The Week Ahead In Biotech (Feb. 7-13): Regeneron FDA Decision, Earnings, IPOs and Conference Presentations In The Spotlight

Biopharma stocks advanced in the week ended Feb. 5, driven higher by a slew of catalysts. Large-cap pharma earnings, vaccine updates, M&A activity, IPO news flow and follow-on offerings all served to lift stocks higher.

In an unexpected move, Jazz Pharmaceuticals PLC JAZZ agreed to buy plant-derived cannabinoid drug maker GW Pharmaceuticals PLC- ADR GWPH for $7.2 billion.

Novavax, Inc. NVAX shares found follow-up buying interest amid vaccine updates. Earnings from large-cap biopharma companies can at best be qualified as mixed. The IPO calendar of the week was heavy, with 10 healthcare stocks making their Wall Street debuts this week.

Conferences

• Transplantation and Cellular Therapy, or TCT, Meeting of the American Society of Transplantation and Cellular Therapy and Center for International Blood & Marrow Transplant Research: Feb. 8-12
• 17th Annual WORLDSymposium: Feb. 8-12
• Guggenheim Healthcare Talks: 2021 Oncology Days: Feb. 11-12
• 2021 ASCO Genitourinary Cancers Symposium: Feb. 11-13
• Angiogenesis, Exudation, and Degeneration 2021 conference: Feb. 12-13

PDUFA Dates

The Food and Drug Administration is scheduled to rule on Regeneron Pharmaceuticals Inc's REGN biologic license application for evinacumab, which is being evaluated for the treatment of homozygous familial hypercholesterolemia, an ultra-rare, inherited form of high cholesterol. The decision is expected by Thursday, Feb. 11.

Clinical Readouts

17th Annual WORLDSymposium Presentations

Regenxbio Inc RGNX: interim results from the Phase 1/2 clinical trial of RGX-121 for the treatment of mucopolysaccharidosis type II (Monday, Feb. 8, at 10:06 a.m.)

Orchard Therapeutics PLC – ADR ORTX: updated Phase 1/2 data for ex-vivo autologous stem cell gene therapy for mucopolysaccharidosis type IIIA; Phase 1/2 data for ex vivo hematopoietic stem cell gene therapy for mucopolysaccharidosis type I (Tuesday, Feb. 9)

Protalix Biotherapeutics Inc PLX: one year of treatment data from BRIDGE, a phase 3 open-label study of pegunigalsidase alfa to treat patients with Fabry disease (Wednesday, Feb. 10, at 2:30-3:30 p.m.)

Avrobio Inc AVRO: new phase 1/2 data for AVR-RD-02 ex-vivo lentiviral vector, autologous gene therapy for Gaucher disease (Thursday, Feb. 11, 2:30-3:30 p.m.); updated results from a phase 1/2 study of hematopoietic stem cell gene therapy for cystinosis (Friday, Feb. 12, 11 a.m.); updated Phase 2 data for AVR-RD-01 in Fabry disease (Friday, Feb. 12)

Abeona Therapeutics Inc ABEO: updated results from Phase 1/2 study of ABO-101 gene therapy for mucopolysaccharidosis IIIB and Phase 1/2 study of ABO-102 gene therapy for mucopolysaccharidosis IIIA (Friday, Feb. 12)

Denali Therapeutics Inc DNLI: data from Phase 1/2 study of DNL310 in mucopolysaccharidosis II patients

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

TCT Meeting Presentations

Gamida Cell Ltd GMDA: results of the Phase 1 study of omidubicel versus standard myeloblative umbilical cord blood transplantation in patients with hematologic malignancies undergoing allogeneic bone marrow transplant (Tuesday, Feb. 9 at 4:45-5 p.m.)

Equillium Inc EQ: interim data from the Phase 1b/2 EQUATE study of itolizumab in acute graft-versus-host disease (Friday, Feb. 12, 3 p.m.)

