Dicer­na shares rock­et up on a $15M-plus-stock deal to set­tle Al­ny­lam claims — will deals fol­low?

Shares of Dicer­na soared more than 30% Fri­day af­ter­noon af­ter the biotech an­nounced that it had set­tled a nasty law­suit with ri­val Al­ny­lam over their IP.

Dicer­na, which had coun­ter­sued in an ag­gres­sive ef­fort to wres­tle free by ac­cus­ing Al­ny­lam of push­ing a mo­nop­oly, is pay­ing a mod­est $2 mil­lion up­front, $13 mil­lion over 4 years and hand­ing over 938,208 shares to its ri­val — which are now worth over $13 a share. That gives Dicer­na a mar­ket cap clos­ing in on $700 mil­lion.

Ac­cord­ing to Al­ny­lam, Dicer­na $DR­NA had im­prop­er­ly swept up tech Al­ny­lam had paid for, hir­ing a group of sci­en­tists oust­ed from Mer­ck af­ter the phar­ma gi­ant had de­cid­ed to shut their RNAi work down and of­fload the as­sets — to Al­ny­lam. Af­ter a long se­ries of le­gal moves, the case was sup­posed to move for­ward to a tri­al around now.

About a year ago Dicer­na was able to raise a cru­cial $70 mil­lion from a syn­di­cate led by Adam Kop­pel at Bain. The fi­nanc­ing of­fered a con­sid­er­able amount of breath­ing room for Dicer­na as it fought with Al­ny­lam. Ac­cord­ing to Sun­Trust an­a­lyst Ed­ward Nash, Dicer­na ev­i­dent­ly watched as three po­ten­tial part­ners walked away due to the lit­i­ga­tion. And he be­lieves it won’t be long now un­til a deal is signed.

We be­lieve the set­tle­ment re­moves a sig­nif­i­cant over­hang on shares of DR­NA and be­lieve as a re­sult it will not take long for Dicer­na to an­nounce part­ner­ships.

The crux of Dicer­na’s counter-claims spot­light­ed some com­pelling anec­dotes about how eas­i­ly re­search leaked out of Mer­ck af­ter the com­pa­ny de­cid­ed to punt their R&D flop. Dicer­na is claim­ing that Mer­ck ex­ec­u­tives prac­ti­cal­ly did every­thing but help car­ry suit­cas­es loaded with re­search out the door as they helped line up new jobs for the de­part­ing staffers. And their case de­tails nu­mer­ous in­stances of just how help­ful they could be.

Dicer­na’s lawyers ar­gued that un­der the law, if a com­pa­ny doesn’t pro­tect its se­crets, they can’t call them se­crets.

“We are pleased that this long­stand­ing is­sue has been set­tled and be­hind us,” said Dicer­na CEO Doug Fam­brough in a state­ment. “We are pleased to be able to con­cen­trate our ef­forts on de­liv­er­ing bet­ter med­i­cines and treat­ments to pa­tients. We look for­ward to run­ning our busi­ness. The lit­i­ga­tion which has been a pri­or fo­cus of our com­pa­ny is now be­hind us.”

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

CDC’s Robert Redford, NIAID’s Anthony Fauci, Admiral Brett Giroir at HHS, and FDA’s Stephen Hahn prepare to testify at a House hearing on June 23 (Getty)

'Ex­treme­ly po­lit­i­cal' — Trump neuters FDA's at­tempt to strength­en vac­cine EUA, ques­tions need to length­en process

Stephen Hahn went before a Senate committee Wednesday and declared he’s fighting. “Every one of the decisions we have reached has been made by career FDA scientists based on science and data, not politics,” he exclaimed, adding that “FDA will not permit any pressure from anyone to change that. I will fight for science.”

A few hours later, he was undermined by President Donald Trump when a reporter asked if he was okay with stricter vaccine guidelines that the FDA was said to be cooking up. “That has to be approved by the White House. We may or may not approve it. That sounds like a political move,” he decided.

