Pro­to­cols: CoLu­cid shares rock­et up on pos­i­tive mi­graine PhI­II; Sage bags a 'break­through' on post-par­tum de­pres­sion

Shares of Cam­bridge, MA-based CoLu­cid Phar­ma­ceu­ti­cals $CLCD soared 90% Tues­day morn­ing af­ter the com­pa­ny de­clared a suc­cess for its Phase III study of the oral mi­graine drug las­mid­i­tan. In­ves­ti­ga­tors say that the drug scored on the pri­ma­ry as well as key sec­ondary end­points in their late-stage study. The pri­ma­ry end­point tracked pa­tients’ ex­pe­ri­ence in the two hours af­ter tak­ing the drug, with the 100 mg and 200 mg dos­ing arms be­ing pain free at rough­ly twice the 15% place­bo re­sponse rate. About a third of all the pa­tients, though, were washed out af­ter fail­ing to qual­i­fy for the mod­i­fied ITT group.

Sage Ther­a­peu­tics $SAGE has picked up the FDA’s break­through drug des­ig­na­tion for Sage-547 as an ex­per­i­men­tal ther­a­py for post­par­tum de­pres­sion. The Cam­bridge, MA-based biotech re­cent­ly tout­ed da­ta from a very small study in­di­cat­ing that its drug had a ma­jor im­pact on PPD. The BTD des­ig­na­tion should pro­vide ready ac­cess to reg­u­la­tors who can help hur­ry along its de­vel­op­ment.

Shares of Berke­ley, CA-based Dy­navax were roast­ed ahead of the La­bor Day week­end, af­ter the biotech put out word that the FDA had can­celled its No­vem­ber pan­el re­view for Hep­lisav-B, a new he­pati­tis B vac­cine. Its stock plunged 30%. The com­pa­ny’s state­ment in­clud­ed this: “The FDA al­so con­firmed to Dy­navax that it will re­view the over­all im­muno­genic­i­ty da­ta from HBV-23, the com­pa­ny’s most re­cent piv­otal Phase 3 tri­al, to sup­port the pro­posed in­di­ca­tion for adults 18 years of age and over. How­ev­er, the Agency has de­cid­ed it will not re­view im­muno­genic­i­ty da­ta re­lat­ed to sub-pop­u­la­tions in­clud­ing re­sults in in­di­vid­u­als with di­a­betes be­cause these da­ta were not a di­rect re­sponse to the FDA’s Feb­ru­ary 22, 2013 Com­plete Re­sponse Let­ter and there­fore fell out­side of the re­view time al­lo­cat­ed to a Class 2 re­sub­mis­sion. Thus, it was sug­gest­ed the da­ta should be sub­mit­ted as a sup­ple­men­tal BLA fol­low­ing ap­proval.”

Hori­zon Dis­cov­ery in Cam­bridge, UK will put its CRISPR tech to work in a dis­cov­ery pro­gram with Ful­crum Ther­a­peu­tics. They’ll be hunt­ing for new ways to treat ge­net­ic dis­eases.

It’s No­vo’s turn to take a back seat at the FDA. Af­ter de­lay­ing a GLP-1/in­sulin com­bo from the Sanofi-Zealand team last month, the agency is now de­lay­ing its fi­nal de­ci­sion on No­vo’s ri­val prod­uct Xul­to­phy (IdegLi­ra) by three months. A de­ci­sion is now ex­pect­ed in De­cem­ber. These prod­ucts are wide­ly ex­pect­ed to earn bil­lions once they make it to the mar­ket, but the FDA has a well-known track record on tak­ing its time on new di­a­betes ther­a­pies in­tend­ed for mass mar­kets.

From left to right: Lilian Kim, Associate Director Business Development; John Moller, CEO; Yooni Kim, Executive Director, Asia Operations; Michelle Park, Director South Korea Operations.

Novotech CRO sees 26% growth in Asia tri­al ac­tiv­i­ty from biotechs, but still plen­ty of ca­pac­i­ty

As the Asia-Pacific clinical trials sector continues to grow rapidly, Novotech the Asia-Pacific-based CRO is seeing biotech clinical activity up by 26%. But says there is still plenty of capacity in the region that features advanced medical facilities, supportive regulatory environments, and more than 2.3 billion people, largely treatment naïve, living in urban areas.

China, South Korea and Australia have the most studies registered as recruiting or about to recruit according to ClinicalTrials.Gov.

Pfizer, South San Francisco — Jeff Rumans for Endpoints News

UP­DAT­ED: Pfiz­er takes aim at a flag­ship fran­chise at Sanofi and Re­gen­eron — and scores a few di­rect hits

Count Pfizer in as a top player in the blockbuster game of JAK1 inhibitors.

Over the weekend the pharma giant posted some stellar Phase III efficacy data for their heavyweight contender abrocitinib in atopic dermatitis (eczema) that lines up ahead of a booming Dupixent (dupilumab), a blockbuster in the portfolios of Regeneron and Sanofi. And they put some real distance ahead of Eli Lilly’s trailing Olumiant, which made a delayed initial arrival on the market for rheumatoid arthritis after the FDA hobbled it with some additional hurdles on safety concerns.

