Bel­gian biotech and pen­ny stock play­er Ox­u­ri­on was al­ready hov­er­ing around the $1.06/share mark this past week on the Eu­ronext stock ex­change in Brus­sels — and with the com­pa­ny’s newest an­nounce­ment, its stock price has tanked.

The eye-fo­cused biotech an­nounced a Phase II fail ear­ly Mon­day in Part A of a Phase II tri­al on the com­pa­ny’s in­te­grin an­tag­o­nist can­di­date to treat di­a­bet­ic mac­u­lar ede­ma or DME. Al­though the can­di­date, al­so called THR-687, was shown to be safe and well-tol­er­at­ed (a fact the com­pa­ny em­pha­sized), ev­i­dence to prove ef­fi­ca­cy was “in­suf­fi­cient” on the main end­points for the tri­al: best-cor­rect­ed vi­su­al acu­ity (the best vi­sion cor­rec­tion pos­si­ble with ei­ther glass­es or con­tact lens­es) and thick­ness of the mac­u­la, al­so known as cen­tral sub­field thick­ness.

The com­pa­ny had first start­ed dos­ing pa­tients with THR-687 back in Oc­to­ber, ac­cord­ing to a press re­lease is­sued at the time.

The biotech said in a state­ment that it is not ad­vanc­ing THR-687 to part B of the tri­al, which leaves it in lim­bo as to what the can­di­date’s fi­nal fate will be. In the mean­time, Ox­u­ri­on is now down to one can­di­date in its pipeline, a PKal in­hibitor named THR-149 cur­rent­ly in an­oth­er Phase II tri­al al­so for DME. Re­sults from Part B of that tri­al are ex­pect­ed some­time next year.

Ox­u­ri­on did not re­spond to a re­quest for com­ment be­fore pub­li­ca­tion time. How­ev­er, CEO Tom Graney said in a state­ment that,

As we dis­con­tin­ue our de­vel­op­ment of THR-687, we will ex­plore po­ten­tial part­ner­ship op­por­tu­ni­ties for the as­set. Ad­di­tion­al­ly, we are un­der­tak­ing a thor­ough re­view of our cap­i­tal and re­source al­lo­ca­tion plans to en­sure that they are aligned with our ob­jec­tive of max­i­miz­ing val­ue cre­ation for all stake­hold­ers.

The biotech’s stock got hit hard short­ly af­ter the an­nounce­ment went out, with the biotech OX­UR open­ing up the mar­ket at a 30% loss at 0.7 eu­ros, or about 75 cents a share and drop­ping even fur­ther to around a 40% drop. Ox­u­ri­on had al­so raised more than $10.5 mil­lion back in March through a pri­vate eq­ui­ty place­ment, of which 80% was ear­marked to help fund the biotech’s clin­i­cal tri­als.

How are top investors navigating the longest biotech bear market in almost 20 years? RBC Capital Markets Healthcare Desk Sector Strategist Chris McCarthy discusses key fundamentals, macro-awareness and the continued impact of COVID with HealthCor’s Ben Snedeker and Omega Funds founder Otello Stampacchia.

Biotech indexes may be down, but both Snedeker and Otello Stampacchia, Ph.D., Founder and Managing Director of Omega Funds, see opportunities in the market. In Snedeker’s opinion, investors need to seek out companies with the potential for meaningful revenue growth, particularly those that are mispriced in the current bear market.

Caribou Biosciences just flipped its first card on human data for its lead off-the-shelf anti-CD19 CAR-T, and it’s an ace.

The biotech reported out on a tiny group of patients — just five treatment-resistant individuals suffering from B cell non-Hodgkin’s lymphoma in this first round — and came up with a 100% overall response rate with an 80% complete response rate.

Those headline numbers quickly registered as a rare win these days in the bleak biotech sector, as Caribou’s share price $CRBU surged 25%.

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Roche has racked up its second straight Phase III fail for its TIGIT tiragolumab, flagging a flop on the progression-free survival co-primary endpoint for the drug combined with Tecentriq as a first-line treatment for PD-L1 high patients suffering from non-small cell lung cancer.

The other co-primary endpoint in the SKYSCRAPER-01 study on overall survival hasn’t reached the readout phase yet. But this time around Roche execs are waiting to see if it just might hit positive after seeing numerical gains for both endpoints.

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NSYNC boy band member Lance Bass didn’t realize his aches and pains weren’t just a byproduct of a busy lifestyle, many years of dancing and of course, aging. Instead, it was psoriatic arthritis.

Now Bass is partnering with Amgen and its anti-inflammatory brand Otezla to help others recognize the signs of psoriatic arthritis. The singer and dancer, whose career began as one of the five boys of NSYNC with popular hit songs and coordinated dance move videos such as “Bye Bye Bye” and “It’s Gonna Be Me,” is translating those moves to a short TikTok-style “Double Take” dance.

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Roche trumpeted a “major advancement” in the retinal space with the approval of its eye drug Susvimo last October, touting it as a more manageable option for patients with wet age-related macular degeneration. However, safety concerns leave some physicians hesitant.

While most ophthalmologists have heard of Susvimo — 86%, according to the latest Spherix survey of 76 doctors — only one in ten believe the benefits completely outweigh the risks. And a majority of the respondents said they’d turn to Regeneron’s Eylea as a safer and more accessible option.

Scynexis is rolling out a new campaign for its Brexafemme yeast infection treatment, but the effort is more than just advertising.

As CEO Marco Taglietti said in wrapping his prepared comments during an earnings call on Thursday, “Let me finish with our new rallying cry — yeast infection, say no more.”

That headline — written as “Yeast infection? Say no more” — appears on Scynexis’ recently launched ad campaign to healthcare providers and will begin rolling out to consumers later this month.

An India-based generics manufacturer is once again feeling the wrath of US regulators.

Aurobindo Pharma has been slapped with a Form 483 following an inspection of the company’s oral manufacturing facility, the company announced in a letter, while keeping the details to a minimum.

The facility is located in Jadcherla, India, outside of the city of Hyderabad. The inspection began last week, and concluded on Tuesday, according to Aurobindo. The FDA noted six observations, though it’s still unclear exactly what went wrong.

There’s a bottleneck in manufacturing right now, and perhaps the category that is the best representative of the issue is cell and gene therapy. Several companies are trying different things to address the issue, but Multiply Labs has enlisted some CDMO powerhouses on its path toward the automation of the process.

Cytiva and the University of California-San Francisco were already members of the robotic cell therapy manufacturing consortium Multiply, founded in 2021. Last week, it was announced that Thermo Fisher Scientific and Charles River Laboratories have joined the team to help develop a cGMP-compliant system that can make gene-modified cell therapies at an individual scale.

The first time Roche reported a failure for its sweeping Phase III program for the TIGIT contender tiragolumab a couple of months ago, quite a few analysts were willing to give the drug — and the class — a pass.

But when the Swiss giant flagged the collapse of the PFS endpoint in SKYSCRAPER-01 in the wee hours of the American market today, there was no mistaking the dark cloud that took shape over the field as the analyst crew shook their heads over the prospects for what had been the latest, greatest hope for immuno-oncology 2.0.

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

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