Four and a half years af­ter first go­ing pub­lic on the promise of build­ing out a fran­chise for its nasal spray, Opti­nose says it has the land­mark Phase III da­ta to fi­nal­ly move for­ward.

The Yard­ley, PA-based biotech is re­port­ing pos­i­tive topline re­sults from Re­Open1, sug­gest­ing that pa­tients with chron­ic si­nusi­tis would im­prove af­ter us­ing XHANCE, an “ex­ha­la­tion” de­vice that de­liv­ers a cor­ti­cos­teroid named flu­ti­ca­s­one.

A brief surge in the stock price as high as 25% quick­ly gave way to more tem­pered growth, and shares $OPTN are up 1.84% to $2.77.

With­out break­ing out the num­bers, Opti­nose said the tri­al, which en­rolled a to­tal of 332 pa­tients, met both co-pri­ma­ry end­points com­pared to place­bo. The first mea­sured symp­toms by a com­pos­ite score of nasal con­ges­tion, fa­cial pain or pres­sure sen­sa­tion and nasal dis­charge at the end of week four; the sec­ond tracked the change from base­line to week 24 in per­cent of eth­moid and max­il­lary si­nus vol­ume oc­cu­pied dis­ease, as mea­sured by CT scan.

While XHANCE is al­ready ap­proved for peo­ple with nasal polyps, Opti­nose has long sug­gest­ed that chron­ic si­nusi­tis — the kind of nasal con­ges­tion and dis­charge that oc­curs with­out nasal polyps — rep­re­sents a much big­ger, and yet un­reached, mar­ket.

Ap­prox­i­mate­ly 1 mil­lion pa­tients in the US are di­ag­nosed with nasal polyps, CEO Pe­ter Miller said last No­vem­ber. By con­trast, Opti­nose es­ti­mates around 30 mil­lion Amer­i­cans live with chron­ic si­nusi­tis — and there are no FDA-ap­proved treat­ments for them.

A la­bel ex­pan­sion for chron­ic si­nusi­tis will ex­pand the tar­get pa­tient pop­u­la­tion for which our spe­cial­ty-fo­cused sales force can pro­mote XHANCE as an ap­pro­pri­ate treat­ment from ap­prox­i­mate­ly 1 mil­lion pa­tients to ap­prox­i­mate­ly 3 mil­lion pa­tients di­ag­nosed and treat­ed by the physi­cians that we tar­get to­day. In ad­di­tion, there is po­ten­tial for a part­ner to lever­age their de­ployed pres­ence in pri­ma­ry care to ex­pand pro­mo­tion of XHANCE to a to­tal of up to 30 mil­lion peo­ple in the U.S. who have chron­ic si­nusi­tis.

Ac­cord­ing to in­ves­ti­ga­tors, the most com­mon side ef­fects were nose bleeds, na­sopharyn­gi­tis, asth­ma and cataract (nu­clear and cor­ti­cal).

A sec­ond piv­otal tri­al is on­go­ing and Opti­nose ex­pects topline re­sults in the sec­ond quar­ter.

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.