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Week Ahead In Biotech: PDUFA Date Ahead For Astra Zeneca, Merck's Lynparza, Pending Clinical Readouts In Focus

Week Ahead In Biotech: PDUFA Date Ahead For Astra Zeneca, Merck's Lynparza, Pending Clinical Readouts In Focus

Biotech stocks advanced in the penultimate week of the year, and the iShares NASDAQ Biotechnology Index (NASDAQ: IBB) is on track to end the year with gains in excess of 25%.

The previous week saw FDA announcements on verdicts for several therapeutic options.

Notable among the therapeutic options that crossed the FDA hurdle were Allergan plc (NYSE: AGN)'s migraine drug; Flexion Therapeutics Inc (NASDAQ: FLXN)'s Zilretta, which was given a label expansion; Intra-Cellular Therapies Inc (NASDAQ: ITCI)'s schizophrenia drug; and two generics for Eliquis, a blood thinner marketed by Bristol-Myers Squibb Co (NYSE: BMY) and Pfizer Inc. (NYSE: PFE).

However, Correvio Pharma Corp (NASDAQ: CORV)'s Brinavess, a drug to treat atrial fibrillation, stumbled at the FDA altar.

A big gene therapy collaboration agreement between Roche Holdings AG Basel ADR (OTC: RHHBY) and Sarepta Therapeutics Inc (NASDAQ: SRPT) was announced. 

The following are key biotech catalysts for the unfolding week:


The FDA is scheduled to rule on the pancreatic cancer drug candidate lynparza, which is being co-developed by AstraZeneca plc (NYSE: AZN) and Merck & Co., Inc. (NYSE: MRK). The PDUFA date is set for the fourth quarter.

Clinical Readouts

Q4 Releases

  • Sol Gel Technologies Ltd (NASDAQ: SLGL): Phase 3 data for the acne treatment candidate TWIN (tretinoin and benzoyl peroxide)
  • Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX): Phase 1 data for VX-147 (for treating APOL1-mediated focal segmental glomerulosclerosis) in healthy volunteers
  • Molecular Templates Inc (NASDAQ: MTEM): updated Phase 1 data for MT-511 in HER2-positive solid tumors, updated Phase 2 data for MT-3724 in combination with chemotherapy for relapsed/refractory diffuse large B-cell lymphoma, updated Phase 2 data for MT-3724 in combination with Bristol-Myers Squibb's Revlimid in diffuse B-cell lymphoma and updated Phase 2 data for MT-3724 monotherapy in relapsed/refractory diffuse large B-cell lymphoma
  • Xeris Pharmaceuticals Inc (NASDAQ: XERS): Phase 2b data for self-administered glucagon in exercise-induced hypoglycemia
  • Gilead Sciences, Inc. (NASDAQ: GILD): Phase 2 data for GS-9688 for HBV
  • Eloxx Pharmaceuticals Inc (NASDAQ: ELOX): Phase 2 data for ELX-02 in cystinosis
  • Celsion Corporation (NASDAQ: CLSN): Phase 1/2 data for GEN-1 in ovarian cancer
  • Novartis AG (NYSE: NVS): NDA: Phase 3 data for PDR001 in BRAFV600 mutant metastatic melanoma
  • Incyte Corporation (NASDAQ: INCY): Phase 3 data for itacitinib in treatment-naïve acute GVHD
  • Applied Therapeutics Inc (NASDAQ: APLT): Additional Phase 1/2 data for AT-007 in galactosemia
  • Axsome Therapeutics Inc (NASDAQ: AXSM): Phase 3 data for AXS-07 in migraine
  • Spero Therapeutics Inc (NASDAQ: SPRO): top-line data from a Phase 1 study of SPR206 in healthy volunteers
  • DURECT Corporation (NASDAQ: DRRX): top-line data from a Phase 2 study of DUR-928 in psoriasis
  • Ultragenyx Pharmaceutical Inc (NASDAQ: RARE): Phase 1/2 third cohort data for DTX301 in ornithine transcarbamylase deficiency
  • Obseva SA (NASDAQ: OBSV): Interim analysis of data from Part B of a Phase 2a study of OBE022 in pre-term labor
  • Principia Biopharma Inc (NASDAQ: PRNB): updated Phase 2 data for PRN1008 in pemphigus
  • Oramed Pharmaceuticals, Inc. (NASDAQ: ORMP): data from the first cohort of a Phase 2 study of ORMD-0801 in non-alcoholic steatohepatitis
  • Inovio Pharmaceuticals Inc (NASDAQ: INO): Phase 1/2a data for INO-4700 for treating MERS virus

