Mer­ck should know be­fore the end of this year whether or not the FDA will ap­prove its drug gefapix­ant for chron­ic cough. The reg­u­la­tor has set a PDU­FA date of Dec. 21 for the drug, giv­ing the phar­ma gi­ant a reg­u­lar re­view for a close­ly watched de­vel­op­ment pro­gram.

Roy Baynes

Gefapix­ant is the leader among a group of P2X3 re­cep­tor an­tag­o­nists that are rac­ing to com­pete for a share of this pro­gram. That’s one rea­son why the agency has in­formed Mer­ck that it plans to hold an ad­vi­so­ry com­mit­tee for the re­view.

Mer­ck’s Roy Baynes has de­scribed this one as an­oth­er “pipeline in a prod­uct,” but it’s no shoo-in. The drug hit sta­tis­ti­cal sig­nif­i­cance on risk re­duc­tion, but in­ves­ti­ga­tors al­so flagged high dropout rates due to ad­verse events in the drug arm. So even with an OK, the phar­ma gi­ant could soon face ri­vals an­gling for bet­ter ef­fi­ca­cy and a stronger safe­ty pro­file.

Bay­er and Sh­iono­gi have com­pet­i­tive pro­grams in the clin­ic, but the chief ri­val right now is Bel­lus, though BLU-5937 failed a Phase II tri­al. That drug is now in an adap­tive Phase IIb. — John Car­roll

Mor­phic shares soar af­ter Phase I read­out for nov­el in­hibitor in IBD

On Mon­day, Waltham, MA-based Mor­phic Ther­a­peu­tics un­veiled Phase I proof-of-con­cept da­ta for its oral α4β7 in­te­grin in­hibitor MORF-057 in IBD. Turns out in­vestors like that da­ta — a lot.

Mor­phic $MORF was trad­ing up about 90% ear­ly Mon­day morn­ing on the heels of the news, putting the biotech’s shares in the range of $70.

In the three high­est dose co­horts of MORF-057’s Phase I pro­gram, the drug showed a mean re­cep­tor oc­cu­pan­cy of 95%, Mor­phic said, of­fer­ing hope that the drug can suf­fi­cient­ly “sat­u­rate” the α4β7 in­te­grin.

Mor­phic is plan­ning a Phase II study based on the ear­ly-stage re­sults in ul­cer­a­tive col­i­tis. Mean­while, the biotech is run­ning a con­cur­rent food-ef­fect study. — Kyle Blanken­ship

Chi­nook hands over up­front pay­ment to launch CKD deal with Evotec

Cana­da’s Chi­nook Ther­a­peu­tics has inked a dis­cov­ery and de­vel­op­ment deal with Evotec on new drugs for chron­ic kid­ney dis­ease.

In the deal the Eu­ro­pean CRO is gain­ing an undis­closed up­front pay­ment, re­search funds and more as Evotec’s team starts the hunt for new drugs.

“CKD is a col­lec­tive term for a va­ri­ety of dis­eases that cause a grad­ual loss of kid­ney func­tion. The di­ver­si­ty in the un­der­ly­ing caus­es makes this area es­pe­cial­ly fa­vor­able for da­ta-dri­ven and sys­tem­at­i­cal­ly per­son­al­ized ap­proach­es,” said Cord Dohrmann, the CSO of Evotec. “By lever­ag­ing our com­ple­men­tary plat­forms, Evotec and Chi­nook have the best pos­si­ble start­ing po­si­tion to tack­le par­tic­u­lar rare forms of CKD with the goal to de­vel­op dis­ease-mod­i­fy­ing ther­a­peu­tics for un­der­served pa­tient pop­u­la­tions.”

Back last sum­mer Chi­nook ex­e­cut­ed a re­verse merg­er with the strug­gling Aduro to get on­to Nas­daq. The biotech raised more than $100 mil­lion to go along with the merg­er. — John Car­roll

Ox­u­lar nets $37M to ad­vance once-a-year eye dis­ease treat­ments

British biotech Ox­u­lar Lim­it­ed com­plet­ed a new $37 mil­lion fund­ing round it hopes to use to fi­nance clin­i­cal tri­als.

