The Week Ahead In Biotech: Big Pharma Earnings, Iterum FDA Decision, Alzheimer's Conference, IPOs and More

·7 min read

Biotech stocks rebounded in the week ended July 23, thanks to the broader market strength. The sector also benefitted from the optimism that was set in motion by the solid start to the pharma reporting season.

Big pharma companies, including Johnson & Johnson (NYSE: JNJ) and Novartis AG (NYSE: NVS) reported forecast-beating results and issued positive guidance. Preannouncements from the space were also largely positive.

Moderna, Inc.'s (NASDAQ: MRNA) buoyancy spilled over into the week. The stock went from strength to strength and ended 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 flagged potential deficiencies in its tenapanor new drug application as a treatment for hyperphosphatemia.

Pfizer, Inc.(NYSE: PFE) also faced a regulatory setback as the FDA communicated a delay in the decisions for its atopic dermatitis treatment and Xeljanz/Xeljanz XR for the treatment of adults with ankylosing spondylitis.

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

The week also witnessed a slew of initial public offerings by biopharma, medical device and diagnostics companies.

Here are the key catalysts that a biotech invest may do well to focus on, in the unfolding week:

Conferences

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

SVB Leerink CybeRx: Big Data, A.I. & Machine Learning in Healthcare Conference (virtual event): July 28

PDUFA Dates

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

Reacting to the development, Iterum's shares fell about 38% in a single session and has not recovered since then.

Clinical Readouts/Presentations

AAIC Conference Presentations

Longeveron Inc. (NASDAQ: LGVN): results of its Phase 1 trial of Lomecel-B infusion for patients with mild Alzheimer's disease

Biogen Inc. (NASDAQ: BIIB): results of the Phase 1b study of antisense oligonucleotide, targeting Tau mRNA ) BIIB080 in patients with mild Alzheimer's disease (Monday); BIIB080 has been in-licensed from Ionis Pharmaceuticals, Inc. (NASDAQ: IONS)

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

Alector, Inc. (NASDAQ: ALEC): results from the Phase 2 study to evaluate the efficacy and safety of AL002 in participants with early Alzheimer's disease (Monday) and six- and twelve-month data from the open-label Phase 2 INFRONT-2 study evaluating AL001 in individuals with frontotemporal dementia due to a progranulin gene mutation (Thursday)

Cyclerion Therapeutics, Inc. (NASDAQ: CYCN): poster on the clinical trial design 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 trial of COR388 (atuzaginstat) for the treatment of Alzheimer's Disease (Monday)

Cassava Sciences, Inc. (NASDAQ: SAVA): Data showing SavaDx diagnostic data confirms mechanism of action of Simufilam (Monday)

Annovis Bio, Inc. ANVS): new Phase 2a data for its lead product candidate, ANVS401 in Alzheimer's and Parkinson's diseases (Wednesday)

AC Immune SA (NASDAQ: ACIU): data from Phase 1b trial of the anti-Abeta vaccine ACI-24 in Down syndrome (Wednesday)

Related Link: How Much A $1,000 Investment In Moderna Stock At the Time Of COVID-19 Vaccine Authorization Would 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 MARIO-3 triple negative breast cancer and MARIO-275 ulcerative colitis clinical studies, both of which add eganelisib to approved standard of care regimens (Tuesday)

Clinical Readouts Scheduled for July

MediWound Ltd. (NASDAQ: MDWD): interim assessment of Phase 2 adaptive design study of EscharEx for the treatment of venous leg ulcers

Earnings

Monday

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

Tuesday

Boston Scientific Corporation (NYSE: BSX) (before the market open)
Masimo Corporation (NASDAQ: MASI) (after the close)
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 the market open)
Viking Therapeutics, Inc. (NASDAQ: VKTX) (after the close)
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 open)
Intercept Pharmaceuticals, Inc. (NASDAQ: ICPT) (before the market open)
NovoCure Limited (NASDAQ: NVCR) (before the market open)
West Pharmaceutical Services, Inc. (NYSE: WST) (before the market open)
Agios Pharmaceuticals, Inc. (NASDAQ: AGIO) (before the market open)
Blueprint Medicines Corporation (NASDAQ: BPMC) (before the market open)
Evelo Biosciences, Inc. (NASDAQ: EVLO) (before the market open)
Travere Therapeutics, Inc. (NASDAQ: TVTX) (after the close)
Emergent BioSolutions Inc. (NYSE: EBS) (after the close)
Bio-Rad Laboratories, Inc. (NYSE: BIO) (after the close)
Seagen Inc. (NASDAQ: SGEN) (after the close)
QIAGEN N.V. (NASDAQ: QGEN) (after the close)
Gilead Sciences, Inc. (NASDAQ: GILD) (after the close)
OPKO Health, Inc. (NASDAQ: OPK) (after the close)
Veracyte, Inc. (NASDAQ: VCYT) (after the close)
Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) (after the close)
PTC Therapeutics, Inc. (NASDAQ: PTCT) (after the close)
Silk Road Medical, Inc (NASDAQ: SILK) (after the close)
Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX) (after the close)
DexCom, Inc. (NASDAQ: DXCM) (after the close)
CareDx, Inc (NASDAQ: CDNA) (after the close)
Edwards Lifesciences Corporation (NYSE: EW) (after the close)

Friday

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

IPOs

IPO Pricing

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

Rallybio Corporation, based out of New Haven, Connecticut is seeking to raise finances by offering 5.75 million shares in an IPO. The shares are likely to be priced between $13 and $15. The severe and rare diseases-focused clinical-stage biopharma has applied for listing its shares on the Nasdaq under the ticker symbol RLYB.

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

Elicio Therapeutics, Inc., also a Massachusetts-based oncology-focused clinical-stage biopharma, will offer 3.077 million shares in an IPO, with the price range estimated to be $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 to offer 3.2258 million shares in an IPO. The company expects to price the offering in the range of $14-$17. The biopharma focuses on licensing tech and innovations and developing them into products. It has applied to list its shares on the Nasdaq under the ticker symbol OCEA.

IPO Quiet Period Expiry

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

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