The Week Ahead In Biotech: Supernus, Sanofi Await FDA Decisions

Biotech stocks turned around with the broader market in the week ended Nov. 6, as investors warmed to the idea of a split Congress and a change of guard at the White House.

The week witnessed a flurry of earnings from several smid-cap companies. Bluebird bio Inc. BLUE shares came under pressure after it announced a push back in the timeline for the regulatory filing for its gene therapy to treat sickle cell disease.

Biogen Inc. BIIB was also in the news over an FDA roadblock regarding its Alzheimer's drug aducanumab. On the M&A front, Merck & Co. Inc. MRK announced a $2.75 billion deal to buy oncology-focused biopharma VelosBio Inc.

Here are the key biotech events to watch out for in the unfolding week:

Conferences

American College of Rheumatology, or ACR, Convergence 2020: Nov. 5-9
Credit Suisse 29th Annual Virtual Healthcare Conference: Nov. 9-10
35th Annual Meeting of The Society for Immunotherapy of Cancer, or SITC: Nov. 9-14
American Academy of Ophthalmology, or AAO, 2020 Virtual meeting: Nov. 13-15
American Association for the Study of Liver Diseases, or AASLD, The Liver Meeting, Digital Experience: Nov. 13-16
American Heart Association, or AHA, Scientific Sessions 2020: Nov. 13-17

PDUFA Dates

The FDA is set to rule on Supernus Pharmaceuticals Inc.'s SUPN NDA for SPN-812 (vilaxazine hydrochloride) for the treatment of attention deficit hyperactivity disorder. (Sunday)

Sanofi SA SNY awaits FDA nod for its BLA for sutimlimab as a treatment option for hemolysis in adult patients with cold agglutinin disease. (Saturday)

SITC Presentations

Gossamer Bio Inc. GOSS: Preliminary results from KEYNOTE-A36, a Phase 1/2 study of GB1275, alone and with Merck's Keytruda or chemotherapy in specified advanced solid tumors (poster presentation Monday)

Corvus Pharmaceuticals Inc. CRVS: updated data from its Phase 1 study of CPI-006 to provide a novel immunotherapy approach for patients with COVID-19 (poster and oral presentations Monday)

I-Mab ADR IMAB: Phase 1 dose escalation trial data from its CD47 program, lemzoparlimab, codenamed TJC4, in relapsed or refractory malignancy and preclinical data for TJ210 as a monotherapy or in combination with immune checkpoint inhibitors such as anti PD-1 therapies as anti-tumor agent

Iovance Biotherapeutics Inc. IOVA: new interim Phase 2 data for the tumor infiltrating lymphocyte therapy LN-145 in combination with Keytruda in head and neck squamous cell carcinoma (poster presentation)

MacroGenics Inc. MGNX: updated data from the Phase 1 dose expansion study of tebotelimab in combination with margetuximab in a cohort of patients with advanced HER2-positive tumors (poster presentation)

Genocea Biosciences Inc. GNCA: emerging safety and activity data from GEN-009-101, a phase 1/2a trial of GEN-009, a neoantigen vaccine in combination with PD-1 checkpoint inhibitors in advanced solid tumors (Monday, poster presentation at SITC and an investor call)

Other presenters at the SITC meeting include:

Fate Therapeutics Inc. FATE
Celldex Therapeutics Inc. CLDX
Amgen Inc. AMGN
Leap Therapeutics Inc. LPTX
Arcus Biosciences Inc. RCUS
Nektar Therapeutics NKTR
OncoSec Medical Inc. ONCS
Repligen Corporation RGEN
Checkmate Pharmaceuticals Inc. CMPI
Agenus Inc. AGEN
Curis Inc. CRIS
Adaptimmune Therapeutics PLC – ADR ADAP
Xencor Inc. XNCR
ALX Oncology Holdings Inc. ALXO
Spring Bank Pharmaceuticals Inc. SBPH
BioNTech SE – ADR BNTX
Genmab 10 Sponsored ADR Ord Shs GMAB
Imv Inc. IMV
Cue Biopharma Inc. CUE
Advaxis Inc. ADXS

ACR Meeting Presentations

Navidea Biopharmaceuticals Inc. NAVB: results from the the second interim analysis of its NAV3-31 Phase 2b clinical study in rheumatoid arthritis (Monday, 9 am to 11 am)

Kiniksa Pharmaceuticals Ltd. KNSA: new data from the global Phase 2 clinical trial of mavrilimumab in giant cell arteritis (at the late-breaking abstract session Monday at 11:30 am)

