Stock flies high on Clear­side’s PhI­II mac­u­lar ede­ma tri­al re­sults as drug im­proves vi­sion

The stock is soar­ing at Clear­side Bio­med­ical $CLSD, a Geor­gia-based bio­phar­ma de­vel­op­ing eye drugs that tack­le blind­ness, fol­low­ing news that one of its treat­ment im­proved vi­sion in pa­tients.

The re­sults are from a Phase III tri­al test­ing the treat­ment against mac­u­lar ede­ma as­so­ci­at­ed with in­flam­ma­tion of a part of the eye known as uveitis. Mac­u­lar ede­ma is the buildup of flu­id in the part of the eye known as mac­u­la, re­sult­ing in dis­tort­ed vi­sion.

Rahul Khu­rana

“Typ­i­cal­ly, uveitic mac­u­lar ede­ma may per­sist de­spite ad­e­quate con­trol of uveitis it­self, and it is chal­leng­ing to treat and may per­sist de­spite mul­ti­ple in­ter­ven­tions,” said Rahul Khu­rana, an in­ves­ti­ga­tor, in a state­ment.

Clear­side’s prod­uct is called supra­choroidal CLS-TA, which is cor­ti­cos­teroid tri­am­ci­nolone ace­tonide for­mu­lat­ed for ad­min­is­tra­tion to the back of the eye.

The com­pa­ny said 47 per­cent of pa­tients be­ing ad­min­is­tered its treat­ment could see at least 15 let­ters, com­pared to 16 per­cent for pa­tients who un­der­went a place­bo pro­ce­dure.

The ran­dom­ized, con­trolled, and masked tri­al in­volv­ing 160 pa­tients met both its pri­ma­ry and sec­ondary end­points.

“While cor­ti­cos­teroids are the most com­mon treat­ment for all com­pli­ca­tions of uveitis, in­clud­ing the as­so­ci­at­ed mac­u­lar ede­ma, sys­tem­at­ic con­trolled stud­ies of this kind are rare,” Khu­rana said. “I be­lieve that based on these pos­i­tive re­sults, and if mar­ket­ing au­tho­riza­tion is ob­tained from the FDA, supra­choroidal CLS-TA has the po­ten­tial to be­come a new par­a­digm for the treat­ment of vi­su­al im­pair­ment as­so­ci­at­ed with mac­u­lar ede­ma as­so­ci­at­ed with non-in­fec­tious uveitis.”

The com­pa­ny plans to sub­mit an NDA for the treat­ment dur­ing the fourth quar­ter of this year. It’s al­so “eval­u­at­ing a num­ber of op­tions” for sub­mis­sions to reg­u­la­to­ry agen­cies out­side the US.

Clear­side’s stock is up 66% in pre-mar­ket trad­ing. As of press time, shares were sell­ing at $13 per share, up from yes­ter­day’s mar­ket close of $7.82.

Mi­no­ryx and Sper­o­genix ink an ex­clu­sive li­cense agree­ment to de­vel­op and com­mer­cial­ize lerigli­ta­zone in Chi­na

September 23, 2020 – Hong Kong, Beijing, Shanghai (China) and Mataró, Barcelona (Spain)  

Minoryx will receive an upfront and milestone payments of up to $78 million, as well as double digit royalties on annual net sales 

Sperogenix will receive exclusive rights to develop and commercialize leriglitazone for the treatment of X-linked adrenoleukodystrophy (X-ALD), a rare life-threatening neurological condition

FDA chief Stephen Hahn on Capitol Hill earlier this week (Getty Images)

As FDA buck­les un­der the strain of a pan­dem­ic work­load, Trump again ac­cus­es the agency of a po­lit­i­cal hit job

Peter Marks appeared before a virtual SVB Leerink audience yesterday and said that his staff at FDA’s CBER is on the verge of working around the clock. Manufacturing inspections, policy work and sponsor communications have all been pushed down the to-do list so that they can be responsive to Covid-related interactions. And the agency’s objective right now? “To save as many lives as we can,” Marks said, likening the mortality on the current outbreak as equivalent to “a nuclear bomb on a small city.”

