The FDA has ex­tend­ed its re­view of Bio­Marin’s gene ther­a­py for he­mo­phil­ia A by three months, for­mal­iz­ing an ex­pect­ed de­lay that will now push out a de­ci­sion to the end of June.

Bio­Marin told in­vestors in No­vem­ber, af­ter sub­mit­ting three-year da­ta analy­sis from a Phase III tri­al, that the FDA said it may con­sti­tute a ma­jor amend­ment that war­rants ex­tra time for re­view.

And that’s ex­act­ly what hap­pened, with the agency cit­ing “sub­stan­tial amount of ad­di­tion­al da­ta,”

It’s been al­most three years since Bio­Marin was slammed with the FDA’s sur­prise re­jec­tion of its then-top pro­gram, val­oc­toco­gene rox­a­parvovec or val­rox. While the biotech had filed for ap­proval with da­ta from a Phase I/II study and pre­lim­i­nary up­dates from a Phase III, reg­u­la­tors de­mand­ed to see two years of fol­low-on da­ta from that Phase III tri­al to prove that val­rox can stem bleeds durably.

The com­pa­ny has since put to­geth­er that da­ta pack­age, with promis­es to of­fer even more. In ad­di­tion to the three-year da­ta it now has on hand, Bio­Marin al­so pro­posed a long-term ex­ten­sion study and oth­er post-ap­proval reg­istry stud­ies.

While the FDA had planned on con­ven­ing an ad­vi­so­ry com­mit­tee, it ul­ti­mate­ly de­cid­ed not to, which an­a­lysts saw as a pos­i­tive sign.

If ap­proved, val­rox would be the first FDA-ap­proved gene ther­a­py to treat se­vere he­mo­phil­ia A by re­plac­ing the gene for the blood clot­ting pro­tein fac­tor VI­II. CSL won ap­proval for a he­mo­phil­ia B gene ther­a­py late last year.

In Au­gust, the Eu­ro­pean Com­mis­sion grant­ed con­di­tion­al mar­ket­ing au­tho­riza­tion to val­rox un­der the brand name Roc­ta­vian.

The FDA today approved Emergent BioSolutions’ Narcan brand naloxone nasal spray for over-the-counter sales. The nod was expected and comes on the heels of a unanimous 19-0 advisory committee vote in favor of approval last month.

The move to OTC means the opioid overdose reversal agent will now be available on grocery, convenience and gas stations shelves, as well as potentially for purchase online.

Microcap biotech Seelos Therapeutics is halting enrollment of its study in spinocerebellar ataxia type 3 (also known as Machado-Joseph disease) because of “financial considerations,” and in order to focus on other studies, the company said today, adding that the pause would be temporary.

The study will continue with the patients who have already enrolled, and the data from them will be used to decide whether to continue enrolling others in the future.

Otonomy may be shutting down, but the lessons learned there will live on at another biotech working on new treatments for hearing loss.

San Francisco-based Spiral Therapeutics has bought certain assets related to three of Otonomy’s programs, ranging from data, patent rights, and know-how to inventory. That includes data around Otonomy’s twice-failed lead program, OTO-104 (Otividex), a sustained-exposure formulation of dexamethasone.

Paul McKenzie took over as CEO of Australian pharma giant CSL this month, following in the footsteps of long-time CSL vet Paul Perreault.

With an eye on mRNA, and quickly commercializing its new, $3.5 million-per-shot gene therapy for hemophilia B, McKenzie and chief medical officer Bill Mezzanotte answered some questions from Endpoints News this afternoon about where McKenzie is going to take the company and what advances may be coming to market from CSL’s pipeline. Below is a lightly edited transcript.