AAO Meeting Presentations

Aldeyra Therapeutics Inc. ALDX: new clinical utility data from the Phase 2 allergen chamber clinical trial of reproxalap in allergic conjunctivitis

MeiraGTx Holdings PLC MGTX: 12-month results from the Phase 1/2 clinical trial of AAV-RPGR, an investigational gene therapy for the treatment of X-linked retinitis pigmentosa (Friday at 5:55 pm)Adverum Biotechnologies Inc. ADVM: additional clinical data for Cohorts 1-4 in the OPTIC Phase 1 clinical trial of ADVM-022 intravitreal injection gene therapy in wet age-related macular degeneration (Friday, 2:15 pm)

ProQR Therapeutics NV PRQR: Phase 1b/2 trial results of intravitreal sepofarsen RNA therapy in Leber congenital amaurosis 10

NGM Biopharmaceuticals Inc. NGM: detailed Phase 1 safety, tolerability and pharmacokinetics findings from single and multiple intravitreal injections of NGM621 in patients with geographic atrophy (Friday, 10 am)

AHA Presentations

Cytokinetics Inc. CYTK and Amgen Inc. AMGN: primary results from the GALACTIC-HFhe Phase 3 event-driven cardiovascular outcomes clinical trial of omecamtiv mecarbil in acute heart failure

Related Link: A Pfizer Analyst's 3 Possible Coronavirus Vaccine Readout Scenarios

AASLD Presentations

NGM Biopharmaceuticals Inc. NGM: comprehensive data from its 24-week Phase 2 study (Cohort 4) of aldafermin in patients with non-alcoholic steatohepatitis (Friday)

Metacrine Inc. MTCR: new Phase 1b data on lead clinical candidate, MET409 for the treatment of NASH

Madrigal Pharmaceuticals Inc. MDGL: early data from the Phase 3 MAESTRO study of resmetirom in NASH and data from the MAESTRO-NAFLD-1 open label study (Friday, 4:30-5 pm)

89bio Inc. ETNB: Phase 1b/2a multiple ascending dose study of BIO89-100 in NASH

CymaBay Therapeutics Inc. CBAY: data from a Phase 2 study of seladelpar in NASH

DURECT Corporation DRRX: additional safety and efficacy signals from a Phase 1b study of 4-Week Oral DUR-928 in NASH subjects

Can Fite Biopharma ADR Representing 30 Ord Shs CANF: data from the Phase 2, dose-finding study of the efficacy and safety Of namodenoson in treating NAFLD and NASH

Earnings

Monday

Neos Therapeutics Inc. NEOS (before the market open)
Xeris Pharmaceuticals Inc. XERS (before the market open)
Intercept Pharmaceuticals Inc. ICPT (before the market open)
Mersana Therapeutics Inc. MRSN (before the market open)
Seres Therapeutics Inc. MCRB (before the market open)
Recro Pharma Inc. REPH (before the market open)
Urogen Pharma Ltd. URGN (before the market open)
Polarityte Inc PTE (before the market open)
Rubius Therapeutics Inc. RUBY (before the market open)
InspireMD Inc. NSPR (before the market open)
Reata Pharmaceuticals Inc. RETA (before the market open)
TherapeuticsMD Inc. TXMD (before the market open)
Biohaven Pharmaceutical Holding Co. Ltd. BHVN (before the market open)
Sesen Bio Inc. SESN (before the market open)
Intra-Cellular Therapies Inc. ITCI (before the market open)
Allakos Inc. ALLK (before the market open)
Apyx Medical Corp. APYX (before the market open)
Atara Biotherapeutics Inc. ATRA (after the close)
Athersys Inc. ATHX (after the close)
Arcturus Therapeutics Holdings Inc. ARCT (after the close)
Arena Pharmaceuticals Inc. ARNA (after the close)
Adamis Pharmaceuticals Corp. ADMP (after the close)
Forte Biosciences Inc. FBRX (after the close)
Pulse Biosciences Inc. PLSE (after the close)
Neurocrine Biosciences Inc. NBIX (after the close)
Kindred Biosciences Inc. KIN (after the close)
Castle Biosciences Inc. CSTL (after the close)
PDL BioPharma Inc. PDLI (after the close)
Evofem Biosciences Inc. EVFM (after the close)
Cara Therapeutics Inc. CARA (after the close)
CASI Pharmaceuticals Inc. CASI (after the close)
Omeros Corporation OMER (after the close)
ChemoCentryx Inc. CCXI (after the close)
Revance Therapeutics Inc. RVNC (after the close)
Infinity Pharmaceuticals Inc. INFI (after the close)
TapImmune Inc. common stock MRKR (after the close)
Novavax Inc. NVAX (after the close)
Fulgent Genetics Inc. FLGT (after the close)
Myriad Genetics Inc. MYGN (after the close)
Organogenesis Holdings Inc ORGO (after the close)
Rockwell Medical Inc. RMTI (after the close)
Xeris Pharmaceuticals Inc. XERS (after the close)
Catalyst Pharmaceuticals Inc. (NASDAQ: CPRX

