→ Pen­ny stock North­west Bio­ther­a­peu­tics is still hang­ing on. The com­pa­ny, which is de­vel­op­ing DC­Vax for sol­id tu­mor can­cers, has an­nounced that they’ve reached a set­tle­ment with the SEC. The com­pa­ny has agreed to pay a fine of $250,000 “in con­nec­tion with past weak­ness­es in its in­ter­nal con­trols” and the com­pa­ny will nei­ther ad­mit nor de­ny any vi­o­la­tions un­der the set­tle­ment.

→ Long-slid­ing biotech Five Prime Ther­a­peu­tics will lay­off 70 em­ploy­ees as part of a cor­po­rate re­struc­tur­ing as it strug­gles to find its foot­ing. The on­col­o­gy-fo­cused com­pa­ny has been in free-fall since late 2017, when its Bris­tol-My­ers Squibb-part­nered drug cabi­ral­izum­ab showed weak ef­fi­ca­cy and a trou­bling safe­ty pro­file in ear­ly-stage pan­cre­at­ic can­cer. In Jan­u­ary, they cut 41 jobs, about a fifth of its work­force at the time, and in Sep­tem­ber they tapped William Ringo as in­ter­im CEO af­ter Aron Knicker­bock­er re­signed. On Thurs­day, Ringo an­nounced the lay­offs. “The com­pa­ny will re­tain a small re­search group fo­cused on ad­vanc­ing three whol­ly-owned, late-stage re­search as­sets and will in­creas­ing­ly re­ly on out­sourc­ing and con­tract­ed ca­pa­bil­i­ties,” the com­pa­ny wrote.

→ Is­raeli biotech Ther­a­pix Bio­sciences — a com­pa­ny that is in­ves­ti­gat­ing the use of cannabi­noid-based drugs in the re­duc­tion of symp­toms in adults suf­fer­ing from Tourette’s syn­drome — has re­vealed up­dates on its planned merg­er with Des­tiny Bio­sciences. Ac­cord­ing to the let­ter of in­tent, “the par­ties agreed to al­low un­til Oc­to­ber 31, 2019, to com­plete the de­fin­i­tive agree­ment be­fore aban­don­ing the trans­ac­tion.” Ther­a­pix’s board of di­rec­tors said that it is will­ing to give Des­tiny ad­di­tion­al time to reach a de­ci­sion. Des­tiny is cur­rent­ly car­ry­ing out a val­u­a­tion analy­sis of the merg­er.

The firehose of biopharma news is gushing these days.

That’s why broader and deeper is the theme for 2021 at Endpoints. You can expect new coverage outside our core R&D focus, with deeper reporting in some key areas. When John Carroll and I launched Endpoints nearly five years ago, we were wading in waist-high waters. Now we’re a team of 25 full-time staffers (and growing) with plans to cover the flood of biopharma news, Endpoints-style.

Eli Lilly’s $1.04 billion takeover of Prevail Therapeutics is officially complete, the company announced Friday.

The sides had entered into the buyout agreement last month with Lilly focusing on Prevail’s pipeline of gene therapies, highlighting two AAV9 programs in Parkinson’s disease and frontotemporal dementia as potential winners. Lilly paid $22.50 per share, which amounted to an 82% premium over the previous day’s closing price and a 117% premium over Prevail’s 60-day average.

It’s time for a new FDA commissioner to come on board, a rite of passage for Joe Biden’s administration that should help seal the new president’s rep on seeking out the experts to lead the government over the next 4 years.

As of now, the competition for the top job appears to have narrowed down to 2 people: The longtime CDER chief Janet Woodcock and Joshua Sharfstein, the former principal deputy at the FDA under Peggy Hamburg. Both were appointed by Barack Obama.