Ab­b­Vie’s Rin­voq racked up an­oth­er ap­proval late Wednes­day af­ter­noon.

The drug is now OK’d in adults with mod­er­ate­ly to se­vere­ly ac­tive ul­cer­a­tive col­i­tis who have had an in­ad­e­quate re­sponse or in­tol­er­ance to one or more TNF block­ers, Ab­b­Vie said in a press re­lease. It’s the first ap­proval for the drug in gas­troen­terol­o­gy, the com­pa­ny added, with da­ta stem­ming from three Phase III stud­ies.

“There re­mains an un­met need for pa­tients with mod­er­ate­ly to se­vere­ly ac­tive UC, who suf­fer from de­bil­i­tat­ing symp­toms that are of­ten un­pre­dictable and bur­den­some,” said Thomas Hud­son, Ab­b­Vie CSO. “With the ap­proval of Rin­voq as a new treat­ment op­tion, Ab­b­Vie con­tin­ues our lead­er­ship in ad­vanc­ing re­search that can help im­pact the lives of peo­ple liv­ing with ul­cer­a­tive col­i­tis.”

Wednes­day’s ap­proval comes a few months af­ter the agency slapped a new warn­ing on the drug af­ter Pfiz­er’s Xel­janz saw in­creased side ef­fects, rel­e­gat­ing the drug to sec­ond-line use in rheuma­toid arthri­tis. The warn­ing came amid the back­drop of a larg­er safe­ty saga play­ing out for the en­tire JAK class of drugs. — Max Gel­man

Sen­so­ri­on claims vic­to­ry on ex­plorato­ry end­points af­ter PhII fail­ure

French biotech Sen­so­ri­on got ham­mered back in Jan­u­ary af­ter its on­ly clin­i­cal stage drug failed to meet the pri­ma­ry end­point in a Phase II study — los­ing 40% of its share val­ue af­ter the news was an­nounced about its lead drug SENS-401, a treat­ment of sud­den sen­sorineur­al hear­ing loss (SSNHL).

To­day, the biotech says it has some more da­ta. And this time, it says that they found some sta­tis­ti­cal­ly sig­nif­i­cant treat­ment ef­fects in spe­cif­ic pop­u­la­tions af­ter they re­viewed ex­plorato­ry end­points. Those in­clude pa­tients suf­fer­ing from pro­found hear­ing loss treat­ed with cor­ti­cos­teroids see­ing an im­prove­ment of 19-26 dB from base­line com­pared to place­bo.

Ex­plorato­ry end­points, how­ev­er, are gen­er­al­ly con­sid­ered far less con­clu­sive than end­points that were set ahead of time, and are gen­er­al­ly used on­ly to de­sign fu­ture tri­als, rather than to of­fer de­fin­i­tive an­swers on ef­fi­ca­cy.

In­vestors re­spond­ed fa­vor­ably to the new de­vel­op­ment, ini­tial­ly sky­rock­et­ing the stock up over 43% be­fore sta­bi­liz­ing at around a 20% in­crease.

The drug is still in play in a col­lab­o­ra­tion on hear­ing preser­va­tion fol­low­ing cochlear im­plants. Sen­so­ri­on and part­ner Cochlear Lim­it­ed are mov­ing for­ward with a tri­al and have sub­mit­ted tri­al de­sign plans to reg­u­la­tors in Aus­tralia and France. — Paul Schloess­er

Though Decibel Therapeutics has largely pivoted toward gene therapies for the inner ear, its lead clinical candidate simply aims to protect cancer patients from chemotherapy-induced hearing loss. On Tuesday, the biotech presented its first efficacy data for the program, and execs like what they see.

Decibel reported interim results from a Phase Ib study showing the experimental drug, dubbed DB-020, largely protected a small group of patients from losing their hearing. Researchers used a particularly unique study design, administering the compound in one of each patients’ ears before they received cisplatin chemotherapy and placebo in the other.

In November, Pfizer disclosed it’s spun out the Phase II dual JAK1/TYK2 inhibitor to a startup formed in collaboration with an unnamed, experienced partner.

We now know who the partner is. And as Pfizer and Roivant officially take the wraps off Priovant Therapeutics, the companies reveal that they have started two registrational trials of the drug, brepocitinib, as part of a broader plan to develop a big, first-in-class franchise spanning multiple orphan and specialty autoimmune diseases.

Ireland has been on a roll in 2022, with several large pharma companies announcing multimillion-euro projects. Now AstraZeneca’s rare disease outfit Alexion is looking to get in on the action.

Alexion on Friday announced a €65 million ($68.8 million) investment in new and enhanced capabilities across two sites in the country, including at College Park in the Dublin suburb of Blanchardstown and the Monksland Industrial Park in the central Irish town of Athlone, according to the Industrial Development Agency of Ireland.