Daniel O'Day, Gilead CEO (Kevin Dietsch/UPI/Bloomberg via Getty Images)

Play-by-play of Gilead­'s $21B Im­munomedics buy­out de­tails a fren­zied push — and mints a new biotech bil­lion­aire

Immunomedics had not really been looking for a buyout when the year began. Excited by its BLA for Trodelvy, submitted to the FDA in late 2019, executive chairman Behzad Aghazadeh started off looking for potential licensing deals and zeroed in on four potential partners, including Gilead, following January’s JP Morgan Healthcare Conference in San Francisco. Such talks advanced throughout the year, with discussions advancing to the second round in mid-August.

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President Donald Trump reacts after signing an executive order following his remarks on his healthcare policies yesterday in Charlotte, North Carolina (Getty Images)

Op-ed: Will phar­ma re­al­ly pay for Trump’s lat­est law­less promise to 33 mil­lion Medicare ben­e­fi­cia­ries? Not like­ly

Sitting atop the executive branch, President Donald Trump is the ultimate authority at the FDA. He can fast track any vaccine to approval himself. If it came to that, of course.

What he can’t do is unilaterally order the legislative branch to loosen the Treasury’s coffers for $6.6 billion. Nor can he command pharmaceutical companies to pay for $200 vouchers sent to 33 million Medicare beneficiaries for prescription drugs before the election.

President Donald Trump and FDA Commissioner Stephen Hahn (AP Images)

FDA is­sues fi­nal rule al­low­ing im­por­ta­tion of drugs from Cana­da — but al­so keeps the pow­er to re­voke it

Just over a month away from the presidential election, the FDA has issued a final regulation fulfilling President Trump’s promise to let states import certain prescription drugs from Canada.

On Thursday, Trump told a crowd in North Carolina that the new rule goes into effect “today.” But the published regulation states that it won’t take effect for 60 days. And even then, it could be a while before cheaper drugs make it across the border.

The win­dow is wide open as four more biotechs join the go-go IPO class of 2020

It’s another day of hauling cash in the biopharma world as four more IPOs priced Friday and a fifth filed its initial paperwork.

The biggest offering comes from PMV Pharma, an oncology biotech focusing on p53 mutations, which raised $211.8 million after pricing shares at $18 apiece. Prelude Therapeutics, developing PRMT5 inhibitors for rare cancers, was next with a $158 million raise, pricing shares at $19 each. Graybug Vision raised $90 million after pricing at $16 per share for its wet AMD candidates, and breast cancer biotech Greenwich Lifesciences brought up the rear with a small, $7 million raise after pricing shares at $5.75.

J&J of­fers PhI/IIa da­ta show­ing its sin­gle-dose vac­cine can stir up suf­fi­cient im­mune re­sponse

Days after J&J dosed the first participants of its Phase III ENSEMBLE trial, the pharma giant has detailed the early-stage data that gave them confidence in a single-dose regimen.

Testing two dose levels either as a single dose or in a two-dose schedule spaced by 56 days in, the scientists from Janssen, the J&J subsidiary developing its vaccine, reported that the low dose induced a similar immune response as the high dose. The interim Phase I/IIa results were posted in a preprint on medRxiv.

Pal­la­dio bags $20 mil­lion Se­ries B to top­ple a prob­lem­at­ic kid­ney dis­ease drug

Palladio Biosciences just took one step further in its quest to topple Otsuka’s Samsca with its own — it hopes safer — autosomal dominant polycystic kidney disease (ADPKD) drug.

The Pennsylvania-based biotech announced a $20 million Series B on Friday, which will fund a 10-person Phase III trial of its vasopressin V2 receptor agonist, lixivaptan. CEO Alex Martin expects to read out data in the first half of next year, then launch straight into a larger pivotal Phase III study with about 1,200 participants.

New York governor Andrew Cuomo (AP Images)

An­drew Cuo­mo says New York will un­der­take its own vac­cine re­view process, and wouldn’t rec­om­mend trust­ing the fed­er­al gov­ern­ment

The concerns keep mounting over President Donald Trump’s politicization of the FDA and other federal agencies guiding the development of a safe and effective vaccine. And today, the telegenic New York governor Andrew Cuomo appeared to introduce even more politics into the matter — latest in an ongoing series of incidents that have cast the proudly independent FDA in starkly political terms.

During his daily press conference Cuomo said that the state will review any coronavirus vaccines approved by the federal government, citing a lack of trust in the Trump administration. The announcement comes one day after Trump accused the FDA of making an “extremely political” move in proposing stricter vaccine guidance.