The Week Ahead In Biotech (July 25-31): Big Pharma Earnings, Iterum FDA Decision, Alzheimer's Conference, IPOs, And More

The Week Ahead In Biotech July 25-31: Big Pharma Earnings, Iterum FDA Decision, Alzheimer's Conference, IPOs and More

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

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

Moderna, Inc.'s (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. (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. (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. (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 investor may do well to focus on in the unfolding week:

Conferences

  • Alzheimer's Association International Conference, or AAIC (to be held virtually and also in Denver, Colarado): July 26-30.
  • 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 (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 the stock has not recovered since then.

AAIC Conference Presentations

  • Longeveron Inc. (LGVN): To report results of its Phase 1 trial of Lomecel-B infusion for patients with mild Alzheimer's disease.
  • Biogen Inc. (BIIB): To report 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. (IONS).
  • Athira Pharma, Inc. (ATHA): To report data, including in Alzheimer's patients, from the Phase 1 a/b trial of its lead development candidate, ATH-1017 (Monday).
  • Alector, Inc. (ALEC): To report 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. (CYCN): To report on the clinical trial design for a Phase 2a study of CY6463 in participants with Alzheimer's disease with vascular pathology (Monday).
  • Cortexyme, Inc. (CRTX): To report 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. (SAVA): To report data showing SavaDx diagnostic data confirms mechanism of action of Simufilam (Monday).
  • Annovis Bio, Inc. (ANVS): To report new Phase 2a data for its lead product candidate, ANVS401 in Alzheimer's and Parkinson's diseases (Wednesday).
  • AC Immune SA (ACIU): To report data from Phase 1b trial of the anti-Abeta vaccine ACI-24 in Down syndrome (Wednesday).

Standalone Releases

Unity Biotechnology, Inc. (UBX): To report 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. (INFI): To report 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. (MDWD): To report interim assessment of Phase 2 adaptive design study of EscharEx for the treatment of venous leg ulcers.

Earnings

Monday:

  • Agile Therapeutics, Inc. (AGRX) (after the close).

Tuesday:

  • Boston Scientific Corporation (BSX) (before the market open).
  • Masimo Corporation (MASI) (after the close).
  • Taro Pharmaceutical Industries Ltd. (TARO) (after the close).

Wednesday:

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

Thursday:

  • Merck & Co., Inc. (MRK) (before the market open).
  • Intercept Pharmaceuticals, Inc. (ICPT) (before the market open).
  • NovoCure Limited (NVCR) (before the market open).
  • West Pharmaceutical Services, Inc. (WST) (before the market open).
  • Agios Pharmaceuticals, Inc. (AGIO) (before the market open).
  • Blueprint Medicines Corporation (BPMC) (before the market open).
  • Evelo Biosciences, Inc. (before the market open).
  • Bio-Rad Laboratories, Inc. (BIO) (after the close).
  • Seagen Inc. (SGEN) (after the close).
  • QIAGEN N.V. (QGEN) (after the close).
  • Gilead Sciences, Inc. (GILD) (after the close).
  • OPKO Health, Inc. (OPK) (after the close).
  • Veracyte, Inc. (VCYT) (after the close).
  • Ligand Pharmaceuticals Incorporated (LGND) (after the close).
  • PTC Therapeutics, Inc. (PTCT) (after the close).
  • Silk Road Medical, Inc (SILK) (after the close).
  • Vertex Pharmaceuticals Incorporated (VRTX) (after the close).
  • DexCom, Inc. (DXCM) (after the close).
  • CareDx, Inc (CDNA) (after the close).
  • Edwards Lifesciences Corporation (EW) (after the close).

Friday:

  • AbbVie Inc. (ABBV) (before the market open).
  • ImmunoGen, Inc. (IMGN) (before the market open).

IPOs

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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