See also: 8 Biotech Stocks Morgan Stanley Recommends For 2020

Second-Half 2019 Releases

  • GlaxoSmithKline plc (NYSE: GSK): Pivotal Phase 1 data for TSR-042 in endometrial cancer

Year-End Releases

  • argenx SE – ADR (NASDAQ: ARGX) and Halozyme Therapeutics, Inc. (NASDAQ: HALO): Phase 1 data for efgartigimod using Halozyme's ENHANZE drug delivery technology
  • Sorrento Therapeutics Inc (NASDAQ: SRNE): Phase 1b data for resiniferatoxin in osteoarthritis of knee
  • MEI Pharma Inc (NASDAQ: MEIP): updated Phase 2 data for pracinostate in combination with Bristol-Myers Squibb's Vidaza in high-risk myelodysplastic syndrome
  • Sellas Life Sciences Group Inc (NASDAQ: SLS): initial Phase 2 data for nelipepimut-S in ductal carcinoma in Situ
  • Lineage Cell Therapeutics Inc (NYSE: LCTX): Phase 1 immunogenicity data for VAC2 in non-small cell lung cancer
  • Amicus Therapeutics, Inc. (NASDAQ: FOLD): additional Phase 1/2 data for CLN6 gene therapy in Batten disease, additional Phase 1/2 data for ATB200 in Pompe disease
  • Oncolytics Biotech, Inc. (NASDAQ: ONCY): interim data for pelareorep and Roche's Tecentriq in breast cancer
  • Regenxbio Inc (NASDAQ: RGNX): updated Phase 1/2 data for RGX-501 in homozygous familial hypercholesterolemia
  • Merus NV (NASDAQ: MRUS): Phase 1 data for MCLA-158 in colorectal cancer

2019 And Late 2019 Releases

  • Alnylam Pharmaceuticals, Inc. (NASDAQ: ALNY): Phase 1/2 data for ALN-AAT02 in alpha-1 anti-trypsin deficiency-associated liver disease

Planned NDA/BLA filings

  • Coherus Biosciences Inc (NASDAQ: CHRS): BLA submission for Lucentis biosimilar planned for the fourth quarter
  • Eli Lilly And Co (NYSE: LLY): NDA filing for LOXO-292 in RET-fusion non-small cell lung cancer, medullary thyroid cancer and other tumors planned for year end 2019
  • Morphosys Ag (NASDAQ: MOR): Rolling BLA submission for lenalidomide in combination with MOR208 in relapsed or refractory diffuse large B cell lymphoma expected to be completed by the end of 2019
  • Incyte and Novartis: NDA submission for INC280 in non-small cell lung cancer due 2019
  • Chiasma Inc (NASDAQ: CHMA): NDA filing for mycapssa in acromegaly due in the fourth quarter
  • G1 Therapeutics Inc (NASDAQ: GTHX): Rolling submission for trilaciclib in second/third-line setting in small-cell lung cancer expected to begin in the fourth quarter
  • Eyepoint Pharmaceuticals Inc (NASDAQ: EYPT): sNDA filing for a six-month formulation of Yutiq in non-infectious uveitis expected to be complete in 2019
  • Bausch Health Companies Inc (NYSE: BHC) and Eton Pharmaceuticals Inc (NASDAQ: ETON) plan to make a NDA resubmission for EM-100 in allergic conjunctivitis
  • Vanda Pharmaceuticals Inc. (NASDAQ: VNDA): sNDA filing for Hetlioz in SmIth-Magenis syndrome due in the fourth quarter
  • Clovis Oncology Inc (NASDAQ: CLVS): sNDA filing for Rubraca in BRCA-mutant advanced prostate cancer planned for the fourth quarter
  • PTC Therapeutics, Inc. (NASDAQ: PTCT): BLA filing for GT-AADC for aromatic L-amino acid decarboxylase deficiency planned for the fourth quarter
  • Sanofi SA (NASDAQ: SNY) and Regeneron Pharmaceuticals Inc (NASDAQ: REGN): sBLA filing for Dupixent in atopic dermatitis for 6-11-year-olds, planned for the fourth quarter
  • Clovis Oncology Inc (NASDAQ: CLVS): sNDA filing for Rucaparib in castrate-resistant prostate cancer planned for the fourth quarter
  • PLx Pharma Inc (NASDAQ: PLXP): sNDA filing for Aspertec in cardiovascular and stroke patients planned for late 2019
  • Aquestive Therapeutics Inc (NASDAQ: AQST): NDA resubmission for APL-130277 in Parkinson's disease with motor fluctuations planned for the fourth quarter

Related Link: 10 Biotech M&A Targets Under The Scanner For 2020


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