TYME Tech­nolo­gies’ SM-88 has been pulled from a Phase II/III study af­ter a clin­i­cal tri­al spon­sor clued the biotech in on an ex­pect­ed fail­ure for fu­til­i­ty against stan­dard-of-care chemo in pa­tients with metasta­t­ic pan­cre­at­ic can­cer, the com­pa­ny said Wednes­day.

Through the Pan­cre­at­ic Can­cer Ac­tion Net­work, TYME said a com­bi­na­tion of SM-88 — a mod­i­fied ty­ro­sine de­riv­a­tive the com­pa­ny be­lieves breaks down tu­mors’ meta­bol­ic process­es — and a reg­i­men known as MPS was ex­pect­ed to un­der­per­form chemo in terms of ex­tend­ing pa­tients’ lives. The study test­ed that com­bo against chemo reg­i­mens in­clud­ing gem­c­itabine and Abrax­ane or mod­i­fied FOLFIRI­NOX.

TYME CEO Richie Cun­ning­ham had this to say in a state­ment:

Giv­en pan­cre­at­ic can­cer’s high mor­tal­i­ty rate, we want­ed to make a dif­fer­ence in the lives of these pa­tients. Our team un­der­stood that many ef­forts be­fore us have failed, but based on SM-88’s pri­or ac­tiv­i­ty and safe­ty pro­file, we were hope­ful we could pro­vide an ef­fec­tive new op­tion for those fight­ing against this dev­as­tat­ing dis­ease.

For tiny TYME, the re­sults were dis­as­trous. Shares in $TYME were trad­ing down near­ly 41% at the open­ing bell. The com­pa­ny was al­ready well with­in the mi­cro­cap range be­fore the news.

The biotech said it still plans to pur­sue clin­i­cal de­vel­op­ment for SM-88 de­spite the flop, say­ing that pre­clin­i­cal da­ta point to some po­ten­tial ben­e­fit in a range of can­cer types.

Eli Lilly has succeeded in its attempt to get the first non-covalent version of Bruton’s tyrosine kinase, or BTK, inhibitors to market, pushing it past rival Merck.

The FDA gave an accelerated nod to Lilly’s daily oral med, to be sold as Jaypirca, for patients with relapsed or refractory mantle cell lymphoma.

The agency’s green light, disclosed by the Indianapolis Big Pharma on Friday afternoon, catapults Lilly into a field dominated by covalent BTK inhibitors, which includes AbbVie and Johnson & Johnson’s Imbruvica, AstraZeneca’s Calquence and BeiGene’s Brukinsa.

Novartis’ sickle cell drug, approved in 2019 and branded as Adakveo, has failed an ongoing Phase III, according to preliminary results.

The Swiss pharma giant unveiled early data from the ongoing STAND Phase III study on Friday, saying that crizanlizumab showed no statistically significant difference between the drug at two different dose levels compared to placebo in annualized rates of vaso-occlusive crises that lead to a healthcare visit over the first year since being randomized into the trial.

Merck’s blockbuster cancer treatment Keytruda has been handed another indication by the FDA.

The US regulator announced on Thursday that it has approved Keytruda to serve as an adjuvant treatment for non-small cell lung cancer (NSCLC), which is its fifth indication in NSCLC and 34th indication overall.

According to a Merck release, the approval is based on data from a Phase III trial, dubbed Keynote-091, which measured disease-free survival in patients who received chemotherapy following surgery. The data from Merck displayed that Keytruda cut down on the risk of disease recurrence or death by 27% versus placebo.

J&J and Legend Biotech’s next step in turning their CAR-T therapy Carvykti into a potential megablockbuster has succeeded, the companies said Friday.

Carvykti achieved the primary endpoint — progression-free survival — in an open-label Phase III study testing the treatment in second- to fourth-line multiple myeloma patients. The CARTITUDE-4 trial, for which there aren’t any hard data yet, represents the biggest development for Carvykti’s ability to compete with Bristol Myers Squibb’s Abecma since its approval last February.