
Current Price | $9.06 | Mkt Cap | $1.3B |
---|---|---|---|
Open | $8.59 | P/E Ratio | -16.73 |
Prev. Close | $9.06 | Div. (Yield) | $0.00 (0.0%) |
Daily Range | $8.42 - $9.06 | Volume | 2,226,743 |
52-Wk Range | $4.07 - $12.43 | Avg. Daily Vol. | 1,961,038 |
Current Price | $9.06 | Mkt Cap | $1.3B |
---|---|---|---|
Open | $8.59 | P/E Ratio | -16.73 |
Prev. Close | $9.06 | Div. (Yield) | $0.00 (0.0%) |
Daily Range | $8.42 - $9.06 | Volume | 2,226,743 |
52-Wk Range | $4.07 - $12.43 | Avg. Daily Vol. | 1,961,038 |
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Aurinia wins the comeback kid award after rebounding to 5.5 just six weeks after crashing to 1.73 on word of a substantial mortality imbalance favoring control in the AURA-LV phase IIb trial of voclosporin for lupus nephritis. Aurinia insists that… More
Read the most recent pitches from players about AUPH.
Recs
Lupkynis 1st oral drug to treat lupus nephritis. May be a game changer. Also likely takeover candidate
Recs
Aurinia has successfully advanced a drug for this condition through Phase 3 trials. The company’s drug, called voclosporin, works by inhibiting an enzyme called calcineurin. Calcineurin activates inflammatory molecules and T cells, and drugs of this class have been used to treat a range of autoimmune diseases.
Voclosporin, however, has a number of advantages over other drugs of this class. These include increased potency and lower diabetes risk. Moreover, after a year of treatment, patients in the Phase 3 trial were almost twice as likely (22% vs. 40.8%) to achieve a positive renal response over patients receiving the current standard-of-care treatment.[2]
Patients were evaluated using urine analysis and voclosporin patients were much more likely to see a reduction of biomarkers like proteins in urine, to healthier levels.
That’s important. This indicates that the drug is reducing kidney inflammation and helping to protect the vital organ from damage.
These good results released late last year enabled Aurinia to file a New Drug Application with the FDA earlier this year. The regulator has not only accepted this small drug company’s application, but it’s agreed to grant it Priority Review status. This indicates that the FDA considers this drug to be important enough to warrant an expedited review process.
Priority Review sets a six-month target for a final decision on whether or not a new drug is approved. Aurinia announced that its application was accepted on June 21, so that means we can expect an FDA decision by Jan. 22, 2021.
Recs
While nothing is a slam-dunk with FDA, AUPH is very likely to get approval for Voclosporin. The biggest risk is a CRL due to manufacturing issues or a request for additional data. That should only cause a delay, however, and an eventual approval is likely. I would expect a run up to approval, with the share price trading sideways for a quarter or two during launch. Given the addressable market and the lack of competition, though, uptake of the drug is likely, and the this should double in the next couple of years.
Find the members with the highest scoring picks in AUPH.
usubanas2 (79.73) Score: +452.49
The Score Leader is the player with the highest score across all their picks in AUPH.
Top Pick |
Member Name |
Member Rating |
Start Date |
Call |
Time Frame |
Start Price |
Stock Gain |
Index Gain |
Score | Commentary |
---|---|---|---|---|---|---|---|---|---|---|
jack0071 | 64.37 | 12/28/2016 |
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5Y | $2.14 | +318.22% | +102.63% | +215.59 | 0 Comment | |
ChanceClub | 84.10 | 8/17/2020 |
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5Y | $14.19 | -36.93% | +35.85% | +72.78 | 0 Comment | |
mmr23 | < 20 | 3/7/2017 |
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NS | $6.82 | +31.23% | +93.50% | +62.27 | 1 Comment | |
shredlee | 53.65 | 2/15/2017 |
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1Y | $3.58 | +150.00% | +96.16% | +53.84 | 0 Comment | |
eyezie1 | < 20 | 11/21/2016 |
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5Y | $3.58 | +149.94% | +109.12% | +40.83 | 0 Comment | |
Under5 | 55.47 | 10/11/2019 |
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5Y | $4.70 | +90.43% | +54.96% | +35.47 | 0 Comment | |
Doppelganger | 46.74 | 10/10/2016 |
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5Y | $4.90 | +82.65% | +112.39% | +29.74 | 0 Comment | |
WildShaman | 78.47 | 7/9/2018 |
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5Y | $5.70 | +57.02% | +66.01% | +8.99 | 0 Comment | |
PayrollGeek | < 20 |
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3Y | $5.29 | +69.14% | +60.61% | +8.53 | 0 Comment | |
NextGenStock | < 20 |
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5Y | $5.26 | +70.15% | +62.27% | +7.88 | 0 Comment |
See what the Wall Street professionals think, according to their public statements and filings.