The tal­ly of re­struc­tur­ings in biotech con­tin­ued to go up to­day with news from two small play­ers that are in fi­nan­cial hot wa­ter.

Tenax Ther­a­peu­tics may be down to its fi­nal cri­sis.

Af­ter years of spikes and plunges, the share price has long been flat­lined in pen­ny stock ter­ri­to­ry. And with dwin­dling cash and a “go­ing con­cern” alert in its SEC fil­ings, the ex­ec­u­tive crew is do­ing what it can to see about set­ting up a deal of some kind — and every­thing, in­clud­ing a sale, is on the ta­ble.

With a nanocap mar­ket val­ue un­der $6 mil­lion and a stock that trades for pen­nies, pre­sum­ably any­one who wants any or all of the out­fit could pick it up at a bar­gain base­ment price.

In the mean­time, Tenax $TENX has de­cid­ed to de­lay a planned late-stage study of an oral ver­sion of Gleevec, shov­ing the start date from lat­er this year in­to 2023. They al­so have a “Phase III-ready” drug, oral lev­osi­men­dan, in the pipeline.

For now, the board says the bat­tered stock price doesn’t re­flect the re­al val­ue of the com­pa­ny. But its op­tions are dwin­dling at a time pub­lic biotechs are find­ing Nas­daq is suck­ing down a host of play­ers in the same po­si­tion.

In the mean­time, the Cana­di­an biotech IMV says that it will axe a third of its staff so the com­pa­ny can con­tin­ue on with their clin­i­cal work, most promi­nent­ly a Phase IIB tri­al for DL­B­CL and an­oth­er in metasta­t­ic ovar­i­an can­cer.

As part of the re­or­ga­ni­za­tion, Saman Male­ki has joined the board and the com­pa­ny pro­mot­ed Brit­tany Davi­son to chief ac­count­ing of­fi­cer. CEO An­drew Hall is chalk­ing it up to max­i­miz­ing share­hold­er val­ue.

“We have made the de­ci­sion to strate­gi­cal­ly re­con­fig­ure IMV in or­der to max­i­mize share­hold­er val­ue and fo­cus re­sources on dri­ving to near-term val­ue-cre­at­ing mile­stones,” Hall said.

APAC is the fastest growing region globally for cell & gene therapy trials representing more than a third of all cell & gene studies globally, with China leading in the region. 

APAC is the leading location globally for CAR-T trials with China attracting ~60% of all CAR-T trials globally between 2015-2022. The number of CAR-T trials initiated by Western companies has rapidly increased in recent years (current CAGR of about 60%), with multiple targets being explored including CD19, CD20, CD22, BCMA, CD30, CD123, CD33, CD38, and CD138.

Right around the beginning of the year, we got a close-up look at what happens after a boom ripples through biotech. The crash of life sciences stocks in Q1 was heard around the world.

In the months since, we’ve seen the natural Darwinian down cycle take effect. Reverse mergers made a comeback, with more burned out shells to go public at a time IPOs and road shows are out of favor. And no doubt some of the more recent arrivals on the investing side of the business are finding greener pastures.

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Back in April, Amgen said it was encouraged by the solicitor general’s anticipated review of its Supreme Court petition to rehear a Repatha patent case. They’re likely much less optimistic about the outcome now.

Solicitor General Elizabeth Prelogar wrote in a recent 27-page brief that Amgen’s arguments “lack merit and further review is not warranted.”

The case traces back to a suit filed in 2014 against Sanofi and Regeneron’s Praluent, which ended up beating Amgen’s PCSK9 blockbuster Repatha to market by a month just a year later.

The EMA is putting EU member states on alert over the shortage of two drugs that counter heart attacks due to an uptick in demand.

On Friday, the EMA sent out a warning that two Boehringer Ingelheim drugs are experiencing a shortage: Actilyse and Metalyse. The drugs are used as emergency treatments for adults experiencing acute myocardial infarction, or a heart attack, by dissolving blood clots that have formed in the blood vessels.

A Cipla drug manufacturing site in India has once again landed in the crosshairs of FDA inspectors.

The facility in question is Cipla’s drug manufacturing facility in the village of Verna, in the state of Goa in India’s southwest. In a sign that foreign inspections might ramp up again, the FDA’s visit from Aug. 16 to Aug. 22 uncovered six observations.

The 11-page report noted that environmental monitoring at the site did not properly ensure that microbial contaminants were not making any impact in the aseptic filling areas. It also found that procedures meant to stop microbial contamination were not adequately conducted in aseptic areas of the facility.

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At Klick Health’s first Ideas Exchange conference with biotech and pharma industry insiders since before the pandemic began, it was no surprise many conversations included Covid topics. Yet while vaccines and treatments were discussed, so too were the effects on drug development, federal responses, health inequities — and what to do now and next.

George Yancopoulos, chief scientist and cofounder of Regeneron, opened the conference responding to a question from Acorda CEO Ron Cohen about the spotlight on the industry during Covid and some of the “flak” biopharma has taken in the past.

FDA’s outside advisors voted in favor of Ferring Pharmaceuticals’ RBX2660, an experimental poop-based drug implant that the company says would be the first microbiota-based live biotherapeutic to receive an FDA green light.

That was a point repeatedly discussed during the Vaccines and Related Biological Products Advisory Committee, or VRBPAC, meeting Thursday when evaluating Ferring’s fecal microbiota transplant, or FMT, for reducing the recurrence of Clostridioides difficile infection in adults who have received antibiotics. Multiple members brought up the need for a regulated product amid a landscape of unregulated FMTs already happening in clinical care.

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Just one day after blockbuster Lynparza got access to another indication in China, its Big Pharma owners have decided to withdraw it in certain patients after reviewing Phase III data.

The two companies that work together on Lynparza decided to recall one of the indications several weeks ago — in a specific type of ovarian cancer, Lynparza’s first indication when it was first FDA-approved in 2014. Initial data showed that rates of overall survival in patients with at least three rounds of chemo before getting on the PARP inhibitor were lower than in patients with less previous chemo treatment.

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Fujifilm’s CDMO arm, Fujifilm Diosynth, has been on a roll this month as the company has recently broken ground on a major project in Europe and it appears to be keeping up the momentum.

Fujifilm Diosynth announced that it has kicked off an expansion project for its microbial manufacturing facility at its campus in the town of Billingham, UK, in the northeast of England.

The 20,000 square-foot, £400 million ($435 million) expansion will add clean rooms, purification suites and a packing area along with more space for the manufacturing itself.

Bioscience & Technology Business Center The University of Kansas Lawrence, Kansas

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