Climbing into the ring with one of the harder – albeit rare – cancers to beat, Atterocor Inc. started a Phase I trial with ATR-101, designed to selectively cause apoptosis in adrenal cell carcinoma (ACC).
“Caveat emptor” is a warning hardly needed by seasoned investors in biotech, many of whom understand the failure-fraught industry and are cautious buyers, when they can be persuaded to buy at all.
While pundits argue over whether the lately upbeat mood for initial public offerings (IPOs) represents a “bubble” or a “boom,” another two biotech firms took the opportunity to file for their chances at the mild frenzy this year.
Alkermes plc’s just-won fast-track status for its depression drug, Alks 5461 – along with the willingness of the FDA to let the company skip the end-of-Phase II meeting and move directly into Phase III, as outlined in the firm’s briefing documents – have brought the pivotal trial’s design into the spotlight.
Alkermes plc’s plan, unveiled this summer, to “retool” its opioid drug R&D got its first vote of confidence from the FDA, which is letting the company forgo the customary end-of-Phase-II meeting and move directly into Phase III trials with Alks 5461 for refractory major depressive disorder (MDD).
Versartis Inc., which holds worldwide rights to the long-acting recombinant human growth hormone (rHGH) VRS-317, may take the treatment for growth hormone deficiency (GHD) all the way to approval and marketing by itself, said Srinivas Akkaraju, general partner with Sofinnova Ventures, a new investor in the company’s $20 million Series D round.
Powered by a deal with Pfizer Inc., Glycomimetics Inc. is looking to solidify further its position in the race for therapies that would treat vaso-occlusive crises (VOCs) in sickle cell disease (SCD). The Gaithersburg, Md.-based company, which filed for a proposed initial public offering (IPO), but did not specify the targeted number of shares or price range, is developing GMI-1070 (rivipansel sodium) with Pfizer, of New York.
Celgene Corp. put still more chips on the biotech table, entering a confirmed $35 million deal to develop cancer and fibrotic-disease therapies with Pharmakea Therapeutics Inc., which at the same time pulled down $10 million in a Series A funding round from Bay City Capital.
Series A funding of $33 million will let Loxo Oncology Inc. move its lead compound through proof-of-concept research and push another into the clinic over the next three years or so, but the Delaware-incorporated firm still is not disclosing more about them.