The Week Ahead In Biotech (July 25-31): Big Pharma Revenue, Iterum FDA Decision, Alzheimer’s Conference, IPOs, and More

Biotech stocks recovered in the week ending July 23, on the back of broader market strength. The industry also benefited from the optimism sparked by the solid start to the pharma reporting season.

Major pharmaceutical companies including: Johnson & Johnson (NYSE: JNJ) and Novartis AG (NYSE: NVS) reported superlative results and provided positive guidance. Pre-announcements from space were also mostly positive.

Moderna, Inc.’s (NASDAQ: MRNA) buoyancy over the week. The stock went from strength to strength, ending the week with a gain of over 21%. On Wednesday, the company was added to the S&P 500 Index.

Ardelyx, Inc. (NASDAQ:ARDX) lost about 77% of its market capitalization after the Food and Drug Administration noted potential deficiencies in the use of new drugs as a treatment for hyperphosphatemia.

Pfizer, Inc.(NYSE: PFE) also faced a regulatory setback as the FDA announced a delay in decisions to treat atopic dermatitis and Xeljanz/Xeljanz XR to treat adults with ankylosing spondylitis.

Albireo Pharma, Inc. (NASDAQ: ALBO), however, have received consecutive approvals, from both the FDA and the European Medicines Agency, for Bylvay for the treatment of pruritus in all subtypes of progressive familial intrahepatic cholestasis, a rare progressive liver disease.

The week also witnessed a slew of IPOs by biopharmaceuticals, medical devices and diagnostic companies.

Here are the key catalysts for a biotech investment to focus on in the coming week:

Conferences

Alzheimer’s Association International Conference, or AAIC: July 26-30 (to be held virtually and also in Denver, Colarado

SVB Leerink CyberRx: Big Data, AI & Machine Learning in Healthcare Conference (virtual event): July 28

PDUFA Dates

The FDA is scheduled to announce its decision on: Iterum Therapeutics PLCs (NASDAQ: ITRM) NDA for oral sulopenem for the treatment of uncomplicated urinary tract infections in patients with a nonsusceptible pathogen to quinolone. In early July, the company said the regulatory agency indicated it identified deficiencies in the application.

In response to the development, Iterum shares fell about 38% in one session and have not recovered since.

Clinical Readings/Presentations

AAIC Conference Presentations

Longeveron Inc. (NASDAQ: LGVN): Results of Phase 1 Study of Lomecel-B Infusion for Patients with Mild Alzheimer’s Disease

Biogen Inc. (NASDAQ: BIIB): Results of Phase 1b Study of Antisense Oligonucleotide Targeting Tau mRNA) BIIB080 in Patients with Mild Alzheimer’s Disease (Monday); BIIB080 has been licensed by Ionis Pharmaceuticals, Inc. (NASDAQ: IONS)

Athira Pharma, Inc. (NASDAQ: ATHA): Data, including in patients with Alzheimer’s disease, from Phase 1 a/b trial of lead development candidate, ATH-1017 (Monday)

Selector, Inc. (NASDAQ: ALEC): Results of the Phase 2 Study to Evaluate the Efficacy and Safety of AL002 in Participants with Early Alzheimer’s Disease (Monday) and Six and 12 Month Data from the Open-Label Phase 2 INFRONT-2 study evaluating AL001 in subjects with frontotemporal dementia due to a progranulin gene mutation (Thurs)

Cyclerion Therapeutics, Inc. (NASDAQ: CYCN): Clinical Trial Design Poster for a Phase 2a Study of CY6463 in Participants with Alzheimer’s Disease with Vascular Pathology (Monday)

Cortexyme, Inc. (NASDAQ: CRTX): Updated and Baseline Data from the Phase 2/3 GAIN Study of COR388 (atuzaginstat) for the Treatment of Alzheimer’s Disease (Monday)

Cassava Sciences, Inc. (NASDAQ: SAVA): SavaDx Diagnostic Data Confirms Mechanism of Action of Simufilam (Monday)

Annovis Bio, Inc. ANVS): New Phase 2a Data for its Leading Product Candidate, ANVS401 for Alzheimer’s and Parkinson’s Disease (Wednesday)

AC Immune SA (NASDAQ: ACIU): Data from Phase 1b Study of the Anti-Abeta Vaccine ACI-24 in Down Syndrome (Wednesday)

Related link: How much would a $1,000 investment in Moderna stock at the time of COVID-19 vaccine approval be worth today?

