When Pfiz­er hand­ed over $650 mil­lion in cash to part­ner on My­ovant’s re­l­u­golix, the phar­ma gi­ant made clear that the deal — val­ued at $4.2 bil­lion to­tal — was just as much about the ap­proved in­di­ca­tion of prostate can­cer as the two women’s health con­di­tions the drug could treat.

A month lat­er, the two com­pa­nies are of­fer­ing an­oth­er glimpse of the ther­a­py’s longterm po­ten­tial in en­dometrio­sis.

The lat­est da­ta snap­shot comes from the ex­ten­sion por­tion of the Phase III SPIR­IT pro­gram. Re­l­u­golix had hit the co-pri­ma­ry end­points in both tri­als, sav­ing a ma­jor­i­ty of women from se­vere pain, but in­ves­ti­ga­tors want­ed to know: Can the ef­fects stretch out to one year?

In short, the an­swer was yes.

In the study, 84.8% and 73.3% of pa­tients re­ceiv­ing a dai­ly pill com­bin­ing re­l­u­golix, re­l­u­golix estra­di­ol and norethin­drone ac­etate reached the thresh­old for “clin­i­cal­ly mean­ing­ful pain re­duc­tions in dys­men­or­rhea and non-men­stru­al pelvic pain, re­spec­tive­ly.” On av­er­age, they re­port­ed an 82.8% re­duc­tion on a scale to mea­sure se­vere men­stru­al pain — go­ing from 7.4 to 1.3 on an 11-point scale.

“Giv­en the de­bil­i­tat­ing im­pact that en­dometrio­sis can have on women in their dai­ly lives, of­ten over many years, we need non-in­va­sive and long-term treat­ment op­tions,” said Lin­da Giu­dice, a lead in­ves­ti­ga­tor in the tri­al, adding that the treat­ment re­mained well tol­er­at­ed through­out.

Con­sis­tent with ear­li­er ob­ser­va­tions, the most com­mon side ef­fects were headache, na­sopharyn­gi­tis and hot flash­es. As for the “min­i­mal” bone loss re­port­ed through week 24, the com­pa­nies added, bone min­er­al den­si­ty re­mained sta­ble at week 52.

My­ovant CMO Juan Cami­lo Ar­jona Fer­reira not­ed that the da­ta build on sim­i­lar­ly pos­i­tive one-year da­ta of re­l­u­golix in uter­ine fi­broids, sup­port­ing longterm use in both dis­eases.

The biotech is ex­pect­ing to hear from the FDA on the uter­ine fi­broid in­di­ca­tion by June 1, while the NDA for en­dometrio­sis will be filed be­fore or around then.

They have Lynn Seely, vet­er­an drug de­vel­op­er and found­ing CEO, to thank for steer­ing them in­to a po­si­tion of po­ten­tial­ly scor­ing three OKs in just a year and a half. But it will be her suc­ces­sor, for­mer Am­gen ex­ec David Marek, who will be spear­head­ing the com­mer­cial game plan as they take on Ab­b­Vie’s Orilis­sa in the field.

Thank­ful­ly for My­ovant — which has al­ways be­lieved it can set it­self apart with a bet­ter safe­ty pro­file while main­tain­ing com­pa­ra­ble ef­fi­ca­cy — it’s no longer a David vs. Go­liath bat­tle.

Not on­ly is Pfiz­er now on board to mar­ket re­l­u­golix, but My­ovant is al­so one of the Vants that Sum­it­o­mo Dainip­pon grabbed a ma­jor­i­ty stake in a $3 bil­lion M&A pact en­gi­neered by out­go­ing Vivek Ra­maswamy. Just in Au­gust, Sum­i­to­vant set aside an­oth­er $200 mil­lion in the form of a loan of­fer to fund the prod­uct launch­es.

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

US regulators cleared an ultra-rare drug from Pharming Group, by way of Novartis, on Friday afternoon.

The Dutch biotech said the FDA greenlit leniolisib for an immunodeficiency disease known as activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome, or APDS. People 12 years and older can receive the oral drug, to be marketed as Joenja, beginning early next month, Pharming said, five days ahead of the decision deadline set by the FDA as part of a priority review.

Digital therapeutics company Better Therapeutics announced on Thursday that it’s cutting 35% of its staff as it awaits FDA clearance for its first product.

The company, which launched eight years ago, is one of a growing group of companies seeking a digital alternative to traditional medicine. The space saw a record $7.5 billion in investments in 2021, according to Chris Dokomajilar at DealForma, with uses spanning ADHD, PTSD and other indications. However, private insurers have been slow to hop on board.