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.
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 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.
- Sponsor: Daiichi Sankyo Company, Limited DSNKY & AstraZeneca plc 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
- Sponsor: Aimmune Therapeutics Inc 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
- Sponsor: Bristol-Myers Squibb Co 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
- Sponsor: Novartis AG 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
- Sponsor: AstraZeneca/FibroGen Inc 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
- Sponsor: Immunomedics, Inc. 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
- Sponsor: Gilead Sciences, Inc. GILD and GALAPAGOS NV/S ADR 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
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