Takeda Pharmaceutical Co Ltd TAK: Phase 3 data for TAK-620 in the treatment of transplant recipients with refractory/resistant cytomegalovirus infections (Friday, Feb. 12)

ASCO Genitourinary Cancers Symposium Presentations

Clovis Oncology Inc CLVS: Pharmacokinetics and safety data from the phase 1b RAMP study evaluating rucaparib plus enzalutamide in patients with metastatic castration-resistant prostate cancer (Thursday, Feb. 11, 8 a.m.)

Infinity Pharmaceuticals Inc. INFI: Preliminary analysis of a phase 2 data for eganelisib in combination with and Bristol-Myers Squibb Co's BMY Opdivo compared to Opdivo monotherapy in patients with advanced urothelial carcinoma (Thursday, Feb. 11)

BioXcel Therapeutics Inc BTAI: updated Phase 1b/2 data for BXCL701 in combination with Merck & Co., Inc.'s MRK Keytruda in men with metastatic castration-resistant prostate cancer (Thursday, Feb. 11, 8 a.m.)

Angiogenesis, Exudation, and Degeneration 2021 Conference Presentation

Kodiak Sciences Inc KOD: Clinical data on its investigational therapy KSI-301 in wet age-related macular degeneration and retinal vascular diseases (Saturday, Feb. 13 at 8:30 a.m.)

Earnings

Monday

Corcept Therapeutics Incorporated CORT (after the market close)
Enanta Pharmaceuticals Inc ENTA (after the market close)

Tuesday

Incyte Corporation INCY (before the market open)
Deciphera Pharmaceuticals Inc DCPH (before the market open)
SurModics, Inc. SRDX (before the market open)

Wednesday

Polypid Ltd PYPD (before the market open)
Veru Inc VERU (before the market open)
Vanda Pharmaceuticals Inc. VNDA (after the market close)
Pacific Biosciences of California Inc PACB (after the market close)
Fluidigm Corporation FLDM (after the market close)
Exelixis, Inc. EXEL (after the market close)
Aethlon Medical, Inc. AEMD (after the market close)

Thursday

Karyopharm Therapeutics Inc KPTI (before the market open)
Myovant Sciences Ltd MYOV (before the market open)
Alnylam Pharmaceuticals, Inc. ALNY (before the market open)
Applied Genetic Technologies Corp AGTC (before the market open)
Alkermes Plc ALKS (before the market open)
Laboratory Corp. of America Holdings LH (before the market open)
AVITA Medical Inc RCEL (after the market close)
Aytu Bioscience Inc AYTU (after the market close)
Otonomy Inc OTIC (after the market close)
Illumina, Inc. ILMN (after the market close)
Ultragenyx Pharmaceutical Inc RARE (after the market close)

Friday

ImmunoGen, Inc. IMGN (before the market open)

IPOs

Adagene, Inc., a China-based, clinical-stage biopharmaceutical company developing antibody-based cancer immunotherapies, has filed to offer 7.354 million ADSs, representing 9,1925 million ordinary shares, in an initial public offering. The company expects to price the offering in the $17-$19 range, and has applied for listing its ADSs on the Nasdaq under the ticker symbol ADAG.

French clinical-stage biotech Biophytis S.A., which focuses on development of therapeutics that slow the degenerative processes associated with aging, is proposing to offer 1.2 million ADSs in an IPO. Each ADS represents the right to receive 10 ordinary shares. The offering price is expected to be between $15 and $18 per ADS. The company has applied to list its ADSs on the Nasdaq under the ticker symbol BPTS.

Longeveron LLC, a clinical stage biotech developing cellular therapies for specific aging-related and life-threatening conditions, is offering 2.73 million shares at an estimated price range of $10-$12. The Miami, Florida-based company has applied for listing the shares on the Nasdaq under the ticker symbol LGVN.

Durham, North Carolina-based Bioventus Inc. is planning a 7.53-million-share IPO, with the offering estimated to be priced between $16 and 18 apiece. The medical device company has applied for listing its shares on the Nasdaq under the ticker symbol BVS.

Related: Pfizer Expects COVID-19 Vaccine To Bring $15B In Revenue This Year

Photo by National Cancer Institute on Unsplash