View more earnings on IBB

Standalone releases

Unity Biotechnology, Inc. (NASDAQ: UBX): Clinical Data from the Phase 1 Study of a Single Injection of UBX1325 in Patients with Diabetic Macular Edema and Wet Age-Related Macular Degeneration (Tuesday)

Infinity Pharmaceuticals, Inc. (NASDAQ: INFI): Updates on the Clinical Trials in MARIO-3 Triple-Negative Breast Cancer and MARIO-275 Ulcerative Colitis, Both Adding Eganelisib to Approved Standard of Care (Tuesday)

Clinical Readings Scheduled for July

MediWound Ltd. (NASDAQ: MDWD): Interim Review of Phase 2 Adaptive Design Study of EscharEx for the Treatment of Venous Leg Ulcers

Income

Monday

Agile Therapeutics, Inc. (NASDAQ: AGRX) (after the close)

Tuesday

Boston Scientific Corporation (NYSE:BSX) (before the market opens)
Massimo Corporation (NASDAQ: MASI) (afterwards)
Taro Pharmaceutical Industries Ltd. (NYSE: TARO) (after the close)

Wednesday

Bristol-Myers Squibb Company (NYSE: BMY)
Pfizer, Inc. (NYSE: PFE)
Integra LifeSciences Holdings Corporation (NASDAQ: IART)
Lantheus Holdings, Inc. (NASDAQ: LNTH)
Myovant Sciences Ltd. (NYSE: MYOV)
Alkermes, Inc. (NASDAQ: ALKS) (before market opening)
Viking Therapeutics, Inc. (NASDAQ: VKTX) (after closing)
BioMarin Pharmaceutical Inc. ((NASDAQ: BMRN)
Exact Sciences Corporation (NASDAQ: EXAS)
PPD, Inc. (NASDAQ: PPD)
Lantern Pharma Inc. (NASDAQ: LTRN)
Hologic, Inc. (NASDAQ: HOLX)
Vanda Pharmaceuticals Inc. (NASDAQ: VNDA)

Thursday

Merck & Co., Inc. (NYSE: MRK) (before the market opens)
Intercept Pharmaceuticals, Inc. (NASDAQ: ICPT) (before the market opens)
NovoCure Limited (NASDAQ: NVCR) (before market opening)
West Pharmaceutical Services, Inc. (NYSE: WST) (before the market opens)
Agios Pharmaceuticals, Inc. (NASDAQ: AGIO) (before market opening)
Blueprint Medicines Corporation (NASDAQ: BPMC) (before the market opens)
Evelo Biosciences, Inc. (NASDAQ: EVLO) (before market opening)
Travere Therapeutics, Inc. (NASDAQ: TVTX) (after the close)
Emerging BioSolutions Inc. (NYSE:EBS) (after closing)
Bio-Rad Laboratories, Inc. (NYSE: BIO) (after closing)
Seagen Inc. (NASDAQ: SGEN) (after closing)
QIAGEN NV (NASDAQ: QGEN) (after the close)
Gilead Sciences, Inc. (NASDAQ: GILD) (after closing)
OPKO Health, Inc. (NASDAQ: OPK) (after closing)
Verracyte, Inc. (NASDAQ: VCYT) (afterwards)
Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) (after closing)
PTC Therapeutics, Inc. (NASDAQ: PTCT) (after the close)
Silk Road Medical, Inc (NASDAQ: SILK) (after closing)
Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX) (after the close)
DexCom, Inc. (NASDAQ: DXCM) (after the close)
CareDx, Inc (NASDAQ: CDNA) (after the shutdown)
Edwards Lifesciences Corporation (NYSE: EW) (after the close)

Friday

AbbVie Inc. (NYSE: ABBV) (before the market opens)
ImmunoGen, Inc. (NASDAQ: IMGN) (before the market opens)

IPOs

IPO prices

Philadelphia, Pennsylvania-based Context Therapeutics, Inc. plans an initial public offering of 1.5 million shares at an estimated price range of $12-$14. The company has applied to list its shares on the Nasdaq under the ticker symbol CNTX. Context is a clinical stage biopharma developing therapies for women with cancer.

New York-based IN8bio is offering 4 million shares in an IPO at an estimated price range of $10-$12. The oncology-focused biopharma has applied to list its shares on the Nasdaq under the ticker symbol INAB.

Rallybio Corporation, based in New Haven, Connecticut, is trying to raise money by offering 5.75 million shares through an IPO. The stock will likely be priced between $13 and $15. The clinical stage biopharmaceuticals focused on serious and rare diseases has applied to list its shares on the Nasdaq under the ticker symbol RLYB.

Candel Therapeutics, Inc., a Massachusetts late clinical stage biopharmaceutical company focused on helping patients fight cancer with oncolytic viral immunotherapies, has applied to offer 6.072 million shares in an IPO. The company expects the offering’s price to be between $13 and $15 and has applied to list its shares on the Nasdaq under the ticker symbol CADL.

Elicio Therapeutics, Inc., also an oncology-focused biopharmaceutical in Massachusetts, will offer 3,077 million shares in an IPO, with the price range estimated at $12 and $14. The company has applied to list its shares on the Nasdaq under the ticker symbol ELTX.

Providence, Rhode Island-based Ocean Biomedical, Inc. has filed an application to offer 3.2258 million shares in an IPO. The company expects the price of the offering to be in the $14-$17 range. The biopharma focuses on licensing technology and innovations and developing them into products. It has applied to list its shares on the Nasdaq under the ticker symbol OCEA.

IPO Silent Period Expires

CVRx, Inc. (CVRX)
Aerovate Therapeutics, Inc. (AVTE)
Acumen Pharmaceuticals, Inc. (ABOS)

Related link: FibroGen Analyst Removes US Roxadustat Sales From Model After AdCom Snub

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