Tuesday

Fulcrum Therapeutics Inc. FULC (before the market open)
STRATA Skin Sciences Inc. SSKN (before the market open)
Aerpio Pharmaceuticals Inc. ARPO (before the market open)
Altimmune Inc. ALT (before the market open)
BioNTech SE – ADR BNTX (before the market open)
Corbus Pharmaceuticals Holdings Inc CRBP (before the market open)
Affimed NV AFMD (before the market open)
Zogenix Inc. ZGNX (after the close)
10X Genomics Inc. TXG (after the close)
Adaptive Biotechnologies Corp. ADPT
Clearside Biomedical Inc. CLSD (after the close)
Viela Bio Inc. VIE (after the close)
CTI BioPharma Corp. CTIC (after the close)
Curis Inc. CRIS (after the close)
Clearpoint Neuro Inc. CLPT (after the close)
Cumberland Pharmaceuticals Inc. CPIX (after the close)
HTG Molecular Diagnostics Inc HTGM (after the close)
Eyenovia Inc. EYEN (after the close)
TRACON Pharmaceuticals Inc. TCON (after the close)
Lumos Pharma Inc. LUMO (after the close)
Silk Road Medical Inc. SILK (after the close)
Osmotica Pharmaceuticals PLC OSMT (after the close)
Precision BioSciences Inc. DTIL
Passage Bio Inc. PASG
Gamida Cell Ltd. GMDA

Wednesday

Royalty Pharma PLCRPRX (before the market open)
Ascendis Pharma A/S ASND (after the close)
TELA Bio Inc TELA (after the close)
Cyclacel Pharmaceuticals Inc. CYCC (after the close)
Trevi Therapeutics Inc. TRVI (after the close)
OpGen Inc. OPGN (after the close)
Salarius Pharmaceuticals Inc SLRX (after the close)

Thursday

Myovant Sciences Ltd. MYOV (before the market open)
Sol Gel Technologies Ltd. SLGL (before the market open)
Galmed Pharmaceuticals Ltd. GLMD (before the market open)
ADC Therapeutics SA ADCT (before the market open)
RedHill Biopharma Ltd. RDHL (before the market open)
ImmuCell Corporation ICCC (after the close)
Aptinyx Inc. APTX (after the close)
Agile Therapeutics Inc. AGRX (after the close)
Achieve Life Sciences Inc. ACHV (after the close)
aTyr Pharma Inc. LIFE (after the close)
Alpine Immune Sciences Inc. ALPN (after the close)
Aytu Bioscience Inc. AYTU (after the close)
Dare Bioscience Inc. DARE (after the close)
Dyadic International, Inc. DYAI (after the close)
Eton Pharmaceuticals Inc. ETON (after the close)
BioNano Genomics Inc. BNGO (after the close)
Helius Medical Technologies Inc. HSDT (after the close)
Thermogenesis Holdings Inc. THMO (after the close)
RA Medical Systems Inc. RMED (after the close)
Onconova Therapeutics Inc. ONTX (after the close)
Opiant Pharmaceuticals Inc. OPNT (after the close)
Inari Medical In.c NARI (after the close)

Friday

PLx Pharma Inc. PLXP (before the market open)
Meridian Bioscience, Inc. VIVO (before the market open)

IPOs

Atlanta-based Inhibikase Therapeutics Inc. has filed to offer 1.364 million shares of its common stock in an initial public offering, or IPO, to be priced between $10 and $12 apiece. The shares are to be listed on the Nasdaq under the ticker symbol IKT. Inhibikase is a clinical stage pharmaceutical company developing therapeutics for Parkinson's disease.

New York-based IN8bio is offering 4.688 million shares in an IPO at an estimated price range of $15-$17. The oncology-focused biopharma has applied for listing its shares on the Nasdaq under the ticker symbol INAB.

IPO Analysts' Quiet Period Expiry

Aligos Therapeutics Inc. ALGS
Kiromic Biopharma Inc. KRBP
Opthea Spon American Depositary Receipts Representing 8 Ord Shs OPT
Praxis Precision Medicines Inc. PRAX
Tarsus Pharmaceuticals Inc. TARS
Codiak BioSciences Inc. CDAK

Related Link: Attention Biotech Investors: Mark Your Calendar For These November PDUFA Dates