Seattle-based Presage Biosciences, which approaches drug development through its microdosing platform, has some new partnerships and cash to come with them.
Presage closed a $13 million financing round Tuesday, aiming to expand its network of clinical trial sites and advance development of its microdosing injection devices. They also closed partnership deals with Merck and Maverick Therapeutics.
The financing included $7 million from new investors, including the LabCorp Venture Fund, Bristol Myers Squibb, and InHarv Partners. An additional $6 million convertible note from Takeda Ventures will convert to equity.
Presage’s big idea centers around what they call Phase 0 testing, which uses microdoses of multiple drugs and combos on patients to gauge their pharmacodynamic effects. Their tech allows researchers to pepper a tumor with multiple therapies while in use by patients, providing a better snapshot of relative activity.
Tuesday’s new research collaborations with Merck and Maverick will utilize Presage’s platform to evaluate new oncology programs in these Phase 0 trials, bringing their total number of partners to five.
KemPharm scored a new approval on Wednesday, and it’s sending their stock soaring.
The Celebration, FL-based biotech notched the FDA OK for Azstarys, a once-daily treatment for ADHD in children aged six and older. Azstarys, formerly dubbed KP415, consists of serdexmethylphenidate, KemPharm’s prodrug of the drug Focalin, co-formulated with an immediate-release version of the product.
Shares of KemPharm $KMPH skyrocketed as much as 90% in early Wednesday trading, settling in at around a 70% increase later in the morning. Azstarys will be commercially available as soon as the second half of this year, and that process will be led by a subsidiary of Gurnet Point Capital.
The approval will also trigger a milestone payment from Gurnet Point Capital to KemPharm, which may total up to $468 million.
ADHD has been a lucrative market for drugmakers, accounting for nearly $18 billion of revenue in 2019, KemPharm said.
The pediatric field has proven tough for competitors, though, with the FDA spurning Supernus’ pitch last November. Regulators cited concerns about an in-house lab used to analyze their experimental drug.
In what could be an early shot in the battle against drugmakers that whiff on confirmatory studies to support accelerated approvals, the FDA ordered Bristol Myers Squibb late last year to give up Opdivo’s approval in SCLC. Now, Merck is next on the firing line — are we seeing the FDA buckling down on post-marketing offenders?
Merck has withdrawn its marketing approval for PD-(L)1 inhibitor Keytruda in metastatic small cell lung cancer as part of what it describes as an “industry-wide evaluation” by the FDA of drugs that do not meet the post-marketing checkpoints on which their accelerated nods were based, the company said Monday.
The global pandemic may have roiled economies, killed hundreds of thousands and throttled entire industries, but the only effect it had on biopharma venture investing was to help turbocharge the field to giddy new heights.
Below you’ll find the new top 100 venture investors in the industry, ranked by the number of deals they were publicly involved in, as tracked by DealForma chief Chris Dokomajilar. The numbers master then calculated the estimated amount of money they put into each deal — divvying up the cash by the number of players — to indicate how they managed their syndicates.
CRLs. 483s. CBER, CDER and RWE. For biopharma professionals, these acronyms command attention because of the fundamental role FDA plays in drug development. Now Endpoints is doubling down on regulatory coverage, and launching a weekly report focusing on developments out of White Oak, with analysis and insight into what it all means.
Coverage will be led by our new senior editor, Zachary Brennan. He joins Endpoints from POLITICO, where he covered pharma. Prior to that he was the managing editor for Regulatory Focus, a news publication from the Regulatory Affairs Professionals Society.
GlaxoSmithKline and Vir Biotechnology were hopeful that one of their partnered antibodies would carve out a win after getting the invite to a major NIH study in hospitalized Covid-19 patients. But just like Eli Lilly, the pair’s drug couldn’t hit the mark, and now they’ll be left to take a hard look at the game plan.
The NIH has shut down enrollment for GSK and Vir’s antibody VIR-7831 in its late-stage ACTIV-3 trial after the drug showed negligible effect in achieving sustained recovery in hospitalized Covid-19 patients, the partners said Wednesday.
A little more than a week after BrainStorm acknowledged that regulators at the FDA had informed them that the biotech needed more data before it could expect to gain an approval for its ALS treatment NurOwn — while still touting a “clear signal” of efficacy and not ruling out an application — the agency has decided to clarify the record in a most unusual statement.
The FDA statement amounts to a straight slap own, offering a different set of efficacy numbers from the company’s public presentation last November and ruling out any chance of statistical significance.
Over the last decade, drugmakers have proven JAK inhibitors can treat a smattering of immune-related diseases ranging from rheumatoid arthritis to Covid-19. Now Eli Lilly has pulled out a new one.
Lilly and its biotech partner Incyte announced Wednesday that their JAK inhibitor baricitinib effectively regrew patients’ hair in a Phase III trial for alopecia areata, an autoimmune condition that can cause sudden, severe and patchy hair loss. Lilly didn’t break down the results from the 546-patient trial, but the primary endpoint was improvement on a standard score for alopecia symptoms.
Soticlestat made it.
Takeda is bringing the drug back into its fold more than four years after first entrusting the team at Ovid with the mid-stage clinical work. For all that — generating what they saw as positive Phase II data in Dravet syndrome and Lennox-Gastaut syndrome — the biotech has been rewarded with $196 million in upfront cash, with another $660 million reserved for regulatory and commercial milestones.
Bob Nelsen’s new, state-of-the-art drug manufacturing initiative is taking shape.
Just 3 months after gathering $800 million of launch money, a dream team board and a plan to shake up a field where he found too many bottlenecks and inefficiencies for the era of Covid-19, Resilience has snapped up a pair of facilities now in line for a retooling.
The company has acquired a 310,000-square-foot plant in Boston from Sanofi along with a 136,000-square-foot plant in Ontario to add to a network which CEO Rahul Singhvi says is just getting started on building his company’s operations up. The Sanofi deal comes with a contract to continue manufacturing one of its drugs.
One of Europe’s most high-profile biopharma investors is getting $540 million to invest in new crossover deals for late-stage companies.
The Paris-based VC says the fresh Sofinnova Crossover Fund raise positions them as the “largest crossover investor in Europe dedicated to late-stage biopharma and medtech investments.”
They got a leg up in France after winning a special “Tibi” designation from the French government, giving them access to a pool of €6 billion that helped them gain an edge with institutional investors. Since they were founded close to 50 years ago, the venture group has backed more than 500 companies and currently has more than €2 billion under management.
Presage在周二前后关闭了一个1300万美元的LION Fience，目的是退出它的三个临床站点网络，并在Jection De上进行销售。他们与merck和maverick thereutics达成了零配件交易。
该基金从new In'vestors,In'cluding The Lab'Corp Ven'ture Fund，Bris tol My'ers Squibb和In'harv Part公司获得了700万美元。从Take da venures开出的一张价值600万美元的假钞将会兑换成Equuity。
Kempharm Kmph Skyrock的股价在周三的交易中上涨了90%，在早上的交易中上涨了70%左右。“Kempharm Kmph Skyrock”的股价在周三的交易中上涨了90%。“Kempharm Kmph Skyrock”的股价在周三的交易中上涨了90%。AZStarys将在今年下半年开始使用，这一过程将由Gurnet Point Capital的一个分支机构领导。
这款产品将从Gurnet Point Capital到Kempharm提供一英里长的支付，最高可达4.68亿美元。