Zo­genix shares are claw­ing back some of the val­ue they lost 2 months ago af­ter the FDA hit the biotech with a refuse-to-file no­tice on their ex­per­i­men­tal ther­a­py for Dravet syn­drome. 

Com­pa­ny ex­ecs said this morn­ing that they worked out reg­u­la­tors’  is­sues with the ap­pli­ca­tion for Fin­tepla, which cen­tered on a pair of big prob­lems: the ab­sence of non-clin­i­cal stud­ies need­ed to al­low as­sess­ment of the chron­ic ad­min­is­tra­tion of fen­flu­ramine and the in­clu­sion of an in­cor­rect ver­sion of a clin­i­cal dataset. Now they plan to re­sub­mit in Q3 af­ter get­ting off the hook on both scores — which trig­gered a sigh of re­lief among in­vestors.

Zo­genix stock climbed 27% be­fore the open­ing bell Thurs­day on hopes of a near-term sec­ond turn at bat. The biotech not­ed:

Based on the fi­nal meet­ing min­utes re­ceived, the FDA has agreed to Zo­genix’s plan to re­sub­mit the NDA for Fin­tepla with­out the in­clu­sion of the new chron­ic tox­i­c­i­ty stud­ies re­quest­ed in the RTF let­ter. With re­gards to the sec­ond is­sue, the com­pa­ny con­duct­ed and dis­cussed with the FDA a root cause analy­sis to ex­plain the in­cor­rect clin­i­cal dataset sub­mit­ted in the orig­i­nal NDA, and the FDA is in agree­ment with the com­pa­ny’s plan for re­sub­mis­sion of the datasets in the NDA.

This time around, though, Zo­genix’s team will not have the ben­e­fit of a break­through ther­a­py des­ig­na­tion to boast about. With 2 drugs on the mar­ket, the FDA no longer felt that their drug qual­i­fied. But the com­pa­ny is still hold­ing out hopes for a pri­or­i­ty re­view.

So­cial im­age: Shut­ter­stock

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.

This week, Moderna announced it would begin testing a modified version of their mRNA vaccine to tackle the vaccine-resistant B1.351 variant that popped up in South Africa. Pfizer said it would test giving people an extra boost of its original vaccine to accomplish the same.

J&J revealed at the adcomm that they, too, have been working on a modified vaccine to tackle emerging variants.

The company didn’t reveal much detail, including how they modified the vaccine or if they were targeting the same B 1.351 variant, but Johan van Hoof said they would begin testing a new construct in the summer. The FDA has said they would allow modified vaccines for variants to be authorized after quick immunological studies that track whether the vaccine elicits antibodies against the new variant.

Genentech has committed $53 million to back a 10-year quest aimed at going back to the drawing board to use new technology and fresh scientific insights to generate a pipeline of drugs for neurological diseases.

Roche’s big South San Francisco hub will mix it up with the scientists drawn together for the Weill Neurohub — formed in 2019 as a joint research partnership involving UCSF, Berkeley and the University of Washington — in an exploration of the field to develop new therapies for some of the toughest diseases in drug R&D: Alzheimer’s, Parkinson’s, Huntington’s, ALS and autism.

On the hunt for a novel competitor to Sanofi and Regeneron’s Dupixent in severe asthma, Amgen and AstraZeneca posted “exciting” results from their next-gen antibody late last year. Now, the partners are showing their hands, and the results look good enough for approval.

Amgen and AstraZeneca’s tezepelumab plus standard of care cut the rate of severe asthma attacks by 56% at the one-year mark compared with SOC alone, according to full data from the Phase III NAVIGATOR study presented Friday at the virtual American Academy of Allergy, Asthma & Immunology meeting. And those significant results were consistent regardless of patients’ baseline eosinophil counts.