The cash will go to­ward Phase II stud­ies be­gin­ning lat­er this year to eval­u­ate the pro­gram OXU-001 for the treat­ment of DME, which Ox­u­lar says is the lead­ing cause of blind­ness in young adults in de­vel­oped coun­tries. Promi­nent Eu­ro­pean VC firm For­bion led the round.

Giv­en that a key chal­lenge for these pa­tients is re­peat­ed clin­i­cal vis­its, Ox­u­lar has de­vel­oped OXU-001 to be a sus­tained-re­lease for­mu­la­tion of dex­am­etha­sone that can pro­vide up to 12 months of treat­ment fol­low­ing a sin­gle dose.

Some of the funds will al­so go to­ward a Phase II study for a sep­a­rate can­di­date in retinoblas­toma. Pro­grams for uveal melanoma and age-re­lat­ed mac­u­lar de­gen­er­a­tion and di­a­bet­ic retinopa­thy will al­so be prepped for IND sub­mis­sions. — Max Gel­man

Rea­ta shoots for fast re­view of its first NDA

War­ren Huff

Af­ter a years-long clin­i­cal quest, Plano, TX-based Rea­ta has filed an NDA in search of an ap­proval for bar­dox­olone in Al­port syn­drome.

The biotech’s CEO, War­ren Huff, adds that they’re shoot­ing for pri­or­i­ty re­view sta­tus in an at­tempt to short­en the FDA’s han­dling of the NDA by 4 months. This ap­pli­ca­tion marks Rea­ta’s first for­mal shot at an FDA ap­proval.

In an up­date, Rea­ta al­so not­ed plans to re­vise an­oth­er clin­i­cal study that had been paused due to the pan­dem­ic.

We are plan­ning to amend the FAL­CON pro­to­col to in­crease the tar­get en­roll­ment from 300 pa­tients to a to­tal of 550 pa­tients.   With the planned in­crease in an­tic­i­pat­ed en­roll­ment, we ex­pect to com­plete en­roll­ment in FAL­CON by the end of 2021.

— John Car­roll

LianBio, a biotech that has operations in both the US and China, announced the terms yesterday for its initial public offering.

The biotech plans to raise $325 million by offering 20.3 million shares priced between $15 and $17.

At the midpoint of the proposed range, LianBio could command a fully diluted market value of $1.8 billion, based on a number of expected outstanding shares.

The two year old biotech has focused on in-licensing and commercialization of therapeutics in China, Hong Kong, Taiwan, Macau and other Asian markets. The company currently has nine programs across five therapeutic areas, including oncology, cardiovascular, and inflammatory diseases.

Three Senate Democrats are backing an FDA plan to require mandatory prescriber education for opioids as overdose deaths have risen sharply over the past decade, with almost 97,000 American opioid-related overdose deaths in the past year alone.

While acknowledging a decline in overall opioid analgesic dispensing in recent years, the FDA said it’s reconsidering the need for mandatory prescriber training through a REMS given the current situation with overdoses, and is seeking input on the aspects of the opioid crisis that mandatory training could potentially mitigate.

Just as Avoro Capital’s campaign to derail Merck’s proposed $11.5 billion buyout of Acceleron gains steam, Bristol Myers Squibb is leaning in with some hefty counterweight.

The pharma giant is planning to tender its Acceleron shares, Bloomberg reported, which add up to a sizable 11.5% stake. Based on the offer price, the sale would net Bristol Myers around $1.3 billion.

To complete its deal, Merck needs a majority of shareholders to agree to sell their shares.

The FDA late Wednesday signed off on authorizing the use of heterologous — or what FDA calls a “mix and match” of a primary vaccine series and different booster doses — for all currently available Covid-19 vaccines, in addition to separately authorizing Moderna and J&J boosters.

On the mix-and-match approach, which FDA officials insisted isn’t too confusing in a press conference, the agency offered the example of an 18-year-old who received the J&J shot at least two months ago and may now receive a single booster of the J&J, a half dose of the Moderna, or the Pfizer-BioNTech booster.

David Livingston, the Dana-Farber/Harvard Med scientist who helped shine a light on some of the key molecular drivers of breast and ovarian cancer, died unexpectedly last Sunday.

One of the senior leaders at Dana-Farber during his nearly half century of work there, Livingston was credited with shedding light on the genes that regulate cell growth, with insights into inherited BRCA1 and BRCA2 mutations that helped lay the scientific foundation for targeted therapies and earlier detection that have transformed the field.