The PDUFA date is November 13, 2018, but new YUPELRI data will be released on September 16, 2018 at ERS.
YUPELRI is an investigational long-acting muscarinic antagonist currently under review by the FDA for the treatment of COPD. If approved, YUPELRI would be the first once-daily, long-acting nebulized bronchodilator for the treatment of COPD. YUPELRI is designed to be compatible with any standard jet nebulizer.
New data from the Phase 3 YUPELRI™ (revefenacin) inhalation solution clinical program will be featured in an oral presentation at the European Respiratory Society (ERS) International Congress 2018, being held in Paris, France on September 15-19, 2018. The presented data will highlight chronic obstructive pulmonary disease (COPD) exacerbation rates observed in the Phase 3 clinical program of YUPELRI in patients with moderate to very severe COPD.
Details of the oral presentation at the ERS International Congress 2018 are as follows:
COPD Exacerbations in the Phase 3 Revefenacin Clinical Trial Program
Sunday, September 16, 2018, 2:45 – 4:45 p.m. (local time)
Session: Oral Presentation: Clinical Trials in COPD: New Results
Location: Room 7.3P (Hall 7.3)
TBPH stock presents a good setup pattern. Prices have been consolidating lately and the volatility has been reduced. A pullback is taking place, which may present a nice opportunity for an entry before the September 16, 2018 new data release. There is a resistance zone just above the current price starting at $28.79. Right above this resistance zone may be a good entry point. There is a support zone below the current price at $28.36, a stop order could be placed below this zone.
I’m not adding TBPH stock to the long-term buy and hold Health portfolio. The catalyst is positive data on September 16, 2018 and if the stock runs up before the weekend. If the data is really positive, the stock could spike Monday and then we would sell into that spike.
This is too much of a role the dice gamble for me so I’m staying out of this trade but wanted to make you aware of the setup and coming catalyst.