The Week Ahead In Biotech (Feb. 28-March 6): KemPharm, Gilead FDA Decisions and More Earnings

Biotech stocks extended their losses in the week ended Feb. 26 amid continued weakness in the broader market. Earnings came in thick and fast, with a skew of small and midcap companies releasing their quarterly results.

Sarepta Therapeutics Inc SRPT won a regulatory nod for its Amondys 45 drug for treating certain types of Duchenne muscular dystrophy. This is the company's third product in a portfolio of related drugs to have received approval.

Merck & Co., Inc. MRK announced a deal to buy Pandion Therapeutics Inc PAND, a company that focuses on therapies for autoimmune disorders, for $1.85 billion.

Moderna Inc MRNA and the duo of Pfizer Inc. PFE-BioNTech SE – ADR BNTX revealed their strategies for emerging coronavirus variants. The companies said they would test additional booster doses as well as variant-specific vaccines.

The week also witnessed multiple clinical readouts, while it was a relatively quiet week on the IPO front.

Here are the key events for the unfolding week:

Conferences

ESMO Targeted Anticancer Therapies Virtual Conference 2021: Feb. 28- March 2
Cowen 41st Annual Virtual Healthcare Conference: March 1-4
38th Annual Miami Breast Cancer Conference: March 4-7

PDUFA Dates

The Food and Drug Administration is scheduled to issue its verdict on KemPharm Inc's KMPH new drug application for KP415, which is being evaluated for the treatment of attention deficit hyperactivity disorder. The decision is due Tuesday, March 2. KemPharm is collaborating with Aquestive Therapeutics Inc AQST for an oral film dosage of KP415.

Gilead Sciences, Inc. GILD has a PDUFA date of Friday, March 5, by which the FDA will decide on Yescarta, or axicabtagene ciloleucel. It is being evaluated for the treatment of certain types of lymphoma. Yescarta is a CAR T-cell therapy that came into Gilead's stable through its acquisition of Kite.

Clinical Readouts

At the ESMO meeting, Spectrum Pharmaceuticals, Inc. SPPI will present safety, tolerability and preliminary efficacy of poziotinib, a lung cancer drug. The presentation is scheduled for Tuesday, March 2, at 11:25 a.m.

Related Link: Novavax Achieves Target Enrollment In Pivotal Phase 3 Coronavirus Vaccine Study In US, Mexico

Earnings

Monday

Reata Pharmaceuticals Inc RETA (before the market open)
Axsome Therapeutics Inc AXSM (before the market open)
Amicus Therapeutics, Inc. FOLD (before the market open)
Biohaven Pharmaceutical Holding Co Ltd BHVN (before the market open)
Athenex Inc ATNX (before the market open)
Agile Therapeutics Inc AGRX (after the close)
Atara Biotherapeutics Inc ATRA (after the close)
Arcturus Therapeutics Holdings Inc ARCT (after the close)
Adverum Biotechnologies Inc ADVM (after the close)
Omeros Corporation OMER (after the close)
ChemoCentryx Inc CCXI (after the close)
FibroGen Inc FGEN (after the close)
Inovio Pharmaceuticals Inc INO (after the close)
Precigen Inc PGEN (after the close)
Turning Point Therapeutics Inc TPTX (after the close)
OraSure Technologies, Inc. OSUR (after the close)
Regenxbio Inc RGNX (after the close)
Xenon Pharmaceuticals Inc XENE (after the close)
Sarepta Therapeutics Inc SRPT (after the close)
Silk Road Medical Inc SILK (after the close)
Novavax, Inc. NVAX (after the close)

Tuesday

Antares Pharma Inc ATRS (before the market open)
Eagle Pharmaceuticals Inc EGRX (before the market open)
GlycoMimetics Inc GLYC (before the market open)
Seres Therapeutics Inc MCRB (before the market open)
TherapeuticsMD Inc TXMD (before the market open)
Rigel Pharmaceuticals, Inc. RIGL (after the close)
Neuronetics Inc STIM (after the close)

Wednesday

Strongbridge Biopharma plc SBBP (before the market open)
OptiNose Inc OPTN (before the market open)
Passage Bio Inc PASG (before the market open)

Thursday

Arbutus Biopharma Corp ABUS (before the market open)
Eyepoint Pharmaceuticals Inc EYPT (before the market open)
X4 Pharmaceuticals Inc XFOR (before the market open)
Syros Pharmaceuticals Inc SYRS (before the market open)
Opiant Pharmaceuticals Inc OPNT (after the close)
Acorda Therapeutics Inc ACOR (after the close)
Anika Therapeutics Inc ANIK (after the close)
INmune Bio Inc INMB (after the close)
Synthetic Biologics Inc SYN (after the close)
T2 Biosystems Inc TTOO (after the close)
Evofem Biosciences Inc EVFM (after the close)
DermTech Inc DMTK (after the close)
Chiasma Inc CHMA (after the close)
Fulgent Genetics Inc FLGT (after the close)
Clearpoint Neuro Inc CLPT (after the close)

IPO Quiet Period Expiries

Sana Biotechnology Inc SANA
Sensei Biotherapeutics Inc SNSE
Landos Biopharma Inc LABP
Angion Biomedica Corp ANGN
Bolt Biotherapeutics Inc BOLT
Immunocore Holdings PLC – ADR IMCR
Lucira Health Inc LHDX
Evaxion Biotech A/S – ADR EVAX
Terns Pharmaceuticals Inc TERN
Pharvaris BV PHVS
Vor Biopharma Inc VOR
Adagene Inc ADAG

Other Events

Avenue Therapeutics Inc (NASDAQ: ATXI), a Avenue Fortress Biotech FBIO portfolio company, is due to resubmit its drug application for intravenous tramadol in February. The company received a complete response letter for the original application in mid-October.

Related Link: Why AstraZeneca Is Voluntarily Withdrawing Imfinzi In US For Advanced Bladder Cancer Indication