→ Shares of Rigel Ther­a­peu­tics $RIGL bound­ed up about 20% this morn­ing af­ter the biotech re­port­ed that the FDA has no plans to call an ex­pert pan­el to­geth­er to re­view fos­ta­ma­tinib in pa­tients with chron­ic or per­sis­tent im­mune throm­bo­cy­tope­nia. The FDA al­so has in­di­cat­ed that it ex­pects to hit its April 17, 2018, PDU­FA dead­line for a de­ci­sion. There are no guar­an­tees, of course, but that’s all gen­er­al­ly con­sid­ered pos­i­tive.

→ Four months af­ter back-to-back set­backs forced En­do­cyte $ECYT to slash its staff and re­or­ga­nize, the lit­tle biotech is back with an in-li­cens­ing deal that it hopes will re­vive its for­tunes. The biotech spent $12 mil­lion up front to in-li­cense PS­MA-617, a ra­di­oli­gand ther­a­peu­tic for cas­tra­tion-re­sis­tant prostate can­cer, from ABX GmbH. En­do­cyte al­so hand­ed over 2 mil­lion shares.

→ Both­ell, WA-based Seat­tle Ge­net­ics $SGEN was boost­ed on the news that the FDA has hand­ed out its break­through ther­a­py des­ig­na­tion for Ad­cetris (bren­tux­imab ve­dotin) in com­bi­na­tion with chemother­a­py for the front­line treat­ment of pa­tients with ad­vanced clas­si­cal Hodgkin lym­phoma.

→ Seres Ther­a­peu­tics — which has had some con­sid­er­able trou­ble form­ing a good first im­pres­sion — stum­bled out of the gate this morn­ing, look­ing to high­light some pos­i­tive, dose-de­pen­dent re­sults from an ear­ly stage study of their mi­cro­bio­me ther­a­py SER-287 for ul­cer­a­tive col­i­tis. The orig­i­nal re­lease didn’t quite get the da­ta right, and there was plen­ty of buzzing on Twit­ter about the role van­comycin may have played in gain­ing a re­sponse. Bot­tom line: the stock $MCRB was down a cou­ple of points in the tur­moil.

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

San Francisco-based biotech 89bio announced on Friday that it expects to rake in $275 million on a stock offering. The raise comes after 89bio announced on Tuesday results of a Phase II study showing that its drug was better than placebo at lessening fibrosis without worsening nonalcoholic steatohepatitis, or NASH.

To run a Phase III study, 89bio CEO Rohan Palekar told Endpoints News that the biotech “would need to raise additional capital.” 89bio offered over 16 million shares of its common stock at $16.25 per share, and expects the offering closes on March 28.