PBE News and Press, Invesco Dynamic Biotech & Genome From 06/21/22

Mirati will probably not get accelerated approval for adagrasib in 2nd line NSCLC. This will delay their program for two years. However, much of their data is stronger than Amgen's lumakras. For further details see: Mirati: Not Looking Good In 2022, But Stronger Prospect...

AVDL's FT218 is going to get delayed further over a patent issue. However, there's a goalpost in sight now, and the date is June 2023. The company is cash-strapped. For further details see: Avadel: Further Delay, But Some Light At The End Of The Tunnel

In the last 12 months, I count four Ionis programs that failed. This series of failures does not generate confidence. So, despite some catalysts up ahead, I will stay away. For further details see: Ionis Pharma: Too Many Programs Have Failed To Produce Confidence

Two ongoing studies for use of paltusotine for treatment of patients with Acromegaly are PATHFNDR-1 and PATHFNDR-2; Results from both studies expected 2023. Paltusotine is also being explored for the treatment of patients with neuroendocrine tumors in a phase 2 study. Phase 1 proo...

A phase 2/3 trial failure in the MDD indication of PRAX-114 allows this biotech to shift focus over to PRAX-944 for Essential tremors and other preclinical drugs. Results from the phase 2b Essential1 study using PRAX-944 for treatment of patients with essential tremors expected 2...

Positive results have been released thus far from a phase 1 study using INBRX-101 for the treatment of patients with Alpha-1 Antitrypsin Deficiency. It is expected that the Alpha-1 Antitrypsin Deficiency Augmentation therapy market could reach $1.95 billion by 2026. If FDA gives g...

BBIO lost hugely after the December phase 3 flop. So, although its business model is very interesting, it is not de-risked. It does have a lot of cash. For further details see: BridgeBio Pharma: Yet To Be Proven Business Model

Today, we revisit Outlook Therapeutics for the first time since March 2021. The company recently temporarily withdrew its marketing application for its main asset, clouding the outlook on this small-cap name even further. Should shareholders bail out or hold tight onto the stock? ...

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Results from the phase 2a INTEGRIS-PSC study using PLN-74809 for the treatment of patients with primary sclerosing cholangitis are expected 1st half of 2023. PLN-74809 is also being explored for the treatment of patients with idiopathic pulmonary fibrosis; Preliminary safety and effic...