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. (NASDAQ: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. (NASDAQ: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. (NYSE: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 (NASDAQ: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.
Johnson & Johnson (NYSE:JNJ)/Legend Biotech Corporation (NASDAQ: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. (NASDAQ: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. (NASDAQ: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. (NASDAQ:NTLA) will present additional interim clinical data from the ongoing Phase 1 study of NTLA-2001 in patients with transthyretin amyloidosis with polyneuropathy. (Monday, at 4:30 pm)
AAAAI Meeting Presentations
KalVista Pharmaceuticals, Inc. (NASDAQ:KALV): new data on KVD900, its lead drug program for oral on-demand treatment of hereditary angioedema (HAE) attacks.
Related Link: Moderna Rallies After Q4 Earnings: What 2 Analysts Have To Say About COVID-19 Stock
Earnings
The earnings list presented is not comprehensive. Click here to access Benzinga's earnings calendar for the complete schedule.
Monday
Tuesday
Wednesday
Amneal Pharmaceuticals, Inc. (NYSE:AMRX) (before the market open)
Thursday
IPOs
IPO Quiet Period Expiry
Arcellx, Inc. (NASDAQ:ACLX)
Nuvectis Pharma, Inc. (NASDAQ:NVCT)
Related Link: Teladoc Health Analysts Give Mixed Prognosis Following Q4 Earnings
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