Dy­navax shares crater af­ter the FDA re­jects Hep­lisav-B, again, and CEO sig­nals for help

Ed­die Gray, Dy­navax CEO

Shares of Dy­navax head­ed south Mon­day morn­ing af­ter the biotech no­ti­fied in­vestors that the FDA has re­ject­ed its ap­pli­ca­tion to mar­ket the he­pati­tis B vac­cine Hep­lisav-B.

Dy­navax {DVAX} made it clear that the agency has not asked for any new tri­als and seems to be sig­nal­ing that it needs more time to as­sess new in­for­ma­tion on the drug that has al­ready been sub­mit­ted. But af­ter a year of ups and downs on this pro­gram, and an ini­tial re­jec­tion dat­ing back three years, the biotech says it needs to sign up a part­ner to help get this vac­cine over the fin­ish line and in­to the mar­ket.

Simos Sime­oni­dis at RBC al­so wasn’t in the least bit hap­py to see Dy­navax flag con­cerns about an im­bal­ance in car­diac events in the da­ta, a point that could come back to haunt the com­pa­ny if it lines up for a new PDU­FA date soon. His note:

The im­bal­ance in car­diac events is some­thing we’re see­ing dis­closed for the first time by Dy­navax, which is sur­pris­ing, giv­en that 1) car­diac events def­i­nite­ly fall with­in the more “se­ri­ous” safe­ty con­cern cat­e­go­ry in drug de­vel­op­ment; and 2) the com­pa­ny had re­cent­ly dis­closed that the ques­tions it had re­ceived from FDA were “in line with ex­pec­ta­tions”. An im­bal­ance in car­diac events in Phase III that would be sig­nif­i­cant enough to be of con­cern to FDA was def­i­nite­ly not among the ex­pec­ta­tions that in­vestors have had for this tri­al and for this pro­gram.

That mes­sage did not sit well with share­hold­ers. The biotech’s stock plunged 72% in ear­ly trad­ing, wip­ing out the bulk of its mar­ket cap and sig­nal­ing a deep breach with in­vestors.

“The CRL is con­sis­tent with our opin­ion that HEP­LISAV-B is ap­prov­able and we are seek­ing to meet with the FDA as soon as pos­si­ble,” said Ed­die Gray, chief ex­ec­u­tive of­fi­cer of Dy­navax. “How­ev­er, the time and re­sources that will be re­quired to gain ap­proval leads us to con­sid­er that we may not be able to ad­vance this pro­gram on our own and we are mov­ing swift­ly to iden­ti­fy a po­ten­tial phar­ma­ceu­ti­cal or fi­nan­cial part­ner. We will main­tain our ef­forts on the on­col­o­gy pro­grams, in­clud­ing our lead can­cer im­munother­a­py can­di­date, SD-101, for which we re­cent­ly an­nounced en­cour­ag­ing ear­ly clin­i­cal da­ta in metasta­t­ic melanoma.”

Back at the be­gin­ning of this year Dy­navax laid out new Phase III da­ta which showed that their vac­cine best­ed Glax­o­SmithK­line’s $GSK ri­val main­stay En­ger­ix-B.

In­ves­ti­ga­tors de­ter­mined that Hep­lisav-B pro­vid­ed a peak sero­pro­tec­tion rate of 90% among di­a­bet­ics, com­pared to 65.1% for En­ger­ix-B. And the en­tire pa­tient group get­ting Hep­lisav-B al­so of­fered a sta­tis­ti­cal­ly high­er re­sponse: 95.4% to 81.3%. The ex­per­i­men­tal hep B vac­cine al­so outscored En­ger­ix-B in every sub­pop­u­la­tion, rang­ing from sex, body mass in­dex, and smok­ing sta­tus to age groups.

That revved up the stock and a num­ber of an­a­lysts cov­er­ing the com­pa­ny, though in­vestors got the jit­ters re­cent­ly when the FDA opt­ed to can­cel a planned Ad­Comm meet­ing.

Turned back at the FDA, Im­muno­Gen is ax­ing 220 staffers, sell­ing pro­grams and hun­ker­ing down for a new PhI­II gam­ble

After being stymied by FDA regulators who were unconvinced by ImmunoGen’s $IMGN desperation shot at an accelerated OK based on a secondary endpoint, the struggling biotech is slashing its workforce, shuttering R&D projects and looking for buyers to pick up some of its experimental cancer assets as it goes back into a new Phase III with the lead drug.

We found out last month that the FDA had batted back their case for an accelerated approval of their antibody-drug conjugate mirvetuximab soravtansine, which had earlier failed a Phase III study for ovarian cancer. Now the other shoe is dropping.

Endpoints News

Basic subscription required

Unlock this story instantly and join 53,600+ biopharma pros reading Endpoints daily — and it's free.

Brent Saunders [Getty Photos]

UP­DAT­ED: Ab­b­Vie seals $63B deal to buy a trou­bled Al­ler­gan — spelling out $1B in R&D cuts

Brent Saunders has found his way out of the current fix he’s in at Allergan $AGN. He’s selling the company to AbbVie for $63 billion in the latest example of the hot M&A market in biopharma.

Endpoints News

Basic subscription required

Unlock this story instantly and join 53,600+ biopharma pros reading Endpoints daily — and it's free.

As­traZeneca chal­lenges Roche on front­line SCLC af­ter seiz­ing an in­ter­im win — and Mer­ck may not be far be­hind

The crowded playing field in the PD-1/L1 marketing game is about to get a little more complex.

This morning AstraZeneca reported that its CASPIAN study delivered a hit in an interim readout for their PD-L1 Imfinzi combined with etoposide and platinum-based chemotherapy options for frontline cases of small cell lung cancer, a tough target which has already knocked back Bristol-Myers’ shot in second-line cases. The positive data  — which we won’t see before they roll it out at an upcoming scientific conference — give AstraZeneca excellent odds of a quick vault to challenging Roche’s Tecentriq-chemo combo, approved 3 months ago for frontline SCLC in a landmark advance.

