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Thursday, October 10, 2019

ProQR’s sepofarsen shows positive action in Phase 1/2 study in LCA10

ProQR Therapeutics (NASDAQ:PRQR) announces positive topline results from a Phase 1/2 clinical trial evaluating sepofarsen (QR-110) in patients with Leber congenital amaurosis type 10 (LCA10) due to a certain mutation in the CEP290 gene.
The target dose (80 µg with a 160 µg loading dose) was associated with a clinically meaningful and statistically significant improvement in vision with a favorable benefit/risk profile. Durable improvements in vision were observed after six months of treatment.
A Phase 2/3 trial is in process.
Management will host a conference call this morning at 8:00 ET to discuss the results.
Shares are up 7% premarket on light volume.
https://seekingalpha.com/news/3504920-proqrs-sepofarsen-shows-positive-action-phase-1-2-study-lca10

Mednax to sell MedData business to Frazier Healthcare

Mednax (NYSE:MD) has entered into a definitive agreement wit Frazier Healthcare Partners under which the company will sell its MedData business to Frazier.
Under the terms of the purchase agreement, MD will receive cash consideration of ~$250M at closing, as well as economic consideration of up to $50M contingent upon short and long-term performance of MedData.
MEDNAX also anticipates certain cash tax benefits from the transaction in the coming quarters.
Net proceeds from the sale will be used for debt repayment, share repurchases and strategic acquisitions.
The transaction is expected to close during Q4 2019.
https://seekingalpha.com/news/3504932-mednax-sell-meddata-business-frazier-healthcare

Emergent Bio gets PRIME designation for chikungunya virus VLP vaccine candidate

The Committee for Medicinal Products for Human Use (CHMP) of the EMA grants Emergent BioSolutions’ (NYSE:EBS) chikungunya virus (CHIKV) virus-like particle (VLP) vaccine candidate, CHIKV VLP, PRIority MEdicines, or PRIME, designation.
PRIME Designation allows for frequent and early interactions with the EMA aimed at supporting accelerated evaluation and approval.
The company expects to initiate a pivotal trial in 2020.
https://seekingalpha.com/news/3504938-emergent-bio-receives-prime-designation-chikungunya-virus-vlp-vaccine-candidate

Alexion teams up with Stealth Bio to advance elamipretide

Alexion Pharmaceuticals (NASDAQ:ALXN) inks an agreement with Stealth BioTherapeutics (NASDAQ:MITO) securing an option to co-develop and commercialize elamipretide for mitochondrial diseases.
Elamipretide, an inner mitochondrial membrane-targeting therapeutic, is currently in Phase 3 development for an inherited disorder called primary mitochondrial myopathy (PMM) characterized by skeletal muscle weakness, chronic fatigue and exercise intolerance. Alexion will have an opportunity to exercise its option based on results from this study.
Under the terms of the agreement, if Alexion exercises its option, the parties will co-develop elamipretide in the U.S. for PMM, Barth syndrome (enlarged & weakened heart) and Leber hereditary optic neuropathy (inherited vision loss). If approved, the companies will co-promote on an equal basis in the U.S. Alexion will have exclusive development and commercialization rights ex-U.S.
Alexion will pay Stealth $30M upfront, including an option fee, an equity investment and development funding. If it exercises its option, it will make additional payments, including an option exercise fee, an additional equity investment, development funding and milestones.
Stealth will host a conference call this morning at 8:30 am ET to discuss the deal.
https://seekingalpha.com/news/3504950-alexion-teams-stealth-bio-advance-elamipretide

Premarket analyst action, Oct. 10

Mereo Biopharma (NASDAQ:MREO) initiated with Outperform rating and $8 (177% upside) price target at SVB Leerink.
BioCardia (OTCQB:BCDA) initiated with Buy rating and $9 (169% upside) price target at Maxim Group.
AIM ImmunoTech (NYSEMKT:AIM) upgraded to Buy with a $2 (251% upside) price target at Maxim. Shares up 14% premarket.
The Medicines Company (NASDAQ:MDCO) downgraded to Hold with a $50 (3% downside risk) price target at Jefferies. Shares down 3% premarket.
UnitedHealth Group (NYSE:UNH) downgraded to Hold with a $235 (6% upside) price target at Jefferies. Shares down 1% premarket.
https://seekingalpha.com/news/3504968-jefferies-softens-view-unitedhealth-premarket-analyst-action

