The Week Ahead In Biotech: Kala FDA Decision, Merck & Pfizer Earnings, Vaccine Updates And IPOs

Biotech stocks posted weekly declines in the week ended Oct. 23, pressured by the broader market decline amid mixed earnings reports and the impasse on fiscal stimulus.

After declining in the first three sessions of the week, the iShares Nasdaq Biotechnology Etf IBB rebounded in the next two, thereby recouping some of the losses.

Biogen Inc's BIIB third-quarter report headlined the biopharma earnings news flow of the week. Although the initial reaction was positive due to the better-than-expected headline numbers, the stock came under selling pressure subsequently, as investors fretted over accelerating decline in Spinraza sales and the looming binary event for Alzheimer's treatment candidate aducanumab.

On the coronavirus vaccine front, AstraZeneca plc AZN experienced another scare as a trial participant was reported as dead in Brazil. The U.K. biopharma, however, was vindicated as reports later said the said participant was administered placebo and not the investigational vaccine.

Moderna Inc MRNA completed enrollment in its Phase 3 COVE study, with the company now looking ahead to the interim readout.

Gilead Sciences, Inc.'s GILD Veklury was accorded full FDA approval during the week.

Expectedly, Zosano Pharma Corp ZSAN was handed down a complete response letter for the NDA for its migraine patch. The penny stock slumped about 40% at one point in time in the week before recovering some of the lost ground.

The week witnessed the Nasdaq debut of Foghorn Therapeutics, which raised $120 million in an initial public offering.

Here are the key catalysts for the unfolding week.

Conferences

  • American Society of Nephrology, or ASN, Kidney Week 2020 Annual Meeting: Oct. 22-25
  • EORTC-NCI-AACR Annual, or ENA 2020, Symposium on Molecular Targets and Cancer Therapeutics: Oct. 24-25
  • ASTRO Annual Meeting 2020: Oct. 24-28
  • Macrophage-directed Therapies Summit: Oct 27-29
  • American Society of Human Genetics, or ASHG, Virtual Meeting 2020: Oct. 27-30
  • Cantor Fitzgerald "Key Considerations for Gene Therapy Manufacturing and Platforms" virtual panel: Oct. 28
  • B. Riley Securities Liver Disease Therapeutics Day: Oct. 29
  • European Academy Dermatology and Venereology, or EADV, Virtual 29th Congress: Oct. 29-31

PDUFA Dates

The FDA is scheduled to rule on Kala Pharmaceuticals Inc's KALA NDA for Eysuvis, or loteprednol etabonate ophthalmic suspension, 0.25%, which is being evaluated for the short-term treatment of the signs and symptoms of dry eye disease. The PDUFA action date is Oct. 30.

By the same day, the agency is set to rule on Merck & Co., Inc.'s MRK sBLA for Keytruda as a monotherapy for the treatment of adult patients with relapsed or refractory classical Hodgkin's lymphoma.

Related Link: Why This Bluebird Bio Analyst Sees Over 125% Upside Ahead

Clinical Readouts

Applied Therapeutics Inc APLT is due to present at the ASHG meeting animal model efficacy data and adult clinical data on the safety and biomarker efficacy of its investigational candidate for Galactosemia, AT-007. (Monday)

Jazz Pharmaceuticals PLC JAZZ has scheduled a webcast on Monday at 4:30 pm to provide investors with an update on Xywav oral solution, which was approved by the FDA in late July for the treatment of cataplexy or excessive daytime sleepiness in patients 7 years of age and older with narcolepsy.

Retrophin Inc RTRX is scheduled to present at the ASN Kidney Week 2020 Reimagined, new data from a post-hoc analysis examining the proportion of patients with focal segmental glomerulosclerosis that achieved complete remission of proteinuria in the Phase 2 DUET Study of sparsentan. Sparsentan has been licensed from Ligand Pharmaceuticals Inc. LGND.

Galera Therapeutics Inc GRTX in combination with stereotactic body radiation therapy for locally advanced pancreatic cancer (Tuesday).

Concert Pharmaceuticals Inc CNCE will present clinical data on CTP-543 for the treatment of alopecia areata as a late-breaker oral presentation at the 29th EADV Virtual Congress (Thursday).

Axovant Gene Therapies Ltd AXGT is due to present at its virtual Parkinson's disease R&D day individual patient-level data from Cohort 2 of the Phase 2 SUNRISE-PD study that is evaluating its AXO-Lenti-PD gene therapy for the treatment of Parkinson's disease (Friday).

