0-for-3 in PhI­II: Au­ris’ late-stage change­up fails to save tin­ni­tus drug from an­oth­er dis­as­ter

Eigh­teen months af­ter the hap­less Swiss biotech Au­ris Med­ical $EARS an­nounced its first Phase III study for its ex­per­i­men­tal drug Keyzilen (AM-101) for tin­ni­tus had flopped, its sec­ond late-stage study has al­so come in snake eyes — even though it re­vised the end­points and made the case it had good rea­son to be­lieve it was on track to win.

Win­ning, though, is not some­thing this com­pa­ny does much of.

In a bare­bones state­ment, the pen­ny stock biotech re­port­ed:

Pre­lim­i­nary top-line da­ta from the TACTT3 tri­al in­di­cate that the study did not meet its pri­ma­ry ef­fi­ca­cy end­point of a sta­tis­ti­cal­ly sig­nif­i­cant im­prove­ment in the Tin­ni­tus Func­tion­al Score from base­line to Day 84 in the ac­tive treat­ed group com­pared to place­bo ei­ther in the over­all pop­u­la­tion or in the oti­tis me­dia sub­pop­u­la­tion. The Com­pa­ny is in­ves­ti­gat­ing the out­comes, in­clud­ing those in the pre­vi­ous­ly con­duct­ed sis­ter tri­al TACTT2, and will pro­vide an up­date in due course.

Au­ris CEO Thomas Mey­er

Re­searchers for the com­pa­ny in­sist­ed that they found in a sub­se­quent analy­sis of the first Phase III that the oti­tis me­dia sub­group of pa­tients demon­strat­ed a sta­tis­ti­cal­ly sig­nif­i­cant im­prove­ment for the Tin­ni­tus Func­tion­al In­dex (TFI) score. And that’s why they went for the re­vamp of the sec­ond Phase III.

It didn’t help, which is of­ten the case with these 11th hour tri­al re­vi­sions.

In the mean­time, Au­ris an­nounced last fall that its hear­ing loss drug, AM-111, al­so failed in its Phase III tri­al.

The com­pa­ny si­mul­ta­ne­ous­ly not­ed to­day that its stock, which closed at 25 cents a share on Tues­day, was in for a one-for-10 split to keep it in line with Nas­daq rules. Be­fore that, the stock took a 40% hit in af­ter-mar­ket trad­ing, falling 10 cents.

Its on­ly oth­er drug in clin­i­cal de­vel­op­ment is AM-125, an in­tranasal for­mu­la­tion of be­tahis­tine for ver­ti­go.

Tar­get­ing a Po­ten­tial Vul­ner­a­bil­i­ty of Cer­tain Can­cers with DNA Dam­age Re­sponse

Every individual’s DNA is unique, and because of this, every patient responds differently to disease and treatment. It is astonishing how four tiny building blocks of our DNA – A, T, C, G – dictate our health, disease, and how we age.

The tricky thing about DNA is that it is constantly exposed to damage by sources such as ultraviolet light, certain chemicals, toxins, and even natural biochemical processes inside our cells.¹ If ignored, DNA damage will accumulate in replicating cells, giving rise to mutations that can lead to premature aging, cancer, and other diseases.

Roivant par­lays a $450M chunk of eq­ui­ty in biotech buy­out, grab­bing a com­pu­ta­tion­al group to dri­ve dis­cov­ery work

New Roivant CEO Matt Gline has crafted an all-equity upfront deal to buy out a Boston-based biotech that has been toiling for several years now at building a supercomputing-based computational platform to design new drugs. And he’s adding it to the Erector set of science operations that are being built up to support their network of biotech subsidiaries with an eye to growing the pipeline in a play to create a new kind of pharma company.

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Fol­low biotechs go­ing pub­lic with the End­points News IPO Track­er

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.

Mark Mal­lon charts post-Iron­wood course by tak­ing CEO job at NeoGe­nomics; Glax­o­SmithK­line vet Feng Ren joins In­sil­i­co as CSO

Mark Mallon steps aside at Ironwood on March 12 after close to two years at the helm, and he already has a new change of scenery squared away. Beginning April 19, Mallon takes charge as CEO of cancer-focused genetic test maker NeoGenomics out of Fort Myers, FL while his predecessor, Douglas VanOort, is retiring after 12 years as NeoGenomics’ chairman and CEO.