Reata reacquires rights to bardoxolone from AbbVie

Reata Pharmaceuticals (NASDAQ:RETA) has reacquired development and commercialization rights to its Nrf2 activator product platform from licensee AbbVie (NYSE:ABBV). Specifically, it owns exclusive global rights bardoxolone methyl, omaveloxolone and all other next-generation Nrf2 activators, excluding certain markets in Asia for bardoxolone which are licensed to Kyowa Kirin Co., Ltd.
Under the terms of the deal, Reata will pay AbbVie $330M in cash, consisting of $75M upfront and the remainder in Q2 2020 and Q4 2021. AbbVie will also receive tiered low single-digit royalties from worldwide sales of omaveloxolone and certain other next-gen Nrf2 activators (bardoxolone excluded).
The companies inked their original license agreement in September 2010.
Reata has amended its loan and security agreement with Oxford Finance LLC and Silicon Valley Bank, freeing up $75M contingent on positive results from either the CARDINAL study of bardoxolone in Alport syndrome or MOXIe study of omaveloxolone in Friedreich’s ataxia. The total loan facility has been increased to $155M (from $125M).
https://seekingalpha.com/news/3504928-reata-reacquires-rights-bardoxolone-abbvie

Wednesday, October 9, 2019

Mitch McConnell meets Cal. pot execs, pitched cannabis banking reform need

Senate Majority Leader Mitch McConnell, a longtime opponent of reforming marijuana laws, is spending more time than usual thinking about cannabis on a trip to California this week.
McConnell is attending at least two days’ worth of meetings with cannabis industry executives, small-business owners and advocates in Southern California, in order to discuss potential cannabis-related banking reform, among other topics, according to people familiar with the matter. McConnell’s schedule includes two cannabis-related lunches with executives and advocates, one of which will take place in Newport Beach, Calif., and a tour of at least one cannabis-related company in the area.
It was not immediately clear whether McConnell’s California Wednesday and Thursday schedule signals a shift in his thinking about cannabis banking reform, the people said. McConnell’s Washington office did not respond to several requests for comment.

“I think this is absolutely positive that McConnell is meeting with stakeholders in the cannabis market,” PI Financial analyst Jason Zandberg told MarketWatch over the phone. “The U.S. market needs the banking act to flourish, without it — there are legitimate companies that are following the rules that are facing major obstacles. Banking legislation would be a huge positive catalyst.”
The cannabis industry representatives will attempt to convince McConnell that reform is necessary because the current legal regime unfairly penalizes businesses that obey federal laws, such as hemp farmers producing the crop for legal CBD products, according to a person familiar with the lobbying strategy.
“We’re happy to see that Leader McConnell is coming to see how a regulated market is an improvement over prohibition,” National Cannabis Industry Association executive director Aaron Smith told MarketWatch in an interview. “Right now the priority is banking, which affects [McConnell’s] constituents in the hemp and CBD industry, as well as legal cannabis businesses here in California. That’s really our primary ask — common-sense policies around banking and public safety, and we’re hopeful [McConnell] will see the need for that and move forward along with Chairman [Sen. Mike] Crapo.”
The senator’s visit to the Golden State comes weeks after the Democratic-controlled House of Representatives passed the Secure and Fair Enforcement (SAFE) Banking Act, a bill aimed at giving banks and credit unions additional clarity around servicing cannabis companies that wish to open accounts for things like paying bills. Because marijuana is illegal at the federal level, financial institutions can encounter legal problems, and cannabis companies — including those that operate cannabidiol, or CBD, businesses — face difficulties banking.
Large amounts of cash sloshing around the cannabis sector makes pot companies the target of robberies and other crimes, lobbyists in favor of the SAFE Act have said.
Up until recently, McConnell appeared to be a major roadblock to the Senate taking up the bill, and has said in the past that marijuana is hemp’s “illicit cousin, which I choose not to embrace.” The hemp industry holds a significant amount of power in Kentucky, McConnell’s home state, and a new provision in the SAFE Act grants specific protections to hemp farmers.

Crapo, an influential Republican senator from Idaho, told Politico in September that he wanted to hold a Senate Banking Committee vote on a cannabis banking bill. Progressive groups such as the American Civil Liberties Union, the Center for American Progress and others have criticized top House Democrats for moving forward with a bill that doesn’t address social-justice issues tied to decades of cannabis prohibition.
ETFMG Alternative Harvest ETF MJ, -0.95%  , which tracks a basket of cannabis stocks, has lost nearly half its value in the past 12 months, while the broad S&P 500 index SPX, +0.91%   has gained 1.6%.
https://www.marketwatch.com/story/mitch-mcconnell-travels-to-california-where-pot-execs-pitch-need-for-cannabis-banking-reform-2019-10-09?siteid=rss&rss=1