Sector News

Reeling from an FDA rejection, Telesta sheds 15% of its staff

March 9, 2016
Life sciences

Montreal biotech Telesta Therapeutics is cutting 15% of its payroll to conserve cash as the company works to get its once-rejected cancer drug back on track.

Most of the layoffs will affect Telesta’s manufacturing operation, management said, and the company is simultaneously slashing its expenditures. The biotech reported cash and equivalents totaling $20.3 million at the end of 2015.

Telesta, which trades on the Toronto exchange, is trying to pick up the pieces after the FDA rejected its application to win approval in bladder cancer last month. The company’s drug, MCNA, failed to satisfy regulators’ demands, and the FDA asked Telesta to conduct at least one more Phase III trial to establish the treatment’s efficacy and safety.

Now Telesta is requesting a so-called Type A meeting with the FDA, angling to sit down with agency staff to “obtain clarity” on what it needs to do to win approval, the company said in a statement.

“In parallel, we are working with our board of directors to review of all of our strategic options over the next few months,” CEO Michael Berendt said in a statement. “We are very aware that this review must be conducted and completed in a timely fashion to ensure that we conserve our key cash resources.”

Since MCNA’s rejection in early February, Telesta has been hinting that it may try to sell itself, with Berendt saying at the time that “the current climate of uncertainty in the financial markets has created opportunities for well-capitalized companies that were simply not available even a few months ago.”

Last year, Telesta flipped the European rights to MCNA to Ipsen, banking a $10 million upfront payment with a shot at $127 million more if the drug wins approval overseas.

By Damian Garde

Source: Fierce Biotech

comments closed

Related News

January 22, 2023

Sun Pharma to buy Concert Pharmaceuticals for $576m

Life sciences

Sun Pharmaceutical Industries has signed a definitive agreement to buy all outstanding shares of Concert Pharmaceuticals in a deal valued at $576m. Under the deal, the company will buy all shares of Concert common stock through a tender offer for $8.00 per share in cash upfront payment.

January 22, 2023

Novo Nordisk diabetes pill wins FDA approval for first-line use

Life sciences

The Food and Drug Administration on Thursday approved Novo Nordisk’s diabetes pill Rybelsus as an initial treatment to lower blood sugar levels, a label expansion that will allow it to compete more directly with other oral drugs from Merck & Co. and Eli Lilly.

January 22, 2023

Bayer feeling more heat from activist investors, this time from Bluebell

Life sciences

Since making an ill-advised $63 billion buy of Monsanto in 2018, Bayer has faced heaps of pressure from investors that have called for the company to oust its leadership and to restructure. Now comes new pressure from a familiar source. Bluebell Capital Partners has bought an undisclosed stake in the company and is agitating for a breakup, sources told Reuters.

How can we help you?

We're easy to reach