JADE-MONO-1 scores well for Pfizer, teeing up what will be an intensely followed breakdown of the JADE MONO-2 data, which the pharma giant recently top-lined as “similar” to the first Phase III when tested against a placebo — a control group that has been easily outclassed by all the drugs in this market niche.

As of now, Pfizer looks to be equipped to run into the review stage — advantaged by a breakthrough therapy designation that is intended to speed up the regulatory process.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 62,000+ biopharma pros reading Endpoints daily — and it's free.

A preda­tor's world? Top an­a­lyst sees the 'haves' and the 'haven't­s' di­verge as biotech bub­bles form — and col­lapse

Josh Schimmer

We’ve all seen the deluge of cash that’s been pouring into biotech from every angle: VCs, IPOs and follow-ons have generated billions in capital for new and emerging drug developers with ready access to some powerful new tech. But Evercore ISI’s Josh Schimmer is asking where we’re headed from here.

His answer is neither apocalyptic nor universally blissful, but if he’s right — and this is a discussion we’re hearing much, much more about at a time of growing economic and industry uncertainty — we may well be at a crossroads that could affect valuations, M&A and the entire global industry that has formed over the past 5 years.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 62,000+ biopharma pros reading Endpoints daily — and it's free.

US mulls tar­iffs on Swiss drug ex­ports, weigh­ing on No­var­tis and Roche –  re­port

The leading Swiss newspaper has reported that the US is considering placing tariffs on pharmaceuticals from Switzerland. Roche and Novartis stock each fell 1% after the news broke.

Neue Zürcher Zeitung reported that US Trade Representative Robert Lighthizer told pharmaceutical representatives the Trump administration was considering the move. Tariffs do not appear to be in the immediate offing, but they would potentially affect Swiss giants Novartis and Roche along with other companies that manufacture in Switzerland, including Merck KGaA and US biotech Biogen, which is currently constructing a new facility in the country.

Neil Kumar, Endpoints

Bridge­Bio drops bid to re­claim Ei­dos af­ter di­rec­tors spurn 3 of­fers

A couple of months ago a newly public BridgeBio turned some heads by disclosing that it had made a bid for subsidiary Eidos Therapeutics in hopes of gobbling up the 34% stake that it doesn’t already own. Two offers later, the parties are calling it off.

A special committee of independent directors at the smaller biotech led by RA Capital’s Rajeev Shah and ex-Portola CEO William Lis first rejected the parent company’s initial offer — which would swap 1.3 BridgeBio shares for each Eidos share — on September 12. In the latest announcement, BridgeBio revealed that it eventually raised the offer to 1.5 shares and made $110 million available for all-cash or mixed consideration options, but Eidos still wasn’t interested.

Mark Foley, Revance

HR vi­o­la­tion push­es Re­vance co-founder out, vault­ing for­mer Zel­tiq chief to the helm

Months after Revance amended the terms of its Botox biosimilar collaboration with Mylan, the Newark, California-based drug developer disclosed its co-founder Dan Browne is stepping down, in what appears to be mysterious circumstances.

The company — which is also developing a rival to Allergan’s formidable Botox franchise — on Monday said Browne is departing “due to misjudgment in handling an employee matter,” that has also culminated in his resignation from Revance’s board of directors.

In-house FDA re­view flags a sus­pi­cious im­bal­ance in deaths as Sh­iono­gi hunts an OK for an­tibi­ot­ic

Shionogi has some big questions to answer if they plan to win an FDA panel’s backing for their new antibiotic.

While investigators have provided positive efficacy data for their new product to treat cases of complex urinary tract infections, an FDA review has flagged an imbalance of deaths between the antibiotic and a control arm. And they want the agency’s outside advisers to take a good hard look at that when they meet on Wednesday.

Cell ther­a­py start­up rais­es $16 mil­lion to fund its quest for the Holy Grail in re­gen­er­a­tive med­i­cine

In 2006, Shinya Yamanaka shook stem cell research with his discovery that mature cells can be converted into stem cells, relieving a longstanding political-ethical blockage and throwing open medical research on everything from curbing eye degeneration to organ printing.

But that process still has pitfalls, including in risk and scalability, and some researchers are exploring another way first hinted at years ago: new technology to convert mature cells directly into other mature cells without the complex and time-consuming process of first making them into stem cells.

Eye­ing $86M, Galera leads a pack of three mod­est biotech IPOs push­ing past high pro­file stum­bles

Exactly one year after kicking off a pivotal Phase III study for its lead drug — a companion for cancer patients receiving radiotherapy — Galera is looking to the Nasdaq for some new cash to complete the clinical work and fuel its commercial drive.

CEO Mel Sorensen has penciled in an $86 million ask, which was filed on the same day as liver disease company 89bio and rare disease diagnostics shop Centogene. The trio marks the first batch of IPO filings in the wake of two highly anticipated but ultimately disappointing public debuts by BioNTech and Vir, signaling dwindling biotech fervor on Wall Street. 89bio and Centogene are seeking $70 million and $69 million, respectively.