“This is the first trial offering the flexibility of combining immunotherapy with different platinum-based regimens in small cell lung cancer, expanding treatment options,” noted AstraZeneca cancer R&D chief José Baselga in a statement.

Endpoints News

Basic subscription required

Unlock this story instantly and join 53,600+ biopharma pros reading Endpoints daily — and it's free.

Bridge­Bio takes crown for biggest biotech IPO of 2019, as fel­low uni­corn Adap­tive rais­es of­fer­ing size and price

Bridge­Bio Phar­ma and Adap­tive Biotech­nolo­gies have not just up­sized IPO of­fer­ings — the pair of uni­corns have al­so raised their of­fer­ing prices above the range, haul­ing in a com­bined $648.5 mil­lion.

Neil Ku­mar’s Bridge­Bio Phar­ma, found­ed in 2015, has a sta­ble of com­pa­nies fo­cused on dis­eases that are dri­ven by de­fects in a sin­gle gene — en­com­pass­ing der­ma­tol­ogy, car­di­ol­o­gy, neu­rol­o­gy, en­docrinol­o­gy, re­nal dis­ease, and oph­thal­mol­o­gy — and can­cers with clear ge­net­ic dri­vers. The start­up mill birthed a pletho­ra of firms such as Ei­dos, Navire, QED Ther­a­peu­tics and Pelle­Pharm, which func­tion as its sub­sidiaries.

Two biotech uni­corns swell pro­posed IPOs, eye­ing a $600M-plus wind­fall

We’ve been wait­ing for the ar­rival of Bridge­Bio’s IPO to top off the wave of new biotech of­fer­ings sweep­ing through Nas­daq at the end of H1. And now we learn that it’s been sub­stan­tial­ly up­sized.

Ini­tial­ly pen­ciled in at a uni­corn-sized $225 mil­lion, the KKR-backed biotech has spiked that to the neigh­bor­hood of $300 mil­lion, look­ing to sell 20 mil­lion shares at $14 to $16 each. That’s an added 5 mil­lion shares, re­ports Re­nais­sance Cap­i­tal, which fig­ures the pro­posed mar­ket val­u­a­tion for Neil Ku­mar’s com­pa­ny at $1.8 bil­lion.

No­var­tis holds back the copy­cat brigade's at­tack on its top drug fran­chise — for now

A fed­er­al judge has put a gener­ic chal­lenge to No­var­tis’ block­buster mul­ti­ple scle­ro­sis drug Gilenya on hold while a patent fight plays out in court.

Judge Leonard P. Stark is­sued a tem­po­rary in­junc­tion ear­li­er this week, forc­ing My­lan, Dr. Red­dy’s Lab­o­ra­to­ries and Au­robindo Phar­ma to shelve their launch plans to al­low the patent fight to pro­ceed. He ruled that al­low­ing the gener­ics in­to the mar­ket now would per­ma­nent­ly slash the price for No­var­tis, even if it pre­vails. 

Novotech CEO Dr. John Moller

Novotech CRO Award­ed Frost & Sul­li­van Best Biotech CRO Asia-Pa­cif­ic 2019

Known in the in­dus­try as the Asia-Pa­cif­ic CRO, Novotech is now lead CRO ser­vices provider for the grow­ing num­ber of in­ter­na­tion­al biotechs se­lect­ing the re­gion for their stud­ies.

Re­flect­ing this Asia-Pa­cif­ic growth, Novotech staff num­bers are up 20% since De­cem­ber 2018 to 600 in-house clin­i­cal re­search peo­ple across a full range of ser­vices, across the re­gion.

Novotech’s ca­pa­bil­i­ties have been rec­og­nized by an­a­lysts like Frost & Sul­li­van, most re­cent­ly with the pres­ti­gious Asia-Pa­cif­ic CRO Biotech of the year award for best prac­tices in clin­i­cal re­search for biotechs for the fifth year. See oth­er awards here.

Af­ter rais­ing $158M, this up­start's founders have star back­ers and plans to break new ground in gene ther­a­py

Back in 2014, Stephanie Tagliatela opted to take an early exit out of her PhD program after working in Mark Bear’s lab at MIT, where she specialized in the synaptic connections between neuronal cells in the brain. She never finished that PhD, but she and fellow MIT student Kartik Ramamoorthi — who was on the founding team at Voyager — came away with some ideas for a gene therapy startup.

Today, fully 5 years later, she and Ramamoorthi are taking the wraps off of a $104 million mega-round designed to take the cumulative work of their preclinical formative stage for Encoded Therapeutics into human studies. They’ve now raised $158 million since starting out in Illumina’s incubator in the Bay Area, and they believe they are firmly on track to do something unique in gene therapy.

Endpoints News

Basic subscription required

Unlock this story instantly and join 53,600+ biopharma pros reading Endpoints daily — and it's free.

FDA re­jects Ac­er's rare dis­ease drug, asks for new tri­al — shares crater

Ac­er Ther­a­peu­tics’ bid to re­pur­pose celipro­lol — a be­ta-block­er on the mar­ket for hy­per­ten­sion — as a treat­ment for a rare, in­her­it­ed con­nec­tive tis­sue dis­or­der has hit a se­vere set­back. The New­ton, Mass­a­chu­setts-based com­pa­ny on Tues­day said the FDA re­ject­ed the drug and has asked for an­oth­er clin­i­cal tri­al.

The com­pa­ny’s shares $AC­ER cratered near­ly 77% to $4.47 in Tues­day morn­ing trad­ing.