It was a dark day of trading on Thursday for biopharma Talaris Therapeutics (US:TALS) after management reported a fatality of a patient that was undergoing the phase 1 trial.
The TALS stock price dropped as low as $1.16, trading -52% lower in early morning trading before marginally recovering some of the losses and closing -44% lower at $1.37 per share.
Talaris disclosed that on Tuesday they received the report of a patient fatality that occurred during the Phase 3 FREEDOM-1 clinical trial in transplant patients that receive donor kidneys.
The patient’s death triggered a temporary stop to the trial and will require a review by the data monitoring committee.
The patient was one of three study subjects that in June were diagnosed with a grade II acute graft-vs-host disease (aGvHD).
The patient was also diagnosed with a moderate grade IV GvHD which was complicated by serious infections that ultimately lead to death.
Talaris stated that after reviewing the facts of the case, the Data Monitoring Committee concluded that the FREEDOM-1 protocol modifications implemented in June of this year should be sufficient to mitigate the risk of GvHD going forward, and recommended that the study can continue without further modifications.
Analyst Mani Foroohar from SVJ Securities highlighted that the patient death raises important safety questions for the remaining patients treated under the prior protocol and will put the stock under the shadow of headline risk from additional safety disclosure that will be required in the future.
Due to the timeline risk Talaris will experience, Foroohar reduced his target from $7 to $2 and remained ‘market perform’ rated on the stock.
It was an unfortunate week for Analyst Raghuram Selvaraju from H.C. Wainwright & Co who initiated the stock with a ‘buy’ recommendation and an extremely bullish target of $18.
Selvaraju published his article only one day before the TALS announcement with upbeat commentary discussing “how the risk of not reproducing FCR0001’s Phase 2 efficacy data in the ongoing Phase 3 study is very low” in their view…
Although the latest development will likely delay the process, the target market opportunity remains attractive with a significant addressable market.
On average, the street remains positive on the stock despite the significantly weakening TALS share price which is trading -91% lower year to date.
The Fintel platform highlighted that TALS has experienced above average insider buying activity. This is described by an officer accumulation score of 60.73 and ranks TALS in the top 7% when screened against 11,634 other stocks.
Three insiders traded TALS stock over the past 90 days.
CEO Scott Requadt purchased 57,444 shares in several transactions over late July and increased his total TALS share count to 508,680.
Senior scientific advisor and Founder of Talaris, Suzanne Ilstad in late August sold 525,000 shares at $2.80 in a transaction worth about $1.5 million. Ilstad still owns 3.08 million shares but was able to save around $800,000 of losses by selling the parcel before shares fell further.
The final transaction was from TALS Chairman Francois Nader who made his first share purchase in the company of 50,000 shares at $3.52 per share. The total transaction was worth around $176 thousand.
This article originally appeared on Fintel
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