News

Theratechnologies FDA Rejection

1 Mins read

Theratechnologies is poised for a significant setback as the Food and Drug Administration (FDA) has rejected its supplemental biologics license application for an intramuscular method of administering a maintenance dose of Trogarzo, an HIV-1 inhibitor.

Stock Performance

In premarket trading on Nasdaq, Theratechnologies shares were down by 30%, following a 1.2% increase in 2024, closing at $1.64 in the previous session. Similarly, in Toronto, the shares closed at C$2.20, reflecting a 2.8% gain in the new year.

FDA’s Decision

The biopharmaceutical company received a refusal to file letter from the FDA regarding its supplemental license application. The FDA cited that the application lacked completeness for a substantive review. Particularly, it mentioned the absence of essential data required to establish the pharmacokinetic bridge between the intramuscular and intravenous infusion route of administration of Trogarzo.

Company Response

Commenting on the FDA’s decision, Christian Marsolais, Theratechnologies’ chief medical officer, expressed disappointment but acknowledged the challenges based on the TMB-302 study results from October 2023. He stated, “We will now assess our options regarding this application.”

Theratechnologies now faces uncertainties concerning the future of its sBLA for Trogarzo’s intramuscular administration.

Related posts
News

7 Token Presales to Watch in 2025: Blazpay ($BLAZ) Takes the Lead

4 Mins read
The world of token presales has always attracted attention, but 2025 is shaping up to be a pivotal year. With a crowded…
News

Naira rallies to N1,455/$; reserves hit $43bn

5 Mins read
The positive rally of the local currency against the dollar continued yesterday with the naira exchanging at N1,455 to one dollar even…
News

Trump Quietly Grants Defense Guarantee To Autocracy That Gave Him A Luxury Jet

4 Mins read
WASHINGTON – Just months after soliciting and receiving a $400 million luxury airliner for himself from Qatar, President Donald Trump has now…

Leave a Reply

Your email address will not be published. Required fields are marked *

44 − 43 =