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 (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.
- 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
- Sponsor: Aimmune Therapeutics Inc (NASDAQ: AIMT)
- Indication: Peanut allergy
- Status: PDUFA date 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 (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
- 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
- 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
- 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
FTSE100 Boosted by Optimism over Potential Coronavirus Drug
A University of Chicago hospital participating in a study of the antiviral medication, made by US firm Gilead Sciences, reportedly found that nearly all patients suffering fever and respiratory symptoms were discharged within a week. The report, by healthcare publication Stat News, spurred hopes among investors that lockdowns around the world could be eased.
The FTSE100 gained more than 3% – or 191 points – to 5819 in early trading on Friday, while Wall Street is expected to open higher on the back of hopes for the drug, first developed as a treatment for the Ebola virus. Gilead shares added 14% in after-hours trading on Thursday evening.
Joshua Mahony, senior market analyst at share trading firm IG, said: “Trial results have breathed a new sense of optimism into markets, with many seeing this as the potential begging of the end for this coronavirus crisis.”
The University of Chicago recruited 125 people into a clinical trial, according to the report, 113 of whom tested positive for Covid-19, with all of them receiving daily remdesivir doses. Two patients died but most of the rest have already been discharged after their symptoms eased significantly.
Last month, Donald Trump flagged up the potential of remdesivir, saying it “seems to have a very good result”.
In a statement, Gilead said: “What we can say at this stage is that we look forward to data from ongoing studies becoming available.”
The biotechnology company, based in Foster City, California, had previously said to expect results for its trial involving severe cases in April.
In a video obtained by Stat News, Kathleen Mullane, the infectious disease specialist overseeing the study, said it was hard to draw conclusions because remdesivir is not being compared against results from a group taking a placebo drug.
“But certainly when we start [the] drug, we see fever curves falling,” she said. “We have seen people come off ventilators a day after starting therapy. So, in that realm, overall our patients have done very well.
“Most of our patients are severe and most of them are leaving at six days, so that tells us duration of therapy doesn’t have to be 10 days. We have very few that went out to 10 days, maybe three.”
Biotechnology: On The Edge of Another Explosion
On the most fundamental level, biotechnology is any technology or product developed using cellular and biomolecular processes. The products as simple as bread and cheese could be considered biotech innovations. Today, the biotech field has expanded substantially, and those involved in it are making significant strides towards solving some of the world’s greatest problems.
Biotech stocks went into one of the greatest abyss in their history which started last summer. However, as they are going down, there are still hope for their recovery.
The three years of running which let it more than quadruples its by value on its highest point last July, IBD’s Medical-Biomed or the Biotech Industry Group surprisingly went down 50% early this February. It was affected by recoils against hike up of drug prices and mergers that are looking for safer with lower taxes.
Despite this downfall, the group has regained 12% since this February 11 low together with some stocks leading better that that as mentioned.
The rise of the stock under Biotech was driven by the first wave of biotech innovation when companies like Amgen and Roche‘s (RHHBY) Genentech proved that biotechnology could produce blockbusters. Vandeventer says that innovation will remain the key to maintaining pricing power, even under political pressure. Despite much political criticism of Sovaldi’s high price, no one could stop it because the drug was superior to anything else on the market.
Signs and indicators that even generalist investors conclude biotech stocks have become cheaper. During the first quarter, a common lament was that every biotech stock got punished for bad news, but this news does not have a bearing at all. But when Biogen issued a mixed earnings report that drew mostly negative reactions from Wall Street on April 21, its stock rose more than 5%.
How Did Pfizer Grow With Weak Dollar?
How was Pfizer helped by the weakening of dollar?
Pfizer topped the expectations when the pharmaceuticals giant on the first-quarter revenue went up to $13 billion with adjusted earnings per share of 67 cents. Not only this, Pfizer also shoots with a full-year guidance not only the top but both the top and bottom lines. Today, it is not expected on 2016 revenue to have $52 billion at the midpoint of guidance, up from $50 billion.
What helped this to happen? – The new products such as breast-cancer drug called Ibrance and the vaccine for pneumonia called Prevnar 13 is selling exceeding the anticipation of analysts. On the other hand, greenback’s recent travails also contributed to this help.
According to the Wall Street Journal Dollar Index, the measure of currency’s strength is up more than 25% over the last five years but also 6% down so far this year. The dollar is accounted for the half of Pfizer’s growth in the mid of its guidance.
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