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© 2026 Benzinga | All Rights Reserved
February 27, 2022 9:26 AM 4 min read

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

by Shanthi Rexaline Benzinga Editor
Follow

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

Market News and Data brought to you by Benzinga APIs

© 2026 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

To add Benzinga News as your preferred source on Google, click here.


Posted In:
BiotechEarningsNewsPenny StocksSmall CapFDAIPOsTop StoriesGeneral
IBB Logo
IBBiShares Biotechnology ETF
$174.840.47%
Overview
ACAD Logo
ACADACADIA Pharmaceuticals Inc
$22.990.17%
ACLX Logo
ACLXArcellx Inc
$68.000.04%
AMRN Logo
AMRNAmarin Corp PLC
$14.510.70%
AMRX Logo
AMRXAmneal Pharmaceuticals Inc
$14.90-1.91%
CCXI Logo
CCXIChurchill Capital Corp XI
$10.26-%
EVFM Logo
EVFMEvofem Biosciences Inc
$0.00900-100.0%
FATE Logo
FATEFate Therapeutics Inc
$1.351.12%
FULC Logo
FULCFulcrum Therapeutics Inc
$10.636.47%
GILD Logo
GILDGilead Sciences Inc
$153.28-1.28%
HRTX Logo
HRTXHeron Therapeutics Inc
$1.162.94%
INMB Logo
INMBINmune Bio Inc
$1.431.79%
INO Logo
INOInovio Pharmaceuticals Inc
$1.672.15%
JAZZ Logo
JAZZJazz Pharmaceuticals PLC
$166.97-0.60%
JNJ Logo
JNJJohnson & Johnson
$243.17-0.07%
KALV Logo
KALVKalVista Pharmaceuticals Inc
$15.012.97%
KOD Logo
KODKodiak Sciences Inc
$21.679.18%
LEGN Logo
LEGNLegend Biotech Corp
$18.19-0.28%
LLY Logo
LLYEli Lilly and Co
$1033.01-1.60%
NTLA Logo
NTLAIntellia Therapeutics Inc
$12.603.07%
NVAX Logo
NVAXNovavax Inc
$8.741.10%
NVCT Logo
NVCTNuvectis Pharma Inc
$9.09-0.67%
ONCY Logo
ONCYOncolytics Biotech Inc
$1.013.34%
PBYI Logo
PBYIPuma Biotechnology Inc
$6.780.44%
PROF Logo
PROFProfound Medical Corp
$7.085.99%
RGNX Logo
RGNXRegenxbio Inc
$8.060.37%
SRPT Logo
SRPTSarepta Therapeutics Inc
$18.312.40%
SUPN Logo
SUPNSupernus Pharmaceuticals Inc
$50.49-2.19%
VTRS Logo
VTRSViatris Inc
$15.890.98%

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

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

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

IBB Logo
IBBiShares Biotechnology ETF
$174.840.47%
Overview
ACAD Logo
ACADACADIA Pharmaceuticals Inc
$22.990.17%
ACLX Logo
ACLXArcellx Inc
$68.000.04%
AMRN Logo
AMRNAmarin Corp PLC
$14.510.70%
AMRX Logo
AMRXAmneal Pharmaceuticals Inc
$14.90-1.91%
CCXI Logo
CCXIChurchill Capital Corp XI
$10.26-%
EVFM Logo
EVFMEvofem Biosciences Inc
$0.00900-100.0%
FATE Logo
FATEFate Therapeutics Inc
$1.351.12%
FULC Logo
FULCFulcrum Therapeutics Inc
$10.636.47%
GILD Logo
GILDGilead Sciences Inc
$153.28-1.28%
HRTX Logo
HRTXHeron Therapeutics Inc
$1.162.94%
INMB Logo
INMBINmune Bio Inc
$1.431.79%
INO Logo
INOInovio Pharmaceuticals Inc
$1.672.15%
JAZZ Logo
JAZZJazz Pharmaceuticals PLC
$166.97-0.60%
JNJ Logo
JNJJohnson & Johnson
$243.17-0.07%
KALV Logo
KALVKalVista Pharmaceuticals Inc
$15.012.97%
KOD Logo
KODKodiak Sciences Inc
$21.679.18%
LEGN Logo
LEGNLegend Biotech Corp
$18.19-0.28%
LLY Logo
LLYEli Lilly and Co
$1033.01-1.60%
NTLA Logo
NTLAIntellia Therapeutics Inc
$12.603.07%
NVAX Logo
NVAXNovavax Inc
$8.741.10%
NVCT Logo
NVCTNuvectis Pharma Inc
$9.09-0.67%
ONCY Logo
ONCYOncolytics Biotech Inc
$1.013.34%
PBYI Logo
PBYIPuma Biotechnology Inc
$6.780.44%
PROF Logo
PROFProfound Medical Corp
$7.085.99%
RGNX Logo
RGNXRegenxbio Inc
$8.060.37%
SRPT Logo
SRPTSarepta Therapeutics Inc
$18.312.40%
SUPN Logo
SUPNSupernus Pharmaceuticals Inc
$50.49-2.19%
VTRS Logo
VTRSViatris Inc
$15.890.98%
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