The Week Ahead In Biotech (Oct. 31-Nov. 6): Earnings Pick Up Pace, Eton Awaits Seizure Drug Approval, Kidney Conference, More IPOs In The Pipeline

Biotech stocks rose a third week running in the week ending Oct. 29 amid positive reaction to earnings. Big pharma earnings were mostly better than expected.

Merck & Co, Inc. MRK led the gains among large-cap pharma companies, with a weekly gain of over 8%, thanks to its third-quarter results that were notably above expectations. Investor optimism can also be attributed to expectations concerning its COVID-19 antiviral treatment being developed with Ridgeback.

Meanwhile, Gilead Sciences, Inc. GILD shares came under pressure after the biopharma tempered its forecasts for non-COVID-19 sales.

Regulatory decisions for the week were mixed. Eyenovia, Inc. EYEN's MydCombi new drug application was shot down with a complete response letter, while Clearside Biomedical, Inc. LSD & Bausch Health Companies Inc. BHC received a regulatory nod for their Xipere for suprachoroidal use for the treatment of macular edema associated with uveitis, a form of eye inflammation.

On a positive vaccine-related news flow Pfizer, Inc. PFE-BioNTech SE BNTX received Food and Drug Administration authorization for their COVID-19 vaccine for use in the pediatric population.

HCW Biologics Inc. HCWB was among the biggest advancers of the week after it was given the nod for proceeding with the Phase 1b trial of its pancreatic cancer treatment candidate. On the other hand, Cortexyme, Inc. CRTX fell about 80% for the week following a failed Alzheimer's trial.

News on initial public offerings exelarated, with three biotechs pricing their offerings and listing on Wall Street.

Here are the key catalysts that are scheduled for the unfolding week:

Healthcare Conferences:

Psych Congress: Oct. 29-Nov. 1, in San Antonio (hybrid)
North American Cystic Fibrosis Conference, or NACFC: Nov. 2-5 (virtual)
International Society for Affective Disorders, or ISAD, Conference: Nov. 3-4 (virtual)
4th Inflammatory Skin Disease Summit: Nov. 3-6, in New York
American College of Rheumatology, or ACR, Convergence 2021: Nov. 3-9 (virtual)
Neuroscience Education Institute, or NEI, Congress: Nov. 4-7, in Colorado Springs, Colorado (hybrid)
The American Society of Nephrology, or ANS, Kidney Week 2021: Nov. 4-7 (virtual)

PDUFA Dates

The FDA is scheduled to rule on Eton Pharmaceuticals, Inc. ETON's NDA for topiramate oral solution as a treatment option for three indications – as a monotherapy for partial-onset or primary general tonic-clonic seizures in patients two years of age and older, an adjunctive treatment of partial-onset seizures, including seizures associated with Lennox-Gastaut syndrome in patients two years of age and older, and as preventative treatment of migraine in patients 12 years of age and older.

The original PDUFA date of Aug. 6 was extended by three months to provide the regulator time to review a recent amendment to the application by Azurity Pharma. Azurity had purchased topiramate, along with two other neurology candidates from Eton. Eton is eligible to receive a $5 million milestone payment, contingent on regulatory approval, and royalties on sales. The new PDUFA date is Nov. 6.

Clinical Readouts/Presentations

Inflammatory Skin Disease Summit Presentations

RAPT Therapeutics, Inc. RAPT: additional efficacy results from a Phase 1b monotherapy trial of RPT193 in patients with moderate-to-severe atopic dermatitis (Wednesday, at 5 pm – 5:30 pm)

NACFC Presentations

Calithera Biosciences, Inc. CALA: data from the Phase 1b trial of CB-280, Calithera's investigational arginase inhibitor for the treatment of cystic fibrosis (poster presentation available on Monday, and poster session with presenting authors available via live video chats on Wednesday, at 1:10 pm-1:50 pm)

ANS Meeting Presentations

Talaris Therapeutics, Inc. TALS: data from continued long-term follow-up of patients treated in the Phase 2 study of FCR001, as well as findings from urinary cell mRNA profiling of a subgroup of those Phase 2 patients (Thursday, at 1 pm to 3 pm)

