Don­ald Trump has turned up on the cov­er of Time mag­a­zine, and he has a big mes­sage for the bio­phar­ma in­dus­try:

“I’m go­ing to bring down drug prices,” he told Time, which de­clared the pres­i­dent-elect as their Per­son of the Year. “I don’t like what’s hap­pened with drug prices.”

That’s all we know right now. There’s no plan tied to it. No dis­cus­sion about get­ting Medicare to ne­go­ti­ate prices of reim­por­ta­tion from Cana­da, which drew some soft sup­port dur­ing the elec­tion. And in­vestors re­act­ed swift­ly, dri­ving down the NAS­DAQ biotech in­dex by 3%.

The pro­nounce­ment brings drug pric­ing front and cen­ter to what will face the drug in­dus­try in 2017, which Brent Saun­ders pre­dict­ed days ago at the Forbes sum­mit.

Af­ter the elec­tion, Trump made it clear that he will back new ways to ac­cel­er­ate drug de­vel­op­ment, an is­sue which is cov­ered by a gen­er­ous 21st Cen­tu­ry Cures Act, like­ly to be passed any day now with mas­sive bi­par­ti­san sup­port. But it’s pric­ing that has con­tin­ued to at­tract the largest amount of spec­u­la­tion.

Imag­ine if he used twit­ter and went af­ter an ac­tu­al drug price in­crease? In­dus­try can fix this w self reg­u­la­tion? #so­cial­con­tract $AGN https://t.co/Fqj6UEaX­EV

— Brent Saun­ders (@brentl­saun­ders) De­cem­ber 7, 2016

Saun­ders and our pan­el of bio­phar­ma lead­ers — mod­er­at­ed by End­points News Ed­i­tor John Car­roll — will tack­le that sub­ject anew in our dis­cus­sion on ac­cess and af­ford­abil­i­ty, slat­ed for Jan­u­ary 10 in San Fran­cis­co dur­ing #JPM17. I hope to see you there. And you can reg­is­ter here. — Ar­salan Arif

End­points News #JPM17 Ex­ec­u­tive Break­fast Page

The FDA has rejected Incyte’s extended-release formulation of ruxolitinib tablets, in a surprise setback for the company’s plans to build on its blockbuster Jakafi franchise.

The ruxolitinib XR tablets are designed to be taken once a day, whereas Jakafi is indicated for twice daily dosage (although some patients can take it once daily).

According to Incyte, the FDA acknowledged in its complete response letter that the study submitted in the NDA “met its objective of bioequivalence based on area under the curve (AUC) parameters but identified additional requirements for approval.”

A small, Santa Ana-based biotech created in 2017 is looking to enter a SPAC deal as it lays out plans to begin trials in its lead cell therapy candidates and bring on new executives.

Graf Acquisition Corp. IV and NKGen Biotech announced Thursday, with few other details, that the two companies signed a non-binding letter of intent to “pursue a business combination.” Graf Acquisition II and III withdrew their IPOs last year.

Cyclerion Therapeutics may have the design of a Phase IIb study ready to go, but it’s scrambling for a way to fund it.

The company said in a press release that it’s “actively evaluating the best combination of capital, capabilities, and transactions available to it to advance the development of zagociguat,” its lead candidate for a rare, genetic mitochondrial disease known as MELAS.

In a separate SEC filing, Cyclerion once again flagged “substantial doubt about (its) ability to continue as a going concern.” As of the end of 2022, it had cash and cash equivalents of only $13.4 million.

The European Commission has once again delayed the release of its proposal for an overhaul of the continent’s pharmaceutical legislation.

The release, previously anticipated on March 29, will occur “slightly later” than expected due to the “very busy College agendas of the last few weeks,” a Commission spokesperson told Endpoints News via email.

While the agency hasn’t provided an updated timeline, the spokesperson said the agenda is “always indicative and adoption dates of Commission proposals may change any time, especially when these proposals concern reforms of complex legislations of major importance.”