While gene ther­a­py com­pa­nies re­joice as the sec­tor gains trac­tion with ap­provals and a flur­ry of M&A ac­tiv­i­ty, one play­er is feel­ing the heat.

Back in 2015, Voy­ager Ther­a­peu­tics joined forces with Sanofi Gen­zyme in a deal worth up to $845 mil­lion ($100 mil­lion up­front + a po­ten­tial $745 mil­lion in mile­stones) to co-de­vel­op gene ther­a­pies for se­vere cen­tral ner­vous sys­tem dis­or­ders. But two years lat­er, the French drug­mak­er re­treat­ed, elect­ing to not pick up the op­tion to work on Voy­ager’s Parkin­son’s dis­ease pro­gram. (Last year, the FDA dis­ap­point­ed Voy­ager, telling the com­pa­ny that it was not open to an ac­cel­er­at­ed fil­ing on the Parkin­son’s drug on the ba­sis of Phase II da­ta — in­stead re­quir­ing an ad­di­tion­al piv­otal study.)

Sanofi Gen­zyme’s re­treat now re­sem­bles a de­ser­tion.

On Mon­day, Voy­ager $VY­GR said Sanofi Gen­zyme is walk­ing away from op­tions to ac­quire US co-com­mer­cial­iza­tion rights and ex-US de­vel­op­ment and com­mer­cial­iza­tion rights to ex­per­i­men­tal Hunt­ing­ton’s dis­ease drug VY-HTT01 and to Friedre­ich’s atax­ia pro­gram VY-FXN01; and a fu­ture Voy­ager CNS or­phan pro­gram. In ad­di­tion, Voy­ager and Sanofi Gen­zyme’s al­liance on SMA has al­so been ter­mi­nat­ed —  the in­tel­lec­tu­al prop­er­ty rights of the pro­gram are be­ing re­turned/ex­clu­sive­ly li­censed to Sanofi Gen­zyme.

Con­se­quent­ly, Voy­ager has agreed to give $10 mil­lion up­front to Sanofi Gen­zyme, and an ad­di­tion­al $10 mil­lion mile­stone pay­ment up­on the po­ten­tial fil­ing of an ap­pli­ca­tion to test in hu­mans the Hunt­ing­ton’s dis­ease drug, VY-HTT01 or, cer­tain back­up com­pounds, as well as po­ten­tial roy­al­ties. In ad­di­tion, Voy­ager is al­so of­fer­ing Sanofi Gen­zyme ex­clu­sive dibs to se­lect AAV cap­sids from its ar­se­nal of drugs in de­vel­op­ment in up to two non-CNS in­di­ca­tions.

Re­cent­ly, Voy­ager has been busy shop­ping for oth­er part­ners. It has inked deals with Ab­b­Vie and Neu­ro­crine this year.

On Mon­day, Voy­ager trans­ferred the ex-US rights to the Sanofi-aban­doned Friedre­ich’s atax­ia pro­gram to Neu­ro­crine. The com­pa­ny al­so sig­naled that it plans to part­ner out its ALS gene ther­a­py, VY-SOD102, (and no longer plans to file an IND for it this year), to fo­cus its re­sources on Hunt­ing­ton’s.

“While it is un­clear ex­act­ly who might be look­ing to in-li­cense this pro­gram, Bio­gen might serve as an in­ter­est­ing can­di­date giv­en their ex­ist­ing work on SOD1 with their an­ti­sense oligonu­cleotide (ASO), tofersen, and close prox­im­i­ty giv­en both com­pa­nies are based in Cam­bridge. How­ev­er, if Bio­gen were to do this deal it might al­so be an ear­ly sig­nal to in­vestors that they view gene ther­a­py as strong al­ter­na­tive to their ASO port­fo­lio, po­ten­tial­ly ac­cept­ing that Zol­gens­ma is go­ing to be a strong com­peti­tor in SMA,” Baird’s Bri­an Sko­r­ney wrote in a note.

So­cial im­age: Shut­ter­stock

Biohaven is at risk of making a habit of disappointing its investors. 

Late Friday the biotech $BHVN reported that the FDA had rejected its application for riluzole, an old drug that they had made over into a sublingual formulation that dissolves under the tongue. According to Biohaven, the FDA had a problem with the active ingredient used in a bioequivalence study back in 2017, which they got from the Canadian drugmaker Apotex.

Let the long battle for biosimilars in the cancer space begin.

Amgen has launched its Avastin and Herceptin copycats — licensed from the predecessors of Allergan — almost two years after the FDA had stamped its approval on Mvasi (bevacizumab-awwb) and three months after the Kanjinti OK (trastuzumab-anns). While the biotech had been fielding biosimilars in Europe, this marks their first foray in the US — and the first oncology biosimilars in the country.

→ On the same day it announced a $17.5 million Series C, life sciences and health data company Seer unveiled that it had lured former FDA commissioner and ex-CMS administrator Mark McClellan on to its board. “Mark’s deep understanding of the health care ecosystem and visionary insights on policy reform will be crucial in informing our thinking as we work to bring our liquid biopsy and life sciences products to market,” said Seer chief and founder Omid Farokhzad in a statement.

Gilead CEO Daniel O’Day’s new task hunting up a CSO for the company isn’t stopping the industry’s dominant antiviral player from doing pipeline deals.

The big biotech today snapped up 3 preclinical antiviral programs from pharma giant Novartis, with drugs promising to treat human rhinovirus, influenza and herpes viruses. We don’t know what the upfront is, but the back end has $291 million in milestones baked in.