Biotechnology and pharmaceutical companies generally face a fair-to-great amount of risk based on the lengthy vetting process for their drug candidates, should a study come back negative or should a candidate not be approved. On the other hand, if a drug is approved or passes a clinical trial, there can be massive upside.
The long and short of the matter is that updates within this industry, as well as U.S. Food and Drug Administration (FDA) rulings, can make or break these companies.
Jefferies has put together a list of 10 companies that could have developments coming up in the next two weeks to start the year. While there are definitely surprise M&A deals that could arise in this time and swing sentiment within the industry, here are 10 biotech events that are likely to kick off 2018.
Celgene Corp. (NASDAQ: CELG) is likely to preannounce fourth-quarter numbers (Jefferies thinks a good result) and provide new 2018 guidance though investors should assume this could be conservative. Also it’s encouraging the stock didn’t actually go down much on RELEVANCE data recently. Shares of Celgene were last seen at $104.73, in a 52-week trading range of $94.55 to $147.17.
Biogen Inc. (NASDAQ: BIIB) could disclose “color” around Spinraza USA or EMA patient numbers and update aducanumab Alzheimer’s enrollment. Shares of Biogen recently traded at $320.43, within a 52-week range of $244.28 to $348.84.
Vertex Pharmaceuticals Inc. (NASDAQ: VRTX) could preannounce fourth-quarter results but may not provide 2018 cystic fibrosis guidance until VX-661 combo is approved in February. More importantly, the company could disclose Phase 3 triple plans and update on the Phase 3 data. Shares of Vertex were last seen at $150.93, in a 52-week range of $73.23 to $167.86.
Alnylam Pharmaceuticals Inc. (NASDAQ: ALNY) guided to initiate ALN-TTRsc02 Phase 3 in 2018. Also Jefferies is waiting on a potential renegotiation of economics with Sanofi. An update is expected for the Phase 1 program (ALN-GO1), which had initial data at the American Society of Nephrology (ASN) annual meeting, or potentially the announcement of a new program. Shares of Alnylam were trading at $129.49, with a 52-week range of $35.98 to $147.63.
AveXis Inc. (NASDAQ: AVXS) may provide FDA meeting updates and next steps after recent regulatory discussions. Shares of AveXis were last seen at $113.72. The 52-week range is $46.41 to $114.28.
Intercept Pharmaceuticals Inc. (NASDAQ: ICPT) may preannounce fourth-quarter Ocaliva sales or initiation of Phase 3 cirrhosis study, or color on upcoming FDA label change. Shares of Intercept were last seen at $63.97, in a 52-week range of $54.98 to $135.59.
Assembly Biosciences Inc. (NASDAQ: ASMB) may possibly announce its Phase 1b HBV data on viral knockdown. Shares were recently trading at $45.39, within a 52-week range of $11.51 to $52.37.
Axovant Sciences Ltd. (NASDAQ: AXON) may report Phase 2B data for intepiridine in dementia with Lewy bodies and nelotansersin in visual hallucinations. Shares of Axovant were last seen at $5.19. The 52-week range is $4.60 to $27.98.
Acorda Therapeutics Inc. (NASDAQ: ACOR) is likely to preannounce 2017 Ampyra net sales and provide 2018 financial guidance. Acorda shares were trading at $22.65, and the 52-week range is $13.60 to $33.00.
FibroGen Inc. (NASDAQ: FGEN) could disclose HRCT imaging IPF data or Phase 2 pancreatic cancer data for pamrevlumab. Shares were at $48.10, in a 52-week range of $20.85 to $60.15.