The Week Ahead In Biotech: Conferences, PDUFA Dates, Clinical Trials, Earnings, IPOs

Biotech stocks came under pressure in the week ending Feb. 22 after advancing in the previous week. The recent week was fairly quiet for the space, with a few earnings reports from small-cap stocks and a handful of conference presentations.

Among the notable events: Merck & Co., Inc. MRK's decision to acquire thinly traded microcap Immune Design Corp IMDZ in a $300-million deal.

The following are key catalysts that could impact the performance of biotech stocks in the unfolding week:

Conferences

• 2019 Transportation and Cellular Therapy, or TCT, Meetings: Feb. 20-24 in Houston, Texas.
• American Academy of Allergy, Asthma and Immunology, or AAAAI, Annual Meeting: Feb. 22-25, in San Francisco, California.
• BTIG Healthcare Conference: Feb. 27-28 in Snowbird, Utah.
• SVB Leerink 6th Annual Global Healthcare Conference: Feb. 27-March 1 in New York.
• 2019 ASCO-SITC Clinical Immuno-oncology Symposium: Feb 28- March 2 in San Francisco.
• 2019 American Academy of Dermatology, or AAD, Association Annual Meeting: March 1-5 in Washington, D.C.

PDUFA Dates

The FDA is set to rule on Bausch Health Companies Inc BHC's NDA for loteprednol gel 0.38 percent Monday, Feb. 25. The investigational drug is being studied for the treatment of post-operative inflammation and pain following ocular surgery.

Adcom Meeting

The FDA's Oncologic Drugs Advisory Committee is set to discuss Karyopharm Therapeutics Inc KPTI's NDA for selinexor tablets. The pipeline asset is being evaluated in combination with dexamethason for the treatment of patients with relapsed refractory multiple myeloma who have received at least three prior therapies and whose disease is refractory to at least one proteasome inhibitor, at least one immunomodulatory agent and an anti-CD38 monoclonal antibody. The stock crashed Friday upon the release of the briefing notes for the meeting. 

Clinical Trial Results

• Actinium Pharmaceuticals Inc ATNM is due to present Phase 3 data for lomab-B, tested in hematopoietic stem cell transplant, at the 2019 TCT Meetings Sunday, Feb. 24.
• Aimmune Therapeutics Inc AIMT is scheduled to present Phase 3 data for AR101, its treatment candidate for peanut allergy, at the AAAAI annual meeting Sunday, Feb. 24.
• Orchard Therapeutics PLC – ADR ORTX will present Phase 1/2 data for its X-linked chronic granulomatous disease candidate OTL-102 at the 2019 TCT Meetings Sunday, Feb. 24.
• Sarepta Therapeutics Inc SRPT is set to release Phase 1/2 data for its Duchenne muscular dystrophy candidate MYO-101 at 8 a.m. Wednesday, Feb. 27.
• Heat Biologics Inc HTBX is scheduled to present interim Phase 2 data for HS-110 in combination with Bristol-Myers Squibb Co BMY's Opdivo at the 2019 ASCO-SITC meeting at 4 p.m. Thursday, Feb. 28.
• AAD Meeting Presentations (scheduled for Saturday, March 2)
• Verrica Pharmaceuticals Inc VRCA will present Phase 3 data for VP-101 in molluscum contagiosum.
• Spark Therapeutics Inc ONCE is due to make an oral presentation of Phase 2 8 mg data for CTP-543, its treatment candidate for alopecia areata.
• Menlo Therapeutics Inc MNLO will present already-released Phase 2 data for serlopitant, which is being evaluated for pruritus associated with psoriasis.
• Athenex Inc ATNX is scheduled to present already-released Phase 3 data for KX-01 ointment to treat actinic keratosis.

