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Biotech stocks had a fairly decent run in 2019, thanks to record deal flow, several path-breaking innovation in drug research & development and the positive broader market sentiment. New molecular entity approvals totaled 48 in 2019, less than the 59 NME approvals in 2018.
The new year is expected to be risk fraught, as lawmakers are expected to step up their rhetoric on drug pricing. Even as the outlook for drug companies remains not-so-promising, some key drug approvals could still impart some momentum to the sector.
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The FDA could expedite the review of some drugs, Evaluate Pharma said, citing some approvals in 2019 that came about well ahead of the scheduled PDUFA date such as Vertex Pharmaceuticals Incorporated's (NASDAQ:VRTX) Trikafta. Trikafta, a treatment option for cystic fibrosis, was approved five months ahead of the PDUFA date.
The following are the drugs with blockbuster potential that could make their way from lab to the shelves, according to Evaluate Pharma.
Trastuzumab deruxtecan
- Sponsor: Daiichi Sankyo Company, Limited (OTC:DSNKY) & AstraZeneca plc (NYSE:AZN)
- Indication: Her2 positive breast cancer
- Status: BLA accepted with priority review status in October and the PDUFA date has been fixed for second quarter of 2020
Palforzia
- Sponsor: Aimmune Therapeutics Inc (NASDAQ:AIMT)
- Indication: Peanut allergy
- Status: Target action date is end of January; A FDA panel, which met in September, voted 7 to 2 that the efficacy data and 8 to 1 that the safety data in conjunction with additional safeguards are adequate to support the use of Palforzia
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Ozanimod
- Sponsor: Bristol-Myers Squibb Co (NYSE:BMY) (came into the company's stable through its Celgene buy)
- Indication: relapsing form of multiple sclerosis
- Status: The FDA accepted for review the BLA in June and has set a PDUFA date of March 25
Inclisiran
- Sponsor: Novartis AG (NYSE:NVS)(came into the company's stable through its Medicines Company buy)
- Indication: LDL-cholesterol lowering therapy
- Status: NDA submitted in December for use in secondary prevention patients with atherosclerotic cardiovascular disease and familial hypercholesterolemia
Roxadustat
- Sponsor: AstraZeneca/FibroGen Inc (NASDAQ:FGEN)
- Indication: treating anemia associated with chronic kidney disease
- Status: FibroGen, AstraZeneca's partner in developing roxadustat, said it has submitted the NDA to the FDA in late December
Sacituzumab Govitecan
- Sponsor: Immunomedics, Inc. (NASDAQ:IMMU)
- Indication: treating metastatic triple-negative breast cancer
- Status: After an initial snub, the company resubmitted the BLA and the FDA accepted the application for review Dec. 26, 2019, fixing a PDUFA action date of June 2
Filgotinib
- Sponsor: Gilead Sciences, Inc. (NASDAQ:GILD) and GALAPAGOS NV/S ADR (NASDAQ:GLPG)
- Indication: rheumatoid arthritis
- Status: The NDA was submitted Dec. 16, 2019, with the review period expected to be expedited due to a priority review voucher submitted along with the application
Crypto Whales Are Loading Up — Are You?
New research shows the biggest crypto buyers are back. And this time? They could hold for the possibility that Bitcoin will surpass $100,000 in 2024. You don’t want to miss the next massive crypto bull run like we saw in 2020 and 2021. To know exactly what’s going on and what to buy… Get Access To Benzinga’s Best Crypto Research and Investments For Only $1.