Close to a year-and-a-half af­ter tap­ping the brakes on one of its pre­clin­i­cal pro­grams to do some added ge­net­ic en­gi­neer­ing work on their next-gen CAR-T, Anixa $ANIX Ther­a­peu­tics says the reg­u­la­to­ry light is flash­ing red on their IND.

The San Jose, CA-based biotech — which changed its name from ITUS in 2018 — ex­plained in late 2019 that they were tak­ing a knee for at least a year so that re­searchers could go back and amp up the ex­pres­sion of fol­li­cle stim­u­lat­ing hor­mone on T cells to im­prove tar­get­ing of the FSH re­cep­tor on a spe­cif­ic set of ovar­i­an cells. That re­quired new vec­tor en­gi­neer­ing work by their part­ners at Mof­fitt Can­cer Cen­ter.

Jose Cone­jo-Gar­cia

The work, though, has ev­i­dent­ly spurred ques­tions at the FDA, which slapped a clin­i­cal hold on the pro­gram, the biotech an­nounced Mon­day morn­ing.

Their shares plunged 28% on the news.

Ac­cord­ing to Anixa:

The study un­der the In­ves­ti­ga­tion­al New Drug ap­pli­ca­tion has been placed on clin­i­cal hold pend­ing sub­mis­sion of ad­di­tion­al in­for­ma­tion re­quest­ed by the FDA. With­in the next 30 days, it is ex­pect­ed that the FDA will pro­vide a let­ter to MCC with de­tailed and spe­cif­ic in­for­ma­tion re­quest­ed.  MCC will as­sem­ble and sub­mit in­for­ma­tion ad­dress­ing the re­quest as soon as pos­si­ble there­after. Suc­ces­sive to the sub­mis­sion, the FDA will con­tin­ue its re­view of the IND.

Jose Cone­jo-Gar­cia, the chair of the de­part­ment of im­munol­o­gy at Mof­fitt, is cred­it­ed as the chief in­ven­tor of the CAR-T tech that Anixa is us­ing.

So­cial: Mof­fitt Can­cer Cen­ter web­site

The FDA late Friday awarded Boehringer Ingelheim the first interchangeability designation for its Humira biosimilar Cyltezo, meaning that when it launches in July 2023, pharmacists will be able to automatically substitute the Boehringer’s version for AbbVie’s mega-blockbuster without a doctor’s input.

The designation will likely give Boehringer, which first won approval for Cyltezo in 2017, the leg up on a crowded field of Humira competitors.

Oyster Point Pharma now has its first FDA-approved product — Tyrvaya. And the biotech has taken a unique route to get there by using an old drug with a storied past.

The New Jersey biotech announced this morning that the FDA has approved their nasal spray product for dry eye disease on Friday — the first nasal spray to be approved for the disease. The product’s active ingredient is 0.03 mg of varenicline, also known as smoking cessation aid Chantix.

Omeros practically warned investors that a complete response letter was coming when it disclosed that the FDA found deficiencies in its BLA for narsoplimab. But the agency did not elaborate on the specifics of those deficiencies for the drug, which was being positioned as a treatment for the rare but serious blood clotting disease known as hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA).

If at first you don’t succeed, and at second you don’t succeed, try, try again.

That’s been the unofficial mantra for Adamis Pharmaceuticals’ high dose naloxone injection, which received two CRLs in the span of a year between the Novembers of 2019 and 2020. But on Monday, word came through that the FDA approved the drug on Adamis’ third attempt, giving doctors another tool to treat individuals who overdose on opioids.