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

Zinger Key Points
  • Reata Pharmaceuticals received a complete response letter for the new drug application for bardoxolone methyl for the treatment of patients with chronic kidney disease.
  • The FDA is required to rule on the NDA submitted by Gilead Sciences relating to its lenacapavir, an investigational, long-acting HIV-1 capsid inhibitor.

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.

Johnson & Johnson JNJ/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. (Monday, at 4:30 pm)

AAAAI Meeting Presentations

KalVista Pharmaceuticals, Inc. 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

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

Tuesday

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

Wednesday

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

Thursday

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

IPOs

IPO Quiet Period Expiry

Arcellx, Inc. ACLX
Nuvectis Pharma, Inc. NVCT

Related Link: Teladoc Health Analysts Give Mixed Prognosis Following Q4 Earnings

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