Hit by FDA red flags, cit­ed for mis­lead­ing in­vestors and bat­tered by a thumbs-down from ex­perts, it’s been one ter­ri­ble week for Treve­na

Treve­na’s fall from grace — and in­to pen­ny stock ter­ri­to­ry — gath­ered steam on Thurs­day evening as a slight ma­jor­i­ty of out­side ex­perts at the FDA turned thumbs down on their pain med and lawyers be­gan to pitch a class ac­tion suit claim­ing the com­pa­ny had ac­tive­ly mis­led in­vestors for 2 years about the biotech’s dis­cus­sions with reg­u­la­tors.

Max­ine Gowen

Al­ready down sharply af­ter the in-house re­view pro­vid­ed a scathing as­sess­ment of mixed ef­fi­ca­cy and safe­ty da­ta, the 8-7 vote against an ap­proval car­ried fresh penal­ties as Treve­na’s stock $TRVN slid down to 71 cents a share in af­ter-mar­ket trad­ing.

But it wasn’t just the vote that count­ed against Treve­na.

At­tor­neys at Bern­stein Lieb­hard ac­cused Treve­na ex­ecs, specif­i­cal­ly ex-CEO Max­ine Gowen — who stepped down a few days ago — of mis­lead­ing in­vestors about an end-of-Phase II meet­ing with the FDA.

At the time, they note, Gowen said in a May 2, 2016 re­lease that she was “very pleased” with the out­come of its dis­cus­sions with the FDA about oliceri­dine (TRV130) and that they had reached a gen­er­al agree­ment about the Phase III de­sign.

The agency, though, out­lined some deep prob­lems the FDA had with that study in their re­view of the drug. The firm notes:

(M)in­utes from the FDA’s April 28, 2016 meet­ing with Treve­na were re­leased and showed that the FDA:

•”did not agree with the pro­posed dos­ing in the Phase 3 stud­ies”;

•”did not agree with the pro­posed pri­ma­ry end­point”; and

•”did not agree with the pro­posed non-in­fe­ri­or­i­ty (NI) mar­gin for com­par­ing mor­phine to oliceri­dine.”

The FDA, though, has its hands tied when it comes to re­veal­ing any­thing about its dis­cus­sions with com­pa­nies about drug de­vel­op­ment pro­grams — up un­til and if they do a re­view for pub­lic con­sump­tion. Reg­u­la­tors have on a num­ber of oc­ca­sions not­ed that com­pa­nies fre­quent­ly have their own ver­sion of events that veer off the straight and nar­row path of hon­esty. But com­mis­sion­er Scott Got­tlieb has al­so re­neged on promis­es to do a few sim­ple things to help im­prove the sit­u­a­tion — such as pub­lish­ing redact­ed ver­sions of com­plete re­sponse let­ters.

About the best thing that hap­pened to Treve­na was that the neg­a­tive vote was so nar­row, with a large mi­nor­i­ty back­ing an ap­proval and leav­ing some hope for die-hard sup­port­ers that the com­pa­ny could yet snatch vic­to­ry from the arms of de­feat.

In­vestors, though, didn’t like the way any of this was pan­ning out, and Treve­na’s share price slid an­oth­er 25% in af­ter-mar­ket trad­ing Thurs­day evening. It end­ed the night at 71 cents.

BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

Pfiz­er’s Doug Gior­dano has $500M — and some ad­vice — to of­fer a cer­tain breed of 'break­through' biotech

So let’s say you’re running a cutting-edge, clinical-stage biotech, probably public, but not necessarily so, which could see some big advantages teaming up with some marquee researchers, picking up say $50 million to $75 million dollars in a non-threatening minority equity investment that could take you to the next level.

Doug Giordano might have some thoughts on how that could work out.

The SVP of business development at the pharma giant has helped forge a new fund called the Pfizer Breakthrough Growth Initiative. And he has $500 million of Pfizer’s money to put behind 7 to 10 — or so — biotech stocks that fit that general description.

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Mark Genovese (Stanford via Twitter)

Gilead woos fil­go­tinib clin­i­cal in­ves­ti­ga­tor from Stan­ford to lead the charge on NASH, in­flam­ma­to­ry dis­eases

With an FDA OK for the use of filgotinib in rheumatoid arthritis expected to drop any day now, Gilead has recruited a new leader from academia to lead its foray into inflammatory diseases.