October schedule

Pfizer Inc. PFE and BioNTech SE – ADR BNTX are scheduled to release results of the Phase 2/3 study of coronavirus vaccine candidate BNT162b2.

Dynavax Technologies Corporation's DVAX partner Medicago is scheduled to release safety and immunogenicity results from the Phase I clinical trial for its plant-derived COVID-19 vaccine candidate that uses Dynavax' adjuvant CpG 1018.

Earnings

Monday

Medpace Holdings Inc MEDP

Tuesday

Laboratory Corp. of America Holdings LH (before the market open)
Merck & Co., Inc. MRK (before the market open)
Pfizer Inc. PFE (before the market open)
NeoGenomics, Inc. NEO (before the market open)
Masimo Corporation MASI (after the close)
DexCom, Inc. DXCM (after the close)
Ultragenyx Pharmaceutical Inc RARE (after the close)
Omnicell, Inc. OMCL (after the close)

Wednesday

Integra Lifesciences Holdings Corp IART (before the market open)
United Therapeutics Corporation UTHR (before the market open)
PPD Inc PPD (before the market open)
Boston Scientific Corporation BSX (before the market open)
Aethlon Medical, Inc. AEMD (after the close)
Amgen, Inc. AMGN (after the close)
Alimera Sciences Inc ALIM (after the close)
Taro Pharmaceutical Industries Ltd. TARO (after the close)
Vanda Pharmaceuticals Inc. VNDA (after the close)
Globus Medical Inc GMED (after the close)
Gilead Sciences, Inc. GILD (after the close)
Merit Medical Systems, Inc. MMSI (after the close)
Penumbra Inc PEN (after the close)
Viking Therapeutics Inc VKTX (after the close)

Thursday

Evelo Biosciences Inc EVLO (before the market open)
Baxter International Inc BAX (before the market open)
Blueprint Medicines Corp BPMC (before the market open)
Alexion Pharmaceuticals, Inc. ALXN (before the market open)
Agenus Inc AGEN (before the market open)
ABIOMED, Inc. ABMD (before the market open)
Pacira Biosciences Inc PCRX (before the market open)
Protalix Biotherapeutics Inc PLX (before the market open)
Insmed Incorporated INSM (before the market open)
Moderna Inc MRNA (before the market open)
Novocure Ltd NVCR (before the market open)
Syneos Health Inc SYNH (before the market open)
Xtant Medical Holdings Inc XTNT (before the market open)
Constellation Pharmaceuticals Inc CNST (before the market open)
Alkermes Plc ALKS (before the market open)
AxoGen, Inc Common Stock AXGN (after the close)
BioTelemetry Inc BEAT (after the close)
PTC Therapeutics, Inc. PTCT (after the close)
Illumina, Inc. ILMN (after the close)
Natus Medical Inc NTUS (after the close)
LeMaitre Vascular Inc LMAT (after the close)
ResMed Inc. RMD (after the close)
NuVasive, Inc. NUVA (after the close)
Vertex Pharmaceuticals Incorporated VRTX (after the close)
Opko Health Inc. OPK (after the close)
Bio-Rad Laboratories, Inc. Class A Common Stock BIO (after the close)
Quidel Corporation QDEL (after the close)
EXACT Sciences Corporation EXAS (after the close)
Cerus Corporation CERS (after the close)
CareDx Inc CDNA (after the close)

Friday

AbbVie Inc ABBV (before the market open)
Ligand Pharmaceuticals Inc. LGND (before the market open)

IPOs

Boulder, Colorado-based Biodesix, Inc., a data-driven diagnostic solutions company, has filed to offer 4.17 million shares in an initial public offering, or IPO, at an estimated price range of $17-$19. The company has applied for listing its shares on the Nasdaq under the ticker symbol BDSX.

Galecto, Inc., a Wilmington, Delaware-based clinical-stage biotech company developing therapeutics for fibrosis, is proposing to offer 5.67 million shares at an estimated price range of $14-$16. The company expects its shares to trade on the Nasdaq under the ticker symbol GLTO.

Atlanta, Georgia-based Inhibikase Therapeutics, Inc. has filed for offering 2.272 million shares of its common stock 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.

IPO Quiet Period Expiry

Pulmonx Corp LUNG

Oncorus Inc ONCR

Immunome Inc IMNM

C4 Therapeutics Inc CCCC

Other Events

CDC's Advisory Committee on Immunization Practices panel will meet Oct. 28-30, which is one of its customary three yearly meetings to review scientific data and vote on vaccine recommendations.

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