The nail-bit­ing among the in­vestors who held on to their con­tin­gent val­ue rights $BMYRT from the Cel­gene buy­out is giv­ing way to pan­ic to­day.

Dur­ing their Q3 call with an­a­lysts, ex­ecs said that the FDA had in­spect­ed the Both­ell, WA plant be­ing used for liso-cel (JCAR017), the CAR-T Bris­tol My­ers picked up in the deal. That’s a plus.

But there was a hitch.

They went on to say that no in­spec­tion had yet even been sched­uled for the Texas CMO in­volved. And with that, the slow trick­le of in­vestors seep­ing out of the CVR group turned in­to an in­stant rout. The stock plunged about 80% from the $3.40 still left for the CVR at the end of the day yes­ter­day. That took it down in­to pen­ny stock ter­ri­to­ry.

Bris­tol CVR took an­oth­er turn down af­ter they said on the call that an in­spec­tion of the Lon­za fa­cil­i­ty has not yet been sched­uled. $BMYRT

— Brad Lon­car (@brad­lon­car) No­vem­ber 5, 2020

Why the stam­pede?

Sal­im Syed

Re­mem­ber that dur­ing last-minute buy­out ne­go­ti­a­tions, Bris­tol My­ers CEO Gio­van­ni Caforio in­sist­ed that they re­place cash on the ta­ble with a $9 CVR tied to the ap­proval of 3 drugs by cer­tain dates. Ozan­i­mod made the dead­line, but the fate of liso-cel (JCAR017) and ide-cel are hang­ing on FDA ac­tions. Liso-cel was de­layed and ide-cel got slapped with a refuse-to-file. That drug has un­til the end of Q1 next year to make good.

As Bris­tol My­ers notes in its Q3 pre­sen­ta­tion to­day, there’s a Nov. 16 PDU­FA date loom­ing for liso-cel, and with­out a clean bill of health on CMC, reg­u­la­tors aren’t like­ly to come through with an OK for a once close­ly-watched ther­a­py that earned break­through sta­tus at the FDA. That could spell an­oth­er sig­nif­i­cant de­lay.

Sal­im Syed at Mizuho, who’s been track­ing every tiny de­tail around the CMC work — in­clud­ing pri­vate eye re­ports com­plete with tele­pho­to lens­es on the Both­ell in­spec­tion — summed it up here:

The way it was couched on the call was that this is due to COVID-19 and the FDA want­i­ng to keep its em­ploy­ees safe. How­ev­er, in­vestors were ex­pect­ing, and what seemed to make most log­i­cal sense, is to in­spect the plants to­geth­er close­ly in se­quence, Both­ell and Texas.

Syed, though, is urg­ing calm in the melee. While the PDU­FA is dat­ed Nov. 16, the dead­line on the CVR is the end of this year — still some weeks out.

Re­mem­ber, the FDA on­ly needs here about ~3 weeks (by rea­son­able stan­dards and our KOL call) post-in­spec­tion to fin­ish up all the pa­per­work and get a drug to the fin­ish line.

Be­sides, he adds, this is a BTD pro­gram, so the FDA should be will­ing to hur­ry up. The ex­ecs at Bris­tol My­ers nev­er said if there could be a vir­tu­al in­spec­tion and be­sides, the com­pa­ny al­ready said that if they learned that they would miss the PDU­FA, they’d say so prompt­ly.

So far, so good on that score. The PDU­FA re­mains in place.

But with the dead­line draw­ing very, very close, a lot of the in­vestors are bolt­ing.

Genmab $GMAB has opted to ax one of its antibody-drug conjugates after watching it flop in the clinic.

The Danish biotech reported Tuesday that it decided to kill their program for enapotamab vedotin after the data gathered from expansion cohorts failed to measure up. According to the company:

While enapotamab vedotin has shown some evidence of clinical activity, this was not optimized by different dose schedules and/or predictive biomarkers. Accordingly, the data from the expansion cohorts did not meet Genmab’s stringent criteria for proof-of-concept.

Novartis is always one of the industry’s biggest R&D spenders. As they often do toward the end of each year, company execs are highlighting the drugs they expect will most likely be winners in 2021.

And they’re also dreaming about some potential big-time lottery tickets.

As part of its annual investor presentation Tuesday, where the company allows investors and analysts to virtually schmooze with the bigwigs, Novartis CEO Vas Narasimhan will outline what he thinks are the pharma’s “Wild Cards.” The slate of five experimental drugs covers a wide range of indications that Novartis hopes can be high-risk, high-reward entrants into the market over the next half-decade or so.

As biotechs look to get clinical studies back on track amid the pandemic, Medable returned to the venture well for the second time this year, bagging a $91 million Series C to build out its virtual trial platform.

The software provider recently launched three new apps for decentralizing clinical trials, and saw a 500% revenue spike this year. And it isn’t alone. Back in August, Science 37 secured a $40 million round for its virtual trial tech, with support from Novartis, Sanofi Ventures and Amgen. Patients and researchers are taking a liking to the online approach, suggesting regulators could allow it to become a new normal even after the pandemic is over.

Ever since President Donald Trump floated the idea of using state-sponsored importation to lower drug prices, PhRMA has made its opposition abundant. Not only is the proposal dangerous and futile,  but the trade group has also argued that it may even be illegal.

Now that the FDA has issued its final rule permitting states to bring certain drugs from Canada, PhRMA is taking the government to court — just a few days before the rule is slated to take effect.

The first time San Diego biotech Ambrx tried to go public in 2014, they failed and the company’s board switched to a radically different strategy: They sold themselves for an undisclosed amount to a syndicate of Chinese investors and pharma companies.

Now, after 5 quiet years, that syndicate has raised a mountain of cash and indicated they’ll soon make another bid to go public.

Earlier this month, Ambrx raised $200 million in what they billed as a crossover round financed by Fidelity, BlackRock, Cormorant Asset Management, HBM Healthcare Investments, Invus, Adage Capital Partners and Suvretta Capital Management. It’s the largest amount they’ve ever raised and, according to Crunchbase figures, more than doubles the total amount of VC capital collected since their launch 17 years ago.

Just to complete the last leg of a running story I’ve been tracking for a few weeks, Olema $OLMA has come through its IPO from the Thursday night pricing at $19 a share with a market cap just north of $2 billion.

That leaves newly-named CEO Sean Bohen holding a batch of 1,110,896 shares with a strike price of $4.82. As of Tuesday morning, the stock is now trading at $53.40, giving him a portfolio value of $53.4 million. Not bad for someone who was hired in September.