It’s a fresh start for Mallon after what will amount to a tumultuous 23 months as Ironwood’s chief executive. Last year was marked by trial failures that spelled double trouble, leaving the Ironwood cupboard bare: first, a Linzess reformulation for irritable bowel syndrome with diarrhea (IBS-D) in May, and then the drug IW-3718 for persistent acid reflux in September. After IW-3718’s discontinuation, Ironwood chopped its staff by 35%. On Feb. 8, Mallon announced his departure at Ironwood, with president Tom McCourt getting bumped up to interim CEO.

Covid-19 roundup: Mer­ck­'s $356M sup­ply deal on hold as FDA asks for more da­ta; FDA ap­proves Pfiz­er/BioN­Tech vac­cine stor­age at stan­dard freez­er temps

Merck is pushing back plans to supply the US government with a Covid-19 drug after the FDA asked for more data to support an emergency use authorization.

The antibody, MK-7110, had looked promising in a Phase III study conducted by OncoImmune before Merck came along and bought the biotech for $425 million. At the interim analysis, investigators looked at data from 203 patients and concluded that a single dose of the drug cut the risk of death or respiratory failure by more than 50% among severe patients. And those taking the drug had a 60% higher chance of improvement in clinical status compared to placebo.

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Ken Frazier, Merck CEO (Bess Adler/Bloomberg via Getty Images)

UP­DAT­ED: Mer­ck takes a swing at the IL-2 puz­zle­box with a $1.85B play for buzzy Pan­dion and its au­toim­mune hope­fuls

When Roger Perlmutter bid farewell to Merck late last year, the drugmaker perhaps best known now for sales giant Keytruda signaled its intent to take a swing at early-stage novelty with the appointment of discovery head Dean Li. Now, Merck is signing a decent-sized check to bring an IL-2 moonshot into the fold.

Merck will shell out roughly $1.85 billion for Pandion Pharmaceuticals, a biotech hoping to gin up regulatory T cells (Tregs) to treat a range of autoimmune disorders, the drugmaker said Thursday.

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Steve Cutler, Icon CEO (Icon)

In the biggest CRO takeover in years, Icon doles out $12B for PRA Health Sci­ences to fo­cus on de­cen­tral­ized clin­i­cal work

Contract research M&A had a healthy run in recent years before recently petering out. But with the market ripe for a big buyout and the Covid-19 pandemic emphasizing the importance of decentralized trials, Wednesday saw a tectonic shift in the CRO world.

Icon, the Dublin-based CRO, will acquire PRA Health Sciences for $12 billion in a move that will shake up the highest rungs of a fragmented market. The merger would combine the 5th- and 6th-largest CROs by 2020 revenue, according to Icon, and the merger will set the newco up to be the second-largest global CRO behind only IQVIA.

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Tal Zaks, Moderna CMO (AP Photo/Rodrique Ngowi, via still image from video)

CMO Tal Zaks bids Mod­er­na a sur­prise adieu as biotech projects $18.4B in rev­enue, plots post-Covid ex­pan­sion

How do you exit a company after six years in style? Developing one of the most lucrative and life-saving products in pharma history is probably not the worst way to go.

Tal Zaks, Moderna’s CMO since 2015, will leave the mRNA biotech in September, the biotech disclosed in their annual report this morning. The company has already retained the recruitment firm Russell Reynolds to find a replacement.

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CEO Fred Aslan (Artiva)

NK cell ther­a­py play­er Arti­va makes some more noise, pulling in $120M Se­ries B less than a month af­ter Mer­ck deal

Not even one month after Big Pharma took notice of Artiva when Merck signed a collaboration worth nearly $2 billion in milestones, the off-the-shelf NK cell biotech already has its next big fundraise.

Artiva returns from the venture well Friday with a $120 million Series B round, money they will use to get their first program into the clinic and to file INDs for another two candidates. The raise marks the latest development in a rapidly expanding footprint for Artiva, which, in addition to the Merck deal last month, has now raised almost $200 million since its Series A last June.