Vas Narasimhan (AP Images)

UP­DAT­ED: Still held down by clin­i­cal hold, No­var­tis' Zol­gens­ma falls fur­ther be­hind Bio­gen and Roche as FDA asks for a new piv­otal study

Last October, the FDA slowed down Novartis’ quest to extend its gene therapy to older spinal muscular atrophy patients by slapping a partial hold on intrathecal administration. Almost a year later, the hold is still there, and regulators are adding another hurdle required for regulatory submission: a new pivotal confirmatory study.

The new requirement — which departs significantly from Novartis’ prior expectations — will likely stretch the path to registration beyond 2021, when analysts were expecting a BLA submission. That could mean more time for Biogen to reap Spinraza revenues and Roche to ramp up sales of Evrysdi in the absence of a rival.

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David Berry (Flagship)

Flag­ship's next big tech­no­log­i­cal bet? The cloud

Earlier this month, Flagship announced their big bet on the software half the industry is talking about, launching the AI and machine learning startup. Now, they and a couple other investors are gambling $100 million on a software that much of the public generally thinks of as a cool, IT afterthought: cloud computing.

The idea, says founder and Flagship partner David Berry, is one of scale: The sheer magnitude of biological data that you can store on cloud technology is unprecedented. And that size, when leveraged properly, can allow you to ask questions and form insights that are similarly unprecedented.

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Jim Roberts and Brian Finrow (Lumen Bioscience)

With a $4M fed­er­al grant, Lu­men jumps in­to the Covid-19 treat­ment race

It’s been less than a month since Lumen Bioscience announced a $16 million Series B to engineer spirulina — a nutrient-packed super food — for diseases like traveler’s diarrhea, norovirus and C. difficile colitis. And now, the biotech has pulled in another $4 million to do the same for Covid-19.

The approach is quite similar to other gastrointestinal targets the company is pursuing, co-founders and Brian Finrow and Jim Roberts said. The Seattle-based company is working on a camelid antibody cocktail to combat GI infection common among Covid-19 patients. In a study published in the American Journal of Gastroenterology, a majority of Covid-19 patients showed GI and respiratory symptoms, and 25% had only GI symptoms.

CEO Markus Warmuth (Monte Rosa)

Monte Rosa rakes in $96M Se­ries B as it pre­pares 'mol­e­c­u­lar glue' plat­form for IND-en­abling stud­ies

About four months after completing an extension to its Series A, Monte Rosa Therapeutics is putting its next foot forward with another heap of cash.

The Boston-based biotech is back with $96 million in Series B financing with a goal to get its lead program ready for IND-enabling studies by the end of the year. Though Monte Rosa is keeping its specific target a secret for now, the company has been researching how to utilize its protein degradation technology in breast cancer and non-small cell lung cancer, among other areas.

FDA commissioner Stephen Hahn at the White House (AP Images)

Un­der fire, FDA to is­sue stricter guid­ance for Covid-19 vac­cine EUA this week — re­port

The FDA has been insisting for months that a Covid-19 vaccine had to be at least 50% effective – a measure of transparency meant to shore public trust in the agency and in a vaccine that had been brought forward at record speed and record political pressure. But now, with concerns of a Trump-driven authorization arriving before the election, the agency may be raising the bar.

The FDA is set to release new guidance that would raise safety and efficacy requirements for a vaccine EUA above earlier guidance and above the criteria used for convalescent plasma or hydroxychloroquine, The Washington Post reported. Experts say this significantly lowers the odds of an approval before the election on November 3, which Trump has promised despite vocal concerns from public health officials, and could help shore up public trust in the agency and any eventual vaccine.

Secretary of health and human services Alex Azar speaking in the Rose Garden at the White House (Photo: AFP)

Trump’s HHS claims ab­solute au­thor­i­ty over the FDA, clear­ing path to a vac­cine EUA

The top career staff at the FDA has vowed not to let politics overrule science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped the FDA and other health agencies under his purview of their rule making ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

PhII Alzheimer's fail­ure deals new blow to Roche, AC Im­mune — but the tau hy­poth­e­sis is far from dead

The leading anti-tau antibody has failed its first Phase II testing, casting a shadow on a popular target (just trailing amyloid beta) for Alzheimer’s disease.

Roche and AC Immune are quick to acknowledge disappointment in the topline readout, which suggested that semorinemab did not reduce cognitive decline among patients with early Alzheimer’s disease, who are either just starting to have symptoms or have mild manifestations.

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