We were in the home­stretch for our an­nu­al 20 un­der 40 project when the pan­dem­ic hit the US. On March 8, I can­celed my train tick­ets to Boston to meet with nom­i­nees Ja­son Kel­ly at Gink­go and David Cheng. The next day was the first warm day in New York City, and the streets and parks were lit­tered with jog­gers and fam­i­lies out chat­ting in shrill, vol­u­ble tones af­ter three months cooped in the cold. I spoke ami­ably on the phone with Otel­lo Stam­pac­chia about how biotech was adapt­ing and about his fam­i­ly in Italy, the cri­sis there and the cri­sis com­ing. The WHO de­clared a pan­dem­ic two days lat­er. Soon, no one was out.

Now, it’s been a year and al­though the pan­dem­ic is still rag­ing, biotech, af­ter some ini­tial fum­bling, has large­ly got­ten back on track.  Some learned to run clin­i­cal tri­als with­out clin­i­cal tri­al cen­ters. Oth­ers de­vel­oped the vac­cines now help­ing curb the pan­dem­ic, help­ing un­lock new tech­nolo­gies in the process. Still more col­lab­o­rat­ed with long­time ri­vals to screen mil­lions of mol­e­cules and help scale up an­ti­body drugs.

Bio­phar­ma has changed since Covid-19 de­scend­ed on the US. Now, as we pre­pare for our third 20 un­der 40 project, we’re ask­ing for your help find­ing the young­sters who are help­ing change it. Send us the un­der-ap­pre­ci­at­ed re­searcher who played a piv­otal role in an mR­NA vac­cine, the hot­shot de­vel­op­ing a sec­ond-gen­er­a­tion jab or an­ti­body, and all the oth­er pre­co­cious aca­d­e­mics, sci­en­tists and ex­ec­u­tives that could re­shape the in­dus­try or a giv­en dis­ease for decades to come. Any name our read­ers should know, or will soon.

It’s very sim­ple. Just give us their name(s) and tell us why you did. And we’ll be back with our spe­cial re­port at the be­gin­ning of April. Here’s the link. The dead­line is Feb­ru­ary 15.

You can al­so email me di­rect­ly at ja­son@end­pointsnews.com.

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.

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.”

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.