Biotech stocks advanced in the penultimate week of the year, and the iShares NASDAQ Biotechnology Index IBB 0.83% 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 AGN 0.12%‘s migraine drug; Flexion Therapeutics Inc FLXN 9.2%‘s Zilretta, which was given a label expansion; Intra-Cellular Therapies Inc ITCI 3.97%‘s schizophrenia drug; and two generics for Eliquis, a blood thinner marketed by Bristol-Myers Squibb Co BMY 0.25% and Pfizer Inc. PFE.
However, Correvio Pharma Corp CORV 9.62%‘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 RHHBY 0.69% and Sarepta Therapeutics Inc SRPT 2.41% was announced.
The following are key biotech catalysts for the unfolding week:
PDUFA Dates
The FDA is scheduled to rule on the pancreatic cancer drug candidate lynparza, which is being co-developed by AstraZeneca plc AZN 1.16% and Merck & Co., Inc. MRK 0.19%. The PDUFA date is set for the fourth quarter.
Clinical Readouts
Q4 Releases
- Sol Gel Technologies Ltd SLGL 5.43%: Phase 3 data for the acne treatment candidate TWIN (tretinoin and benzoyl peroxide)
- Vertex Pharmaceuticals Incorporated VRTX 0.33%: Phase 1 data for VX-147 (for treating APOL1-mediated focal segmental glomerulosclerosis) in healthy volunteers
- Molecular Templates Inc MTEM 1.69%: 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 XERS 4.61%: Phase 2b data for self-administered glucagon in exercise-induced hypoglycemia
- Gilead Sciences, Inc. GILD 0.66%: Phase 2 data for GS-9688 for HBV
- Eloxx Pharmaceuticals Inc ELOX 4.41%: Phase 2 data for ELX-02 in cystinosis
- Celsion Corporation CLSN 4.12%: Phase 1/2 data for GEN-1 in ovarian cancer
- Novartis AG NVS 0.94%: NDA: Phase 3 data for PDR001 in BRAFV600 mutant metastatic melanoma
- Incyte Corporation INCY 0.44%: Phase 3 data for itacitinib in treatment-naïve acute GVHD
- Applied Therapeutics Inc APLT 2.27%: Additional Phase 1/2 data for AT-007 in galactosemia
- Axsome Therapeutics Inc AXSM 4.01%: Phase 3 data for AXS-07 in migraine
- Spero Therapeutics Inc SPRO 1.76%: top-line data from a Phase 1 study of SPR206 in healthy volunteers
- DURECT Corporation DRRX 0.31%: top-line data from a Phase 2 study of DUR-928 in psoriasis
- Ultragenyx Pharmaceutical Inc RARE 4.07%: Phase 1/2 third cohort data for DTX301 in ornithine transcarbamylase deficiency
- Obseva SA OBSV 4.15%: Interim analysis of data from Part B of a Phase 2a study of OBE022 in pre-term labor
- Principia Biopharma Inc PRNB 1.19%: updated Phase 2 data for PRN1008 in pemphigus
- Oramed Pharmaceuticals, Inc. ORMP 1.89%: data from the first cohort of a Phase 2 study of ORMD-0801 in non-alcoholic steatohepatitis
- Inovio Pharmaceuticals Inc INO 5.92%: Phase 1/2a data for INO-4700 for treating MERS virus
Second-Half 2019 Releases
- GlaxoSmithKline plc GSK 0.81%: Pivotal Phase 1 data for TSR-042 in endometrial cancer
Year-End Releases
- argenx SE – ADR ARGX 0.24% and Halozyme Therapeutics, Inc. HALO 1.69%: Phase 1 data for efgartigimod using Halozyme’s ENHANZE drug delivery technology
- Sorrento Therapeutics Inc SRNE 2.75%: Phase 1b data for resiniferatoxin in osteoarthritis of knee
- MEI Pharma Inc MEIP 1.14%: updated Phase 2 data for pracinostate in combination with Bristol-Myers Squibb’s Vidaza in high-risk myelodysplastic syndrome
- Sellas Life Sciences Group Inc SLS 5.45%: initial Phase 2 data for nelipepimut-S in ductal carcinoma in Situ
- Lineage Cell Therapeutics Inc LCTX 3.75%: Phase 1 immunogenicity data for VAC2 in non-small cell lung cancer
- Amicus Therapeutics, Inc. FOLD 2.5%: 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. ONCY 0.71%: interim data for pelareorep and Roche’s Tecentriq in breast cancer
- Regenxbio Inc RGNX 2.03%: updated Phase 1/2 data for RGX-501 in homozygous familial hypercholesterolemia
- Merus NV MRUS 3.15%: Phase 1 data for MCLA-158 in colorectal cancer
2019 And Late 2019 Releases
- Alnylam Pharmaceuticals, Inc. ALNY 0.2%: Phase 1/2 data for ALN-AAT02 in alpha-1 anti-trypsin deficiency-associated liver disease
Planned NDA/BLA filings
- Coherus Biosciences Inc CHRS 1.97%: BLA submission for Lucentis biosimilar planned for the fourth quarter
- Eli Lilly And Co LLY 0.77%: 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 MOR 0.37%: 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 CHMA 6%: NDA filing for mycapssa in acromegaly due in the fourth quarter
- G1 Therapeutics Inc GTHX 4.3%: Rolling submission for trilaciclib in second/third-line setting in small-cell lung cancer expected to begin in the fourth quarter
- Eyepoint Pharmaceuticals Inc EYPT 1.35%: sNDA filing for a six-month formulation of Yutiq in non-infectious uveitis expected to be complete in 2019
- Bausch Health Companies Inc BHC 0.08% and Eton Pharmaceuticals Inc ETON 1.13% plan to make a NDA resubmission for EM-100 in allergic conjunctivitis
- Vanda Pharmaceuticals Inc. VNDA 2.16%: sNDA filing for Hetlioz in SmIth-Magenis syndrome due in the fourth quarter
- Clovis Oncology Inc CLVS 2.36%: sNDA filing for Rubraca in BRCA-mutant advanced prostate cancer planned for the fourth quarter
- PTC Therapeutics, Inc. PTCT 0.25%: BLA filing for GT-AADC for aromatic L-amino acid decarboxylase deficiency planned for the fourth quarter
- Sanofi SA SNY 1.11% and Regeneron Pharmaceuticals Inc REGN 0.41%: sBLA filing for Dupixent in atopic dermatitis for 6-11-year-olds, planned for the fourth quarter
- Clovis Oncology Inc CLVS 2.36%: sNDA filing for Rucaparib in castrate-resistant prostate cancer planned for the fourth quarter
- PLx Pharma Inc PLXP 0.86%: sNDA filing for Aspertec in cardiovascular and stroke patients planned for late 2019
- Aquestive Therapeutics Inc AQST 9.26%: NDA resubmission for APL-130277 in Parkinson’s disease with motor fluctuations planned for the fourth quarter
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