The Week Ahead In Biotech (Feb. 27-March 5): Earnings, Multiple Regulatory Decisions Take The Spotlight

The Week Ahead In Biotech Feb. 27-March 5: Earnings, Multiple Regulatory Decisions Take The Spotlight

Biopharma stocks lock-stepped with the broader market in the week ending Feb. 25 before finishing higher. The trajectory was the same, with the sector declining in the first two sessions of the holiday-shortened week before making a comeback.

Earnings news picked up pace during the week and served as catalysts for stock moves. Kodiak Sciences Inc. (KOD) was among the worst decliners for the week after it's lead candidate KSI-301 could not ace a Phase 2/3 study in wet age-related macular degeneration.

On the regulatory front, Reata Pharmaceuticals, Inc. (RETA) received a complete response letter for the new drug application for bardoxolone methyl for the treatment of patients with chronic kidney disease, caused by Alport syndrome.

Meanwhile, Eli Lilly & Co. (LLY) and partner Boehringer Ingelheim announced the Food and Drug Administration's nod for expanding the label for Jardiance to be used for reducing the risk of death and hospitalization for all patients with heart failure.

Here are the key catalysts that can influence trading in biopharma stocks in the unfolding week.

Conferences

  • American Academy of Allergy, Asthma & Immunology, or AAAAI, Annual Meeting: Feb. 25-28, in Phoenix, Arizona.
  • Credit Suisse London Global Healthcare Conference: March 1-2 (virtual event).

PDUFA Dates

The FDA is scheduled to rule on Amryt Pharma plc's (AMYT) NDA for Filsuvez, which is being evaluated as a treatment for the cutaneous manifestations of junctional and dystrophic epidermolysis bullosa, a rare genetic skin disorder affecting young children and adults for which there is currently no approved treatment. The PDUFA goal date is Monday, Feb. 28.

Both Johnson & Johnson (JNJ) and Legend Biotech Corporation (LEGN) have a tryst with the FDA on Monday regarding their biologic license application for ciltacabtagene autoleucel (Cilta-cel). Cilta-cel is a B-cell maturation antigen CAR-T therapy that is being investigated for the treatment of adults with relapsed and/or refractory multiple myeloma.

The FDA is also required to rule on the NDA submitted by Gilead Sciences, Inc. (GILD) relating to its lenacapavir, an investigational, long-acting HIV-1 capsid inhibitor, for the treatment of HIV-1 infection in heavily treatment-experienced people with multi-drug resistant HIV-1 infection. The decision is due by Monday.

CTI BioPharma Corp. (CTIC) has a PDUFA goal date of Monday for its NDA for Pacritinib for the treatment of myelofibrosis patients with severe thrombocytopenia.

Clinical Data Readouts/Presentations

  • Intellia Therapeutics, Inc. (NTLA) will present additional interim clinical data from the ongoing Phase 1 study of NTLA-2001 in patients with transthyretin amyloidosis with polyneuropathy. The company is presenting on Monday, Feb. 28, at 4:30 p.m.
  • KalVista Pharmaceuticals, Inc. (KALV) will present new data on KVD900, its lead drug program for oral on-demand treatment of hereditary angioedema (HAE) attacks.

Earnings - Monday

  • Reata Pharmaceuticals, Inc. (RETA): reporting before the market open.
  • Viatris Inc. (VTRS): reporting before the market open.
  • ACADIA Pharmaceuticals Inc. (ACAD): reporting after the market close.
  • Fate Therapeutics, Inc. (FATE): reporting after the market close.
  • FibroGen, Inc. (FGEN): reporting after the market close.
  • Mirati Therapeutics, Inc. (MRTX): reporting after the market close.
  • Novavax, Inc. (NVAX): reporting after the market close.
  • Endo International plc (ENDP): reporting after the market close.
  • Heron Therapeutics, Inc. (HRTX): reporting after the market close.
  • Supernus Pharmaceuticals, Inc. (SUPN): reporting after the market close.

Tuesday

  • Amarin Corporation plc (AMRN): reporting before the market open.
  • Amyris, Inc. (AMRS): reporting before the market open.
  • Epizyme, Inc. (EPZM): reporting before the market open.
  • Horizon Therapeutics Public Limited Company (HZNP): reporting before the market open.
  • Intra-Cellular Therapies, Inc. (ITCI): reporting before the market open.
  • ChemoCentryx, Inc. (CCXI): reporting after the market close.
  • Inovio Pharmaceuticals, Inc. (INO): reporting after the market close.
  • Jazz Pharmaceuticals plc (JAZZ): reporting after the market close.
  • REGENXBIO Inc. (RGNX): reporting after the market close.
  • Sarepta Therapeutics, Inc. (SRPT): reporting after the market close.

Wednesday

  • Amneal Pharmaceuticals, Inc. (AMRX): reporting before the market open.

Thursday

  • Fulcrum Therapeutics, Inc. (FULC): reporting before the market open.
  • Puma Biotechnology, Inc. (PBYI): reporting after the market close.
  • Profound Medical Corp. (PROF): reporting after the market close.
  • Oncolytics Biotech Inc. (ONCY): reporting after the market close.
  • INmune Bio, Inc. (INMB): reporting after the market close.
  • Evofem Biosciences, Inc. (EVFM): reporting after the market close.
  • Calyxt, Inc. (CLXT): reporting after the market close.

IPO Quiet Period Expiry

  • Arcellx, Inc. (ACLX).
  • Nuvectis Pharma, Inc. (NVCT).

© 2022 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

How did you like this article? Let us know so we can better customize your reading experience.

Comments

Leave a comment to automatically be entered into our contest to win a free Echo Show.