Earnings

Monday, Feb. 25

• Aerie Pharmaceuticals Inc AERI (after the market close)
• Corcept Therapeutics Incorporated CORT (after the market close)
• Insulet Corporation PODD (after the market close)
• Veracyte Inc VCYT (after the market close)
• Orthofix Medical Inc OFIX (after the market close)
• Xencor Inc XNCR (after the market close)

See also: Intercept Shares Soar To Multimonth High After NASH Drug Aces Late-Stage Trial

Tuesday. Feb. 26

• Transenterix Inc TRXC (before the market open)
• Epizyme Inc EPZM (before the market open)
• Vericel Corp VCEL (before the market open)
• Blueprint Medicines Corp BPMC (before the market open)
• Clovis Oncology Inc CLVS (before the market open)
• Strongbridge Biopharma plc SBBP (before the market open)
• Avanos Medical Inc AVNS (before the market open)
• MacroGenics Inc MGNX (after the market close)
• GW Pharmaceuticals PLC- ADR GWPH (after the market close)
• Wright Medical Group NV WMGI (after the market close)
• Voyager Therapeutics Inc VYGR (after the market close)
• Supernus Pharmaceuticals Inc SUPN (after the market close)
• Merit Medical Systems, Inc. MMSI (after the market close)
• Penumbra Inc PEN (after the market close)
• Jazz Pharmaceuticals PLC JAZZ (after the market close)
• Mylan NV MYL (after the market close)
• Tandem Diabetes Care Inc TNDM (after the market close)
• Masimo Corporation MASI (after the market close)
• Dynavax Technologies Corporation DVAX (after the market close)
• Global Cord Blood Corp CO (after the market close)
• AxoGen, Inc AXGN (after the market close)
• Akcea Therapeutics Inc AKCA (after the market close)
• ACADIA Pharmaceuticals Inc. ACAD (after the market close)

Wednesday. Feb. 27

• Adaptimmune Therapeutics PLC – ADR ADAP (before the market open)
• Horizon Pharma PLC HZNP (before the market open)
• Ionis Pharmaceuticals Inc IONS (before the market open)
• Acceleron Pharma Inc XLRN (after the market close)
• Synthetic Biologics Inc SYN (after the market close)
• CytomX Therapeutics Inc CTMX (after the market close)
• Glaukos Corp GKOS (after the market close)
• Collegium Pharmaceutical Inc COLL (after the market close)
• PRA Health Sciences Inc PRAH (after the market close)
• Sarepta Therapeutics Inc SRPT (after the market close)

Thursday, Feb. 28

• Pacira Pharmaceuticals Inc PCRX (before the market open)
• Novocure Ltd NVCR (before the market open)
• Syneos Health Inc SYNH (before the market open)
• Endo International PLC ENDP (before the market open)
• Amneal Pharmaceuticals Inc AMRX (before the market open)
• Amicus Therapeutics, Inc. FOLD (before the market open)
• Akorn, Inc. AKRX (before the market open)
• PTC Therapeutics, Inc. PTCT (after the market close)
• ICU Medical, Incorporated ICUI (after the market close)
• Radius Health Inc RDUS (after the market close)
• Foamix Pharmaceuticals Ltd FOMX (after the market close)
• Bio-Rad Laboratories, Inc. BIO (after the market close)
• Harvard Bioscience, Inc. HBIO (after the market close)
• Coherus Biosciences Inc CHRS (after the market close)
• Puma Biotechnology Inc PBYI (after the market close)
• AtriCure Inc. ATRC (after the market close)
• KemPharm Inc KMPH (after the market close)
• Editas Medicine Inc EDIT (after the market close)
• Sangamo Therapeutics Inc SGMO (after the market close)
• Nektar Therapeutics NKTR (after the market close)

Friday, March 1

• Evofem Biosciences Inc EVFM (before the market open)
• Portola Pharmaceuticals Inc PTLA (before the market open)

IPO

Kaleido Biosciences is planning to offer 4.76 million shares in an IPO priced between $20 and $22. The company, which develops microbiome therapies for rare genetic disorders, is seeking to list its shares on the Nasdaq under the ticker symbol KLDO.

IPO Quiet Period Expiry

• INmune Bio Inc INMB

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