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.

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