Mark Genovese — a longtime Stanford professor and most recently the clinical chief in the division of immunology and rheumatology — was the principal investigator in FINCH 2, one of three studies that supported Gilead’s NDA filing. In his new role as SVP, inflammation, he will oversee the clinical development of the entire portfolio.

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No­var­tis chips in $10M for IPO-bound part­ner Pli­ant; Tenax shares soar on heart drug da­ta

Novartis is coming in with $10 million to help support the looming IPO of a partner. Pliant Therapeutics posted a new filing with the SEC showing that Novartis is buying the shares at $15, the mid-point of the range. It’s adding several million shares to the offering, bringing the total to around $135 million. Biotech companies have been enjoying quite a run on virtual Wall Street, with investors boosting new offerings to some big hauls.

Stephen Isaacs, Aduro president and CEO (Aduro)

Once a high fly­er, a stag­ger­ing Aduro is auc­tion­ing off most of the pipeline as CEO Stephen Isaacs hands off the shell to new own­ers

After a drumbeat of failure, setbacks and reorganizations over the last few years, Aduro CEO Stephen Isaacs is handing over his largely gutted-out shell of a public company to another biotech company and putting up some questionable assets in a going-out-of-business sale.

Isaacs —who forged a string of high-profile Big Pharma deals along the way — has wrapped a 13-year run at the biotech with one program for kidney disease going to the new owners at Chinook Therapeutics. A host of once-heralded assets like their STING agonist program partnered with Novartis (which dumped their work on ADU-S100 after looking over weak clinical results), the Lilly-allied cGAS-STING inhibitor program and the anti-CD27 program out-licensed to Merck will all be posted for auction under a strategic review process.

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Gilead re­leas­es an­oth­er round of murky remde­sivir re­sults

A month after the NIH declared the first trial on remdesivir in Covid-19 a success, Gilead is out with new results on their antiviral. But although the study met one of its primary endpoints, the data are likely to only add to a growing debate over how effective the drug actually is.

In a Phase III trial, patients given a 5-day dose of remdesivir were 65% more likely to show “clinical improvement” compared to an arm given standard-of-care. The trial, though, gave little indication for whether the drug had an impact on key endpoints such as survival or time-to-recovery. And in a surprising twist, a 10-day dosing arm of remdesivir didn’t lead to a statistically significant improvement over standard of care.

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Fangliang Zhang (Imaginechina via AP Images)

The big mon­ey: Poised to make drug R&D his­to­ry, a Chi­na biotech un­veils uni­corn rac­ing am­bi­tions in a bid to raise $350M-plus on Nas­daq

Almost exactly three years after Shanghai-based Legend came out of nowhere to steal the show at ASCO with jaw-dropping data on their BCMA-targeted CAR-T for multiple myeloma, the little player with Big Pharma connections is taking a giant step toward making it big on Wall Street. And this time they want to seal the deal on a global rep after staking out a unicorn valuation in what’s turned out to be a bull market for biotech IPOs — in the middle of a pandemic.

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Bris­tol My­ers Squib­b's just-launched MS drug Zeposia makes the cut in key ul­cer­a­tive col­i­tis tri­al

In March, Zeposia became the third oral S1P modulator to secure US approval for multiple sclerosis. Now, the drug has succeeded in a key ulcerative colitis study.

The immunomodulator, akin to others in its class, controls lymphocyte trafficking by limiting the white blood cells to the lymphatic system, in the lymph nodes, and thwarting their ability to jam up lymph nodes — precluding their ability to penetrate the bloodstream and the central nervous system.

Hill­house re­casts spot­light on Chi­na's biotech scene with $160M round for Shang­hai-based an­ti­body mak­er

Almost two years after first buying into Genor Biopharma’s pipeline of cancer and autoimmune therapies, Hillhouse Capital has led a $160 million cash injection to push the late-stage assets over the finish line while continuing to fund both internal R&D and dealmaking.

The Series B has landed right around the time Genor would have listed on the Hong Kong stock exchange, according to plans reported by Bloomberg late last year. Insiders had said that the company was looking to raise about $200 million.

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