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

Shanthi Rexaline

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.

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Among the notable events: Merck & Co., Inc. (NYSE: MRK)'s decision to acquire thinly traded microcap Immune Design Corp (NASDAQ: 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 (NYSE: 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 (NASDAQ: 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 (NYSE: 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 (NASDAQ: 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 (NASDAQ: 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 (NASDAQ: 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 (NASDAQ: HTBX) is scheduled to present interim Phase 2 data for HS-110 in combination with Bristol-Myers Squibb Co (NYSE: 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 (NASDAQ: VRCA) will present Phase 3 data for VP-101 in molluscum contagiosum.
  • Spark Therapeutics Inc (NASDAQ: 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 (NASDAQ: MNLO) will present already-released Phase 2 data for serlopitant, which is being evaluated for pruritus associated with psoriasis.
  • Athenex Inc (NASDAQ: 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 (NASDAQ: AERI) (after the market close)
  • Corcept Therapeutics Incorporated (NASDAQ: CORT) (after the market close)
  • Insulet Corporation (NASDAQ: PODD) (after the market close)
  • Veracyte Inc (NASDAQ: VCYT) (after the market close)
  • Orthofix Medical Inc (NASDAQ: OFIX) (after the market close)
  • Xencor Inc (NASDAQ: 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 (NYSE: TRXC) (before the market open)
  • Epizyme Inc (NASDAQ: EPZM) (before the market open)
  • Vericel Corp (NASDAQ: VCEL) (before the market open)
  • Blueprint Medicines Corp (NASDAQ: BPMC) (before the market open)
  • Clovis Oncology Inc (NASDAQ: CLVS) (before the market open)
  • Strongbridge Biopharma plc (NASDAQ: SBBP) (before the market open)
  • Avanos Medical Inc (NYSE: AVNS) (before the market open)
  • MacroGenics Inc (NASDAQ: MGNX) (after the market close)
  • GW Pharmaceuticals PLC- ADR (NASDAQ: GWPH) (after the market close)
  • Wright Medical Group NV (NASDAQ: WMGI) (after the market close)
  • Voyager Therapeutics Inc (NASDAQ: VYGR) (after the market close)
  • Supernus Pharmaceuticals Inc (NASDAQ: SUPN) (after the market close)
  • Merit Medical Systems, Inc. (NASDAQ: MMSI) (after the market close)
  • Penumbra Inc (NYSE: PEN) (after the market close)
  • Jazz Pharmaceuticals PLC (NASDAQ: JAZZ) (after the market close)
  • Mylan NV (NASDAQ: MYL) (after the market close)
  • Tandem Diabetes Care Inc (NASDAQ: TNDM) (after the market close)
  • Masimo Corporation (NASDAQ: MASI) (after the market close)
  • Dynavax Technologies Corporation (NASDAQ: DVAX) (after the market close)
  • Global Cord Blood Corp (NYSE: CO) (after the market close)
  • AxoGen, Inc (NASDAQ: AXGN) (after the market close)
  • Akcea Therapeutics Inc (NASDAQ: AKCA) (after the market close)
  • ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD) (after the market close)

Wednesday. Feb. 27

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

Thursday, Feb. 28

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

Friday, March 1

  • Evofem Biosciences Inc (NASDAQ: EVFM) (before the market open)
  • Portola Pharmaceuticals Inc (NASDAQ: 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 (NASDAQ: INMB)

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

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