GlaxoSmithKline plc GSK: late-breaking Phase 3 data for daprodustat as a potential treatment for patients with anemia due to chronic kidney disease in both dialysis and non-dialysis populations (Friday, 1:30 pm)

Alnylam Pharmaceuticals, Inc. ALNY: full results from the ILLUMINATE-C Phase 3 study of lumasiran in Primary hyperoxaluria type 1

Equillium, Inc. EQ: an Interim subgroup analysis from a Phase 1b study of itolizumab in systemic lupus patients with proteinuria

Chinook Therapeutics, Inc. KDNY: initial results of a Phase 1/2 study of BION-1301 in patients with IgA nephropathy

Vera Therapeutics, Inc. VERA: data for the company's lead product candidate, atacicept, from the Phase 2a JANUS clinical trial in patients with IgA nephropathy

DiaMedica Therapeutics Inc. DMAC: late-breaking data from the Phase 2 REDUX trial of DM199 in chronic kidney disease (Thursday, 1 pm)

Dicerna Pharmaceuticals, Inc. DRNA: data from the PHYOX2 trial of nedosiran, an investigational RNAi candidate for the treatment of primary hyperoxaluria

ACR Convergence Presentations

Tonix Pharmaceuticals Holding Corp. TNXP: Positive results of a Phase 3 efficacy and safety trial of TNX-102 SL for the treatment of fibromyalgia (Saturday, at 11:45 am-12 pm)

Earnings

Monday

Hologic, Inc. HOLX (after the close)
Neurocrine Biosciences, Inc. NBIX (after the close)

Tuesday

Sage Therapeutics, Inc. SAGE (before the market open)
Pfizer Inc. PFE (before the market open)
Myriad Genetics, Inc. MYGN (before the market open)
Incyte Corporation INCY (before the market open)
Integra LifeSciences Holdings Corporation IART (before the market open)
Esperion Therapeutics, Inc. ESPR (before the market open)
Catalent, Inc. CTLT (before the market open)
Bio-Techne Corporation TECH (before the market open)
Avanos Medical, Inc. AVNS (before the market open)
Pulmonx Corporation LUNG (after the close)
Amgen Inc. AMGN (after the close)
Deciphera Pharmaceuticals, Inc. DCPH (after the close)
Exelixis, Inc. EXEL (after the close)
Exact Sciences Corporation EXAS (after the close)
Halozyme Therapeutics, Inc. HALO (after the close)
Inspire Medical Systems, Inc. INSP (after the close)
Pacific Biosciences of California, Inc. PACB (after the close)
MacroGenics, Inc. MGNX (after the close)
REGENXBIO Inc. RGNX (after the close)
Ultragenyx Pharmaceutical Inc. RARE (after the close)
Vertex Pharmaceuticals Incorporated VRTX (after the close)
Related Link: Novavax Rips Higher After Completing Regulatory Filing For Authorization Of COVID-19 Vaccine In UK

Wednesday

Agios Pharmaceuticals, Inc. AGIO (before the market open)
Amneal Pharmaceuticals, Inc. AMRX (before the market open)
Horizon Therapeutics Public Limited Company HZNP (before the market open)
Amarin Corporation plc AMRN (before the market open)
Intercept Pharmaceuticals, Inc. ICPT (before the market open)
Ionis Pharmaceuticals, Inc. IONS (before the market open)
Pacira BioSciences, Inc. PCRX (before the market open)
Syneos Health, Inc. SYNH (before the market open)
United Therapeutics Corporation UTHR (before the market open)
Praxis Precision Medicines, Inc. PRAX (before the market open)
Viking Therapeutics, Inc. VKTX (after the close)
Outset Medical, Inc. OM (after the close)
Zymergen Inc. ZY (after the close)
Heron Therapeutics, Inc. HRTX (after the close)
Ortho Clinical Diagnostics Holdings plc OCDX (after the close)
Supernus Pharmaceuticals, Inc. SUPN (after the close)
Sarepta Therapeutics, Inc. SRPT (after the close)
QIAGEN N.V. QGEN (after the close)
Penumbra, Inc. PEN (after the close)
ICU Medical, Inc. ICUI (after the close)
Corcept Therapeutics Incorporated CORT (after the close)
AtriCure, Inc. ATRC (after the close)
Adaptive Biotechnologies Corporation ADPT (after the close)
10x Genomics, Inc. TXG (after the close)

