→ As­traZeneca has won a pri­or­i­ty re­view for its an­ti-CD22 ther­a­py mox­e­tu­momab for hairy cell leukemia. The phar­ma gi­ant can now ex­pect a de­ci­sion on third-line use in the third quar­ter, mark­ing an­oth­er prospec­tive ad­vance for its crit­i­cal­ly im­por­tant on­col­o­gy pipeline.

→ With ma­jor help from Fra­zier Health­care Part­ners, a stealthy gene ther­a­py com­pa­ny from the Uni­ver­si­ty of Penn­syl­va­nia has se­cured $9.29 mil­lion in in­vest­ment. Gene ther­a­py pi­o­neer James Wil­son co-reg­is­tered the com­pa­ny in 2016, the Philadel­phia In­quir­er notes, but has since been re­placed on the board by Penn med­ical school vice dean Kevin Ma­honey. Kr­ish­na Polu, a for­mer Cy­tomX chief med­ical of­fi­cer who joined Fra­zier as an en­tre­pre­neur in res­i­dence, is the CEO. Sev­er­al Fra­zier ex­ecs, in­clud­ing Patrick Heron and Tadata­ka Tama­da, are al­so on the board.

→ Switzer­land’s Glycemi­con an­nounced to­day that af­ter a sec­ond clos­ing, it has raised a to­tal of $5.28 mil­lion (CHF 5.05 mil­lion) to ad­vance cat and hu­man stud­ies of its neu­traceu­ti­cals. The biotech is de­vel­op­ing a pipeline of nov­el food prod­ucts that man­ages pre­di­a­betes, the “gray area” be­tween nor­mal blood sug­ar lev­els and di­a­betes, as well as weight.

The Endpoints News team is continuing to track IPO filings for 2021, and we’ve designed a new tracker page for the effort.

Check it out here: Biopharma IPOs 2021 from Endpoints News

You’ll be able to find all the biotechs that have filed and priced so far this year, sortable by quarter and listed by newest first. As of the time of publishing on Feb. 25, there have already been 16 biotechs debuting on Nasdaq so far this year, with an additional four having filed their S-1 paperwork.

After getting beaten up by investors over the key failure of its lead drug GB001, Gossamer had already indicated that they thought they could move ahead in asthma, though likely through a partnership. And the biotech is pushing forward on that front, according to a Q4 statement today, following talks with regulators.

The company reported:

Gossamer engaged with the FDA and the EMA about the clinical development path in asthma, and based off those interactions, Gossamer believes that there is a viable clinical development path for GB001, or its backup molecule, in asthma. Gossamer does not currently plan to move forward with GB001, or its backup molecule, in further clinical trials without a partner.

J&J has spent the day touting the data behind their Covid-19 vaccine, but one advisor pointed that, in a few months, another batch of data could force them into a curious dilemma.

J&J was the only major vaccine developer to attempt to produce a single-dose vaccine, a huge asset when trying to rapidly inoculate the world against an ongoing public health threat, but they hedged their bets. Alongside their main Phase III trial, they also launched another that would test two doses, each spaced two months apart.