND biologic license application for TransCon hGH, which is being evaluated for the treatment of pediatric patients with growth hormone deficiency.

The FDA could also rule on AbbVie Inc.'s ABBV sNDA for Rinvoq as a treatment option for patients with active ankylosing spondylitis. Given the regulatory application was accepted for regular review on Aug. 25, 2020, a decision could come by Friday, June 25.

Clinical Readouts

ICML Presentation

Innate Pharma SA IPHA: preliminary mycosis fungoides data from the Phase 2 TELLOMAK trial evaluating lacutamab, an anti-KIR3DL2 cytotoxicity-inducing antibody in development for T-cell lymphomas (Tuesday)

EASL Meeting Presentations

Alnylam Pharmaceuticals, Inc. ALNY and Vir Biotechnology, Inc. VIR: Preliminary on-treatment data from a phase 2 study evaluating VIR-2218 in combination with pegylated interferon alfa-2a in participants with chronic hepatitis B infection (Wednesday). Also up for Vir Biotechnology, is additional data from the Phase 1 study evaluating the neutralizing, vaccinal monoclonal antibody VIR-3434 in participants with chronic hepatitis B virus infection (Friday)

Assembly Biosciences Inc. ASMB: Phase 2 data for second-generation hepatitis B virus core inhibitor ABI-H2158 (Friday)

Inventiva ADR IVA: SUbgroup analysis of data from the Phase 2b study of Lanifibranor therapy in patients with NASH and F2 and F3 fibrosis stages (Friday)

Akero Therapeutics Inc AKRO: Results from the Cohort C extension of the Phase 2a BALANCED study of efruxifermin in F4 non-alcoholic steatohepatitis patients with compensated cirrhosis (Saturday)

Arbutus Biopharma Corp ABUS: Phase 1a/1b data for AB-729 in subjects with chronic hepatitis B (Saturday)

DURECT Corporation DRRX: Phase 1b data for DUR-928 in NASH

PPMD Conference Presentation

Capricor Therapeutics, Inc. CAPR: Phase 2 HOPE-2 open-label study of CAP-1002 in Duchenne Muscular Dystrophy (Wednesday)

PWSA Meeting Presentation

Radius Health, Inc. RDUS: Data from Phase 2 study of RAD011 in Prader-Willi Syndrome (Wednesday)

FSHD Congress Presentation

Fulcrum Therapeutics In. FULC: Data from the Phase 2b clinical trial of Losmapimod, a treatment for FSH muscular dystrophy that is intended to stop the expression of the DUX4 gene and slow the progression of symptoms (Thursday)

Regulus Therapeutics Inc RGLS: Data from the first cohort of Phase 1b study of RGLS4326 in patients with autosomal dominant polycystic kidney disease (Friday)

2021 PNS Annual Meeting Presentation

Intellia Therapeutics, Inc. NTLA: Interim Phase 1 data from NTLA-2001, its lead CRISPR/Cas9 in vivo therapy in development as a single-dose, systemically administered treatment for transthyretin amyloidosis (Saturday)

IPOs

IPO Pricings

Miromatrix Medical Inc., a life sciences company developing a technology for bioengineering fully transplantable human organs to help save and improve patients' lives, has filed to offer 4 million shares in an initial public offering. The company expects to price the offering between $7 and $9. It has applied for listing its shares on the Nasdaq under the ticker symbol "MIRO."

Unicycive, a California-based biopharma that focuses on treatment of kidney diseases, has filed to offer $2.635 million shares at an estimated price range of $8.50-$1.50. The company has applied for listing its shares on the Nasdaq under the ticker symbol "UNCY."

Acurx Pharmaceuticals, a New York-based clinical-stage biopharma developing a new class of antibiotics for infections caused by bacteria listed as priority pathogens, has filed to offer 2.5 million shares in an IPO at an estimated price range of $5-$7. The company has applied for listing its shares on the Nasdaq under the ticker symbol "ACXP."

Hong Kong-based Regencell Bioscience Holdings Limited is proposing to offer 2.3 million 2.35 million shares in an IPO. The company expects to price the offering between $8.50 and $10.50 apiece and has applied for listing the shares on the Nasdaq under the ticker symbol RGC.

Regencell focuses on treatments for neurocognitive disorders and degeneration, specifically Attention Deficit Hyperactivity Disorder and Autism Spectrum Disorder.

IPO Quiet Period Expiry

Day One Biopharmaceuticals Inc DAWN
Centessa Pharmaceuticals PLC - ADR CNTA
Singular Genomics Systems Inc OMIC