Thursday

Zimmer Biomet Holdings, Inc. ZBH (before the market open)
Regeneron Pharmaceuticals, Inc. REGN (before the market open)
NeoGenomics, Inc. NEO (before the market open)
Moderna, Inc. MRNA (before the market open)
Lantheus Holdings, Inc. LNTH (before the market open)
Ironwood Pharmaceuticals, Inc. IRWD (before the market open)
Intellia Therapeutics, Inc. NTLA (before the market open)
Sangamo Therapeutics, Inc. SGMO (before the market open)
Jounce Therapeutics, Inc. JNCE (before the market open)
Fulcrum Therapeutics, Inc. FULC (before the market open)
Chimerix, Inc. CMRX (before the market open)
Provention Bio, Inc. PRVB (before the market open)
Aerie Pharmaceuticals, Inc. AERI (after the close)
Aligos Therapeutics, Inc. ALGS (after the close)
Allogene Therapeutics, Inc. ALLO (after the close)
Global Blood Therapeutics, Inc. GBT (after the close)
Caladrius Biosciences, Inc. CLBS (after the close)
Bionano Genomics, Inc. BNGO (after the close)
Kura Oncology, Inc. KURA (after the close)
Y-mAbs Therapeutics, Inc. YMAB (after the close)
Zogenix, Inc. ZGNX (after the close)
Vir Biotechnology, Inc. VIR (after the close)
Quidel Corporation QDEL (after the close)
Puma Biotechnology, Inc. PBYI (after the close)
Novavax, Inc. NVAX (after the close)
Nektar Therapeutics NKTR (after the close)
Natera, Inc. NTRA (after the close)
Insulet Corporation PODD (after the close)
Illumina, Inc. ILMN (after the close)
Guardant Health, Inc. GH (after the close)
Iovance Biotherapeutics, Inc. IOVA (after the close)
Collegium Pharmaceutical, Inc. COLL (after the close)
Globus Medical, Inc. GMED (after the close)
Glaukos Corporation GKOS (after the close)
Fate Therapeutics, Inc. FATE (after the close)
Endo International plc ENDP (after the close)
Emergent BioSolutions Inc. EBS (after the close)
Axonics, Inc. AXNX (after the close)
Arena Pharmaceuticals, Inc. ARNA (after the close)

Friday

Elanco Animal Health Incorporated ELAN (before the market open)

IPO Calendar

IPO Pricing

Hamburg, Germany-based Evotec SE EVO has filed a preliminary prospectus with the SEC for a 22-million ADS initial public offering at a price of $26.16 per ADS. Each ADS represents one-half of one ordinary share. The per-ADS pricing is based on the closing price of the company's ordinary shares on the Frankfurt Stock Exchange Friday and assuming an exchange rate of $1.163 per euro. The company is a drug discovery and development partner for the pharmaceutical and biotechnology industry. The shares are expected to be listed on the Nasdaq under the ticker symbol "EVO."

Mainz Biomed B.V. MYNZ is planning to offer 2 million ordinary shares in an IPO, with the offering expected to be priced between $4 and $6. The molecular genetics cancer diagnostic company has applied for listing its shares on the Nasdaq under the ticker symbol "MYNZ."

Belgium-based MDxHealth SA MDXH is offering 3.75 million ADSs in an IPO, assuming an offer price of $13.46 per ADS. Each ADS represents ten ordinary shares. The commercial-stage precision diagnostics company has applied to list the ADSs on the Nasdaq under the ticker symbol "MDXH."

Nuvectis Pharma, Inc. NVCT, a New Jersey-based biopharma focused on the development of precision medicines for the treatment of serious unmet medical needs in oncology, is planning a 2.3-million share IPO. The company expects the offering to be priced between $12 and $14 and has applied for listing its shares on the Nasdaq under the ticker symbol "NVCT."

IPO Quiet Period Expiry

Theseus Pharmaceuticals, Inc. THRX
Cognition Therapeutics, Inc. CGTX
IsoPlexis Corporation ISO
Pyxis Oncology, Inc. PYXS

Related Link: Moderna To Supply Additional COVID-19 Vaccine Doses To COVAX Alliance