The Week Ahead In Biotech (Nov. 14-Nov. 20): BioMarin FDA Decision, Tapering Earnings News Flow, Conference Presentations And More

Biotech stocks declined for the second straight week amid a broader market pullback, along with earnings news from small- and micro-cap companies and presentations at multiple conferences.

Among the biggest news of the week is Johnson & Johnson's JNJ announcement regarding the spin-off of its Consumer Health business.

Eton Pharmaceuticals, Inc. ETON's topiramate oral solution received approval from the Food and Drug Administration for certain types of seizures in patients two years of age and older and as a preventative treatment of migraine in patients 12 years of age and older.

Azurity Pharma, the sponsor of the new drug application, had purchased topiramate, along with two other neurology candidates from Eton. Eton is eligible to receive a $5 million milestone payment and also royalties on sales.

Oncorus, Inc. ONCR was among the biggest decliners of the week following the company's presentation of early-stage data for a cancer immunotherapy candidate at the Society for Immunotherapy of Cancer conference.

Here are the key upcoming catalysts that a biotech investor should focus on in the unfolding week:

Conferences

Society For Immunotherapy of Cancer: Nov. 10-14 (hybrid event, to be held in Washington D.C. and to be available virtually)

American Association for the Study of Liver Diseases, AASLD, The Liver Meeting 2021: Nov. 12-15 (virtual meeting)

American Hear Association, or AHA, Scientific Sessions: Nov. 13-15

Guggenheim Healthcare Talks: 3rd Annual Neuro/Immunology Conference: Nov. 15-16 (virtual)

The Stifel 2021 Virtual Healthcare Conference: Nov. 15-17

The 34th International Papillomavirus Conference: Nov. 15-19 (virtual)

Jefferies London Healthcare Conference: Nov. 16-17 (in London) and Nov. 18-19 (virtual)

2021 Society For Neuro-Oncology, SNO, Annual Meeting: Nov. 18-21 (in Boston)

The American Society For Dermatologic Surgery, or ASDS, virtual Annual Meeting: Nov. 19-21

PDUFA Dates

The FDA is scheduled to rule on BioMarin Pharmaceutical Inc.'s BMRN NDA for vosoritide, an investigational, once daily injection for treating children with achondroplasia, the most common form of disproportionate short stature in humans. The PDUFA date is set for Saturday, Nov. 20.

Clinical Readouts/Presentations

Standalone Releases

Kezar Life Sciences, Inc. KZR: interim Phase 2 data for KZR-616 in lupus and data for KZR-261 (Monday, at 4:30 pm)

ProQR Therapeutics N.V. PRQR: updated data from the Phase 1/2 InSight extension study of Sepofarsen in Leber congenital amaurosis type 10 (Thursday)

Plus Therapeutics, Inc. PSTV: Phase 1 data for Rhenium-186 NanoLiposome in glioblastoma multiforme (Thursday)

AASLD Presentations

CymaBay Therapeutics, Inc. CBAY: Phase 3 data for seladelpar in patients with primary biliary cholangitis

AHA Presentations

Milestone Pharmaceuticals Inc. MIST: new analyses on the impact of etripamil on heart rate in patients with paroxysmal supraventricular tachycardia (Sunday)

PhaseBio Pharmaceuticals, Inc. PHAS: prespecified interim analysis of pivotal REVERSE-IT Phase 3 trial of bentracimab for the reversal of the antiplatelet effects of ticagrelor in patients who present with uncontrolled major bleeding or who require surgery or invasive procedure (Monday)

Amarin Corporation plc AMRN: main results of the Phase 3 PREPARE-IT2 study of Vascepa vs placebo in outpatients With Covid-19 (Monday)

International Papillomavirus Conference Presentations

Vaccitech plc VACC: safety and immunogenicity data from the lead-in portion of the Phase 1/2a clinical trial of VTP-200

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

SNO Meeting Presentations

Candel Therapeutics, Inc. CADL: initial safety data on CAN-2409 in combination with Bristol-Myers Squibb Company's BMY Opdivo from a phase 1 clinical trial in high-grade glioma

Chimerix, Inc. CMRX: clinical efficacy of ONC201 in recurrent H3 K27M-mutant diffuse midline glioma patients (Saturday)

ASDS Meeting Presentation

Dermata Therapeutics, Inc. DRMA: efficacy and safety results for its Phase 1b proof of concept study evaluating a single application of DMT410 to treat multiple aesthetic skin conditions (Friday)

Earnings

UroGen Pharma Ltd. URGN (Monday, before the market open)
Milestone Scientific Inc. MLSS (Monday, before the market open)
Trevena, Inc. TRVN (Monday, before the market open)
Kala Pharmaceuticals, Inc. KALA (Monday, before the market open)
Vascular Biogenics Ltd. VBLT (Monday, before the market open)
DarioHealth Corp. DRIO (Monday, before the market open)
Gamida Cell Ltd. GMDA (Monday, before the market open)
Protalix BioTherapeutics, Inc. PLX (Monday, before the market open)
AcelRx Pharmaceuticals, Inc. ACRX (Monday, before the market open)
Athersys, Inc. ATHX (Monday, before the market open)
Aytu Biopharma, Inc. AYTU (Monday, after the close)
Pulse Biosciences, Inc. PLSE (Monday, after the close)
INVO Bioscience, Inc. INVO (Monday, after the close)
Evofem Biosciences, Inc. EVFM (Monday, after the close)
Biocept, Inc. BIOC (Monday, after the close)
ImmuCell Corporation ICCC (Monday, after the close)
Eton Pharmaceuticals, Inc. ETON (Monday, after the close)
Syndax Pharmaceuticals, Inc. SNDX (Monday, after the close)
OptiNose, Inc. OPTN (Monday, after the close)
Osmotica Pharmaceuticals plc OSMT (Monday, after the close)
Mirum Pharmaceuticals, Inc. MIRM (Monday, after the close)
Ra Medical Systems, Inc. RMED (Monday, after the close)
Rockwell Automation, Inc. ROK (Monday, after the close)
Precipio, Inc. PRPO (Monday, after the close)
TFF Pharmaceuticals, Inc. TFFP (Monday, after the close)
MediWound Ltd. MDWD (Tuesday, after the close)
PAVmed Inc. PAVM (Tuesday, after the close)
EDAP TMS S.A. EDAP (Wednesday, after the close)

IPOs

IPO Quiet Period Expiry

Context Therapeutics Inc. CNTX
Minerva Surgical, Inc. UTRS
Xilio Therapeutics, Inc. XLO
Ventyx Biosciences, Inc. VTYX

Related Link: President Biden Nominates Robert Califf As New FDA Commissioner: Report