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

Shanthi Rexaline

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.

  • 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

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

  • 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

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

  • 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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