Canaccord ups Theratechnologies on FDA approval

Canaccord Genuity has raised its price target on Theratechnologies (TSX:TH) to $7.85 from $7 after the FDA approved the company’s lead drug Egrifta for the treatment of HIV lipodystrophy, a metabolic disorder associated with HIV.  The stock closed at $5 on Wednesday. Analyst Neil Maruoka writes that he expects Egrifta to be launched in the [...]

Theratechnologies CEO retires; Amorfix’s steps down

Yves Rosconi, CEO and President of Theratechnologies (TSX:TH), has informed the board of his decision to retire on Dec. 31, 2010, saying he deferred his decision until the company’s lead tesamorelin product was in the final stages of the FDA approval process. A strategic committee of the board will immediately begin the formal search for [...]

FDA committee clears Theratechnologies’ tesamorelin

An FDA advisory committee recommended by a 16-to-0 unanimous vote that Theratechnologies’ (TSX:TH) tesamorelin drug should be granted marketing approval by the FDA for the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy, based on a favourable benefit-risk profile. “This recommendation reinforces our belief that the tesamorelin benefit-risk profile seen in clinical trials [...]

RBC ups Theratechnologies to buy

Citing a recent sell-off and upcoming milestones, RBC Capital Markets upgraded Theratechnologies (TSX:TH) to “outperform” from “sector perform,” but kept its price target unchanged at $6.50.  The shares finished at $5.09 on Wednesday after touching a 52-week high of $5.61 earlier this month. “Theratechnologiesis in the enviable position of having a number of important upcoming [...]

Peer-reviewed journal publishes data on Theratechnologies’ HIV drug

The 52-week data of Theratechnologies’ (TSX:TH) second Phase 3 trial evaluating tesamorelin for the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy was published in the latest issue of JAIDS Journal of Acquired Immune Deficiency Syndromes. “We are proud to have data from our Phase 3 clinical program published in another recognized scientific [...]

FDA procedural delay hits Theratechnologies

The FDA has informed Theratechnologies (TSX:TH) that it plans to reschedule an advisory committee meeting to consider the company’s tesamorelin drug to treat excess abdominal fat in HIV patients. Originally scheduled for Feb. 24, the delay is “entirely procedural and is not related to the tesamorelin new drug application,” the company said in a statement. [...]

Dundee biotech outlook sees ‘ample room for upside’

While we were at the J.P. Morgan Healthcare Conference in San Francisco last week, Dundee Securities issued its latest biotech sector update. On the bright side, analyst David Martin writes that there are signs Biovail, Angiotech and QLT stocks are bouncing back – supported by new strategies and new products in development for each company. [...]

Theratechnologies presents combined Phase 3 results

Theratechnologies (TSX:TH)  presented pooled results from both its phase 3 clinical trials evaluating tesamorelin for the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy at a conference in Germany. Treatments with two milligrams of tesamorelin daily for 26 weeks resulted in a significant decrease in visceral adipose tissue, no clinically significant changes in [...]

Theratechnologies’ new drug application for tesamorelin to be reviewed by FDA advisory committee

An advisory committee of the FDA will review Theratechnologies’ new drug application for tesamorelin to treat excess abdominal fat in HIV patients with lipodystrophy. “We view the solicitation of additional viewpoints from various external groups as positive and, over the next few months, we will work together with the FDA to prepare for the meeting,” [...]

In conversation with Maher Yaghi

As Desjardins Securities’ healthcare and biotech analyst for the past five years, Maher Yaghi has gained a wide following with a blunt, tell-it-like-it-is approach to covering a sector that has struggled to win the hearts and minds of investors in recent years.  His early research and “buy” recommendations on Theratechnologies and Paladin Labs established his [...]

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